How biopharma and medical device companies can avoid digital health regulatory pitfalls
The coronavirus pandemic has spurred healthcare organizations to accelerate and scale up adoption of telehealth after years of gradual adoption. It’s also leading medical device and biopharma executives to re-evaluate digital health opportunities, and in many cases increasing the focus and investment in digital health.
“I think what the Covid-19 health crisis is doing is making it very real for folks. They are beginning to view digital not just as a nice to have in order to compete in the future but as a must have,” said Kal Patel, MD, the CEO and co-founder of BrightInsight. “That’s something that you weren’t really hearing three years ago. We’re at a massive shift in the healthcare industry.”
The healthcare industry has been on a journey for the past several years, moving from simple companion apps that add little to no value to more regulated solutions. We have gone from wellness apps and simple solutions that display data to regulated products such as drug dosing recommendations or algorithms with robust data analysis.
As biopharma and medtech digital health solutions have matured, regulatory authorities around the world are responding differently. In the U.S., for example, many were encouraged when the FDA began to embrace digital health with a series of reforms aimed at creating a regulatory pathway and building confidence in these tools. And yet as the years have passed, the regulatory landscape has become thornier, creating new, unanticipated challenges for biopharma and medical device companies seeking to add automated services and insights to provide more value to their products.
The FDA has made several announcements around digital health guidelines referenced in a BrightInsight blog post in January last year including:
- Issued a guidance document on how it approaches digital technologies used in clinical trials.
- Announced final guidelines in 2017 for how best to determine whether combination products should be classified as drugs, biologics, or medical devices.
- Issued a new clinical and patient decision support software draft guidance, which attempted to provide clarity regarding software used by both clinicians and patients.
Amidst that lack of clarity, Patel maintains that the only reasonable answer is to use a regulated infrastructure because it future-proofs businesses and protects your patients.
Patel highlighted the value of using a regulated Internet of Things (IoT) infrastructure to host and manage digital health products in an interview following the publication of a whitepaper that illustrates the challenges of the current regulatory landscape for companies developing software to support medication management, remote patient monitoring and more. The paper offers examples of how companies can use BrightInsight’s regulated platform to develop digital health solutions in a way that meets quality and regulatory requirements of the FDA, but also in other regions where laws vary.
One source of confusion the whitepaper seeks to clear up is that the need for a regulated platform should rely on the intended use of the data collected from apps and devices and where the data are processed or analyzed. It shouldn’t depend on whether companies use hosting data from a regulated Class II or III (FDA) or Class IIa, IIb or Class III (EU) device.
BrightInsight has a regulated IoT platform geared for biopharma and medical device companies to host and maintain their regulated drugs, devices and Software as a Medical Device solutions, and to analyze data to generate insights for the biopharma or medical device companies to optimize their therapies.
Some of BrightInsight’s customers are pharma companies, including Novo Nordisk, Roche, AstraZeneca and, most recently, CSL Behring. Asked what kinds of digital technologies he sees biopharma companies investing in, Patel said the technologies at the heart of these collaborations are nothing short of game changing.
“We’re working in diabetes, respiratory, oncology, ophthalmology, obesity, hematology, immunology, neurology and more. Within these therapeutic areas, we have folks that are building regulated apps, algorithms, connected combination products and digital therapeutics on our infrastructure with regulated intended uses. We’ve been really impressed with the advanced product functionalities our customers want to introduce and their visions for the future where digital technologies play a major role in optimizing their traditional drugs or devices.”
Patel noted that the decisions companies face on whether to choose an unregulated versus regulated infrastructure can mean the difference between going down a path that is regulated and de-risked, or one that is incredibly high risk, high cost, and time-consuming if they choose an unregulated infrastructure.
“Standing up an unregulated infrastructure can still be costly. But then add to that the time and cost of trying to reverse engineer your way back into using that infrastructure for a regulated intended use,” Patel said. “That’s years of remediation and documentation and many millions of dollars. It is much more strategic, much more effective on all fronts to use a regulated infrastructure.”
Patel highlighted three types of pitfalls where he commonly sees companies make mistakes.
1. Conducting an accurate self-assessment of whether or not you need a regulated infrastructure. Most companies get this part wrong. You need to look at your product today and the future evolution of that product and its features and functionalities. A company may not initially be convinced that an application needs to be regulated, but then they often go back and move into a regulated use case — that means they have to start over. So, the first self-assessment is critical to get right.
2. Another pitfall we see is companies start by picking what they regard as the easiest markets from a regulatory or a privacy perspective to launch their products in. The idea being that they’ll evolve to the more complicated markets down the road. But this is not the right way to think about it. If you’re making decisions that are not going to meet the requirements of the more stringent markets, you’re going to have to go back to try to remediate or rework your product because you didn’t solve for the highest bar. You have to start by solving for the highest bar, not the easier bar.
3. We’ve seen folks who think that they can develop and manage a homegrown platform themselves. No matter how big a biopharma or medical device company is today, or how talented an IT org they have, they just don’t have the scale to bend the learning curve for all the various things that are going to be required and capabilities that are going to be needed to support digital innovation across their whole company. And then, do that at a global level when you have these constantly evolving regulatory, security and privacy requirements.
A biopharma company would never take a shortcut with a drug or a device so why would they take one for a digital solution by using an unregulated platform?
Sizing up the response to the coronavirus pandemic, Patel is impressed with the number of companies that have stepped up, such as the automotive industry to make ventilators as well as pharma and medtech companies going after drugs, vaccines, diagnostic testing as well as the 70+ companies working on antibody testing. But he deplored the lack of a data infrastructure to unify their efforts.
“You’re going to have employees and citizens getting tested at drive-up clinics, at pharmacies, at their doctor’s offices, at hospitals, at home. And there’s going to be no common back-end to capture this data. So that’s going to leave us with a really suboptimal response in the short term, because we won’t have an ability to have a heat map of what’s happening where. What results are coming out where? It’s a real shortcoming when we think about getting back to work and instilling trust in consumers again.”
As companies develop more sophisticated, regulated tools such as artificial pancreas systems, connected drug delivery, devices, personalized drug dosing systems, and more, the use of a regulated IoT infrastructure can make a significant difference in providing a smoother path to market.
For more information, read BrightInsight’s whitepaper here.
Photo: metamorworks, Getty Images
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