The Front End of Medical Device Innovation: From Idea to Market

September 22, 2025 ░░░░░░

#425 The Front End of Medical Device Innovation From Idea to Market B

This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, defining the front end as the crucial period between applied science and new product development, where teams identify unmet clinical needs and shape a product concept. This conversation offers a clear roadmap for balancing creativity with structure, using the Design Council's Double Diamond model and Stuart’s 10 key insights for observing user behavior.

Stuart Grant’s discussion on the front end of innovation highlights the importance of deeply understanding the user and the environment in which a device will be used. He introduces a number of tools and techniques, such as the Pugh Matrix and the NVivo software, to help teams transition from a broad exploration of ideas to a focused, viable product concept. Stuart explains that while the front end may seem "fuzzy," it can be a systematic process that uncovers the true clinical and market needs that will determine a product's success. He emphasizes that the most successful devices aren't just incrementally better, but are born from a deep understanding of customer insights.

This episode is an essential guide for anyone involved in MedTech innovation, from academic researchers to seasoned engineers. Stuart's insights challenge the conventional reliance on key opinion leaders and provide a framework for a more holistic, user-centric approach. He outlines how to identify and interpret subtle user behaviors, from workarounds and unconventional uses to unspoken frustrations, all of which are critical for developing a truly impactful and user-friendly medical device. Whether you're at the very beginning of a project or looking to improve your current innovation process, this episode provides actionable strategies to bridge the gap between a great idea and a marketable product.

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Key timestamps

(2:00) Defining the "Front End": Stuart explains what the front end of innovation is and why its name has evolved from the "fuzzy front end."
(8:00) The Double Diamond Model: An explanation of the UK Design Council's Double Diamond, illustrating the divergent and convergent phases of problem-solving.
(12:30) Common Pitfalls: Discussing the three critical questions to answer: Is there a market (viability)? Is the technology possible (feasibility)? Do users want it (desirability)?
(15:00) Balancing Creativity and Structure: The roles of different team members and how to manage the creative (divergent) and critical (convergent) phases of innovation.
(21:00) 10 Ways to Find User Insights: Stuart breaks down the specific techniques and red flags to look for when observing users, including workarounds, affordances, and areas of disjuncture.
(26:00) The Problem with KOLs: Why relying solely on key opinion leaders can be a mistake and the importance of observing a wider range of users.
(30:00) Triggers of Use: How unconventional uses of a device can reveal new product opportunities.

Top takeaways from this episode

Observation is Key: Go beyond interviews. The most valuable insights come from observing users in their natural environment, such as a surgeon in the operating room. Pay attention to "workarounds" or unconventional uses, as these often reveal critical unmet needs.
Balance Divergence and Convergence: Use a structured approach like the Design Council's Double Diamond to manage the innovation process. Start with a broad, creative phase to gather information and ideas (divergence), then narrow down and refine them into a concrete solution (convergence).
Assemble a Diverse Team: The best innovation teams include a mix of skill sets, from engineers and designers to marketers and clinical representatives. Each function plays a critical role in controlling the process and ensuring the product is viable from multiple perspectives.
Look for Disjuncture: Be on the lookout for inconsistencies between what a user says and what they actually do. This "disjuncture" can reveal hidden pain points and lead to profound insights that others might miss.
Don't Over-Rely on KOLs: While key opinion leaders offer valuable expertise, their extensive experience can cause them to overlook usability issues that affect the majority of users. Include a diverse range of users in your research to ensure your product is accessible and effective for the broader market.

References:

Design Council Double Diamond: A visual representation of the design process, emphasizing phases of divergent and convergent thinking.
Donald Norman, "The Design of Everyday Things": A foundational book on human-centered design, which discusses concepts like affordances.
Pugh Matrix: A tool used to compare and evaluate multiple design concepts against a set of criteria.
Etienne Nichols's LinkedIn Profile

MedTech 101: The Double Diamond

Imagine you have a new idea for a medical device. Where do you start? The Double Diamond model is a simple but powerful framework to guide you. Think of the first diamond as the "problem space." You start by diverging, or expanding your view, to explore every angle of a problem. This is like brainstorming—you collect a wide range of information about the user, the environment, and the clinical need without judgment. Then, you converge on a single, clear problem statement.

The second diamond is the "solution space." You diverge again, this time to come up with many different ideas and concepts to solve the problem you've defined. You're thinking creatively about all the possible solutions. Finally, you converge one last time to select and refine the best solution, turning it into a concrete product concept. This process ensures you're not just solving a surface-level issue but a real, well-defined problem with a well-considered solution.

