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:
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.
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
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.
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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1. Image, courtesy, Pexels: https://www.pexels.com/photo/black-and-white-blackboard-business-chalkboard-356043/
Wednesday, July 05, 2017
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.
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.
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
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.
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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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
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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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
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...
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.
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.
1. The Innovator's Solution. Clayton Christensen and Michael Raynor
Tuesday, June 20, 2017
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.
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.
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
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!
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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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/
Sunday, June 18, 2017
There is a disease slowly spreading across many industries. It is not AI (and no, this is not a Luddite post, I am a huge fan of AI). It is NOT-AI, or Fake-AI or Pretend-AI - we don't have a term for it yet, and sooner or later, one will catch on. But first, let's take a look at the semantics and the problem. It is generally accepted that there are three levels of AI - Machine Learning (ML), Deep Learning (DL) and Artificial Intelligence (AI), progressively, more complex and capable. Variants exist, and yes, semantics are really important.
Machine Learning is a reincarnation of Data Mining, where algorithms help automate learning and response to new data without explicit programming. This is most of what we have as of now. Most "AI" tools, apps and companies you hear of, are limited to Machine Learning. Deep Learning applies artificial neural networks to go beyond Machine Learning algorithms to understand and analyze data. Deep Learning, will hopefully, eventually lead to a true AI that can use its innate intelligence to respond to data by analyzing it and make decisions based on it. This has not happened yet, except in some very narrow situations.
Like I said before, so far, what we have are algorithms, that look at data and perform meaningful, analyses and help us gain insights from them. Some might even make rudimentary decisions, but that is where things stop. Yes, Google's DeepMind and IBM's Watson are quite capable at AI, but they themselves are very good examples as to why, a lot of others claiming to be "AI" are not!
Here is an example:
Perusing through press releases a couple of days old, I came across "Mindstrong", a company that just raised $14mn in Series A Funding. I read about the company, and it is fascinating, but then I have to wonder who wrote the release and why they decided to distract from the clever things the company plans to do by mislabeling the technology/methodology as AI. I mean, you have the $14mn already, so why embellish it now? Moreover, the company is painting a very rosy picture of its clinical trial results, and while one hopes they are truly so, most of us, outside the investors haven't see any of these supposed results. So, this really is a stretch in multiple dimensions.
The company wants to passively collect data on the method of mobile phone usage employed by people with mental health and neurodegenerative issues and then improve treatments based on lessons gleaned from the data. This is great, a first step in using Machine Learning to improve patient outcomes, but without actual decision making, that would be at the same level as, or exceed healthcare decisions made by humans, it would not be an AI. This is not trivial. We live in a time where the FDA is yet to allow Clinical Decision Support (CDS) software to be less regulated. An approved AI is years away, at least.
Moreover, it creates unfortunate impressions in the minds of the public as to how far technological progress has actually been made in healthcare. While I understand start-ups ought to generate enthusiasm in the public and in existing and future investors, I don't think fairy tales will cut it. Moreover, the existing technology Mindstrong describes, which I am pretty sure is clever use of ML, is sufficiently exciting enough, it puzzles me that they would decide to engage in wordplay. An oversight in the press release, perhaps? That would not be so bad. If it is deliberate, then one has to start wondering about other things, such as the stated superiority of the clinical trials.
In general, I now worry, a trend I thought is a few months/years away is here now. Healthcare companies bandying about the word "AI" for things that are far from it. We need brutal honesty (the kind that lost Berkeley access to the CRISPR patents, but nevertheless, a very lofty approach - more on this another time) in helping us understand diseases, standard of care, technologies and all the limitations therein. Only through this, can we engage in disruptive as well as continual improvement of healthcare. Not, by embellishing press releases.
1. The Release about Mindstrong Health: http://www.marketwired.com/press-release/mindstrong-health-raises-14-million-in-series-a-funding-2222154.htm
2. Image, Courtesy Pexels: https://www.pexels.com/photo/black-and-white-blank-challenge-connect-262488/
Saturday, June 17, 2017
I am going to write about one of my favorite topics, where I will, take somewhat of an antithetical position, and that is going to piss some of you off. If it does, it was meant to. If you are looking for a post that sings the praises of genetic screening, you are in the wrong place, but please do read on and find out exactly why. And no, I am not writing simply because genetic sequencing based ancestry ads have taken over my television with nauseating and stupid repetition focused on letting people know about their "ancestry" (which can be useful, yes, but more on that later). The reasons are deeper.
