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: https://linkedin.com/in/yamanoor/

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! 

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.

1. AIDS/HIV

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.

References:

1. Map of the World: https://www.pexels.com/photo/black-green-brown-continent-87652/

2. Blood Draw Image: https://unsplash.com/photos/Zp7ebyti3MU

3. Image of Breast Cancer Ribbon: https://www.pexels.com/photo/awareness-cancer-design-pink-579474/

4. Image of Blood Testing Equipment: https://www.pexels.com/photo/health-medical-medicine-diet-46173/

5. Image of Broken Glass: https://burst.shopify.com/photos/broken-shards-of-glass-hanging-in-a-boarded-up-window?q=looking+glass

6. Image of Syringe: https://isorepublic.com/photo/syringe-with-blood/

7. Image of Hammer: https://www.pexels.com/photo/close-up-court-courthouse-hammer-534204/

8. Image of Beautiful Old Lady: https://www.pexels.com/photo/grandmother-making-faces-34540/

9. Image of Cheerful Team: https://www.pexels.com/photo/group-of-people-raising-right-hand-1059120/

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.

References:

1.Star Tribune: http://www.startribune.com/fda-says-it-will-make-more-info-available-on-medical-device-problems/507788372/

2.The Kaiser Health News Report: https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

3. Image of Woman: https://www.pexels.com/photo/black-and-white-black-and-white-depressed-depression-568025/

4. Image of Right and Wrong: https://pixabay.com/photos/ethics-right-wrong-ethical-moral-2991600/

5. Image of Seated Person: https://stocksnap.io/photo/95TESM9499

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.

References:

1. Sterilizer Shutdown: https://www.mddionline.com/fda-scrambles-prevent-shortages-wake-sterilization-shutdowns?ADTRK=UBM&elq_mid=7944&elq_cid=74447

2. Image of basket filled with poultry eggs: https://www.pexels.com/photo/basket-filled-with-poultry-eggs-1625385/

3. Image of blackboard: https://www.pexels.com/photo/addition-black-and-white-black-and-white-chalk-374918/

4. Image of the number 1: https://www.pexels.com/photo/bike-chain-number-one-1061142/

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

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

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

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

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

THE ISSUE

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

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

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

THE PROBLEM

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

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

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

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

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

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

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

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

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

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

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

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

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

CONCLUSION

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

Reference:

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

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.

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

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

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

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

The link: http://medpund.it/index.php/2017/12/07/slides-how-artificial-intelligence-is-changing-medical-devices/

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.

Two summaries on my panel on cross-pollination of ideas into Medtech

As I was thinking of getting to summarize, what I thought were some of the cool things I myself learned while being a panelist at MD&M Minneapolis, Amanda Pedersen over at MD&DI wrote a very neat summary of the panel, and I know she did it meticulously because she got one of my quotes very accurately. And that makes things easy for me. I don't have to repeat some of the very excellent points Dale, Alex and Bonnie made. I am going to focus on some key things I learned besides what you will find in Amanda's write up (article link below).

The "looks-like/works-like" prototypes

Dale Larson reminded everyone of the need to bring prototypes to healthcare professionals. I liked the idea of a "looks like" prototype, which is not necessarily functional, and the "works like" prototype that works, but may not look like the anticipated final product. I think these are important considerations and Project Managers, R&D leaders and Engineers alike should consider practicing.

Killing Projects Without Fear

Dale's advice is definitely one of wisdom. He suggested that once it looks like a project has no viable path to commercial success, it ought to be killed. In keeping with my wry wit, I suggested, "you will never get an engineer to agree to that". He responded, taking my comment in stride that life is short, and reminded us we are all here for a limited time and that we should look at spending that time efficiently. I am paraphrasing here. I really liked that line of thinking, and of course, jokes aside, I know that killing unviable projects is important!

Groupthink in the Devices Industry

Again, paraphrasing, in the sense that I am using the word "groupthink", but Alex did point out that it is important to make sure that you are not only expecting people with medical device experience to be on your team. This is something I will be writing about in much detail later, but I tend to agree with Alex. In fact, on the panel, I followed him up by agreeing that this is a huge problem. If you fill your room with a bunch of people who have spent "n years doing balloons/catheters/other lather/rinse/repeat run of the mill nonsense" will NEVER get you to a single innovative solution.

