Wednesday, December 5, 2018

Reprise: Everyone -- Stop Playing Bingo and Get into the Gym!

Here's another article that demonstrates the benefits of weight training ... this time for everyone!

https://www.nytimes.com/2018/12/04/well/move/even-a-little-weight-training-may-cut-the-risk-of-heart-attack-and-stroke.html?em_pos=small&emc=edit_hh_20181205&nl=well&nl_art=3&nlid=67594383emc%3Dedit_hh_20181205&ref=headline&te=1

Here are a few quotes from the article ...

The findings were dramatic: The risk of experiencing these events (stroke & heart attacks) was roughly 50 percent lower for those who lifted weights occasionally, compared with those who never did — even when they were not doing the recommended endurance exercise. People who lifted twice a week, for about an hour or so in total, had the greatest declines in risk.

As an associational study, the results show only that people who occasionally lift weights happen to have healthier hearts ...


Saturday, December 1, 2018

Commentary: HE-75 and IEC 62366 and Cleaning Up the Messes

I received a reminder recently when I was made aware of the International
Consortium of Investigative Journalists' database of medical device recalls of what human factors professionals working in the area of human engineering for medical devices are often called on to do: clean up the mess created by a failed design process that somehow failed to incorporate research. (Note that medical device development isn't the only domain where this kind of failure occurs, however, the impact of medical device failures can often result in fatalities.) 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!

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 clear to anyone who reads this: Process and the resulting design should be considered as two sides of the same coin. The outcome of a good design process generally results in a good design. A nonexistent or poor design process often times leads to a poor design and a design that gets worse with each design iteration when attempts are made to fix problems or incorporate enhancements.

The processes and design direction provided by HE-75 and IEC 62366 can serve as a foundations for research and designing systems with user impacts within nearly any industry, particularly in those industries where the potential for harm is likely.

Wednesday, November 28, 2018

Careband: Keeping track of those with dementia

I was at an evening venture capitalist meeting on 13 November 2018. I'm not a venture capitalist but I have a few connections to this community and I periodically receive invitations to their meetings. Most of the time I pass on attending. I'm interested in science, mathematics and technology. VCs are interested in ways to make money. Nothing against them. We just live on different planes of existence.

However, I attended this meeting because I read the description of one of the companies doing a presentation, careband (http:www.careband.co).

careband

Careband provides a capability to track the location of people with dementia. This is a more difficult problem than you might imagine. In institutions, patients with dementia are known to wander away: from the institution, from their homes, from family members. The patients do not know where they are or how to return. Institutions who care for dementia patients frequently need to find their patients who have wandered away from the institution's grounds or to areas of the institution that caregivers do not expect that they would be able to wander. 

Thus there's a clear need to be able to keep contact track of dementia patients. To know where their location at all times and be notified when they've wandered off the grounds of the institution.  Here's a page from the careband.co website that summarizes the capabilities of their system.


The diagram above shows the elements of system for patients and customers/caregivers -- those responsible for caring for the dementia patient(s). Caregivers can see at a glance the current location of each patient. Each dementia patient wears a band about the size of a large wristwatch on the wrist that periodically sends a location related message to the network. All data is sent to careband's cloud server system. Patient location data is made accessible to the caregiver systems that are connected to the cloud server system.

The wrist bands connect to the Internet to the low-power communications system: LoraWAN. More information about this wireless data communications network is available here: https://lora-alliance.org/about-lorawan The LoraWAN network is a low-power, low-speed (0.3 kbps to 50 kbps) but long distance (up to 3 miles from an access point outside) and robust wireless communications system. 

The wristband also includes Bluetooth that is used to provide indoor location data. And an accelerometer has been included to provide information regarding whether the patient has moved his or her body during the reporting period. 

