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/

Sunday, August 20, 2017

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/

Wednesday, July 12, 2017

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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Tuesday, July 11, 2017

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.

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Reference:

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

Wednesday, July 05, 2017

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/

Friday, June 30, 2017

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!

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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

Thursday, June 29, 2017

A couple of thoughts on skin and medical devices


I know a lot of people dislike being advertised to, but I lap it up, depending on what it is. This morning, LinkedIn had a suggested post, on skin adhesives for wearable devices by a very knowledgeable 3M Professional. It makes for a very interesting read, and I recommend you peruse it, from the linked reference below. Just so you know, I do NOT have any relationship, financial or otherwise with the organization, in case you are wondering.

The article had a lot of good advice, basics yes, but worth the refresh. I thought I would recount some, with a few thoughts of my own.

It is true that adhesives must be understood and tested before and during design. It is also important not to over-design, and to pick and use an adhesive that is just appropriate for the application.

Now, I want to recount a few thoughts, also relevant to skin, wearables etc., from my own design and use experience:

1. Understanding Skin

My first major project in graduate school was as part of a team, where we designed a skin testing device for Unilever. They wanted us to design a device that would reproduce a measure of one of skin's properties. We searched and searched, and learned a lot about skin through the design process. We even met a quirky expert in skin research at UCSF and learned a lot from him. This is the first step in design. Education. Skin is very quirky. It is an organ, the largest in the human body, and essentially, its outer layers are dead. It destructs and regenerates on a fairly regular basis.

Skin varies in its properties based on the sex, age and race of a person, sure, but it doesn't stop there. It ALSO varies based on the exposure of the person to sun and other environments harsh or gentle. Exposure to moisture, illness and other factors also change its properties and nature.

Skin doesn't just protect your internal organs, which it does really well by the way, it also engages in thermoregulation through sweat.

All in all, it is a very fascinating organ. And you need to understand it deeply and well. Hire a skin expert. Talk to a number of them, but more importantly, you HAVE skin (in the game, and otherwise)! Well, duh! Your designs - you should try them on yourself. I will expand on this later, but unless we are talking about ablation and such, for most other products, such as wearables, you have no excuse if you are not using the devices on yourself, at least at some basic level to develop a much better understanding of skin and its properties.

2, Testing Skin

So, in our design project, after much learning and planning, we wanted to measure torsional stiffness as an analogue to skin elasticity. We theorized that skin that is exposed to harsh environments, or skin in older people would be less elastic and thus stiffer. We designed our device and with the generous help of a Design Expert from IDEO turned our prototypes into a beautifully 3D Printed device in 2002!

However, well before we got there, not only were we testing ourselves, we were also testing others. Our device needed to attach itself to skin temporarily. We, in fact, found these wonderful, round, adhesive-backed, single use Velcro Pads (that I remembered today, after all that time) that 3M made, for attachment with skin. We liked it, and it ended up dictating the size of our shaft, but would other people?

So, in a way, that if we were a real company would have gotten us in a lot of trouble, we went down and waited outside Stanford's famous TreeHouse eatery and just asked people to tell us what they felt like, using our device. We had done this with the famous "dark horse prototype" as part of our class, where we had literally used Digital Calipers (Vernier's Calipers for those with a British/Indian background) to stretch skin and see how it bounced back. That time, we had used double sided sticky tape (yuck, yes, but prototype, remember!)

In return, we told them what we were doing, and gave away chocolates (perhaps for a future dental device project, maybe? :D ). I do not suggest you do that. But, like we did in a start-up I worked for, later, you can get an IRB and do some testing on people, compensating them for real cash. Ask them about how they feel wearing, or using or testing with your device. Ask them about comfort and seek to understand.

Even before that, make sure you like it. If you can't dogfood your own devices (perhaps, not the right attitude when designing a radiotherapy device), why use it on others. For example, we quickly ruled that men like me, with large, grubby, hairy hands are NOT the ideal candidate for our device! Velcro can stick to hear and make you uncomfortable!! Unilever mainly wanted to market this to women, so this was not a huge drawback you see....

