Wednesday, April 10, 2019

With Microsoft following Google on the way out of EHRs, it is disconcerting that Apple is getting in on the game...

It is official, Microsoft is exiting the Health Records business altogether, shuttering HealthVault completely and sending consumers elsewhere. In lieu of admitting defeat, they are issuing hyperboles about looking at the enterprise and so on. That is just fine. Like Google, they have probably learned that their holier than thou attitude doesn't extend to many areas of healthcare.

Why Apple is worse

I must admit. I have never been a fan of Apple. Most of what they have done involves being second, or third, or fourth in class, slapping pricey labels on things and bully vendors. And their things are getting more expensive all the time. And honestly, while the media hypes about how Apple is the next best thing since sliced bread (pun intended), you have to take a few things into consideration.

First, they said the same thing about Google and while they were "verily" solving blood glucose monitoring on Powerpoint, er, Google Slides. We know how that ended.

Second, Apple is a very controlling company, with closed systems in silos. Unless you are apathetic or ignorant, how can you call that a good thing for healthcare?

Third, they charge well above what their services are worth, and so once again, I repeat, unless you are apathetic or ignorant, how can you call that a good thing for healthcare?

Fourth, and this is stated with quite  bit of pleasure - remember Apple maps? 

So, there is no guarantee that they will succeed, and should they do so, I am almost certain it is not a good thing. 

Some Further Thoughts

EHRs are complex. Patient privacy is involved. Data vulnerability is an ever-present danger. Healthcare is already very expensive - adding unreasonably expensive products and services from vendors does not make any sense. It may be slightly better than giving out fake contracts worth millions of dollars to your friends for PR - paging Seema Verma, but that does not make it a good thing!

Anything related to healthcare needs to be part of the long game. The problems are complex, there is a lot of politics involved, and cost-efficiency is a must. Tech companies, especially of the Google kind think that they can use customers as guinea pigs, releasing products in wishy-washy cycles, and remove features, or shutter products and services on a whim. This is NOT how healthcare problems will be successfully solved. 

Can T. Rex play Ping-Pong? 

Besides the go-it-alone-because-we-know-everything approaches that Apple and Google (although, they now have Verb Surgical) like, there is the approach IBM took with an entirely different problem - using Watson to solve cancer by pairing up with M.D. Anderson. 

I liken that to two T. Rex (the word has no plural, mind you), deciding to play Ping-Pong and then after much agonizing effort, finding out, they have really short forearms, and should have taken the time to consider that first. 

Today, especially when it comes to the Artificial Intelligence hype cycle, "partnerships" are being announced at such a breathtaking pace that it is hard to keep up. Nothing wrong with partnerships, but you have to make sure that it is strategically sound, is actually complementary and clearly steers away from being a partnership, only in name, where one party just dumps their technology and a lot of funds and grants to desperate researchers and practitioners!

So what would drive success with EHRs?

Well thought, secure, planned and executed products, that are iterated in an evolutionary manner through testing and improvement. The approach, whether a solo effort, or a partnership or involving several partners, needs to put patients first and take a humble approach to a problem no one has solved yet! 

There are several experts who have spent their lifetimes thinking about digitization. Playing the game without involving them is just irresponsible. It is also important to play the long game, be respectful of patients and not change features and products on whim. EHRs and emails are completely different. 

Interoperability should be more than a nice bell or whistle, and something you actually strive for. Along with that should come some degree of openness - more the better, so that it is not a dog-eats-dog approach, but rather a co-operative, collaborative one, acknowledging that not everyone wants to be bound by your product or service. 

Subscribe and Support, Please! 

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


Monday, April 08, 2019

In Boston May 15 - 16? I am giving away a VIP pass to the BIOMEDevice Boston Conference!

I am speaking at the Boston BIOMEDevice Conference and the ESC. As a speaker, I have ONE complimentary pass to give away.

Since most everyone I know in the Boston area, will probably be at the show, I am  giving away the pass.

That's it. No forms to fill, no subscriptions to get into, no feedback, no nothing! Just the desire to soak in all the expertise and industry experience on display for two whole days.

If this strikes you as something you can enjoy, get in touch with me at yamanoor at gmail dot com, or via LinkedIn:

I need the following information from you to forward on to the good folks at MDDI:

First and Last Name
Job Title
Company Name
Email Address

That's all for tonight folks! 

