Date(s) - 10/03/2018
9:00 am - 12:00 pm Central Time
TMC Innovation Institute
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 Naglreiter from Naglreiter, 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:
- Design and development
- Medical device testing
- Clinical research
- Regulatory strategy
Sessions provided include:
I. Product Development Process
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 manufacturers truly recognize how to operate effectively within the new paradigm to become, and remain, competitive.
This presentation will:
- Explain how and why investment in novel medical device technology has quickly evolved
- Formulate expectations related to paradigm shifts and understand their impact to the New Product Development operating environment
- Identify necessary activities in order for start-ups to remain competitive in medical device innovation and development efforts
- Identify the various development options that exist and their key differences
- Understand the benefits of the Medical Research Organization (MRO®) development approach, a process that accelerates development, reduces costs, and drives value
II. 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:
- Provide an understanding of current FDA regulatory trends
- Allow an understanding of how to navigate the ever-evolving U.S. regulatory landscape
- Examine proven, time-tested strategies and frameworks that lead to accelerated regulatory approvals for any device type
Who Should Attend?
The recommended audience for NAMSA’s Start-Up Summit includes these individuals in early-stage product companies:
- Founders and CEOs
- Research & Development (R&D) Professionals
- Quality Assurance (QA) & Regulatory Professionals
- Marketing Professionals