Groupthink is like a disease, and until culture change happens at the organizational level to include diversity of backgrounds and ideas, you can forget being able to innovate or bring out the best from other industries. This is truly one of the gravest shortcomings of the medical device industry.

Technical/Manufacturing Readiness Levels

Bonnie, our moderator, made several key observations. One of them was that the medical devices industry doesn't have a common language that talks about the readiness of technology. She referred to terms used in defense, such as Technology Readiness Level and Manufacturing Readiness Level. These were eye openers for me. And I always find it interesting, how you could go years without knowing something and then you hear it all over the place. This past Friday, I was at a bootcamp for a Space related Business Plan Competition in Austin, TX and I heard a NASA scientist turned entrepreneur define the TRL of his company!

The Medical Devices Industry, only appears to standardize around what the FDA and EU want and from a business/strategy standpoint, appears to have large gaps in using terms that other industries use. This is clearly something that needs remedying!

So, these are some of the key concepts I learned from the panel in Minneapolis last week. I may remember a few other things, and if I do, I will definitely write about them. Until next time..

Subscribe and Support, Please!

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

References

1. Amanda Pederson's article: https://www.mddionline.com/how-identify-crossover-technologies-work-medtech?elq_mid=2025&elq_cid=74447&ADTRK=UBM&elqTrackId=70616da339d1400d8950d401f3f7a18a&elq=82a208b2fc0046ffbe34539622753c2d&elqaid=2025&elqat=1&elqCampaignId=838

2. Image, courtesy Pexels: https://www.pexels.com/photo/black-and-white-blood-pressure-kit-220723/

Musings on the future of the medical devices industry - start-ups, M&A, funding and so on..

This past Friday, I had dinner with my graduate school roommate. We'd met after nearly 11 years and still, we were able to pick up where we left off. While I have been in Engineering since, he moved on through Engineering in memory chips to M&A, an Executive MBA and is now doing Equity Research focused on the Semiconductor Industry. Therefore, our conversation drifted towards industry comparisons. He related how the semiconductor industry is more or less consolidated, and there is very little left by way of M&A left. Then, we both agreed that there are not going to be many, if any, "start ups" in the semiconductor industry. This is why he moved on to Equity Research. It all made sense.

Then, this weekend, I went away on one of my usual solitary camping trips to the Sequoia and Kings Canyon Parks, and I started thinking about the conversation and the industry and I have a few thoughts that I will share here. Of course, I could be wrong over the long run, but we'll wait and watch. These ideas or thoughts are not in chronological order, and I am not going to try too hard to pin down specific timelines, not the least because of how difficult that would be.

1. Consolidation - Mergers and Acquisitions

Consolidation is what killed off creativity and entrepreneurship largely, in the semiconductor industry. Sure, here and there something crops up, but the sense of revolution, that is missing. A cooling start up here or there doesn't get you much far. I am sure, upstarts will always shake up every industry, but successful industries need a healthy supply of start ups - the breakthroughs and the incremental innovations. You might say, well, anyone can start up, right, so why would consolidation matter?

Most, but not all start ups exit through acquisition, when successful, and also when at least moderately successful. To set this up, you need as many competing buyers as you can get. If you have one Medtronic-Covidien in the place of two, and one Abbott-St. Jude in the place of two, and eventually, as has been guessed, one Boston Scientific-J&J instead of two, you have start ups and their investors left with fewer options. Already, many investors balk at the regulatory environments the start-ups face, now they have to settle for smaller marginal returns and fewer buyers.

There really is no way around this. This happens in every industry. Pharma was already there a while ago, and medical devices will get there.

2. Start-Up Costs

One reason you wont see too many semiconductor start ups or pharma start ups popping up all over the place is that, you can't just make the next Gallium Arsenide replacement or the next CRISPR in your garage that easily anymore. Never say never, but this is an issue that is also unavoidable when industries reach a certain level of maturity.