Now, I am all FOR genetic screening. Eventually, it will be the norm. This post is about WHY it is not being accepted by people at large yet, what is driving that, and the consequential desperation with which advertisements and strong-arming by physicians of their patients. A better understanding of these issues will clear the way for acceptance and genetic screening. So, let's take a dive.
Fear motivates humans in ways almost no other emotion can. Any time new technologies, methodologies, philosophies etc. emerge, people always respond with fear. And with something immensely personal, such as one's own genetic information, people will fear. In a society where science and scientific thinking is shunned and ignored, this is to be expected. So, education and awareness are not only important, they also take time.
And instead, it appears companies and physicians are jumping the gun, trying to push patients and parents, as in the case of a project titled BabySeq, that allows for babies' genetic codes to be sequenced, which apparently 93% of parents, have rejected.
To anyone who has been following clinical trial enrollment, especially in Oncology would not be surprised at this number. In fact, notwithstanding that genetic sequencing doesn't offer any immediate benefits, the numbers, at 7% of babies sequenced, is higher than, in some cases, where oncology trials only draw 5% of those eligible. Yes, a small number of patients would fear the possibility that they will get something other than the standard of care and might even perish. However, fear that a new treatment would fail or have unwanted side effects is probably what keeps a significant number of eligible patients off clinical trials.
A deeper understanding of how people react to new things and ideas, and what it would actually take to convince them to do adopt these things an ideas is essential.
2. Understanding the Non-Scientific Mind and the Non-Entrepreneurial Mind
Given that you are reading this blog, you and I think along the same lines - a mind with a high affinity towards science or entrepreneurship or both. We don't think alike, but, we embrace science, new technologies etc. more readily. When offered an opportunity to have my genetic screening done, I will do so readily, even though I fear, it may not reveal good news.
Much has been written about how entrepreneurs think, and to a large extent, how scientists think. But, consider those who do not readily embrace either, or both think. For them, something intangible, with a lack of immediate benefits, does not present an attractive proposition. They don't care that you can take the genetic information of hundreds of thousands or even millions of people and use "big data" and "machine learning" to glean insights.
When faced with such people, prudent strategies are required to create awareness and help them espouse genetic screening.
3. A million Henrietta Lacks?
If you are yet to hear of her, congratulations on living in a really airtight vacuum. However, as most of you know, her cancer cells were turned into an immortalized cancer line and innumerable research projects were carried out. Her family was never compensated for it. Now, when it comes to giving up their genetic codes, patients have to wonder if the benefits will be reaped by a handful of organizations.
It is clear that gene sequencing and the data analysis has the potential to allow for faster diagnoses and better treatments, the openness of the resulting analyses and findings should be paramount. This must be really hard for some companies to swallow, especially for one, started with the main aim of over-promise, under-delivery and essentially dominate the gene sequencing market, that had to be slowed down by the FDA, only to now peddle ancestry identification advertisements.
Yes, ancestry related data can further help point towards specific disease vulnerabilities among patients. However, as you know a lot of those types of studies have so far resulted in open information (stomach cancer risk in the Japanese population as an example), and this should continue. Give people assurances that you are not planning to profit off their data, and you will get much farther with gene sequencing, especially among healthy people and parents.
4. Genuine Legal Concerns
There are genuine legal concerns here. Will genetic data be properly blinded? Will insurance companies take advantage of the data to deny or reduce coverage? Will government agencies use the data to track babies or others?
This is more important to a lot of people than the fact that Penn was able to alter the treatment for 80% of the patients whose genetic sequencing had been completed. Finding out what the pain points are for people is key.
Now that at least some of the major concerns surrounding gene sequencing have become apparent, doctors and organizations should implement solutions that are appropriate. Blind the data, prevent unauthorized access to patient information by third parties, including governments and insurance agencies, empower patients and the general population to have control over how and when the data is used, and prevent a random few from profiting off gene sequencing.
Make the future benefits of sequenced genetic information clear to people who think unlike scientists and/or entrepreneurs. And please keep off trivializing sequencing with nonsense such as ancestry. If you are going to use that angle, use it wisely, drawing a clear line to have that is actually beneficial.
