Determining User Needs for Your Medical Device

January 13, 2023

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What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’ll hear about in today’s episode.

Jesseca Lyons joins the podcast today to share more information about user needs. Jesseca is a Mechanical Engineer who’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry.

During today’s conversation, you’ll learn more about how Jessica is thinking about challenges in getting to user needs, using Root Cause Analysis to get to true user needs, and determining who will be interacting with the medical device and which ones are users.

Listen now:

Like this episode? Subscribe today on iTunes or Spotify.

Some of the highlights of this episode include:

  • Themes that trip people up regarding user needs and how Jesseca helps them

  • Fears about problems during FDA inspections and 510k submissions

  • What Jesseca thinks of when she thinks of user needs

  • Guiding a customer through figuring out a user need

  • What makes it difficult to get to user needs

  • An example of a standalone design input

  • When to stop divergent thinking

  • More user needs pitfalls

  • Which people are users


Jesseca Lyons LinkedIn

Etienne Nichols LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Jesseca Lyons:

“Most of the time, our user needs aren’t really doing a good job of telling us what the user is actually looking for; what problem we’re trying to solve.”

“I always found it interesting that we were so willing to solve a problem before we really understood what the requirements were.”

“Anyone who comes in contact with your medical device could be a user.”

“Every fear is a legitimate fear.”

“Your design inputs shouldn’t be so restrictive that there’s only one right answer.”

About the Global Medical Device Podcast:


The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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