Now, surely, you will note, medical devices don't have this problem. You CAN build a start up in a garage, and go a long way. In fact, my brother and I or an a mission to demonstrate this vividly, and publish some research work soon. However, there will come a point when even parts of the industry become so complex, that innovation and breakthroughs will, of necessity become harder and slower to get to.

I see that at least as far as this factor goes, we are about 10 years or so away, but the time factor is wrinkled by other causes as well, as we shall see.

3. Funding for Start-Ups

This happened to pharma. Despite spending years in academy to identify molecules and then running up second mortgages, company founders were having a hard time staying put past a point. Because of the 4-phase process and the high risks of failures all along the way, many times companies would be really close to success and then fail.

To apparently avoid this, and in the name of innovation, Venture Capital Funds took to condensing the funding rounds, in many cases A through D, to provide anywhere from $50mn to $150mn or more in funding for an entity at the very start. Of course, they are very selective about who gets funded.

Then, there are the instances where, big pharma pre-selects start-ups for "collaboration" and does milestone based investments.

The underlying theme in all of this is control, and pseudo-random selection. None of which is good for the industry, the start-ups or anyone in general. Will the devices industry come to this? I think, for the large part, yes. But it will again, probably be a while before we get there. So, far I have seen examples where, unsure of the chances of success of a given device start-up, the buyers provided milestone based payments.

However, it is only after medical devices themselves become quite complex will we see the real need for such funding models to take over and become predominant. Although, devices that can no longer depend on the 510(k) model and require an IDE with an extensive clinical trial would be the first ones to fall victim to such models. This has already happened, though maybe not for the reason I have stated, as in the case of Ardian.

4. Standardization - Boon or Bane?

Standardization has always been a part of industries, be it semiconductor, pharmaceuticals or medical devices. In many ways, this factor itself leads to a lot of success. For example, if you are vending a catheter product, you'd have to tell your potential customers, the surgeons for instance, the French size of your catheter. In fact, you'd probably use it as a differentiating factor. This is great. Also, standardization means, getting cheaper components, easier training and so many other benefits. These are the boons.

However, consider this. Standardization also means conforming to a specific size, or category and so on. This can also limit you. It already does. If you ever order anything non-standard, just by virtue of that, you pay more. And not only that, by having to standardize your products, you lose out on innovation and freedom to operate. This is a double-edged sword. For right now, besides the IEC Standards and certain other aspects, this has only helped and certainly has not taken over the industry. However, a time will come when this wont remain as it is.

5. Will the Medical Device Industry fall in with High Technology (and the hype)?

So, the Technology industry is riding its next hype cycle - AI. Even though IBM's Watson and Google's DeepMind maybe the closest we have come to AI, most companies are using mere Machine Learning, most of it in its misshapen infantile stage as a substitute for AI. This has slowly started creeping into medical devices as well. However, the industry is still behind on the IoT wave itself, and therefore, it seems like a good and a bad thing that the devices industry is not in lock-step with high technology.

Because, the bad thing about hype cycles is that most of the craze doesn't amount to any success, and much by way of investment is lost in an effort to create success at any cost. Then, the technology industry crashes and burns gloriously, further scorching the Earth for otherwise promising start ups with incremental or even disruptive potential. This is not to say that the medical devices industry does not have its own hype cycles and the concomitant problems, but I hope that the industry doesn't fall in lock-step with the other, for the benefit of everyone.

6. Conclusion

This post is a collection of a few thoughts that came to my mind, comparing the medical devices industry, a maturing one, to two mature ones, semiconductors and pharmaceuticals. As I mentioned before, I don't expect all of my predictions to pan out, or pan out the way I think they would, nor would the timelines probably get to fruition as proposed. However, the medical devices industry appears to be inescapably sailing along to maturity much like others have, and some of the stops are going to be the same.

For innovation, funding and success, the lessons others learned along the way could prove to be very insightful, and that, is something, all of us, entrepreneurs, managers, engineers and others alike should focus on.

7. 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.

Reference:

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

Interesting investment might cause upheaval among medical device contract manufacturers

Previously, I have received feedback with suggestions to write more about investments in the medical device field. I didn't want to mirror the usual press releases that suggest X invested Y in Z. I was on the look out for something really interesting and noteworthy that can be reviewed, and today landed on one such exact item! 3i, an investment company is investing $136mn in Cirtec Medical, already a leader among medical device contract manufacturers.

