Medical Monitoring & Remote Programming

Some Articles of Interest Before the 4th

2011-07-01T17:14:00.002-05:00

I came across two long investigative articles that I thought could be of interest those in the medical products field. One article is from the National Journal and the other from Pro Publica. Here are the links to the articles with short clips.

Spinal Product Controversy Raises Red Flags on Medical Journals’ Disclosure Policies

Medical journals have long had to wrestle with the possibility that financial bias influences the work they publish, but if the growing controversy over Medtronic's Infuse spinal product is any indication, they may not be doing enough.

Comment: This is an area that should concern everyone in the field of medical devices and device research. I am very aware that companies fund a lot of empirical and academic research much of which is published in peer-reviewed and respected medical journals. On the face of it, nothing wrong with that. When I was a graduate student, some of my research was funded the research and development division of a well-known (non-medical) company. The funding had absolutely no bearing of the design of the research program, the data collected or interpretation of the data. The concern expressed in this article is whether data maybe suppressed or not reported in an unbiased fashion particularly when it comes to reporting data related to the risks. You be the judge.

How the Media Fell for McKinsey's Twisted Health Care Report

Critics of last year’s health care law pounced on what seemed like a damning new survey, but the details were a lot murkier than the headlines.

Comment: This is an interesting article well worth your time to read.

Finally, here's a short article that just came across indicating how rural health may well be the driver behind telemedicine. Here's the link to the article:

Rural Healthcare to Drive the Global Telemedicine Industry

...[C]ountries face various problems in the provision of medical services and health care, including funds, expertise, and resources. To meet this challenge, the governments and private health care providers are making use of existing resources and the benefits of modern technology. Besides, with limited medical expertise and resources, telecommunication services have the potential to provide a solution to some of these problems. As telemedicine has the potential to improve both the quality and the access to health care regardless of the geography; the rural market is driving the incessant growth of the telemedicine market.

Are Electronic Prescription Systems Failing to Trap Errors?

2011-06-30T11:20:00.003-05:00

A Brief Introduction

Before I jump into the topic of electronic prescription systems, I want to make known how I came across the article I am about to post. I am creating a website that includes a substantial portion of the human factors related work I have produced over the years. That website also includes posting articles on the home page related specifically to human factors - and that includes article related to medical errors: a topic of interest to me.

The new human factors website is not yet ready for viewing. I have just created a usable home page. The bulk of the work is to come. I'll post the address when it's reached a usable state.

What's Going on with Electronic Prescription Systems?

Bloomberg news recently reported the results of a study that indicated that prescription errors are as frequent whether handwritten or written through an electronic prescription system. Here is the address of the Bloomberg article:
http://www.bloomberg.com/news/2011-06-29/errors-occur-in-12-of-electronic-drug-prescriptions-matching-handwritten.html

I have not yet had the opportunity to read the study. However, I shall and I'll continue to update this blog on this topic based on what I find.

With respect to the Bloomberg article, this quote caught my eye:

"The most common error was the omission of key information, such as the dose of medicine and how long or how many times a day it should be taken, the researchers said. Other issues included improper abbreviations, conflicting information about how or when to take the drug and clinical errors in the choice or use of the treatment, the researchers said."

I have been a human factors professional for a long time and as I read the quote above my jaw dropped. The errors described in the quote are some of the most fundamental and easily trappable and correctable errors. It seems beyond belief that an electronic prescription system would allow a user to make such errors. In the environments where I have worked, I have designed and installed subsystems to insure that users do not make the kinds of errors as described in the Bloomberg article. When I have a chance to read the report, I'll cover specific errors, their detection and correction. And means to insure that patients are not harmed.

Here's a link to another publication that reported on the same study:

http://www.eurekalert.org/pub_releases/2011-06/bmj-oep062811.php

Hacking Grandpa's ICD: Why do it?

2011-06-28T15:00:00.017-05:00

Background

I am part of another professional discussion group with an interest in Medical Data, System and Device security. One of the topics was whether medical devices are a likely target for cyber-attacks. I made a contribution to the discussion and stated that I believed that although unlikely, I thought that medical devices will eventually be targets of cyber-attacks. But putting data security measures into medical devices is at odds with the directions that the medical device industry wants to take its product lines. The trends are for smaller and less power-hungry devices. Adding data security measures could increase power demands, increase battery sizes and thus increase device size. Nevertheless, I believe that starting the process of putting data security measures into the medical devices has merit.

I received a well-reasoned response that hacking medical devices was highly unlikely and research funding on security measures for medical devices would be money best spent elsewhere. That response started a thought process to develop a threat scenario to address his points.

I reviewed my earlier article on "hacking medical devices," http://medicalremoteprogramming.blogspot.com/2010/04/how-to-hack-grandpas-icd-reprise.html. I revisited the paragraph in my regarding the motivation for hacking a medical device, an extortion scheme.

When I wrote that article, I did not have any particular scheme in mind. It was speculation based more on current trends. Furthermore, I did not other motivations as particularly viable - data theft, not much money or value in stealing someone's implant data or killing a specific person, there are easier ways to do this although it might make a good murder mystery.

I did come up with a scenario, and when I did, it was chilling.

The Threat Scenario

First, as I had previously suggested, the motivation for hacking medical devices would be extortion. The target of the extortion would be the medical device companies. Before getting into the specifics of the extortion scenario requires that you understand some of the technologies and devices involved.

The wireless communications of interest occurs between a "base station" and a wirelessly enabled implanted device as shown in the figure below.

The base station need not be at a permanent location, but could be a mobile device (such as with the Biotronik Home Monitoring system). The base station in turn communicates with a large enterprise server system operated by the medical device company.

The two systems communicate use wireless or radio communication. For example, St. Jude Medical uses the MICS band - a band designed by the FCC for medical devices in the range of 400Mhz. To insure that battery usage for communications is minimal, the maximum effective range between is stated as 3 meters. (However, I have seen a clear connection established at greater 3 meters.)

In general, the implant sends telemetry data collected it has collected to the base station. The base station sends operating parameters to the implant. Changing the operating parameters of the medical device is know as reprogramming the device and define how the implant operates and the way the implant exerts control over the organ to which it is connected.

Device Dialogue of Interest to Hackers

As you probably have guessed, the dialogue of interest to those with criminal intent is the one between the base station and the device. The "trick" is to build a device that looks like a legitimate base station to the medical device. This means that the bogus device will have to authenticate itself with the medical device, transmit and receive signals that the device can interpret. In an earlier article (http://medicalremoteprogramming.blogspot.com/2010/03/how-to-hack-grandpas-icd.html), I discussed an IEEE article (http://uwnews.org/relatedcontent/2008/March/rc_parentID40358_thisID40398.pdf**) where the authors had constructed a device that performed a successful spoofing attack on a wireless Medtronic ICD. So, based on the article, we know it can be done. However, based on the IEEE article, we know that it was done at distance of 5 cm. This was aptly pointed out in a comment on my "How to Hack Grandpa's ICD" article.

Could a Spoofing/Reprogramming Attack be Successful from Greater than 5 cm or Greater than 3 meters?

I believe the answer to the question posed above is "yes." Consider the following lines of reasoning ...

As I had mentioned earlier, I know that base stations and medical devices communicate at distances of 3 meters and can communicates greater distances. The limitation is power. Another limitation is the quality of the antenna in the base station. The communication distance could be increased with improvements in the antenna and received signal amplification.
The spoofing/reprogramming attack device could be constructed to transmit at significantly greater power levels than current base station. (Remember, this is something built by a criminal enterprise. They need not abide by rules set by the FCC.) Furthermore, a limited number, maybe as few as one or two, of these systems need be constructed. I shall explain why later.
A base station can be reverse-engineered. Base stations can be easily obtained by a variety of means. Medical devices can be stolen from hospitals. Documentation about the communication between the medical device and the base station can be obtained.

Thus, I believe the possibility exists that a device that emulates a base station and could successfully perform a spoof/reprogramming attack from a significant distance from the target is possible. The question is, what is to be gained from such an attack?

Attack Motivations

Extortion: Earlier I mentioned that in an other article, I suggested that the motivation would be extortion: money, and lots of it. I think the demands would likely be in the millions of US dollars.

In this scenario, the criminal organization would contact the medical device companies and threaten to attack their medical device patients. The criminal organization might send device designs to substantiate their claims of the ability to injure or kill device patients and/or send the targeted company with news reports sudden unexplained changes in medical devices that have caused injuries or deaths in device patients.

Market Manipulation: Another strategy would be as a means to manipulate the stock prices of medical device companies - through short-selling the stock. In this scenario the criminal organization will create a few base station spoofing/reprogramming systems. Market manipulation such as placing the value of the stock at risk could be a part of the extortion scheme.

Book of Interest: Hacking Wall Street: Attacks And Countermeasures (Volume 2)

In another article I'll discuss how someone might undertake an attack.

** Halperin, D, Heydt-Benjamin, T., Ransford, B., Clark, S., Defend, B., Morgan, W., Fu, K., Kohno, T., Maisel, W. Pacemakers and Implantable Cardiac Defibrillators: Software Radio Attacks and Zero-Power Defenses, IEEE Symposium on Security and Privacy, 2008, pp 1-14.

How to Hack Grandpa's ICD: New Develoments

2011-06-28T13:31:00.000-05:00

A little over a year ago I published a couple of articles in this blog regarding "Hacking Grandpa's ICD." Here are the links:

I receive a bit of flack from some people regarding the unlikelihood of such a thing occurring. I even wrote another article that I never published because I had convinced myself that ICD hacking scenario would be so unlikely.

Well, it suffices to say that I have changed my mind. It seems that McAfee has take this seriously. Here are two articles for your consideration.

After this, I'm publishing the article that I had originally decided not to publish.

HE-75 Topic: Cleaning Up the Mess

2010-08-01T15:24:00.000-05:00

I received a reminder this week of what usability professionals are often called on to do – cleaning up the mess created by a failed process. Somehow, the persons responsible for designing an awful, unusable and in some case, useless user interface expect the usability expert to come in, take one look and create a beautiful user interface. This is absurd! It was the "nightmare" come true - something related to one of my other postings: HE-75 topic: Design first and ask questions later

Writing from my own perspective, there is nothing that a usability professional likes to do less than to correct a failed design that resulted from a failed design process. This week I was asked to save a group of programmers and user interfaced designers from the monstrosities that they had created. What was particularly strange was that the leader of the project thought that I could just redesign something by looking at what they had created. It was bizarre. Unfortunately, I had to deliver several harsh messages regarding the design process and the design, that were not well received. (Nevertheless, that is my job.)

Here is the point I want to make to anyone who reads this. Process and the resulting design should be considered as two sides of the same coin. Good design process nearly always results in a good design. A nonexistent or poor design process leads to a poor design. HE-75's design process can serve as a foundation design process for designing user interface in nearly any industry, particularly in those industries where the harm is particularly severe. Where I am currently working, I plan to use HE-75 as one of the foundation documents to set user interface design standards. And as I mentioned, I am not currently working in the medical or medical device industry. However, I have come to believe that in this industry, the level of harm can be significant. Thus, I shall incorporate HE-75.

Next time, I'll review so of the literature that might be of some use to the community.

Advanced Technology

2010-07-24T19:39:00.001-05:00

I mentioned in an earlier article that I have move out of medical devices for the time being. However, I have moved out of remote monitoring or remote programming (it is called "remote configuration" where I am now.)

We have been given the go ahead to explore a variety of new and what some may consider, off the beaten path technologies. Although I shall not be able to discuss specific studies or approaches, I shall be able to discuss how some technologies not currently used by the medical and medical device communities might be useful to them.

I shall have periodic updates on this topic from time to time.

Here are some platforms to consider for mobile technology. (This is not part of the work that I am doing now. It is more related to my earlier work.)

Useful Verses Usable

2010-07-24T19:16:00.000-05:00

This is a discussion that you are not likely to read in usability texts – the topic of useful verse usability, and the value of each. Just recently I had a discussion with someone on just this topic. Furthermore, I have had numerous discussions with others and each time it surprises me that people often do not know the difference between the two and the value of each.

Useful and Usable

If you go to the dictionary, you will discover that “useful” means “to be of serviceable value, beneficial” and in addition “of practical use.” Pretty straight forward.

On the other hand, the definition of “usable” is “capable of being used” and “convenient and viable for use.” Also a straightforward definition.

However, if you probe more deeply into the definitions, you will note that “useful” is the first, necessary quality of a tool or system. It must be useful or why use it? Usable is a quality of a tool or system. However, it is not primary in relationship with the quality of the being “useful.” It is secondary. Necessary, yes, nevertheless, it is still secondary.

The usefulness as a quality of a tool or system is not addresses in HE-75, or any other usability standard that I have encountered. (If any one knows of a standard where usefulness is addressed, please add a comment to this discussion.) Usefulness is assumed.

However, I have learned that in the real world, the usefulness of any tool or system should not be assumed. It should be tested. Furthermore, with complex systems, the fundamental capabilities of a system or tool are often useful. However, not all of the capabilities of that system may be.

I direct experience with a remote monitoring system where the primary or fundamental capabilities of the system have clear use. However, with each release of this system, as more capabilities are added, the useless capabilities may be on the verge of out numbering the useful ones.

Bottom Line

Usefulness is always more important than usability. If it is not useful, it is fundamentally worthless or at best, excess baggage, and a drag on the actual and perceived quality of the tool or system.
Usefulness should never be assumed. It should be demonstrated. I know of too many projects where usefulness was not demonstrated. This lead to capabilities being developed that waste time and money, and can damage reputations.

Gadgets of the Future

2010-07-18T21:35:00.000-05:00

An interesting and to some degree a light-hearted article about future systems that could monitor us. This was published in the Chicago Tribune.

Here's the link: http://www.blogger.com/post-create.g?blogID=1944904461287889974

HE-75, Usability and When to Prototype and Usability Test: Take 1

2010-07-18T11:56:00.000-05:00

Prototyping and Testing will be a topical area where I shall have much to contribute. Expect numerous articles to appear on this topic.

I had a discussion a few days ago with one of my colleagues who has worked as a user interface designer, but has little knowledge of human factors. He was completely unaware of the concepts of "top-down" and "bottom-up" processes to user interface design. I provide for you the essence of that discussion.

Top-Down Approach

The top-down approach begins with a design. Most often the initial design is a best or educated guess based on some set of principles. Could be aesthetics or "accepted" standards of good design, or something else. The design is usability and/or acceptance tested in some manner. (Anywhere from laboratory testing to field-collected data.) In response to the data, the design reworked. The process is continual. Recent experience has suggested that the top-down approach has become predominant design methodology, particularly for the development of websites.

Top-down is a valid process, particularly for the deployment of new or unique products where the consequences of a failed design do not lead to serious consequences. It can get a design into user hands more quickly. The problem with a top-down approach (when practiced correctly) is that it relies on successive approximations to an ill-defined or unknown target. To some degree it's similar to throwing darts blindfolded with some minimal correction information provided after each throw. The thrower will eventually hit the bull's eyes, but it may take lots and lots of throws.

The top-down approach may have a side benefit in that it can lead to developing novel and innovative designs. Although, it can have the opposite effect when designs are nothing more than "knock-offs" of the designs from others. I have seen both coming out of the top-down approach.

Bottom-Up Approach

HE-75 teaches the use of a bottom-up approach where first one defines and researches the targeted user population. Contextual Inquiry is also a bottom-up approach. Since I have already discussed researching the targeted user population in depth, I'll not cover it here.

With the bottom-up approach, the target is clear and understood. And tailoring a design to the user population(s) should be a relatively straight forward process. Furthermore, the bottom-up approach directly addresses the usefulness issue with hard data and as such, more likely to lead to the development of a system that is not only usable, but useful.

Useful vs. Usable

I'll address this topic more deeply in another article. It suffices to say that usability and usefulness are distinctly different system qualities. A system may be usable, that is, the user interface may require little training and be easy to use, but the system or its capabilities are not useful. Or, and this is what often happens particularly with top-down approaches, much of what the system provides is not useful or extraneous.

Personal Preference

I am a believer in the bottom-up approach. It leads to the development of systems that are both usable and useful sooner than the top-down approach. It is the only approach that I would trust when designing systems where user error is of particular concern. The top-down approach has its place and I have used it myself, and will continue to use it. But, in the end, I believe the bottom-up approach is superior, particularly in the medical field.

HE-75 Touch Screen Recommendations

2010-07-17T20:42:00.000-05:00

I have found HE-75 to be one of the best human factors standards ever produced. However, I have found their analysis and recommendations regarding touch screens lacking, and out of date. To place a perspective on the HE-75 touch screen recommendations ... in the late 1980's and early 1990's, I ran a user interface design and implementation project inside of a larger project at Bell Laboratories. To make a long story short, one of the user interfaces we needed to design and produce was a touch screen interface. The touch screen used a CRT as a display device and it was as flat as we could make it. In addition, the distance between the touch screen surface and the display was about 35 mm. When I read of the issues related to touch screens and the recommendations in HE-75, I experience deja vu and I feel as if I've been transported back to that time.

Some of the most significant advances in user interfaces have been in the areas of display technology and touch screens with respect to hardware and in particular software. Apple Computer has been a leader in combining the advances in both display technology, touch screen design and touch screen interface software. I would have expected the HE-75 committee to have incorporated these advances and innovations in touchscreen software into the standard. However, what I have found appears to me as ossified thinking or ignoring what has transpired.

People in the medical field are using smart phones with their advanced touch screen interfaces in their medical practice. Smart phone touch screens and now the Apple iPad have become the de facto standard in touch screen technology. My previous article related to consistency ... here's a consistency issue. Is it wise to suggest that medical device touch screen interfaces look and operate in a way different from the accepted standard in the field? I know this is not a simple question, but I think it is one that will need to be addressed in future editions of HE-75.

The Return: The Value of Consistency

2010-07-17T17:34:00.000-05:00

I have been distracted for a couple of months ... working to find and land another consulting contract. I have completed that task. However, it is outside of the medical device industry. I am not completely happy with the situation, however, having a position outside of the medical device industry does afford some freedom when commenting on it.

Another reason for the significant gap between my last post and this one has been that I was working on a long and intricate post regarding hacking or hijacking medical device communications. The post began to look more like a short story than a commentary. The more I worked on it, the longer and more convoluted it became. At some point, I may publish portions of it.

This experience with the article that would never end has lead me to change the way I'll be posting articles in the future. In the future, my articles will be short - two to four paragraphs. And will address a single topic. I think that some of my posts have been too long and in some cases, overly intricate. I still plan to cover difficult topics, but in a format that is more readable and succinct.

Consistency in User Interfaces

When it comes to making user interface "usable," the two qualities are 1. Performance and 2. Consistency. Performance is obvious. If the interface is slow, unresponsive, sluggish, etc. people will not use it. Or those who are stuck with using it will scream. Consistency is somewhat less obvious and more difficult to describe. However, when you encounter a user interface that has changed dramatically on an application that you thought that you knew, you understand the value of consistency.

Recently, I encountered a newer version of Microsoft Office. Gone are the pull down menus, the organization of the operations and tools has changed dramatically. Frankly, I hate the new version. If I had encountered the newer version of Office as my first encounter with Office, I know that my reaction would be different. The new version is inconsistent with the older version. My ability to transfer my knowledge about how to use the newer version is being hindered by the dramatic changes that have been made.

Consistency is about providing your users with the capability to reapply their knowledge about how things work to new and updated systems. Operations work the same between applications and between older and newer versions. In the case of the new version of Word, I am grateful that once I have selected a particular operation, such as formatting, it essentially works the same as the older version. However, I have tried to use the newer version of PowerPoint and it's drawing capabilities. I have not yet been successful and am a drawing tool that I know how to use.

Consistency has a side benefit for the development process as well. When operations, layouts, navigation, etc. become standardized, extending the design of a user interface becomes easier, less risky and less likely to be rejected by users. The effect of creating consistent user interfaces is similar to having a common language. More on consistency and HE-75 in a later post.

HE-75 Topic: Design First and Ask Questions Later?

2010-05-04T23:10:00.117-05:00

I was planning on publishing Part 2 of my Medical Implant Issues series. However, something came up that I could not avoid discussing because it perfectly illustrates the issues regarding defining and understanding your user population.

A Story

I live in the South Loop of Chicago - easy walking distance to the central city ("the Loop). I do not drive or park a car on the streets in the city of Chicago. I walk or take public transportation.

