Global Medical Device Podcast powered by Greenlight Guru

Determining User Needs for Your Medical Device

Jan 14, 2023

Jesseca Lyons, a Mechanical Engineer, discusses challenges in determining user needs for medical devices. She highlights using Root Cause Analysis, guiding customers through defining user needs, and the importance of understanding the problem before solving it. Lyons emphasizes the significance of identifying core user needs early in the design process to avoid pitfalls and ensure successful outcomes.

42:23

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Episode guests

Jesseca Lyons

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Episode notes

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Quick takeaways

User needs must be defined early in the development process to align with real user problems.

Balancing technical precision and user-friendly language is crucial in crafting user needs for medical devices.

Deep dives

Understanding User Needs and Design Controls

User needs are a critical aspect of developing medical devices, ensuring they meet the requirements of the end users. In a podcast episode featuring Jessica Lyons, a mechanical engineer with extensive experience in gathering and defining requirements for medical device development, user needs were highlighted as a fundamental aspect of the design process. Key points discussed include the importance of defining user needs early in the development process, common pitfalls in crafting user needs, such as being overly technical or not aligning them with the actual problems users face, and the necessity of involving cross-functional teams in identifying user needs to ensure a comprehensive understanding of user requirements and preferences.

Introduction

3min

Unveiling User Needs in Medical Device Design Controls

8min

Insights from Elementary School Kids: Designing User-Centric Experiences

2min

Identifying User Needs Through Recurring Themes

2min

Prioritizing User Needs for Effective Medical Device Design

6min

Consideration of Various Users in Medical Device Design

2min

Optimizing User Needs for Medical Device Design

18min

Enhancing User-Centered Design and Communication in Medical Device Development

2min

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.

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

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.”