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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Elements of Safe Medical Device Design for Clinical Trials

Mark Wehde (Section Head, Division of Engineering, Mayo Clinic)

Location: 210B

Date: Wednesday, February 6

Time: 2:00pm - 3:00pm

Track: MD&M West: Product Development & User-Centered Design

Vault Recording: TBD

There inevitably comes a time when your medical device needs to be trialed on a human. Regardless of where the device was developed, there are similar requirements governing the development process, the safety risk management activities, and the verification and validation of a new medical device in preparation for a clinical trial. This session will provide a summary of the best practices for the development of new and innovative medical devices to ensure a smooth transition to human use.

Topics covered include:
  • What are the considerations for developing a device to be tested on humans?
  • Answers to questions around the use of investigational medical devices, the Investigational Device Exemption (IDE), and the Institutional Review Board (IRB)
  • How can the elements of safety risk be managed, including electromechanical, software, biocompatibility, reprocessing (sterilization), human factors, and cybersecurity?

Presentation File