Tuesday, January 09, 2018

Simple Usability Problems that medical device companies fail to resolve and why - an example


So today, I will tell you a story. In a galaxy not so far away, I visited a medical device company, where nepotism, hubris and a "we are always right" are fostered and promoted. The result is of course, disastrously bad medical devices, but because the customers know no better, they continue to stay in business. One of those odd, disgusting things no one can fully explain...

To set the stage further, they have a device that does a number of things, for a meaningless endpoint to help, lets say vain people who'll pay anything to think they'd look better.

Among the things it does, let's say there is a "heater" that heats by passing fluid. So, you have to connect this fluid element that flows from one subsystem of this raving madness of complexity to another. Along with it, are other connections for signals, grounding and a variety of "thingamaboobs", all part of the grand act of impressing the gullible.

Now, they use one portion of the device to test the other. They ensure that the connection is made, the heating element is connected and so on.

THE ISSUE

When the grounding connection between the two device subsystems fails, an error is generated. This is how the system addresses the error:

1. The visual display shows an image of the heating element prominently, with the grounding element lurking somewhere in the background.

2. The text display reads out that it is indeed the grounding element that has failed.

THE PROBLEM

Many of the assemblers and testers at this organization tend to see the heating element fail, and conclude that it is the heating element that has failed when other culprits lurk in the background.

Until each individual is told to "read the message" and "ignore the image" to get to the specific cause, they stop said testing and blame it on the heating element.

Work stoppage, frustration, being talked down to, and all around perplexity ensue!

See, the problem is that the image is essentially incorrect, and the text clarifies the actual cause of error for you!!

Imagine walking around with your shoe laces untied, and being shown a picture of a nose with a booger hanging out with the shoe laces somewhere in the background, completely out of focus!

USABILITY and why this is a problem for so many medical device companies

1. Usability is an after thought for such organizations. Devices that are incredibly cumbersome to use are quite common in the field. This is, but one clear example of a group of people ignorant of usability, also ignoring it.

User manuals are published grudgingly, just to meet the regulatory guidelines, and then, completely ignored. Same goes for the assignment of error codes, explanations and visual examples. With that attitude, you will never develop a more usable device. You have to knock the socks off regulatory requirements, not whine and complain about them, given that most of these requirements themselves, leave much to be desired. Otherwise, of course, there are other job opportunities for people with attitude issues. But, yay, groupthink!

2. If you have managed to confuse your own people, how do you expect complete strangers to do it? This is mainly because the people who design such problematic systems express unwarranted arrogance about their ability to design products.

People learn differently. Some people like visual messages, and give them a preference. Others do better on text. Honestly, this is why you have at least these two, if not an audio read out of the error. Usually, you use tones to do that. Onto that point, these messages need to be coherent and get to the point. Telling someone, "don't just look at the picture, read the text", should get you fired, technically.

3. You may have used the device you designed yourself (hopefully!) but it is not enough. You need to be aware of how others are perceiving your devices, how they are using it and what issues they encounter when using it. Your own assemblers and testers might be the best place to get started. You should also see what your sales people are doing. Go talk to the end users. Get their permission (and incentivize them) to shoot videos of them using your stuff, ask them about the problems they run into - basically be data driven! Sounds like commonsense, right? You'd be surprised.

4. It takes a village...for everything! If you outsource your design, or the usability portion of it, and then ignore these people in the data collection and feedback loop, well then you are going to have issues. This is one of the biggest problems with contract manufacturing (blog posts later this year on this stuff). You need everyone in the design chain to be involved in collecting and using data on how usable your devices are.

5. Have you really studied and understood usability? It is not simply about making connections between subsystems, or making sure the ground pad is appropriately positioned on the patient. Devices are never perfect and all kinds of error conditions pop up. It is important to communicate error conditions, and the appropriate remedy for those conditions. Otherwise you run the risk of patient injury or death! A lot of people who should not be making key design decisions without a class or two in usability for healthcare, are out there, making decisions!

CONCLUSION

These are but some thoughts on why so many medical devices are not usable. There are more, and as I encounter them, I will lay them out. It is sufficient to say that there are some devices out there, with alarming issues, and it takes the right kind of education, experience, humility and curiosity to design usable medical devices, as much as anything else usable!

Reference:

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

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Sunday, December 31, 2017

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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Tuesday, December 19, 2017

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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Friday, December 08, 2017

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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Monday, November 20, 2017

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

Wednesday, November 15, 2017

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/

Thursday, November 09, 2017

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/#

Sunday, October 01, 2017

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!

Thursday, September 28, 2017

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/

Monday, September 18, 2017

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/

Friday, September 15, 2017

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/

Monday, September 11, 2017

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/

Tuesday, August 29, 2017

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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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 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/

Thursday, August 24, 2017

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.

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. 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/