I am not familiar with all of the current capabilities of the careband.co system. However, I know that the wristband continually transmits to the cloud the following data:
  • Patient ID data
  • Transmission time 
  • Location data
  • Movement (whether or not the person has moved from the time of the last data transmission and the time of the current data transmission)
  • Battery charge level
How careband.co is currently analyzing is something of which I am presently unsure, but there are a number of pieces of information that can be derived from this relatively small amount of data. Here's what's possible:

  1. Current patient location
  2. Map of patient's activity and the distance covered over time
  3. Amount of time that the patient was moving
  4. Alarm initiation: should the patient stray away from the institution, the system can automatically notify the caregivers. (Boundaries should be able to be drawn on the display.)
  5. Trend and trend line analysis for patient activity time and distance covered. These could be indicators of the patient's cognitive health. Significant deviations from calculated trend lines could be indicators of a slip or improvement in a patient's cognitive and/or physical health.
  6. Suggest that the patient has removed the band from his or her wrist (when the patient appears not to have moved during normal activity time) or that the patient maybe in distress or died.
There could be more information that can derived from the wristband data that I have yet to think of. As I come up with additional thoughts regarding this, I shall post them.

Upgrades to the wristband could include pulse oximetry and pulse rate data. Again, there are other capabilities that could be added that I have yet to think of.

Since the transmission speed is so low, careband.co will likely need to develop a data compression system to effectively communicate this data back to the cloud server system. 

Careband.co is one more interesting product for remote medical monitoring. It's not designed for remote patient management largely because most patients will normally be closely supervised. However, it could be an aid to enable people with dementia to live for a longer time in their own homes. The benefits to both the patient and to society are massive. Six months to a few years of being able to live in one's own home would improve both the quality of life for people with dementia and significantly, dramatically reduce the cost of care.

I shall continue to monitor careband.co's progress. Stay tuned.

Careband.co plans on making their products available through medical device distributors. Their products are not yet commercially available. They are about to manufacture the wristband. Their wristband has been approved by the FCC. FDA approval is not required.  If you are interested in purchasing their product, please contact them at care band.co.

I should mention that careband.co is looking for investors. If you're interested in what careband.co is selling, please contact them directly using the URL listed above.

Sunday, November 25, 2018

International Medical Device Database

For anyone interested in medical device safety, you should bookmark this website: https://medicaldevices.icij.org

It has been created by the International Consortium of Investigative Journalists to:

"Explore more than 70,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers." 

Thursday, September 20, 2018

Apple Watch 4: New York Times Review

Here's an article reviewing the Apple Watch 4 that was published in the New York Times on 19 September 2018.

Here's the link: https://www.nytimes.com/2018/09/19/technology/personaltech/apple-watch-series-4-review-health.html?em_pos=large&emc=edit_ct_20180920&nl=technology&nlid=67594383edit_ct_20180920&ref=headline&te=1

As of the posting of this article, Apple has yet to release their ECG app -- the thing I guess that most of us have interest with regards to the Apple Watch 4. It's the one thing that moves the Apple Watch 4 from a consumer to a medical device and a hardware platform on which to base medical applications and services. So, until the ECG application is available, I'm holding off on reviewing the Apple Watch 4.


Friday, September 14, 2018

Apple Watch 4 -- FDA Announcement: Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health

The FDA just provided what amounts to a "shout-out" to companies that design and manufacture intelligent, wearable devices that include medically-related monitoring devices and specifically, the Apple Watch 4.

Here's the link to the FDA statement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm

And here's an interesting quote from the announcement:

... [There have come] a new swath of companies that are investing in these new opportunities [e.g., wearable, intelligent monitoring devices measuring medically-related, physiological characteristics with analysis capabilities.] These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.

---------------
I find it interesting that Dr. Gottlieb states that the Apple Watch analyzes pulse rate data, not the ECG, to detect "rhythms suggestive of atrial fibrillation." Yeah, that's a way to do it, but analysis of the ECG is a much better way. When I do a deep dive on the Apple Watch 4, I'll look into this and questions like it.


Thursday, September 13, 2018

Seniors: Stop Playing Bingo and Get into the Gym!

I've included an article from the New York Times that's not only worth reading, but passing around no matter what their age, but especially to those who are 50 years old and older. Here's the bottomline: resistance/strength training using weights and/or bands may be the key to staying out of (or at least postponing as long as possible a stay in) a nursing home when you grow older.