Memorable quotes from this episode

"A craftsman will build you exactly what you ask for. An artist will build you what you didn't know you need." - Etienne Nichols

"You don't just do what the customer says because that could lead to a terrible product." - Stuart Grant

Feedback Call-to-Action:

What are your thoughts on the "front end" of innovation? Have you experienced any of the user insights Stuart discussed? We'd love to hear your stories and questions. Email us at podcast@greenlight.guru with your feedback or to suggest a topic for a future episode. We read every email and will respond to you personally.

Transcript

Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. Today we're diving into one of the most critical, yet often un misunderstood parts of medical device development, which is the front end of innovation.

Joining me to talk about the front end of innovation is Stuart Grant, who is the founder and principal consultant of Archetype MedTech. Stuart has over two decades of experience leading many MedTech product innovation, including senior leadership at Johnson and Johnson, where he steered teams through complex regulatory transformations like the EMDR.

And now at Archetype, he now helps companies around the world to navigate the toughest questions that determine whether a product's actually going to make it to market. So, in this conversation, we're going to unpack what the front end really means, where it sits in the product innovation process and how teams can balance creativity with structure.

What did I miss, though? I'm sure there's lots of different things that we could go with your background and your experience. How are you doing today, Stuart?

Stuart Grant: I'm good, Etienne. Thank you for having us on. Yeah. What did you miss?

Not much. That's pretty much my career in a nutshell. I've spent over 20 years working in MedTech in J and J, developing mostly orthopedic devices and some surgical. In that time, I've worked in the US and in China and here in the UK, doing, just talking to people, developing products.

And this is where what we're going to talk about today is the front-end innovation. Right. And it's about what I did my doctoral research on. So, when I came back to the UK eight years ago, I decided to start my PhD, do it part time and I was thinking about what I could, what subject in product development I was going to do and I was like, well, let's think about something that they call fuzzy front end and what this thing is and try to apply some of my experience over the years doing the front end and then started to understand the theory around it and what the actual academics are saying about front end.

So, I can share some of that with you today?

Etienne Nichols: Yeah, I'd love to talk about. I mean, I think we should start with some definitions. What is the front end? Can we define that?

Stuart Grant: Yeah, sure. So, if you think about the entire process of innovation, so you start with basic Science right at the beginning where the universities are researching something, then it moves into APPL science where they're actually putting that science into in our case, medical device products.

And that point usually companies start taking over from the applied science and start taking on those technologies, those patents.

And between that applied science and new product development, the part that we know that inputs, outputs, verification, validation, design transfer and commercialization, that new product development phase in between, there's is what we call the front end, and it's got a terrible name. The front end really doesn't mean much, but is what came about 20 years ago.

So, it's where the innovation teams start talking to customers, understanding the problem they're trying to solve, looking at the business case in the market and just trying to figure out where, what unmet clinical need and medical devices, our case, what we're trying to do. And it's really specifying that problem before it moves into the development phase.

So, to give you a little bit of history, back in the 90s it was called the fuzzy front end, which you might have heard of, which is just sort of came about. It sort of grew out of this bit between applied science and product development and that's why it's termed the fuzzy front end.

And as we move through in the last 30 years, researchers have gained more experience and said, well, it's not fuzzy anymore. We think we know a lot about what we're doing now. We don't want to keep calling it fuzzy, a bit insulting. So, they came up with cone, one of the major researchers came up with the front end of innovation to give it its proper title. We're still trying to get away from fuzzy.

Etienne Nichols: So, I have, I guess I've not utilized the term front end of innovation, but I've talked with lots of different people about, and maybe you can tell me where the differences are.

Maybe I'm talking about something slightly different, but I think about the gap between the academic research and actually having a product on the market. And that is a big leap.

And it's, it's, it's a, it's a, it's a big gap that a lot of technology doesn't make.

And, and I'm curious if that's kind of, I mean it sounds like we're, we're talking about somewhere in that area anyway.

Stuart Grant: So usually that gap is split into two areas is the front end and new product development now.

So, between getting into market and doing the research.

So, the product development is still the biggest activity. That's multiple years, usually depending on the Complexity of the medical device between two to five years, usually the front end usually takes less than a year to accomplish even a complex medical device.

Go and talk to your users and your customers, collect the market research data.

Understand the market in general takes six months to a year. So, it's quite a short period compared to product development or the basic science stuff or commercialization which never actually ends.

So, it's quite a short period, but it's quite contained and the activities we have to do are quite understood now.

But I'll get onto some of the problems with the front end and why it still needs to be researched and understood a little bit more. But yeah, yeah, we've been looking at this for 30 years, so.

Etienne Nichols: And how does one start with this? The reason I ask that is I'm trying to imagine, or I guess place myself in the, in the scenario. So, someone, is it an academic researcher who has a technology or is it a physician who has a problem they're facing and what is what goes through their mind and how they go through this process versus how it should.

