Theranos lives... to die another day?

I would be surprised if you were either in the medical devices/diagnostics or the general greed, stupidity and avarice industry and had never heard of Theranos. I mean you'd be in some strange Rip Van Winkle territory there. And, of course, being aware doesn't mean staying in touch. And of course, after all the revelations of unethical behavior, lawsuits and settlements, I thought this pathetic organization was going to go off into the sunset. Clearly, I am wrong!

Fortress Investment Group, probably consisting of people who have gone out of their minds (but perhaps not so much as the folks of Japan's SoftBank who plan to acquire Fortress) has invested in Theranos, with a $100mn loan based on "certain product and operational milestones", apparently. Interestingly enough, the lack of a product and any meaningful operations is what got Theranos here. The founder, used the valley's insanity and potentially other influences, as well as the valley's ignorance of medicine to raise money and label herself as all kinds of the "next big thing".

I could go on and on, but I am not sharing my sense of hubris or bitterness. I do have to point out, I was always quite suspicious of Theranos (I had even considered blogging about this, but unfortunately, I was much busier at that time). When suspicions that Theranos is a failure and had engaged in deceptive practices (they really, really ticked someone off at WSJ, where people engaging in such practices are adored and revered typically), I had posted something on social media, and one of my own close friends, who fancies himself a Valley entrepreneur said, "you have to fake it till you make it". Not so in healthcare, friends. Just give up the idea. Reality eventually catches up to you.

There is more here as to the irrationality that Silicon Valley pushes. Let's take a look at a few salient points:

1. From Theranos to Google's Powerpoint Slides (or is it Google Deck?, as if that is what matters) about using your disposable contact lenses to monitor blood glucose, there is a lot of remarkable ignorance of basic science and the stringent requirements of accurate diagnosis of health condition parameters.

2. The irrational exuberance also extends to complete ignorance that diagnosis is only part of the problem. There are no instant, magical cures. A cure for diabetes does not exist today. Yes, it may and well certainly exist in the future through CRISPR or some equivalent, but even then, there is a business model gap here that people simply don't get. There is NO difference, if you instantly diagnose me with diabetes or sickle cell anemia, or if it takes two weeks. Well heck, knowing that most of these diagnoses can be false positive, I will go to the clinic any way and spend time and money getting a deeper blood draw and go through with a detailed test and a human-in-the-loop diagnosis.

There are specific times and places where a certain subset of diseases would require diagnoses. They would also afford patients and healthcare professionals significant savings at such times. War, post-natural disasters, space travel, travel and living in extreme locations on the planet are all examples of such situations. At other times, the advantages and cost savings are far and few.

You could ask, "well, then why did Walgreens even get in on that awful deal with Theranos? " I assume they just fell for shoddy marketing. Regardless of whether or not they extract a payment from Theranos, some of the procurement folks at Walgreens need to be retrained.

Sure, there are tests that are growing in popularity, such as Cologuard, or mail-in free to cheap testing for HIV. Well, there are advantages to both. And, specificity. Colon cancer testing is painful. And this test, that has you mailing stool samples is only predicated for people who have never had the cancer before and who are not hereditarily pre-disposed to have colon cancer. As to HIV testing, you can now get on PREP, or, at best, knowing sooner means the condition remains chronic but not terminal for most people. Where advantages are afforded, costs and pain can be saved and treatment is available, diagnostic tests will succeed commercially and with purpose.

3. I did give away some of the farm at the end of the last point, but patient/population enthusiasm is key. Yes, you'd get the hypochondriacs to jump on it. And of course the health-crazy (there is a line where consciousness crosses over to plain nuttery). But what about the vast majority of people out there? How are you going to convince them to use such tools when they feel healthy? This is always going to be a problem. Behavior modification and awareness are key areas of my own research and I can tell you, when you separate reality from the valley's hype, adoption is really slow.

4. There is a reputation problem, a problem that Theranos has created. Sure, like a swamp monster, Theranos somehow lives and may raise one day again. However, they have created a genuine problem for everyone, including the competitors whose devices they ran as a cover to provide some of the diagnostic information. When some organization (hopefully someone else) creates an actual working diagnostic scan, they are going to have to put in immense effort to prove that their tests are accurate, and they have an actual value.

5. What would I recommend?

I am sorry, but I think for a long time, till genetics and diagnostics become better and have corresponding interventions become available, these mass tests are going to be absolutely worthless nonsense.

Tests that have high precision and accuracy, and can lend specific therapeutic interventions as a result of their use are probably the way to go.

The fundamentals have not disappeared just because the valley has decided they must: commonsense, realities of diagnostics, treatments, patient interest, payment issues and more. Focus on them, solve the problems, look for innovation, not nonsensical disruption (I still have a magazine advising us all to be "like Uber". Would you?).

References:

1. On the funding (Fortune calls it a perverse Christmas Gift, in case you thought I was being harsh): http://fortune.com/2017/12/23/theranos-secures-100-million-in-new-funding-from-fortress-capital/

2. Image, Courtesy: https://www.pexels.com/photo/white-and-clear-glass-syringe-161628/

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Quick Post: The FDA takes part of a much needed change of approach towards homeopathic "remedies"

Traditional/Alternate non-allopathy medicine certainly has a place in the healthcare industry. However, the problem is that a lot of these are entirely devoid of any basis in scientific evidence. These medications can provide, limited healing for a small subset of simple disease conditions at best. For the more aggressive disease conditions such as cancer, where the mechanism of disease itself is not understood well under most circumstances, they quickly fall apart.

That is not the only issue with the practices. There are no cGMP practices, and usually no standard controls on how the drugs are manufactured. Routine examinations have found that Ayurvedic and Homeopathic drugs are found to have dangerous contaminants (worse in Ayurveda than in Homeopathy - links provided below).

Remember, this is not a criticism of the forms of alternate medicine.

It is that a lot of these drugs are being manufactured without the controls afforded to the mainstream (if you can call it that) pharmaceuticals. This is a non-trivial problem. From poisoning to a range of other side-effects, this can actually affect the health of unsuspecting patients.

The Key Issue

The Key Issue is however that the purveyors of these drugs over-promise, with no scientific backing. One key danger, as you can imagine, is that in lieu of actually taking drugs that actually work, patients could opt for drugs that do little, or nothing and in many cases, cause actual harm. This is really a huge problem.

The FDA steps in

In 1988, the FDA decided it would not regulate homeopathic drugs. This decision reverses that. However, this doesn't go far enough. Here are some quick thoughts:

1. The new policy unveiled by the FDA only covers certain categories of homeopathic drugs - for infants and children and more serious diseases such as heart conditions and cancer, as well as for drugs that contain certain substances, such as Belladonna.

2. It doesn't cover manufacturing and contamination issues on a global scale.

3. It also doesn't talk about requiring more scientific rigor, per se. I get that more scrutiny would indicate a demand for scientific rigor, but that needs to be explicitly stated. Why? Because if you follow mainstream medicine, and create a drug or a device, you are EXPECTED to conduct trials, have the work examined by experts in medicine, get the work published and so on. You are ALSO expected to do post-market follow up. It is awfully dangerous that even the shifted policies don't give me the comfort that any of this will be imposed on homeopathic medicine.

