Digital Health Companies have to be careful, otherwise they could spoil the game for everyone

NOTE: It has been a busy few weeks and it is going to be a busy few months ahead. So, my blogging frequency is going to be erratic at best. It is a shame, because I wanted to write on the Prostate Awareness Month and then on Breast Cancer Awareness in October. However, Maker Faire Exhibits, Conference Presentations, Panels and Judging lie ahead for me, so please excuse the varied publishing schedule.

SyncThink

MedCity Newes reported on a warning letter from the FDA to a burgeoning company, SyncThink and they seemed to have responded promptly, as one would hope. However, the tailwinds still leave behind a trail of caution for companies going forward. Here's a quote from the MedCity Article:

SyncThink’s device Eye-Sync was cleared as a prescription device for the purpose of recording, viewing, and analyzing eye movements to help identify visual tracking impairment in human subjects, according to the letter.

However, it appears their overzealous marketing folks decided to go ahead and bump up the device to include concussion detection as a "feature". Why not? What with studies about the NFL, and various sports agencies deliberately ignoring issues have rendered many sportspeople with permanent ailments. Concussions also happen due to accidents, falls, etc., and thus the available market obviously spans a wide range of ages and gender is no bar. And yes, they can be life threatening. All this, of course, does not mean that you need to put the proverbial cart in front of the horse.

SyncThink of course claims it removed the materials that offended the FDA immediately from all of its marketing mechanisms.

Good, Right? Well...

A Trail of Bad and Unacceptable Behavior

The history of Digital Health is rife with examples of bad behavior.

Let's start with Not-AI/Maybe-AI/Most-Likely-ML

Actually this behavior spans all aspects of Healthcare, including, IBM Watson, according to a recent STAT article - promoted as a cancer therapy recommendation system, and sold prematurely resulting in a number of problems. This is something I have suspected for a while now, and it has been confirmed. Jumping the gun, declaring poor, dysfunctional Machine Learning products, worse than what a teenager can do with TensorFlow has become the order of the day for some companies. And to see IBM, glorified by Satell in one of the iconic books on Innovation do this is just sad. It should make you wonder about others.

Real AI is really not here. Excuse the pun. Google and IBM have friendly monsters that do a great job at Deep Learning. The actual independent decision making that would be the functional result of actual intelligence (not algorithmic analysis output), simply does not exist yet, at least in the public eye. And most of what you hear, is really just Machine Learning. More on this in a few blog posts before my December talk at the San Jose BIOMEDevice talk on AI in Medical Devices.

The problem with packaging stuff as AI?

It will always be the same. Overpromise, under-deliver, dilute your brand AND make it worse for the people that follow you. Just read my blog post on renal denervation, when I complete it and get it out later this week. The World Faires saw fewer contortionists in all of their existence, compared to people still, desperately trying to peddle renal denervation.

And while Scott Gottlieb wants to make the FDA business friendly and what not, two things to keep in mind - the FDA was created to avoid the kind of mortality and morbidity seen in Europe because all kinds of snake-oil merchants walked in and did whatever they wanted, and second, Europe, after about 50 years or so, has finally decided to take a more FDA-like approach.

So lying, fluffing or overstating, will get you trapped somewhere with regulatory problems. And, then, there will be the face-saving that all the other regulatory agencies will do by trying to get in on the game: bashing you.

My recommendation: Just don't do it.

But, let's go through one more example, before we get back to the recommendation that you have, hopefully heard since you were a child.

23-and-you-maybe, but not me!

Years ago, when 23andme came out, I was very irritated and wrote unequivocally about how they were going to make things hard for everyone. Why? All they could do was process your DNA. However, they marketed it in a way to make gullible people believe that as long as you joined the mania, and got your DNA mapped, suddenly a cure for just about anything to be found. Again marketing, with a serious disregard of facts. I am sure at least initially, they were not able to meet their price point profitably (this is just an assumption I make), and were hoping to ride the hype wave of people thinking suddenly, all they needed was Microsoft Excel (or Google Drive, given the company's origins) and compare their DNA with a bunch of friends - and lo!, the answer to everyone's problems would be laid bare with genetic certainty. Well...

Back then (and even now, and for at least a handful of years to come), even confirming a Single Nucleotide Polymorphism (SNP), where a single pair of nucleotides is off its hinges on the DNA ladder, took months to years to confirm. So, the company was essentially planning to capitalize on the desperation of the sick. Well, long story short, it took YEARS for the FDA to tell the company to go pound sand (too bad, neither the FDA, nor I are allowed to use more colorful language).

