Submission of the Human Engineering File to the FDA and Other Regulatory Bodies: Part II

These are the sections we'll cover in this article.

Sec	Contents
1	Conclusion The device has been found to be safe and effective for the intended users, uses and use environments. Brief summary of HFE/UE processes and results that support this conclusion Discussion of residual use-related risk
2	Descriptions of intended device users, uses, use environments, and training Intended user population(s) and meaningful differences in capabilities between multiple user populations that could affect user interactions with the device Intended use and operational contexts of use Use environments and conditions that could affect user interactions with the device     Training intended for users
3	Description of device user interface  Graphical representation of device and its user interface Description of device user interface Device labeling Overview of operational sequence of device and expected user interactions with user interface

With the exception of Section 1 each one of these sections will have a document or document attached to that section. Each section of the narrative document will be a summary of the foundational document or documents attached to that specific section. Make sure that the foundational documents are clearly referenced in each section.

Section Content Analysis

Section 1: Conclusion

This section is an abstract that includes the conclusion of the research program: that the device is "safe and effective" for those intended to use it. I suggest that this section include a brief description of the device at the beginning, its purpose and what medical issues it addresses. For example, if the medical device was a pacemaker, describe what it does, for whom it is intended and what medical issues it addresses. This description should be about one paragraph in length. And the paragraph should end with the "safe and effective" statement and that as to why this conclusion had been reached is briefly listed below in this section. You can add that a full and complete summary follows this section. 

A brief description of the device may well be helpful to the reviewer(s). Although submitted as a complete package that includes a full and detailed description of the device, the package is often split among several reviewers with specific specialties such as human factors. Therefore, the reviewer of the human engineering file may not read or even see the entire submission. Thus a brief description of the device may well provide some welcome context to the reviewer.

The brief summary of human engineering processes can be as simple as a list of steps that were performed. That could include observational studies/contextual analysis, structured interviews of members of the user population and/or subject-matter experts, prototype testing, use-error identification, etc.

Finally, this would be the place to disclose any lingering use-error problems that remain and how they're being addressed. Also, note that these lingering use-error problems have been determined to be low risk: before or after risk mitigations.

Section 2: Descriptions of intended device users, uses, use environments, and training

This section consists of a discussion who would be using the device -- their characteristics, training, education, certification, etc. -- where and how it would be used and the circumstances were it would be used. And finally, a description of the instructions or training that may be required in order to operate the device.

This section will likely be lengthy and comprehensive. Not as lengthy as the foundation document or documents, but it should include a significant portion of what that document(s) contains. You should include enough information to provide the reviewer with a full understanding of who is expected to use the device, how and when it should be used, where it's expected to be used and what positive outcomes would be expected when it is used. And finally what if any are the circumstances such as  the use environment that could how it might be used or effect whether or not it is used correctly.

Your foundational documents will likely include several specific device use scenarios. Include some of the most illustrative of those scenarios in your narrative. 

Devices are often targeted for use by specific classes of users in specific environments. For example, a device may be targeted for use by ICU nurses in the ICU. However, the device could conceivably be used in the general hospital setting by general practice nurses, especially inexperienced or recently graduated nurses. This section should discuss this possibility and what might be needed to be done to adapt the device to other environments and more groups of users with different skills and skill levels.

Finally, summarize the research evidence collected as well as the analysis performed that pertain to this section. Be sure to reference all the foundational documents as well as any internal or outside, published research not specifically performed for this device but applicable to this section. 

Section 3: Description of device user interface 

It may be worth considering lifting the entire description with the images from the foundation document and placing it in the narrative. And then consider what you can remove and still provide the reviewer with adequate information to evaluate the operation of the device. The entire user manual will likely not be necessary to be included in the narrative. You could consider having someone who is not familiar with the device read the description to determine if enough information has been provided. If the person can accurately describe how users would interact with the user interface in order to accomplish specific task (with the images of the user interface that you have provided), then your description is adequate.

Although not stated, this would be an acceptable section to summarize the design process, the evidence that lead to the finalized design and how that evidence was used to both create the initial design and iterate the design until it reached its final form. 

Submission of the Human Engineering File to the FDA and Other Regulatory Bodies

Background

About a year ago I was asked what I thought was the most difficult phase of the medical device human engineering process. Frankly, I'd never before considered such a question. I could not identify any phase of the process that I considered more difficult than any other. I considered whether early phase formative research and testing or risk identification, use errors and risk management would be the most difficult. No, actually for me these phases have always proven to be the most interesting phases in the process. Challenging, yes; difficult, no.

The questioner had an answer in mind: she believed that the validation testing was the most difficult. I disagreed. I believe that the validation testing was most often the least difficult of all the phases of the process. Why? Because validation comes at the end of the entire process and is based on all of the work that you've done previously to get one to the point of validation testing. Thus the procedure of a validation test should flow naturally and easily from the earlier work.