4. In other good news, the FTC is joining the FDA in some of the enforcement and so things are looking up from a safety and efficacy as well as labeling point of view.

Conclusion

However, the FDA's shift in policy is a welcome change in the right direction. Again, it is not a criticism of alternate forms of medicine, I just think that in the interest of patients, there has to be scientific rigor, honest marketing, follow up and cGMP implemented. Let us see what Scott Gottlieb's FDA does as time goes on!

References:

1. The FDA on regulating homeopathic medicine: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm

2. Image, Courtesy Pexels: https://www.pexels.com/photo/tablet-medical-medicine-grind-39522/

3. Contamination in Ayurvedic Medicine: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2755247/

4. Concern for contaminants in Homeopathic Medicine: https://www.ncbi.nlm.nih.gov/pubmed/20674842

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Slides from my AI Presentation at BIOMEDevice 2017 and introducing a new site

If you have been following the blog, you have heard I was presenting at the San Jose BIOMEDevice Conference this week. In connection with this, I have a new site, http://medpund.it/, focused on discussing my research in Artificial Intelligence, as well as to discuss the impact of the field on Medicine and Medical Devices. There will be discussions on technology, business and social aspects as well.

From time to time, I will highlight my posts from there on this blog, but I invite you to support me on that site, as you do here as well, by subscribing to updates using one of the means provided. I am trying to keep my focus areas separated on different sites. I would like to see how this experiment pans out. As always, you will not be bombarded with any advertisements, ever (maybe a couple of plugs here and there, but that's it).

Meanwhile, do head over to the site and download my slides, and provide me some feedback. The slides themselves, prepared in my style of minimal wordiness, do not tell the full story, but I will write posts on the various topics discussed in my presentation. Feedback is welcome.

The link: http://medpund.it/index.php/2017/12/07/slides-how-artificial-intelligence-is-changing-medical-devices/

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I have a full conference pass to give away for the San Jose BIOMEDevice Conference

This is going to be a brief post. I am honored to have been accepted to present on how AI is influencing Medical Device Design and Manufacturing, this December, at the San Jose, BioMEDevice show, happening on the 6th and 7th. I am told, as a presenter, I can give a pass to one person. For additional folks, I can provide a 20% discount code.

If you are in the Medical Devices Industry and/or think you may benefit from participating in this conference (and I think you can immensely benefit from attending the conference), please get in touch with me. I do not need you to explain why you think you will benefit from. Just do so immediately, and I am probably going to give the pass away on a first-come-first-serve basis.

I am to submit the following information on your behalf, to the conference organizers, to get you a pass: name, job title, company name and email address

Please note again, there is only one pass I can give away.

Do get in touch with me, with the above details at yamanoor at stanfordalumni dot org

I hope you take advantage of this, and if possible, drop by during my talk and say hello!

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Reference:

To learn more about the conference, please go to: http://biomedevicesj.mddionline.com/conference

Two summaries on my panel on cross-pollination of ideas into Medtech

As I was thinking of getting to summarize, what I thought were some of the cool things I myself learned while being a panelist at MD&M Minneapolis, Amanda Pedersen over at MD&DI wrote a very neat summary of the panel, and I know she did it meticulously because she got one of my quotes very accurately. And that makes things easy for me. I don't have to repeat some of the very excellent points Dale, Alex and Bonnie made. I am going to focus on some key things I learned besides what you will find in Amanda's write up (article link below).

The "looks-like/works-like" prototypes

Dale Larson reminded everyone of the need to bring prototypes to healthcare professionals. I liked the idea of a "looks like" prototype, which is not necessarily functional, and the "works like" prototype that works, but may not look like the anticipated final product. I think these are important considerations and Project Managers, R&D leaders and Engineers alike should consider practicing.

Killing Projects Without Fear

Dale's advice is definitely one of wisdom. He suggested that once it looks like a project has no viable path to commercial success, it ought to be killed. In keeping with my wry wit, I suggested, "you will never get an engineer to agree to that". He responded, taking my comment in stride that life is short, and reminded us we are all here for a limited time and that we should look at spending that time efficiently. I am paraphrasing here. I really liked that line of thinking, and of course, jokes aside, I know that killing unviable projects is important!

Groupthink in the Devices Industry

Again, paraphrasing, in the sense that I am using the word "groupthink", but Alex did point out that it is important to make sure that you are not only expecting people with medical device experience to be on your team. This is something I will be writing about in much detail later, but I tend to agree with Alex. In fact, on the panel, I followed him up by agreeing that this is a huge problem. If you fill your room with a bunch of people who have spent "n years doing balloons/catheters/other lather/rinse/repeat run of the mill nonsense" will NEVER get you to a single innovative solution.

Groupthink is like a disease, and until culture change happens at the organizational level to include diversity of backgrounds and ideas, you can forget being able to innovate or bring out the best from other industries. This is truly one of the gravest shortcomings of the medical device industry.

Technical/Manufacturing Readiness Levels

Bonnie, our moderator, made several key observations. One of them was that the medical devices industry doesn't have a common language that talks about the readiness of technology. She referred to terms used in defense, such as Technology Readiness Level and Manufacturing Readiness Level. These were eye openers for me. And I always find it interesting, how you could go years without knowing something and then you hear it all over the place. This past Friday, I was at a bootcamp for a Space related Business Plan Competition in Austin, TX and I heard a NASA scientist turned entrepreneur define the TRL of his company!

The Medical Devices Industry, only appears to standardize around what the FDA and EU want and from a business/strategy standpoint, appears to have large gaps in using terms that other industries use. This is clearly something that needs remedying!

So, these are some of the key concepts I learned from the panel in Minneapolis last week. I may remember a few other things, and if I do, I will definitely write about them. Until next time..

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References

1. Amanda Pederson's article: https://www.mddionline.com/how-identify-crossover-technologies-work-medtech?elq_mid=2025&elq_cid=74447&ADTRK=UBM&elqTrackId=70616da339d1400d8950d401f3f7a18a&elq=82a208b2fc0046ffbe34539622753c2d&elqaid=2025&elqat=1&elqCampaignId=838

2. Image, courtesy Pexels: https://www.pexels.com/photo/black-and-white-blood-pressure-kit-220723/

Interview: A preview of my talk on AI and Medical Devices this December

I know I have not been blogging as frequently as I would like. It has been a busy few weeks filled with Maker Faires, conferences, competition judging and participation in competitions and panels myself. Just yesterday, I was a panelist at the MD&M Minneapolis Show, talking about issues surrounding cross-pollination of ideas in Medtech Development. Time permitting, I will summarize a few things I myself learned while sharing my thoughts and views. I hope to be able to blog again with regularity soon, hopefully, after my AI presentation.

On December 6, 2017, I will be presenting a talk on how AI is and will continue to affect medical device development and use. I gave a preview interview to MD&DI, Qmed on AI and Robotics and how they affect medical device development. The broad strokes interview, linked below doesn't address my entire talk, so if you are in San Jose, please tune in. In the meanwhile, do read the interview and let me know your thoughts.

Also, if there are any burning questions you would like me to answer, please leave a comment, or write me at yamanoor at gmail dot com . I look forward to hearing your thoughts!