Stuart Grant: A really good visual to get your head around is this problem is the design Council double diamond. And you can Google this called UK Design Council Double Diamond. And it's basically just two diamond shapes, rhombuses stuck together.

And what this represents is the front end, the two major activities within the front end of divergent and convergent thinking.

So, the first part of the front end, before you begin, to answer your question, before you begin, is a person has recognized an unmet clinical need.

Either a surgeon in a surgery, a salesperson or hospital staff have said that clinical need is not being met very well or not at all. And that's really the genesis of the front end.

And they might, depending on their background, might go backwards to find out some technologies, some new technologies or new science to help meet that new clinical unmet need. Or they might start advancing to start looking at technologies available.

So, the first part of the diamond, sort of the divergent part of the diamond, where you're going up is looking at all of the technologies available, understanding the problem, collecting all that data.

And then once you think you've got enough data, you start to converge, looking through the data, sorting out, affinitizing it, to use a fancy word, to get to a point of, okay, this is the problem we need to solve, and this is roughly how we're going to do it.

Then the second part of the diamond is more divergent thinking is where you're concepting, you're ideating to come up with lots of different solutions to meet that need.

And then you converge again, you start throwing out the solutions, converging some solutions into a single proof of concept. And that's the solution to the unmet need, is the end of the front end. And that's when it goes into the new product development process and is got the engineering requirements, the testing, the verification, manufacturing, all that part brings it to an actual physical, sellable medical device.

Etienne Nichols: Okay. And I've. I just pulled it up. I'm looking at it and that is really interesting. I love the converging, diverging imagery there. I, I was very into experimental fluid dynamics in college, and we talked a lot about converging, diverging nozzles.

It's just bringing back a lot of memories. But if I'm looking at, if I'm thinking about this front end of innovation and you mentioned a few of the different people who might start to go down that path, and they're on the very beginning, I suppose they're on the diverging part of that double diamond.

What are the things that they, you know, that consistent. I would imagine there's lots of different consistent pitfalls. That's usually. There's lots of different ways to do things wrong. Very few things to do things right.

Can you speak to that a little bit?

So, yeah, whichever way you want to start. Yeah.

Stuart Grant: Yeah. Okay. Obviously in the divergent part, you don't. There's nothing. You can't do anything wrong. You're finding information, right?

Etienne Nichols: Yeah.

Stuart Grant: The only thing you can do wrong is not stopping when you should think, probably stop and just keep going and collecting more and more information which could. Could be the problem.

But there's sort of areas that you need to look into. So firstly, as I said, there's the market.

Is there a market there?

How big is the market?

What's the price? You could probably sell this thing for.

Then what's the technology? Is the technology there?

And then it comes to the customer side. Is it actually what somebody wants, though? There's an unmet clinical need. It doesn't mean anybody really wants it. You know, we have lots of needs.

They were never, never satisfied, but were okay having that, not being satisfied.

So that's where one of the things on design thinking is viability, feasibility and desirability.

Feasibility is technology, viability, is there a business case for it?

And desirability is, does somebody want it? Is it desirable enough? And if you can answer those three questions through the front end, that's the most critical aspect. To boil it down with the sort of basics there.

Etienne Nichols: How are they able to. So, when I think about that, there's different minds usually that think about converging and diverging. At least that's in the past that I've thought about this constricting or expanding.

And my mind automatically goes to risk management when I think about those things. Because when it comes to risk management, you have to be pretty expansive in your thinking. Okay, is there anything else?

Is there anything else? Whereas engineers, they like to optimize and kind of neck down to a problem.

It seems like it's two different mindsets that would be good at one or the other. I don't know if that's something you've seen or found, but how do you. What's the.

What's the balance there with that creativity and the structure?

Stuart Grant: So, yeah, that's exactly what divergent and convergent thinking is.

So divergent thinking is the. What people think is creativity.

Right. Coming up with crazy ideas, solutions, problems, and not having a critical eye on any of it and just saying, okay, here's another idea, and just keep going and going.

Create lots and lots of different concepts that are sort of around that problem.

And the convergent thing is where you say, okay, you start ranking them and saying which meets those best and you set certain criteria.

One of the. A great tool to use for this is quite easy is the Pugh Matrix P U G H matrix, which helps you classify your concepts for different criteria.

And the P matrix is one aspect of the. What's it called?

The House of Quality?

DQE

You know, the.

Etienne Nichols: Yeah, yeah.

Stuart Grant: House of quality. I can't explain it. It's really the complicated thing in design excellence and Six Sigma that I don't think anybody really uses anymore.

So, Pew Matrix is really helpful for that convergence.

And as long as I think from a creative point of view, as long as people know that this is a divergent phase where we're coming up our ideas, but we need to get to a convergent phase within four weeks or six weeks.

We need to stop this and move on to the next one. And then we need to switch our brains to be critical and not creative.