One morning I had to run a couple of errands and as I was walking up the street from my home, I saw a man who had parked his car and was staring at the new Chicago Parking Meter machine with dismay. I'll tell you why a little later.

Depending on how closely you follow the news about Chicago, you may or may not know that Chicago recently sold its street parking revenue rights to a private company. The company (that as you might imagine has political connections) has recently started to remove the traditional parking meters (that is, one space, one meter) with new meters. Separate painted parking spaces and their meters have been removed. People park their vehicles in any space on the street where their vehicle fits, go to a centralized meter on the block where they parked and purchase a ticket (or receipt) that is placed on the dashboard of the vehicle. On the ticket is printed the end time wherein the vehicle is legally parked. After the time passes, the vehicle can receive a citation for parking illegally. Many cities have moved to this system. However, this system has something missing that I have seen on other systems.

Here's a photograph of the meter's interface ...

Chicago Street-Parking Meter

I have placed black ellipse around the credit card reader and a black circle around a coin slot. Do you see anything wrong in the photo? ...

Getting back to the man who was staring at the parking meter ... he saw something that was very wrong ... there was no place to enter paper money into to the meter.

I was surprised. This was the first time I had ever taken the time to really look at one of these meters.

As street parking goes, this is expensive. One hour will cost you $2.50. The maximum time that you can park is 3 hours - translated, that's 30 quarters if you had the change. You can use a credit card. However, there are a lot of people in the City of Chicago who don't have credit cards. And this man was one of them, nor did he have 30 quarters.

I have seen machines used other cities and towns, and they have a place for paper money. Oak Park, the suburb immediately west of Chicago, has similar meters and they have a place to use paper money to pay for parking. What gives with this meter?

I take the City of Chicago off the hook for the design of this parking meter. I don't believe they had anything to do with the design of the meter. I have parked in city garages over the years (when I was living in the suburbs), and the city garages have some pretty effective means to enable one to pay for parking - either using cash (paper money) or credit card. But I think they should have been more aware of what the parking meter company was deploying. I think they failed the public in that regard.

I can take the cynical view and suggest that this is a tactic by the private company to extract more revenue for itself and the city through issuing parking citations. However, I think is the more likely that some one designed the system without any regard to the population that was expected to use it and the city fell-down on its responsibility to oversee what the parking company was doing.

Failure to Include a Necessary Feature

For the purposes of examining the value of usability research - that is, the research to understand your users and their environment, what does this incident teach? It teaches that failure to perform the research to understand your user population could result in the failure to include a necessary capability - such as a means to pay for your parking with paper money.

What I find interesting (and plausible) is that this parking meter design could have been usability tested and passed the test. The subjects involved in the usability test could have been provided quarters and credit cards, and under those conditions the subjects would have performed admirably. However, the parking meter fails the deployment test because the assumptions regarding populace, conditions and environment fail to align with reality of the needs of the population it should have been designed to serve.

Another Failure: Including the Unnecessary or Unwanted Features

As I was walking to my destination, I started composing this article. While thinking about what to include in this article, I remembered what a friend of mine said about a system wherein he was in charge of its development. (I have to be careful about how I write this. He's a friend of mine for whom I have great respect. And, defining the set of features that are included in this system is not his responsibility.)

He said that "... we build a system with capabilities that customers neither need nor want." The process for selecting capabilities to include in a product release at this company is an insular process. More echo-chamber than outreach to include customers or users. As a result this company has failed to understand their customers, users, their work environment, etc.

Some might suggest that the requirements gathering process should reduce the likelihood of either failure occurring - failure to include or include unnecessary or unwanted features. Again, I know that in case of my friend's company, requirements-gathering takes its direction largely from competitors instead of customers and/or users. So what often results is the release of a system that fails to include capabilities that customers want and includes capabilities that customers do not want or need.

I don't know about you, but I see the process my friend's company engages in as a colossal waste of money and time. Why would any company use or continue to use such a process?

Ignorance, Stupidity or Arrogance - Or a combination?

I return to the title of this article "Design First and Ask Questions Later?" and the question I pose above. I have seen company after company see design as an end in itself and failing to understand that creating a successful design requires an effective process that includes research and testing. Failure to recognize this costs money and time, and possibly customers. It is not always a good idea to be first in the market with a device or system that includes a trashy user interface.

So why to companies continue to hang on to failing processes? Is it ignorance, stupidity or arrogance? Is it a combination? My personal experience suggests a combination all three factors with the addition of two others: delusion and denial. These are two factors that we saw in operation that lead to the financial crisis of 2008. I think the people will continue to believe that what they're doing is correct up to the point until the whole thing comes crashing down.

The Chicago Parking Meters has a user interface with poor and inconsiderate design ... inconsiderate of those who would use it. (If I get comments from city officials, it will probably be for that last sentence.) However, I don't believe that the parking meter company will face any major consequences such as being forced to redesign and redeploy new meters. They will have gotten away with creating a poor design. And they're not alone. There are lots of poorly designed systems, some of the poor designs can be and have been life threatening. Yet, there are no major consequences. For medical devices and systems, I believe this needs to change and I hope the FDA exerts it's oversight authority to insure that it happens.

Medical Device Design: Reader Suggested Books

One of my readers provided me the following list of books related to usable medical product designs. I pass this list of three books on to you. I do not yet have them in my library but these would be suitable additions.

Medical Design Article: FDA announces Medical Device Home use Initiative

2010-05-04T14:55:00.000-05:00

As I was working on a human factors related article, this article from Medical Design appeared. Here's the link to the article: http://medicaldesign.com/contract-manufacturing/fda-announces-medical-device-home-050310/

I thought that this article is interesting and telling with respect to how the FDA will assert it regulatory authority regarding usability issues. Here are a few quote from the article.

Recognizing that more patients of all ages are being discharged from hospitals to continue their medical treatment at home, the U.S. Food and Drug Administration announced an initiative to ensure that caregivers and patients safely use complex medical devices in the home. (My emphasis.) The initiative will develop guidance for manufacturers that intend to market such devices for home use, provide for post-market surveillance, and put in place other measures to encourage safe use of these products. The FDA is also developing education materials on home use of medical devices.

These home care patients often need medical devices and equipment such as hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators.

HE-75 Topic: Risk Management

2010-05-03T13:08:00.001-05:00

One more HE-75 topic before proceeding into design and design related activities. The topic, risk management.

Reading HE-75, you will note that this document continually discusses risk management and reducing risk. In fact, the entire document is fundamentally about reducing risk, the risks associated with a poor or inappropriate design.

If you drive a car, especially if you have been driving cars for more than a decade or two, you will note that a driving a car with well-designed controls and well-laid out and designed displays seems inherently easier than one that is poorly designed. Furthermore, it has been demonstrated time and again that driving safety increases when a driver has been provided well-designed controls and displays, driving become less risky for everyone concerned.

Car makers now see safety as selling point. (Look at a car that was built in the 40s, 50s or 60s and you'll note how few safety features the car included.) Manufacturers are beginning to include in their luxury models driver-error detection systems. For example, one manufacturer has a system that signals the driver of the existence of an other vehicle the space the driver wants to move to. One of the qualities of a well-designed user interface is the ability to anticipate the user and identify and trap errors or potential user errors, and provide a means or path for preventing or correcting the error without serious consequences. Car manufacturers have been moving in this direction. I suggest that the adoption of HE-75 will be the FDA's way of pushing medical manufacturers in the same direction.

Risk Management: Creating a Good Design and Verifying It

My many blog postings on HE-75 will address the specifics of how to create a good design and verify it, and the process of incorporating these design and verification processes in the a company's risk management processes. In this posting I want to address a two issues at a high level.

First, I want to address "what is a good design and how to do to create it." Creating a good design requires a process such as one outlined by HE-75. I am often amused at hiring managers and HR people who want to see a designer's portfolio having no conception regarding how the design were created. A good design for a user interface is not artistry, it is a result of an effective process. It should not only look good, but it should enable users to perform their tasks effectively and with a minimum of errors. Furthermore, it should anticipate users and trap errors and prevent serious errors occurring. And finally, it should provide users with paths or instructions on how to correct the error. This is what HE-75 teaches in that it instructs researchers and designs And to that end, the design process should reduce risk. Think this is not possible? Then I suggest you spend some time in the cockpit of a commercial airline. It is possible.

Second, HE-75 teaches that design verification should be empirical and practiced often throughout the design process. This is an adjunct to classic risk management that tends to be speculative or theoretical in that it relies on brainstorming and rational analysis. HE-75 teaches that medical device and system manufacturers should not rely just on opinions - although opinions provided by subject-matter experts can provide valuable guidance. HE-75 instructs subjects drawn from the targeted population(s) should be used to guide and test the design at each stage of the process. This becomes the essence of risk management and risk reduction in the design of user interfaces.

Additional Resources

I have this book in my library. It provides some good information, but it's not comprehensive. Unfortunately, it's the only book I know of in this field.

These books I do not owe, but provide you with the links for information purposes. I am surprised at how few books in the field of medical risk management there are. It may go a long ways to explain the large number medical errors, especially the ones that injure or kill patients.

Risk Management Handbook for Health Care Organizations, Student Edition (J-B Public Health/Health Services Text)

Medical Malpractice Risk Management

HE-75 Topic: Meta Analysis

2010-05-01T17:55:00.000-05:00

The definition of a "meta-analysis" is an analysis of analyzes. Meta analyzes are often confused with a literature search, although a literature search is often the first step in a meta-analysis.

A meta-analysis is a consolidation of similar studies on a single, well defined topic. The each study may have covered a variety of topics, but with the meta-analysis, each study will have addressed the common topic in depth and collected data regarding it.

The meta-analysis is a well-respected means of developing broad-based conclusions from a variety of studies. (I have included a book on the topic at the end of this article.) If you search the literature, you will note that meta-analyzes are often found in the medical literature, particularly in relationship to the effectiveness or problems with medications.

In some quarters, the meta-analysis is not always welcome or respected. Human factors (Human engineering) is rooted in experimental psychology, and meta-analyzes are not always respected or well-received in this community. It is work outside of the laboratory. It is not collecting your own data, but using the data collected by others, thus the tendency has been to consider the meta-analysis as lesser.

However, the meta-analysis has a particular strength in that it provides a richer and wider view than a single study with a single population sample. It is true that the studies of others often do not directly address all the issues that researchers could study if those researchers performed that research themselves. In other words, the level and the types of research related controls were employed by the researchers themselves. But, again, the meta-analysis can provide a richness and the numeric depth that a single study cannot provide.

Thus the question is, to use or not to use a meta-analysis when collecting data about a specific population? Should a meta-analysis be used in lieu of collecting empirical data?

Answer. There are no easy answers. Yes, a meta-analysis could be used in lieu of an empirical analysis, but only if there are enough applicable studies recently performed. However, I would suggest that when moving forward with a study of a specific, target population that the first response should be to initiate a literature search and perform some level of a meta-analysis. If the data is not available or is incomplete, then the meta-analysis will not suffice. But, a meta-analysis is always a good first step, and a relatively inexpensive first step, even if the decision is made to go forward with an empirical study. The meta-analysis will aid in the study's design and data analysis. And will act as a guide when drawing conclusions.

Additional Resources

Meta Analysis: A Guide to Calibrating and Combining Statistical Evidence (Wiley Series in Probability and Statistics)

How to Hack Grandpa's ICD, Reprise ...

2010-04-30T21:54:00.000-05:00

Several weeks ago I published an article (How to Hack Grandpa's ICD) discussing another article published in an IEEE journal that described a variety of ways to hack, illicitly manipulate or modify an ICD. To those in the know, this is a potentially greater concern than I had imagined. As it turns out, not surprisingly enough, the concerns about hacking are not limited to ICDs.

One of my readers notified me of a recent article published by the CNN website that discusses concerns regarding the capability to hack ICDs. Here's the link to the article that was published on 16 April 2010. I was also republished in the Communications of the ACM (of which I am a member) on 19 April 2010.

Much of the article appears below Before proceeding, I would like to add a little background about myself and a little bit of commentary regarding hacking. I am a co-founder of data leak security company, Salare Security (http://www.salaresecurity.com). If anyone is interested in what the company does, please do follow the link above. (As of this point, I am a silent partner in the company. My partners are currently running the business.) I mention this because I have some real-world based knowledge regarding system vulnerabilities.

From experience and research I have found that even vulnerabilities that seem unlikely to be exploited, inevitably are exploited. If something can be gained from a target and a vulnerability exists, you can be assured that the vulnerability will be exploited.

For example, specific vulnerabilities that Salare Security addresses months ago were considered unlikely to be exploited because of the lack knowledge and a lack of interest on the part of hackers. However, the vulnerabilities are of significant interest because if exploited, the damage to a government, a company or other organization could be severe. Nevertheless, the thinking in the industry has been that exploitation of the vulnerabilities over the near term were remote.

However, recently, we have received information that the system vulnerabilities that Salare Security addresses have been exploited by a government funded group of hackers. So much for "nothing happening in the near term."

In the case of the vulnerabilities that Salare Security protects ... the hackers were after information. (I do not know the details of the attack so I cannot tell you what information they stole.) But, why might hackers develop systems to exploit medical device vulnerabilities?

My sense is that the hackers most likely are not out to attack, injure or kill people with medical devices. In my estimation, these hackers would be engaged in an extortion scheme against a device manufacturer or manufacturers. This suggestion is based on some of the current trends in criminal activity. (Please see: http://searchsecurity.techtarget.com/news/article/0,289142,sid14_gci1510919,00.html?track=NL-102&ad=763387&asrc=EM_NLN_11442713&uid=6228713) The article references other possible motives for hacking medical devices. I would strongly side with any motivation that opens the door for extracting money from a manufacturer.

Here is the article published by CNN

Scientists work to keep hackers out of implanted medical devices
By John D. Sutter, CNN (4/16/2010)

(CNN) -- Nathanael Paul likes the convenience of the insulin pump that regulates his diabetes. It communicates with other gadgets wirelessly and adjusts his blood sugar levels automatically.
But, a few years ago, the computer scientist started to worry about the security of this setup.
What if someone hacked into that system and sent his blood sugar levels plummeting? Or skyrocketing? Those scenarios could be fatal.

Researchers say it is possible for hackers to access and remotely control medical devices like insulin pumps, pacemakers and cardiac defibrillators, all of which emit wireless signals.
In 2008, a coalition of researchers from the University of Washington, Harvard Medical School and the University of Massachusetts at Amherst wrote that they remotely accessed a common cardiac defibrillator using easy-to-find radio and computer equipment. In a lab, the researchers used their wireless access to steal personal information from the device and to induce fatal heart rhythms by taking control of the system.

This article references the same IEEE article that I referenced in my blog posting.

"Medical devices have provided important health benefits for many patients, but their increasing number, automation, functionality, connectivity and remote-communication capabilities augment their security vulnerabilities," he wrote.

FDA spokeswoman Karen Riley declined to say whether the FDA is looking into new regulations of wireless medical devices; she added that the responsibility for making the devices secure falls primarily on the manufacturer.

"The FDA shares concerns about the security and privacy of medical devices and emphasizes security as a key element of device design," she said.
Wendy Dougherty, spokeswoman for Medtronic Inc., a large maker of implantable medical devices, said the company is willing to work with the FDA to establish "formal device security guidelines."
The company is aware of potential security risks to implanted medical devices, she said. "Safety is an integral part of our design and quality process. We're constantly evolving and improving our technologies."
In a written statement, Dougherty described the risk of someone hacking into a wireless medical device as "extremely low."

Wireless connections

The security concerns stem from the fact that pacemakers, defibrillators and insulin pumps emit wireless signals, somewhat like computers.
These signals vary in range and openness. Researchers who reported hacking into a defibrillator said some in-the-body devices have a wireless range of about 15 feet.

Many devices do not have encrypted signals to ward off attack, the researchers say. Encryption is a type of signal scrambling that is, for example, employed on many home Wi-Fi routers to prevent unknown people from accessing the network.

Motive

There's some question as to why a person would hack into a pacemaker or insulin pump and how the hacker would know a person uses a medical device.
Maisel listed some possible scenarios in his New England Journal article.
"Motivation for such actions might include the acquisition of private information for financial gain or competitive advantage; damage to a device manufacturer's reputation; sabotage by a disgruntled employee, dissatisfied customer or terrorist to inflict financial or personal injury; or simply the satisfaction of the attacker's ego," he wrote.
Denning, from the University of Washington, said the current risk of attack is very low, but that someone could hack into a pacemaker without apparent motive.
She referenced a case from 2008 in which a hacker reportedly tried to induce seizures in epilepsy patients by putting rapidly flashing images on an online forum run by the Epilepsy Foundation.

I emphasized Denning's comments because in my experience those are "famous last words." If there is a way to profit from exploiting a vulnerability, be assured, it will be exploited.

Additional Resources

Hacking For Dummies

Gray Hat Hacking, Second Edition: The Ethical Hacker's Handbook

Hacking Exposed: Network Security Secrets and Solutions, Sixth Edition

Hacking: The Art of Exploitation, 2nd Edition

Hacking Wireless Networks For Dummies (For Dummies (Computer/Tech))

Medical Implant Issues: Part 1, A True Story

2010-04-23T10:00:00.001-05:00

When I started this article, I thought I could place it into a single posting. However, having written just the first section, noted it's length and how much more there was to write. Thus, I decided to turn this into a serialized publication just as I am doing with HE-75. Thus, here is Part 1 ...

Part 1: Background Story

Before I dive into the technical details of this issue, I want to tell a true story from my own experience. It involves a friend of mine. (I need to be vague regarding the person's identity including gender and how I came to know this person. As you read this, you'll understand.)

My friend was incredibly intelligent (e. g., the best applied statistician I have ever known) and physically attractive, and diagnosed as a paranoid schizophrenic. In the early 1990's, my friend underwent back surgery. To my amazement, my friend claimed that the surgeon had placed a "chip," small processor into the person's spinal cord. My friend said that the chip could be activated by people with controls that looked like garage door openers. When activated, the chip would cause my friend to have a sudden, overwhelming desire to have sexual relations with the person who had activated the chip. My friend called this chip a "tutu."

At the time I had been part of the cutting-edge technology community to know that such a chip was absurd. And I told my friend that this chip did not exist. My information was not well received by my friend who was convinced of the reality of this chip.

I tell this story because at the time my friend informed me of the "tutu," the idea of embedding a chip in a human being and activate it using wireless means was patently absurd. Embedding programmable chips with wireless communications less than a decade and a half later is no longer considered absurd, but real. And for some people, frightening with religious overtones. Consider what the Georgia state legislature just passed and you'll understand what I mean. Here's a link to that article: Georgia Senate Makes "Mark of the Beast Illegal."

The reaction from the Georgia Senate makes my paranoid-schizophrenic friend's story seem plausible. Interestingly enough and I did not realize it at the time (but I do now), that was my introduction to wireless, medical remote programming. As I said, my friend was extremely intelligent and as it turned out more creative and prescient than I realized at the time. Turns out that today a device embedded in the spinal cord with the ability to trigger sexual experience is real. And the ability to embed microprocessors and controls in people with the capability of wireless communication and medical management is also real.

I tell you that story not to make light of people's stories and fears, but as a "sideways" introduction to the technical topic of dealing with multiple, embedded medical monitoring and remote programming systems. And to suggest that people may have real fears and concerns regarding the capabilities that technologists like myself often overlook. In this series I discuss real and imagined fears as well as the technical problems with multiple, implanted devices.

Part 2: Multiple, Implanted Wireless Communicating Devices

Books sold by Amazon that might be of interest in this series

New Frontiers in Medical Device Technology

MEMS and Nanotechnology-Based Sensors and Devices for Communications, Medical and Aerospace Applications

Remote Monitoring Demonstration System for Diabetes & COPD Available

2010-04-23T09:49:00.000-05:00

I want to share the article and it's link to the the demonstration system. Here are a few quotes from the article.

Health Revolution Sciences Inc. has launched a new Website demonstrating its remote health care monitoring capabilities for perspective patients and care givers.
Called ForVida, the software application represents a sea change in health care technology.

The software allows physicians and patients to watch streaming cardiac telemetry or reference steadily growing actionable patient EKG and heart rate histories.

The system apparently uses a communication model similar to one I have described in an earlier article. (http://medicalremoteprogramming.blogspot.com/2009/10/communication-model-for-medical-devices.html) I do not know what data integrity and security measures they have taken.