Stepping into the shoes of others is critical, and this, I clearly believe is missing in the campaign to have people sequence their genes.
1. Health IT News Article: http://www.healthcareitnews.com/news/precision-medicine-fight-brewing-between-clinicians-public-health?mkt_tok=eyJpIjoiTmpWbU0yWmhNR1kyTnpZNCIsInQiOiJ1T0lTMVdTTitQeHczUWxlOEtnczR1aWR2Mnc2allvbkd0cEVneU5NNzlwSnJSQzY4dkxzVmJPRHNQa04ybUhtQlVrRloyR2lpdER3VlRrQ1krM1hhdkVoRUJcL2FWZXlGbEZSMnVsRzV5Wk1VMFg4V3pGZVNYYzFPUVwvOXRGYjhkIn0%3D
2. Image, Courtesy WallpaperCave: http://wallpapercave.com/w/PYYchEd
Friday, June 16, 2017
I find it quite interesting that, just yesterday, I had complained about how the FDA and other regulatory agencies are behind the curve on cyber-security, and today, at least with regard to digital health, the new FDA Commissioner Scott Gottlieb is promising some key changes and efforts going forward. This is, to say the least, heartening to hear, especially since at least some of the efforts continue on from the previous administration and that is a good thing. Not only do we get continuity, but also rapid progress as opposed to a back to the slate approach. I only hope that in the long run, the FDA stays guarded against haphazard deregulation, the kind that eventually caused patient injury and sparked anger and intense debate in 2007. I also want to remind everyone that the FDA has only provided forward looking promises, and only when these things come to fruition would a better picture emerge.
Most of the information, comes directly from a blog post by Scott Gottlieb (that quite irritatingly leaves out the definite article when addressing the FDA throughout the post). The post is linked below, along with an article from CNBC with some caricatured, over the top reactions. I wanted to discuss a few, salient points here.
The Stratified Regulation of Digital Health
When it comes to digital health, things have been haphazard so far. Some organizations decided by themselves that regulation did not apply to them. Ever guarded about their role, the FDA stepped in and refused to simply give up. Then came the uproar about what should and shouldn't be regulated. As Gottlieb points out, the 21st Century Cures Act rids the FDA of the need to act on simple applications, such as healthcare lifestyle/motivational mobile apps and administrative software programs. This is a great step forward. However, for example, blood glucose monitors and accessories, pictured above will continue to be regulated (in the past, poor design decision making led to patient death and a company shut down).
Clinical Decision Support (CDS) Software
Clinical Decision Support Software programs, either by themselves, or in conjunction with medical devices will provide recommendations for diagnoses, treatment, dosages etc. As such the FDA has regulated them without guidance and this has led to much stress and discussion. There has been a long, ongoing effort to try and make some clarity available, and it appears that the FDA is finally promising (mind you, that is all we have as of now) that this will happen. What exact shape and form this will take is unclear as of now.
Something, Something, Opioid Crisis
The opioid crisis is real, and action is necessary, but from Gottlieb's writing, it is unclear what the FDA will do. Past contests and prizes are great, but if they plan to do something more concrete, I was not able to glean any of that from the blog post.
Pilot Programs and Cutesy Abbreviations
So today, through Gottlieb's blog post, I was introduced to a new term - Software As a Medical Device (SaMD). Apparently, a third party certification agency will allow low risk devices to be "per-certified" and marketed without FDA pre-market review, and high risk devices will be undergo an FDA review. Who will do this classification is unclear from the blog post, and frankly worries me. Information on an apparent pilot underway to accomplish this is also thin on details.
On Third Parties and the Risk Based Approach
Terms such as "third party certification agencies" make me a bit squeamish. Almost never in the open, but heavily so in private, Regulatory Professionals in the Industry writhe, squirm and complain about how the third party certification agencies that oversee CE Marking wreak havoc on their day to day jobs. Privatization is always a mainstay of the GOP agenda, but it is very disconcerting to see this discussed in the context of regulation. One fundamental qualifier for the FDA has been that, holding devices, software, pharmaceuticals and much more to a very high standard has proven quite (safe and) effective for those of us here in the US. I wonder, if the pilot, is but a pilot to extend this "third party" business into other areas that come under FDA purview.
Sure, it is good for businesses and a new crop of companies and consultants it will foment, but is it good for the US consumer in the long run? My answer is - NO!
