Human-Centered Design in Medical Devices

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion on the essence of human-centered design in medical devices.

Delve into the importance of understanding user needs beyond surface-level assumptions and learn how Fearsome's approach to product development is setting new standards in MedTech.

From Glasgow's design desks to global market impacts, this episode is a deep dive into making MedTech better by truly connecting with the end-user experience.

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Some of the highlights of this episode include:

The Pitfalls of Premature Solutions: Morven emphasizes the need for extensive user understanding before jumping to design conclusions, challenging the common industry haste to offer solutions.
The Evolution of Fearsome: Morven shares the growth story of Fearsome from a broad design firm to a specialized MedTech developer, emphasizing the value of a diverse industry background.
The Nuances of Usability: The conversation reveals the stark differences between consumer product design and medical devices, particularly the rigorous safety and risk management requirements in MedTech.
Defining the User: A deep dive into identifying the 'user' in medical device design, considering all stakeholders, from clinicians to patients and even those involved in device maintenance.
Real-world Feedback and Its Impact: Morven recounts a powerful anecdote where candid feedback from clinicians significantly redirected a product's development path.
The Risk and Reward of Human Factors: An exploration of how human factors, beyond safety, can become a competitive edge and a catalyst for enjoyable product experiences.
Regulatory Hurdles and Human-Centered Design: A critical look at the intersection of regulatory standards and human-centered design, advocating for earlier and more integrated human factors consideration.

Memorable quote:

"Quality management is about quality, it's not just about proving that you can sell in the market because you've got a certain certification." - Morven Shearlaw

Transcript

Etienne Nichols: Hey everyone. Welcome back to the podcast. My name is Etienne Nichols. I'm the host of today's episode, and with me today is Morven Shearlaw. Super excited to have her with us. She's the co-founder of Fearsome.

Maybe I'll just hand the mic to you to see how you're doing, and you want to give a little bit of your origin story and maybe some of what you're doing over there at Fearsome.

Morven Shearlaw: Yeah, absolutely. So nice to meet you, SN, and thanks for having me on.

So, fearsome, we are a design and development agency specializing in medical devices. So, we help our customers bring their innovations to the market. So, we help them design, develop, build, test, and ultimately, hopefully launch into the marketplace. We're based in Glasgow, in Scotland.

And as you mentioned, I'm co-founder of the business. So, there's two of us started the business around about 20 years ago. We have a team of around about 20.

The last ten years we've started to focus towards medical devices and that's primarily what we do now.

Identifying Users

Etienne Nichols: Well, it's enough to make me curious about a few things. And I know we want to get to the topic of usability and focusing on a human centered medical device design.

So, I'll just go ahead and throw that out there, my preview to the overall topic.

Morven Shearlaw: Yes. So, a thing that we would always try and introduce as early into a project or product development is figuring out who the end users are but also making sure we're talking to as many stakeholders within that product ecosystem.

These could be the end user. So, it could be a clinician if it's a surgical device. But there's also people that are going to be cleaning that. The system of like how is this reused?

So, we would always do a kind of an exercise at the beginning. It just goes even before the product exists or the concept exists, say right here are all the people involved in it. We need to speak to as many of these people as possible just to understand what the issues are going to be, what the requirements are going to be.

Understanding the Problem

Etienne Nichols: If we zoom out and think of it from end to end, maybe if we could do a very skim flyover.

Morven Shearlaw: Well, I mean, they're broadly sort of two sides of the same coin. In that medical device development, you start with your user needs, which gives you your design inputs, which then gives you your design outputs, which is your design, which you then test against your user needs.

You need to make sure the intellectual property as well. That's a huge factor. Are there other things out there that are doing a similar thing?

Engaging with Users

Morven Shearlaw: It is a bit of a sticking plaster on design issues ultimately, but it’s really important to remember that actually human factors is a broader thing. It's about where people meet products, and things should be nice to use and enjoyable to use, and that's where human factors can help in that design process.

Etienne Nichols: I love that you brought that up because you basically hit the nail on the head as far as the mistake I would have come to you with.

Conclusion

Morven Shearlaw: Just go out and talk to people, go out and seek feedback because ultimately it makes better design happen, it makes better products happen.

Thank You

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