3. More On Testing

I interned at a start up focused on a wearable blood glucose diagnostic device that was trying to use 100nl - 250nl of blood only for glucose level testing. The idea was to encourage diabetics to actually test themselves up to 4X a day, a plan for which the adherence was quite low. The reason is simple. It is QUITE painful to test yourself when a device requires higher quantities of blood. Do you know how I know? We tested ourselves. Me, other engineers, and even non-engineering employees in the start up. Lancing causes quite a bit of pain, and then if you lance yourself enough times, your vessels get protected by, you guessed it, your skin, and they go deeper and getting blood out is even harder.

We even joked about carrying some paperwork to show we weren't addicts, in case we were pulled over. We half-joked actually. We really had that many lances on our arms, forehands, etc. Because, even with recruited patients, we could only get so many draws out. For the rest, and to gain a deeper understanding, we did have to lance ourselves quite a number of times.

Yes, there is a CLEAR market for non-invasive blood glucose testing!

4. Wear Your Wearables

Or, at least wear someone else's. I bought this Fitbit Surge, almost 16 years after the last watch I wore! I did, in the interim try to get back to watches, but I just gave up as the phones were able to tell time. Of course, the resurgence of these devices is due to their ability to keep time, but also to give you your Heart Rate, your step count and so on. It was very very compelling to get one of these!

In fact, because we both own Fitbits, my brother and I have designed some motivational open source hardware jigs to help us boost our counts when we start lagging. We will be presenting this at a couple of different conferences as the design iteration progresses. Watch out this space for announcements!

But more to the point, wearing this device has taught me a number of things. I had that initial ramp up where my skin reacted to the device as if it is an allergy. Then, I got back to that problem of a certain portion of my hand looking lighter due to reduced sun exposure. Also, this particular device keeps track of my sleeping habits, and even though I suffer from insomnia, I do not like wearing this thing at night, because after about 16 hours or so, this thing does get irritating. And yet, I like the belt-buckle design, because I can remove it whenever I want. I am having a hard time envisioning a long-term, Velcro or adhesive backed device on me. But, I know, other people might react differently.

Look closer at the picture. Dust and dirt are another problem. (The scratches are from my cats showing me love, so there's not much a medical device can do there :) ) I hope you get the general idea. Wearing the devices yourself, whether yours, or a competitor's, or of someone else (I am not working on a wearable right now, but hey, if you are looking for someone...), helps you understand the underlying issues. And you know, this extends beyond just skin and wearables!

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References:

1. The 3M Article on Adhesives for Skin: https://www.mdtmag.com/article/2017/06/six-stick-skin-challenges-medical-device-engineers-must-understand?WT.mc_id=pr_MedTech_WearItWell_07/01/2017&WT.tsrc=Article

2. First image, courtesy, Pexels: https://www.pexels.com/photo/person-with-black-pedicure-raise-both-2-hands-218939/

Wednesday, June 28, 2017

A thought on research methodology, anomalies and outliers


I am presenting on continual innovation at the ASQ Innovation Conference this Fall. I have been gathering some interesting reading materials on innovation. Clayton Christensen has written excellent books on innovation and is a true Guru in the field. Flipping through the first chapter of his book, "The Innovator's Solution", I found this gem, pictured above.

If you are like me, time and again, you re-read the fundamentals, and still go, "ah, how pithy!" Some of you also probably wonder why such fundamentals need to be repeated over and over. It never hurts to go back to the basics, even if we have read it many many times. Because certain concepts are fundamental, we tend not to think deeply about them. So, it doesn't hurt to sit back, relax and think about these concepts and what they mean.

Because, by rethinking key concepts, we can strengthen our understanding and methodology. We can also think about our adherence to this, and maybe adjust the sails a little bit, from time to time. So, join me...