The article can be found at:
http://www.healthrevolutionsciences.com/2010/04/forvida-demo-up-and-running/

Remote Monitoring and Preventing Unnecessary ICD Shocks

2010-04-21T17:07:00.000-05:00

In 2009 there was an interesting editorial written by Joseph E. Marine from Johns Hopkins University School of Medicine, published in the journal, Europace (European Society of Cardiology). The title of the editorial was "Remote monitoring for prevention of inappropriate implantable cardioverter
defibrillator shocks: is there no place like home?" The entire article can be found at the following location: http://www.europace.oxfordjournals.org/content/11/4/409.full.pdf

For those of you unfamiliar with ICD's (implantable cardioverter
defibrillator), the ICD delivers a relatively high-voltage shock to the heart when conditions indicate that the heart may be about to go ventricle fibrillation (a rapid irregular heartbeat that will likely lead to death) or that the heart ceases beating. The latter condition is easily detected, however, determining the former condition is more difficult. Because the conditions are not always clear, ICD (and a companion system, the CRT-D) too frequently deliver shocks unnecessarily. (I have discussed issues related to detection in other articles in the blog. Here are the links to those discussions: http://medicalremoteprogramming.blogspot.com/2009/11/remote-monitoring-sensitivity-and.html, http://medicalremoteprogramming.blogspot.com/2009/11/remote-monitoring-update-to-sensitivity.html
http://medicalremoteprogramming.blogspot.com/2009/11/remote-monitoring-predictability.html) Another reason that an ICD might deliver unnecessary shocks would be because of sensor lead failure or near failure.

Joseph Marine examined the value of remote monitoring to the prevention of unnecessary shocks. He concluded that remote monitoring was particularly suited to providing early detection of failing sensor leads. However, ...

[f]inally, most inappropriate ICD shocks are not caused by
lead failure, but rather by supraventricular arrhythmias, and this
study does not provide any evidence that home monitoring
reduces risk of inappropriate shocks from this cause.

In other words, remote monitoring could not aid with improving the false positive rate - the delivery of unnecessary shocks.

To those who have not been involved with ICDs, it may seem that the delivery of an unnecessary may not be so bad given the alternative, that a failure to deliver a shock will likely lead to the patient's death. And there are many cardiologists who will argue the case for a "hair-trigger" system - acceptance of false positives, but no acceptance of false negative: that is a failure to deliver a shock when conditions warrant.

However, unnecessary shocks will do damage over time. Furthermore, those patients who have received a shock describe it as feeling like "... a mule kicked" them in the chest. I know of situations where patients who a received shocks eventually have the ICD removed.

So, I want to make the case to the medical device industry that remote monitoring may be the key to solving the false positive problem. In that the data that remote monitoring systems collect and transmit may lead to better detection and discrimination. In addition with reference to my article on prediction, remote monitoring may enable physicians to tune ICDs based on specific predecessor events that could enable remotely adjusting the parameters on the ICD to allow better targeting.

I'm not an expert in this area. However, I know enough about indicator conditions in other areas that can be used to adjust systems and improve their accuracy.

HE-75: Collecting Data and Modeling Tasks and Environment

2010-04-21T13:18:00.001-05:00

This article expounds on my earlier article related to AAMI HE-75: Know what thy user does and where they do it.

Collect and Represent the Data

Ideally the first steps in the design process should occur before a design is ever considered. Unfortunately, in virtually every case I have encountered, a design for the user interface has already been in the works before the steps for collecting user and task related data have been performed.

Nevertheless, if you are one of the people performing the research, do as much as you can to push the design out of your mind and focus on objectively collecting and evaluating the data. And, in your data analysis, following the data and not your or the preconceived notions of someone else.

There are a variety of means for collecting data and representing it. The means for collecting the data will generally involve:

Observation - collecting the step-by-step activities as a person under observation performs their tasks.
Inquiry - collecting data about the a person's cognitive processes.

Once the data has been connected, it requires analysis and representation in a manner that is useful for later steps in the design process. Data representations can include:

Task models - summary process models (with variants and edge cases) of how users perform each task. This is different from workflow models in that in task models no references to specific tools or systems should be included in the task model. A task model should be abstracted and represented at a level without reference to actions taking place on a particular device or system.
Workflows - summary process models (with variants and edge cases) similar to the task flows with reference to a particular device or system. For example, if the user interface consists of a particular web page, there should be a reference to that webpage and the action(s) that took place.
Cognitive models - a representation of the cognitive activities and processes that take place as the person performs a task.
Breadth analysis - I have noted that this is often overlooked. Breadth analysis organizes the tasks by frequency of use and if appropriate, order of execution. This is also the place to represent the tasks that users perform in their work environment but were not directly part of the data collection process.

Detailed Instructions

I cannot hope to provide detailed instructions in this blog. However, I can provide a few pointers. There published works on how to collect, analyze and model the data by leaders in the field.

Here are three books that can recommend and several can be found in my library:

User and Task Analysis for Interface Design by J. Hackos & J. Redish

I highly recommend this book. I use it frequently. For those of us experienced in the profession and with task and user analysis, what they discuss will seem familiar - as well it should. However, what they do are provide clear paths and methods for collecting data from users. The book is well-structured and extremely useful for practitioners. I had been using task and user analysis for a decade before this book came out. I found that by owning this book, I could throw all my notes away related to task and user analysis, and use this book as my reference.

Motion and Time Study: Improving Work Methods and Management
by F. Meyer
Motion and Time Study for Lean Manufacturing (3rd Edition) by F. Meyer & J. R. Stewart

Time and motion study is a core part of industrial engineering as the means to improve the manufacturing process. Historically, time and motion studies go back to Fredrick Taylor (http://en.wikipedia.org/wiki/Frederick_Winslow_Taylor) who pioneered this work in the later part of the 19th and in early part of the 20th Century. I have used time and motion studies as a means for uncovering problematic designs. Time and motion studies can be particularly useful when users are engaged in repetitive activities and as a means for improving efficiency and even as a means for reducing repeated stress injuries. The first book I have in my library however it is a bit old (but very inexpensive) so I include the second book by Meyers (and Stewart) that more recent. I can say that the methods of time and motion can be considered timeless, thus adding a book published in 1992 can still be valuable.

Time and motion studies can produce significant detail regarding the activities that those under observation perform. However, these studies are time-consuming and as such, expensive. Nevertheless, they can provide extremely valuable data that can uncover problems and improve efficiency.

Contextual Design: Defining Customer-Centered Systems (Interactive Technologies) by H. Beyer & K. Holtzblatt &

Rapid Contextual Design: A How-to Guide to Key Techniques for User-Centered Design (Interactive Technologies) by K. Holtzblatt, J. B. Wendell & S. Wood

The first book I have in my library, but not the second. I have used many of the methods described in Contextual Design before the book was published. The contextual design process is one of the currently "hot" methods collecting user and task data, and as such, every practitioner should own a copy of this book - at least as a reference.

I believe what's particularly useful about this contextual inquiry is that it collects data about activities not directly observered. It's able but that affect the users and the tasks that they perform. For example, clinicians engaged in the remote monitoring of patients often have other duties, many of them patient related. Collecting data exclusively targeting remote monitoring activities (or the activities specific to a targeted device or company) can miss significant activities that impact remote monitoring and vice versa.

Additional Resources

As a graduate student, I had the privilege of having my education supported by Xerox's Palo Alto Research Center. I was able to work with luminaries of the profession, Tom Moran and Allen Newell on a couple of projects. In addition I was able to learn the GOMS model. I have found this model useful in that it nicely blends objectively observed activities with cognitive processes. However, the modeling process can be arduous, and as such, expensive.

Allen Newell and Herbert Simon are particularly well known for their research on chess masters and problem solving. They were well-known for their research method, protocol analysis. Protocol analysis is a method that has the person under observation verbally express their thoughts while engaged a particular activity. This enables the observer to collect data about the subject's thoughts, strategies and goals. This methodology has been adopted by the authors of contextual inquiry and one that I have often used in my research.

The problem with protocol analysis is that it cannot capture cognitive processes that occur beyond the level of consciousness, such as the perception. For example, subjects are unable to express how they perceive and identify words, or express how they are able to read sentences. These processes are largely automatic and thus not available to conscious processes. (I shall discuss methods that will enable one to collect data that involves automatic processes when I discuss usability testing in a later article.) However, protocol analysis can provide valuable data regarding a subject's thoughts particularly when that person reaches a point where confusion sets-in or where the person attempts to correct an error condition.

Here's a link from Wikipedia: http://en.wikipedia.org/wiki/GOMS.

Another book that I have in my library by a former Bell Labs human factors researcher, Thomas K. (TK) Landauer, is The Trouble with Computers: Usefulness, Usability, and Productivity.

This is fun book. I think it's much more instructive to the professional than Don Norman's book, The Psychology Of Everyday Things. (Nevertheless, I place the link to Amazon just the same. This is a good book for professional in the field to give to family members who ask "what do you do for a living?")

Tom rails against the many of the pressures and processes that push products, systems and services into the commercial space before they're ready from a human engineering standpoint. Although the book is relatively old, many of the points he makes are more relevant today than when the book was first published. The impluse to design user interfaces without reference or regard for users has been clearly noted by the FDA, hence the need for HE-75.

Market Research Report Available: Remote & Wireless Patient Monitoring Markets

2010-04-19T13:09:00.001-05:00

A new market research report has just been made available that discusses the market and investment potential of remote and wireless monitoring of patients. I do not endorse this study or suggest it's purchase. I am making it's existence known.

Here's a list of some of disorders covered by the study:

Asthma
COPD
CHF
CHD
Diabetes

Here are a few quotes from the press release:

Patient monitoring systems are emerging in response to increased healthcare needs of an aging population, new wireless technologies, better video and monitoring technologies, decreasing healthcare resources, an emphasis on reducing hospital days, and proven cost-effectiveness.

Of these new high-tech patient monitoring systems, nearly all focus on some form of wireless or remote patient monitoring. ...

... the following companies are profiled in detail in this report:

Abbott Laboratories, Inc
Aerotel Medical Systems
GE Healthcare
Honeywell HomMed LLC
Intel Corporation
Philips Medical Systems
Roche Diagnostics Corporation

Here's the link to the press release and links to purchasing this study: http://www.marketresearch.com/product/display.asp?productid=2645944&g=1

Article: Investments in Real Time Medical Monitoring

2010-04-17T11:20:00.001-05:00

This is an article targeted to the investment community regarding investment in real time medical monitoring. I do not endorse anything in this article. However I do find it interesting. I do not know the track record of this publication. Nevertheless, here a link to the article: http://www.onemedplace.com/blog/archives/4878

Article: Initiation of a Telemonitoring Study of Heart Failure, COPD and Diabetes Patients

2010-04-17T10:05:00.002-05:00

A study will be performed by researchers from Case Western Reserve University and Cleveland State University with patients suffering from heart failure, diabetes and COPD. The objective of the study will be to determine how effective remote monitoring is with maintaining the health of these patients and with keeping them out of the hospital.

Here's a link to a report on this study: http://www.physorg.com/news190634143.html

Additional Resources

COPD

The Complete Guide to Understanding and Living with COPD: From A COPDer's Perspective

COPD For Dummies

Diabetes

Diabetes For Dummies (For Dummies (Health & Fitness))

Tell Me What to Eat If I Have Diabetes: Nutrition You Can Live With

The Official Pocket Guide to Diabetic Exchanges

Heart Failure

The Cleveland Clinic Guide to Heart Failure (Cleveland Clinic Guides)

Manual of Heart Failure Management

Medtronic Remote Monitoring Study: CONNECT

2010-04-16T18:43:00.001-05:00

At the American College of Cardiology 59th annual conference George H. Crossley, MD presented evidence that cardiac patient from remote monitoring (one scheduled in-office visit per year with remote monitoring) verses standard in-office care (four in-office visits per year) cuts the time between the time a cardiac or device related event occurs and when a treatment decision is made.

The title of the study: "The clinical evaluation of the remote notification to reduce time to clinical decision (CONNECT) Trial: The value of remote monitoring."

I present a summary of the method and the results of the study gleaned from the slides presented by Dr. Crossley at the conference.

Hypothesis

Tested hypothesis: Remote monitoring with automatic clinician notifications reduces the time from a cardiac or device event to a clinical decision.

Additionally investigated were rates utilization of the health care system including hospitalization and between treatment groups.

Method

Study participants: 1997 newly implanted CRT-D and DR-ICD patients from 136 US centers were randomly assigned to one of two groups. The first group had 1014 patients assigned to the remotely monitored group and the second had 983 patients assigned to the standard in-office care group. The patients were reasonably well matched for age and gender characteristics. (A procedure similar to the Biotronik TRUST studies.)

The patients were followed for 12 months. (On first reading, I found the the time relatively short in that I would not expect enough differentiating events would occur during that time. However, on further reading, I believe my first impression was incorrect.)

Findings

Time from Event to Clinical Decision

The median time (used nonparametric inferential statistics for the analysis) from the cardiac or device event to clinical decision was 4.6 days in the remote group and 22 days in the in office group. This difference was significant. The remote group involved 172 patient while the in-office group involved 145 patients.

The cardiac/device events included:

Atrial Tachycardia/Fibrillation (AT/AF) for 12 hours or more
Fast Ventricular rate. Of at least 120 beats per minute during at least a 6 hour AT/AFT event
At least two shocks delivered in an episode
Lead impedance out of range
All therapies in a specific zone were exhausted for an episode
Ventricular Fibrillation detection/therapy off
Low battery

Total number of events Remote group: 575 and In-office group: 391. The slides show the breakdowns.

Office Visits

The number of office visits per patient reported are shown below.

Scheduled Unscheduled All office

Remote group: 1.68 2.24 3.92

In-office group: 4.33 1.94 6.27

The TRUST studies showed a slight increase of more unscheduled visits for the remote group. However, given the nature of the study and that remotely monitored patients would receive only one in-office visit per year, it's remarkable how similar the numbers between the two groups are.

Utilization of the Health Care System

Number of incidents where patients used the health care system show virtually no difference, hospitalization or emergency room.

However, a remarkable difference was the significant difference in length of stay when there was a hospitalization. The remote group had a mean hospital stay of 3.3 days while the in-office group was 4.0 days with an estimated savings per hospitalization of $1659.

Conclusion

The CONNECT and (Biotronik) TRUST studies show clear benefits from a number of standpoints for remote monitoring. In addition, the CONNECT study showed clear cost and hospital resource utilization benefits from remote monitoring in that hospitalized patients had shorter stays indicating that they were in better shape than patients in the in-office group when admitted to the hospital. Quick responses seem to lead to better outcomes as well as cost reductions.

Here is the link to Medtronic's press release of the study: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1268659150410&lang=en_US

Here is another link to an article on the study that includes a link to Dr. Crossley's slides: http://www.cmio.net/index.php?option=com_articles&view=article&id=21235:acc-remote-monitoring-shortens-event-response-time-reduces-hospital-costs

Additional resources

Reimbursement for Remote Patient Monitoring in the United States- Regulatory Antennae Picking Up Demand Signals

Remote ICD monitoring speeds diagnosis of arrhythmias.(CARDIOVASCULAR MEDICINE)(implantable cardioverter defibrillators)(Report): An article from: Internal Medicine News

Reader Article: Controlling Glucose Level to Prevent Diabetes

2010-04-16T12:11:00.001-05:00

Here's something I have been wishing for ... a guest article authored by one of my readers. If you have something that you would want me to publish in this blog, by all means, please send it and if I think it has technical merit and seems appropriate, I shall publish it.

This article is written by Kristina Ridley who writes for the diabetes blood glucose blog. (http://www.diabetesmeters.org/)This is her personal hobby-blog that focuses on healthy eating and tips to measure blood glucose levels at home to help people understand early diabetes symptoms.

This article may have bearing on remote monitoring technology for diabetes in the what people consume has likely impact on glucose and insulin levels. I know that heart failure patients (whom I understand are often diabetic) can remotely report to caregivers their weight, blood pressures, etc. I would seem reasonable that diabetics could report their food and fluids intake for remote monitoring by their caregivers.

I am particularly interested in Kristina's last section, "Too Much Control." My experience in cardiac rhythm management suggest close monitoring and control are strong positives. I hope that Kristina or someone else could write a rejoinder to this section.

Here is Kristina's unedited article:

Here’s a Quick Way to Control Glucose Level to Prevent Diabetes

Our pancreas is affected by diabetes – specifically, Type 2.Our body contains glucose found in the blood stream, which it gets from the sugar in food. Our body uses the glucose, but only when it goes into our blood cells and the insulin released by our pancreas converts it. Insulin production and utilization is difficult for someone who lives with Type 2 diabetes. There is a lot of glucose in the body, but your cells cannot locate them.

The American Diabetes Association has become very important when it comes to gathering critical information about this medical condition. With approximately 23.6 million citizens living with diabetes, America is an extremely unhealthy country. Over 90% of all patients with diabetes have Type 2.Most diabetics tend to be overweight and have relatives with the same condition. Too much glucose can cause serious, irreparable damage to internal organs and to the overall nervous system.

Diabetes and Your Life

If you have Type 2 diabetes, you need to live in a healthy manner. Living healthy and engaging in healthy practices will affect you tremendously. Two common examples of healthy routines include exercising and consuming healthy foods. Making sure that your glucose levels stay in the recommended range translates into being able to avoid complications in your health. A finger prick test is a common and reliable way to monitor your body’s blood glucose levels.

This test, according to physicians, is sufficient enough for glucose monitoring like the HbA1c test. The amount of glycated hemoglobin in your blood is determined by this HbA1c test, aside from it alerting you if you reach a high glucose level. Results of these A1c tests show that people with diabetes are at a seven percent level. The CDC reports that if one maintains their a1c levels at seven percent, they could reduce the possibility of risks as high up as forty percent.

Too Much Control

Recently, there have been medical studies that seem to indicate that maintaining A1c levels below 7% may be a bad idea after all. One of these studies, conducted at the Lancet and Swedish Medical Center in Seattle, has found that people who have median levels may be at a far greater risk of death, especially for those taking insulin. However, other tests have indicated that A1c levels of 7 percent is still perfectly healthy. Matt Davies, An accredited Endocrinologist, has stated that maintaining a 7% A1c level is healthy according to recent studies, but that physicians should always take the individual patient's history into account prior to planning treatment.

Kristina provides diabetic recipes in here blog. In addition, I have provided a link to Amazon that will initiate a search for diabetic cookbooks.

Search Amazon.com for diabetic cookbook

Why the Moniker "RemoteProgrammerGuru?"

2010-04-16T11:32:00.000-05:00

For those who have wondered ... there is a story behind why I use the moniker, "RemoteProgrammerGuru." Any identity that has as part of the name, "guru" could be considered more than a little ostentations. Here's the definition as provided by Wikipedia:http://en.wikipedia.org/wiki/Guru.

The definition describes someone with "supreme knowledge." Fortunately for me, the term in India is synomous with "teacher." For me, the "term" teacher was more appropriate and the role of a teacher came as a surprise.

I was part of a project where remote programming was the technical centerpiece of a proposed solution. Frankly, I was new remote programming for medical devices as are most. However, I have a rich telecommunications background including expertise in wireless communications. (I was the principal investigator on two federally funded telecommunications research grants.) I know the technologies and I know how things work.

As it turned out, I knew more than my colleagues who had been working in remote programming for longer than I ... much more. And I started teaching them, about communications and about remote programming and necessary processes to insure communication integrity. In effect, I became a "guru," a teacher.

Finally, since remote programming when designed and implimented correctly, involves sophisticated monitoring, I decided to incorporate the term "remote programmer" to represent someone who informs people about remote monitoring and programming. Thus the moniker, "RemoteProgrammerGuru" was created.

Announcement: Biotronik has MRI Conditional Pacemaker Approved in Europe

2010-04-09T21:57:00.000-05:00

Announcement that Biotronik has gained European approval for an MRI conditional pacemaker and leads. Here's a link to the announcement from Business Wire:
http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100407006972&newsLang=en

I have worked on the usability issues related to providing MRI conditional pacemakers and leads. Without disclosing too much, my work related to MRI conditional pacemakers and leads got me interested in remote monitoring and remote programming. So, for me there's a link between MRI conditional pacemakers and leads, and remote monitoring and programming.

