DTx East Panel Recap: Building Regulated Software as a Medical Device (SaMD)

Our team just returned from Boston where we attended DTx East, one of our first in-person events in almost two years! It was great to mingle with everyone and see our clients face to face. The DTx conference content was fantastic and the audience included representatives from across the digital health industry – from academia to digital therapeutics to biopharma to FDA.

Kudos to the team at GreyGreen media for executing an outstanding event that included representatives from across the digital health industry—from academia to digital therapeutics to biopharma to FDA.

On the first day, Karan Arora, Chief Commercial Digital Officer and Global Vice President, AstraZeneca and Dhairya Mehta, former Director, Device and Combination Products, Takeda, joined me on stage to discuss why and how to build regulated Software as a Medical Device (SaMD). They both provided important insights and real-world anecdotes from their experience successfully developing and launching regulated digital health solutions within leading biopharma companies.

Here’s a recap of our panel discussion.

Biopharma is in the early days of SaMD

Brightinsight recently surveyed top biopharma company executives and found that over 90% believe digital will be core to their business within the next 3-5 years. Not as an additional wrapper to a drug or device, or a simple Marketing companion app, but as a core regulated product.

Yet, given this conviction that digital will be core to their business, most biopharma companies have launched zero to one SaMD. Because SaMD is a nascent category, there are many questions about why and how to go digital. We dove into these during our panel discussion.

First off, why focus on SaMD?

So, why focus on building regulated SaMD vs. an unregulated marketing app? There are many compelling reasons and macro trends driving development:

  1. Pricing pressure on pharma with increased demand for real-world evidence, not just clinical trial data. Software can provide that needed data.
  2. Delivering personalized care: algorithms allow you to better identify patients, optimize dosing, drive adherence and manage disease.
  3. Validation: in contrast to an app, SaMD goes through regulatory approvals, so it’s validated, making it more likely for providers and patients to feel confident using it.
  4. Profits: While software will never generate revenues of the level of drugs, more accurate and efficient patient identification and improved medication adherence can increase market share.
  5. Providing value: Regulated SaMD unlike a marketing app, enables regulated intended use cases including patient identification and dosing. Patients are not just getting medication reminders or general disease information. Rather the personalized recommendations from these digital solutions can potentially improve outcomes and increase adherence. Dhairya noted, “If industry cracks the code on digital, it’s not only good for pharma, it’s good for patients.”

Now, how do you build SaMD?

If you’re now convinced of the why, the next step is how to build a SaMD. Part of that “how” is adopting new ways of doing things. While drug development can take years or decades, digital development is faster and requires a “fail fast and adjust” approach. Our panelists advise not making digital an afterthought and both recommend bringing digital in early in the process of drug development.

Karan advised the audience to “seek out your peers in industry to learn about best practices and ideas.” It’s more than a shift in mindset, it requires learning how to do agile software development in a highly regulated industry.

Our panelists shared additional insights into the how:

1. Build SaMD on scalable technology

One size does not fit all in healthcare—and that’s true of regulated digital health as well. It’s important for it to be scalable—across geographies as well as disease states. To accomplish that, build or purchase platforms built on microservices. At the outset, assess how much of your underlying platform is fixed and how much can be changed over time. Karan shared an analogy of Nike’s customizable sneakers, which was spot on—every color, size, style, etc. can be configured to each person’s specifications, but they’re all built using the same materials.

2. Engage clinicians so that your SaMD integrates into the workflow

Clinicians do not have the time to leave their Electronic Health Record (EHR) to log in to new systems or portals. They also don’t have the time – or the interest – in wading through loads of new patient data. Ensure your SaMD integrates into the clinician’s existing workflow and provides actionable insights that they can leverage at the point of care.

3. Identify the key pain points along the patient journey where digital can have the most impact.

From faster patient diagnosis, to personalized therapy matching, to more accurate dosing, to improved adherence and enhanced disease management – digital can play a huge role. It’s important to think through where the pain points are for your patients or clinicians in their specific disease state, and develop compelling SaMD to solve for that challenge.

For instance, Karan explained that when he was at Abbott, they learned from meeting with nurses that manually calculating doses on the Hospira infusion pumps for each patient was slowing down their processes. This pain point led to the idea of integrating a digital dosing calculator for the pumps, which ended up creating more stickiness with their product and increasing market share by 8%.

4. Know your strengths and weaknesses

As Dhairya noted, “Pharma is really good at making medicines.” What pharma may not be really good at is SaMD development, and building and maintaining a compliant QMS. And that’s why bringing in a partner with the expertise and experience building regulated digital health solutions is critical.

Digital can help with adherence, traction, utility and stickiness—and impact revenue as well as outcomes. It’s clear that in the next 5 years digital will be integrated into the full drug development lifecycle on a broader scale as more biopharma companies adopt SaMDs.

Thank you to Karan and Dhairya for sharing their insights and we look forward to seeing everyone in person again soon!

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