Research Methodology

Just recently I interacted with someone who had collected some device data and was really worried about an outlier skewing results. They were so concerned even as they were collecting the data (!), they created an additional data set (quite expensive, just so you know), and when helping with the analysis, I did agree to throw out the outlier. The analysis went fine and the data fit the assumptions to an acceptable extent and they moved on.

However, that and reading Christensen made me think about this deeper, last night.

Why do people fear, and consequentially loathe outliers? I remember, when first being taught about linear regression and the box and whisker plot, I was told, it is common to find outliers and then explain them, and eliminate them from the analysis, or represent them in a certain wahy. So, there was a certain effort to go ahead and get us to explain what we should do with values outside the expected range, but we were never really told that we might be biasing ourselves. While the way different people are taught about data handling is different, I think we have all been exposed to this idea at some point.

Later, just like me, you must have come across the caveat. Don't just give an oversimplified example and run away from the data. It might have been an instructor, a lab manager or some speaker, urging you to look much, much closer at the outliers. This is true. A theory, many times is best shaped by phenomena it cannot explain, because then, it grows out of the crude form to a more refined form which makes the theory stronger. An over simplified example is Newton's Third Law. Yes, every action has an equal and opposite reaction BUT, the reaction is divided among signal and noise - your frictional losses, etc. Without that qualifier, the theory would be hard to disseminate and use.

Evolutionary Principles?

So, yes, we have all seen both sides of the coin, but why do people want to pretend like the outliers never happened? Why do others want to pass quick judgment and run away from the issue? It appears, humans evolved to try and form communities and categories and try to fit everyone tightly into these strata. This is why we have people who try very hard to force everyone to belong, and once, even burned people at the stake for being different!

I recently spoke to a recruiter who was shocked that I have a résumé with color and graphics in it. He wanted me to change it to the boring version (!) and sensing my reluctance to do so, he appears to have become uncommunicative! Well, in my defense, in other industries, they want graphics, numbers, data and so on, and I put in the energy to innovate my résumé.

Yes, it looks different. But, if you can't even handle a document that looks different, how could you handle disruptive products, and at that point, why claim you want to hire people to innovate? It appears you want to hire people to do more of the same - throw a stent, a balloon or RF signals at the problem and then wonder loudly as to why Google and Apple are about to take over the industry!!

Unfortunately though, it appears that this is human nature. Shun anything different and it appears that principle has crept into people's research activities. And that is not good!

Root Cause Analysis

It is important to know the whys and whats of unexpected results. At times, yes, the explanation is simple. Errors, erroneous measurement, bad sample, etc., but there are instances where the explanation is not simple. You need to dig deeper. Even when you know a measurement error was made or the sample was "bad", you need to know why. That is how we got to Penicillin, because Fleming was dogged. And that is just one example.

Plus, in chasing down the problem, you could find new and exciting opportunities. This is what Christensen and Raynor are getting to. Innovation has many origins. Looking closely at a problem, is one of those. So, what can you and I do about all this?

What do we do?

In our own research, we need to go after the outliers and anomalies. Just as there is a push for the inclusion of negative results in publications, publications that clearly lay out outliers, and try to provide a deeper explanation for those data points, must be encouraged.

When we mentor new and young researchers, whether in an instructional setting or in a professional setting, we should discourage the masking or elimination of data that doesn't fit a model. Removing bias from research is not easy, but a fundamental necessity. And it can lead to your next business idea. It can help you develop a better device or drug. It can save lives!

And it has a funny effect. It helps you root out bias in other areas of your life - how you interview candidates, judge people, promote and mentor professionals and much more!

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.

Reference:

1. The Innovator's Solution. Clayton Christensen and Michael Raynor


Tuesday, June 20, 2017

Scott Gottlieb's Magical Risk-Based Powers and Orphan Drug Applications


Interesting Numbers

In a Senate Hearing today, FDA Director said that there are over 200 orphan designation applications pending with the agency. He then promised a turnaround on ALL (yup, you read that right) pending applications within 90 days. For anyone interested, that is approximately 2.2 applications per day. Now assume a day is 8 hours and FDA employees are jailed to their desks even on weekends...

