The Role a Design Plan Plays in Technical Transfer

Thu. November 1| 2:30 PM - 4:00 PM | 211A

Conference: MD&M Minneapolis 2018

Track: MD&M Track A: R&D & Product Development

Format: 90-Minute

Pass Type: Conference Pass (Paid)

Every medical device begins as a solution to a patient's problem. Taking the idea from concept to delivered product requires rigorous planning. The first step is to define the user's needs; the second is to create the design plan. The design plan is the roadmap for medical device creation that defines what needs to be done, who will do it and when it needs to be done. Often design teams take wrong turns using this roadmap. There are many ways design plan creation can fail.

Topics covered include:
  • Roles and responsibilities of the drivers of the design plan and how they should interface for successful product delivery
  • The importance of defining risk in the design process and how crucial documentation is to the validation process
  • The process of closing out the DHF, RMF, final DMR and final protocol approval for process
  • Do's and don'ts garnered from years of experience guiding---and rescuing---medical device design teams who lose their way on the road to device creation

Speakers

Walt Murray

Walt Murray

Principal Consultant and Strategic Partner

MasterControl

Role: Speaker