The Interview:

https://www.mddionline.com/qa-how-prepare-ai-driven-future?ADTRK=UBM&elq_mid=1929&elq_cid=74447

My Presentation Schedule:

http://schedulebmsj.mddionline.com/session/how-artificial-intelligence-is-changing-medical-devices

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Image Courtesy, Pixabay: https://pixabay.com/en/hand-robot-machine-697264/#

Quick Post: Head Over to Gyn.io for some Breast Cancer Awareness Month posts in October

As some of you know and have seen me post here, earlier this year, I branched out my research and blogging on Women's Health onto a separate site, a domain of my own, http://gyn.io

I am very excited to bring you news about my impending posts on Breast Cancer over there. Have a look when you have a moment! Consider subscribing and supporting me there as well!

MDDI: Machine Learning in Healthcare getting some well deserved love

MDDI, a versatile source for healthcare industry news has some good news for AI/ML fans. This morning they provided news on two different companies that got funding for Machine Learning (ML) news. I cringe a bit when people keep confusing ML for AI. However, since ML is a focus area of AI, it is all good. I have provided the link to the article below.

Low Hanging Fruits

Healthcare cost prediction is tough. However, it is ripe for innovation with huge amounts of data and of course Machine Learning, now gathering steam through new technologies and paradigms. MDDI is reporting that Cardinal Analytx Solutions, here at home in Palo Alto has raised $6.1mn to do exactly this. I haven't had time to research the specifics of this company yet, having woken up to this news, but if I find something interesting, I will get back to you.

Analytics 4 Life, another company that is in the same article, is aimed at diagnostics, another area ripe for disruption through Machine Learning. It is apparently aimed at being a low-impact cardiac diagnostic, eliminating the need for radiation, angiography or other invasive techniques. This is intriguing, given how it will lower costs and be less intrusive to the potential patients. Accuracy is a concern, but reviewing some of the other ML based diagnostic projects through the O'Reilly AI Conference archives from NY earlier this year, I can say there is every possibility that a diagnostic can be created to be accurate enough using ML. Plus, when you are sitting atop $25mn from several investors, I say, you can do it.

Some Thoughts

1. I believe we are still in the pre-bubble stage of AI based investments in healthcare. This is really good!

2. Commonsense is still the norm in investments and that is also very good news.

3. Investments and start-ups are still mostly scratching the surface. It would be nice, if we saw investments in companies with deeper ambitions and technologies before the mad rush begins.

4. If start-ups don't pick up the pace, there will be an unfortunate stranglehold on AI by companies such as Google, Apple, IBM etc., especially on the analytics side of things. Overall, this is not good for competition or for innovation. Moreover, when the larger economy slows down, or at a minimum, when "tech" slows down, there will be a slowdown in the implementation of AI in Healthcare. This would not be good, should it come to pass, as, given political intractability and general cost increases are making healthcare expenditure rates go up.

5. Still no sight of innovation in medical devices or pharma, and this is also not very comforting.

There is of course, much more to be seen as data-intensive companies, use Machine Learning (ML), Deep Learning (DL) and eventually Artificial Intelligence (AI) and try to democratize healthcare. Of course, there will be a bubble, small or large to go through along the way, as it is in every changing industry, and yet, these are amazingly exciting times ahead! We are still taking baby steps!!

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References:

1. The MDDI+QMED Brief: https://www.mddionline.com/two-ai-startups-bag-new-funds?ADTRK=UBM&elq_mid=1221&elq_cid=74447

2. Image, Courtesy Pexels: https://www.pexels.com/photo/man-with-steel-artificial-arm-sitting-in-front-of-white-table-39349/

A very interesting connection between Stainless Steel Sinks and Legionnaire's Disease

People think little of Stainless Steel on a day to day basis. I mean, it is a wonderful, class of alloy and surrounds all walks of our life. It is strong, durable and easily rolled, formed and otherwise manufactured into multiple shapes, sizes and devices. Add a little Chromium here or Vanadium there, mess with the Carbon percentages and you can extend the applicability, life or property of choice. Therefore, most people are at least a bit surprised when they find out that Stainless Steel too, is vulnerable.

Just today, I came across a rather interesting study, that makes a connection between Stainless Steel degradation and rust in sinks with Legionnaire's Disease. At first reading, this must seem quite odd, but if you consider that a Legionnaire's safety expert oversaw the study, the connection makes more sense. Well, let us take a look at both of these for a minute.

Legionnaire's Disease

Legionella, a genus of gram-negative bacteria, has several species that have been known to cause the disease, with symptoms ranging from headaches to pneumonia, and rarely mortality. Luckily, under most conditions, it doesn't get transmitted from patient to patient. And apparently, the disease is present in bathtubs, sinks, showers and other places we wash up, shower, etc. I learn something new every day. I will provide a couple of reference links at the bottom, if you were not familiar with Legionnaire's Disease as well.

Stainless Steel

Now, as an Engineer, with enough experience on the applications side, I can speak with some strength on Stainless Steel. Everyone who studies Materials Engineering is taught that Chromium (Cr), when added to Stainless Steel can make it resistant to rust. However, when you try to balance its properties you can't just keep adding Chromium. There is an upper limit.

Passivation on the other hand, is a process, I like many Engineers became familiar with. Using diluted strong acids such as Nitric Acid or weak acids such as Citric Acid, Stainless Steel is made rust-resistant through the addition of a very thin layer of oxide that prevents further rusting. For those interested, there are ASTM standards and plenty of reading materials out there.

The Study

The study, performed over 3 years, found that when tested on rusted taps, Legionella survived quite well. Non-rusted stainless steel taps were not inclined to serve as breeding grounds. The same was true of brass. I tend to know a little bit about brass as well. My undergraduate education involved a heavy dose of industrial training. And, I was accustomed to encountering brass impellers in submersible and other pumps designed for use along Oceans and Seas. Perhaps it is the presence of Zinc, but whatever it is, brass is wonderful in that, it can also be machined easily, like cutting into butter. Understandably, brass is expensive!

Therefore, your options are limited. Expensive sinks, or ceramic sinks. Most ceramic sinks still have stainless steel fittings, such as drains, etc. Perhaps you can limit the alloy portion of ceramic sinks to brass. It will make for both great looks and infection prevention.

How about re-passivation? Is that a thing?

I am not sure. Also, the problem is that you can't expect people to check their sinks and use Citrate to passivate their Stainless Steel bathtubs, sinks etc. And what about large buildings with many such sinks, such as, say Hospitals? There is already a big battle going on with Hospital Acquired Infections, and this ups the challenge.

It is a bit unclear that there is a single solution, but it appears, material substitution and regular inspection and servicing are the minimum requirements here. Maybe on-spot passivation can be a thing. Perhaps nanotechnology based coatings and solutions will emerge. Only time can tell!

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References:

1. Legionnaire's Disease: https://www.cdc.gov/legionella/about/causes-transmission.html

2. A slightly different take on Legionnaire's: http://www.mayoclinic.org/diseases-conditions/legionnaires-disease/home/ovc-20242041

3. An article on the study: https://www.newscientist.com/article/2145448-stainless-steel-sinks-may-up-your-risk-of-legionnaires-disease/

4. Image Courtesy, Pexels: https://www.pexels.com/photo/blur-bubbles-cleaning-close-up-545021/

Help me gift an AAAS student membership

AAAS - American Association for Advancement of Science

Help me help with a STEM/Human Experiment!

