Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based integration of medical devices, which promises to improve the delivery of healthcare, often at reduced costs. Telemedicine, wearable devices, artificial intelligence (AI), and remote diagnostic and monitoring systems are just some of the areas of development in which new products are being developed and commercialized, requiring medical regulatory submissions for FDA review.
As a leading medical regulatory consulting firm, we’re seeing a lot of activity from the FDA through its Digital Health Innovation Action Plan, which is working to redefine how digital health technologies are regulated. Part of the challenge facing medical device manufacturers will be to effectively partner with the FDA to manage submission data expectations.
A major concern for all parties involved will be how to view the fundamentally different product design development processes of traditional manufactured medical devices and heavily software-based digital technology, with its constant Agile iterations and updates. In an attempt to tackle that issue, the FDA recently unveiled version 1.0 of its new Pre-Cert program, designed to streamline the regulatory process for digital health companies with software-based tools. It relies on an initial judgement of the developers of the program through a so-called Excellence Appraisal which would put companies on a pathway to more personalized regulatory review and approval. In some ways, this is the opposite of how the FDA has traditionally worked. It is essentially admitting that it doesn’t have all of the answers and is turning to the medical device industry and medical device consulting firms to help them figure out what the new program should actually look like. The FDA appears to be willing to learn from the industry in this case; to develop policy with industries input.
Digital technology innovation requires an added level of engineering sophistication that hadn’t been needed previously in non-software-based products. This requires greater involvement by doctors and patients in the early design phases, something that software engineers may not be used to, resulting in apps that don’t necessarily do what they’re supposed to do. That makes it more difficult to get products validated technically, clinically, and commercially. Documentation and quality system development is required earlier in the design process to assure proper medical regulatory submissions. Again, something software engineers are not familiar with, but is essential for any successful medical regulatory submissions.
There is no question that digital health technology is the next generation of healthcare products. Still left to be determined, however, is how the government will respond to a rapidly-evolving industry and how manufacturers will efficiently and cost-effectively navigate regulatory compliance waters in the face of an also-evolving regulatory environment. Now, more than ever, it’s critical for medical device manufacturers to work with a medical regulatory consulting firm like MEDIcept to help ensure they avoid any compliance setbacks in the new world of digital healthcare.