Medical Device Data and Evidence: An Integrated Approach

One of the most formidable challenges in bringing a medical device to market is generating clinical and commercial evidence for a diverse group of stakeholders, such as the FDA, insurance payers and healthcare providers. It’s a complicated process where any misstep can lead to costly delays and a loss of profits.

In this webinar with Orthogonal, distinguished MedTech leaders including MIP’s Kwame Ulmer share insights, case studies and best practices for developing effective evidence gathering strategies. These pioneers will speak to shifts in the regulatory and reimbursement landscape related to integrated data strategy, including Total Product Life Cycle (TPLC), Predetermined Change Protocol Plans (PCCP), CMS's TCET pathway and FDA/CMS Parallel Review. They also discuss a new industry collaborative from the Digital Medicine Society (DiME) working on an Integrated Evidence Plan for Digital Health Products. You’ll leave this webinar with actionable advice to achieve success in obtaining evidence needed to satisfy stakeholders and set you up to successfully bring a medical device to market.

If you’d like to learn more about strategies that will move innovative medical devices to market faster, visit our blog.