The ability to collect and leverage data — whether be it from the patient or from provider — is transforming the medtech industry. Consider companies that once largely developed hardware-based products. Now they provide a more comprehensive view of how patients behave. All of this creates new compliance challenges. How should they address those? Medtech companies should have a team of FDA advisors at the ready to develop and implement pre- and post-market strategies, prevent and resolve pre- or post-market issues and guide lifecycle management, with a keen understanding of how FDA works and how to leverage regulatory mechanisms and pathways to achieve business objectives. Medtech partners Kristin Havranek, Martin Gomez, Matt Wetzel, Steven Tjoe and Stephanie Philbin identify key topics for medtech companies to consider in MedCity News.