Sunday, April 07, 2019

How Healthy are we? Pondering the status quo on World Health Day

The good folks at JDRF woke me up on a lazy Sunday morning with an email about April 7th being World Health Day. As I lay in bed listening to some Carnatic Music renditions (a form of South Indian music), a sometimes-morning routine for me on weekends, I noodled on the topic of health. For a while now, since we heard about the second ever patient to be rid of HIV, I have been thinking about writing a post about how slow progress in medicine has been, and how much progress is yet to be made.

Yes, the post is somber in many ways, but the goal here is not to depress or take away from the progress we have made, but to serve as a yardstick for where we need to go from here.


The HIV virus is the most impacting of several that jumped to humans from other animals - a phenomenon termed Zoonosis. Humans have been suffering from HIV infections and its consequence, AIDS, for just about 5 decades now, and we have so far cured TWO patients, and that is, only because of their special circumstances!

Given the fatal consequences, and the innumerable deaths the virus has led to, it stands in stark contrast to other victories of the past, such as against smallpox, another consequence of Zoonosis.

Yes, the HIV virus is very tricky and is ancient (it appears the Chimpanzees fought it off millennia ago). However, it shows that for all our understanding of chemistry, biology, microbiology, virology and genetics, we are as of now, quite unequal to the task.

And as I mentioned above, both patients who are in remission for HIV had special circumstances, and their doctors were courageous, taking more risks than most have. And that is one of several problems I wish to discuss in this post.

2. Cancer

Yes, decades of promises and billions of dollars we have no cure for cancer, except for the most incidental cases. In fact, we don't even understand cancer well enough. Theories have come and gone, resembling fads of yesteryears.

For the most part, cancer therapies resemble what I call "fancy bloodletting"with the rare exception, such as with thyroid cancer. Thyroid cancer, in some cases can be cured by injecting radioactive Iodine, which the thyroid gland laps greedily, as it evolved to (it will take up Iodine, radioactive or otherwise, that is). You then wait as the radioactive Iodine destroys the cancerous thyroid cells.

You may then ask, why we haven't found extended this type of solution to mos types of cancer. Well, we haven't done a good job of understanding genetics, biomarkers and the other aspects of biological science which would provide us with the tools necessary to advance cancer therapy past horrifying drugs or radiation.

I personally find it appalling that it is not illegal to use "inoperable tumor" as an excuse to send a patient home to die!

3. Chronic "Lifestyle" Diseases

Now, we all share the blame for this. As societies prosper, especially in developing countries like India, unhealthy lifestyles are leading to High Blood Pressure, Obesity, Diabetes and other conditions that cause decline in Quality of Life and in some cases, also lead to mortality. In the past couple of decades, there has been some modicum of progress with respect to blood pressure (no, NOT renal denervation, more on that in a minute), diabetes and cardiovascular care, but people are making themselves sicker faster than medicine can catch up. More awareness will get us part of the way, but this is one of those areas of health that can be tackled as a team effort.

4. Barbarism, Renal Denervation and the Poverty of R&D

When I first learned of renal denervation, I was immediately alarmed. It continues to irk me today, that this was not the universal reaction. Maybe I am overly sensitive to such nonsense, which is whata this is, because I have come across this before. I was once an intern at a company that burned millions of dollars (!) on the path to treating migraine with visual aura by closing the inter-atrial septum. Yeah!

Renal Denervation is based on some "research" around the middle of the previous century, in a Mary-Shelley-esque manner, someone toasted renal nerves to notice a drop in blood pressure. Without much further research into the long term effects of doing this, someone dusted this off the basement of some library and turned it into Ardian, which Medtronic then hyped the medical device industry into a frenzy, by ridiculously overpricing Ardian during the acquisition.

I do not buy the theory that Medtronic "botched' the clinical trials. I think humanity is lucky in that pharmaceuticals have progressed enough to be better than the weed-killer approach to blood pressure management.

What we should truly focus on is this - the medical device industry is really behind the curve on basic research. Too much of the focus is on development, some of it quite mindless, like the use of drills to remove arterial plaque!

This poverty of R&D efforts is one of the key reasons why progress in medicine has been so slow. 

5. Private Fraud and other Misbehavior

Elizabeth Holmes and Theranos are but the latest examples of people and organizations behaving badly. History is full of such examples, and this is in fact how the FDA came into existence. That, there is an assault underfoot to water down the FDA will be discussed momentarily.