Article: Updates to the Development of Medical Body Area Networks (MBANS)

2010-04-09T21:36:00.000-05:00

Mobihealth News has published an article indicating that Philips is interested in a 10MHz spectrum dedicated to MBANS. Here's the link to the article:
http://mobihealthnews.com/7178/philips-suggests-dedicated-mhealth-spectrum/

Mobihealth suggests that Philips is taking a different approach to MBANs than GE who wants 40Mhz of spectrum dedicated to MBANs. The GE is interested in MBANs that would be used in hospitals. Philips is interested in the deployment of MBANs to the field, and that Philips would produce consumer and not medical grade products. I am not sure how this could work in the US. However, this development is worth continuing attention.

Article: Wireless Remote Monitoring Prevents Complications of Chronic Diseases

2010-04-09T17:16:00.000-05:00

An interesting article about the benefits of remote monitoring in the care of patients with chronic diseases from the Press of Atlantic City, 8 March 2010. Here's the link to the article: http://www.pressofatlanticcity.com/life/monday_health/article_1333e585-e3a6-5ba8-a411-75530f6b63cf.html

Quotes from the article:

Improving management

By early 2012, Americans will use about 15 million wireless health-monitoring devices, according to a forecast from ABI Research, which tracks mobile-technology trends. The mobile health market is projected to more than triple to $9.6 billion in 2012 from $2.7 billion in 2007, according to study from Kalorama Information Inc

[T]he first pilot project in the nation to assess whether the use of remote digital devices with data sent over the Internet to a doctor's office improved management of multiple chronic diseases - diabetes, heart disease and high blood pressure, also known as hypertension.

Diabetics and hypertensive patients increased the number of days between appointments by 71 percent and 26 percent respectively ...
"One of the great promises of wireless (health) is making it a part of the patient's daily life, not an interruption to what they're doing every day," ...

From personal experience I believe the last sentence I quoted is among the most important in the article. The entire process should be so smooth, so automated, so uncomplicated and unintrusive that the patient's life is uninterrupted and that the data is seamlessly collected and sent to the patient's caregiver.

Two other items to note. The first is a brief discussion of the sensors connected to the patient's body. They mention band-aid size electrodes. I am not sure if these are the "digital plaster" that I've discussed in an earlier article. http://medicalremoteprogramming.blogspot.com/2009/11/digital-plaster.html
Or something else. I do not know, but it would be interesting to find out. If I have any informational, I'll post it. If you have any information, please enlighten us with a comment.

The second issue of note is the discussion in the article regarding payment, and who will do it. Given the convoluted nature of our system of payments, this will be the most difficult issue to resolve, I believe. It's ironic considering that remote monitoring saves money. I think the technical issues will be minor in comparison. I hope I am proved wrong.

Remote Monitoring/Programming and Diabetes Management

2010-04-09T15:23:00.000-05:00

Diabetes management is a personal area of concern for me. No, I'm not diabetic. However, my late mother-in-law was. She had Type II diabetes; however, she was not overweight. She died of a sudden cardiac arrest that was a direct result of her diabetes. Although she did a great deal to manage her diabetes, her insulin would swing widely. Those wide swings damaged her heart muscles leading to a cardiac arrest. I can't help but believe if remote monitoring had been available to her, that she should would be alive today.

In the past my primary topical area has been cardiac rhythm management. I plan to broaden my focus. Diabetes management using remote monitoring and even remote programming will be a topical area of increasing focus in this blog. In later weeks I plan to branch out into COPD.

For those of you who have domain expertise in diabetes management and COPD, I would appreciate your comments. You can make your comments in the comment area of this blog or email them to me. Whatever way you feel the most comfortable.

To get things started, I have three links that I would like share. The first link is a blog article titled, "Finding patterns in diabetes treatment may be key for telemedicine." The article is a brief discussion about a presentation by Dr. David Klonoff of Mills-Peninsula Health Center and UC San Francisco. His focus was on Type I diabetics, however, I believe what he discussed has significant implications for Type II diabetics as well. Dr. Klonoff's interest is technology "...for automatic measurement of blood glucose, automatic dose calculation, and automatic insulin delivery." From the article ...

For this ideal scenario to develop, five technologies need to be solved, and Klonoff sees printed electronics being used in every one:
Self-monitoring of blood glucose
Continuous (and ultimately non-invasive) monitoring of blood glucose
Alternate routes for delivering insulin rather than needles, such as micro-needles. (Klonoff referred to work being done at UC Berkeley; I saw some demonstrated at the University College Cork/Ireland (PDF poster here) although using traditional semiconductors, not printed electronics.)
Artificial pancreas
Telemedicine

In the quotation above, there are several links. The one of greatest interest to me and to this forum, is the "non-invasive" link. This will link you to an article titled, "The Search for Noninvasive Glucose Technology That Works: Where It Stands Now".

The article is a discussion of a need for a means for non-invasive monitoring of glucose levels. The capability of having a non-invasive means of monitoring glucose levels would go a long ways towards supporting automatic, remote monitoring of glucose levels. This could be an extension of the body area networks work (BANs). So if anyone has any ideas in this area, apparently this is a wide open area for invention.

Finally, I want to provide a link to a brief report by the Whittier Institute of Diabetes. The report is undated, but a brief review of the document's properties indicated that it was created in 2004. It's not as recent as I would like, however, I believe that it's findings are relevant. In summary, it showed that even relatively crude means for monitoring diabetes could lead to some positive outcomes at relatively low cost.

More on Knowing Thy Target User Population

2010-04-08T21:33:00.000-05:00

Before moving forward into product development, I want to elaborate on the issues in my first two articles. This article elaborates on the importance of knowing the target population and ways to gather that information.

The next article will discuss I have had some recent experiences that reinforced that importance of defining and clearing understanding the targeted user population. And the importance of fully understanding and documenting what those members of the user population do and the environment(s) wherein they live and work.

Before proceeding any further, please review my previous article on understanding your target population. The link to the article is below:

http://medicalremoteprogramming.blogspot.com/2010/03/know-thy-target-population.html

HE75 clearly emphasizes the importance of understanding your target population. The standard instructs that companies who develop medical devices should:

Know their targeted user population
Involve users early and often
Accommodate user characteristics and capabilities. And in order to do this, one must first know what they are.

The information gathered about a target population should enable one to clearly define the qualities and characteristics of that population. This can be particularly important when designing medical devices, particularly when those devices are targeted to patients.

I have seen organizations a company, organizations that include program management, marketing and engineering assume that they know the characteristics of the targeted population. Once the product is deployed, the company comes to a rude awakening and learns that their assumptions were often times false. Neither the company nor the targeted user population(s) benefit from such a failure.

Methods for Gathering Target Population Data

The target population data is the most elemental data in the product development process. All the descriptions about the targeted user population, their characteristics, culture and capabilities originate from this step in the research and development process.

So, how is this crucial data gathered? First, a confession ... the amount of work I have performed at this stage of the process has been limited. My training is in cognitive psychology and computer science. Most often I have been the recipient of such information about the targeted user population. I have used the results of this first step as a means for recruiting subjects in my usability experiments and evaluations. The training that is most suited to gathering this kind of data is anthropology and sociology. The process of collecting target user population data draws on ethnographic and participant observation research methodologies. The research can be observational. It can be based on questionnaires administered orally or in writing. It can be structured interview. It can participant observation where the observer becomes participates in the activities of the target population. It can be a combination of a variety of methods and include methods not listed above.

The objective is the development well-grounded description that captures the important, defining characteristics of the target population. The description can be provided in variety of ways, verbal or graphic. The description should use the clearest and most appropriate methods available to covey that information to the members of the product development organizations.

Interestingly enough, I have used the data gathering methods I listed above. However, I used those methods to collect data for the second step, Knowing what the user does and where they do it. In other words, to gather task and environmental data.

Potential Costs for Failure to Correctly Define the Target User Population

Consider the following scenario ... that I collect task and environmental data about the wrong population, about a population that is not the target population. What is the value of the results of my research? And what could be the cost to the company for this failure? What could be the cost to the target user population, to have a device with a user interface unsuited to their needs?

In reality, the cost could be high, but the product may not be a dismal failure. Given the fact that we are all human, we share a wide variety of characteristics. However, in the more stringent regulatory environment that is anticipated, it could mean delay, additional research, engineering and product development costs. If the product is intended to provide a new capability to providers and/or patients, a delay could mean that a competitor could be first to the market the product. Thus company could miss the competitive advantage to being first.

I have recent experience with two products targeted to patients. In one case the target population was well understood and well defined, and members of that population were used in usability testing. In another case, there was a limited understanding of the target population by the research and development organization. And no member of the target population involved at any stage of the research and development process or in the development of the user interface. In the first case where the target population was well understood and well defined, the user interface research and development process was clear and logical. On the other hand, the research and development process that did not have a clear understand of the target population is struggling, it is learning as it goes. Each time it learns something new about its target population, the user interface has to be updated. It has been a costly process with constant reworks of the user interface. So many reworks that the integrity of the original design has been lost. It appears deconstructed. At some point the entire user interface will have to be redesigned and that will likely come at the behest of the FDA enforcing HE75.

A Final Thought

HE75 instructs that medical product user interfaces should accommodate a diverse groups of users and should be maximally accessible. I see this as design objective of any user interface in that vernacular should be limited as much as possible and that limiting qualities should not be designed in or should be removed when detected. However, all products may not be accessible to all users but should be clearly accessible to the target population. And I believe that the FDA will insist on this.

How to Hack Grandpa's ICD

2010-03-30T21:55:00.000-05:00

I've discussed possible communications security problems with implanted devices in an earlier post. The link below provides a link to a University of Washington study that was published in 2008 in IEEE Symposium on Security and Privacy. Here's a link to the University of Washington article.

Researchers find implantable cardiac defibrillators may expose patients to security and privacy risks

The article includes a link to the published paper. I suggest that you download the paper and read it.

Although the article was published in 2008, I believe it still has relevance. First, it references a Medtronic Carelink Home Monitoring unit that I am quite certain is still in widespread use. Second, they reverse engineered the Medtronic unit to create their own system that could mimic the Medtronic unit. Although I am not an electrical engineer by any stretch of the imagination, I can attest to soundness of their methods. I have worked with a variety of engineers who have tested communications system security using similar methods. Furthermore, I have worked with engineers who have successfully cracked harden communications systems. Thus I shall continue to monitor developments and findings in this field because this could impact the engineering of the communications systems for remote monitoring and programming.

One of the flaws in the Medtronic unit that made reverse engineering relatively easy was that the data was not encrypted. I do not know if currently any or all communications between home monitoring units from any device company and implanted devices is encrypted. Encryption adds significant overhead to communications. Thus it makes the communication between the device and a home monitoring unit significantly longer. It can impact battery life because encrypted transmissions have more bytes to transmit.

One of the potential limitations to hacking implant radio communications is the extremely low power level of that communication. The low power levels suggest that the hacker would have to be in close proximity to the device, within three meters. However, their article did not extensively investigate the communications distance issue or methods that might be used to get around the proximity problem.

Third, the authors also had access to a Medtronic programmer. A study of the operations of the programmer enable the authors extend their capabilities to hack communications with the implanted device.

The scariest part of the article is a discussion of how it would be possible to kill a person with an ICD using the device they constructed. Here's that section of the article (edited):

Inducing fibrillation

During implantation surgery, it is common for a physician to test the newly implanted ICD to ensure that it can both sense and appropriately treat a cardiac
condition known as ventricular fibrillation (V-Fib), one of the most common kinds of heart rhythm problems. Accordingly, the ICD has several testing modes in which it can induce VFib. Such a test — called an electrophysiological (EP) study — is normally conducted with cardiologists standing by to stop the fibrillation if the ICD fails to do so. ... [a] programmer sends the ICD a sequence of commands that ... [a] shock to be applied to the patient’s heart at a precise point in the patient’s cardiac rhythm, with the goal of inducing V-Fib. When its automatic therapies are enabled, the ICD should immediately detect and treat the fibrillation by delivering the proper therapy. ... We then used our commercial programmer to conduct an EP study ... We then replayed a recording of the EP study command sequence via our software radio. At least three of 30 replay attempts succeeded. We successfully triggered command shocks via replayed commands even after turning off all of the
ICD’s automatic therapies.
Quoted from:
Halperin, D, Heydt-Benjamin, T., Ransford, B., Clark, S., Defend, B., Morgan, W., Fu, K., Kohno, T., Maisel, W. Pacemakers and Implantable Cardiac Defibrillators:
Software Radio Attacks and Zero-Power Defenses, IEEE Symposium on Security and Privacy, 2008, pp 1-14.

Know What Thy User Does and Where They Do It

2010-03-30T14:03:00.000-05:00

Review ...

Last time, I discussed the importance of knowing your target population and their use environment. That first step identifies and specifies the population for inclusion. It is the means for including who should be included and excluded, and the environment where they work. For example, a targeted population for a particularly medical product could be surgical nurses who work in hospitals. The target population does not include all nurses or even all surgical nurses. In addition, the use environment in which the targeted population performs their work needs to be a part of the definitional equation.
Thus, the first step in the design process is defining the properties of the target population, determining who is and who is not part of that population. And include a complete description of their working environment, the environment where the product or service will be used. Field research will be necessary to establish the target population and its characteristics and the work environment. When this step is finished, the next step is perform additional research to establish the details of the work of interest and the environment in which it performed. (The means for collecting this information and form of the analytic product will be discussed in a later article.)

Know What Thy User Does and Where They Do It

Knowing what the user does consists of documenting the tasks that the target user population would perform with the product or service that a company plans to provide.

Once the product or service has been conceptually defined, the following information from the target population must collected:

The preconditions that lead to performing each task,
The steps required to perform a task, and
How frequently each is performed (in absolute terms and in relationship to other tasks.

The information collected focus on the actions performed by a user localized to the product or service in development. The data would have little or no reference to the use environment – the full set of activities and environmental conditions wherein this product or service will be used. Thus once having collected the task data specific to the product or service in development, the next step would be placing this product or service within the environment wherein it will used.

A full and complete description or representation of the use environment may not always be possible. Moreover, often times there are multiple use environments. And a description or descriptions may be only of a representative sample. Nevertheless, it can be extremely useful to understand how the product or service in development will be used in context.

The final research products resulting from this step in the product development process are:

Task analyzes: pertaining only to the product or service in development.

That include:

Breadth analysis, that consists of:
The number of tasks users would perform using the product or service in development
Their frequency of performance
Depth analysis
Define how each task is performed
The level is detail required will vary with the complexity of the task
Each task analysis should include likely errors and the steps required to correct them.
There are a variety of means to represent task analyze. The representation method should be agreed on by the affected parties.

Task execution within the wider use environment

The tasks that users will perform with the product or service in development will be performed within a larger context.
The tasks within the wider context and how those other tasks relate to each other requires documentation.
The other tasks require a breath analysis. Rarely is a depth analysis required unless tasks are intermingled.

I discuss the benefits of knowing what your user does and where they do it in my next article. I shall discuss with reference to HE75 and what the FDA will likely require from the medical product companies.

Where in a company's organizational structure is this work performed?

Knowing your 1) target population and their use environment, and 2) what your users do (task analysis) are the first two steps in the product formation stage of development. This precedes requirements gathering stage of product development. Thus, this would require the engagement of human factors engineers working with marketing and other product and field-focused organizations to engage those working at this early stage. St. Jude Medical with whom I consulted for 15 months has placed their all their human factors engineers in systems engineering. Thus, the placement of human factors engineering only in systems engineering means that important data impacting the beginning of product development is either not produced, or produced at a later stage in the development process where its impact is minimal or non existent.

As I shall discuss later, it is important that human factors engineering be involved from concept to deployment, thus human factors engineers should be distributed throughout an organization.

Stirrings in the Regulatory Environment

Medical product producers are regulated by the Federal Government. Anyone who reads this blog is highly likely to know that. Drug companies are acutely aware of governmental regulation in that their products must be “safe and effective.” Drug companies must prove through research safety and effectiveness. Implanted device manufacturers must demonstrate that the implanted devices themselves are safe and effective. Devices and drugs that deliver therapy have to prove to the FDA safety and effectiveness.

But what about the user interfaces for devices that enable users to make changes to the operation of implanted devices, deliver therapies, provide information about the patient, etc., where's the proof in the form of empirical data to prove that they're safe and effective?

In the US, more people are killed by medical errors each year than are killed in automobile accidents and in the military service combined. Yet, the FDA has placed few relatively requirements on the process for designing user interfaces on medical products and services. This is a disgrace and the FDA knows it. FDA mandates for insuring the usability of medical devices, products and services has been merely to determine only that a usability process is in place. FDA mandates for usability have not reached the level of the Departments of Defense or Transportation. Companies that design and build medical systems have not been required to prove to the FDA that their products are usable in their use environment. Yet, it is clear that usability is just as important in medical practice as with combat systems and cars – particularly when one considers the number of injuries and deaths resulting from medical errors. And with more powerful and complicated systems are being designed and planned, the need for the FDA to act and act effectively in the area of usability grow substantially.

In my personal experience, I saw a device under development that if used improperly, could injure or in one case, lead the to death of a patient. In fact, I uncovered a condition in which the device when used properly could lead to death. And, it would have been surprisingly easy to do. Of course, I raised my concerns regarding this device and its potential for injuring patients. Nevertheless, in the current regulatory environment, I believe that it would be possible that the device could be approved for use by the FDA because of the lack of a clear standard from the FDA that the company prove empirical data regarding that the device is usable and safe.

The Department of Defense has been particularly forceful with contractors regarding insuring that members of the target population will be able to use systems within the environment of their intended use. It does not take a great deal of contemplation to understand the value of insuring that a system can be operated effectively by a soldier in a combat environment. A system that could save the lives of fellow soldiers or civilians would be useless if it could not be used effectively by a member of the target population (i. e., a soldier) in combat. If the user interface is too cumbersome or complicated when used in the stress and difficulties of the combat environment, then all the time and effort taken to create that system has been wasted. NASA and the FAA have taken a stance similar to the DoD. The Department of Transportation in conjunction with Congress have taken a strong stance with respect to the design of user interface of vehicles.

I believe that the FDA will begin to strong stance similar to other regulatory bodies of the Federal Government regarding insuring that the user interfaces of medical devices meet specific usability standards and the meeting of these standards must be demonstrated experimentally with empirical data. I think that one of the first step in the process of ever increasing regulation of the user interfaces of medical will be the adoption of HE75 by the FDA. This would start the process towards mandating that companies prove their products meet user performance standards.

A more complete article on the NIST Grant fund BANS research

2010-03-27T17:27:00.000-05:00

I have added a more complete article without comment regarding the NIST funded study to advance the capabilities of Body Area Networks (BANS). It appears to be largely taken from the press-release from Worcester Polytechnic Institute.

Here's the link: http://itisinteresting.me/2010/03/1-2-million-award-from-nist-facilitates-groundbreaking-study-of-wireless-body-area-networks/

Know Thy Target Population

2010-03-25T13:00:00.000-05:00

Background

Members of the project core team including myself were sitting around a meeting table at St. Jude Medical. We had received a sample of work from a well-known human factors and design consulting company. It was a detailed design of a user interface of a web-based system that the consulting company had designed. (I withhold the nature of the system because some of you may know this consulting company and have received the same sample system. I want maintain the anonymity of this company.)

Most of the members of the core team were impressed by the design and the level of detail provided in the sample of work. I was not impressed. Why? There was nothing in the design that tied back to the target population the system would serve, nor was their any reference to any research performed that justified the design or the services that would provide its users. In other words, I had no way to evaluate whether the design was good or bad, whether it suited the user needs or not. Furthermore, there was no information provided by the consulting company regarding the target population, its needs, skill-level, etc.

If I understand the objectives of HE75 correctly, then medical device companies will be required to demonstrate through research - it is unclear whether the research required will involve the need for empirical research or a literature search. However, companies will be required to demonstrate a clear understanding of the targeted population and the use environment of that target population for whom their products and services are intended for use. The consulting company who provided St. Jude Medical with work samples failed to demonstrate any knowledge of the targeted population.

Know Thy Target Population

And know the use environment of thy target population: objectives, distractions, dangers, skills, needs, etc.

There are few things that rankle a human factors professional more than an ascetically pleasing design that fails to take in account the population of the actual users. I will not discuss any specific examples in this article. However, you can look around the Web, around your home or office, or a hospital or clinic and see all kinds of products and displays that were designed without regard to the target user population. Companies continue to build products with user interfaces ill-suited to the target populations. Why?

