A blog on medical devices, biotechnology, bioengineering, healthcare, etc. Join me on discussions about devices, regulations, the FDA, policies, law, and what not! Chaaraka is take on Charaka, an ancient Indian Physician of lore...
Showing posts with label diagnostics. Show all posts
Showing posts with label diagnostics. Show all posts
Sunday, February 17, 2019
February: American Heart Month - how much do we REALLY know, of the heart?
It has been nearly a year since I last posted here. I have had an eventful year, including employment changes, more conferences and illnesses sundry. I have been itching to get back on this blog
Very recently, I got tested for cholesterol, and received mixed, yet mostly bad news. Yes, yes, medical privacy, blah blah, but I am a scientist and don't fear sharing a bit about myself. So, my triglyceride count (119, 879 mg/dL max) appears to be within control, as is my LDL (134, 159mg/dL max), but my HDL came in at a disappointing 35 (40 min, 60mg/dL preferred).
Turns out, this is quite the cause for alarm! For men, HDL is not supposed to fall below 40mg/dL. So, I started doing research. And maybe I watch too many sci-fi movies and CSI shows (not CSI, but I am a sci-fi and true crime junkie), but what I found is quite disappointing.
First, the bias
Being in the medical devices industry can be quite irritating. On one end, we are part of an industry, that along with pharma and biotech oversells treatment benefits, disease cure rates, etc. Every week, one conference or the other has one SME or the other, spinning tales of how far we have come and how well we are doing. In context, cardiovascular surgeons and doctors tend to fight off the brain and nerve guys to be labeled the more effective rock stars.
It is perhaps absolute heresy then, to state that we actually know very little of what we work with. And by "we", I mean all of us - doctors, engineers, scientists, the whole shebang! Yes, we know more than we did, say, about 50 years ago, but there are still way too many unknowns. I have long lamented that many medical devices are not truly rooted in research and basic science. Formerly, my example used to be those "fancy drills" that root through your arteries trying to get rid of plaque (breaking and sending smaller bits into narrow vessels in the brain, necessitating an old-fashioned sink drain style filter). Along came renal denervation. Before DNA and genetics, a doctor or doctors, decided to cut off nerves around the kidney, and found that it dropped blood pressure. And then, some company took that, and with almost no scientific basis, turned that into a device solution. Medtronic, either due to naivety or an effort to drum up the hype, spent a billion odd dollars buying that company. People, especially with their own nerve-chop shops, like to pretend it was the design of the trial that screwed up renal denervation.
In reality, even if the trial was poorly designed, things still look bad. Blood Pressure Reduction has been a tricky problem for a while now. Medication developed through trials on Caucasians was found to be mostly useless when prescribed to African Americans. The Obama administration, seized on this genre of problems and tried to refocus the NIH and other agencies towards research on the basis of race. (As a side note, most devices are also built for adult males, making them unsuitable for women).
More recently though, Iceland became the subject of research that helped isolate genes responsible for High Blood Pressure. Since the population of Iceland is nearly uniform, and because of cultural proclivities, the islanders were typed and the gene was isolated. Now the race is on to build drugs to reduce blood pressure, based on genetics. In the face of that, a crude nerve-searing gizmo falls flat.
The message?
When fundamental science is applied as the basis for developing drugs or devices, things go far better. However, most of the time, this is not the case. Now, let us turn to my misadventures with cholesterol.
What we know and don't know about cholesterol:
[This is part of ongoing research. So, I will either create new posts or append references here later, but all of the below stated facts are easily found through basic search engine research.]
1. Cholesterol medications such as statins, mostly lower LDL, but do not help with increasing HDL much.
2. When HDL is increased naturally, it helps fight off cardiovascular conditions and death due to them consequentially. Apparently, when HDL is increased via medication, the cardiovascular benefits are not realized! The reason is unknown!!
3. To make things worse, there is only a correlation, unexplained scientifically between HDL levels and cardiovascular disease (yes, high HDL can reduce LDL and thus eventual atherosclerosis, but the other benefits are not clearly related).
4. Research indicates low HDL levels can be correlated to other disease conditions such as cancer! Again, the relationship is not very clear.
5. Many of us have been exposed to the simplified explanations of LDL and HDL as two molecules. In fact there are variants of HDL, and the effects of the individual molecules is not known.
6. Certain foods and exercise are listed as the mechanisms to increase HDL in a way that allows for resilience towards heart diseases. Nutritional science has huge gaps, and it is unclear how many of these recommendations are actually reliable.
7. The FDA doesn't really know how accurate the in-home cholesterol tests are. The only known comparisons to hospital tests are those done by the vendors themselves. Follow up lab tests can happen at intervals of six months or longer, unless you are asked to take medication, in which case the follow up would be six weeks - but this is all typically geared towards those with high LDL levels. An appropriate alternate could be in-home tests, but if no one is particularly able to verify the accuracy claims of the test vendors, how could one use this as a metric? This is not a pedometer we are talking about. This is cholesterol.
