Medical Devices, where are we ?

Sreedhar Kumar
Sep 6, 2018 · 9 min read

Karen was a cheerful, energetic and positive individual excelling at work and having a wonderful and supportive family with two kids. A week after turning 31, she starting noticing that her typing errors at work were on the rise. She ascribed those to fatigue and went on with her life. The same week her husband Frank, pointed out that she had stopped swinging her arms while walking. Then a flurry of symptoms hit her. Smack!

She had difficulty washing her hair and started exhibiting tremors in her finger. For someone who was always cheerful, people starting pointing out that she had a depressed angry look. Then things started worsening and a battery of tests from the doctor finally confirmed the diagnosis — she had Parkinson’s. Now what ? Her condition was having a big effect on her family, and being the independent woman she was, she could not stand that she had to depend on others for even simple things.

Finding that drugs were not helping, she opted for deep brain stimulation (DBS). Electrodes were first placed in her brain via surgery and then connected to a neurostimulator that was embedded in her chest just under the skin below her collarbone. This provided a continuous stream of electric pulses to certain brain regions, a type of “pacemaker” for the brain, which she could control wirelessly via a remote.

Just like that a few milliamps of current made quite an impact, it seemed magical!

She felt like a switch had been thrown on her life. She was functional again and her symptoms reduced drastically. She was self reliant now, but had to continue taking medicines in conjunction with physical exercises, meant to help heal her functional brain networks. You could see the joy and relief on the faces of the family, Karen was functional and that meant a world to her more than anyone else. She was independent again! (Though there were some side effects, the quality of life improved drastically)

(Case in point this video below of Richardson )

As an innovator, scientist and engineer these are the moments that you work hard for. Seeing the impact that it has on the people, makes you extra responsible and work all the more to excel in what you do. It just amplifies your internal drive and passion for your craft.

The human body is an amazingly complex machine, one that has been perfected to function in an uncertain environment by millions of years of slow evolution.

One of the reasons I took up bioengineering has its roots in my thirst for understanding the human body and mind, “reverse engineering” it in the hope of answering a few philosophical, neuroscientific and existential questions, and helping people deal with debilitating diseases like Cancer, Epilepsy, Alzheimer’s and Parkinson’s etc. I have and am continuously exploring different domains, gaining a cross disciplinary understanding of underlying common patterns, and still have just an outline of how the body functions and a skillset that enables the creation of tools and devices to probe, study and treat human conditions.

But more importantly, working in the medical device and life sciences domain has engendered an empathy and a sense of compassion for the people we build for. You get to study and interact with very humane situations and end users. You would expect that this is sufficient to drive innovation vis-a-vis other domains. The need is big and the impact is obvious.

According to a 2016 report by the Information Technology and Innovation Foundation (ITIF), mental and neurological disorders and diseases cost the U.S. economy more than $1.5 trillion per year i.e 8.8 percent of the gross domestic product (GDP). Think of it, it is about 50% the GDP of Great Britain!

According to a 2017 report by the American Heart Association — “By 2035, cardiovascular disease (CVD), the most costly and prevalent killer, if left unchecked, will place an economic and health burden on the nation’s financial and health care systems. According to the study, in the next two decades, the number of Americans with CVD will rise to 131.2 million — 45 percent of the total U.S. population — with costs expected to reach $1.1 trillion.” That’s almost half the population of the U.S.

Then there are diseases like cancer that infiltrate every nook and cranny of your body if untreated, and whose mechanisms we have been trying to unravel since long. (More than 15.5 million Americans with a history of cancer were alive on January 1, 2016). And this is just the burden due to a small sample of lifestyle and genetic diseases, the overall impact could as well be ten times bigger.

To deal with such an imposing disease burden we have developed robust institutions of research, healthcare systems and technology innovation programs that enable an understanding of the mechanisms at multiple scales — systemic, molecular, organismic etc. On the one hand, the rapid progress brought about by scientists and physicians in characterizing and understanding them has enabled innovators to build devices and tools to deal with them, on the flip side, the more we know, the greater has been our realization of our own ignorance, and it has galvanized and motivated us to rethink and build new solutions and tools from ground up. (Case in point: Optogenetics)

From a scientific perspective a lot of pioneering programs have been launched, both in the U.S and outside, to this end. (The BRAIN Initiative, Genomics research programs, The Human Connectome Project etc.) The tools developed for research in the life sciences industry are thus a benchmark for innovation that need to be harnessed and emulated by the medical device industry.

But bringing a product from research to market has a lot of challenges and responsibilities specific to MedTech.

Releasing a product in the EU market is faster and easier as compared to the U.S, where innovations arrive, on an average, 3–5 years later. The U.S has a centralized regulatory system with the FDA as its head, while Europe has a decentralised but still rigorous system that has ensured that the nooses of funding and time do not strangle or delay access to innovations, even while ensuring the safety and quality of the device.

Having seen the European medical device market first hand, I was intrigued to see a decentralised approach to regulation. But then it struck me: decentralization doesn’t necessarily mean loss of standards and safety, it actually expedites the process by putting the patient on priority and the decision making in the hands of diverse bodies and informed physicians, and a strong emphasis on self-regulation on the part of the manufacturers. Paralysis by analysis and bureaucratic red tape are minimised to an extent, providing speedy access to life saving devices.

