Joe Sapiente describes the function of Medical Device Innovation Consortium (MDIC) and its mission to bring together diverse stakeholders so they can work through regulatory science, quality processes, and access to medical devices in order to improve outcomes. Creating a safe place to discuss the common challenges that are shared industry-wide and do so in a collaborative relationship with the FDA.
Bakul Patel, the Director of Digital Health Center of Excellence for the FDA, shares how his organization thinks about digital health as a way to empower the part of healthcare that will be digitized while continuing to provide assurance and efficacy with all medical devices.
Cassie Scherer, the Director of Digital Health Policy and Regulatory Strategy at Medtronic. The word “digital health” may not be best defined as a characteristic or focus of a specific technology or functionality. Cassie points out that there are a lot of common components in healthcare solutions that can be augmented with the use of “digital health” platforms.
Cassie and Bakul discuss how digital health will empower us to reach people that we have not been able to reach before. Digital health can also reach a person before they get labeled as a patient. The provision of information through data analytics, greater access to actionable information for patients as well as an opportunity to make healthcare more personalized for patients are changing the landscape.
Cassie provides some insight as to how a digital health product from Medtronic and the collaboration with MDIC was part of a cleared device.
Joe Sapiente shares his insights surrounding the impact the digital healthcare landscape will have for patients. Patient voices, patient advocacy groups, voice of the patients beyond the KOL. Early feasibility and concept phases.
Cassie discusses how digital healthcare will impact chronic care costs. Patients being able to have actionable, timely and meaningful information in order to manage their disease and not need to go to a doctor every time. Being able to monitor themselves. Empower and take an active part in the management of their disease without overwhelming them will be key.