A relative of mine told me that once he reached 80 years old that was when he felt himself truly growing old: loosing his strength and stamina. I had always assume that 80 was a point in life when the body reached a point where no matter what you did, everything would decline ending in death. 

Well ... that may not necessarily be the case. My relative never engaged in any resistance training ... at all, ever. Certainly not when I knew him. He was active, but never when into a gym to lift weights or engage in any resistance training. Turned out that was a significant mistake. 


Here's an interesting quotes from the article:

...  many people past 50, have a condition called sarcopenia (my emphasis) — a decline in skeletal muscle with age. It begins as early as age 40 and, without intervention, gets increasingly worse, with as much as half of muscle mass lost by age 70. (If you’re wondering, it’s replaced by fat and fibrous tissue, making muscles resemble a well-marbled steak.)

“Sarcopenia can be considered for muscle what osteoporosis is to bone,” Dr. John E. Morley, geriatrician at Saint Louis University School of Medicine ... he pointed out that up to 13 percent of people in their 60s and as many as half of those in their 80s have sarcopenia.

But — and this is a critically important “but” — no matter how old or out of shape you are, you can restore much of the strength you already lost. 

So, what are you waiting for? If you’re currently sedentary or have a serious chronic illness, check first with your doctor. But as soon as you get the go-ahead, start a strength-training program using free weights, resistance bands or machines, preferably after taking a few lessons from a physical therapist or certified trainer.

----

And by the way, you'll need to increase your protein intake as well. Read the article. I think you'll find it to be of value and something to place in your personal archive.




Wednesday, September 12, 2018

Apple Watch 4, Preview of Medical-Monitoring Features

Here's an article regarding the Apple Watch 4 and what are suppose to be built in medical monitoring features.

Here's the link: https://www.mobihealthnews.com/content/apple-watch-series-4-will-have-fda-cleared-ecg-fall-detection?mkt_tok=eyJpIjoiTkRVMk0yVmxNamsyWkRneiIsInQiOiJjWXRoaVpENmhJYlBRNFlzVVBYZ3hrc0VEVFdsYmNLUG1FQUIrQmcyMnVHMTRwSnBORDh6cW1Da1kzbjJqS2JxbHcydjRuTk0zaG5qRzBvMFR1MmdiMmZyNGhyXC9SZmYyYkduaSs5R0tyRG85TXkrMHVxTnFFYXFrVE5jWHpIRWwifQ%3D%3D

Here's the list of new medically-related features:


  1. ECG (30 second rhythm "strip")
  2. A-Fib detection (of course, if you're paying attention and you know the symptoms, you'll probably know sooner than the watch.)
  3. Fall detection (as in when the person falls, the watch detects that it has occurred)
All information is sent back to Apple Health Records where all this information be accessible to a physician/cardiologist.

Apple has received FDA approval, according to the article. 

I'm not going to comment until I've had a little more time to study the Apple Watch 4 except to say, if you can detect A-Fib, then why not V-Fib? V-Fib is much more life threatening. Also too, if you've got a 30 second rhythm snap shot, you can do a lot with that. 

I'll touch on these and other questions regarding the Apple Watch 4 and Apple's effort to product a remote medical monitoring device and medical monitoring system later. 


Friday, September 7, 2018

Public Health Crisis: Suicides

This is a public health related piece. I produced a video about suicides. The data that I analyzed was from the Centers for Disease Control.

Suicide has been on the public radar recently because of the scrutiny it has received in the press. And the concerns expressed in the press about the rising numbers and rate of suicide.

When I was in college, I was taught that suicide was a largely based on the victim's emotional state. That the answers of how to address it were to be found in psychology and psychiatry. That may have been true then, but the data that I analyzed, that you will see in this movie, says that suicide may now be more of a socio-economic problem.

Here is the link to the video:

Let us know what you think.

