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

Wed. May 15| 3:00 PM - 4:00 PM | 160A

Track: BIOMEDevice Boston, Track A: Product Development

Badge Type: Paid

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

Speakers

DiMeo, Andrew

DiMeo, Andrew

Innovation & Design Coach

Trig

Role: Speaker

Robertson, Galen

Robertson, Galen

Chief Operating Officer

410 Medical

Role: Speaker

Crespo-Mariño, Juan Luis

Crespo-Mariño, Juan Luis

Professor, Mechatronics Engineering Academic Area

Tecnologico de Costa Rica

Role: Speaker

Gelfman, Danny

Gelfman, Danny

Senior Principal Solutions Designer

Medtronic

Role: Speaker