Conclusion
There is perhaps much more that is unknown about cholesterol and HDL, and that is very scary. I think there are two important things to consider:
1. Collectively, we have drifted away from considering fundamental scientific research. Pharma is better than devices, but one it is not enough. Secondly, while the endpoint of research has to be the development of a drug, device, combination or a diagnostic, etc., it is important to promote fundamental research. Organizations such as IBM once did this really well in the high technology industry. This is really missing in the medicine universe.
2. Uncovering knowledge will not be enough. We live in some truly perplexing times, ranging from an anti-science US Government, to people who deny vaccines and face no consequences for exercising such antithetical beliefs, putting children and society at large, in grave danger, unnecessarily.
May we use commemorations such as the Heart Health Month, to create awareness, not just of disease conditions, but on how little we actually know of them!
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Image, Courtesy, Pexels: https://www.pexels.com/photo/bright-cardiac-cardiology-care-433267/
Sunday, December 31, 2017
Theranos lives... to die another day?
I would be surprised if you were either in the medical devices/diagnostics or the general greed, stupidity and avarice industry and had never heard of Theranos. I mean you'd be in some strange Rip Van Winkle territory there. And, of course, being aware doesn't mean staying in touch. And of course, after all the revelations of unethical behavior, lawsuits and settlements, I thought this pathetic organization was going to go off into the sunset. Clearly, I am wrong!
Fortress Investment Group, probably consisting of people who have gone out of their minds (but perhaps not so much as the folks of Japan's SoftBank who plan to acquire Fortress) has invested in Theranos, with a $100mn loan based on "certain product and operational milestones", apparently. Interestingly enough, the lack of a product and any meaningful operations is what got Theranos here. The founder, used the valley's insanity and potentially other influences, as well as the valley's ignorance of medicine to raise money and label herself as all kinds of the "next big thing".
I could go on and on, but I am not sharing my sense of hubris or bitterness. I do have to point out, I was always quite suspicious of Theranos (I had even considered blogging about this, but unfortunately, I was much busier at that time). When suspicions that Theranos is a failure and had engaged in deceptive practices (they really, really ticked someone off at WSJ, where people engaging in such practices are adored and revered typically), I had posted something on social media, and one of my own close friends, who fancies himself a Valley entrepreneur said, "you have to fake it till you make it". Not so in healthcare, friends. Just give up the idea. Reality eventually catches up to you.
There is more here as to the irrationality that Silicon Valley pushes. Let's take a look at a few salient points:
1. From Theranos to Google's Powerpoint Slides (or is it Google Deck?, as if that is what matters) about using your disposable contact lenses to monitor blood glucose, there is a lot of remarkable ignorance of basic science and the stringent requirements of accurate diagnosis of health condition parameters.
2. The irrational exuberance also extends to complete ignorance that diagnosis is only part of the problem. There are no instant, magical cures. A cure for diabetes does not exist today. Yes, it may and well certainly exist in the future through CRISPR or some equivalent, but even then, there is a business model gap here that people simply don't get. There is NO difference, if you instantly diagnose me with diabetes or sickle cell anemia, or if it takes two weeks. Well heck, knowing that most of these diagnoses can be false positive, I will go to the clinic any way and spend time and money getting a deeper blood draw and go through with a detailed test and a human-in-the-loop diagnosis.
There are specific times and places where a certain subset of diseases would require diagnoses. They would also afford patients and healthcare professionals significant savings at such times. War, post-natural disasters, space travel, travel and living in extreme locations on the planet are all examples of such situations. At other times, the advantages and cost savings are far and few.
You could ask, "well, then why did Walgreens even get in on that awful deal with Theranos? " I assume they just fell for shoddy marketing. Regardless of whether or not they extract a payment from Theranos, some of the procurement folks at Walgreens need to be retrained.
Sure, there are tests that are growing in popularity, such as Cologuard, or mail-in free to cheap testing for HIV. Well, there are advantages to both. And, specificity. Colon cancer testing is painful. And this test, that has you mailing stool samples is only predicated for people who have never had the cancer before and who are not hereditarily pre-disposed to have colon cancer. As to HIV testing, you can now get on PREP, or, at best, knowing sooner means the condition remains chronic but not terminal for most people. Where advantages are afforded, costs and pain can be saved and treatment is available, diagnostic tests will succeed commercially and with purpose.