Then you can get through the process a lot easier and involve all those different functions. We know, you know, engineers and marketers and designers are the.

Typically, the creative ones who come up with all these crazy ideas and quality and regulatory may be the convergent people.

That's an unfair generalization, right?

Etienne Nichols: Sure. Yeah. From an industry, I think it's fair, you know, just from the industry itself and what's required of but that's why.

Stuart Grant: You need all those different functions to help control the process. Yeah, to a certain. Keep that creativity but have a certain level of control as well.

Etienne Nichols: At that level or at that early stage. It's hard to imagine even having something of a team though. I mean, how does that work?

What's a realistic team look like at that level in that stage?

Stuart Grant: So in my, in the research I did so I interviewed nine teams doing all different medical devices and followed them through the front end for about nine months to 12 months through all their activities, interviewed them at certain stages to understand what they were doing, to understand from a medical device what the front end process was.

So that team can. Most of the teams consisted of an engineer, lead engineer, maybe another engineer, a designer using an industrial designer of some sort because they're physical products, a marketeer, so a commercial person from a commercial perspective and maybe a clinical representative, maybe a clinical engineer they're sometimes called or medical operations or scientific operations, medical affairs. Those types of people will bring in the clinical aspect view of it as well.

Quality and regulatory really weren't involved in that part of the front end. But some of them, sometimes they were not the people I interviewed, but sometimes you get other quality engineer or manufacturing engineer who has a lot of experience and different ideas and concepts that can really help the creative process.

Etienne Nichols: What. So, what were some of the patterns and some of the consistent things you saw across those teams? Because that had to be very interesting to interview those.

Stuart Grant: What they were doing or what they were.

Etienne Nichols: I'm. I guess I. So, when I think of like interviewing multiple people doing all the same but different things,

I would guess that they're all doing it differently or.

But at the same time, they're trying to accomplish a similar goal, trying to get a medical device to market. So, there are some themes and patterns I would expect to show up from.

From a best practice standpoint. And so, I'm curious what some of those might have been.

Stuart Grant: So, the best practice. So, in the front end, best practices in medical devices, particularly in surgical and orthopedics. Right.

Is going to watch the surgery and going to see it done multiple times, videoing it, going back and reviewing the videos on your own, maybe having multiple cameras set up in the. Or not just watching what the surgeon's doing, but watching what the operating nurses are doing, the circulating nurses, all the other people in the OR what they're doing and what all the other medical devices are doing.

ORs have got hundreds of medical devices all operating at the same time. If you're developing a shoulder or hip, that's just one medical device in that or but the staff are dealing with all of them.

So, you've got to think about the entire environment that your medical device works in. And that's all about understanding the user and usability.

That's probably the number one thing that's really important is what we call ethnography or consumer ethnography or observation and interviews, semi structured interviews afterwards because we can get onto this.

But there's things you can, techniques you can use to find the problems, the pain points.

That is not just reviewing the videos, looking at it with a critical eye of what the surgeon saying or the staff are saying and what you're actually seeing them doing.

Etienne Nichols: Well, let's talk about that because I think I would, I would imagine the engineers who are building a medical device, I mean maybe they've not been trained on how to watch somebody do something necessarily.

But I mean depending on if you're immersed in CAD or immersed in these different, different tools, what are some of the different tools that are available to find those and pull those things out.

Stuart Grant: So, from a, from a SaaS perspective, one of the best tools is called NVivo, N V I V O in life type of thing.

Etienne Nichols: SaaS being software as a service.

Stuart Grant: Yeah, exactly.

So that's where you can put all your videos and all your transcripts in and you can start coding those and finding the codes and the themes that start to emerge.

That's a really useful tool to capture all this data and you can put in your anything you find on patents because they're a useful source of information, surveys, et cetera, interview data, all into NVivo and it can start coding it and it's got an AI now.

Not sure. It's great, I wouldn't use it quite yet. Could miss a few key points. But when you're reviewing this data, when you're trying to find the nuggets of information, those golden points that make your product better than everybody else's, that's the important thing.

As an engineer and marketer, you can come up with a hundred customer needs, and you can produce an incremental product. Well done.

Please don't come again.

It's finding those two or three what we call customer insights. That's the ones that make it special and solve that problem, particularly for that customer.

So, in my research, looking not just what the teams are doing but what the research, the literature said, I found 10 points that probably the really critical things you need to look for and we can go for those if you like, on a taser.

Etienne Nichols: Yeah.

Well, I. I had one question because I. You talked a. I. I want to just revisit the double diamond just for just a moment, and then I want to get into those 10.

But the. The converging time. You said one of the problems is people don't stop early, or maybe they stop too early.

What's the. How do you know when you're done? And maybe these 10 will help us understand that. If you've gone through all these, I would assume, or just how do you define that?