Contract Manufacturing in Medical Devices is highly competitive, with many small and large firms competing for customers ranging from the ideation stage to really large device manufacturers such as Johnson and Johnson, Medtronic and Boston Scientific. At the outset, it might appear that there is plenty of room for everyone, and while this is somewhat true, there are several issues that confront contract manufacturers and their customers. I'll lay out a few here:

1. This is a regulated industry. Which means, any old shop cannot start manufacturing medical devices. They'll need a Quality System, regulatory compliance, GMP and other Good Practice adherence, etc.

2. Capabilities can be limited for many organizations. Some may excel at capital equipment, some on disposables, and so on, making their specialties hard to choose from, and many times a product will have to be manufactured with two or three different entities, and the customer has to audit, select and manage them, as long as their products stay on the market.

3. Margins can be really low, even when the potential rewards could be high. This can cause contract manufacturers to be forced to select projects, which is not something they'd prefer.

4. The Medical Devices Industry is fraught with high failure rates, especially among start ups. Contract Manufacturers will have to put up with losses from such failures, including loss of scaled efforts, investments and so other financial pains.

5. Aware of all this, investment banks may not be ready to extend or increase lines of credit, which can sometimes become a positive feedback issue.

Of course, customers, especially large ones work with their contract manufacturers to help scale and succeed. However, as I laid out above, competition, margins and other issues make this a tough subsection of the medical devices industry.

As I mentioned before, Cirtec is already fairly large and successful, with three locations, a full range of services and the ability to design and manufacture a device from start to finish. This is why I believe the investment is a nifty shot in the arm for the organization. With such a large cash infusion, they can examine their capabilities end-to-end and fill gaps. While they expand and grow, they can also compete against others in the field from many different angles, including costs and capabilities.

And now, if you are a competitor, you have to go find your own investor, or another alternate technique to fend off Cirtec. This is where I think things can get really interesting. Another investor or two, that props up one or two competitors, say, for instance Creganna, which already saw an investment years ago, deep in the recession.

Another possibility would be the merger/acquisition among a few competitors. These are just some of the possibilities.

A Caveat

When one or more organizations in a field get disproportionately big, it does reduce competitiveness, limiting choices to customers. The chances that this might come to pass are low in the medical devices industry, but not negligible.

With the emergence of newer high technology such as Bluetooth, SDN, etc., on one end and constant innovations in 3D Printing, and in the future, 4D Printing, as well as in materials and manufacturing methods, newer, more nimble organizations can carve out sections of the market to themselves.

In addition, when organizations get to a certain size, they can't always stay as nimble as they once did. Larger organizations will also seize or seek customers of a certain size. So, smaller organizations can exploit such gaps and succeed.

All in all, with an investment like this, 3i is now going to induce all alert contract manufacturers to come up with competitive strategies. Competition for cost, quality and timely deliveries, should in the meanwhile, make for some happy customers. This is the kind of breakthrough that can actually help the medical devices industry go through innovative growth.

References:

1. The investment announcement: https://www.pehub.com/2017/07/3i-to-invest-136-mln-to-cirtec/

2. Image, Courtesy Pexels: https://www.pexels.com/photo/black-calculator-near-ballpoint-pen-on-white-printed-paper-53621/

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!

Subscribe and Support, Please!

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

References:

1. The 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/

On Wrong Site Surgeries...

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

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

Honesty through anonymity?

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

Don't consider the US alone

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

Taking Surgery OFF the Assembly Line

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

Surgeon Fatigue and other factors

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

Obviating Site of the Surgery

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

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

Would large monitors indicating the correct surgical site help?

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

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

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

How would an AI Surgical Robot be error proof?

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

Conclusion

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

A Note: If you liked my blog post, consider subscribing to my regular blog updates using one of the options on the right. Feedback is always welcome.

References:

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

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

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

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

No improvements in cyber-security for Pacemakers and Implantable Cardioverter Defibrillators (ICDs)

Cyber-security of medical devices is a critical issue, and surprisingly, one that still fails to gain appropriate attention, despite repeated publications and shocking revelations. The FDA has made some efforts, but as you will see from the report linked below, the efforts clearly fall short of what is actually needed. Through LinkedIn, I found an article and a report on ICD/Pacemaker security issues, that was revealing.