I don't understand why the FDA would have difficulties doing the classification and the consequential pre-certification. This is something that gives me a long pause, but let's wait and see how the pilot pans out and what comes of the actual efforts at guidance and regulation after.
Over all, medical device and pharmaceutical companies already consider a risk based approach in design and manufacture and the FDA also encourages this. This part, I like. It is important to focus on critical, high risk items that have bigger impacts and not on the minor details.
National Evaluation System for health Technology (NEST)
This was fun to learn about. Through the Medical Device Innovation Consortium (MDIC), post market data is apparently to be made available to engineers and designers to improve product design, by 2019. This is quite interesting and exactly the kind of innovation that SHOULD be outsourced to "third parties" and made available to all. You wont hear me disputing this one.
Scott Gottlieb's blog post appears to be well thought out. It makes promises, most, if not all of which appear lofty and beneficial. However, as I have mentioned previously, these are just onward looking statements and only time will tell how they all play out. So, I would advice everyone to take a more measured approach and wait for more concrete information to emerge.
1. Scott Gottlieb's Blog Post: https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/
2. An unjustifiably jubilant CNBC Article: http://www.cnbc.com/2017/06/15/fda-commissioner-scott-gottlieb-outlines-new-digital-health-strategy.html
3. A cool Fiercehealthcare article on CDS Software Regulation Guidance: http://www.fiercehealthcare.com/special-report/fda-s-approach-to-clinical-decision-support-software-a-brief-summary
4. Image, Courtesy Pexels: https://www.pexels.com/photo/health-medical-medicine-diet-46173/
Thursday, June 15, 2017
Cyber-security of medical devices is a critical issue, and surprisingly, one that still fails to gain appropriate attention, despite repeated publications and shocking revelations. The FDA has made some efforts, but as you will see from the report linked below, the efforts clearly fall short of what is actually needed. Through LinkedIn, I found an article and a report on ICD/Pacemaker security issues, that was revealing.
I will let you read the report, an easy read, and use this post to address some high level concerns based on what I learned. Here are a few concerns/thoughts:
1. It is clear that the FDA and other regulators don't fully understand cyber-security issues associated with medical devices. In fact, I would venture, most of us don't, at least not enough to pass robust regulations. Yes, it is a learning process and should happen in iterations, but the rate of progress and the quality of the outcomes are quite poor, when it comes to implementing cyber-security in devices. Even the basics appear to have fallen through the cracks - such as data encryption, hardware and code/firmware obfuscation, etc., which I had simply assumed were foregone conclusions, having seen a cyber-security upgrade to a product through to market that went well above the basics.
2. It is a bit surprising to learn that off-the-shelf hardware, and third party libraries are freely used. I thought, Class III devices would, by necessity see customization at every level. While this has been educational, it represents another layer of failure in security implementation. I have seen simple $20 - $30 prototype level sensors and such come with epoxy dipped circuits that were essentially impossible to reverse engineer. I can see how due to functionality concerns and medical device regulations, this is not the solution you'd see medical device manufacturers use, but clearly, some form of encryption and lock-out should be mandated.
3. Re-sale and re-use of devices is always an area of debate. Manufacturers would like to stop them altogether, first for financial reasons; reprocessors and resellers would love to be given unbridled access. Common ground is important, and it should be fundamentally unacceptable for un-encrypted (!), patient-data laden devices to show up online for sale (per the report, this has happened). Either data should be encrypted - how this is not mandated, still surprises me, or, at a minimum, anyone reselling any medical devices online should be required to "flash" devices/sub-systems that carry patient data.
4. From a business standpoint, having seen some companies, that were not necessarily visionary, but had learned through dealing with counterfeit capital goods and disposables, enforce encryption and obfuscation, I fail to see how all 4 manufacturers that make expensive and critical devices such as ICDs simply stand by and ignore fundamental security implementations. It further perplexes me that the FDA does not require stringent security features!
5. When it comes to physician programmers, I can see how, within the clinical setting, it would be dangerous to waste time entering user names and passwords when potentially dealing with critically ill patients, there should be a global lock on such devices the minute they are outside a clinical setting. The ability of random third parties (as the researchers at WhiteScope did, for example) to obtain these programmers and access the removable (!) hardware through unlocked (!) USB ports etc., is simply unacceptable. This shows that both the manufacturers and the regulatory agencies lack vision in implementing good, logical security systems. This is a very dangerous notion and immediate correction is essential. But, like the mice at the meeting, one has to sit and wonder, who will bell the cat?!
