October 4–5, 2017 | Chicago, IL

American Medical Device Summit 2017

Key Speakers

Featured Attendees

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The Generis American Medical Device Summit sets the standard on how the industry should connect and exchange ideas.

Join the discussion with over 175 of your industry peers as we explore the challenges and opportunities in product development, quality management, speed to commercialization, and regulatory harmonization. Hear first-hand case studies and walk away with strategic insights to streamline processes, reduce costs, and remain compliant in an ever evolving environment. This October we encourage you to join us for two days of thought provoking content and exceptional networking at the 2017 Generis American Medical Device Summit.



  • Senior Level Executives
  • 100+ Business Meetings On-Site
  • Thought Provoking Case Studies
  • Key Implementable Ideas

Well structured program — good balance of sessions and opportunities to network and meet with vendors. Speakers topics were useful and vendors were relevant!Neil Landry – Director, Quality Compliance, Edwards Lifescience

Key Themes

Recognize how public policy impacts the medical device industry in terms of leadership and competitiveness in the world
Identify the opportunities and challenges in various regulatory markets, alongside an analysis on potential modifications to 510k policy
Incorporate performance, safety, business economics, risk management, and regulatory requirements as a basis for device design
Understand the impact of the IMDRF and increased harmonization in the Medical Device Industry
Leverage digital manufacturing to accelerate time to market while reducing risk
Create a successful partnership with suppliers and contract manufacturers
Apply ‘Design Thinking’ as a driver for medical device development
Lower the cost of product R&D while improving speed to market
Utilize your post-market surveillance system to feed your risk management and product lifecycles
Reduce up-front investment and market risk through effective and frequent prototyping early in the development cycle
Ensure that the design of the medical device can be correctly translated into production specifications
Develop and sustain the gains of a quality culture and adopt proven change management techniques

Knowledge Center

The Generis American Medical Device Summit brings together innovative, exciting and timely content delivered by today’s top minds within the medical device industry. Visit our Knowledge Center to view the full presentation library.

Marjorie Shulman

Director, Premarket Notification Program

Developing a Strategic Medical Device Clearance & Approval Plan

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available:  Slides

John Daley

VP Quality Assurance and Regulatory Affairs
IBM Watson Health

Optimizing Medical Device Development with Quality in Mind

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available:  Slides |  Video

Laura Whitsitt

SVP, Research & Emerging Technologies
Smith & Newphew

Best Practices in Medical Device Portfolio Management: Strategies for Device Development Selection

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available:  Slides |  Video


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