A few days ago, I was positive after reading his blog post and I even reported on it here. Now, I am just perplexed to say the least (and pretend that I do not want to say something else altogether!). The FDA is not a clearing agency. Orphan designation requests are not like Fishing Permits or Back Country Hiking Permits. How could we expect any relevant level of review under such stringent timelines?

I understand it is important to clear back logs. I understand the importance of orphan drugs/devices/diagnostics and how anxious patients must be. But there is efficiency and then, there is general madness.

Trust Issues

The FDA's success in keeping US patients safe is seminal to ongoing trust people place on it. Slowly, reluctantly, agencies world over are following the FDA. To go on a mad rampage, potentially endangering patient safety to just move rapidly on applications makes for bad precedent. And, without providing any actual strategy, Gottlieb simply repeats the words "risk based approach".

The magical incantation?

You hear risk based tools once, and you go, okay, that sounds nice. When someone keeps offering the same thing as a "fix it" for everything, you start getting suspicious. Earlier this week, he touted risk-based tools as means to approve digital health applications. Okay. And I do see how they can be applied on all applications. But there is more to a review of applications.

In his defense, he did also say "modern" tools as well, and wants to improve the orphan designation application form. However, none of this sounds too comforting when taken in context.. Yes, risk based approaches to regulation will help improve things. However, they are not a panacea. You obviously need good quality reasoning. Is the condition indeed rare? Are there indeed no other drugs/devices that work? Is the applicant trying to abuse the orphan designation to take advantage of anxious patients? These are all important considerations, and I fail to see, how in about 3.5 hours or so, a decision on all these pertinent questions can be made. This is essentially what Gottlieb promised Congress.

A warning on orphan designations

Some in industry might see dollar signs and be thrilled with this laissez-faire attitude. However, I will remind you, that all is well, only till something goes wrong. Already, the pricing of orphan drugs has created quite a storm, with many questioning whether the Orphan Drug Law is being abused. If applications get a very light review, and the result is either more expensive, poorly effective drugs and devices, or if it results in serious patient injury, it will be a disaster. Patients and advocates engaged in less covered disease and therapy areas are already very vocal and will not excuse failure. Therefore, I sincerely hope this is not a thinly veiled attempt to reduce the quality of the FDA review process.

Since I have always been interested in oprhan drugs, I will keep a close eye to see how he directs the agency to rapidly respond to applications, with the level of scientific review, focused on safety and effectiveness and report back.

References:

1. The RAPS Article: http://www.raps.org/Regulatory-Focus/News/2017/06/20/27941/FDA-Commissioner-Vows-to-Eliminate-Backlog-of-Orphan-Drug-Designation-Requests/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

2. Image Courtesy, Pexels: https://www.pexels.com/photo/blur-bokeh-dark-evening-75360/

Monday, June 19, 2017

On Wrong Site Surgeries...


Surgery can be really personal. I once nearly lost my left arm to a benign cyst, because the first Orthopedic specialist didn't alert us to the dangers of repeat fractures, and another specialist wanted to amputate. My eventual surgeon in India, Dr. Daivanga Perumal decided to take a risk with the Iliac Crest replacement and I got to keep my left arm. He was able to present my X-rays at some conference or the other, and was invited to our family events and will always be welcomed and cherished by my family. My own lateral interest in medicine originated from there. Now, imagine if they had opened up my right arm instead of my left!

Wrong Site Procedures are uncommon, but when they do occur, the consequences are mostly devastating. This morning, news of a judgement reached in favor of a gentleman, who underwent an orchiectomy for the removal of his right testicle, and instead had his left testicle removed has been making the rounds. And as it should, it is creating debate everywhere. No one is comforted by statistics when confronted with issues where the healthy kidney or testicle is removed as opposed to the diseased. That this happens at all is appalling, but let us see if we can explore the issue and any possible solutions.

