Healthcare, like other industries, is undergoing huge technological transformation. From the way drugs are designed and manufactured to the growing popularity of tele-health, every facet of patient care is going from analog to digital.
At this year’s J.P. Morgan Healthcare Conference, the largest healthcare investment symposium in the industry, top executives from the biopharmaceutical and technology sectors came together to discuss key drivers to further fuel innovation.
The Jan. 13 panel included Kal Patel, MD, CEO and Co-Founder of the company BrightInsight, which has built the leading regulated IoT platform for biopharma and med-tech. The audience also heard from Brent Saunders, President and CEO of Allergan; Tariq Shaukat, President of Industry Product and Solutions for Google Cloud; Sara Nayeem, MD, Partner at New Enterprise Associates; and Emmy-winning journalist Rebecca Jarvis of ABC News.
As Patel describes in his recent Forbes article, the panelists shared high-level strategies around fostering intellectual diversity on teams, ensuring data integration across clinical workflows, and leveraging all that data to ultimately improve patient outcomes. It was a very thought-provoking conversation.
Afterward, I spoke with Patel to help ground that important discussion with his personal thoughts on the changes he expects to see in patient care over the coming decade, how he interprets those changes as a medical doctor himself, and what role connected devices — and digitization in general — will play in all this.
1. How will connectivity change the face of medicine over the next 10 years?
Connectivity, and more broadly, digitization, will vastly transform the face of medicine. There are already over 400 million connected medical devices worldwide. The healthcare IoT and connected healthcare “things” are only the beginning. The data that you can capture from these devices are what will really make an impact. Imagine the advanced, regulated digital health use cases that this data can provide: real-time, insight-driven disease monitoring, personalized drug dosing algorithms and interventions, clinical decision support systems for providers. That’s where this is all heading.
For instance, Novo Nordisk, the global biopharma leader in diabetes, will capture data from its connected insulin pens, and is integrating that data with blood glucose data from leading blood glucose meter manufacturers, like Dexcom and Abbott. The ability to aggregate and contextualize data for people with diabetes provides them with a more holistic view of their diabetes and can help them better manage their disease.
2. Where are the biggest opportunities for pharma companies to utilize these new real-time connections with their patients? What are the biggest risks?
While the digital health opportunities for biopharma and med-tech companies are vast, some of the biggest ones we see are enhancing clinical trials and improving adherence.
Developing a new drug actually takes 10 to 15 years and costs around $2.6 billion. Given these long product development lifecycles, even slight improvements in accelerating clinical trials carry huge benefits. McKinsey estimates that big data can help generate $100 billion in value across the U.S. healthcare system just by accelerating clinical trials and optimizing R&D activities.
On the commercial side, there’s a big opportunity with improving adherence: 25 percent of people don’t fill their prescriptions, and half don’t take their drugs correctly. Improving adherence not only saves lives, it can be a revenue windfall for biopharma companies. Just a 10 percent adherence improvement would generate huge benefits in patient outcomes.
3. As a medical doctor, how do you see practices change as patients get connected and drugs go digital?
Two things that were very frustrating when I was in medical school, and have basically not changed, are 1) very limited and poor clinical data about how the patient was doing outside of the clinical environment, and 2) siloed information. These are two critical areas that I expect will change dramatically with the digitization of devices and therapies.
We are seeing a real explosion from not just startups but, more importantly, from the large incumbents to digitize and connect their next-generation and even existing drug and device portfolios. This will unlock a transformation in our understanding of what is going on between provider visits.
We are also seeing the developers of connected devices and drugs begin to realize that their products need to be part of an ecosystem and, hence, can’t have siloed data backends. Many leading companies have already shifted to platforms like BrightInsight, and we see that trend accelerating.
As devices become connected, data is liberated across health IT systems (which is not true today — most EHRs are siloed) and smart, regulated digital health solutions are developed, I believe patient care will improve dramatically. Many of the data siloes and inefficiencies will be eliminated, enabling care providers to spend more face-to-face time with patients, and these smart, data-driven solutions will make care more personalized and efficient for patients.
4. What are the biggest obstacles for a company in the medical IT space, and how are they different than in traditional IT?
The biggest obstacles for a medical company trying to develop digital health solutions are figuring out how to structure for success and the complex regulatory landscape.
In terms of structuring for success, we see the biggest challenge for our biopharma clients is figuring out what to buy versus what to build, and then how to execute on that strategy. We firmly believe, for instance, that it’s not strategic at all for a biopharma or med-tech company to try and build their own underlying regulated IoT infrastructure. There is far more value and competitive differentiation in developing advanced algorithms or digital wrappers around your therapies than building the regulated IT plumbing.
That being said, we see companies make the mistake of trying to build their own IoT platform, and after wasting years and tens of millions of dollars, realizing how challenging it is as a regulated healthcare company to recruit and retain software developers who understand how to develop solutions in an agile, yet compliant way. These are the questions we help our customers and potential customers sort out.
The other obstacle is the regulatory landscape. The one thing that is clear is that the regulatory requirements across countries and regions are varied, complex and fluid. Given the evolving and persistently complex regulatory environment biopharma companies face, their inertia around launching digital health solutions is understandable.
For instance, the requirements for the European Union’s Medical Device Regulations (EU MDR) will be enforced in May 2020. These new regulations are aimed at improving the traceability features and safety management of medical devices for sale within the EU. Most of our customers fundamentally do not understand how to interpret updates such as EU MDR when it comes to regulated digital health or medical device software.
Biopharma and med-tech companies need to contemplate their solution roadmap and what type of regulatory strategy they need to support their current and future regulated digital health products.