As far as you know when you're.

Stuart Grant: Done, you sort of don't. So you never. You're never sort of done researching. That's why we have multiple generations of products.

Etienne Nichols: But that's true. Yeah.

Stuart Grant: Okay. But to.

What you do is you. I would say you go and depending on your product or researching is you go and do five to 10 visits to an hour, videos and interviews, start analyzing that, and go and do another five, start analyzing that, and you'll get to a point around about 30 that you get to what we call saturation point.

You're not getting anything new, any new information out.

So, it's sort of giving you an indicator that you're done.

But it comes to that 80, 20 rule, right? You'll get 80% of the information in your first 10, and the next 20, you'll get another 10%.

Next 30, you only get another 4 or 5% of the information.

So, you never get to 100%.

But you've got to make that determination.

And it's a bit like risk management. You know, how many risks do you write on your FMEA? When do you know you've got to stop and move on?

Etienne Nichols: It can be an art versus a science. But, yeah, okay, let's talk about the 10 things that you found, because this is really cool.

Stuart Grant: So, the first one is called a workaround.

And this, everybody's experienced this. This is when your product you're using doesn't quite work, right? And you just start using it slightly different to get, you know, you use your screwdriver as a hammer because you can't find your hammer. That's called a workaround.

And if you're watching surgeons, you can see lots of workarounds. And typically, the user doesn't know they're doing a workaround. And that's where the video helps. And you can watch a surgeon using the existing product go, why are they doing that?

That's not how it was designed. And then you figure out, actually, if I change this product to do this.

They can use it both ways and they may solve it.

Affordances.

A handle on a door affords you way to open the door.

A grip on a hammer. I use a hammer because everyone knows what a grip on a hammer is an affordance. It affords you the way to hold it. And knowing where, especially medical instruments you put the affordance or the grips is really critical to the usability.

So always look at whether the surgeon is holding that product or the user's holding that product.

It might not be where the designer originally intended them to use it or hold it.

Etienne Nichols: And.

Stuart Grant: Well, I think a lot of analogies on that one.

Etienne Nichols: Yeah, it makes me think of design and every day. What is that book? Design of Everyday things. Affordances and signifiers. Yeah, yeah, absolutely.

Stuart Grant: Donald Norman was the author of that one. Yeah.

So, the other one is when you're interviewing people. So, these are usability problems, the first two. The next one is overgeneralization.

So, when someone's talking, they'll use even absolute descriptive. I always do this; I always do that.

And when you look at the videos, you find out they never do that. So.

And you're like, okay, so they think one thing, but they're actually doing another.

Why. And this is where another quality thing comes is the five whys. Right.

Etienne Nichols: Why?

Stuart Grant: You ask it five ways, and you could probably get down to the right answer.

Next is metaphorical glosses.

So, they are.

When they go, they basically gloss over the problem. That's not a problem. Don't worry about it.

You know, and you're like, you might be thinking, okay, they didn't say it's a problem, so we'll ignore it. But they're just being nice sometimes to the designers sitting in front of them. And you've got to think, okay, what is the real problem here?

Is there a problem?

So, start to investigate that a little bit. When they gloss over issues, are there.

Etienne Nichols: Any specific examples for that one? Because I think I can think of a couple of specific examples for some of the others. That one, I'm.

I may just need to dig deep, I guess. So. Any thoughts?

Any specifics?

Stuart Grant: Yeah, I had one in my career where the hex screwdriver would never engage in the hex properly. But because we're using KOLs, key opinion leader surgeons who were really expert, they always got it to work and they were like, oh, no, it's not proper.

I didn't find it a problem.

And we were like, I'm sure there's an issue, but nobody's saying it's. A problem until it got into the field. And then some of the other surgeons who hadn't gone through the design process and understood the problem were really encountering issues and we had to fix it quickly.

Etienne Nichols: Yeah.

Stuart Grant: So that would have been one, that, and that's a point when we back to the teams, we always engage key opinion leader surgeons, the top tier surgeons to help us design our products. And they're sometimes not the best because they're not the users, the main user actually using it. And they will do lots of workarounds, know how to fix problems very easily because they're so experienced.

You've got to, when you develop, especially in MPD and design validation, use the majority of surgeons who are going to be using it, the jobbing surgeons, to make sure you get your proper validation, not the kms.

Etienne Nichols: I could see somebody, especially if they have a little bit of vested interest, they've built some of this and so yeah, it works, it works. Okay, I'm with you now.

I could see that. Okay. Yeah.

Stuart Grant: Next, number five, claims of idiosyncrasy.

Okay, this is, someone says, well, I'm a bit different than everybody else. I do it this way.

