Diabetes data management company Tidepool is one of nine companies working with the FDA as part of the agency’s digital health pre-certification pilot program. In a blog post published yesterday, the company’s founder, president & CEO wrote that he hopes industry works to keep up with the evolving regulatory landscape and that the FDA should work to make its pre-certification process scalable to companies of all sizes.
The chief exec, Howard Look, specifically noted that he has urged the agency to ensure that any pre-certification process open to companies like Apple (NSDQ:AAPL) also be available to open-source diabetes projects.
“One of my favorite parts of the conversation with the FDA was about do-it-yourself open source projects like Nightscout, Loop and OpenAPS. I have been very vocal about about my love and support for these projects – I even had the honor of sharing the importance of projects like these with President Obama. There is simply no doubt in my mind that by being on OpenAPS and Loop, my daughter and hundreds if not thousands like her, have been getting safer, more effective therapy for, wait for it, THE LAST TWO YEARS. That’s two years sooner than she could have gotten with any commercially available system,” he wrote.
“Here’s how this could play out: First, imagine that an insulin pump company delivers an open protocol pump, perhaps catalyzed by JDRF’s Open-Protocol Automated Insulin Delivery System Initiative. Now imagine that a project like Loop or OpenAPS, or even a small company that bases their app on open source code, applies to the Pre-Cert program. Once that organization demonstrates its commitment to quality and organizational excellence, it can then deliver a pre-built app in the app stores. An app that you can easily download and use, that’s supported by great processes. An app that can improve and be updated in months, not years, with an expedited review process.”
Look argued that the FDA is jumping ahead of the industry when it comes to digital health. In most cases, companies are taking the conservative path towards regulatory approval and following old-school regulatory guidance, potentially delaying a product’s availability to the public, he wrote.
Look encouraged companies within the diabetes industry to rethink the way that they interact with the FDA, adding that changes to digital health regulation will ultimately be of great benefit to the public.
“Companies that historically have held their cards close to the vest with the FDA should reconsider their approach,” he explained. “The FDA is a partner that wants to get better, safer, more effective digital health solutions to market as quickly as possible. Engage with them early, engage often, and be as open and transparent as you can.”