Thursday, August 16, 2018

Public Health Alert: Centers for Disease Control records 72,300 Drug Related Deaths in 2017

Here is the article from the New York Times reporting the number of drug related deaths from the Centers for Disease Control (CDC) for 2017.

https://www.nytimes.com/2018/08/15/upshot/opioids-overdose-deaths-rising-fentanyl.html?em_pos=small&emc=edit_up_20180815&nl=upshot&nl_art=0&nlid=67594383emc%3Dedit_up_20180815&ref=headline&te=1

In my own analysis https://professionalpredictivemodels.blogspot.com/2018/07/drugs-deaths-1999-to-2016-and.html my worst case prediction was for approximately 69,000 in 2017. To have a worst case exceeded by over 3000 deaths is a stunning development. My worst case prediction for 2018 is for the number of deaths to be between 76,000 and 77,000. And by 2025 my worst case prediction is for the number of drug related deaths to be between 150,000 and 160,000. I have had a difficult time believing the trends that the numbers appear to show. They seem unbelievable, but given that my own worst case, my own worst fears have been outstripped by the actual numbers ... well it now it appears that my own worst case fears may exceeded by reality.


Wednesday, August 8, 2018

Measuring cortisol — the stress hormone, remotely

Having the ability to remotely and continuously measure the level of a stress-related hormone would seem to be something of real value.

A new wearable biosensor, developed by the Salleo lab at Stanford, measures the amount of cortisol in a person’s sweat. 

Here is the link to the announcement/article: https://www.medicaldesignbriefs.com/component/content/article/mdb/insider/32762?utm_source=TBnewsletter&utm_medium=Email&utm_campaign=20180808_Medical_Newsletter&eid=376600177&bid=2199287

Monday, August 6, 2018

FCC approves telemedicine pilot for veterans, low-income, rural Americans

I'm actually surprised that this trial had not been approved earlier. Here is the announcement from the FCC.

 This is a link to an article that provide more detail on this program.

https://www.mobihealthnews.com/content/fcc-approves-telemedicine-pilot-veterans-low-income-
rural-americans?mkt_tok=eyJpIjoiT1dJNVl6UmxaVFExT1RkaCIsInQiOiJrb1B5Y0drbTRBMzRoMHFcLzBpUlpCTVljT1lBUGhhcUNCazA2RndKOW8zXC94dTFVSU5ua1VYY1NzeHBQazRsYW5hMkdsaTRETndXb01CTDZjN1Zva2VRYmRIUElic0FCc21BYVowSWdFTGVtTSt1Y2kxTXFGSHRuYlNCcitSRU5TIn0%3D

Since this is a pilot program, data should be collected about it's effectiveness. This is something that those who are interested in medical remote monitoring and remote patient management should be interested in following. I know I will.




Sunday, August 5, 2018

New York Times Magazine Article: Losing Earth - CO2 concentration in the atmosphere and it's relationship to global average temperature

This is related to public health not just for now but in the future as well. Here's the link to the article: https://www.nytimes.com/interactive/2018/08/01/magazine/climate-change-losing-earth.html This article is definitely worth your time.

I use this as a lead in to something that I posted on my other blog, Professional Predictive Models. I did this analysis on the connection between CO2 concentration in the atmosphere and it's relationship to the global average temperature. The strength of the relationship of these two measurement actually startled me. Here's the link to the blog post: https://professionalpredictivemodels.blogspot.com/2018/08/relationship-between-carbon-dioxide.html


Saturday, August 4, 2018

Article: Wearable Technology Is the Future of Healthcare

A bit of light reading about wearable fitness and medical devices.


An interesting quote from the article ...

There is no doubt that the adoption and retention of medical wearable devices will, at least for now and the foreseeable future, outrun that of general fitness wearable devices. This is understandable, as they fulfill a direct and current need for the consumer. However, my belief is, and I assume yours too, if you believe in prevention over treatment, that the more general one of these two has the feared but powerful potential to truly change the status quo. Where now, overall health goes down just before the age of 50, general fitness wearable devices could move up that number.  ...

Drugs Deaths: 1999 to 2016 and Predicting Outcomes in Future Years

I write another (new) blog that dedicated to statistical analysis of a variety of sources of data and to predictive models. I recently wrote an article that is public health related. Although it has nothing to do with medical devices, it nevertheless is related to public health, treatment and sorry to say, death rates.

