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ESC Boston 2019 Schedule Viewer

 

Welcome to the Biomed Boston & ESC Boston 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.

How Employing Evolutionary Design Can Help Satisfy Requirements for a Regulatory-Compliant Process

Andrew DiMeo (Innovation & Design Coach, Trig)

Galen Robertson (Chief Operating Officer, 410 Medical)

Juan Luis Crespo-Mariño (Professor, Mechatronics Engineering Academic Area, Tecnologico de Costa Rica)

Danny Gelfman (Senior Principal Solutions Designer, Medtronic)

Location: 160A

Date: Wednesday, May 15

Time: 3:00pm - 4:00pm

Track: BIOMEDevice Boston, Track A: Product Development

Vault Recording: TBD

Evolutionary design is not an excuse to avoid processes or the burdens of regulation. It does, in fact, require more discipline to manage the ambiguity and relies on an unfailing trust in the process. To be successful leading an iterative design process, one must understand the intent of the regulations, a clear idea of how to satisfy the intent through an iterative process, and an ability to deal with uncertainty.

Topics covered include:

  • An overview of an evolutionary design process suitable for medical devices
  • Targeted discussions on human-centered design, software development, and hardware development
  • A focus on rapid prototyping, collaboration, iteration, and feedback



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