AAAS recently communicated to me that as a member, I have the opportunity to gift an undergraduate or graduate student a year's worth of membership for $25 as an investment in the future of STEM. People I know personally are either ineligible or members themselves. I think more students should engage with AAAS as early as possible. Certainly, I would have benefited!

So here is my offer:

This year, I would like to offer ONE student membership for $25, to one student, as long as they are eligible as defined by AAAS and are hopefully a student in one of the STEM areas.

In the future years, should they or another of the half a dozen or so Professional Membership Organizations offer such deals, I would, based on the level of interest, like to sponsor more students.

Anyone who wishes to express their opinion on this notion can leave a comment, or send me an email at yamanoor at gmail dot com. Your thoughts are appreciated!

The help I seek from you

Very simple. Are you a student who would put a year's worth of membership at AAAS if you are eligible (link provided at the bottom, please check). Essentially, you will need a "dot edu" email address. So, possibly high school students may be eligible(?), but I am not sure, and I am not sure if you are ready for an AAAS membership. If you think you can benefit from it, do contact me.

If you are not a student, do you know a student with a dot edu address that can benefit from an AAAS membership? If so, please send me the relevant information as required by the link below, or have them contact me.

I would like the student to confirm that they signed up after I make the necessary payment. This way I can close this request.

What I am promising

This is a simple membership. You don't have to tell me anything about why you/the student is deserving of it. I am going to follow an honor system here. I am also going to follow a first come first serve basis here. As soon as I make the offer and the student (hopefully) confirms they took up the offer, I will update this post. Or, alas, if no one expresses interest, I will update so by October 1, after the deadline has passed. I hope it doesn't come to that!

What I hope you do if you take up the membership

Please enjoy it as much as you can! If you feel up to it, drop me a line and tell me if and how much use you got out of it. It might help me plan for the future.

Subscribe and Support, Please!

Did you enjoy this post? Please subscribe for more updates, using the sidebar. Have ideas or blog posts you'd like to see here? Contact me at yamanoor at gmail dot com.

References:

1. The AAAS Offer: https://pubs.aaas.org/Promo/promo_setup_rd.asp?utm_medium=email&utm_source=Membership&utm_campaign=backtoschool&utm_content=giveagift_body3_&dmc=P7XLX7EM&et_rid=247418798&et_cid=1533584

2. Image, Courtesy, Pexels: https://www.pexels.com/photo/clinic-doctor-health-hospital-4154/

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/

It is high time the FDA considers taking down DTC ads rather than confounding them further

Word is out that the FDA is trying to curtail the number of side-effects stated in Direct-To-Consumer (DTC) pharmaceutical advertisements, in an apparent effort to try and get consumers to understand the key side effects and remember them. This is apparently considered a benefit to the consumer. How? Don't ask me. I think this is a bad idea, and the focus should be to de-emphasize DTC, so that prescribing medicine goes back in the practitioners' courts and pharmaceutical companies can focus on R&D and Translational Research spending. For years now, I have advocated AGAINST DTC ads.

1. Why am I against DTC ads?

The United States is one of the few countries that actually allows DTC ads of this nature. And I have a few critical reasons why many of us, and not just me, are against DTC ads.

1.1 An uninformed public is either given unnecessary hope, with some advertisements. Advertisements have a misleading way of sounding positive, and appear to offer a single point solution, that is quite effective. Needless to say, we don't know how age, sex, gender and other factors differentiate the effectiveness of treatments for many conditions in various patient groups. And where, we do know the effects, the advertisements simply ignore to state such information. Sure, there too, we could be like the FDA and pretend that information overload is the problem. However, when the Doctor finally informs the patient that the drug wont work on them (or tell them so after a few courses of treatment and the associated side effects take their toll), there are the 5 stages of grief, the second opinions, the ensuing loss of trust, the negative effects are too numerous to recount.

1.2 Confusion is the next problem. As the old joke in many television situation comedies (which run the advertisements they mock) that a simple headache medicine could include side-effects ranging from death to, yes, you guessed it, headaches.

Now, let us say that you found a headache medicine or allergy medicine that did indeed have side effects ranging from death to headaches. If you mentioned death only, does that make the patient feel relieved or better prepared? Or, if you leave out the headaches, and the Doctor only mentions them in passing, does the patient take that side-effect seriously? Do they decide to take the medicine? And if they are indeed plagued by headaches from taking the medication, then what?

1.3 Unnecessary Fear is the next problem. Imagine watching a cholesterol ad that warns you of cancer, heart disease or rectal bleeding? This is why the solution is not to MAGNIFY the main side effects. That somehow just makes the problem worse, not better.

1.4 The drug ads are also comically nightmarish. First of all, who in real life walks around telling people they have "moderate to severe Crohn's disease". If they did, it would actually be indicative that they need help of a different kind. And some of the so-called patients appear so deliriously happy after medicating themselves, it almost appears that something else is being advertised. Are you surprised at all that the United States is suffering from an opioid crisis?

Then there are the ads that are downright creepy. While the FDA has agonized over the presence of dogs, I would be more worried about ads that show a patient wandering through some ghoulish cartoon world, right out of the mind of someone who has consumed quite a quantity of hallucinogenic mushrooms.

Now, let me dismantle the reasoning behind this misguided effort at distilling DTC ads to accentuate fear, confusion and misinformation:

2.1. It is based on a study conducted with almost no rigor. The FDA asked 1500 people to watch a few advertisements, asked a few questions and mixed up a cocktail of street-side psychology and came to conclusions. This makes absolutely no sense at all. And this somehow took them years to get to.

2.2. Who decided information retention is the problem? This is what perplexes me. The problem here is patients who probably don't even understand what they ail from fully well, walking into the Doctor's office, demanding to be prescribed WEIRDCONSONANTFILLEDNAMEERASTUMINALIBAB because they watched an ad, that, sure, told them they could have nasal bleeding or brain cancer and something something, but that woman was up the next day smelling flowers and high-five-ing strangers. You see, if we get past all that distraction - the basic problem is - patients should not be making any decisions on their prescription (why have Doctors go through medical school at all then?) and should really leave this to professionals.

2.3. When was the last time a practitioner said, "Phew, I almost forgot about, but I am glad Patient X brought up EASYTOFORGETEXA for his moderate to severe such and such"? (Yes, the "moderate to severe" thing PISSES ME OFF, and to be clear, there is nothing moderate about how much it pisses me off.)

The Solution

This is one of several favorite quotes from one of the shows I love the most, House M.D. :

Dr. Gregory House: You wake up in the morning, your paint's peeling, your curtains are gone, and the water is boiling. Which problem do you deal with first?
Dr. Eric Foreman: House!
Dr. Gregory House: None of them! The building's on fire!

See, the problem is not that there is too much information in DTC ads, or that the amount of side effects retained is the problem. The dog running around in the ad is most certainly NOT the problem.

The problem is the burning house, that is, the fact that we unleash ads about NEARXIGA on people till 11PM, after which the "Non-Attorney Spokesperson" shows up and scares the living lights out of you and does not leave before letting you know that the FDA knows NEARXIGA kills, and equipped with this information, should you notice you've just died, call them.