The way some companies approach regulations is not as the framework to work within, but the dilapidated fencing to test aggressively for weaknesses. The lack of ethics causes problems for medicine and society.

6. Bad Governance

Just a couple of days ago, I posted about the secret database FDA maintained and helped an unknown number of medical devices cover up a further unknown adverse medical device events, masking the true limits of such devices and the harm caused by them. Spanning multiple administrations, this struck a blow to the very heart of why the FDA was created in the first place.

World over, many governments are undermining healthcare, in more ways than one, eventually harming both current and future generations.

7. Medicine Inequality

Under-served populations suffer from many inequalities in medicine. The aged, women, people below the poverty line, entire regions of the planet - several cohorts constitute under-served populations. Pricing is one. Access is another. The deliberate act of making medical devices disposable, fundamental to the chosen business model for many organizations in the industry is another. Patents, regulatory pathways, corporate greed - the factors abound. Suffice it to say, much work remains to be done.

Conclusion - Opportunities abound! 

The aforementioned points can be seen one of two ways. One way would be to be angry and depressed. The more positive approach would be to see all of these as opportunities ripe for innovation to cause true, lasting change.

That is the purpose and spirit with which this post was written.

Rooting out unethical behavior, bad governance, downright criminal behavior, making medicine affordable and equal, causing real technological progress, improving Quality of Life (QoL), reducing morbidity and mortality are all challenges we can take up and whittle down!

So, Happy World Health Day!

As usual, if you want to be reminded of the event annually, here is an event:

Subscribe and Support, Please! 

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


1. Map of the World:

2. Blood Draw Image:

3. Image of Breast Cancer Ribbon:

4. Image of Blood Testing Equipment:

5. Image of Broken Glass:

6. Image of Syringe:

7. Image of Hammer:

8. Image of Beautiful Old Lady:

9. Image of Cheerful Team:

Friday, April 05, 2019

So, what will the FDA's secret hidden database lay bare?

NOTE: By now, if you haven't heard of the secret database the FDA has been keeping to help companies hide adverse events, I'd say you are not keeping up! I will supply a couple of links for you to peruse to get yourself up to speed.

ON THE ETHICS: It is key to discuss the ethics or rather their absence, in detail. However, I want to focus on something else for now. I am curious about what we will learn, and I want to focus on that. However, I will leave you with a couple of points to ponder:

1. It is typical for controversies to take a political bent. But here is an alarming example of something that started with one administration, and sustained through several.

2. There are something like 780+ federal agencies, that we know of. Just the potential of the spread of this type of bold unethical behavior, that will go unpunished is just jarring!

3. Congress is completely asleep at the wheel!

4. THIS ONE IS KEY: How many company executives know about this, have participated in this, and what are the implications of all this?

What I Expect We Will Learn

1. Just how many medical devices and their manufacturers been accessing the database?

2. What type of adverse events were being hidden?

3. The relationship between adverse events that we were made aware of, previously and what was in the database. Do we get a chance to just sum them up and say, "well, we thought this device had 5 adverse events per year, and now we know it was 25 per year because we found thata on an average, 20 were being hidden per year?"

4. What if certain types of adverse events were hidden from us?  What if injuries were made public, but deaths hidden?

5. What if companies got preferential treatment in terms of access to the database and how was this decided?

6. To what extent can we answer the question: how far was the true harm to patients?

Lost Opportunities

1. Imagine how many start ups could have germinated to solve issues caused by devices that people falsely believed to be better than they are!

2. Imagine how many patients could have chosen alternate treatments or devices. One also has to wonder how many credible lawsuits were not filed owing to the fact that the evidence was hidden!!

3. Doctors could have better cared for their patients, and provided them with adequate warnings, alternates or protection.

4. The FDA is meant to protect us. Medical Device Companies are supposed to be ethical. And now, it is anyone's guess how deep the loss of credibility is going to go!!!

There is more to come

This database raises far more questions and alarms. I am sure in the days, weeks and months to come, we will discuss more of these issues, as details become apparent. Currently, we know something like 3X the data was hidden, in just a year, per Star Tribune. Who knows what the real depth of the problem is.

Subscribe and Support, Please! 