Here's the link to the article.

https://professionalpredictivemodels.blogspot.com/2018/07/drugs-deaths-1999-to-2016-and.html

Here is a preview:

The Centers for Disease Control (CDC) has a comprehensive online database known as Wonder (https://wonder.cdc.gov) that is accessible to all. So if you have public health related questions, the data to answer them can be found in Wonder.

Unless you've been living under a rock, you know that deaths from drug overdoses particularly opioid related deaths have been steady increasing. I am interested in not only in the number of deaths, but the rate of increase and what that suggests for the future. I believe you will find the results of my analysis both interesting and troubling, particularly for the future.

Here's a chart showing the number deaths from 1999 to 2016:










...
Using the equation derived from the 2008 to 2016 data, the picture that arises is much more concerning. In fact the crude rate in 2025 is twice the rate predicted by the trend line equation derived from the 1999 to 2016 data. This suggests that the number of drug related deaths would be near 500,000 by the mid 2020s and that the number of drug related deaths during the 2020s would be closer to 1 million to 1,500,000 where the number of deaths per year would be no less than 100,000 and possibly up to 150,000 each year. Most of these deaths would come about as a result of opioid overdoses.

Monday, July 30, 2018

Apple Watch 4: Will it be suitable as a remote medical monitoring device? Part 1

When I first commented about the Apple Watch as being a possible platform for a remote medical monitoring system in 2015, I was initially excited about the possibilities. Sadly, the technology in 2015 was not quite ready as a platform for remote medical monitoring systems. However, Apple may be turning a corner with the Apple Watch 4 due to be released in Fall 2018. 

To be an effective remote medical monitoring and remote patient management device, the Apple Watch will need to reach acceptable levels of performance in the following seven areas of concern:

  1. Bio-sensors
    • Built in: are there enough bio sensors with enough resolution?
    • Extended: the capability to have additional bio sensors that communicate wirelessly with the watch?
  2. Communications over the Internet: Is there a reliable and secure means of communication back to the patient's monitoring system? And the means to communicate with the patient over that same communications channel(s)? 
  3. Processing capability, hardware and software: Does the watch have the processing capability to host medical applications?
  4. User interface: Visual, touch screen - will patients be able to interact with medical application using the touch screen? Will the watch have an effective audio user interface in order to hear instructions and make requests of the application running on the watch?
  5. Reliability: Will the hardware and software reliable enough for a remote medical monitoring and patient management application to run on it?
  6. Battery life: When running a remote medical monitoring and patient management application(s) on the watch, will the battery life before needing to recharge be acceptable?
  7. Rugged: Is the Apple Watch 4 rugged enough to be a remote medical monitoring and patient management device?
I'm going to touch on each of the areas of concern regarding the performance of the Apple Watch 4.

  1. Bio-sensors: I'm not going to address this issue until the Apple Watch 4 has been released. Once it has been released, I'll write an article specifically discussing this topic.
  2. Communications over the Internet: A model of the Apple Watch 3 does have the capability of communicating over 4G so reliable communication over the commercial wireless provider networks is possible. We can assume that this capability will continue to the next release. So communications capabilities are likely to be adequate. 
  3. Processing capability, hardware and software: Improvements in both are promised over the Apple Watch 3. We can probably assume that hardware and software capabilities will be adequate.
  4. User interface:
    • Visual, touch screen: The Apple Watch screen has been targeted to those with good visual acuity (with or without glasses) and fine finger control to be able to use the touch screen effectively. Current reports say that the screen will be larger than the Apple Watch 3. Nevertheless it's still a small screen. 
    • Auditory: The Apple Watch 3 has Siri, meaning it does have an auditory user interface. More on this after the release of Watch 4.
  5. Reliability: Apple has made positive strides in reliability with each release of the Apple Watch. We can assume that this will continue and that the Apple Watch 4 will be reliable enough to serve as a platform for remote medical monitoring and remote patient management applications.
  6. Battery life: The Apple Watch 3 has a reported battery life of up to 18 hours. Again Apple has continued its improvements in this area. Patient medical monitoring should be continuous and without long breaks. Even with one or more days of battery life, the watch will still need to be changed and that could take hours. However, having said that, the price of an Apple Watch (because of the ruggedness requirement) that would serve as a remote medical monitoring and patient management device would be around $600. As medical devices go, that's inexpensive and inexpensive enough so that the patient could or should have at least two Apple Watches that would enable the patient to switch watches when necessary. That would place a burden on application software developers to manage when patients change watches, however, this should be manageable.
  7. Rugged: The Apple Watch 3 has a version in a stainless steel case. This should be adequate for most situations. Also the issue of reasonably low price and the ability to have redundant watches should effectively address this issue.