What the FDA needs to do is to advice pharmaceutical companies to advertise as less of their drugs as possible and focus on spending money over new and more effective therapies. It is that simple. And in fact, that is exactly what a "business friendly" FDA ought to do.

And everyone should watch Dr. House.

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References:

1. The Forbes Article: https://www.forbes.com/sites/arleneweintraub/2017/08/29/fdas-gottlieb-wants-to-rein-in-risk-info-in-drug-ads-but-will-he-succeed/#74f9bf7e2042

2. Dr. House Quotes: http://www.imdb.com/title/tt0774238/quotes

3. Image Courtesy, Pexels: https://www.pexels.com/photo/colors-colours-health-medicine-143654/

The "Jaipur Foot", India's amazing, frugal medical device innovation is back in the news!

With most medical device innovation happening in the West, it is easy to simply ignore some marvelous innovations coming from elsewhere. The Jaipur Foot/Leg, conceived in India and used for decades, there and elsewhere, is a great example of frugal, yet effective medical device innovation. There are a few excellent resources where you can read about the Leg, it's developmental history etc. Since it has been in the news recently, I thought we could instead take a look at what makes the Jaipur Leg so special:

1. The prosthetic is very effective. It does have an average age of about 3.7 years, after which the patients usually go for a re-fitting, but according to an IEEE write up, the prosthetic could last a lot longer [2].

2. It is QUITE cost-effective. At approximately only a $45 a fitting, due to frugal innovation and donations, a run-of-the-mill $10,000 can't even compare, for the patient populations this device serves. Combine the price with the 3.7 average years of usage, and it still is an excellent bargain!

3. It has attracted a lot of attention from Universities, which has only made its use quite effective. Stanford University teamed up with BMVSS[1] to create an artificial knee (the reason why the Jaipur Leg is, rightfully in the news again), the tour de force behind the Jaipur Leg to create hands. And, so has MIT [3], both with very fruitful results. It also appears to have inspired an artificial hands project [4]!

4. Besides the frugal design, the Jaipur Leg is also marvelous for both cost-effective and rapid manufacturing.

The primary challenge

Of course, the fundamental mechanism that allows poor amputees afford the prosthetic is through donations by philanthropic donors, thus cutting the costs, or making the cost of attachment almost entirely free. This is an ongoing challenge for an organization that is almost entirely built on frugal innovation, and acting as a charity. Some day, there might be an innovation in the compensation/business model, that shall make it even more effective! You might use this as a brainstorming/problem-solving/innovation exercise in your class. There are obvious solutions such as a BOGO option (Buy One Gift One), but there might also be non-obvious ones, so cool, they can be pitched to the BMVSS folks!

Parting Thoughts

Growing up in India, I found that practically no one could miss hearing about the Jaipur Leg. The innovation, deservedly so, even entered popular fiction, through a Telugu Movie (one of the multitude of languages spoken in India, and particularly, at home by my family), and then was either translated or remade in multiple languages, portraying the travails of a Classical Indian Dancer, Sudha Chandran[5], who was fitted with a Jaipur Leg after an amputation, and eventually had a successful dance career.

All this makes me sad and wonder, why the Jaipur Leg has not inspired many many more such innovations, frugal or otherwise in India. It has inspired some, yes, but one would expect more. Instead, revered as it as, it is wrongfully seen as an artisan masterpiece, rather than as a source for more medical device innovation. This is something worth considering, and perhaps something ought to be done to transform the way the Jaipur Leg and the problems patients in India face are viewed by innovators and inventors alike.

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References:

1. http://jaipurfoot.org/

2. IEEE on the Jaipur Leg: https://pulse.embs.org/may-2016/the-jaipur-foot/

3. http://news.mit.edu/2008/itw-jaipur-tt0305

4. http://archive.fabacademy.org/2016/fablabvigyanashram/students/93/finalproject.html

5. https://en.wikipedia.org/wiki/Jaipur_leg

6. Image, Courtesy, Pexels: https://www.pexels.com/photo/asphalt-clouds-endurance-grass-421160/

World Mosquito Day - August, 20, Annual.

Rarely do people get to declare everyone in the world to commemorate a day as "World X Day", but according to Wikipedia:

World Mosquito Day, observed annually on 20 August, is a commemoration of British doctor Sir Ronald Ross's discovery in 1897 that female mosquitoes transmit malaria between humans.[1] Ross is responsible for the annual observance, having declared shortly after his discovery that the day should be known as World Mosquito Day in the future.

Well, if you make an important discovery and get Knighthood for it, I suppose you can make such demands and get them to be heeded. I don't see a problem here, but an opportunity.

As a nature lover, rarely do I wish that a species be controlled. The mosquito is definitely one such species. Mosquitoes have been cause of much grief for the human species (and their companion species, such as dogs and cats as well) the world over. First, the bite, ouch! Then comes the fact that they are a malaria vector and a vector for other diseases . Followed by incredibly dangerous chemicals such as DDT that caused all kinds of health issues and environmental damage, while the mosquitoes happily evolved to be resistant to DDT!

Therefore, it is important to consider a few things on our battle with mosquitoes:

1. It is important to fund research that looks at controlling mosquitoes, eliminating them in non-native regions, research on reducing their ability to act as vectors, and disallowing them from being able to reproduce as profusely.

2. Standing water is one of the best breeding "grounds" for mosquitoes. Such bodies must be treated to prevent mosquito breeding, and where unnecessary, standing water must be eliminated. If not, birds and fish that eat mosquitoes should be encouraged.

3. When you go out, make sure you wear protection, preferably non DEET based materials. Where possible, such as when you camp, use mosquito nets. Remember, some of the chemicals like the mosquito coils, which you set off using a match, are suspect of containing carcinogenic materials.

Be safe out there!

References:

1. Wikipedia: https://en.wikipedia.org/wiki/World_Mosquito_Day

2. Image, courtesy, Pexels: https://www.pexels.com/photo/black-white-mosquito-86722/

There is Design Thinking. Then, there is such a thing as Single-Use Thinking! And so is Device Thinking.

By now, I hope you have heard about Design Thinking, a term, though surprisingly old, has now become popular among Designers, and those who would like to apply this way of thinking about problems and solutions to problems in all walks of life. Lacking one core owner (thankfully), the term has come to enjoy diverse interpretations. The basic idea remains the same. As a designer, you are asked to understand the problem you are trying to solve very well, however, the impetus is on spending more time thinking in solutions, or, grammatically, of solutions, to your problem.

The idea is to understand the problem, and instead of being stuck on the analytical side, you then try to prototype solutions, learn from your failures fast and move towards a better solution. There is of course, much depth and diversity associated with this concept, but I am just throwing this out here to explain how I have usurped the title of the concept to describe the way in which we ought to think about medical devices, especially the disposable ones.

The Strategy behind Single-Use Disposable Devices

Once upon a time, devices were rarely designed for single use. One of my late aunts, a Doctor herself, had a clinic in a semi-rural town in South India. I remember visiting her clinic as a child, and being fascinated by the steam autoclave in which she had one of her aides sterilize all her instruments. That was typical of that era in a developing nation, and much of it is still probably practiced where money is tough to come by. Of course, we have always had your bandages, the gauze pads and more that became disposable much early on, due in part, to the wars people were fighting, were there was need for speed and reusability was neither a priority nor an option.

