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Date/Time
Date(s) - 04/25/2018
12:30 pm - 5:30 pm EST

Location
Hilton Garden Inn Boston/Waltham

Categories

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 Peter Madras, MD, President, MDG Boston and 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:

  • Design and development
  • Medical device testing
  • Clinical research
  • Regulatory strategy
  • Manufacturing

Highlighted during the event will be the following three presentations:

Wrapping Your Arms Around Medical Device
Presented by Peter Madras, MD, President MDG Boston

As opposed to the pharmaceutical industry  with which everyone is familiar, the Medical Device Industry is large, confusing, and diverse with few apparent common features.  It requires scientists and engineers of many backgrounds to work together, as equal participants on a team with physicians and others, very differently from their counterparts in pharma in which the development team tends to consist of professionals with similar backgrounds under the direction of a distinct leader.  In this presentation, I will discuss common features affecting all device developers, proper team building for device development, and common pitfalls which may entrap both novices and experienced professionals.  Finally I will discuss how those transitioning into medical devices, as well as those just starting out in this industry as their first innovative adventure may accelerate their bearings while expanding their horizons under the medical technology umbrella.

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:

  • 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.

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&S) Professionals
  • Quality Assurance (Q&A) & Regulatory Professionals
  • Marketing Professionals