Hardware Podcasts

Determining User Needs for Your Medical Device

Global Medical Device Podcast · 14 Jan 2023 · 42m · Episode 300

What this episode covers

Jesseca Lyons, a mechanical engineer and regulatory expert at Greenlight Guru, discusses the common pitfalls of defining user needs in medical device design controls. She explains how to distinguish true user problems from premature solutions using root cause analysis and emphasizes the importance of cross-functional input to identify who the actual users are. Lyons also clarifies the relationship between user needs and design inputs, noting that not every design input requires a corresponding user need and that design inputs should define performance requirements rather than specific solutions.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, ISO 13485, 510(k)

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