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


1.Star Tribune:

2.The Kaiser Health News Report:

3. Image of Woman:

4. Image of Right and Wrong:

5. Image of Seated Person:

Tuesday, April 02, 2019

World Autism Day and World Autism Month

Just this morning (it is still the 2nd of April as I compose the email) I found out that the UN declared April 2nd and the month of April, Autism awareness day and month. This is obviously one of the best things the UN has done. Autism is a general term for a class of conditions that cause people to be differently able.

I wish I had known earlier, so that I could have alerted you all to it myself, and written about some of the latest research to help people with autism integrate well. Our busy lives keep us all quite occupied and therefore, many moons ago, I created a calendar, to remind myself. I have created two events, if you wish to remind yourself:

World Autism Month:

Note: Unfortunately, Google doesn't allow me to take a monthly block event and repeat it annually. I will try to figure something out for this.

Meanwhile, here is an event that will repeat itself annually and you can set reminders to yourself after importing:

I will try to post more after I have had time to gather my thoughts.


Thursday, March 28, 2019

The Sterigenics Brouhaha: A Teaching Moment

A Note: I have found the people at Sterigenics to be very forthcoming in my previous interactions with them. They are "singled" out here, only because they made the news for all the wrong reasons!

What happened: It appears that Sterigenics was putting out untenable amounts of EtO into the atmosphere surrounding its Willowbrook, IL facility, and after the breakdown of negotiations, the State EPA shut down the facility. Viant in Michigan took a more voluntarily approach once the state level environmental agency started eyeing them.

This has created a gaping hole for many medical device companies - something that could have been totally avoided. The FDA with its highly tenuous and underwhelming leadership, is restating clearly obvious solutions as some sort of a strategy: use other techniques or other facilities. Yes, you can say, "D'uh!".

Bad Precedents: 

1. False Expertise: Thinking all experience is equal, many companies hire the same "experts". This has led to what can be ironically described as "extreme pigeonholing". That is the notion that EtO is the most effective way, Sterigenics is the only vendor to go with, and stupidly enough (any expert who tries to convince you otherwise, is not one, by paradox), a very specific chamber, at a very specific location within that organization.

Of course, this has created all kinds of logistics gymnastics for medical device companies and quite the financial cash-cow for Sterigenics. Instead of basing project planning on device safety and effectiveness, many companies planned it on when they "could get in on the queue for the chamber"! And of course, to jump the queue, you had to pay a fee!

Some smart companies at least got more than one chamber validated for their sterilization needs, but that is where most of it ended!

I have seen contract manufacturers suggest this to start ups, and I saw them agree to this utter, inexcusable madness as SOP! This has been the norm for as long as I have worked in the industry, and I used to sit up and wonder when the chickens will come to roost...well!

2. "Single Source" usually means you have not tried hard enough: Among some insane arguments I have heard, a common one is, "the stuff we want is so complex, only this one shop wants to do it". Yes, that is true, but that just means you have not worked to reduce complexity! And guess what? Sterilizing product, while challenging for some extreme cases, is usually not so.

A lot of irresponsibility abounds in the medical device industry, where again, the same people are recycled across companies as experts, ignorance of the fundamental principles of Supply Chain Management is fairly common!

Single sourcing, the use of unnecessarily obscure materials and processes and the absence of long term risk-mitigation and elimination strategies is plainly flabbergasting!

Now granted, there are exceptions, but it cannot be the norm. Part of your ongoing efforts from the very start has to be the effort to multi-source everything. This will help you mitigate unnecessary risks for your patients, your investors and your organization.

Imagine, if you have a device that works, but you can't use it to treat a loved one, because you didn't do enough! 

What you can learn and do

1. No sterilization technique is perfect. As you can clearly see, neither is EtO. So, in sterilization, as with everything else, look for diversity of options - vendors, methods, all of it!

2. Treat single-sourcing as a critical business risk! Risk mitigation and/or elimination is important for critical business risks, and sterilization is no exception.

3. Rid yourself of false prophets. No, EtO is not the best. No, you don't HAVE to stick with one vendor, and one chamber. No one sane has to!

4. Talk to different vendors. Diversify!

5. If you are the vendor: Don't pollute and cause harm to humans and offer more options and sites to your customers. Yes, every chamber must be validated, but find scientific means to make this more generic. There will always be enough medical devices for you to make money off of sterilization.


