From Concept to Commercialization: What Every Medical Device Startup Needs to Succeed

Bringing a medical device to market requires more than a great idea—it demands strategy, structure, and stamina. Join us for a practical discussion designed for early-stage medical device founders navigating the complex journey from prototype to patient. We’ll cover how to define a clear go-to-market path, build a strong FDA strategy, decide when to partner versus build in-house, and extend your financial runway for long-term success.

Presenter:

Tim Nieman is the Founder and CEO of ZIEN Medical Technologies, an ISO 13485-certified firm that supports startups and established companies in medical device development, manufacturing, and regulatory strategy. With over two decades of experience at organizations including Edwards Lifesciences and CR Bard, Tim brings deep expertise in product design, FDA and CE-Mark pathways, and commercialization. He is passionate about helping innovators navigate the complex journey from concept to market launch.