The company shockingly enough first tried to push back, and eventually gave in. Remarkable. And along the way, they slowed things down for everyone else, who could have behaved themselves, and gradually introduced a usable product, legally, when its time actually came.

My Recommendations:

1. The Valley (there really is only one here, contextually) is full of "people", who think the rule of law exists for others. They quaintly call such behavior: DISRUPTION. Ask Uber how that is working out. You might tell me, well, AirBnB broke the rules and bullied everyone, and got away with it. I ask you, what is likely: will you be the Uber of Concussion Detection or the AirBnB of it?

2. Regulations exist for a reason. No, not that you may flout them and find your own Lucy Koh (of the Apple/Samsung fame), sitting on the Federal Bench, just waiting to bite off more than he or she can chew! Again, your business plan can't be, "let's burn the bridge and when we need to cross one, get acquired".

3. Don't ruin it for others. When you flout regulations, or put out a terrible, immature product (read about what Medtronic did with Renal Denervation), you screw over quite a number of companies. People lose jobs, patients don't get the care. Do you really want to be the geniuses that got everyone in that swamp?

4. Following the rules is actually not that hard. Hire people with experience doing this. Go to RAPS, or the ASQ and look up good people. And I got good news for you: "Talented people in medical devices actually get paid terribly". Compared to the so-so CS grad you hired, only to have to give him bags of money, feed him and do his laundry, so he may write misogynist memos ruining your already flaky reputation because you funded 23andme!

5. Regulatory Agencies are almost always behind the curve. If you doubt me, go ask a Software Quality Engineer, what it takes to provide a software-update on an FDA approved product. But they learn. In the meanwhile, do not try to hoodwink them because they don't understand the gibber jabber of AI and so on and so forth. These are really smart people, and prone to anger (if you had to read and interpret text only pdfs all your life - and NO, your ML algorithm cannot do a better job, you'd be on the edge too). Play nice. Explain yourself to them. Show them your intentions are good. And work with them.

Doing all of the things I have stated are not going to earn you brownie points. You are expected to do them. There is a lot of change ahead with Digital Health, 3D Printing, 4D Printing (yes, it exists, mostly in labs), ML/DL/AI, IIoT and who knows what. It is important that when applying these technologies and paradigms to healthcare, good judgement, patience and care is essential.

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Reference:

1. On SyncThink: http://medcitynews.com/2017/09/fda-slaps-syncthink-warning-letter-concussion-detection-claims/?_hsenc=p2ANqtz-8nrGCq5sErFwlSoErAZCVWLTeQMaeWZlOm465jisv-uu2z4yqUt-sfcRu-YPPwD_LNPpWqAHnDZ-vxrsb-YPv7d0K6xA&_hsmi=56142139


2. IBM's Watson on STAT: https://www.statnews.com/2017/09/05/watson-ibm-cancer/?utm_source=STAT+Newsletters&utm_campaign=1793b79d98-Weekend_Reads&utm_medium=email&utm_term=0_8cab1d7961-1793b79d98-150030301

3. Image, Courtesy Pexels: https://www.pexels.com/photo/black-and-blue-electronic-tools-on-green-circuit-board-39290/

The FDA promises a path forward, in digital health and other areas...

I find it quite interesting that, just yesterday, I had complained about how the FDA and other regulatory agencies are behind the curve on cyber-security, and today, at least with regard to digital health, the new FDA Commissioner Scott Gottlieb is promising some key changes and efforts going forward. This is, to say the least, heartening to hear, especially since at least some of the efforts continue on from the previous administration and that is a good thing. Not only do we get continuity, but also rapid progress as opposed to a back to the slate approach. I only hope that in the long run, the FDA stays guarded against haphazard deregulation, the kind that eventually caused patient injury and sparked anger and intense debate in 2007. I also want to remind everyone that the FDA has only provided forward looking promises, and only when these things come to fruition would a better picture emerge.

Most of the information, comes directly from a blog post by Scott Gottlieb (that quite irritatingly leaves out the definite article when addressing the FDA throughout the post). The post is linked below, along with an article from CNBC with some caricatured, over the top reactions. I wanted to discuss a few, salient points here.