Doing this type of thing, companies such as J&J, Colgate and others started seeing huge profits, from disposable products, especially in healthcare and related areas, such as personal hygiene. Thus burgeoned an industry, the medical devices industry, which, according to an NY Times Article I read today, is worth something like $148bn USD!

Single-Use Devices can lead to significantly more profits than repeatable use devices. Of course, some of you will question the ethics of this, and rightfully so. However, there are also significant advantages Single-Use Devices have over devices that require reprocessing, including:

1. Ease-of-Design,

2. The ability to be rendered in various sizes and forms to treat patients of varying age, gender, body dimensions and other factors, and,

3. Primarily, the prevention of infections and their spread.

Unless, there are serious failures of biocompatibility or failures of the sterility barrier, single-use devices are safe to use. Anyone who has heard of the debacle with the poorly reprocessed Olympus Medical Endoscopes can relate to the advantages of using a single-use system where possible.

While it is only one factor, once you find out about infections as a factor, most of you will become fans, at least in part, of single-use as well! However, do not discount reusable devices, or even the reprocessing of single-use devices performed by third parties, for repeated use, especially in developing nations where most patients cannot afford new devices. Even Implantable Cardioverter Defibrillators (ICDs) are reprocessed and implanted!

On to the thinking

So, leave alone business and revenue strategy, for the sake of patients, you'd still want to think of the various situations where you specifically design, or turn reusable devices into single-use ones. As a device engineer and/or an entrepreneur, this sort of design thinking, or solution thinking or industry-specific/strategy-specific thinking is important, regardless of what you want to call it! And with this premise laid out, let me go on to my example.

Cats, Tongue Depressors and Popsicle Sticks!

I love to adopt old cats, and they love being adopted because they are often overlooked by people at shelters. However, with that, comes illness and hospice care. I am vacillating between those two stages with one of my beloved felines, appropriately named Gi-Ve, who has picked up multiple sufferings as she ages, but is still loving exploration, play and companionship. Her illness is causing her to be unable to hold food down well, even though she chows down enthusiastically. Previously, another one of my cats Bob had a similar problem for a while. So, vets recommend you force feed cats using a high-energy gel, that comes in tubes (disposable, like the erstwhile toothpaste tube), which I have become accustomed to.

Now, because of the tube, I guess I have thus far been motivated to force feed (actually with Gi-Ve, who is a living angel, the force required is very low) the cats with toothbrushes. However, the gel never completely gets into their mouths, so I am constantly having to "sterilize" the toothbrushes with hot water, followed by vigorous rubbing, rewashing, visual inspection and so on. It is painstaking and time consuming as any cleaning process typically is. I wanted to get away from it, and last night, what I call Single-Use Thinking came to the fore. Necessity, as many have said, and as Clayton Christensen has improved upon, which I have mentioned before in this blog, remains the mother of invention.

The Mighty/Humble Tongue Depressor/Popsicle Stick

I didn't want to be a burden on the environment, and I still wanted an easy way to get the gel to the cats and not have the darned toothbrush "reprocessing" routine. Lo! I thought of the mighty, yet humble Tongue Depressor/Popsicle Sticks. These things are just genius. There are hundreds of uses for them, not the least of which is to give Doctors and Nurses the ability to look down the throats of patients, the ability of enterprising vendors to freeze flavored ice creams for (yup, disposable) consumption and so on!

In my own garden, with enough plants to approach the Law of Large Numbers, I have semi-successfully used colored popsicle sticks to differentiate and classify my plants as gymnosperms/angiosperms, succulents, vegetable garden plants, etc. So, I always keep a stash of popsicle sticks in my home lab, and I have now started the attempt of feeding the cat her gel with this. Only time and a good sample size can tell me if this is the ultimate solution for my problem.

However, it has all the promising elements - it is cheap, multiply available, ease to pre-rinse, and compostable (the wood ones are)! Once I hit upon this, I had that sigh of relief and then realized, I am doing exactly what Design Thinking wants you to do:

1. I understand the problem. The cats, especially older ones will need to be force-fed from time to time.

2. Using toothbrushes means reprocessing, or a fairly expensive disposable. Spoons are usually too large for the quick 2-5 seconds in which a cat will tolerate your efforts to pry his or her mouth open without getting homicidal (they are carnivores, with the ability to bite and kill prey!).

3. I wanted to try something quick, and there handily are my swords - the popsicle sticks!

4. The next step is to prototype, learn and see what happens and I am already underway.

Device Thinking

However, I also think this is one of the ways in which we Device Design Professionals should consider problems. Don't forget, we have other factors to consider - safety, the prevention of infections, biocompatibility, repeatable effectiveness and so on. Taken together, I would like to call this "Device Thinking".

Of course, I think Single-Use Thinking is also real, and is a branch of Device Thinking. This is a topic on which I hope to expand further on this blog. Let me know your thoughts.

A quick note - "Home Lab"

With life interests (they are not mere hobbies with the amount of energy, money and time I have invested), ranging from photography and travel to gardening and cooking, I have a wide variety of tools and equipment I need. Therefore, like many of you out there, my house is full of "junk" that gets used laterally, so to speak. Years ago, when I visited IDEO, one of the world's most famous and premier design firms, I learned of how they collect interesting tools, materials and other items to help their designers prototype solutions to very challenging design problems. So, I have always been on the right path - buying and picking up stuff I think I can somehow use for a project. Of course, they are much more organized, but I am looking to get there. I also will be posting about some of the really cool things I have collected over the years in my Home Lab, in a few posts here.

A second quick note - cats!

Just a reminder, it takes guts, leadership and motivational ability to get a cat to repeatedly open his or her mouth and be fed forcefully. And, skills as well as talent. Let no one tell you otherwise. I have sometimes thought I should put this on my resume! Giving cats a bath or two, of course, is the true sign of heroism (been there as well)!! :D

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Musings on the future of the medical devices industry - start-ups, M&A, funding and so on..

This past Friday, I had dinner with my graduate school roommate. We'd met after nearly 11 years and still, we were able to pick up where we left off. While I have been in Engineering since, he moved on through Engineering in memory chips to M&A, an Executive MBA and is now doing Equity Research focused on the Semiconductor Industry. Therefore, our conversation drifted towards industry comparisons. He related how the semiconductor industry is more or less consolidated, and there is very little left by way of M&A left. Then, we both agreed that there are not going to be many, if any, "start ups" in the semiconductor industry. This is why he moved on to Equity Research. It all made sense.

Then, this weekend, I went away on one of my usual solitary camping trips to the Sequoia and Kings Canyon Parks, and I started thinking about the conversation and the industry and I have a few thoughts that I will share here. Of course, I could be wrong over the long run, but we'll wait and watch. These ideas or thoughts are not in chronological order, and I am not going to try too hard to pin down specific timelines, not the least because of how difficult that would be.

1. Consolidation - Mergers and Acquisitions

Consolidation is what killed off creativity and entrepreneurship largely, in the semiconductor industry. Sure, here and there something crops up, but the sense of revolution, that is missing. A cooling start up here or there doesn't get you much far. I am sure, upstarts will always shake up every industry, but successful industries need a healthy supply of start ups - the breakthroughs and the incremental innovations. You might say, well, anyone can start up, right, so why would consolidation matter?