And every, I've had a unique career. And you're like, I think I found five or six people who've got the same career but so that they, they've got an idiosyncrasy somehow. Right.

And they're saying, they state it quite clearly so that something is like why is this person saying it's so different than everybody else? Is he, is, are they different or is, are they the same?

They need, that needs to, that problem needs to be investigated deeper.

Etienne Nichols: Yeah, yeah, that's good. I, I, I can imagine that one being especially interesting.

Stuart Grant: Okay, and this is, this is number six is one that probably most people are aware of is called areas of disjuncture. This is where somebody's, as I think I mentioned, somebody's saying they do something, but actually in life, in surgery, they're doing something completely different.

But they think they're doing it this way.

And I've seen a lot of that between the difference between the interview and the video.

That's why you've got to go through the transcript. When you're watching the video, go through the transcript at the same time and try and pick up why they say, oh, I used screwdriver this way.

And then you see it like, no, they're, they're not excellent video.

They're not even using the screwdriver; they're using the wrench or the hammer.

Etienne Nichols: Yeah. Interesting.

And I guess you come through at some point.

I'm trying to think through the process of the actual utilization of that video and transcript.

When you see that, I guess the goal in that moment, they've said this one thing and they're doing this other thing.

Is the idea to get into their mind of what they feel like should be versus what is. Is that really what you're after?

Stuart Grant: Yeah, sometimes they're remembering that what they're trained to do.

Etienne Nichols: Okay.

Stuart Grant: Because they're talking to you. They want to make sure they're telling you how they should be doing it.

Etienne Nichols: Yeah.

Stuart Grant: Not the way they're really doing it.

And you don't necessarily want to design the product the way they should be doing it.

Really design it the way they are doing it because that'll get the best results.

Because they're doing that. It goes back to that workaround. They're doing it for a reason.

They might not know the reason. It's the team's job to find out the reason.

Etienne Nichols: And I guess the motivation behind this disjuncture communication is maybe even embarrassment. Well, I, I do it this other way, but I mean. Yeah, you. So, you're talking about the way you were trained in doing it.

That's really interesting.

Stuart Grant: Okay, what have we got next here? Is this young ship covered that one. Dissonance.

So, this is where something.

And this is in your mind doesn't quite stand up.

So, dissonance is difference between what you think is going to happen and what actually is happening.

And your mind is basically split in two trying to understand the problem.

And this is when you.

From a researcher side. So, when you're actually looking at the data, if you experience that, it's like there's something going on here. There's a gut feel problem going on. You need to stop and think about it and not just move on because your subconscious is telling you something that you may not be aware of.

And that comes back to creativity as well. Which.

Etienne Nichols: And do you have any examples of this one? Because I, I'm very curious about that. And, and I'm sure this, this is going to vary individual by individual and the person actually sitting there experienced it and so on.

But how did you observe it? I mean, if this is one of the 10 that you established from these 10 or from these nine teams that you watched, how did you pull this one out? I'm curious. It just seems like this one's so deep within someone.

Stuart Grant: Yeah, well, that's, that, that's the problem with the research. So sometimes when you're interviewing people after they've done the job, they, you're interviewing researchers after they've done the job, you've got the same problems. Of these 10 that I've just mentioned, interviewing surgeons, you're like two steps away.

So, they, they have an interpretation of it as sometimes you can, you pick up things they're saying. It's like I just didn't believe him when he was saying that there was no proof.

I couldn't see in the video, but I just didn't believe him. So yeah, I, I, and I decided to ignore what they were saying and do it this way because I think that was right.

Etienne Nichols: Yeah, yeah. And that gut feel. Yeah, yeah.

Stuart Grant: As an engineer, it's your imperative to do or you feel right as well.

Etienne Nichols: Right.

Stuart Grant: You don't just do what the customer says because that could lead to a terrible product.

Etienne Nichols: Yeah.

Stuart Grant: Engineers and marketers and designers, we have our skills as well that we can apply to the product we're developing and interpret how we should think it works as two.

Etienne Nichols: There's a phrase that comes to mind just you having said that, I think it's. See if I can remember it correctly. A craftsman will build you exactly what you ask for.

An artist will build you what you didn't know you need.

Stuart Grant: Yeah, that's a good one. Yeah.

Etienne Nichols: And so that's what makes, think of with this dissonance. Okay, what about trigger of use?

Stuart Grant: Triggers of use this.

So, this is a little bit about workarounds as well, but this is about unconventional uses for products and you know, hammer and screwdriver problem that you, I keep coming back to.

But if they're using a product, maybe not off label and go that far, but using an instrument that's not been designed to do it that way, but is solving a major clinical problem, maybe that is the use for that product, and it needs to be developed for that actual clinical application.

And there's a few, there's a, there's a few, there's a few pharmaceuticals that were developed for some application, clinical application, found out they were better in other applications.