1. Sterilizer Shutdown:

2. Image of basket filled with poultry eggs:

3. Image of blackboard:

4. Image of the number 1:

Monday, March 11, 2019

The problem with ambition in medicine - don't implement solutions till people are ready for them!

Disclaimer: I work in Surgical Robotics currently, and Kaiser Permanente, featured in the story below is my current insurance provider.

The Story: CNN just picked up a rather sad and disturbing story of a patient and at least one of his family members being given sad news, perceived to be delivered in an insensitive manner, through a telepresence robot.

I suspect the story will gather steam, and much alarm and machination will ensue about robotics, AI, the practice of medicine and so on. Well, the discussion is due, and as much as all of us wish more caution had been applied, the first of hopefully, a small number of such incidents has come to pass.

The link for the story itself is available below.

The Summary: After determining that a 78 year old patient with COPD had but days or hours to survive, the Doctor chose to make that alarming and pithy revelation to the patient's granddaughter, in his presence, remotely.

The patient did die the next day, and the family is rightfully quite unhappy. The hospital has apologized and attempted to mend the situation, but I am sure the issue is not over. Now that at least one news outlet has picked it up, as well as other possibilities that I am shy to speculate here, this issue will probably persist in the public eye, and will most likely lead to arguments that drag technology in medicine in several directions.

I wanted to present a few thoughts of my own.

Timing and Technology: To serve patients and their families better, to make medicine more effective
and cost efficient, technology is always being used to push boundaries. The latest agents of change include, but are not limited to robots in pharmacies, surgeries,  comfort (it has been proven time and again to work wonders with autistic people) and other areas.

There is already immense fear of AI and robotics "taking over". It doesn't help that seemingly intelligent people like Musk and Hawking have said some incredible things about Artificial General Intelligence and Artificial Super Intelligence, while we are at a minimum, decades away from achieving such feats.

That said, it is very important to pick and choose how new technologies are implemented. Clearly the Doctor and Hospital Staff lacked sensitivity in this issue. They might have chose expediency, but that is no excuse for what happened here. It would have been so much easier to ask another Doctor to go up and deliver the news in person. I really don't want to hear nonsense about patient privacy being used as an excuse here.

All Fear and Animosity is NOT Ludditism: The other day, I saw a video posted by the passenger of a car, showing their neighboring driver in a Tesla, in a state in between, quite distracted and fast asleep at about 75mph an hour!

The problem is that, "auto-pilot" and "self-driving cars" are far from reality. Tesla has marketed the false notion that their cars can do this well (they can only do this up to a very limited level, and driver attention is very much required).

This distracted driver, and some of the others who have actually succumbed in Teslas tend to anger, just not me, but several people. This is not Ludditism. This is just a criticism of the lack of responsibility with those who use this particular piece of technology.

The Path Forward: We should start with responsibility, in medicine, as much as everything else. Patients are not soldiers. Neither are their loved ones! You can't command them to adapt to technology. A patient and his or her relatives are already quite anxious, and you can't really expect them to adjust to your attempts at unthinking efficiency.

Responsible, gradual, measured introduction of technological solutions and improvements is essential. Yes, it is very difficult to to time things. But rushing in is not the answer.

As technology moves the needle, we expect AI, robotics, telepresence, AR, VR and paradigms we haven't even visualized yet, to become part of the medical toolkit. This behooves us to make sure that the human side is not lost. Solutions must be implemented with care, caution and compassion. In a heightened state of anxiety, most people will not respond to new, shocking delivery mechanisms thrown at them.

Being Uncaring and Careless have Consequences: When people perceive a technology or solution negatively, it can have serious consequences. Patients can revolt, and that cannot be a good thing.

Heard of bedside manners? Not all lessons are new. Doctors are supposed to have the training, no matter what they treat, how they treat it, and who they treat. This is something that medical schools and residency programs are supposed to cultivate. So clearly, some are not getting the basics right!

The problem is that when too much is being dumped on Doctors, Nurses and the Hospital Administrators as well as Healthcare Systems, things get muddled quite quickly. In fact, this is the kind of chaos by fragmented distraction that some politicians and charlatans are using quite effectively, even as we speak.

Every actor in the healthcare network, including patients and their loved ones, have a responsibility to make sure that there is an effective balance. To this extent, I applaud the family, despite their sorrow, in bringing this to the public eye, so that we get a chance to talk about it, think about it and learn from it. Onward we must march, but with care, caution and compassion. 