Designing research, collecting and analyzing data and turning the analysis into appropriate products and in particular, well-suited user interfaces takes time and money. In highly competitive environments, time can be more of a concern than money. For companies that have adopted a "fast follower" business model, time often looms larger than money when planning and developing products, and designing user interfaces. Products based on a fast follower approach can often be successful if the product or product upgrade does not require a user interface. Development is nothing more than the implementation of a proven algorithm. However, when there is a user interface, the lack of attention to understanding the target population can become painfully obvious once the product or service is introduced.

When a company uses a "fast follower" model or does not want to devote the time, effort and money to research, the temptation can be to rely on opinion leaders, other companies' products, best guesses, or "expert" opinions. These approaches often bring fast outcomes. Furthermore, I have noticed that often times decision-makers believe that they can determine what is and what is not a good user interface - that a good user interface design is something that anyone can assess.

I believe that some of the faith that decision-makers have placed in themselves comes from their experience with consumer products, such as the Apple's iPhone. The iPhone is an combination of excellent physical design ascetics and small, touch-screen user interface design. What many people forget is that Apple devoted copious amounts of time, money, expertise to research and development of the physical design and the user interface of the iPhone.

The iPhone was designed with the general public in mind. Apple may have targeted the iPhone to a more youthful population, however, I have noticed that many, many older people pulling out their iPhones. I have also noted that there are numerous medical applications targeted to iPhones, applications that would be of interest to older people. The iPhone may have been targeted to a more youthful population, but its touchscreen interface with its large, wide buttons, high contrast and high resolution screen enables elderly users to access its capabilities.

When user interfaces are targeted to a specific population, it becomes imperative that the characteristics, needs, qualities, etc. of the target population be well-known and understood. The user interfaces introduced to that population will likely be tied to a specific set of tasks with clear objective within a specified environment. The use environment maybe more complex and stressful than the use environment of a consumer product. Furthermore, and this is particularly true of many medical devices, the consequences of making an error can be significantly more harmful than any consumer product.

For decades, the Department of Defense has pressed its contractors to follow standards and demonstrate usability in the use environment. The first step in that process is understanding the target population and the use environment. Given the accumulating evidence that medical errors kill more people per year than automobile accidents and war, I believe that the FDA will take strong steps such as the steps taken by the Departments of Defense and Transportation. Judgment will no longer substitute for data and analysis. The evidence that I have seen is that HE75 and HE74 will provide significant guidance towards directing companies towards gaining a full understanding of the target population and their use environment.

One thing to note, target populations and use environments are dynamic, not static. Continuing research is essential.

Next time: Now that you have an understanding of your target population and the use environment, what do you do next? I shall come back to specific techniques for research a target population and their use environment in a later article. However, I want to provide a process overview before diving into specifics and specific techniques.

Overcoming the Power Connudrum

2010-03-25T00:14:00.000-05:00

I have written about the power consumption issue in earlier articles. I now include a link to another article that discusses further positive developments in towards solving the power requirements problem inherent in remote patient care. Here's the link to the article: Breakthroughs with Sensing in the Human Body By Dr Peter Harrop, Chairman, IDTechEx

The article discusses the following developments towards solving the power problem. The two fundamental areas are:

Advancements in reducing the levels of power required for body sensor nets.
Methods for harvesting power: either from the wearer or from the environment.

Developments in power for portable and wearable devices are worth watching because the capabilities of remote patient care are limited primarily by power requirements. Power requirements for pacemakers, ICDs and CRT(-D)s devices have by in large been met, that is, for those devices where the communications requirements are minimal. However, as communications requirements increase, so will power consumption. And all indications are that data traffic requirements will increase, thus the need to both find more power and reduce power requirements will increase as well.

I shall continue to publish further developments in this area.

An another article on BANs

2010-03-24T16:46:00.000-05:00

Another article on Body Area Networks and the Federal Government's continuing interest in furthering its development. Here's the link to the article: http://www.informationweek.com/news/healthcare/mobile-wireless/showArticle.jhtml?articleID=224200068

Much of the work seems analogous vehicle telemetry research and development. One of the applications for the technology we developed at Rosetta-Wireless was for the transport of vehicle telemetry over the commercial wireless network in real-time or near real time. The problem that we solved was handling gaps, faults and multiple types of wireless connections while the vehicle was in motion. Again, body data will need to be transported over wireless using a robust logical connection to overcome the imperfections of the wireless network and perform the task without burdening the user - an extremely important consideration.

The next article will discuss the implications of HE75 and the means, methods and importance of not burdening or overtaxing the user.

Human Factors Issues in Remote Monitoring and Remote Programming

2010-03-24T01:44:00.000-05:00

Series Overview and Background

Human factors issues related to remote monitoring and remote programming (remote patient care) will predominate in my postings over the next several months. If I learned anything while working at St. Jude Medical, I learned the value of human factors engineering in relationship to remote monitoring systems. Before I discuss what I learned, I want cover a few issues regarding remote patient care.

If you talk to a device clinic clinician, that person will have few difficulties in communicating to you the value of remote monitoring technology. I heard stories from cardiologists that before remote monitoring technology was in place that device nurses would have to telephone device patients. The emotional strain on the nurses was so great that device nurses would burn-out in two years.

Remote monitoring provides a service to patients and their caregivers. Most patients do not want to come to the device clinic and caregivers would rather that they did not. Remote monitoring lengthens the time between clinic appointments. Furthermore, remote monitoring can detect signs of potential problems much earlier than a visit to the clinic. Remote monitoring can keep patients out of emergency rooms and can provide patients with a better quality of life. Finally, remote monitoring can lower the cost of care while improving it.

Among the medical trail blazers, there is an interest in remote programming. The ability to remotely make changes in the operation of a medical device could enable caregivers to be more proactive and provide patients with care where ever they are located, rather than just in the clinic. This capability significantly lowers barriers and limitations on patients and their caregivers. Patients can lead more free and independent lives and less tethered to clinic appointments.

Sounds wonderful, doesn't it? Remote patient care technology does provide the underlayment, the enabling capability. However, remote patient care system cannot be limited to the technology. From my perspective working at St. Jude Medical, roles of caregivers and patients have been under valued, misunderstood or neglected in the development of systems to provide remote patient care. I cannot speak for other medical device manufacturers. I can say, because this is public information, that St. Jude Medical's remote monitoring system has come under fire because of issues related specifically to the performance and design of the user interface of their remote monitoring system.

I am not singling-out St. Jude Medical regarding the design and implementation of their remote monitoring system. St. Jude Medical implemented a beneficial and desired medical system. However, it appears that they failed to understand two essential elements who are just as essential to the remote care system as the hardware and software. Thus the current state of St. Jude Medical's remote monitoring system serves as a starting point for the articles that will follow this one.

My next two articles will focus on the new AAMI/ANSI standard HE75 due to be officially released in April 2010. I cannot quote from the document at this time, however, I can say that HE75 is founded on the basic foundations of human factors. Thus, from that standpoint, there is nothing new about what is contained in HE75. I know several people on the HE75 committee and I can say that they are consumate human factors professionals, and dedicated to the profession.

I can also say that should the FDA adopt this document (and all expectations are that the FDA will adopt it), the relatively lax approach that FDA approach to usability and human factors will come to an end. There is a massive body of literature that documents the massive number of injuries and deaths from medical errors, and some of those medical errors can be traced back to poor device designs. It may well be that the FDA will believe that it is time to "crack down" on poorly designed medical system user interfaces. Furthermore, medical systems are becoming increasingly more powerful and complicated, thus the capability to do injury to patient will increase. Thus, the need to insure that medical devices and their user interfaces will meet specific and unambiguous performance standards before being approved by the FDA.

I plan to focus specifically on medical devices related to remote patient care in this blog. However, I may stray from time to time when there is something that seems particularly relevant or interesting.

I shall not discuss anything regarding future St. Jude Medical products or services in this blog. However, I can discuss some of the issues I faced in general terms to illustrate points. I suspect that the experiences I relate will resonate with others.

Next time: Human factors in the research and development of medical devices.

Development of BANS Expected to Accelerate

2010-03-24T00:12:00.000-05:00

For those not in the "know," BANs is an acronym for Body Area Network. It is a technology to capture and transmit body-related telemetry. The National Institute of Standards and Technology (NIST) has granted the Center for Wireless Information Network Studies at Worcester Polytechnic Institute (WPI) Worcester, MA, $1.2 million over three years to advance BANs technology. The research will focus on the propagation of radio waves around and through the human body. This could have real potential for the development of robust communications standards to enable medical devices to send and receive data and instructions over wireless networks. This research is something to watch.

http://medicaldesign.com/engineering-prototyping/research-development/development-bans-expected-accelerate-032210/

Receiving a NIST grant is a significant achievement. I was the Principal Investigator on a $2 million, two year grant to Rosetta-Wireless. The NIST vetting process is arduous, but the grants generally fall into the seven figure range over two to three years. I know that wireless data communication is an important area of interest to NIST particularly as it relates to medical applications, more specifically into the areas of wireless medical monitoring and remote programming. I know that NIST has continued hopes for a medical application of the technology that my company, my research and development team created.

For those who have an interest in BANs, one of the technical problems is getting the data collected by BANs back to a location where medical professionals can review and evaluate it. And, if need be, make changes remotely in the operation of the implanted medical system (e. g., pacemaker, ICD, insulin pump, etc.). If you review some of my earlier posts, you'll note that I have described methods to transport data and instructions over the commercial wireless network from and to a patient's implanted medical device.

I shall continue to bring to light any further developments in BANs.

Wireless Telehealth Needs Standards and Inter-operability

2009-12-17T18:58:00.000-06:00

I am providing the link to an article in MobiHealthNews with little commentary. The article can be found at: http://mobihealthnews.com/5797/nhs-wireless-health-needs-standards-interoperability/. My one comment is that it appears that his objectives for tele-medicine are similar to my own: provide medical care that keeps patients out of hospital and nursing homes.

The article is an interview with George MacGinnis who is with the Assistive Technology Programme at the NHS Connecting for Health in the UK. He was interviewed by MobiHealthNews at the Mobile Healthcare Industry Summit in London. I think it is well worth taking the time to read this interview. In addition, MobiHealthNews has included a video of the interview.

Revamping the Revenue Generation Model in the Medical Device Industry

2009-12-15T22:53:00.000-06:00

My fourth posting on this blog on 29 September 2009 was part of a multi-part examination of Medtronic's remote programming patent (US Patent # 7,565,197 that was granted in 21 July 2009). I suggested that the patent patent implied two directions in the development of medical devices:

The development of a single, common hardware platform based on a generalized processor, similar to TI's low power processor. (Add urls).
Medtronic device capabilities would be defined primarily by software. Furthermore, the patent defines a capability for software to be downloaded to a device, thus defining the capability for updating the software on the device.

We've learned that there are technologies in development that could significantly increase the battery life of devices: maybe at some point eliminating the need for battery replacement all together.

Today, physicians, hospitals and device manufacturers receive the bulk of their payment when a device is implanted or replaced. Thus, the current business model of device manufacturers relies on primarily on product such as an ICD or CRT and leads.

However, the Medtronic patent suggests the possibility, maybe even the likelihood of strategic shift from a product to a licensing business model. This would suggest a business similar to software companies who charge a flat or yearly fee for the use of software. Instead of a replacement, the patient receives a software upgrade and the device company receives payment for the software upgrade. This is one step removed from a pure product to a service-oriented model, but it still treats the software as a product. Nevertheless, it provides flexibility to the medical device company in that revenue comes less tied to the sale of objects, and more tied to the services provided to the customer.

An even more innovative approach and more in-line with a service-oriented business model would be to have the software redefine the capabilities of the device itself while implanted in the patient. For example, upgrade an ICD to a CRT-D by changing software. I do not know the technical, implantation or leads-related issues of doing this, however, from a software standpoint, there should be nothing stopping a device manufacturer who has taken the common hardware design approach.

A pure service-oriented model would change on the basis for the services provided. Since I'm a technologist and not an MBA who has worked in the device industry for decades, I cannot define all the possible revenue-producing services medical devices with remote monitoring and remote programming could provide device companies. I can say that the services that medical device companies can provide medical care providers and their patients is becoming less and less tied to the devices themselves. So a more service-oriented perspective in the medical device industry seems warranted.

It seems apparent that for medical device companies to expand their services and patient-care and management capabilities with information-based services over the communications infrastructure, they are going to have to change the way they receive revenue. The current business model and means of generating revenue does not provide incentives to companies to expand into information based services given the current product-based revenue model currently in use. I suspect that in a relatively short time, Medtronic will propose a new revenue model. I shall be watching for the signs.

Essay: Economical Medicine

2009-12-13T19:12:00.000-06:00

To my readers: I have been engaged in high-priority activities for my current client and have unfortunately neglected this blog. I plan on publishing a flurry of articles from now to the end of this year. Furthermore, I am re-initiating my review of patents and patent applications.

Preface

In this essay I discuss some of my observations regarding the US medical system. I discuss what I consider could be the impact of remote monitoring technology on US medical practice.

I hope that people outside of the United States read my blog. I provide my perspective as one US citizen about the US culture and medical practice. I hope that others may chime in, and provide their perspectives regarding the US medical system, their own medical systems (if citizens of another country) and provided me with their perspectives.

I argue that remote monitoring can provide high quality health care at a lower cost. Remote monitoring provides lower cost health care primarily by keeping people out of the hospitals. As a result, the huge infrastructure devoted to hospital will likely whither. Hospitals will always have a place, but they'll become smaller and targeted to providing critical services such as trauma care, critical care and post-operative recovery. People will spend less time in the hospitals, but physicians and automated care-givers will be able to monitor patients where ever they are located - mostly, away from the hospital.

But before I discuss my views on remote monitoring and it's place in economical medicine, I discuss my concepts of economical medicine.

Economical Medicine

My home is Chicago, Illinois, and over the last few years, I have seen a spat of new hospital construction. Admittedly, there are areas where there are too few hospital beds and services. I have been astonished by the amount of recent construction. It seems that the hospital are competing with each other to see who can provide the newest, most up to date hospital. Furthermore, many of these same hospitals purchase the most expensive scanning equipment available and build large testing laboratories.

The United States provides some of the worst and the best medical treatment available in the industrialized world. If you want something extra-ordinary performed, come to the US. Where the US fails is providing mundane care to the majority of its populace. Our outcomes for the extraordinary are fabled, but the US ranks 37 in the WHO health care rankings behind countries such as Costa Rica, Columbia, Dominica, besides the obvious ones such as France, Switzerland, Austria, Italy, etc.

A landmark study published in 2000 showed that the US has the most expensive health care system in the world based on per capita and total expenditures as a percentage of gross domestic product.

In 1998 the US spent $4,178 per person on health care in 1998. The study median was $1,783 and the closest competitor was Switzerland at $2,794. US spending as a percentage of gross national product was 13.6 percent. The countries closest were Germany (10.6%) and Switzerland (10.4%). And things since 1998 have only gotten more expensive in the US to the point where the US care costs have reached crisis proportions.

Yet in the midst of an attempt to repair the US crisis, members of the US Congress, including nearly every member of the Republican party, have demonized any attempt to make the cost of health care more reasonable. Particularly, when the costs of US health continued to increase at a pace that would eventually drastically lower the standard of living of the majority of Americans. Why is this?

The roots of the opposition are clearly political and rooted in the economic interests of primarily the US health insurance companies. Health insurance companies nearly own and operate many members of the House and Senate on matters of health care. And these health care companies decided to declare war against any and especially a strong public insurance option - e. g., anything close to Medicare for the rest of us. However, there is cultural resistance as well.

Culturally, Americans are profligate. We are a non-economical culture and that believes itself to have no limits. Our sense of limitlessness is our greatest strength and weakness, and it has been running out of control for a long time.

Americans build roads and cars instead of building trains and tracks. We built muscle cars with large and powerful engines for decades instead of fuel-saving vehicles. We built suburbs along our superhighways and commute long distances to work in vehicles that consume excessive amount of fuel. We built large houses and houses with little insulation that consume excessive amounts of fuel to heat and excessive amounts of electricity to cool and light. Growing up in this culture, my sense is that many Americans construe excess with the good life. That need not be case.

We have a medical system that costs too much, delivers too little, places undue burdens on it's practitioners such as malpractice insurance costs and excessive paperwork. In addition it has been perceived by a wide variety of players as a way to make massive, excessive amounts of money. Getting fairly paid for a medical service, product or drug is a good thing. Excessive payments can corrupt or bankrupt an entire system.

Lower Cost Does Not Necessarily Equal Lower Quality

Over the past several decades we have be privy to a revolution, a revolution in ubiquity of computer power. Compare the cost of an 1984 Apple Macintosh or a 1984 PC with one today. The costs are either comparable or lower, but the computational power has skyrocketed from then to now. Everything in the computational and communications sphere has increased while the cost has decreased. Supercomputers and supercomputer availability, rare in the 1980s and early 1990s, has exploded in the last decade. Sophisticated hand held computers with voice and data capabilities that dwarf the powers of 1990's desktop computer are available for hundreds of dollars.

Remote Monitoring

Remote monitoring is a minor outgrowth of the computing and data communications revolution. It makes some use of the continuing computer and telecommunications developments, but so far, relatively little. However, the potential is there as well as the interest in spreading the capabilities of the computing and communications revolution to the medical community. In fact, I believe that many computer scientists and engineers consider medicine one of the last frontiers to thoroughly swept-up in this revolution.

Medicine by nature is a conservative discipline. It deals with people's lives. In the US there's the added problem of the legal profession and malpractice insurance companies breathing down a physician's neck.

I believe that the medical industry finally fully leverages the capabilities of the computer and communications revolution, medical costs will be lowered, people will spend either no or little time in hospitals. Physicians will have the capability of tuning the dosages of medication in real time. Sophisticated computer systems that have made use supercomputer models will be able to determine the medical status of a patient in real time or near real time. These systems will be able to determine if a patient is showing signs of a pending medical crisis and requires intervention before the crisis appears.

All this can be available to the citizenry at a cost that would surprise you. This is the ounce of prevention on a grand scale.

I shall continue to discuss economical medicine in future articles and how leveraging the computational and communications revolution will contribute to providing better medical care at a lower cost.

Biotronik TRUST Studies: Reprinted Abstracts and Commentary

2009-12-01T09:00:00.000-06:00

What follows are published abstracts of the Biotronik studies that provided evidence that Home Monitoring can substitute for quarterly check-ups for ICD patients. That care of ICD patients can be just as effective with one per year in-clinic check-ups instead of the normal three month in-clinic check-ups. This was supported primarily by 2008 study.

The 2009 study is a logical follow-up to the 2008 study. This study provided evidence that the Biotronik remote monitoring (Home Monitoring) system can provide early-warning notifications of significant cardiac events faster and more effectively than quarterly, in-clinic visits. This study has wider implications. It provides evidence that remote monitoring can provide the kind of care that at one time could only be provided in hospitals. Furthermore, it demonstrates the kind of capability necessary to provide the kind of early warning that can keep specific, targeted populations out of hospital, thus providing more economical and more desirable health care.

These studies are reprinted with permission from Biotronik. (I have no affiliation with Biotronik.)

2008 Study

Evaluation of Efficacy and Safety of Remote Monitoring for ICD Follow-Up:

The TRUST Trial

Authors: Niraj Varma, Cleveland Clinic, Cleveland, OH; Andrew Epstein UAB Medical Center, Birmingham, AL; , Univ of Alabama Birmingham Medical Center, Birmingham, AL; Robert Schweikert Cleveland Clinic, Cleveland, OH; , Akron Medical Center, Akron, OH; Charles Love, Davis Heart and Lung Research Institute, Columbus, OH; Jay Shah, Carolina Cardiology Associates, Rock Hill, SC; Anand Irimpen; Tulane University Medical Center, New Orleans, LA

Background: Remote monitoring (RM) of ICDs may provide daily, automatic device and patient status data and cardiac event notifications. TRUST tested the hypothesis that RM was safe and effective for ICD follow-up for 1 year in a prospective, randomized controlled clinical trial.

Methods: 1282 patients were randomized 2:1 to RM or to conventional (RM disabled) groups.Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. In the RM arm, RM was used before office visits (OVs) at 3 and 15 months. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. Conventional patients were evaluated with OVs only. Follow up was “actionable” if system reprogramming/revision or change in anti-arrhythmic therapy occurred. Scheduled and unscheduled OVs (including responses to event notifications in RM) were quantified for each individual patient per year (pt yr) of follow up. Incidence of death, strokes and surgical interventions (morbidity) was tracked in both groups.