The Stratified Regulation of Digital Health

When it comes to digital health, things have been haphazard so far. Some organizations decided by themselves that regulation did not apply to them. Ever guarded about their role, the FDA stepped in and refused to simply give up. Then came the uproar about what should and shouldn't be regulated. As Gottlieb points out, the 21st Century Cures Act rids the FDA of the need to act on simple applications, such as healthcare lifestyle/motivational mobile apps and administrative software programs. This is a great step forward. However, for example, blood glucose monitors and accessories, pictured above will continue to be regulated (in the past, poor design decision making led to patient death and a company shut down).

Clinical Decision Support (CDS) Software

Clinical Decision Support Software programs, either by themselves, or in conjunction with medical devices will provide recommendations for diagnoses, treatment, dosages etc. As such the FDA has regulated them without guidance and this has led to much stress and discussion. There has been a long, ongoing effort to try and make some clarity available, and it appears that the FDA is finally promising (mind you, that is all we have as of now) that this will happen. What exact shape and form this will take is unclear as of now.

Something, Something, Opioid Crisis

The opioid crisis is real, and action is necessary, but from Gottlieb's writing, it is unclear what the FDA will do. Past contests and prizes are great, but if they plan to do something more concrete, I was not able to glean any of that from the blog post.

Pilot Programs and Cutesy Abbreviations

So today, through Gottlieb's blog post, I was introduced to a new term - Software As a Medical Device (SaMD). Apparently, a third party certification agency will allow low risk devices to be "per-certified" and marketed without FDA pre-market review, and high risk devices will be undergo an FDA review. Who will do this classification is unclear from the blog post, and frankly worries me. Information on an apparent pilot underway to accomplish this is also thin on details.

On Third Parties and the Risk Based Approach

Terms such as "third party certification agencies" make me a bit squeamish. Almost never in the open, but heavily so in private, Regulatory Professionals in the Industry writhe, squirm and complain about how the third party certification agencies that oversee CE Marking wreak havoc on their day to day jobs. Privatization is always a mainstay of the GOP agenda, but it is very disconcerting to see this discussed in the context of regulation. One fundamental qualifier for the FDA has been that, holding devices, software, pharmaceuticals and much more to a very high standard has proven quite (safe and) effective for those of us here in the US. I wonder, if the pilot, is but a pilot to extend this "third party" business into other areas that come under FDA purview.

Sure, it is good for businesses and a new crop of companies and consultants it will foment, but is it good for the US consumer in the long run? My answer is - NO!

I don't understand why the FDA would have difficulties doing the classification and the consequential pre-certification. This is something that gives me a long pause, but let's wait and see how the pilot pans out and what comes of the actual efforts at guidance and regulation after.

Over all, medical device and pharmaceutical companies already consider a risk based approach in design and manufacture and the FDA also encourages this. This part, I like. It is important to focus on critical, high risk items that have bigger impacts and not on the minor details.

National Evaluation System for health Technology (NEST)

This was fun to learn about. Through the Medical Device Innovation Consortium (MDIC), post market data is apparently to be made available to engineers and designers to improve product design, by 2019. This is quite interesting and exactly the kind of innovation that SHOULD be outsourced to "third parties" and made available to all. You wont hear me disputing this one.


Conclusion

Scott Gottlieb's blog post appears to be well thought out. It makes promises, most, if not all of which appear lofty and beneficial. However, as I have mentioned previously, these are just onward looking statements and only time will tell how they all play out. So, I would advice everyone to take a more measured approach and wait for more concrete information to emerge.

References:

1. Scott Gottlieb's Blog Post: https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/

2. An unjustifiably jubilant CNBC Article: http://www.cnbc.com/2017/06/15/fda-commissioner-scott-gottlieb-outlines-new-digital-health-strategy.html

3. A cool Fiercehealthcare article on CDS Software Regulation Guidance: http://www.fiercehealthcare.com/special-report/fda-s-approach-to-clinical-decision-support-software-a-brief-summary

4. Image, Courtesy Pexels: https://www.pexels.com/photo/health-medical-medicine-diet-46173/

Quick Post: Digital Health Investments by Pharma

The CB Insights Blog has a great post about investments in Digital Health Companies, that go beyond the traditional VC Investors. They have prepared a nice infographic-like visual chart that serves as a map for companies that have been investing in Digital Health. Without much ado, I am leaving the link here for you to read:

Click Here