Subscribe and Support, Please! 

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


1. The CNN Article:

2. Image of Robot:

3. Image of Watch:

4. Image of Patient:

Thursday, February 21, 2019

Human Nature - the biggest and most untackled barrier for Medication Adherence

The other day, I wrote about my cholesterol issue and the research surrounding it. I got some interesting feedback, so I thought, I'd write another post along that vein based on a personal experience. It was, in fact, my Iliac Crest Replacement Surgery that led me to develop an interest in Healthcare later on! (A blog post for another day).


Recently, I developed a bacterial infection, and I was put on some strong antibiotics. It has been nearly two decades since I was on antibiotics, and yet, I vaguely remembered it playing havoc with my digestive system. And along came my new medication. In approximately 24 hours, after I started a two-week regimen (last time too, I was on a two-week regimen), my digestive system was shot in the middle of my President's Day Weekend Photography Shoot (I am a Nature Photographer, and I frequently travel to California Destinations). Incidentally, I had to refuse the one-shot Penicillin that was originally recommended, because again, I vaguely remember being "allergic" or something to Penicillin and being taken off the drug when I was a child. The Doctor didn't want to take a chance that I might have an issue with the drug, so here we are.

Reacting to the Side Effect

I was feeling quite a bit of discomfort after taking the medication. The first day of facing the side effects, I took it like a sport. By day two, it became quite annoying, then irritating and finally exasperating!

So, guess what I did?

I skipped my medication!

Here I am, highly literate, working in Healthcare, and the thing I did was skip my medication. I did not forget to take my medicine. I chose not to! There was no way the side effects would make me forget the medication. I just could not stand the damn thing.

I did get back on the bandwagon, but I still reserve the right to skip and go to the next dose. So, while I turn a 14 day regimen into a 28 day or longer regimen, let us look at the implications for a second.

The Implications

See, what many Medical Device folks and others, including yours truly, have been thinking, is that Medication Adherence is a logistics issue.

Logistics: I have suffered from migraines all my life. I self-medicate using OTC drugs. Given that full doses of the standard issue pain relievers consisting of 250mg Acetaminophen, 250mg Aspirin and 65mg Caffeine relieve my headaches, but sometimes upset my stomach, over the years, I developed little tricks:

1. I try to eat something before taking the pills

2. I mash the pills into smaller pieces and try to never eat more than a quarter at a time.

3. And sure, I try to make my headaches be as far and few in-between as possible.

Limits of Solutions to Logistics Issues: Everyone is tinkering with all manners of pill boxes. My medication adherence and behavior modification solutions. I now see some commercial solutions, that I consider likely predatory, that purport to pack and give you pills meant for consumption based on the day of the week.
brother Sai Yamanoor and I also developed some

Yes, there are viable solutions. However, they cannot do anything when the underlying behavioral issues don't get resolved.

Human Nature and Its Implications: The things that stopped me were the side effects. A number of people are stopped by this too. When the treatment makes other parts of your body suffer, you are not too happy about it. If you go on to develop a fear or aversion to the medication, getting back on track can be quite difficult.

The Nature of Cats? 

When it comes to studying behavior, cats are perhaps the best alternate to humans, in certain areas. As someone who has been around cats for nigh on a decade now, I have learned much. Early on, I made it a point to adopt senior cats, and with that came the somewhat frequent need to medicate them.

Cats, like dogs, have highly tuned perceptions, and they just hate pills! I now wonder if it is owing to the displeasure the side effects cause them. I had cats run away, hide, and one that quaintly ate the pill pocket around the pill without getting anywhere close to touching the pill! I suspect, cats are informing us of the problem with medication adherence, in their own way.

A Difficult Problem: Some day, we will have genetics help determine what medications work for us. Perhaps, with 3D Printing, measured release mechanisms and other tools, we can titrate dosage much
better, and thus mitigate side-effects. And on and on she goes.

Until then, a bunch of pill boxes with LEDs and cute kitten sounds is only going to get us so far.

Solutions: It appears to me, that getting to some of that 3D Printed drug solutions, bringing back that sense of "compounding" that was once the mainstay of pharma, looking at device/drug combos would all be good ways to go.

It would also behoove to get psychiatrists and psychologists involved, as well as measure patient responses to the side-effects and find ways to help them continue therapy. This is not that far fetched. This is done with pediatric patients, cancer patients and others to quite an extent already.