I will let you read the report, an easy read, and use this post to address some high level concerns based on what I learned. Here are a few concerns/thoughts:

1. It is clear that the FDA and other regulators don't fully understand cyber-security issues associated with medical devices. In fact, I would venture, most of us don't, at least not enough to pass robust regulations. Yes, it is a learning process and should happen in iterations, but the rate of progress and the quality of the outcomes are quite poor, when it comes to implementing cyber-security in devices. Even the basics appear to have fallen through the cracks - such as data encryption, hardware and code/firmware obfuscation, etc., which I had simply assumed were foregone conclusions, having seen a cyber-security upgrade to a product through to market that went well above the basics.

2. It is a bit surprising to learn that off-the-shelf hardware, and third party libraries are freely used. I thought, Class III devices would, by necessity see customization at every level. While this has been educational, it represents another layer of failure in security implementation. I have seen simple $20 - $30 prototype level sensors and such come with epoxy dipped circuits that were essentially impossible to reverse engineer. I can see how due to functionality concerns and medical device regulations, this is not the solution you'd see medical device manufacturers use, but clearly, some form of encryption and lock-out should be mandated.

3. Re-sale and re-use of devices is always an area of debate. Manufacturers would like to stop them altogether, first for financial reasons; reprocessors and resellers would love to be given unbridled access. Common ground is important, and it should be fundamentally unacceptable for un-encrypted (!), patient-data laden devices to show up online for sale (per the report, this has happened). Either data should be encrypted - how this is not mandated, still surprises me, or, at a minimum, anyone reselling any medical devices online should be required to "flash" devices/sub-systems that carry patient data.

4. From a business standpoint, having seen some companies, that were not necessarily visionary, but had learned through dealing with counterfeit capital goods and disposables, enforce encryption and obfuscation, I fail to see how all 4 manufacturers that make expensive and critical devices such as ICDs simply stand by and ignore fundamental security implementations. It further perplexes me that the FDA does not require stringent security features!

5. When it comes to physician programmers, I can see how, within the clinical setting, it would be dangerous to waste time entering user names and passwords when potentially dealing with critically ill patients, there should be a global lock on such devices the minute they are outside a clinical setting. The ability of random third parties (as the researchers at WhiteScope did, for example) to obtain these programmers and access the removable (!) hardware through unlocked (!) USB ports etc., is simply unacceptable. This shows that both the manufacturers and the regulatory agencies lack vision in implementing good, logical security systems. This is a very dangerous notion and immediate correction is essential. But, like the mice at the meeting, one has to sit and wonder, who will bell the cat?!

6. This is a bit of a repetition, but I see this as the core of the issue. Medical Device Manufacturers are not taking leadership on product and patient security. The FDA, veritably, the world's leading medical device regulatory agency is not. Therefore, no one is! We don't need obscure, soporific "guidance documents". I am sure the FDA has published a handful of these and will probably put out a handful more. What appears to be missing is a clear, forward looking visionary form of leadership, that doesn't just get bogged down on encrypting software code and locking down hard drives, but plans ahead to evolving paradigms and problems in cyber-security, such as the spread of ransomware for example. Given that off-the-shelf components, common architecture, readable code and data are used, as well as the fact that all components in the system/network can be purchased easily, all it will take is for an unscrupulous group of individuals to buy these devices, decode the overtly simple security features and then sell the mechanisms to nefarious groups, or decide to hold groups of patients, individuals or entire hospital systems hostage.

Conclusion

The problem of lax/absent cyber-security in medical devices of all kinds, is present and continues to evolve alongside the emergence of digital health and digitization in general. I can sit here and spin doom and gloom all day and all night, but what I am left to wonder about, instead is, given all we know, when and from where will we see this vision and leadership emerge from. Right now, I can only ask the question and have no answers to offer. If you can think of any, do let me know.