In the end, we agreed to disagree. However, the question never left me. 

I have finally come up with the answer. The most difficult phase of the process is the creation of the narrative for the regulatory reviewers. What I refer to is more than putting together the folder of documents of all of the human engineering related activities. It is the construction of a cohesive and understandable narrative the provides to a reviewer an overall view of the reasoning and logic of the steps taken and that the procedures performed that will demonstrate that the human engineering process was sound and resulting from it is a system that will be safe to use. This is the most difficult phase of the human engineering process, especially if writing the narrative comes at the end.

Human Engineering Pre-Market Submission

Here is the outline of what the FDA expects in a Human Engineering Pre-Market Submission as provided by the FDA on their website:

Sec.	Contents
1	Conclusion The device has been found to be safe and effective for the intended users, uses and use environments. Brief summary of HFE/UE processes and results that support this conclusion Discussion of residual use-related risk
2	Descriptions of intended device users, uses, use environments, and training Intended user population(s) and meaningful differences in capabilities between multiple user populations that could affect user interactions with the device Intended use and operational contexts of use Use environments and conditions that could affect user interactions with the device     Training intended for users
3	Description of device user interface  Graphical representation of device and its user interface Description of device user interface Device labeling Overview of operational sequence of device and expected user interactions with user interface
4	Summary of known use problems  Known use problems with previous models of the subject device Known use problems with similar devices, predicate devices or devices with similar user interface elements Design modifications implemented in response to  post-market use error problems
5	Analysis of hazards and risks associated with use of the device Potential use errors Potential harm and severity of harm that could result from each use error Risk management measures implemented to eliminate or reduce the risk Evidence of effectiveness of each risk management measure
6	Summary of preliminary analyses and evaluations Evaluation methods used Key results and design modifications implemented in response Key findings that informed the human factors validation test protocol
7	Description and categorization of critical tasks  Process used to identify critical tasks List and descriptions of critical tasks Categorization of critical tasks by severity of potential harm Descriptions of use scenarios that include critical tasks
8	Details of human factors validation testing Rationale for test type selected (i.e., simulated use, actual use or clinical study) Test environment and conditions of use Number and type of test participants Training provided to test participants and how it corresponded to real-world training levels Critical tasks and use scenarios included in testing Definition of successful performance of each test task  Description of data to be collected and methods for documenting observations and interview responses Test results: Observations of task performance and occurrences of use errors, close calls, and use problems  Test results: Feedback from interviews with test participants regarding device use, critical tasks, use errors, and problems (as applicable)   Description and analysis of all use errors and difficulties that could cause harm, root causes of the problems, and implications for additional risk elimination or reduction

Each one of the items listed will include one or more documents that address in some manner each one of the sub-points listed in each one of the items. You could place these documents into a folder, identify where they belong and submit this to the FDA or other regulatory body. However, I advocate something more: write an over arching narrative that takes the reader through the path of not only what was performed but why as well. The narrative can be and probably should be based on the outline above. (I'm sure there are exceptions, but beginning with the outline above should be your starting point.)

The narrative should provide a comprehensive flow that interconnects each of the phases and explains reasoning for what was done including the rationale behind the design and operation of the system as well as why it's appropriate for use by the identified user population as well as other likely populations who might encounter it.

Why Write a Narrative?

Is a narrative required as part of a submission? From all that I can tell: no, it's not a requirement as part of a submission to regulatory bodies. 

However, consider the fact that if you can't explain the logic of what you did to yourselves, how hard will it be for a reviewer to comprehend? And if the reviewer can't comprehend what you did -- including the reasoning and logic behind it -- could your submission be at risk for rejection? The answer is "yes," you may be putting your submission at risk for rejection.

The narrative is analogous to a completed jigsaw puzzle. A human engineering file without a narrative is analogous to just the jigsaw puzzle pieces. Yes everything is there, but what is it suppose to be? 

Submitting a human engineering file that includes a comprehensive narrative can insure that your submission is understandable: to you as well as your reviewers. It can insure that there are no gaps or issues that should have been included in your submission are left out. Again, going back to the jigsaw puzzle analogy, you don't know that you've got a missing piece or pieces until you've assembled the puzzle.

The narrative provides reviewers with framework to understand what you've done. Interestingly enough this will likely minimize any questions reviewer might have about your submission. And will likely minimize the likelihood that you'll get questions that you cannot answer.

One more thing to note: if your narrative is clear and comprehensive, it's likely that the reviewer or reviewers will often read no further or will simply scan the foundational documents to insure that the foundational documents do in fact support what is stated in the narrative. This could speed the regulatory review and acceptance. 