But yeah, there's lots of medical devices that have been developed for one application and then surgeons start using it for a different application and it works great and then we've developed it for another one.

So, you should always watch out for cross clinical applications that products can be useful.

Etienne Nichols: Yeah, I can see that because I.

Stuart Grant: Mean you would think every cannulated trauma screws for hip were then used in the ankle and used in the spine. Now Spine screws are properly developed for the spine, but they were originally just synthes.

Cannulated screws.

Etienne Nichols: Yeah. Yeah. Seeing how people use things. Okay. Trigger abuse. So, if that one makes total sense, now that you explain it. Okay. Context of product use.

Stuart Grant: Okay. So, this is how and where it's being used, the environment.

So as engineers, sometimes we. Or designers, sometimes we get focused on the product in that.

Where it's actually being used in the body, in the anatomy and who's using it.

But the context is really important, and we have to design for that. Usability engineering tells us we have to start designing for this. But from the videos or from your research, trying to expand a little bit, just not from the. Or maybe further into the hospital.

How it circulates around the hospital. Cleanability is important. One, sterilizability.

How that. If talking about instrument tray type of thing, how that's transported, how the sales put people throw it in the back of their trunk and ship it around and to the next hospital.

That always. That affects the entire product because a salesperson is a user of the instrument as well, not just the people in the or.

Try and think of how.

And we call it journey mapping. Journey mapping is mapping the entire journey of the product through its lifecycle, not just its point of where it's actually used.

Etienne Nichols: Yeah. And I use this term, and I probably shouldn't. I should probably align my terms with that. The product lifecycle and journey. But the supply chain of a medical device as it goes through.

So. And as it changes hands from the shipper to the nurse to the surgeon to the trash can to the whatever, you know, you think about the entire thing. That makes sense.

Stuart Grant: Yeah. And then, you know, where does the packaging go? Depending on where the implant goes. They're two different problems that people have to solve somewhere.

Etienne Nichols: Yeah.

Or if. If it's sterilized and the nurse opens it up, throws the thing away, puts it in her pocket or his pocket and walks into the room, what do you do with that? And so, yeah, lots of different situations like that.

Stuart Grant: Yeah. And so, then the last one is customization.

And lots of companies do this. Sports sneaker companies do this. You know, you can go onto the Nike website and design your own Nike trainers with different colors. That's customization.

There's a really famous one. I think it's Cheetos chips. I've heard. Have you heard this one?

Etienne Nichols: No, I don't think so.

Stuart Grant: So, this is America. It's been a long time since I've been in America. But there's the Cheetos, which are the hot and spicy ones.

Etienne Nichols: Yeah.

Stuart Grant: So, in the factory where Cheetos were made, they're just the, the cheesy ones.

One of the, the workers one was from Mexico, and he wanted spicy cheese, and he went, he submitted his idea to the Cheetos senior management, and they were said, hell no, we're not doing that.

So, he took a bag home with him which hadn't been flavored yet and spent a year or two playing with different flavors and different spices and coating his Cheetos.

And then he just made his own Cheetos.

And then his friends started buying the Cheetos off him.

Etienne Nichols: Yeah.

Stuart Grant: And then the factory went, okay, we want to mass produce this. And now you obviously can buy it wherever you like. And the guy's a wealthy guy for customizing his Cheetos to exactly how he wanted them.

Etienne Nichols: I never heard that story. That's really good. Yeah.

Stuart Grant: Good innovation story.

Etienne Nichols: Yeah, absolutely.

Well, that's a lot. So, of these 10 of the nine teams that you did, were they all kind of used or referenced or was it just a smattering from this team had about four or five of these and then this other team had three or four.

And uh, but you saw a lot of overlap or what, Were there anything that fell out? I'm always curious if there's things that fell out from your list. Cause you had 10.

Yeah, I'm sure there were other things that ah, this was sort of on the table. But then, eh, you know what? It's not really, I don't know.

Stuart Grant: Can't remember.

Etienne Nichols: No, I, I'm imagining, I'm guessing.

Stuart Grant: Yeah, that's, I, I, I guess most of the, because it's 10 is quite a, a long number. Oh yeah, there was probably ones that I consolidated into the top 10.

They said okay, that's similar to this one. I don't want to go over 10 because people can't remember over five. So having 10, there's a lot of crossover between a few of these anyway. They're sort of similar but different.

Etienne Nichols: So, one of the things I'd be curious about too. So, if I'm a team, I think lists like this are incredibly helpful to get my brain kind of tuned and calibrated to what I should be looking for and thinking about.

How do you, how do you recommend going, making sure you're comprehensive enough with all of these. Is it a. I'm going to go look through it with this lens. I'm going to use the workaround lens and I'm going to look for that.