Tuesday, July 24, 2018

Adhesives: Part of the Future for the Remote Monitoring Sensors?

I just ran across this article a few minutes ago. It's a serious article published in Machine Design. Here's the link: http://www.machinedesign.com/mechanical/adhesives-enabling-future-wearable-medical-devices?NL=MD-005&Issue=MD-005_20180724_MD-005_524&sfvc4enews=42&cl=article_1_b&utm_rid=CPG05000003255032&utm_campaign=18775&utm_medium=email&elq2=5b76b40ea8f44d76b2b883c5c09f23fe

It's an extremely readable article and what's being described has in my opinion real applicability in the future of medical sensors. Adhesive, "band-aid" or strip sensors development applies to both the fitness set as well as to remotely monitored patients.

Transmitting data to monitoring systems and people will likely require an intermediate device such as a smart phone. I suspect that the real issues and hurdles will likely revolve around digital communications issues and standardization. Having worked most of my life in the communications domain, communications issues can be successfully overcome.

Here are a few quotes from the article:

Device manufacturers are taking steps to create medical devices that are smaller, lighter, and less invasive. Whether they’re adhering device components together or sticking a device to skin, adhesives are uniquely bonded to a device’s success.

Both consumers and patients want wearable devices to be smaller, lighter and less cumbersome to use for seamless integration into their everyday lives. The design process can get challenging when devices must maintain accurate sensing capabilities, but also reduce friction to ensure precise data collection. Adhesives can help to keep friction to a minimum by being breathable and maintaining a low profile. In addition, options with flex electronics, as well as addressing battery implications and electromagnetic interference, provide opportunities for advancement.

Adhesive wear time is a crucial consideration when designing a wearable device, impacting overall resilience and durability, as well as how often the user will need to change their device. 

______________

I should mention that by the looks of things, it appears to me that 3M maybe behind the article. Nevertheless, I think that considering adhesives in the research, design and development process of a bio-sensor is worth your time. 


Sunday, July 22, 2018

15 Game-Changing Wireless Devices to Improve Patient Care

I happened across this slide show today and decided to share it.

https://www.medscape.com/features/slideshow/wireless-devices#17

Remote monitoring has by implication another side to it: remote patient management. The remote monitoring side of these devices seem to be on a strong, positive path of development, but I'm not seeing the same level of development on the remote patient management side. That piece of seems to be lagging and probably for good reason: it's the more difficult. And I can say that from experience working in the area. In addition, it will likely require further development of supporting automation, that is, artificial intelligence or expert systems.


Article: Remote Monitoring of Heart Failure Patients

Although this article was published in 2013, it's findings are still applicable today. Moreover, there is applicability of this system remote monitoring and remote patient management to patients with other chronic conditions other than heart failure. 

I have experience with engineering methods to support remote monitoring and treatment of heart failure patients and this article is an extensive review many of the systems that were and would be coming available in 2013 and later.

Here is the link: Remote Monitoring of Heart Failure Patients by Arvind Bhimaraj, M.D., M.P.H. I recommend this article if you have an interest in many of the details of remote monitoring and remote patient management.

Heart Failure


Heart failure is a chronic disorder and requires continual monitoring and management. The management of heart failure patients remotely can serve as a model for managing patients with other chronic disorders such as diabetes or COPD.