Most, but not all start ups exit through acquisition, when successful, and also when at least moderately successful. To set this up, you need as many competing buyers as you can get. If you have one Medtronic-Covidien in the place of two, and one Abbott-St. Jude in the place of two, and eventually, as has been guessed, one Boston Scientific-J&J instead of two, you have start ups and their investors left with fewer options. Already, many investors balk at the regulatory environments the start-ups face, now they have to settle for smaller marginal returns and fewer buyers.

There really is no way around this. This happens in every industry. Pharma was already there a while ago, and medical devices will get there.

2. Start-Up Costs

One reason you wont see too many semiconductor start ups or pharma start ups popping up all over the place is that, you can't just make the next Gallium Arsenide replacement or the next CRISPR in your garage that easily anymore. Never say never, but this is an issue that is also unavoidable when industries reach a certain level of maturity.

Now, surely, you will note, medical devices don't have this problem. You CAN build a start up in a garage, and go a long way. In fact, my brother and I or an a mission to demonstrate this vividly, and publish some research work soon. However, there will come a point when even parts of the industry become so complex, that innovation and breakthroughs will, of necessity become harder and slower to get to.

I see that at least as far as this factor goes, we are about 10 years or so away, but the time factor is wrinkled by other causes as well, as we shall see.

3. Funding for Start-Ups

This happened to pharma. Despite spending years in academy to identify molecules and then running up second mortgages, company founders were having a hard time staying put past a point. Because of the 4-phase process and the high risks of failures all along the way, many times companies would be really close to success and then fail.

To apparently avoid this, and in the name of innovation, Venture Capital Funds took to condensing the funding rounds, in many cases A through D, to provide anywhere from $50mn to $150mn or more in funding for an entity at the very start. Of course, they are very selective about who gets funded.

Then, there are the instances where, big pharma pre-selects start-ups for "collaboration" and does milestone based investments.

The underlying theme in all of this is control, and pseudo-random selection. None of which is good for the industry, the start-ups or anyone in general. Will the devices industry come to this? I think, for the large part, yes. But it will again, probably be a while before we get there. So, far I have seen examples where, unsure of the chances of success of a given device start-up, the buyers provided milestone based payments.

However, it is only after medical devices themselves become quite complex will we see the real need for such funding models to take over and become predominant. Although, devices that can no longer depend on the 510(k) model and require an IDE with an extensive clinical trial would be the first ones to fall victim to such models. This has already happened, though maybe not for the reason I have stated, as in the case of Ardian.

4. Standardization - Boon or Bane?

Standardization has always been a part of industries, be it semiconductor, pharmaceuticals or medical devices. In many ways, this factor itself leads to a lot of success. For example, if you are vending a catheter product, you'd have to tell your potential customers, the surgeons for instance, the French size of your catheter. In fact, you'd probably use it as a differentiating factor. This is great. Also, standardization means, getting cheaper components, easier training and so many other benefits. These are the boons.

However, consider this. Standardization also means conforming to a specific size, or category and so on. This can also limit you. It already does. If you ever order anything non-standard, just by virtue of that, you pay more. And not only that, by having to standardize your products, you lose out on innovation and freedom to operate. This is a double-edged sword. For right now, besides the IEC Standards and certain other aspects, this has only helped and certainly has not taken over the industry. However, a time will come when this wont remain as it is.

5. Will the Medical Device Industry fall in with High Technology (and the hype)?

So, the Technology industry is riding its next hype cycle - AI. Even though IBM's Watson and Google's DeepMind maybe the closest we have come to AI, most companies are using mere Machine Learning, most of it in its misshapen infantile stage as a substitute for AI. This has slowly started creeping into medical devices as well. However, the industry is still behind on the IoT wave itself, and therefore, it seems like a good and a bad thing that the devices industry is not in lock-step with high technology.

Because, the bad thing about hype cycles is that most of the craze doesn't amount to any success, and much by way of investment is lost in an effort to create success at any cost. Then, the technology industry crashes and burns gloriously, further scorching the Earth for otherwise promising start ups with incremental or even disruptive potential. This is not to say that the medical devices industry does not have its own hype cycles and the concomitant problems, but I hope that the industry doesn't fall in lock-step with the other, for the benefit of everyone.

6. Conclusion

This post is a collection of a few thoughts that came to my mind, comparing the medical devices industry, a maturing one, to two mature ones, semiconductors and pharmaceuticals. As I mentioned before, I don't expect all of my predictions to pan out, or pan out the way I think they would, nor would the timelines probably get to fruition as proposed. However, the medical devices industry appears to be inescapably sailing along to maturity much like others have, and some of the stops are going to be the same.

For innovation, funding and success, the lessons others learned along the way could prove to be very insightful, and that, is something, all of us, entrepreneurs, managers, engineers and others alike should focus on.

7. Subscribe and Support, Please!

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Reference:

1. Image, courtesy, Pexels: https://www.pexels.com/photo/black-and-white-blackboard-business-chalkboard-356043/

Interesting investment might cause upheaval among medical device contract manufacturers

Previously, I have received feedback with suggestions to write more about investments in the medical device field. I didn't want to mirror the usual press releases that suggest X invested Y in Z. I was on the look out for something really interesting and noteworthy that can be reviewed, and today landed on one such exact item! 3i, an investment company is investing $136mn in Cirtec Medical, already a leader among medical device contract manufacturers.

Contract Manufacturing in Medical Devices is highly competitive, with many small and large firms competing for customers ranging from the ideation stage to really large device manufacturers such as Johnson and Johnson, Medtronic and Boston Scientific. At the outset, it might appear that there is plenty of room for everyone, and while this is somewhat true, there are several issues that confront contract manufacturers and their customers. I'll lay out a few here:

1. This is a regulated industry. Which means, any old shop cannot start manufacturing medical devices. They'll need a Quality System, regulatory compliance, GMP and other Good Practice adherence, etc.

2. Capabilities can be limited for many organizations. Some may excel at capital equipment, some on disposables, and so on, making their specialties hard to choose from, and many times a product will have to be manufactured with two or three different entities, and the customer has to audit, select and manage them, as long as their products stay on the market.

3. Margins can be really low, even when the potential rewards could be high. This can cause contract manufacturers to be forced to select projects, which is not something they'd prefer.

4. The Medical Devices Industry is fraught with high failure rates, especially among start ups. Contract Manufacturers will have to put up with losses from such failures, including loss of scaled efforts, investments and so other financial pains.

5. Aware of all this, investment banks may not be ready to extend or increase lines of credit, which can sometimes become a positive feedback issue.

Of course, customers, especially large ones work with their contract manufacturers to help scale and succeed. However, as I laid out above, competition, margins and other issues make this a tough subsection of the medical devices industry.

As I mentioned before, Cirtec is already fairly large and successful, with three locations, a full range of services and the ability to design and manufacture a device from start to finish. This is why I believe the investment is a nifty shot in the arm for the organization. With such a large cash infusion, they can examine their capabilities end-to-end and fill gaps. While they expand and grow, they can also compete against others in the field from many different angles, including costs and capabilities.