References:

1. The Healthcare IT News Article: http://www.healthcareitnews.com/news/pacemaker-device-security-audit-finds-8600-flaws-some-potentially-deadly

2. The WhiteScope Report: https://drive.google.com/file/d/0B_GspGER4QQTYkJfaVlBeGVCSW8/view

3. Image, Courtesy Pexels: https://www.pexels.com/photo/blur-bright-business-codes-207580/

Cross Posting "Endologix Study on AAA treatment for women shows promise"

As I mentioned here a few weeks ago, I write a blog exclusively on Women's Health issues. This morning, I posted about an Endologix Device and Trial on AAA repair that looked at both men and women, and showed that more women could be treated with the Ovation Graft for AAA.

Read here, and subscribe fore more udates:

http://gyn.io/index.php/2017/06/03/endologix-study-on-aaa-treatment-for-women-shows-promise/

Now, Nepal challenges India on Medical Tourism - what protectionism brings!

A few days ago, I wrote about India's Medical Device Market: http://chaaraka.blogspot.com/2017/04/indias-bizarre-medical-device-market.html

And then, today, I came across an article that makes things even more interesting. Turns out, Nepal is, as one should, taking advantage of the Indian Government's narrow minded attempts at making medical devices available to the market. While India's ominously named NPPA (National Pharmaceutical Pricing Authority - "Authority", puts a nice Democratic spin to things indeed) has decided to control stent prices (especially for drug eluting ones!) at ridiculous rates, at least two companies, Abbott and Medtronic proposed withdrawing from the market. And, it is possible, Boston Scientific wants/wanted to follow suit.

To further wrinkle matters, the NPPA apparently rejected requests by Abbott and Medtronic to pull out of the Indian market! Yes, and apparently so, because, there is no provision in the law to allow a company to withdraw its products from the Indian Market. Well, if companies did not hesitate about bringing their products to India, now they sure as hell will!

Getting back to Nepal, apparently, not only are Nepali Hospitals accommodating Indian patients, but also the Indian doctors that want to operate on them. In my last post, I had lamented about India losing out on medical tourism, and even I hadn't imagined the problem to be as deep as it is. Doctors from India already have lucrative opportunities to do small stints in the US and Europe, when local doctors, especially specialists, go away on vacation, or are unavailable otherwise. This, apparently extends to regions such as Dubai, Singapore, etc. and that is good for them. I am sure, exchanges happen the other way too, but when talent is displaced due to protectionism, it results in a loss of competitiveness. I assume Nepal is even cheaper than India. So, if you didn't have the price controls in place, even with the cost of the stents on market, and the travel expenses, Indian patients, and patients from around the world can only benefit from going to Nepal, not to say anything about the winning local economy.

Confounding Issues and the Ultimate Losers!

I know I keep saying bizarre, but what shocks me is, apparently the NPPA, egged on by a court decision, and at least one organization, All India Drug Action Network, believes that price control is the way to police, regulate and prevent abuse of stents by hospitals, in their search for profits. Before we jump into further arguments on this, it is puzzling enough that the NPPA also wants the Cardiological Society of India to regulate and police itself, to prevent over-use of stents.

So what does the NPPA believe then? Price control works, but is not enough? Or do they doubt that price control would work? The whole thing looks like a mess, and I can tell you one thing - the ultimate and severe losses appear to be that of India's patients.

We'll keep watching the Indian Government and the industry and see what shakes out. It looks like the road ahead is long and bumpy.

References:

1. The article (loading issues and spelling errors lie ahead): http://www.firstpost.com/india/nepal-cashes-on-as-indias-price-cap-send-stents-disappearing-from-country-3427822.html

2. Image, courtesy Pexels: https://www.pexels.com/photo/glacier-snow-mountains-sunny-199/

A Review of the 2nd Stanford Drug Discovery Conference, Part 1

I found about this exciting event on Friday, about to happen today, and the first thing I did was sign up, as it was free for the public. My alma mater always puts on the best shows (very objective I am), and the price was right (along with excellent Stanford Dining supplied lunch, coffee, dessert...). I did have some things to do this morning, so I arrived about two hours into the event, and still I ended up taking enough photos of slides and taking enough notes, I am going to split this into two posts.

The program details are linked below.

