April 2013 Forum - Risk Management for Medical Devices: Addressing FDA concerns, Usability and IRBs

Presented By Medical Development Group


Emerging Enterprise Center at Foley Hoag

Bay Colony Corporate Center, North Entrance
1000 Winter Street - Suite 4000
Waltham, MA 02451

Directions »


April 3, 2013 5:30PM–9:00PM


Risk comes in different forms when designing and launching a new medical device technology. Beyond the financial risk that investors must consider when entertaining ideas of launching a potentially expensive new technology, there are the actual physical risks surrounding the operation and application of the device itself. The development team must consider the risks to the environment, to the operator of the device, as well as to that of the patient. Usability testing has become an effective tool of medical device developers in not only collecting design refinements but also in discovering potential risks involved with employing medical devices.

When an investigational medical device gets to the point of the clinical research trial, the FDA entrusts a good deal of responsibility in determining what the risk of an individual device in a study is with the Institutional Review Board (IRB). The IRB’s role in the protection of human research participants in clinical research boils down to weighing the benefit to society against the potential risks presented to the individual participants. Understanding, identifying and mitigating physical risk is an essential requirement of medical device developers.


  • John Cadigan, Independent Consultant, Former General Manager, Emergency Care Solutions, Philips Healthcare


  • David Vogel, Founder and President, Intertech Engineering Associates, Inc. 
  • Michael Wiklund, President, Wiklund Research & Design 
  • Rick Clunie, CEO, Asentral, Inc. Institutional Review Board

Benefits of Attending:

  • Learn the methodology of identifying, assessing, documenting, and mitigating potential risks of medical device.
  • Learn about usability testing and how such testing can expose potential risk that you might otherwise not have discovered.
  • Learn what the IRB is looking for in their review of the clinical research study involving your medical device. How the IRB weighs benefit vs. risk.

Registration Fee:

  • Members: $25 (Early), $30 (Week Prior), $35 (At the Door)
  • Non-Members: $35 (Early), $42 (Week Prior), $50 (At the Door)
  • Cutoff for preregistration is 6 p.m. April 1.