Last September, Tidepool — a diabetes data management platform — was among the nine companies chosen to participate in the FDA’s experimental pre-certification program pilot. Along with Apple, Samsung, Verily, Johnson & Johnson, and others, Tidepool would work with the agency to prove its overall development processes are responsible and safe, negating the need for product-by-product regulation.
In , Tidepool President, CEO, and founder Howard Look detailed some of the conversations his company has had with the FDA throughout the pre-certification process, as well as some of the insights and advice he’s gleaned from the experience.
“The FDA is now pulling industry to go faster, but industry has not yet responded,” he wrote in the post. “Many companies are still being guided by old-school regulatory groups that believe they need to comply with old-school regulatory guidance, much of which was invented before the Internet even existed. This overly conservative approach is causing digital health products to take way too long to get into the public’s hands, and this delay is a detriment to public health and corporate bottom line.”
Look noted that the standard regulatory process has led many digital health companies to avoid shipping products with medical uses, while potential investors in the space have stayed away due to fears of regulatory impediments. With the FDA now looking to pursue streamlined regulation, he urged companies that “historically have held their cards close to the vest with the FDA” to rethink their stance and engage the agency as frequently and openly as they can.
Tidepool, for its part, met with Bakul Patel, associate center director for digital health at the FDA, and his team over the course of two days in December to go over the company’s internal regulatory process. More specifically, they reviewed the company’s key performance indicator metrics and tools, which Look detailed as measuring the frequency and severity of issues related to patient safety, product quality, clinical responsibility, cybersecurity responsibility, and a proactive culture. They also discussed how the scale of the pre-certification program could be shaped to accommodate the full spectrum of digital health.
“One of my favorite parts of the conversation with the FDA was about do-it-yourself open source projects like Nightscout and OpenAPS,” Look wrote. “At our meeting with the FDA, we asserted that however the Pre-Cert program evolves, not only does it need to keep learning and iterating, it also needs to scale. Not only should it work for large, well-funded companies like Apple, Google, and Samsung, it also needs to accommodate projects like Nightscout, Loop, and OpenAPS.”
Discussions between Tidepool and the agency also covered importance of customer issue reports and the benefits of system transparency. Reflecting on these, Look wrote that health companies have a responsibility to consider all available feedback channels and integrate any issues or insights into their product; any companies doing otherwise “are abdicating their responsibility to public health,” he wrote. He argued that the new regulatory ecosystem, “totally open” to unique quality system approaches and faster approvals, leaves little reason for companies not to pursue higher class approvals or additional health functionalities if applicable, especially when considering the hugely beneficial impacts these products could have.
“If you left a decision support algorithm out of your product to keep it at Class 1 instead of Class 2, instead think ‘I’m not afraid of Class 2, and I can do more to benefit public health if I do it. I’ll engage with the FDA and figure out how to do it quickly, safely and effectively,’” he wrote.
Look encouraged any companies that did not apply for the pre-certification program’s pilot due to concern about the potential impact on their in-development products to attend an about the pre-certification program.
“Engage with the other Pre-Cert participants to help make sure we get this right together,” he wrote.
Last week, the FDA released its 2018 Strategic Policy Roadmap, which listed digital health technologies as one of the agency’s prime focuses for the new year. According to the document, the FDA will “adapt its traditional approaches to regulation to better fit the challenges presented by new areas of technology.” It listed the pre-certification program pilot as an example of future initiatives.