One of the first astounding things I heard this morning was that NO off-target effects have apparently been reported with CRISPR either in mouse or in human models! There appears to be some modicum of disagreement on this, but more later.

The Molecular Stethoscope

Another cool thing I learned of, is a company that proposes to use cell free RNA to monitor various health and disease conditions. They got a nice and well deserved plug. Link below.

CIRM

One more excellent presentation was that of Stephen Lin from CIRM, reminding us all of the wisdom of California voters in creating CIRM through Proposition 71 at a time when the Federal Government made several narrow-minded choices on restricting stem cell research. CIRM's creation has made power houses of Universities and Teaching Hospitals up and down the state, and CIRM is on a roll, with $700mn more to give away!

I had a standing lunch, off excellent Italian food, steamed potatoes and beans, chatting with a gentleman, when he pointed out this to me. If true, it saddens me, but kudos on some well timed marketing!

The plane was fast, and the phone didn't do a great job, but it says "Stanford unfair to disabled workers". I will try to find out more about this.

Industry Presentations

The Post-Lunch Industry Presentations were indeed quite exciting! The presentations were from Novartis, Amgen and Takeda, each offering a unique perspective, all praise to whoever picked the three choices. Here are some observations:

1. Novartis needs to be involved earlier rather than later in drug development.

2. Novartis – “We innovate in isolation, we prescribe in combination”. This was in reference to their attempt to prescribe a combination of therapies, and this appears to be a recurring theme, especially in oncology, something I have observed over the past decade.

3. "We need to innovate a new science of therapeutics”. The idea here is that there are many diseases to fight and more work needs to be done. The presenter also alluded to CRISPR's potential for helping create new therapies.

4. The presenter also left us with this really nice reminder that when companies and academy share capabilities through collaboration, success can be achieved.

5. The presenter from Amgen stressed how important it is to first identify the correct targets, and not simply try to fit modalities to targets, or pick the wrong targets and then ask biologists to come up with satisfactory animal models for test. With focus on modalities, you say, “I have a hammer and I am looking for nails”. I can definitely relate to this quite well. My first position, right off academia, was as a Front-End Research Scientist, and my manager wanted me to do both - identify diseases and try to extend our existing, patented technologies far and wide. This has always stood with me as great strategy and I don't see why it wont work well for drugs, as well as it does for devices.

6. "Be extremely disciplined in the scientific approach you take." He reiterated that even though this might sound cliched, that it is very important. Again, who can disagree?

7. Again, striving to remind us of the fundamentals, he said the following. You have to patent the interdiction that you inhibit/activate the target with to fight the disease. The interaction of the target with the disease is not patentable.

8. Perhaps the biggest takeaway of his presentation is of how nearly half of Iceland's population has had their genome sequenced! From this, various therapeutic and other knowledge can be gleaned.

9. From the Icelandic population, it was gleaned that people with very very low Cholesterol LDL levels had a PCSK9 protein mutation. Similarly, a French team found that a mutation caused others to have very very high LDL levels. More such discoveries are possible through genome sequencing.

10. The speaker from Takeda mentioned headwinds and tailwinds affecting the industry.

11. We are able to basically target any gene with small molecules. This can indeed lead to lot of therapies.

12. In today's world, the patient's voice is valuable. We will come back to this in the second part blog post.

13. "If you look at the top 10 pharmaceutical companies, there is not a single one saying, give me a “me-too” molecule and I can commercialize it." An interesting rebuttal follows in the next post.

14. An analysis of the top 15 R&D spends in the industry, showed Takeda is 15th at $3.2bn.

15. Intense focus on Japan for about 236 years in existence! In 236 years, there have been 9 CEOs. 7 had the same last name.

16. Culture is everything. The science is important, but culture is very important.

17. Takeda used to be a platform company – small molecule synthetics company.

18. Takeda has established a partnership with Nobel Laureate Yamanata to make “models for human disease” and then find therapies.

Enjoy the images and the notes. More exciting stuff to follow in Part 2!

References:

1. The Program:

http://med.stanford.edu/content/dam/sm/cvi/documents/pdf/drug-discovery-program-2017.pdf

2. The Molecular Stethoscope

http://molecularstethoscope.com/