gBETA Medtech - Navigating Critical Pathways to Market for Medical Devices

Presenter - Chris Mullin, Director of Product Development Strategy @ NAMSA
www.namsa.com

Compared to others, medical device start-ups have extra challenges due to regulatory requirements. These requirements affect product design, scientific and clinical requirements, pricing/reimbursement, and marketing. In this session, we’ll cover a high-level overview of some of these challenges. We’ll then dive into some examples of past successes and failures to better understand the requirements and extract lessons for navigating the challenges.

About Chris: is currently the Director of Product Development Strategy at NAMSA where he oversees and manages client partnerships surrounding product development and market commercialization strategies. Chris began his career working on National Institute of Health (NIH)-funded clinical trials, and over the last ten years, he has consulted for medical device organizations throughout the U.S. Asia, and Europe on various clinical trial programs. A highly sought-after industry expert, Chris has helped hundreds of global manufacturers optimize study design and research, providing proven strategies to address regulatory requirements for market approval and introduction. Chris has worked with multiple innovative technologies across a wide array of therapeutic areas, which has allowed him to provide valuable perspectives to clients on scientific and regulatory challenges – and suggested strategies for success – that impact the advancement of novel medical technology. Chris has authored multiple peer-reviewed publications a book chapter on clinical study design for translational research and serves as a journal editor. Chris holds a Master’s Degrees in Biostatistics from the University of Minnesota. He earned his Bachelor’s Degree at the University of Wisconsin-Madison in Mathematics

About gBETA Medtech:

gBETA Medtech is a free, seven-week accelerator for early-stage companies. It is made possible by the generous sponsorship of Boston Scientific, with support from Mayo Clinic and the University of Minnesota.

www.gBETAMedtech.com
www.gBETAAccelerator.com
www.gener8tor.com