Bench to Community - Seminar 2: Medical Device Development Processes

Session 2 of the Bench to Community Series will provide an overview of engineering design and development for medical devices.


  • Composing a clearly defined need statement
  • Defining all stakeholders in chain-of-use
  • FDA Design Input Criteria: establishing metrics for Functions, Performance, Constraints
  • Ideation, concept development and evaluation
  • Prototyping - initial methods: “frankenstein” prototypes, “alpha” prototypes
  • Engineering Design Specification (EDS) 
  • FDA design verification; bench evaluation
  • Getting feedback from multiple users
  • Preparing for multiple “beta” prototypes for clinical evaluation
  • FDA Design Control documentation requirements

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