According to a report by Dr Ariel Stern of Harvard Business School titled “Innovation under Regulatory Uncertainty: Evidence from Medical Technology”, the path from prototype to market in the U.S is one strewn with a lot of delays and monetary pressures, and the companies have to make a tradeoff between patient needs and financial sustainability. One of the most eye-opening findings from the report has been that, on an average, pioneer entrants spend 34% (i.e 7.2 months) longer than follow on entrants in regulatory approval, negating the first mover advantage. The average price to bring a new high-risk medical device to the market is about 100 million dollars — this is one of the biggest putoffs for both big and small innovators. Infact just 7 percent of the new product launches are by small innovators and a delay of seven months translates to roughly 7% of the total cost.

The report surfaces the realities that innovations and innovators face while bringing products to patients, and emphasizes the need to streamline the regulatory process.

But the problems are not simple. There are many factors that contribute to innovation being held back in the medical domain

  1. The human body functions on a slower timescale than electronic devices. Hence clinical testing trials take up significant resources — time, people and money.
  2. The market size is small and this means the rewards might not be comparable to the investment made in commercializing those devices, resulting in a failure to attract investors to the medical domain. (As of today VC investments in the medical domain are miniscule compared to other domains)
  3. Regulation is a necessary evil. You need to have an oversight over devices whose failure could be catastrophic. Imagine someone dying or having a seizure every time an app crashed! This has rightly lead to a safety-first approach, but that has resulted in significant delays in getting the devices in time to the patients for whom early access might be a question of life and death.
  4. Diagnosis is software heavy and “Software is eating the world”, but for treatment and interventions hardware is of critical importance. The bottleneck is in the hardware, the lack of understanding and the partial knowledge of the diseases, human body and their interaction with novel materials.
  5. High cost of the devices and procedures. We would want life saving inventions both drugs and medical devices to be available at an affordable and subsidized cost. As of today, the insurance backed healthcare system in the U.S is so complex that a teacher with a salary of 54000$ has to foot a bill of 108000 $, inspite of having paid premiums for insurance. The high cost of insurance and deductibles, sometimes acts as a deterrent, causing patients to forego or postpone care, resulting in lower adoption rates for the device.

The solution to these problems are also not simple. If we need to have a healthcare system that puts people at its forefront, while ensuring financial feasibility, safety and early and equal access, then we need to facilitate innovations and innovators by creating a conducive ecosystem.

(Fact check: Recent announcements by the FDA and European Union with regard to policy changes in medical device regulation has reduced the differences between the two and gives hope for further alignment, discussion and standardization of policies across markets).

A few developments and measures that would help accelerate this process and provide partial solutions are

  1. Modeling and simulating the human system insilico: This can help reduce the timelines for clinical testing, but is still some time away from maturity. AI and machine learning have the potential to accelerate and automate this process and provide hope going into the future. In the meantime, virtual clinical trials are already reducing the cost by allowing remote participation of the patients. In addition, companies like Antidote are providing platforms that democratize clinical trials, bringing down the time and costs.
  2. Costs for manufacturers need to be reined in through innovative business models and operational practices that can create a win-win situation for all stakeholders.
  3. Regulation needs to be streamlined with premarket and post-market data being used to validate a product in a facilitative manner. In medicine and life sciences, time is the enemy of quality and cost savings, and hence regulation needs to be evolving towards a more facilitative role.
  4. Democratization of device design and manufacturing can be achieved with 3-D printing, enabling production in smaller batches with the ability to redesign while in production, resulting in lower costs. (Additive Manufacturing is the future!)
  5. Decentralization of healthcare can drastically bring down the costs to patients and that is where digital health initiatives and telemedicine provide promise. May be in future, all diagnosis can be performed by an AI, enabling lower costs and faster processing. (The impact of AI on various aspects of healthcare is going to be big and diagnosis is just one piece.)

In addition, the private sector is already doing its bit to provide affordable healthcare and early access to medical devices.

GSK, Medtronics, Philips, Siemens, GE and a host of other companies are already ensuring that innovations reach the market by partnering, co-creating and collaborating with smaller companies and innovators.

The entry of non-traditional players like Apple, Fitbit etc into the Health Technologies space has accelerated the push towards more streamlined regulations and provides for more financial muscle behind innovation in the field. Innovators like Devi Shetty have brought about affordable healthcare to the U.S masses, but have had to take strategic decisions to circumvent the roadblocks posed by bureaucracy. (Narayana Health City located at Cayman Islands has been able to provide procedures which are priced at 30–50% of the U.S costs, an excellent case study of frugal innovation and utilizing economies of scale. )

This push from the private sector needs to be augmented and supported by societal and federal policies, structures and incentives. We live in times of fast changing technology, changes that provide us hope that they would percolate down to other domains.

Technology and Business Models live for us and not the other way round.

We as a society have to prioritize life sciences, healthcare and medical innovation and the only way to do that is by creating the right evolutionary pressures for the industry by actively building an ecosystem that encourages risk taking and innovation. The solutions and problems are not simple. But with a focus on pushing innovations and keeping patient outcomes at the forefront we can recalibrate ourselves to create the ecosystem that will get us what we want.

Ultimately human life should not be determined by a price.

Next Post: Challenges in making Life Science and Medical Devices

P.S — All suggestions and comments are welcome. If you would like to discuss anything related to medical device development, life sciences and healthcare, please contact me at sreedhar.kumar.verified@gmail.com

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