3. I did give away some of the farm at the end of the last point, but patient/population enthusiasm is key. Yes, you'd get the hypochondriacs to jump on it. And of course the health-crazy (there is a line where consciousness crosses over to plain nuttery). But what about the vast majority of people out there? How are you going to convince them to use such tools when they feel healthy? This is always going to be a problem. Behavior modification and awareness are key areas of my own research and I can tell you, when you separate reality from the valley's hype, adoption is really slow.
4. There is a reputation problem, a problem that Theranos has created. Sure, like a swamp monster, Theranos somehow lives and may raise one day again. However, they have created a genuine problem for everyone, including the competitors whose devices they ran as a cover to provide some of the diagnostic information. When some organization (hopefully someone else) creates an actual working diagnostic scan, they are going to have to put in immense effort to prove that their tests are accurate, and they have an actual value.
5. What would I recommend?
I am sorry, but I think for a long time, till genetics and diagnostics become better and have corresponding interventions become available, these mass tests are going to be absolutely worthless nonsense.
Tests that have high precision and accuracy, and can lend specific therapeutic interventions as a result of their use are probably the way to go.
The fundamentals have not disappeared just because the valley has decided they must: commonsense, realities of diagnostics, treatments, patient interest, payment issues and more. Focus on them, solve the problems, look for innovation, not nonsensical disruption (I still have a magazine advising us all to be "like Uber". Would you?).
References:
1. On the funding (Fortune calls it a perverse Christmas Gift, in case you thought I was being harsh): http://fortune.com/2017/12/23/theranos-secures-100-million-in-new-funding-from-fortress-capital/
2. Image, Courtesy: https://www.pexels.com/photo/white-and-clear-glass-syringe-161628/
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Labels:
blood glucose monitoring,
Cologuard,
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Diabetes,
diagnostics,
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therapeutics,
Walgreens
Thursday, September 28, 2017
MDDI: Machine Learning in Healthcare getting some well deserved love
MDDI, a versatile source for healthcare industry news has some good news for AI/ML fans. This morning they provided news on two different companies that got funding for Machine Learning (ML) news. I cringe a bit when people keep confusing ML for AI. However, since ML is a focus area of AI, it is all good. I have provided the link to the article below.
Low Hanging Fruits
Healthcare cost prediction is tough. However, it is ripe for innovation with huge amounts of data and of course Machine Learning, now gathering steam through new technologies and paradigms. MDDI is reporting that Cardinal Analytx Solutions, here at home in Palo Alto has raised $6.1mn to do exactly this. I haven't had time to research the specifics of this company yet, having woken up to this news, but if I find something interesting, I will get back to you.
Analytics 4 Life, another company that is in the same article, is aimed at diagnostics, another area ripe for disruption through Machine Learning. It is apparently aimed at being a low-impact cardiac diagnostic, eliminating the need for radiation, angiography or other invasive techniques. This is intriguing, given how it will lower costs and be less intrusive to the potential patients. Accuracy is a concern, but reviewing some of the other ML based diagnostic projects through the O'Reilly AI Conference archives from NY earlier this year, I can say there is every possibility that a diagnostic can be created to be accurate enough using ML. Plus, when you are sitting atop $25mn from several investors, I say, you can do it.
Some Thoughts
1. I believe we are still in the pre-bubble stage of AI based investments in healthcare. This is really good!
2. Commonsense is still the norm in investments and that is also very good news.
3. Investments and start-ups are still mostly scratching the surface. It would be nice, if we saw investments in companies with deeper ambitions and technologies before the mad rush begins.
4. If start-ups don't pick up the pace, there will be an unfortunate stranglehold on AI by companies such as Google, Apple, IBM etc., especially on the analytics side of things. Overall, this is not good for competition or for innovation. Moreover, when the larger economy slows down, or at a minimum, when "tech" slows down, there will be a slowdown in the implementation of AI in Healthcare. This would not be good, should it come to pass, as, given political intractability and general cost increases are making healthcare expenditure rates go up.
5. Still no sight of innovation in medical devices or pharma, and this is also not very comforting.
There is of course, much more to be seen as data-intensive companies, use Machine Learning (ML), Deep Learning (DL) and eventually Artificial Intelligence (AI) and try to democratize healthcare. Of course, there will be a bubble, small or large to go through along the way, as it is in every changing industry, and yet, these are amazingly exciting times ahead! We are still taking baby steps!!
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References:
1. The MDDI+QMED Brief: https://www.mddionline.com/two-ai-startups-bag-new-funds?ADTRK=UBM&elq_mid=1221&elq_cid=74447
2. Image, Courtesy Pexels: https://www.pexels.com/photo/man-with-steel-artificial-arm-sitting-in-front-of-white-table-39349/
Monday, September 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/
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/
Labels:
adhesives,
blood glucose monitoring,
Diabetes,
diagnostics,
elasticity,
lancets,
lancing,
medical devices,
properties of skin,
skin,
therapeutics,
torsional stiffness,
wearables
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