More Articles on This Topic

I'll be writing a series of articles on the topic of human engineering file submission narratives over the next week or two. I'll focus on specific areas of the narrative and discuss some of what I have done with regards to putting together narratives for submission to regulators. 

Article: Year of Telehealth

Here's an article telling us what lots of us already have learned, that telehealth is an up a coming method of providing effective and cost-effective as well as continuous medical care where ever a patient may be. Here's the link to the article: https://www.beckershospitalreview.com/telehealth/dr-toby-cosgrove-2019-will-be-the-year-of-telehealth.html

Here's a quote from the article that I think is of interest:

"[Oakland, Calif.-based Kaiser Permanente] is seeing over 50 percent of their patients distantly," Dr. Cosgrove told CNBC.

What Cosgrove isn't telling us is how telehealth is being provided. Telehealth is pretty loosely defined. It can mean that patients have access to a health care provider through chat or the telephone. Or it can mean something more sophisticated such as continuous medical-device communication and automated monitoring. One way or another telehealth is clearly on the rise and will likely become the standard for providing care.

Training a Damaged Brain

One of my medically related interests is a neurological disorder know as CTE, Chronic Traumatic Encephalopathy. I became aware of this disorder largely through an exceptional documentary on PBS Frontline, League of Denial. It's a history of the discovery of this disorder as found in NFL players and the lengths the NFL had gone to deny that this disorder is common among those in NFL and football players in general. If you're not familiar with CTE and its connection to playing tackle football, I strongly suggest that you see this documentary. And consider reading and watching much of the source material. The work in this area continues to progress with more and more sufferers of CTE being discovered among those who were NFL players. Many of the changes in the rules and football equipment has been driven by research on CTE and the accumulating findings.

CTE is not the only type of brain damage that afflicts older NFL players. CTE is particularly troubling because its severity on suffer's cognitive and emotional functioning. There are brain damage related disorders are not at the level of severity as CTE that plague older football players.

A few days ago I ran across a treatment system that trains damaged brains. Many of the former football players, particularly those from the hard-hitting NFL, live in a kind mental haze, as if they were living in a dream state. They're unable to concentrate or focus for even a short period of time on anything without mentally drifting from the task at hand. This training system has been shown to significantly increase lift patient's emotions and apparently, lift them out of the mental hazy they have been living with for years. Here's a link to video and the article: https://denver.cbslocal.com/2016/02/08/former-broncos-seek-concussion-relief-through-neurofeedback/

The treatment system is called neuro-feedback. Because it appears to run on a computer, it would seem that it would be something that a patient could use on their own home computer.

Now, one of the reason's I mention this is because one of the people mentioned in the article and who is in the video is Jon Keyworth (and his wife). I mention that because Jon and I were childhood friends. He and I grew up in the same neighborhood. Jon is a few years older than I am. And we went to different high schools and different universities. Our paths diverged, but I haven't forgotten Jon. I followed his career from a distance and I've been in contact with people who have known him over the years.

Jon was an exceptional athlete. (Interestingly enough, the only person I've ever know who had athletic skills at Jon's level is my younger brother.) Me? I'm no athlete. I kept trying and continue to ride a road racing bicycle at respectable speeds, low to mid 20s MPH over reasonable distances, but in truth my athletic skills are at the opposite end of the bell curve from Jon. I'm not ashamed to say that I'm jealous. I always wondered what it would be like to have athletic skills at his level. (I bet there are others out there who have wondered the same thing.)

Let me go through Jon's success as a football player. Jon played for the Denver Broncos as number 32 for his entire NFL career from 1974 to 1980. (Seven seasons.) He was fullback meaning that his primary job was as a blocking back, nevertheless Jon is listed the 10th best all time rusher for the Broncos. He played in Super Bowl 12. (Not only can I not imagine what it's like to play in an NFL game, I certainly can't imagine what it would be like to play in the Super Bowl. I haven't had anything close to that kind of an experience. I guess it must have been nice, but that's something I'll never know.)

One more thing I want emphasize. Jon was, is and will be a much nicer, kinder person than I ever have been or will be. Forget about any stereotypes that you might hold about NFL players, particularly the stars of the game. At least as it applies to Jon. Jon is someone filled with warmth, kindness and generosity. And when I ran across the article and video above that talked about Jon's plight and his way back, I felt that I needed to share this treatment as well a little bit of Jon's story. It could be that these players and the treatment they're undergoing may have an impact on a much wider group, maybe people suffering from dementia, especially early dementia. Maybe it can be slowed or possibly reversed. But these former players may be blazing a trail for the rest of us.

So, thank you, Jon. And your wife. And thanks to the people who have developed the treatment and continue to refine it. 

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 ...

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.

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.

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." 

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.

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.