American Medical Device Summit 2016

October 5th & 6th, 2016
Starting at 7:30AM
Chicago, IL
The Westin Lombard Yorktown Center
View All

Key Speakers

Palani Palaniappan

EVP, Innovation and Development
Terumo BCT

James Donnelly

CSO / VP, Medical, Statistical & Scientific Affairs
Siemens Healthcare

Marjorie Shulman

Director, Premarket Notification [510(k)] Program

Dr. Marco Costa

VP & Chief Innovation Officer
University Hospitals

Emmanuel Nyakako

Corporate VP, Global Quality & Regulatory Affairs
Hologic, Inc.

Rick Naples

EVP and Chief Regulatory Officer
View All

Featured Attendees

Key Themes

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 2016 Generis American Medical Device Summit.

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

Industry Insights

Last September, senior executives in the medical device industry gathered in Chicago for the American Medical Device Summit 2015. Discussions centered on the newest developments in medical device technology, innovation, regulation, quality management and manufacturing. Medical Design Technology editorial director David Mantey sat down with some key speakers to discuss the science and business of medical device design, development and commercialization.

Laura Whitsitt
Laura Whitsitt explains the challenges the medical device industry faces as a result of rising costs and increased regulation. As the SVP of Research & Emerging Technologies at Smith & Nephew, Laura is well versed with emerging technologies and discusses the possibility of biologic medical procedures.
John Daley
John Daley, VP of Quality Assurance at Boston Scientific describes the global implications of increased regulation in the medical sector. John also remarks on the growing self-care revolution, driven by wearable medical devices such as pulse, glucose, blood and pressure readers.
Roger Bailey
Roger Bailey, Vice President of Business Development at Sanmina explains the growing popularity of medical manufacturing outsourcing. Addressing this growing trend, Roger offers advice to companies looking to outsource their medical manufacturing and discusses the burgeoning locations, growth trends and how to plan to outsource successfully.


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
Great event with valuable information.
Blake Johnson
Director of Operations, Inspire Medical Systems
Overall experience was interesting and informative.
Susan Degnan
VP, R&D, Siemens Healthcare Diagnostics
Very good, tracks were well thought out.
Ryan Bauer
Director, New Product Development, Medela


The Westin Lombard Yorktown Center
70 Yorktown Center, Lombard, IL, 60148
+1 (630) 719-8000

The Westin Lombard Yorktown Center Hotel, located in the heart of the Lombard/Oak Brook business and shopping corridor, blends downtown style and sophistication with the convenience of a full-service, green certified hotel. Plus you're just steps from Yorktown Center Shopping Mall featuring the very best selection of retail.

  • Westin Executive Club Lounge
  • 24-hour business center
  • Indoor lap pool, whirlpool, sun deck