NAMSA’s complimentary Start-Up Summit event provides a unique opportunity for early-stage medical device organizations to learn directly from NAMSA’s teams of medical device testing experts, including Brett Nagelreiter from Nagelreiter; a medical device development organization. This small, intimate gathering will offer attendees with limited medical device knowledge to draw upon NAMSA’s 50+ years’ experience with efficient, cost-effective product development. Presenters will draw upon real-world global development efforts to share recommendations, best practices and resources that are critical to successful market introduction and commercialization, including:

Highlighted during the event will be the following two presentations:

Product Development Process
Presented by Brett Nagelreiter, President, Nagelreiter

Times have changed for the medical device industry. Any new or innovative medical device concept now days is rarely enough to gain investor interest or commitment, even when supported with unique or novel IP. Development professionals within the field not only need to understand why this ‘truth’ has evolved so dramatically, but also how it will drive change for future development efforts. Only then will device organizations truly recognize how to operate effectively within the new paradigm to become, and remain, competitive.

This presentation will:

FDA Trends & Guidance for Industry

The old adage that “the only constant in life is change” directly applies to the medical device landscape, and even more so to the U.S. Food & Drug Administration (FDA).

With a new Medical Device User Fee Act in its fourth iteration, a series of changes from the FDA are expected over the next five years. Likely shifts include shorter approval decision times, more patient involvement, and increased utilization of real-world evidence. Broader trends in government, technology, and society will also directly drive new requirements within the medical device industry. Staying abreast of these trends, and understanding practical aspects of FDA roll-out, is key to accelerating development of innovative technologies and creating successful product introductions.

This presentation will:

Who Should Attend?

The recommended audience for NAMSA’s Start-Up Summit includes these individuals in early-stage product companies:

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