Results: RM and conventional patients were similar in age (63.3 ± 12.9 vs 64.1 ± 12.0 yrs, p = 0.30), gender (71.9% vs 72.4% male, p =; 0.89), pathology (LVEF 29.1 ± 10.8% vs 28.6 ± 9.8%, p = 0.47;coronary artery disease 64.5% vs 71.4%, p = 0.02), medications (Beta blockers 79.5% vs 75.9%, ACE inhibitors 42.4% vs 46.8%, ARBs 7.8% vs 9.9%, p = NS), indication (primary prevention 72.3% vs 74.2%, p = 0.50), and dual chamber implants (57.9% vs 57.0%, p = 0.76). RM reduced scheduled OVs by 54% and total OVs by 42% without affecting morbidity. Event notifications were managed using RM alone in 92% of cases. Of the remainder resulting in unscheduled OVs, 52.2% were actionable. RM improved adherence to follow-up.

Conclusions: TRUST demonstrated that remote monitoring is safe, decreases the need for in-office visits, provides early detection of significant problems, and improves ICD surveillance without increasing unscheduled office visits. In conclusion, remote monitoring is a safe alternative to conventional care.

2009 Study

EARLY DETECTION OF ICD EVENTS USING REMOTE
MONITORING: THE TRUST TRIAL

Authors: Niraj Varma, MD, FRCP, Andrew Epstein, MD, Anand Irimpen, MD, Robert Schweikert, MD, Jay Shah, MD, Lori Gibson, DVM and Charles Love, MD. Cleveland Clinic, Cleveland, OH, University of Alabama Birmingham Medical Center, Birmingham, AL, Tulane University Medical Center, New Orleans, LA, Akron Medical Center, Akron, OH, Carolina Cardiology, Rock Hill, SC, Biotronik, Inc., Lake Oswego, OR, Davis Heart & Lung Research Institute, Columbus, OH

Introduction: ICDs have extensive self-monitoring capability with diagnostic data available at interrogation. Remote Monitoring (RM) may facilitate data access but this has not been tested. The secondary endpoint of the TRUST trial tested the hypothesis that RM with automatic daily surveillance can provide rapid notification thereby facilitating prompt physician evaluation.

Methods: 1312 patients were randomized 2:1 to RM or to conventional (C) groups. Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. RM was used before office visits (OVs) at 3 and 15 months in RM group. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. C patients were evaluated with OVs only. Unscheduled checks between these time points were tracked. The hypothesis was tested by determining time elapsed from first event occurrence in each patient to physician evaluation.

Results: RM and C patients were similar (age 63 ±13 vs 64 ±12 yrs; gender 72 vs 73% male, NYHA class II 56 vs 61%, pathology LVEF 29 ±11 vs 28 ± 10%; CAD 65 vs 72%, amiodarone 14 vs 14%, primary prevention indication 72 vs 74%, and DDD implants 58 vs 57%). Median time to evaluation was < 3 days in RM compared to < 30 days in C (p < 0.001) for all arrhythmic events (figure) including silent episodes eg AF. System (lead/ generator) problems were infrequent (20 events in RM +C).

Conclusions: Remote monitoring with automatic daily surveillance provides rapid detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling early physician evaluation.

Commentary

2008 Study

Of significant interest would be morbidity rate. The remote monitoring group showed a .9% higher death rate than the conventional group. This result was also nonsignificant. The nonsignificant difference appears to be expected outcome. Demonstrating a negative - or no difference - is always a concern in research because of the logical problem in demonstrating that something did not happen or that there are no difference between the groups.

I have an additional concern with respect to the unbalanced design. Unbalanced designs have lower power of your statistical power - that is, the ability to reject the null hypothesis - than balanced designs. And that would be of concern in study where the expected outcome is no difference. However, the numbers are extremely large that should off-set the reduction in statistical power created by the unbalanced design. Since I do not have the raw data, I cannot be sure. Nevertheless, this seems reasonable.

The remote monitoring group did have a slightly higher rate of unscheduled appointments - .6 per year in the RM group and .5 in the conventional group; and the actionable percentage was .7% higher in the RM group. The differences could be considered marginally significant with a p = .104. If I understand the circumstances correctly, it seems reasonable that remotely monitored patients would have a higher rate of unscheduled appointments. Remote monitoring should have the capability of earlier detection of arrhythmic events. Thus a detected cardiac event would trigger the patient's to request that the patient come to the clinic as soon as possible thus an unscheduled appointment would be registered. One might expect remotely monitored patients would have appointments that are more demand or situation based than regular, scheduled appointments.

In spite of this difficulties of this design, the conclusions of this study seem reasonable in that the remotely monitored patients who received in-clinic check-ups once per year had similar outcomes to those who receives conventional care with four in-clinic visits per year.

A point of interest. No comparisons were made between Biotronik and remote monitoring systems provided by other companies such as Medtronic, St. Jude Medical or Boston Scientific. I understand the difficulties and roadblocks in the attempt to assess whether the other systems would be just as effective. However, Biotronik effectively side-stepped the issue by comparing their home monitoring system against conventional care thus avoiding comparisons with other remote monitoring systems. Biotronik focused on effectiveness against conventional care and in this case they were successful.

2009 Study

As a study to show the effectiveness of remote monitoring, I believe this study is more effective. First, it's a better design in that the expected outcome is to reject the null hypothesis - that is, to find a significant difference. Second, there is a clear case made by the findings that remote monitoring leads to earlier discovery of an adverse event. One truism in medicine, particularly when it comes to cardiac events, is the earlier the discovery, the better the outcome. Another thing, ICD patients have been identified as a vulnerable population and rapid reports of adverse events within this population are particularly welcome.

In theory, over time patients remotely monitored should show better outcomes than those who are not. The data in these two studies does not show that. However, data from other studies are starting to demonstrate that remotely monitored patients are less likely to be admitted to the hospital. This is a new area of technology and more research is required. However, the trends are favorable for remote monitoring.

In this study, the Biotronik remote monitoring system reported arrhythmic events. The data reported was not early warning or predictive. The capability to collect predictive data would increase the value of remote monitoring. Predictive data would allow the clinic (or computer system) following the patient to intervene before the adverse event occurs. In this study, this was not the case.

Remote Monitoring Equals Healthier Patients

2009-11-20T17:01:00.000-06:00

I know I promised an article that discussed the Biotronik studies. However, I just came across a brief article that I wanted to share. It's a brief description of an article that shows the introduction of remote monitoring can substantially reduce hospital admissions. Here's the link: http://articles.icmcc.org/2009/11/20/remote-monitoring-yields-healthier-patients/.

This is the kind of article that provides additional, supporting evidence that demonstrates the benefits of remote monitoring: to patients and to the bottom-line of health care. Furthermore, as I remarked in http://medicalremoteprogramming.blogspot.com/2009/11/virtual-doctor-visit-washington-post.html, the people I've known have wanted to stay out of hospitals. So this should be considered a win all way around.

Body Area Networks

2009-11-19T19:12:00.000-06:00

This is one of the best articles I have seen recently that discusses emerging technologies and standards for Body Area Networks. It's published by ZDNet. Here's the link: 7 things you should know about Body Area Networks (BANs).

Next article I'll discuss the two articles on the Biotronik Home Monitoring system: TRUST articles.

The Virtual Doctor Visit: Washington Post

2009-11-17T17:50:00.000-06:00

I grew up around elderly people. My parents were middle-aged when I was born, grandparents were elderly, many of my parents friends were elderly. I cannot think of one person who said that they liked being in a hospital. A continual fear of my parents, grandparents and my parents elderly friends was the fear of wasting way in either a hospital or nursing home. Death was a better alternative. Not that they wanted to die, but that they did not want to die in the confines of a hospital or nursing home.

This is an article published today (Tuesday, 17 November 2009) in the Washington Post that discusses remote monitoring as an alternative to a hospital admission. There's a trial underway to determine if remote monitoring can provide the kind of information that physician require to keep people from being admitted to the hospital. It's care in the home. Here's the link: The Virtual Doctor Visit.

Here's an update on the Digital Plaster trial: http://tech.kikil.com/2009/11/medical-debut-for-smart-band-aid/.

Maintaining Communication Security

2009-11-16T12:24:00.000-06:00

Having a secure channel is particularly important for remote monitoring and remote programming. Here's an article that was recently published regarding a company that has taken an interest approach to the problem. Here's the link: Boosting the security of implantable devices.

I am the inventor of a data communications security technology and a founder of a security company. (I am currently a silent partner.) So, I have an interesting in security technology and systems. In later articles, I'll cover some of the issues regarding maintaining communications security.

Biotronik Home Monitoring: Update

2009-11-13T12:18:00.000-06:00

Biotronik Home Monitoring recently received the industry's first European CE Mark. Here is the link to one of the publications that announced this: Biotronik Home Monitoring Receive Industry Approval. The approval appears to be founded on the studies conducted by Varma that are referenced in the article. I hope to have more information on this subject in the near future.

Near Future: Remote Monitoring and Programming

2009-11-12T21:37:00.000-06:00

This article will focus on a system of remote medical monitoring and remote programming as shown in the figure below.

I've discussed elements of this design in earlier posts, so I'll not go into detail about things that I have already covered. This is particularly true with respect to the communications model wherein that involved a mobile and a central server. The model I show in the figure is more "ready" for commercial deployment in that there multiple, redundant Central Servers in multiple locations. This is in keeping with telecommunications philosophy for achieving near perfect connectivity through the backbone systems.

Another addition is that of WiMax (802.16 standard, for more information: WiMax Wikipedia) that is now being commercially deployed. This adds another viable data channel from which to send data. As I mentioned before, the system that we developed was able to move traffic over one or all channels simultaneously, and traffic can be rerouted based on additional channel acquisition or loss.

The important elements of this design for this discussion are at the ends. Let's begin at the bottom of the diagram. A patient could be implanted with multiple devices from multiple manufacturers. In the diagram I show an insulin pump from Medtronic (http://www.medtronic.com/our-therapies/diabetes-management/index.htm), an ICD from St. Jude Medical (http://www.sjmprofessional.com/Products/US/ICD-Systems/Current-RF-ICD.aspx) and a pacemaker from Boston Scientific (http://www.bostonscientific.com/Device.bsci?page=HCP_Overview&navRelId=1000.1003&method=DevDetailHCP&id=10103841&pageDisclaimer=Disclaimer.ProductPage). We could include devices from Biotronik (http://www.biotronik.com/portal/home) as well. The mobile server in the diagram can communicate with all the devices and address and communicate with them individually. (We have already proven this technology.) We would assume that the data traffic from the devices would be bidirectional and that delivery is guaranteed and secure across the connection, to and from the analysis and device servers.

Without going into substantial detail, each device has a specific and separate device managing process running on the mobile server. Using a "plug-in" architecture, each process communicates with the multi-layered, distributed system that moves data across the network. Each device has a continuous, virtual connection with its counterpart Analysis and Device Management server to support both remote monitoring and remote programming.

The digital plaster (or plastic strips) would generate various types of monitoring data as shown in the diagram. A single, multi-threaded process could manage any number of strips.

It would be conceivable for the device managing processes to subscribe to any of the digital plaster processes and send the collected data from the patients to any or all of the Analysis and Device Management Servers. The digital plaster strips could collect data from any number of locations and a variety of types of data. This would reduce the need for building the monitoring capabilities inside of the devices and conceivably provide the kind of the data the device could never provide.

This system is primarily software-defined and is highly flexible and extensible. Furthermore, it provides the flexibility to incorporate a wide variety of current and future monitoring systems. I'll continue to update this model as I find more products and technologies to include.

Remote Monitoring: Predictability

2009-11-08T18:52:00.000-06:00

One of the most controversial subjects in measurement and analysis is the concept of predictably. Prediction does not imply causality or a causal relationship. It is about an earlier event or events indicating the likelihood of another event occurring. For example, I've run simulation studies of rare events. If any of my readers have done this, you'll notice that rare events tend to cluster around each other. This means that if one rare event has occurred, it's likely that the same event will occur again in a relatively short time.

Interestingly, the clustering does not seem to be an artifact of the simulation system. There are some real-world examples. Consider the paths of hurricanes. At any one time, it is rare that a hurricane will make landfall at a particular location. However, once a hurricane has hit a particular location, it appears that one can predict that the likelihood of the next hurricane hitting in that same general area goes ups. I can think of a couple of examples in recent history. In 1996, hurricanes made landfall two times around the area of Wilmington, NC. Furthermore, a third hurricane passed by. In 2005, New Orleans was hit solidly twice. If you look at two hurricane seasons - 1996, 2005 - you'll note that they show quite different patterns. The rare event paradigm suggests that when the patterns for creating rare conditions are established, they will tend to linger.

In medicine the objective is to find an event or conditions preceding an event before the event of concern occurs. For example, an event of concern would be a heart attack. It is true that once one has had a heart attack, another one could soon follow. The conditions are right for a follow-on event. However, the objective is to prevent a heart attack - not wait for a heart attack to occur in order to deal with the next one that is likely to soon occur. Physicians employ a variety of means to attempt to detect possible conditions that may indicate an increased likelihood of a heart attack. For example, cholesterol levels that are out of balance might signal an increase in likelihood of having a heart attack.

The problem is that most of the conditional indicators that physicians currently employ are weak indicators of an impending heart attack. The indicators are suggestive. Let me provide an example using a slot machine as an example. Let's assume that hitting the jackpot is equivalent to an heart attack. Each pull of the lever represents another passing day. On it's own, with the settings that the machine is initially set to, the slot machine has a possibility of hitting a jackpot with each pull of the lever. However, the settings on the slot machine can be biased to make it more likely to hit a jackpot. This is what doctors search for ... the elevated conditions that make a heart attack more likely. Making hitting a jackpot more likely does not mean that you're ever going to hit one. It just increases the likelihood that you will hit one.

To compound the problem, the discovery of biasing conditions that appear to increase the likelihood of events such as heart attacks are often difficult to clearly assess. One problem is that apparent biasing indicators or biasing conditions generally don't have a clear causal relationship. They are indicators, they have a correlative relationship (that is not always strong), and not a causal relationship. There are other problems as well. For one, extending conclusions to an individual from data collected from a group is generally considered suspect. Yet, that is what's going on with respect to measuring performing assessments on individuals. Individuals are compared to norms based on data collected from large groups of individuals. Overtime and with enough data, norms may be considered predictors. Search out the literature. You'll note that many times, measurement that once were considered predictive, now no longer are.

The gold standard of prediction is the discovery of predecessor event or events. It is something that precedes the watched-for event. In Southern California everyone is waiting for the great earthquake. Scientists have been attempting to discover a predecessor event to that great earthquake. Same goes for detecting a heart attack or other important medical events that are threats to ones health. Two clear problems stand in the way of discovering a clear predecessor event. The first is finding that event that seems to precede the event of interest. This not easy. A review of the literature will inform you of that. Second, is once you've found what appears to be a predecessor event, what's its relationship to the target event, the event of interest? Often times that is a very long process and even with effectively predictive predecessor events, the relationship is not always one to one. In that, one predecessor event may not precede the event of interest. Several predecessor events could precede the event of interest. Or, the predecessor event does not always appear before the event of interest.

This ends my discussion of predictability. Next time ... I'm going to speculate on what may be possible in the near term and how the benefits of remote monitoring and remote programming can be made available relatively inexpensively to a large number of people.

Article update notice

I have updated my article on Digital Plaster. I have found an image of digital plaster that I have included, plus a link to one of the early news releases from the Imperial College, London, UK. I shall include Digital Plaster in my next article.

Remote Monitoring: Update to Sensitivity and Accuracy

2009-11-08T15:06:00.000-06:00

Before I dive into the subject of predictability (following article), I have an update on one of my previous articles: Remote Monitoring: Sensitivity and Accuracy. It comes from a discussion I had with a colleague regarding what appeared to be counter-intuitive results. The issue was the data sampling rate over a fix period of time. As the sampling rate increased, accuracy decreased. Thus with seemingly more data, accuracy went down.

Going back to the Signal Detection paradigm, the paradigm suggests that as a rule increasing the number of data points will reduce the false positives (alpha). And reducing false positives was a major objective of this research. Frankly for a time I was flummoxed. Suddenly I realized that I was looking at the problem incorrectly. I realized that the problem is with the resolution or granularity of the measurement.

The Signal Detection paradigm has as a fundamental assumption the concept of a defined event or event window - and detecting whether or not within that event window a signal is present. The increased sampling rate compounded error, particularly false positive errors. In effect, the system would take two samples, within the conditions that set-off the false positive. Thus producing more than one false positive within an event window where only one false positive should have been recorded.

How to overcome the problem of oversampling, of setting the wrong size event window? Here are some things that come to mind:

First, recognizing that there's an event-window problem may be the most difficult. This particular situation suggested an event-window problem because the results were counter to expectations. Having primarily a theoretical perspective, I am not the best one to address this issue.
Finding event windows may involve a tuning or "dialing-in" process. However it is done, it may take many samples at various sampling resolutions to determine the best or acceptable level of resolution.
Consider adding a waiting period once a signal has been detected. The hope is that the waiting period will reduce the chances of making a false positive error.

On a personal note: I find it amusing that before this time, I had never encountered a granularity-related issue. I theory I have understood it, but ever encountered it in my own research. This was in part because the research I have performed has always had clear event boundaries. Nevertheless, within days of writing about Sensitivity and Accuracy and the granularity issue in this blog, I encounter a granularity problem.

Sensor Technology: Digital Plaster and Stethoscope

2009-11-03T19:28:00.000-06:00

Digital Plaster

Toumaz Technology has announced the clinical trials of what they are calling "digital plaster" that should enable caregivers to remotely monitor patients. In the initial trial it would allow caregivers to remotely monitor patients when they are in the hospital. However, conceivably patient could carry a mobile monitoring system like the one that I discussed in my article: Communication Model for Medical Devices.

Here is a link the article on Digital Plaster: http://www.sciencecentric.com/news/article.php?q=09110342-digital-plaster-monitoring-vital-signs-undergoes-first-clinical-trials.

Update: Here's an image of digital plaster from a UK website. This is to provide you with an image of the size and means of application of digital plaster. It's a sensor placed into a standard plastic or cloth strip. Simple to apply and it's disposable.

For more information, here's the link: Imperial College, London, UK. This is a 2007 article. This is a good reference point to investigate the technology.

Digital Stethoscope

Another development was the announcement at TEDMED of the digital ste. Here's the link to the article: http://mobihealthnews.com/5142/tedmed-wireless-health-has-killed-the-stethoscope/. This article discusses this and other new wireless medical devices that will enable patients to be remotely monitored from virtually anywhere. Thus providing the capability to keep people out of hospitals or keep them for shorter periods of time. Furthermore, these technologies have the capability of improving care while lowering costs. Again I think it would be instructive to read my articles on mobile, wireless data communications: 1) Communication Model for Medical Devices and 2) New Communications Model for Medical Devices.

Remote Monitoring: Sensitivity and Accuracy ... using wine tasting as a model

2009-11-01T21:05:00.000-06:00

This article focuses on measurement accuracy, sensitivity and informativeness. Sometime later I shall follow will an article that will focus on predictability.

I discuss measurement accuracy, sensitivity and informativeness in this article in the abstract and use an example, wine tasting. However, in later articles when I drill-down into specific measurements provided by remote monitoring systems. I shall make reference to concept foundation articles such as this one when I discuss specific measurements and measurement systems.

For remote monitoring to be a valuable tool, the measurements must be informative. That is, they must provide something of value to the monitoring process - whether that monitoring process is an informed and well trained person such as a physician or software process. However, there are conditions that must first be met before any measurement can be considered informative.

For any measurement to be informative, it must be accurate. It must correctly measure whatever it was intended to measure. For example, if the measurement system is designed to determine the existence of a particular event, then it should register that the event occurred and the number of times that it did occur. Furthermore, it should reject or not respond when conditions dictate that the event did not occur - that is, it should not report a false positive. This is something that I covered in detail on my article on Signal Detection. Measurement extend beyond mere detection and to the measurement tied to a particular scale, e. g., such as the constituents in a milliliter of blood.