And then I'm going to focus for affordances or triggers of use or what's the best way to utilize this list?

Stuart Grant: Exactly, that's exactly, that's what.

Etienne Nichols: Okay.

Stuart Grant: You just can't keep all of the, all of the ideas in your head at the same time while you're watching a video.

And it does take a long time. You know, one hour of video could probably takes you between five and eight hours to analyze.

So, it's a significant amount of work just to keep going back through it, looking at things, reading the transcriptions, breaking down, coding everything into the buckets and starting to authentize all those problems into themes.

So yeah, it is about just going through it over and over again and getting a bit bored as researchers start to find out boring is the new creative, creative space.

If you're bored, you start to be creative.

Etienne Nichols: Yeah.

Stuart Grant: And as I said as the. Use the five whys a little bit, you know, why, why, why, why?

Etienne Nichols: Yeah, why are they doing this? Why are they doing that?

Stuart Grant: And you can irritate your customers by using the five whys on them if. Why, why? Until they think you're a child and run away.

Etienne Nichols: Well, yeah, kids are some of the best designers. I have a five-year-old myself who builds anything out of anything and yeah, it's pretty impressive.

Stuart Grant: One of, one of the good, one of the good times. Your question, one of the good frameworks is the jobs to be done framework by Christensen.

That, that's a real.

Because he, his thesis on this one is people don't buy products, they buy solutions.

And yeah, his analogy is you're not buying a power drill, you're buying a hole.

Yeah, you need a hole, you don't need a power drill.

Etienne Nichols: Right.

Stuart Grant: That opens up your creativity. It's like holes can be created in all sorts of way. You just get laser beam and burn, burn a hole into your wall with. Put a nail in if you screwdriver in or something.

Etienne Nichols: Yeah, yeah, yeah. I was thinking about that actually a while back and cause I was on a job site with some, just some friends and I realized that a lot of us buy.

You might buy a hammer, and you can use a hammer just as well as you can a lot of things in a lot of places. But some people buy a tool for the status on the site too.

And I don't know if that's, you know, if you take that to robotics with certain hospitals and so on. But there's lots of different, I think truly understanding what they're trying to solve, whether it's status from a marketing standpoint or truly just trying to put a hole in the wall, what are you actually trying to do?

Maybe we can even be a little bit too not specific enough or comprehensive enough with that analysis as well. I've realized.

Stuart Grant: Yeah, if you're going with Milwaukee or DeWalt or RB.

Etienne Nichols: I'm a DeWalt man myself, but yeah, that is very cool. Any if so, is there any advice you give every startup or early-stage company who's going through this front end of innovation? I mean, I mean the 10.

I think you've given a lot of pieces of advice, but if you were to sum this up into one piece of advice or one takeaway for the audience, what would that thing be?

Stuart Grant: Test your unmet clinical need.

Because that is the North Star of all your research you're going to be doing and all your divergent and convergent thinking. It's all around solving that unmet clinical need.

And that needs to be tested all the time.

Etienne Nichols: Yeah.

Stuart Grant: Not just at the beginning of the front end or the end of the front end.

As you move through the years and years of developing it, you always have to go back and test if that unmet clinical need is still exists and is it real.

I think that would be the one piece of advice because things move, technology changes, people change, perceptions change, regulations change around you without the externalities are huge. So always test then met clinical need.

Etienne Nichols: I look at that as the little V of validation. So, you're always validating your user needs with the doctors you come to. Is this really the need we're after? You know, you're not necessarily going through validation, you know, putting it in their hand and see if you met your user needs.

But the little V of validating what you're actually trying to accomplish, I think that's good advice.

Test those clinical needs.

Where can people find you to learn more about what you're doing, your research or the work that you're doing now?

Stuart Grant: Yeah. So, they you can go on my LinkedIn page, Stuart Grant, that'll take you and I'll love to connect anybody. Send me a message if you've got any questions and my company website is archetype-medtech.com and go in there and submit any questions you have there.

Happy to help and happy to give anybody advice on the front end or NPD in MedTech.

Etienne Nichols: Okay. We'll add those links to the show notes so that people can easily find that as well and really appreciate it. I'm looking forward to learning more about this. I love the list that you have, and I'm just going to run through it real fast one more time in case people weren't or maybe they were driving and now they're sitting in their driveway.

I'm thinking, what were all the 10 the workarounds, affordances, overgeneralizations, metaphorical glosses, probably my favorite phrase, claims of video sequency, areas of disjuncture, dissonance, trigger of use, context of product use, and user customization.

That's fantastic. I really appreciate it and thank you for sharing. Really appreciate all the work you're doing.

Stuart Grant: And cheers.

Etienne Nichols: Yeah, better to meet in person.

All right, take care, Stuart. We'll see you all later.

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Etienne Nichols

Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...