The Medical Device Innovation Consortium (MDIC) announced today the launch of its Digital Health initiative. The scope of digital health-related efforts crosses over several existing programs at MDIC, including Data Science and Technology, Clinical Science, Health Economics and Patient Value, and NESTcc. This launch of the new Digital Health initiative recognizes the convergence of connectivity, information, and software of these active programs and provides an opportunity to focus additional efforts in Software as a Medical Device, Software in a Medical Device, Mobile Medical Application, Interoperability, Wireless Medical Devices, Patient-Generated Health Data, and In-silico validation/modeling.

“The launch of this new initiative reflects our commitment to adapting to the evolution of the medical device ecosystem. We are eager to work with our members and partners to advance innovation and integration of digital health technologies into healthcare decision-making,” said Pamela Goldberg, MDIC President and CEO.

Earlier this year, MDIC hosted a webinar with experts from FDA, a consumer electronics and fitness firm, a medical device manufacturer as well as patient advocates to discuss the existing regulatory framework for digital health, key considerations for patients and healthcare providers, and implications for the future of digital health innovation. The Digital Health working group has identified 5 initial workstreams to complement FDA’s efforts to develop an innovative regulatory pathway for software that is tailored to its unique and iterative nature, including leveraging the learnings from the FDA pre-cert pilot program.

"As digital health technologies are increasingly becoming an integral part of medical devices, I am excited to see that MDIC is launching this new initiative which is well poised and will drive synergy and advance this field,” said Bakul Patel, Director of FDA’s Digital Health Center of Excellence.

The initial workstreams are:

• Change Control
• Excellence Appraisal
• Review Determination
• Streamlined Premarket Review
• Evidence Generation, including Real-World Data (RWD) Collection and use of Real-World Evidence (RWE) such as Patient Generated Data and Computer Modeling & Simulation

Each of these workstreams comprises short- and long-term goals which are detailed further in the Digital Health webinar. Learn more about the initiative and how to get involved here.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) focuses on advancing medical device regulatory science throughout the total product lifecycle. MDIC’s mission is to leverage its unique position as the only public-private partnership of its kind to transform health care into human care. Collaborating with our partners to advance science, we enable medical technology to shape the world we want to live in and make that world possible by shortening the path from innovation to safety to access. For more information, visit http://www.mdic.org.

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