A constituent of accuracy is granularity. That is, how fine is the measurement and is it fine enough to provide meaningful information. Measurement granularity can often be a significant topic of discussion, particularly when defining similarities and differences. For example, the world class times in swimming are to the hundredth of second. There have been instances when the computer that sensed that two swimmers touched the end simultaneously and that the times were identical. (I can think of a particular race in the last Olympics that involved Michael Phelps and the butterfly.) At the resolution of the computer touch-timing system (and I believe it's down to a thousandth of a second), the system indicated that both touched simultaneously and that they had identical times. However, is that really true? If we take the resolution down to a nanosecond, one-billionth of a second, did they touch simultaneously?

However, at the other end, if measurements are too granular, do they lose their meaningfulness? This is particularly true when defining what is similar. It can be argued that with enough granularity, every measurement will differ from all other measurements on that dimension. How do we assess similarities because assessing similarities (and differences) is vital to diagnosis and treatment.

We often make compromises when in comes to issues of granularity and similarity by categorizing. And often times, categorization and assessments of similarities can be context-specific. This is something that we do without thinking. We often assess and reassess relative distances. For example, Los Angeles and San Diego are 121 miles from each other. (I used Google to find this distance.) To people living in either city, 121 miles is a long distance. However, to someone is London, England, these two cities would seem to be nearly in the same metropolitan area. They appear within the same geographic area from a far distance.

Sensitivity is a topic often unto itself. Since I discussed it at some length when I discussed Signal Detection, I shall make this discussion relatively short. In the previous discussion, I discussed the issue related to a single detector and its ability to sense and reject. I want to add the dimension of multiple detectors and the capability to sense based on multiple inputs. In this case I am not discussing multiple trials to test a single detector, but multiple measures on a single trial. Multiple measurements on different dimensions can provide greater sensitivity when combined even if the accuracy and sensitivity of each individual measurement system is less accurate and sensitive than the single measurement system. I'll discuss this more in depth in a later article.

Informativeness ... this has to do with whether the output of the measurement process - its accuracy (granularity) and sensitivity - provides one with anything of value. And determining the value depends on what you need that measurement to do for you. I think my example provides a reasonable and accessible explanation.

Wine Tasting - Evaluating Wine

Over the years, people interested in wine have settled on a 1-100 scale - although, I do not know of an instance where I have seen anything less than an 80 rating. (I am not a wine expert by any stretch of the imagination. I know enough to discuss it, that's all. If you're interested, here's an explanation, how ever they will want to sell you bottles of wine and some companies may block access, nevertheless, here's the link: http://www.wine.com/v6/aboutwine/wineratings.aspx?ArticleTypeId=2.)   Independent or "other" wine raters use a similar rating system. Wine stores all over the US often have their own wine rater who "uses" one of these scales. In theory, you'll note that they're reasonably similar. In practice, they can be quite different. Two 90 ratings from different wine raters don't always mean the same thing.

So, what is a buyer to do? Lets look at wine rating in a mechanistic way. Each wine rater is a measuring machine who is sensitive to the various constituents of a wine and how those constituents provide an experience. Each rating machine provides us with a single number and often a brief description of the tasting experience. But, for most people buying wine, it's the number that's the most important - and can often lead to the greatest disappointment. When we're disappointed, the measurement has failed us. It lacks informativeness.

How to remedy disappointment of expectation and often times, over payment? I think of four ways:

Taste the wine yourself before you buy it. The wine should satisfy you. You can determine if it's worth the price. However, I've met many who are not always satisfied with this option for a variety of reasons, ranging from they do not trust their own tastes or lack of "wine knowledge" to the knowing that they are not in a position to taste the wide variety of wines available to professional wine tasters, and thus are concerned about "missing out." Remote monitoring provides a similar situation. A patient being remote monitored is not in the presence of the person doing the monitoring, thus the entire experience of seeing the patient along with the measurement values is missing. However, remote monitoring provides the capability to provide great deal of information about many patients without the need to see each individual. The problem is, the person doing the monitoring needs to trust the measurements from remote monitoring.
Find a wine rater who has tastes similar to yours. This might take some time or you might get lucky and find someone who likes wine the way you like it. Again, this all boils down to trust.
Ask an expert at the wine store. The hope is that the person at the store will provide you with more information, ask you about your own tastes and what you're looking for. Although this is not experiential information, you are provided with more information on more dimensions with the ability to re-sample on the same or different dimensions (i. e., ask a question and receive an answer). In this sense, you have an interactive measurement system. (At this juncture, I have added by implication remote programming to mix. Remote programming involve adjusting, tuning or testing additional remotely monitored dimensions. In this sense, the process of remote monitoring can be dynamic, inquiry-driven. This is a topic for later discussion.)
Consolidate the ratings of multiple wine raters. Often several wine raters have rated the same wine. This can get fairly complicated. In most cases not all wine raters have rated the same wine and you'll probably get a different mix of raters for each wine. This too may involve some level of tuning based on the "hits" and "misses."

This ends this discussion of measurement. Measurement is the foundation of remote monitoring. For remote monitoring what its measuring and the accuracy and sensitivity of that measurement and whether that measurement is informative is key to its value. We've also seen a place for remote monitoring as a means for getting at interesting measurements; changing measurement from a passive to an active, didactic process.

Next time I discuss a recent development with respect to physiological measuring systems. Here's a link to an article that I believe many will find interesting. http://mobihealthnews.com/5142/tedmed-wireless-health-has-killed-the-stethoscope/

Biotronik Home Monitoring Claim

2009-10-28T11:59:00.000-05:00

I'm posting this article before my discussion on measurement and sensing because it has relevance to my immediately preceding posting.

Biotronik released to the press on Tuesday 27 October 2009 an announcement regarding their Evia Pacemaker. In that press release was some additional information regarding Biotronik's Home Monitoring system. Here's the link to the press release: http://www.earthtimes.org/articles/show/biotronik-launches-evia-pacemaker-series,1016041.shtml

The relevant quote from the press release is the following:

Now physicians have the choice to call in their patients to the clinic or perform remote follow-ups with complete access to all pertinent patient and device information, including high quality IEGM Online HD^®. Importantly, BIOTRONIK Home Monitoring^®has also received FDA and CE Mark approval for its early detection monitoring technology which allows clinicians to access their patients’ clinically relevant event data more quickly so they can make immediate therapy decisions to improve patient care.

The indications are that the Biotronik claims that their system provides quicker access to relevant data, not that the data (and analysis) yield earlier warning results. This is consistent with my earlier analysis and that seems to be supported by Biotronik's own admission.

I do wonder about Biotronik's long-term objective. I suspect that Biotronik wants to be one of the big three implantable device manufacturers, not just become one of four. It would mean that Biotronik would likely target one of the big three to replace and that would likely involve targeting the weaknesses of the company that Biotronik wants to replace. I'll continue to monitor Biotronik and report what I find.

Next, my discussion on measurement and detection.

Remote Monitoring: Deep Dive Introduction

2009-10-25T19:34:00.000-05:00

I am going to change course over the next few entries to focus on remote monitoring. This article is the first in a series of articles on Remote Monitoring and what can be gleaned from the data remote monitoring collects. The Biotronik press releases and some of the claims they have been making have driven me to investigate and speculate on remote monitoring, its capabilities, potential and possible future.

Two claims that Biotronik have made for it's Home Monitoring system have intrigued me. First, Biotronik claims as a proven capability of earlier detection than other systems of critical, arrhythmic events. Second, they also claim that they can report these events earlier than other systems.

Let's take the second claim first, Biotronik has created a system with the capability to more quickly notify (e. g., transmit) implant data. The Biotronik mobile capability enables a faster detection and quicker transmission of those events by virtue of its mobile capability. Their claim is rooted in mobility of their monitor and its communication system. So, the second claim appears plausible.

The first claim is more difficult not only because it is more difficult to prove, but because it's more difficult to define. I think of at least two ways the capability could be defined and implemented. One, consider the signal-detection paradigm. I have a drawing that defines the basic signal detection paradigm below.

The basic concept of signal detection is extraordinarily simple. On any given trial, a signal is either present or not. It is the job of the detector to accurately determine whether or not the signal is present. There are two right answers and two wrong answers as shown in the diagram. The type 1 error is the indication by the detector that is signal is present when it is not. (The probability of a type 1 error is represented by Greek letter alpha.) The type 2 error is incorrectly indicating that a signal is not present when in fact it is. (The probability of a type 2 error is represented by Greek letter beta.)

The objective of detector improvement is to reduce both type 1 and 2 errors. However, often times adjustments are made to alpha or beta to make it look like there's an improvement. For example, if sensitivity is the crucial characteristic, the engineers may be willing to sacrifice an increase in type 1 errors to reduce type 2. (This gets into what's called receiver operating characteristics or ROC. Something for a later blog article.)

I discuss the signal detection paradigm for two reasons. First, the signal detection paradigm is an engineering and scientific touchstone that I'll refer to in later articles. Second, it allows one to assess just what is accurate detection, increasing sensitivity, etc.

Thus Biotronik's claim of earlier detection could be real or it could reflect Biotronik's acceptance of more type 1 errors in order to raise sensitivity. This could lead to earlier detection but at the expense of increasing the likelihood of type 1 errors. In the next article, I'll explore ways to improve detection capabilities, not by increasing accuracy of a particular detector, but by increasing the number of different detectors.

Early detection could also be interpreted as predictive. This is the more difficult than simple detection. This would be the computed likelihood of a particular event based on one or more measurements. This does not fit into the simple signal detection paradigm. It often involves finding a pattern and extrapolation. Or it could involve finding a predecessor indicator; finding a condition that is a know precondition to the target. The specifics of a predictive capability will be discussed in a later article.

This ends the Introduction. The next article will discuss detection capabilities in greater detail.

Update: Future-Market Analysis: Global Patient Monitoring

2009-10-23T00:25:00.000-05:00

I'm posting a link to an article that provides some information from the Global Patient Monitoring Marketing study. Here's the link: Europe Remote Patient Monitoring Market: Strategic Analysis and Opportunity Assessment. One warning, the article is loaded with embedded ads and links to services that they want to sell you. Go to the article, you'll see what I mean. However, it article provides some information about to size and the growth potential for remote monitoring in Europe.

Verizon's Offering at the Connected Health Symposium

2009-10-21T19:17:00.000-05:00

Article from Mobihealthnews.com (@Connected Health: Verizon highlights partners) briefly describing the benefits and cost savings from tele-medicine. For example, Verizon claims that "IT healthcare solutions and services can help organizations save close to $165 billion annually, according to the carrier. The carrier also cites a report from the Insight Research Corporation that estimates $800 million per year could be saved if more treatment was shifted from physician’s offices to home health visits."

Of course, tele-medicine and the applications bring revenue to that Verizon (and other carriers), thus the cost savings amounts should be viewed sceptically. However, in general tele-medicine solutions nearly always provide cost savings over clinic and hospital visits. And they also provide an additional level freedom that improves quality of life.

I want to add this link that sounds a significant concern regarding the supply and demand for communications bandwidth in the near future. Here's the link: http://www.reuters.com/article/pressRelease/idUS121240+21-Oct-2009+PRN20091021. The title of the article is: "Are we ready for the Exabyte Tsunami? (Here's a link to explain an exabyte: http://en.wikipedia.org/wiki/Exabyte).

Biotronik Home Monitoring Operational in Europe

2009-10-20T17:42:00.000-05:00

I've mentioned Biotronik's Home Monitoring system in an earlier post. One of the attractive things about the Biotronik version is that their home monitoring has been deemed a replacement for clinic visits. Quote from the article (link immediately below)

Biotronik Home Monitoring Goes Live in Europe

"Designed to avoid regular visits to the clinic by patients wearing company's ICD's, CRT's, and similar devices, the system sends readings from the chest straight to your doc over the cellular phone network."

This is an interesting development because Biotronik has been taking market share from the big three medical device makers. I think that the Biotronik capability reduce clinic visits translates into either more revenue or more free time. Either one would be attractive for device managing physicians who may suggest to implanting physicians to choose Biotronik. This may be a situation where a robust home monitoring system drives the choice of the brand of device to implant. I do not have clear evidence, but I think the issue is worth investigating.

Three aspects of the Biotronik home monitoring system seem to differentiate it from others. First, the monitoring unit is mobile and uses the GSM to communicate with the monitoring servers. The monitoring servers in turn can notify the device managing physician or clinic with an email, SMS (text) message or fax. Second, Biotronik home monitoring unit has what they call an intelligent traffic light system. I haven't any information on how the intelligent traffic light system operates. Finally, and I think most importantly, the Biotronik system has the capability of earlier detection than other systems of critical, arrhythmic events. They claim that this is a "proven capability." Since I have no information on the operational details or algorithms that they use, I cannot confirm or deny their claims.

The German Government has shown its belief in the bright future of Biotronik and its Home Monitoring technology: Nominated for the German Federal President`s "Deutscher Zukunftspreis" (German Future Award): BIOTRONIK Home Monitoring for Online Monitoring of Heart Patients.

Update: 21 October 2009. A little more information about the research the Biotronik performed with respect to the value and capabilities of their Home Monitoring system.

Biotronik Press Release Published in Reuters Regarding Home Monitoring. This press release mentions three publications of the results of the Biotronik study. I have not yet been able to obtain a copy. From the outside, it's hard to assess of the significance of the technology or technologies that Biotronik has incorporated into their system. However, from the outside, it appears that with the possible exception of the mobile monitoring unit, it looks more like a publicity campaign than substance because there is nothing that I can see that clearly sets Biotronik's remote monitoring system from anyone else with respect to data collection and/or analysis.

Update on 29 September 2009 Posting

2009-10-19T23:07:00.000-05:00

I have an update related to my 29 September posting, Medtronic Remote Programming Patent.I stated the following in that posting ...

I believe that Medtronic's patent ... reveals not only the extent of Medtronic's work on remote programming and their level of development of this technology, it reveals a product development path. ... The strategy that I believe Medtronic has taken is in keeping with long-standing trends in technology development.

Over the last several decades, the trend has been to move away from specialized to more powerful, general-purpose processors. This enables products to be defined more by software than by hardware. Processing power has become smaller, less power hungry and cheaper, thus allowing software to become the means for defining the system's capability. Furthermore, this enables multiple products to be defined by a single hardware platform. ...

The Medtronic patent suggests a similar product strategy ... that different products will use fundamentally the same hardware architecture, but they will be defined by the software that they run. So, a pacemaker, a neurostimulator and a drug pump will share the same processor hardware platform, but their operation will be defined primarily by the software that they run. For example, take some time and examine pacemakers, ICDs. CRTs/CRT-Ds, neuro-stimulators, drug pumps, etc. Although they have different purposes, they have enough in common to consider the possibility that all of them could share a common processor platform.

The implications are significant for all functional areas within Medtronic, from research and development, product development, software development and management, and from product support. Medtronic can leverage its enormous scale to make its scale as a company a major asset. It can substantially reduce the number of hardware platforms it supports, it can leverage its software development capabilities to have its software development groups produce software for multiple product lines, it can create more products without a substantial requirement for additional support each time a product is produced. ...

I unearthed an article published in the August 2008, Journal of Computers, titled "Design Overview Of Processor Based Implantable Pacemaker" authored by Santosh Chede and Kishore Kulat both from the Department of Electronics and Computer Science Engineering at the Visvesvarayan National Institute of Technology. (I do not have an address for you to access this article, however, if you search on the journal, the title and authors, you will find it.)

Their article describes the means by which they created a pacemaker using at Texas Instrument (TI) MSP430F1611 processor to build a pacemaker. The TI MSP430 processor (TI MSP430 Microcontroller Website) is a general purpose RISC processor similar in architecture to the DEC PDP-11. The TI MSP430 is designed for ultra-low power consumption and targeted to battery-powered, embedded applications. In other words, this would be the kind of processor on which to base a line of implantable medical devices. Having looked around the website, I noted that the application of the processor included medical devices, but not implants. However, based on the Journal of Computers article, I can see a clear route to creating implants using this processor. (I haven't yet found a comparable processor, however, I suspect the existence of one or more. As I find additional processors in this class, I shall make them known in this blog.)

Finally, I think the important message of the Journal of Computers article is that it is possible to use a general purpose processor and software to create a pacemaker or any other implantable medical device such as a neuro-stimulator, CRT-D, or drug-pump. As I discussed earlier, using a general purpose processor and software to create the product, can be an effective business and technical strategy.

New Communication Model for Medical Devices, Continued

2009-10-18T20:50:00.000-05:00

I came across an IEEE journal article published in 2008 by two Welch Allyn research engineers. The article has enough relevance to the topical area of my blog that I plan to devote at least one article to discuss it's contents. The article addresses wireless communications and specifically, medical-grade wireless networks and issues surrounding their deployment.

I mention the IEEE article because having a reliable connection is a major concern to anyone who would implement a medical application that uses remote programming. Remote programming would involve downloading new instructions, new software or software patches to a device. That download must be performed safely, securely and without error. Furthermore, entire connection system would have to be extremely tolerant of errors and connection breaks. In that vein, I discuss the Rosetta-Wireless connection model in more detail with special emphasis on how the model provides a reliable, logically stable and secure connection with significant throughput. This is a continuation of the article titled "New Communications Model for Medical Devices" that I published 11 October 2009. It is also a continuation of the article that I published on 14 October 2009," Medtronic Patent Application: Communication system for medical devices ."

I provide a slightly revised drawing of the connection model below. (You should see a larger drawing in another window/tab if you click on the drawing).

The area of interest of this discussion is defined by the curly-brace on the right. It is the communications path between the mobile server and the central server. As I had mentioned in my previous post the Central and Mobile Servers are logically identical; i.e., whatever data is on the Central Server will migrate to the Mobile Server and vice versa. So, if a file appears on the CS, it will be mirrored to the PS automatically. Furthermore, since the two servers are logical twins, they continue to maintain a logical connection with each other even when disconnected.

From a security standpoint, all transmissions are encrypted, all data on the mobile server is encrypted and the two system authenticate each other using a shared secret. The data on a Mobile Server is managed by a secure, centralized authority, thus if the Mobile Server is ever stolen, once that stolen Mobile Server contacts a Central Server, the Central Server will send a signal to erase it's data and terminate its operation. This is important because should anyone consider such a model as this for the transfer of medical data, the data and any device that manages that data in the field will have to be secured.

Wireless networks are inherently unreliable, they rely on radio technology with all it's physical instabilities to provide a connection. Anything moving adds instability by continually moving in and out of coverage. The TCP/IP protocol was not designed to handle communications where there are frequent breaks and re-connections. The protocol was designed for an “always connected” state. Furthermore, the endpoints of the communications link – the service provider (server) or the user's equipment (client) – have been designed to “expect” an “always connected state as well. Neither the network, appliances, user devices or users are designed to handle frequent communication breaks.

The crux of this model and the point of this article is to describe a means for transforming an intermittent and unreliable wireless connection environment into a reliable one. It does this in two ways.

First, the Mobile Server has the capability of utilizing more than one connection simultaneously (opportunistic routing). If two or three connections are available, data can be send over all the connections simultaneously. Should a connection suddenly drop, the system reconfigures itself and starts moving data over the remaining channels. For example, the Mobile Server could have connections both with WiFi and 3G. The WiFi connection could suddenly drop, but the data would be routed over the 3G connection, seamlessly and without interruption. Thus the system is able to use connection redundancy in an effective manner and without the need to suddenly switch to an available wireless connection once that wireless connection drops. Since it can connect to an infinite number of wireless connections (the software is capable of doing this. There are no limits on the number of simultaneous connections.), all the software does is move the traffic to the active connection(s).

Second, the two servers, Mobile and Central, continually maintain a stable connection between each other. Should their be a connection break, each server preserves the state of the data transfer (in the case of a file - a data or software file - with a known end point) or the state of the session should the transfer be a streaming connection (such as video or voice). Should all connections drop, when the Mobile and Central Server reconnect, they authenticate each other and restart the transfer of data.

(One aspect of the system related to its reliability is the capability of the Mobile Server to connect to a variety of Central Servers thus increasing system reliability by providing multiple connection paths to the System Service Provider Servers.)

Finally, it's time to describe the value of the model I've described to the endpoints. The System Service Provider Servers (or Enterprise Server) is provided a stable, hardwired connection. The applications running on the System Service Provider Servers are not required to handle any connection problems. Adding the code to handle intermittent connections just adds to their complexity. The engineers developing services, particularly those based on remote programming, can be assured that the transfer of data between the System Service Provider Servers and the Mobile Server is reliable and assured.

Once the necessary data or software reaches the Mobile Server, the Mobile Server connects in the usual manner to manage uploads, downloads and messages with a patient's device or devices. (A discussion for a later article.)