6. This is a bit of a repetition, but I see this as the core of the issue. Medical Device Manufacturers are not taking leadership on product and patient security. The FDA, veritably, the world's leading medical device regulatory agency is not. Therefore, no one is! We don't need obscure, soporific "guidance documents". I am sure the FDA has published a handful of these and will probably put out a handful more. What appears to be missing is a clear, forward looking visionary form of leadership, that doesn't just get bogged down on encrypting software code and locking down hard drives, but plans ahead to evolving paradigms and problems in cyber-security, such as the spread of ransomware for example. Given that off-the-shelf components, common architecture, readable code and data are used, as well as the fact that all components in the system/network can be purchased easily, all it will take is for an unscrupulous group of individuals to buy these devices, decode the overtly simple security features and then sell the mechanisms to nefarious groups, or decide to hold groups of patients, individuals or entire hospital systems hostage.
The problem of lax/absent cyber-security in medical devices of all kinds, is present and continues to evolve alongside the emergence of digital health and digitization in general. I can sit here and spin doom and gloom all day and all night, but what I am left to wonder about, instead is, given all we know, when and from where will we see this vision and leadership emerge from. Right now, I can only ask the question and have no answers to offer. If you can think of any, do let me know.
1. The Healthcare IT News Article: http://www.healthcareitnews.com/news/pacemaker-device-security-audit-finds-8600-flaws-some-potentially-deadly
2. The WhiteScope Report: https://drive.google.com/file/d/0B_GspGER4QQTYkJfaVlBeGVCSW8/view
3. Image, Courtesy Pexels: https://www.pexels.com/photo/blur-bright-business-codes-207580/
Tuesday, June 13, 2017
Front End Research is important for innovation in any industry. It was once my job to look to expand my company's existing devices to various health conditions, and to identify technologies, health opportunities, etc. I enjoyed it the most, and I still look around for opportunities.
A stroke is an event that disturbs blood flow in the brain. There are three broad classifications of stroke:
1. Hemorrhagic Stroke
2. Ischemic Stroke
3. Transient Ischemic Stroke (TIA)
Transient Ischemic Stroke is when the flow of blood to the brain is blocked, due to a transient blood vessel blockage. Among the other two, Ischemic strokes account for about 87% of all strokes and Hemorrhagic Strokes, the remaining 13%. Ischemic Stroke occurs when a fatty deposit blocks the flow of blood to the brain. This may worsen by breaking off into smaller emboli and blocking smaller arteries further up the brain. Hemorrhagic strokes occur when when a blood vessel weakens and undergoes a rupture, leaking blood into the brain and applying pressure on the surrounding brain tissue.
As reported by MedCity News, it appears that experts at a conference were recommending that medical device companies look at endovascular treatment for stroke. They exemplified mechanical means as an example, such as the thrombectomy/emboloctomy devices, one seen from Stryker and stents, one example stated being that of a stent from Medtronic. A combination of urgent care in terms of pharmaceutical treatment and medical devices does make a compelling case, and you can read more in the attached article. I want to move on and express a few thoughts of my own on all this.
1. First, I have been aware of the mechanical abrasion devices, with cutesy names such as the "rotablator" and so on, essentially biocompatible drills, which were patented, and thus, many organizations had stayed away from following on, with weak patents, especially because they were rumored (mind you, mostly, just rumored) to not work as well as hoped. It is interesting to note that Stryker has a device along the same lines. I assume they have access to existing patents, or have filed new ones.
2. One of the problems with cutting through plaque is that you need a distal filter to capture the plaque, to prevent it from causing transient ischemic strokes, or other ischemic strokes and damaging parts of the brain by cutting off blood flow. Since the brain is second only to the heart in importance, the aorta pumps blood into the brain at really high velocities, so, though, embolic protection devices exist, they are limited by size, the geometry of the carotid artery and other vessels, the high velocity of blood and the fact that the patients have typically already experienced a stroke and are weak to endure much by way of surgical procedures.