Honesty through anonymity?

With malpractice lawsuits hanging like a sword on their heads, surgeons and other healthcare practitioners might be tempted to embellish facts. This of course hampers the search for the truth. I would urge that information on wrong site procedures/surgeries etc. be collected anonymously. This would immensely help with root cause analyses that can afford better solutions that prevent wrong site procedures.

Don't consider the US alone

It would appear that since the number of wrong site procedures in the US is low, it is a small problems. Perhaps, it is time to look around the world. Yes, how healthcare is practiced is different across the world, but that is where practices such as stratified sampling could come into hand. And after all, it is good to solve the problem globally. Who knows, it might be possible that the root causes remain the same, and the Swiss Cheese Model by James Reason might have to be modified. Or, not. I think there is value in looking at data from multiple sources.

Taking Surgery OFF the Assembly Line

It has become common practice now to treat healthcare as an assembly line process, where the surgeons just whistle in and out of surgeries many times without making any personal connection with the patient. If you replace something like, "this male, caucasian, 34 needs an orchiectomy on testicle, right", with something like, "Dave came in last week complaining about pain in his right testicle. He is single and dating a r....", you get the picture. Whether surgeons will be willing to make this connection or will be allowed to make one like this anymore, I am not sure. It helped me. I don't see why this would be a bad thing at all.

Surgeon Fatigue and other factors

Was the surgeon tired? Did he have enough time in-between procedures? Did he get an opportunity to study the patient records ahead of time? What could have caused this, or any other surgeon to make such a mistake? These should be examined closely.

Obviating Site of the Surgery

Site marking has been repeatedly suggested. However, it is probably something to keep exploring, if we want to get to a zero defect scenario with surgical site errors.

It might be possible to better mark the correct site, especially when it comes to limbs by dressing the ones needing surgery specifically.

Would large monitors indicating the correct surgical site help?

Would a pre-surgery check explicitly stating the surgery, its purpose and the site help? We all know scans and such are reviewed, but is that enough? This surgeon who was involved in the testicle removal was not off in a shady closet with the patient, all by himself! There has been a systemic failure, so should everyone in the room be briefed?

Would special medical devices help? Like wraps, cloths, tags, other external markers and differentiators?

Should all Left-Right surgeries, where left-right anatomical parts are involved, such as eyes, kidneys, breasts, testicles, etc., have a different protocol, a different room, lighting, specialists, etc? Like how about setting all surgical equipment, oriented in the right direction? Should brighter light shine on the correct surgical side?

How would an AI Surgical Robot be error proof?

As I was thinking about this problem today, I started wondering about how the robots get prepared and used in surgery. I also started to thinking about the future where one or more AI systems come into play. Maybe, it is time to think ahead and make them more error proof from the get go!

Conclusion

Obviously, surgical site errors are avoidable, and should be avoided. It is not like we'd be okay with a plane falling off the sky every 100,000 flights. And many things had to go wrong for a wrong testicle to be removed. After all, there are really not that many people getting orchiectomies! It is time to move from a Six Sigma strategy to a Zero Defect strategy.

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References:

1. The Washington Post Article: https://www.washingtonpost.com/news/to-your-health/wp/2017/06/18/he-underwent-surgery-to-remove-his-right-testicle-when-he-woke-up-his-left-one-was-missing/?utm_term=.7cd9902bd83e

2. AHRQ on wrong site surgeries (via WaPo): https://psnet.ahrq.gov/resources/resource/3621

3. The Joint Commission on Wrong Site Surgery (also from WaPo): http://www.centerfortransforminghealthcare.org/assets/4/6/CTH_WSS_Storyboard_final_2011.pdf

4. Image Courtesy, Pexels: https://www.pexels.com/photo/blue-care-disease-doctor-236066/