One thing is for certain. Until technology presents us with the ability to thread the needle, we need creative ways to accomplish medication adherence.

Subscribe and Support, Please! 

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

Image References:

1. Assortment of Pills:

2. Question Mark:

3. Gears:

4. Man and Cat:

5. Chess:

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.


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!

Subscribe and Support, Please!

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

Image, Courtesy, Pexels:

Wednesday, February 28, 2018

Another day, another medical device contract manufacturer acquisition...

Last July, I wrote a post about an interesting investment by 3i in Cirtec Medical (link below), that I predicted would shake up competition among medical device contract manufacturers. Of course, much of this type of activity happens behind the scenes, especially, since the focus of most investors and industry-watchers happens to be on medical device makers, especially the large ones. That said, since I started watching the industry in the early parts of this century, I have kept my ears open for intriguing details. Today's post comes by way of one of those seemingly obscure acquisitions, which I personally believe adds fodder to the intriguing changes happening among medical device contract manufacturers, pressured by various factors.

My paths crossed with some of the folks at Corpus Medical, a while ago when working on a project. Therefore, I kept tabs over the years and flipping through some recent archives, I learned that Confluent Medical Technologies,
a large contract manufacturer (billing itself as the largest, for specialized medical devices, whatever they are, apparently) has acquired Corpus Medical.

I find this very interesting. With the economy quite hot (and probably headed towards a crash at some point in the not so distant future), an administration that is business friendly (but still can't get the medical devices taxes permanently abolished, apparently) and a rather too friendly FDA, medical device organizations, especially those like contract manufacturers are well positioned to grow, through acquisitions (Corpus), or investments (Cirtec). The question of course is, is this significant, and if so, is it a good or a bad thing.

That is a difficult question to answer. There are a few things I consider, when attempting to answer this question (which should only muddle things further, I promise!):

1. Some see consolidation as limiting customer choices. And this, can be true when viewed through a certain lens. When you have the opportunity to work with fewer vendors, your choices, the ability to get competitive quotes etc. go down. This is definitely an issue.

2. Vertical Integration is a good thing for a customer. Vendor Management, especially at the Design and Manufacturing Scaling stages is ripe with room for disaster. Companies can be made or broken during these stages, and I have seen several fall. Some people like to say, "well, 9 of 10 start-ups fail". We all know, all 9 didn't have to fail, and I can tell you (in several agonizing, long posts to come in the future) that they all didn't have to fail, and that many failed because of mismanagement at various stages. Thus, if you are managing 5 different vendors, 2 for components, 2 for design and 1 for manufacturing, I can promise, you wont be getting much sleep. You could then flip my point and say, "well, what if I picked one really huge, but bad vendor?" See, how I said things will get muddled? All said, some companies go for vertical integration, because negotiations, costs, management efforts and integration all go really well, even in cases that are far from ideal.

3. Vendors for the semiconductor industry and the IT industry, among others can serve as precedents, where they grew really big over time, and also merged and acquired each other. At the end of the day, it allowed smaller players to gain in strength by defining niches and fight nimbly against the more mature, slower moving large players. I suspect this is one of the good things for the industry, especially the customers. For newer technologies or implementations, they can go to smaller organizations.

So, like I said before, the long term impact is a bit hard to assess. But, there is consolidation happening, and it will be interesting to see where this leads all of us.

Subscribe and Support, Please!

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


1. The release on the acquisition:

2. My previous post on Medical Device Contract Manufacturers:

3. Image, Courtesy, Pexels:

Tuesday, January 09, 2018

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

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

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

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

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


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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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


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


1. Image, Courtesy Pexels:

Subscribe and Support, Please!

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

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?).


1. On the funding (Fortune calls it a perverse Christmas Gift, in case you thought I was being harsh):

2. Image, Courtesy:

Subscribe and Support, Please!

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

Tuesday, December 19, 2017

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

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

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

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

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

The Key Issue

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

The FDA steps in

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

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

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

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

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


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


1. The FDA on regulating homeopathic medicine:

2. Image, Courtesy Pexels:

3. Contamination in Ayurvedic Medicine:

4. Concern for contaminants in Homeopathic Medicine:

Subscribe and Support, Please!

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

Friday, December 08, 2017

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

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

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

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

The link:

Subscribe and Support, Please!

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