Article Abstract (from the article)

Heart failure continues to be a major burden on our health care system. As the number of patients with heart failure increases, the cost of hospitalization alone is contributing significantly to the overall cost of this disease. Readmission rate and hospital length of stay are emerging as quality markers of heart failure care along with reimbursement policies that force hospitals to optimize these outcomes. Apart from maintaining quality assurance, the disease process of heart failure per-se requires demanding and close attention to vitals, diet, and medication compliance to prevent acute decompensation episodes. Remote patient monitoring is morphing into a key disease management strategy to optimize care for heart failure. Innovative implantable technologies to monitor intracardiac hemodynamics also are evolving, which potentially could offer better and substantial parameters to monitor.

My Analysis

With the advent of smartphones and increasingly sophisticated, smaller and lower power bio-sensors, remote monitoring and remote patient management of all types of chronic conditions should be on the rise. Furthermore, the rise and acceptance of computerize expert medical systems (artificial intelligence), should make remote monitoring and remote patient management a first choice. Not only will this lower costs, but as we have seen it: increases patient satisfaction and mobility, enabling a patient to spend time traveling and enjoying the life that remains.

One more thing ... and I have to add this as a point of pride, a quote from the article:

Also, advancements in implantable wireless technology seen with the pulmonary capillary pressure monitoring device CardioMEMS® (CardioMEMS, Inc., Atlanta, GA) and the left atrial pressure monitor HeartPOD System (St. Jude Medical, Inc., St. Paul, MN) or Promote® LAP System (St. Jude Medical, Inc., St. Paul, MN) bring us closer to finding the holy grail of home monitoring systems. (my emphasis)

I had a part in SJM's LAP project. I was working at SJM when this project was in the state of early patient trial. The project manager needed assistance with issues related to and testing of operation of the user interface including the how the computerize system would interact with patients to collect necessary data and provide the patient with directions on what to do to manage their current condition -- mostly, taking medication and performing certain activities. I provided that assistance, design direction and usability testing for this early stage product. Although I haven't seen this system in it's commercial form, I suspect that a lot of what I did was included in the commercial product. The "holy grail" comment is personally gratifying. And I should mention that my experience with the LAP system was one of this things that lead me to starting and continuing with this blog.


Saturday, July 21, 2018

The Low-Power Mantra Rings Louder with Next-Gen Medical Wearables

My interest in remote monitoring and the focus of this blog is primarily on wearable or implanted devices that support chronically ill or elderly patients. I link remote monitoring with remote patient management. I sometimes drift into the realm of wearable fitness devices because of the similarity in technology. However I think what really differentiates wearable fitness devices and medical remote monitoring devices is reliability, particularly when it comes to insuring that medical remote monitoring devices have a reliable source of power -- constant and steady.

Reliable and constant power is a major concern to any engineer who's designing a medical monitoring device. So this article should be of interest to those involved with the design, development and testing of medical remote monitoring devices. 


Here's a quote from the conclusion of the article: 

"Wearable devices represent the current and future wave in medical care. They hold promise in multiple areas from real-time patient monitoring to drug delivery, but the small space available for a battery imposes strict constraints on the designer, particularly in the area of power consumption."

Harvesting Power

When I was the principal investigator and Chief Technologist of a company focused on research and development of mobile and wearable devices, we were extremely concerned with power and reliable and constant sources for power for mobile devices. One of the ideas we began to pioneer was the ability to harvest power from the environment, from bioelectric sources such as people. I mention this because the article discusses this issue and some of the promising technologies and those interested in  this area should find this section interesting.

Friday, July 20, 2018

Washington Post: These Louisiana physicians can monitor your blood pressure — and you don’t even have to leave your living room

Interesting article from the Washington Post. What's interesting is that they focus on high blood pressure. Yes, high blood pressure is a concern, but with heart patients of even greater concern is low blood pressure. Nevertheless, it does discuss in detail and in a readable manner, the real benefits of remote monitoring and remote patient management.

Here's the link to the article:  https://www.washingtonpost.com/business/economy/these-louisiana-physicians-can-monitor-your-blood-pressure--and-you-dont-even-have-to-leave-your-living-room/2018/07/11/6d57f198-7beb-11e8-93cc-6d3beccdd7a3_story.html?utm_term=.383dd5c9dfb0

It's worth your time to read.