And now, if you are a competitor, you have to go find your own investor, or another alternate technique to fend off Cirtec. This is where I think things can get really interesting. Another investor or two, that props up one or two competitors, say, for instance Creganna, which already saw an investment years ago, deep in the recession.

Another possibility would be the merger/acquisition among a few competitors. These are just some of the possibilities.

A Caveat

When one or more organizations in a field get disproportionately big, it does reduce competitiveness, limiting choices to customers. The chances that this might come to pass are low in the medical devices industry, but not negligible.

With the emergence of newer high technology such as Bluetooth, SDN, etc., on one end and constant innovations in 3D Printing, and in the future, 4D Printing, as well as in materials and manufacturing methods, newer, more nimble organizations can carve out sections of the market to themselves.

In addition, when organizations get to a certain size, they can't always stay as nimble as they once did. Larger organizations will also seize or seek customers of a certain size. So, smaller organizations can exploit such gaps and succeed.

All in all, with an investment like this, 3i is now going to induce all alert contract manufacturers to come up with competitive strategies. Competition for cost, quality and timely deliveries, should in the meanwhile, make for some happy customers. This is the kind of breakthrough that can actually help the medical devices industry go through innovative growth.

References:

1. The investment announcement: https://www.pehub.com/2017/07/3i-to-invest-136-mln-to-cirtec/

2. Image, Courtesy Pexels: https://www.pexels.com/photo/black-calculator-near-ballpoint-pen-on-white-printed-paper-53621/

Data is the key to assessing medical device efficacy, but it is extremely poorly studied

MedCity News pointed me to a very interesting retrospective study on Gastric Lap Bands, and a Danish reporting system that led to findings on a hernia mesh in an article today. This got me thinking about medical device post-market surveillance and efficacy analysis in general. Based on data from two different countries, on two completely different products, it is easy to understand, how data is key to assessing medical devices once they are in the market. However, problems remain. As Andrew Ibrahim et. al. themselves showed, there are problems, and then there are solutions.

What would be the advantages of the assessments?

Let's get the obvious out of the way first. Good Quality Assessments can lead to a lot of benefits:

1. Patients will be the winners. If it is discovered earlier, as it could have been in the case of the Gastric Band, that a device is not working, then it could change the standard of care.

2. Both the manufacturer and the competitors can improve their devices. Or, abandon going down the wrong path. Either way, patients benefit again.

3. Medicare and Medicaid, and thus the US Government and consequently patients and all tax payers would benefit from wasting money unnecessarily. The JAMA Study indicated that of the $470mn spent on gastric bands, 47.6%, or $22.4mn was spent on re-operations and removals of the bands. That is quite a wastage.

Reducing waste, increasing standard of care, improving or withdrawing devices, these are all great great motivations to make sure that medical device efficacy assessments be done thoroughly and routinely. However, this would be the time to take the discussion back to the problems facing this effort.

Problems with Medical Device Post-Market Data Collection

1. Reporting is Voluntary

Obviously, it would be counterproductive to force data collection on over-burdened medical facilities and practitioners. However, are there incentives that can make reporting more attractive to practitioners? Like a rewards program with all carrots and no sticks. What if facilities doing more and complete reporting got awards, and priority when it came to reimbursements and such?

2. Incomplete reporting plagues the system

As with the above problem, the FDA does receive reports, but most of them incomplete. Should the device manufacturer be burdened with opening up a CAPA and sending agents to the reporting entity to complete the reports? I know some companies train their employees to think of a CAPA as the black plague, but if you have a good system and train your personnel properly, it is a great tool. Perhaps, organizations should take this on themselves, without being forced to do so.

3. The FDA doesn't know about Device Usage

Ibrahim et. al. report this, but I think the more curious question, does CMS know? Do private insurers know? It is a bit concerning that post-market monitoring doesn't call for regular reporting on data usage statistics! And yes, because no one knows how much of a device is used, and on what cohorts, no one knows. This is truly appalling!

4. Does the FDA know how to analyze the data?

This one is not on the paper or the write up, and is not exactly a problem, but do the FDA and/or the CMS or medical practitioners themselves know how to judge when a device is slipping. When do you worry? Let us say you have all the data and you find that there is a 5% failure or re-operation/removal rate. Then? Or at 10%? Or, like in the gastric band's case, at nearly 50% at one point?

5. What about Patient Reported Outcomes (PROs)?

Patient Reported Outcomes, especially of pain, discomfort and other important Oncological treatment related factors are all the rage in Oncology. This doesn't seem to be the case with any medical devices in any other fields.

The Key Issue

As Data Scientists (formerly Statisticians, but that is no longer sexy) point out, just having the data is not enough, you need to know how to analyze it, and when to set the alarms off! Sadly, it would appear, neither the FDA nor the nearly dozen or so agencies tasked with disseminating healthcare in one form or the other have the required data, or how to analyze it. This is a really alarming problem! The term "information processing" was coined by Watson in the '20s and here we are, learning about how poorly information gathering is done, in 2017, from a JAMA paper. Hyperbole? NO!

These issues must be looked at with a sense of urgency and I am not sure the Government is solely equipped to do this.

The Solution

1. Overburdened or not, perhaps, medical practioners need to take reporting more seriously. Without reporting, frankly, the data itself is lost and patients suffer.

2. Medical Device Manufacturers can benefit from knowing how a device is performing. They should voluntarily engage in superior data collection practices and share that with Doctors and agencies alike. Yes, sometimes this leads to a loss of market, but many times, they can benefit from the good will, iterate designs and generally benefit the public, which is the stated Vision of most, if not all medical device organizations.

3. The UDI is no panacea, and yet, it can lead to greater efficiency in data collection. The FDA should reduce barriers for adoption, reward successes and organize conferences and gather inputs to see why failures occur and how to fix them.

4. Patients and other stakeholders should be recruited in helping monitor device efficacy. This is an important step and we are still not there yet.

5. Going beyond the current device classification, the FDA, and Medical Organizations such as JAMA and others should categorize risk, and try to pinpoint at what rate of failure a device's use should be reassessed based on its need vs performance and other factors.

6. Better analytics and more research, like the one Ibrahim et. al. engaged in, is needed, not just retrospectively, but also, on an ongoing basis.

If you can think of other solutions, do let me know!

Subscribe and Support, Please!

Did you enjoy this post? Please subscribe for more updates, using the sidebar. Have ideas or blog posts you'd like to see here? Contact me at yamanoor at gmail dot com.

References

1. The MedCity News Article: http://medcitynews.com/2017/06/gastric-band-claims-data-study/?_hsenc=p2ANqtz-_93trtq6QMBJwrNSxKilEsh9NUgh-0NfjtgRy0ng5U2u4CmgMK8VTl7VwzyJYWBJJz-5AlNVJQLEdLjHQXHBYjV-f9UA&_hsmi=53765476&rf=1

2. The JAMA Study Summary: http://jamanetwork.com/journals/jamasurgery/article-abstract/2626422

3. The JAMA "Viewpoint": http://jamanetwork.com/journals/jama/fullarticle/2635359?utm_source=TWITTER&utm_medium=social_jn&utm_term=936126693&utm_content=content_engagement%7Carticle_engagement&utm_campaign=article_alert&linkId=38701658