Biotronik (http://www.biotronik.com/portal/home) has just introduced a new Home Monitoring system. Their Home Monitoring system uses a wearable device monitor/wireless communications device similar to the Mobile Server I have described. Their Home Monitoring Device appears to be tasked only for remote monitoring, not remote programming. Biotronik bears watching.

Future-Market Analysis: Global Patient Monitoring

2009-10-15T18:50:00.000-05:00

http://www.reuters.com/article/pressRelease/idUS78250+14-Oct-2009+BW20091014

Although I do not endorse any products or companies in this blog, I did come across the notice from Reuters about a market research study regarding the market for global patient monitoring. I thought that some of my readers might have an interest in the findings from study such as this, so I'm providing the link to the Reuter's press release. I believe that obtaining the results of this study will require a substantial payment, although I suspect that some of the data will become freely available when journalists review and discuss it. Anyway, I'm posting this for anyone who might be interested. I ask that if anyone obtains a copy of this study, please leave a comment regarding it on this blog. Thank you.

2 Million Dollars Stimulus Grant To Fund Research On Wireless Patient Monitoring

2009-10-15T18:15:00.000-05:00

http://www.medicalnewstoday.com/articles/167340.php

Wireless researchers and physicians from Rice University and The Methodist Hospital Research Institute won a $2 million Federal grant with the mandate to design and test next-generation wireless platforms and remote patient monitoring devices in Houston. This program should be worth watching.

Medtronic Patent Application: Communication system for medical devices

2009-10-14T23:44:00.000-05:00

On May 31, 2007, the US Patent Office published the Medtronic patent application, Communication system for medical devices, Application number: 20070123955. I came across this patent application today (10/14/2009). Here's the abstract to the patent application:

A communications device facilitates communication between a medical device and a wireless communications network and comprises a telemetry circuit configured to wirelessly communicate with one or more medical devices, and a computer network communication interface configured to wirelessly communicate directly with a wireless computer network.

I invite my readers to go to the USPTO website, look-up the patent application, and refer to Figure 3. You will notice that this looks remarkably like the figure that I published in this blog on 10/11/2009. There are a few differences, first, the Medtronic communications model is less robust than the one I showed. Second, the Medtronic model does not show a multi-channel wireless communication or opportunistic routing capability. Third, the Medtronic model does not include a Central Server and is missing the means to manage the unreliable network-side wireless connection. The differences I discussed are disclosed in a patent application filed in June 2004. All indications are that a patent will be issued.

The Medtronic patent application bears a remarkable resemblance to US Patent 7,149,511, Wireless Intelligent Personal Server. The major difference is that the Medtronic patent application is directed towards a medical application whereas Patent #7,149,511 is directed towards general use.

The communication model defined by Patent #7,149,511 was extended and turned into the model that I showed after extensive analysis and systems modeling. The communications model shared by both Patent #7,149,511 and the Medtronic patent application showed a lack of robustness. While the model that I drew has shown itself to be extremely robust, secure and scalable. The software that Rosetta-Wireless developed used the communications model that I drew.

I mention this because I was part of a research and development program geared fundamentally towards the development of a secure, sophisticated and robust communications system with capabilities to support the transport of medical communications. I mentioned in an earlier article in this blog that the NIH was interested in our communications model and it's ability to transport data for medical applications.

I say all this because I believe I understand the purpose of this Medtronic system as proposed in the patent application. The Medtronic patent application discloses a means for transporting data and programs bidirectionally. Thus, it is an enabling technology for supporting remote programming. And if you read the Medtronic application, you will note that it does in fact mention remote programming.

I believe this application is a marker that defines the level of interest that Medtronic has in remote programming. And that level of interest appears significant. They have a series of patents including a significant and broad patent that clearly marks-out the intellectual boundaries of remote programming. Now, I have come across what can only be defined as an "enabling" technology patent application that defines how data and programming could be transported over wireless.

More to come ...

Washington Post: David Steinhaus: Telemedicine Is Here

2009-10-14T00:06:00.000-05:00

Recent article in the Washington Post (9/23/2009) discussing the value of telemedicine. David Steinhaus is an employee of Medtronic. Here's the link:

http://www.washingtonpost.com/wp-dyn/content/article/2009/09/23/AR2009092303525.html

Harvest Bioelectricity to Power Implants?

2009-10-12T22:48:00.000-05:00

Do you remember the movie The Matrix? There's an important scene where Morpheus tells Neo that the people connected to the matrix are nothing more than batteries to power the machines. The matrix exists to harvest biologically generated power.

I cannot state that everything in the movie's script was accurate. However, I can state with confidence that biological organisms generate electrical power. The question is whether that electrical power can be harvested? The matrix could do it, but anything can happen in the movies.

I recently came across a new start-up company that has licensed technology from the University of Colorado that will allow implanted devices to harvest electrical power from their environment, the human body. The company is called Biotricity Medical Inc. (www.biotricitymedical.com) and they're headquartered in Hopkinton, Massachusetts. Here's the announcement as printed in The Tech Transfer Blog:

The University of Colorado at Boulder (CU-Boulder) has executed an option agreement with Biotricity Medical Inc. to develop technology for implantable biogenerators, which would provide a potentially inexhaustible power supply to implanted medical devices such as pacemakers and insulin pumps. The underlying technology was developed in the lab of Simon Rock Levinson, professor of physiology and biophysics at the University of Colorado School of Medicine. The company’s first planned product, EpiVolt, is a tiny, implantable biogenerator that will provide power indefinitely to devices such as pacemakers, insulin pumps, cochlear implants, artificial retinas, and vagal nerve stimulators. The device is composed of living electricity-generating cells that use the body’s natural chemicals and processes to create electric power. “It’s an inexhaustible source of power that will be much smaller than the batteries it will replace,” Levinson says. “This will allow the EpiVolt to be permanently implanted in very small spaces along with the device that it powers, without the need for long connecting wires running through the body to a remote battery power source."

The question is whether or not this will work. This technology does seem to be worth watching.

As I had mentioned in an earlier article, limited power was the intractable problem that we faced when I worked for Rosetta-Wireless. We had overcome of variety of significant problems and built a software system with a "bullet-proof" communications system and a variety of other capabilities. The remaining problem was powering the mobile server.

The fundamental problems that we faced several years ago have largely been solved by developments in battery and processor technology over the past few years. That experience taught me a great deal about coming up with different methods for powering a mobile system. We attempted to devise methods that would enable us to harvest power from the environment to supplement the battery. Biotricity's method for harvesting power won't have solved the power problems for Rosetta-Wireless, but it could provide the additional power demands required by sophisticated, wireless medical implants.

The next post will discuss the specifics for creating a secure and robust connection over wireless.

Savings from Telehealth

2009-10-12T12:18:00.000-05:00

http://www.cataractoutsourcing.com/healthcare-it/telehealth-save-billions/

Supporting data to indicate that telehealth has both medical and financial benefits. Remote monitoring and programming are some of the technologies that support telehealth systems.

New Communications Model for Medical Devices

2009-10-11T23:06:00.000-05:00

I was the Chief Technologist for Rosetta-Wireless, a high-technology start-up company that won a $2 million Advanced Technology grant from the National Institute of Standards and Technology (NIST). I was the primary author of the technology grant proposal, the systems architect and the principal investigator on the project. With the intelligence, talents and hard-work of a highly talented group of telecommunications and computer software engineers, we created a software system that with minor modifications could support the system pictured below. In this post, I describe the fundamental capabilities of this system depicted. (I have no concerns about describing this system, it's patent protected.) In later posts, I'll go into greater detail how this system could be the best means to support bi-directional communications with implanted medical devices.

Let's begin at the top of the drawing. The top portion of the diagram shows a basic configuration that allows device clinics to access patient data from a repository (Remote Programming & Data Monitoring Servers) managed by the device manufacturer. The device clinics access the repository over a web connection. From their browser they can manage the patient data collected on the device company's computerized repository. Currently, device clinics can only monitor patients. Remote programming would allow patients' devices to be managed through this same user interface.

The important part of this diagram is the communications model between the patient's device and the company's server system. Beyond the company's firewall is a system called the "Central Server." It has a reliable, high speed connection from itself to the company's server system. The Central Server has a logical "twin," the "Mobile Monitoring Server." It is a logical twin in the sense that when ever something is sent to one server, that server mirrors whatever it is to the other server.

The Mobile Monitoring Server is a mobile computer system similar to an iPhone. It is intended to be with the patient at all times. It communicates with a Central Server (and can communicate only with a Central Server thus providing exceptional security and reliability) over any available wireless connection. It uses a system that we call "Opportunistic Routing to communicate over a diversity of wireless channels. It can communicate with the Central Server over one or more channels simultaneously. The Mobile Monitoring Server is also responsible for managing the wireless connection. The system is designed to seamlessly communicate data bi-directionally over an unreliable data communications network without losing a single bit of information and it has the ability to send large amounts of data over wireless connections reliably, and without error. And it works.

Furthermore, the Central Server provides a stable connection to the company's server system. This would be crucial to remote programming to insure that once a set of instructions or new software is sent, destined for the patient's implanted device, that it get's there, guaranteed. And even if there's a break in the wireless connection, it will still get to it's destination.

The Mobile Monitoring Server connects to the implanted device (I show a St. Jude Pacemaker model that currently uses this wireless communications channel) using an FCC designated channel calls MICS. (I'll leave it to you to research.) MICS operates in the low 400 Mhz range and has substantial limits on the level of power that can be used for transmission. Both the frequency and the power levels insures that the implanted device cannot communicate directly with either WiFi or 3G. Furthermore, medical devices can use only limited power for communications. Their batteries are small and the battery life is calculated in years.

Many of my next posts will cover specific scenarios related to remote programming and how they would communicate over this communications model. I'll probably do some gloating and describe why this is a superior model to all others.

However, even with relatively low power consumption, remote programming faces a problem, one that might be it's Achilles heel. That's the problem of power and having enough of it. When I was with Rosetta-Wireless, power was the major problem that we had to face. There have been significant improvements in battery technology and the development of low power processors, etc. But, as far as I can tell, the problem for remote programming does not lie with the Mobile Device, it lies with the implanted device. The amounts and frequency of data communication required for a full-fledged remote programming system to be effective is extremely large. Many megabytes, possibly gigabytes of data and software would be transferred to the implanted device. This will require significant amounts of power. However, I have come across a new company that I think may provide a significant breakthrough with the ability to harvest electrical power from the person with the implanted device. Stay tuned.

Medtronic International Patent Application: Remote Programming of Implantable Medical Devices

2009-10-10T23:27:00.000-05:00

Medtronic has an international patent application that extends Remote Programming, particularly, the capability to maintain security and safety of patients. Before I dive into the details, the authors of this patent application make some very interesting points regarding the value of remote programming. I'd like to quote a few items from that application. It provides a clear argument regarding the value of remote programming.

... if the medical conditions of a patient with an implantable device warrant continuous monitoring or adjustment of the device [e. g. a pacemaker], the patient would have to stay in the hospital indefinitely.

From personal and discussions with others, people want to live at home, not in a hospital or a nursing home. Remote programming can be one tool that makes this possible even for people with severe, irreversible heart failure.

Yet another condition ... requires that a patient visit a clinical center for occasional retrieval of data from the implanted device ... . Depending on the frequency of data collection, this procedure may pose a serious difficulty and inconvenience for patients who live in rural areas or have limited mobility. ... in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come to the clinic or hospital to have the upgrade installed.

Consider a patient who lives in the middle of the Navajo Reservation. The Navajo Reservation (that surrounds the Hopi Reservation) lies in the northeast corner of Arizona and takes in parts of Utah and New Mexico. To say the least, it is huge, rural and a very long way from any major metropolitan area. It would be a significant burden for someone living in the middle of the Navajo Reservation to travel to any of the likely places where a device physician would be located. Remote programming would be a significant help to these patients.

The essence of the patent application

The following quote summarizes the purpose of the patent application.

The present invention is directed toward providing a remote programming method for use with implantable medical device systems that helps ensure safe, secure programming of a medical device in a remote location.

The quote isn't particularly well-written, but it does convey what this patent is addressing: it's addressing the security problem. Briefly, here's the problem, as it stands, anyone in a device clinic or for that matter, a hospital with a computer log-in who has access to a patient's records or has the ability to perform remote programming is provided with the ability to do virtually anything to the patient's device remotely. This is a not a safe situation for the patient and it's a potentially massive legal problem for the device managers.

Medtronic has defined a multi-layered or tiered system whereby certain people are provided with a specific level or levels of authorization. For example, a clerical person may be granted authorization to review patient records and verify that certain scheduled changes and updates to patients' devices have been performed. On the other hand, device physicians may be granted full authorization to see and do anything and everything.

The security system that they propose is not unlike other security systems in the field. Agencies in the Federal Government, National Laboratories, many companies, etc. all have authorization systems similar to the one being proposed. The difference is that this addresses remote programming of medical devices.

The patent application is narrow enough so that I suspect that Medtronic will likely receive an International Patent. That's assuming that there are no patent applications in the same domain that have preceded the Medtronic application. It does make clear Medtronic's strong interest in this area of technology. Patient care is the future of the medical device industry and clearly, Medtronic has clearly recognized this.

Next time, I'll dive into remote programming and issues related to data communication. I'll intersperse these posts to discuss the Achilles Heel of Remote Programming: Electrical Power. And a way that this problem might be solved. Say tuned. These next posts should be interesting and informative.

Medtronic Patent 7,565,197: Migrating Instructions Among Implants

2009-10-05T23:28:00.000-05:00

An intriguing but not fully explained claim in this patent is claim number 29. It is a double-dependent claim in that it depends on two previous claims (claims 1 and 25); nevertheless, it describes a means for migrating instructions or data from one implanted device to another. Here's the claim ...

The method of claim 25 wherein the remote medical device is an implantable medical device and
transmitting the remote programming instructions comprises transmitting the data to a remote external medical device capable of communicating with the implantable medical device and further transmitting the remote programming instructions from the external medical device to the implantable medical device, the remote external medical device receiving the updated state token value whenever the implantable medical device and the external medical device are in communication.

Here's how I read the meaning of this claim.

A patient could have two or more implanted devices both of whom are in communication with a single external device.
The implanted devices operate more or less independently from each other, however, they could be working as part of a therapeutic system to address a single problem or a particular class of problems, e. g., cardiac or neurological.
For those not familiar with implanted medical devices, they have both sensing and stimulation capabilities. The stimulation is most effectively delivered when the conditions are right ... as sensed by the sensors and computed by implant's internal processor.
If implanted devices are working semi-autonomously, there may be a need for one implanted device to send its data to another device to which it is logically connected.
If two or more implanted devices are going to work as a system, they must have the capability to transmit data to each other and/or have the capability to transmit to an external device that will in turn relay the information to the other devices or would act as a central manager, take the data produced by the implanted device, perform it's own calculations and then send instructions to all the implanted devices.
I believe this claim describes fundamentally both methods for managing two or more implanted devices working to deliver systematic and multi-faceted therapy to address a single medical problem.

I am most familiar with cardiac devices and I cannot think of a reason to have more than one device implanted to manage any heart problem. The heart is nicely contained and localized. However, the nervous system is well distributed and it would be reasonable to consider having multiple devices collaborating to deliver a particular therapy or set of therapies.

Medtronic Remote Programming Patent

2009-09-29T22:07:00.000-05:00

Medtronic has been working on remote programming for medical devices for at least a decade. I cannot be certain because I do not and have not worked for Medtronic. But, I have on good authority that I am not far off.

I believe that Medtronic's patent (#7,565,197, please see earlier posts) reveals not only the extent of Medtronic's work on remote programming and their level of development of this technology, it reveals a product development path. I can make this statement with confidence because I have been in this business for a long time. The strategy that I believe Medtronic has taken is in keeping with long-standing trends in technology development.

Over the last several decades, the trend has been to move away from specialized to more powerful, general-purpose processors. This enables products to be defined more by software than by hardware. Processing power has become smaller, less power hungry and cheaper, thus allowing software to become the means for defining the system's capability. Furthermore, this enables multiple products to be defined by a single hardware platform.

I think most everyone in the industrialized countries have had some experience with software-defined systems. Numerous products that many of you have encountered run on a standard hardware platform. This is particularly true of products based on a PC hardware platforms. I have been part of the early stage development of two companies who both use a PC platform, but define their products with software. The products could not be more different, but nevertheless they still use the same hardware platform.

The Medtronic patent suggests a similar product strategy ... that different products will use fundamentally the same hardware architecture, but they will be defined by the software that they run. So, a pacemaker, a neurostimulator and a drug pump will share the same processor hardware platform, but their operation will be defined primarily by the software that they run. For example, take some time and examine pacemakers, ICDs. CRTs/CRT-Ds, neuro-stimulators, drug pumps, etc. Although they have different purposes, they have enough in common to consider the possibility that all of them could share a common processor platform.

The implications are significant for all functional areas within Medtronic, from research and development, product development, software development and management, and from product support. Medtronic can leverage its enormous scale to make its scale as a company a major asset. It can substantially reduce the number of hardware platforms it supports, it can leverage its software development capabilities to have its software development groups produce software for multiple product lines, it can create more products without a substantial requirement for additional support each time a product is produced. The list of benefits goes on and on. I shall cover those benefits in later posts.

In the next post I shall drill down into the technical specifics of this patent.

Medtronic Patent, Continued: Managing Multiple Devices

2009-09-27T16:05:00.000-05:00

To my readers, you should read the posting that immediately precedes this one for background information.

One of the more intriguing aspects of the recently issued Medtronic patent is the capability to manage multiple implanted devices. Here's a list of possible implanted devices included in the patent's description ...

"cardiac stimulation devices, cardiac or other physiological monitoring devices,
neuromuscular stimulators, implantable drug pumps, or the like."

An earlier patent application from St. Jude Medical (Pacesetter) filed in 2001 (listed in this patent as "System and method for remote programming of implantable cardiac stimulation devices" by Snell, et al) was limited to cardiac implanted devices. I find it interesting that this broader and more inclusive patent application has receive a patent, and the narrower, earlier filed patent application from the cardiac device division of St. Jude Medical has not.

Nevertheless, the broad coverage of the Medtronic patent does make things more interesting. As I discussed in an earlier post, patients who have implanted medical devices (IMDs) generally have more than one medical problem, and one or more of those additional medical problems have a significant likelihood of being addressed by an implantable device. For example, a patient may have both a heart problem and diabetes, both of which can be treated with implanted medical devices.

So, if a patient has more than one IMD, how does one manage that? Medtronic makes a wide range of devices. Would every device require it's own external patient management and communications unit? (See Figure 1 of the patent. The external unit is pictured as a laptop computer.) I've seen the solution from one large medical device provider and the answer is "yes." Each device would require it's own monitoring unit.

It may be that Medtronic is attempting to address this issue. The patent application suggests a single, intelligent external patient management and communications unit could manage any of the devices Medtronics produces. I find it interesting that in Figure 1, the monitoring unit shown is a laptop computer. A laptop should be able to provide more than enough computing power and communications capability to manage multiple implanted devices.

Let's take this mode of thinking a bit further ... the patent suggests that Medtronic might well be settling on a single platform, a single system to manage its IMDs, in any combination. This makes sense and it would be a significant cross-company breakthrough if they were able to pull it off.

To contrast with the smallest of the big-three medical device companies, St. Jude Medical is a much smaller company, but makes many of the same devices that Medtronic produces. However, St. Jude Medical is highly fragmented due in part that much of its growth has come through acquisition. Its much of its cardiac device division was originally Pacesetter that was acquired from Siemens. Other companies have been acquired and have been integrated into its cardiac device division. (This is no small achievement.) However, the cardiac division remains separate from the rest of the St. Jude Medical divisions. There is no cross division platform.

Medtronic is a more integrated company than St. Jude Medical, but it is significantly larger and more un-wieldy. Nevertheless, Medtronic may be able to pull it off and settle on a company wide external patient management and communications unit platform and software architecture.

I want to take my speculation one step further. I shall not go into to detail here, but I want to raise the question and address it more detail in a later posting. I think it's fair to speculate that if Medtronic is considering a company-wide platform and software architecture for their external patient management and communications unit then it makes sense to consider a common platform and architecture for their implanted medical devices. This would be a revolution in medical device technology, but is Medtronic considering this? It is anyone's guess and I shall devote at least one posting to this issue.