A new effort aims to help digital health startups incorporate regulatory considerations into their business strategies early and avoid nasty surprises as they seek product approval.
By early 2023, the Digital Health Regulatory Path Project plans to launch a free, open-access resource that will guide startups along the right regulatory path. The Boston-based Association for Digital Medicine (DiMe) is sponsoring the project, which was announced this week.
Regulators have made progress, especially in the UStowards embracing a new generation of digital health tools.
But DiMe CEO Jennifer Goldsack said startups often make decisions based on limited knowledge of the regulatory process.The nonprofit’s partners include Abbott, GoogleThis Consumer Technology Association and U.S. Food and Drug Administration.
According to a recent DiMe survey, 25% of digital health developers don’t know if their digital health products should be regulated. Of those who knew regulation was needed, 75% said they didn’t know the best way.
“We don’t see this kind of strategic thinking emerging in the market,” Goldsack said in a phone interview. “And we feel very strongly that a really strong regulatory strategy … can and should be a differentiator.”
The right strategy can help startups unlock the full value of their products by ensuring they find a market and payers. It can also reassure investors at a time when funding is expected to tighten, Goldsack said.
Getting to grips with the regulatory pathway doesn’t just help startups determine which program might be a better fit. It helps them make decisions about product strategy, portfolio strategy and internal capabilities, Goldsack said. “It’s not a single decision point.”
For example, she cites clinical decision support tools that combine artificial intelligence and machine learning. These tools may simply provide consumers with data they can act upon, and they may help clinicians make diagnoses, or developers may want the tools to make their own diagnoses without clinical oversight or additional data.
“That’s where we think this tool is valuable to the field,” Goldsack said.
Companies that don’t choose the right path may have to back away from past decisions or lose access to their target markets, she added.
In addition to identifying the right path, the tool is expected to help startups answer questions about the pros and cons of pursuing a regulatory path, as well as the key milestones and evidence needed to succeed.
“We’re delighted that DiMe has brought this group together to develop and expand tools that can support the wider ecosystem so that we can all help accelerate the transition of new technologies from idea to everyday use,” said Linda Peters, VP of Quality, Regulatory/Security and Google health, said in a statement.
Other partners include love to move, AmgenThis Digital Healing Coalition, GenentechHarvard-MIT Center for Regulatory Science, Jensen, Otsuka Pharmaceutical, rock healthySidekick Health and Tide pools (puddles of water left on shore reefs after low tide).
