Chrysalis

Mark Gardner, MBA, Esq., is a seasoned entrepreneur and business strategist with over 25 years of experience in the healthcare industry, specializing in FDA regulatory affairs for medical devices. As Co-Founder and Managing Partner of Chrysalis Incubator, he guides physician inventors through the complexities of bringing their groundbreaking ideas to market, with a focus on navigating FDA and CMS requirements.

Mark also founded Gardner Law, an FDA law firm specializing in regulatory, compliance, privacy, and litigation matters. His deep understanding of these areas is further enriched by his roles as an adjunct professor at Mitchell Hamline School of Law, the Carlson School of Management, and the University of Minnesota Law School.

Throughout his career, Mark has held commercial roles at several successful medical device companies, contributing to the development and launch of impactful products like Medtronic’s TurboHawk, Alliqua BioMedical’s MIST Therapy System, and various Labcorp-MedTox diagnostic tests.

A recognized thought leader, Mark is a frequent speaker and author on topics such as AI in healthcare and medical device regulations.

With his proven track record and passion for innovation, Mark is the ideal partner for physician inventors seeking to navigate the regulatory path to commercialization.