Common Pitfalls in Developing Combination Products and Medical Devices

09:45 - 10:20

  • Fundamental steps in development
  • How devices and combination products fail and steps to avoid failure
  • Project and people related issues

This presentation will go over the common sources of failure in delivery device and combination product development and how to systematically avoid them while optimizing the likelihood of a successful product approval and launch.  Emphasis is placed upon design integrity, simplicity and effectively meeting the needs of patients and healthcare professionals. The impact of parts count on reliability and the importance of good human factors engineering are also covered. A useful checklist is provided to provide guidance on what should be established before investing in capital equipment for manufacturing and assembly.

 

Scott Brown, Device Development Lead & Executive Director, Merck