Remote Patient Monitoring System Market Expected to Grow USD 31 Bn by 2023

https://sectorhealthcare.com/remote-patient-monitoring-system-market-expected-to-grow-usd-31-bn-by-2023/

An article pointing to a research report regarding the growth in the market for remote monitoring and by implication, remote patient management.

From the article:

The global remote patient monitoring market was valued at around USD16 billion in 2017 and is expected to cross USD31 billion by 2023, increasing at an annual growth rate of 12% between 2017 and 2023. The increase in the geriatric population and individual spending on the medical treatments have supported the need for remote patient monitoring technology.

... 
There is a "however" in this article. As expected with the medical establishment, there are some concerns, slow-downs and possible blockers.

Also from the article:

However, hospitals in few countries are not showing any willingness to adopt these remote monitoring technologies owing to the huge expenditure involved in the setup of infrastructure and equipment, and the shortage of skilled human resources. Patients are advised by few healthcare professionals to implement the technology by themselves to avoid hospital expenses and repeated clinical visits. Strict government regulations and lack of proper reimbursement mechanism are also impeding the growth of global remote patient monitoring market.

Like it or not, governments ... most likely national and regional/state ... will need to be the ones pressing the medical establishments to make changes because governments in so many countries ... and believe or not, including the US because so much health care is paid out of Medicare and Medicaid funds ... are the ones ultimately footing the bill. 

Here's a link to the report. https://www.researchcosmos.com/reports/global-remote-patient-monitoring-system-market-professional-survey-report-2018/19032600

I warn you that it's an expensive report. You may work for a company that either can pay for this report or has access to the reporting service.

Also the article (and the report) discuss an area of remote monitoring and remote patient management that I have extensive experience in and that I've discussed in this blog:

Cardiac monitors are the most preferred remote monitoring systems due to the rise in heart-related diseases causing more than 31% of deaths world. Cardiac monitors include heart rate monitor, fetal heart rate monitors, ECG monitor, and blood pressure monitors that are having a huge demand in the global markets. To capitalize on the growing cardiovascular disease conditions, product developers across the world are implementing portable and wireless ECG monitors that easily carried around to anyplace.

Remote Monitoring Keeps Patients with Chronic Conditions out of the Hospital

https://www.prnewswire.com/news-releases/remote-monitoring-keeps-patients-with-chronic-conditions-out-of-the-hospital-300683952.html

From previous studies we know the economic value and cost reductions of remote monitoring and remote patient management. Here is an article about a study by Mercy Virtual regarding the value to patients of being remotely monitored and remotely managed. The results of this study although not surprising show without a doubt the use of remote monitoring and remote patient management have profoundly positive results not only for patients but for wider medical system. And that remote monitoring and remote patient management should be employed not only for patients who live long distances from medical facilities, but for all patients who require frequent monitoring and attention.

Overview and results of the study:


Mercy Virtual piloted vEngagement in WashingtonMissouri, beginning in September 2015. The program is now available at Mercy hospitals and clinics in ArkansasKansasMissouri and Oklahoma.
Results of the vEngagement program have been impressive among nearly 1,000 patients:
    • 50 percent reduction in hospital readmissions 
    • 50 percent reduction in emergency department visits and hospitalizations 
    • 98 percent of patients who are extremely satisfied or satisfied

The article includes a case study of the experiences of one of the patients in the study:

After several hospitalizations for breathing problems over two years, Dolorse Murray agreed last September to try a home-based health management program her primary care physician believed would improve her health.
Murray, 71, of Neosho, Missouri, has chronic heart and lung conditions that make breathing difficult and sometimes lead to swelling in her legs and feet. Through the program, called vEngagement, a Mercy Virtual care team monitors Murray and makes suggestions about changes at home to better manage her symptoms.
After just a few months in the program, Murray said she feels better and is able to breathe easier. She has returned to her favorite hobbies, like gardening and painting, which she was too sick to do last year. 
"This is the most wonderful program, and I tell a lot of people about it," said Murray. "I feel like it's saved my life."
Murray meets by phone with her care team several times per month to discuss how she is feeling and determine any changes to her treatment plan. She can also hit a button to let Mercy Virtual co-workers know she doesn't feel well.