3. In the business of dissolving plaques, pharmaceuticals and medical devices compete. Other than in drug eluting stents, the two industries are in opposition to each other. Of course, Doctors would like to prescribe their patients a combination of drugs and device-based procedures, if medical device companies are to succeed, they need partnerships with pharmaceutical companies, and strong evangelism from practitioners.
4. Newer possibilities such as nanotechnology and MEMS should not be ignored in the quest for physical solutions to ischemic stroke treatment. Drills and stents become tiring after a while, and it is my hope that a newer generation of medical device solutions will rise to the occasion.
Yes, there is a clear problem, in need of solutions, when it comes to follow on treatments with ischemic stroke. Challenges remain, and yet, the good news is that these challenges are really well known, and therefore, so are the solutions. Perhaps, newer medical devices can emerge, alongside pharma and become integrated into the Standard of Care.
1. The MedCity News Article: http://medcitynews.com/2017/06/medtech-startups-look-ishecmic-stroke-area-unmet-need/?rf=1
2. Image, Courtesy Pixabay: https://pixabay.com/en/brain-triunique-reptilian-limbic-2235831/#
Sunday, June 04, 2017
You cannot really take them to task, as the forces of capitalism are biased towards success, and competitors as well as naysayers tend to take on the slightest negative news and turn it into bugaboos, confounding issues further. However, for the progress of science, results must be reported without bias. If you try technique A, device B or molecule C, and it doesn't work, and if you state the results appropriately, you will do two things:
1. If you are able to show why something didn't work as expected, you prevent researchers from trying that exact thing in the future.
2. Or, you give future researchers options to try other things, or through your reasoning, try different ways or improved ways of doing things.
At the end of the day, at least in healthcare, hopefully most researchers and organizations remember that our eventual goal is the betterment of human lives and not just profit seeking.
Therefore, researchers must be motivated to boldly publish negative results and data, and be allowed to theorize/hypothesize and collaborate with the scientific community at large to identify the causes for the negative outcomes. This takes support, especially from study sponsors, and this is exactly what Nike has done.
This morning, STAT led me to Eurekalert, to a Nike sponsored study on the potential beneficial effects of compression socks on runners, touted to reduce fatigue by reducing muscle vibrations, causing them to expend less energy. The study was conducted by researchers at the Ohio State University Wexner Medical Center, and the results were presented at the American College of Sports Medicine's (ACSM) Annual Meeting, which occurred 30 May – 03 Jun, 2017.
The study had runners perform a 30 minute workout in a study setting, with heart rate monitors and imaging devices measuring their level of fatigue and muscle vibrations.
The study showed that there was a reduction in muscle vibrations. That is why I called the results "negative-ish". Please watch the video (link below), as Ajit Chaudry explains how, despite reducing vibrations, the socks did not have any effect on the three factors weighed, their fatigue, strength and jump height. Initially, before watching the video, I had wondered if the effect was a placebo effect. It is not. There are clear reductions in vibrations, it is just that the reduction is small enough, it doesn't have an effect. Of course, as the video suggests, there is always a psychological angle, that should not be ignored, especially with marathons, and competitive sport, where every little advantage, real or perceived, counts.
However, what is to be truly appreciated here is that Nike and the researchers did not back off reporting the results. This is very important and should be encouraged. As you can see, the results themselves are not too bad, and runners will probably wear compression socks anyway, and even if they don't, they will clearly have to realize that to lower fatigue, they will have to look elsewhere. It is precisely this type of reporting that we need to see on devices, drugs and basic research.
They say, "reward successes and celebrate failures". Well, commercially, successes have the potential to be rewarded any way. So what about failures? Or, in this context, negative results?
Journals, Professional Organizations and others should consider instituting rewards to both sponsors and researchers that go ahead and publish negative results and data, and share related theories and hypotheses. A concerted effort is required to stave off the stigma of publications focused on failures, if the quality of our research and our march towards cures is to be rapid.
1. The STAT Article: https://www.statnews.com/2017/06/01/compression-tights-fatigue/
2. The Eurekalert Article: https://www.eurekalert.org/pub_releases/2017-06/m-src052417.php
3. The OSU Press Release: http://osuwmc.multimedia-newsroom.com/index.php/2017/06/01/study-reveals-compression-tights-dont-help-runners-cross-finish-line/
4. Image Courtesy, Pexels: https://www.pexels.com/photo/adult-architecture-athlete-boardwalk-221210/