Why Usability Matters

November 24, 2021


Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.

In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices.

Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user.



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Some highlights of this episode include:

  • Medical device professionals may develop something that they view as perfect, but what matters is what the person or patient using the product thinks of it. Medical devices/software should support people with health issues/problems.
  • Those in the medical device industry and at Custom Medical have a major impact on the quality of life for many people. They can save and improve lives as well as prevent damage by doing their work correctly.
  • Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. They should not have to overcome barriers and adapt to the device. It should be easy to use, safe, and supportive.
  • Determine if you are on track when developing a product by conducting formative evaluations of tasks that need to be done and how they should be done.
  • When done with development, a summative evaluation shows the use of a medical device does not come with any unacceptable risks. It offers proof of use.
  • Opportunities for Improvement: Some mistakes that Michaela has observed include not meeting or listening to users, starting too late, and not conducting formative before summative evaluations for feedback.



Michaela Kauer-Franz

Custom Medical

Certification: Introduction to Usability Engineering and IEC 62366-1

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru


Memorable quotes from Michaela Kauer-Franz:

“It’s not about me being excited about it, but about the user being excited about it. Being able to understand it. I think this is a very valuable insight.”

“You have so much impact on the quality of life of so many people. You can save life, you can improve life, you can prevent damage if you do your work right.”

“Usability is the translation from the capacity that an expert or user has into a device that is being easily used and intuitive, understood, and safe.”

“See usability as something that you have to do constantly. It’s not a one-time activity that you do.”



Announcer: Welcome to The Global Medical Device Podcast, 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.

Jon Speer: Many days where I am just so appreciative and grateful because I feel like I have one of the best jobs in the world or, I get to at least do some of the most fun things a medical device nerd can do. And one of those things is I get to record podcast episodes with some really smart people, some experts in our industry and today was one of those cases. Yes, we have talked about usability a few times before and I am quite confident we'll talk about it quite a few more times in the future on The Global Medical Device Podcast. Today, I got to speak with Michaela Kauer- Franz. Michaela is the CEO of Custom Medical, you can learn a lot more about her and her team and their products and services when it comes to usability by visiting custom- medical. com. It's a lot of fun somebody who's been in this space for 20 years has a lot of expertise, just a very pragmatic and practical approach to the topic and understands the role, the importance that we all have as Medical Device Professionals. This is part of how she's wired and part of what she focuses on, it's really about improving that quality of life. So, I hope you enjoy this episode of The Global Medical Device Podcast as much as I did. Hello and welcome to The Global Medical Device Podcast, this is your host and founder at Greenlight Guru, Jon Speer and, I'm going to be honest folks, I've been pretty excited about this one today. We were supposed to talk before now, but it's probably something that happened on my end but nonetheless it's happening, we're here today. So joining me is Michaela Kauer- Franz from Custom Medicals. Michaela welcome.

Dr. Michaela Kauer-Franz: Thank you so much, Jon. It's a pleasure to be here today.

Jon Speer: Absolutely. So, I know why I'm excited to chat with you today. Tell folks a little bit about who you are and your background. And I'm sure they'll start to pick up why they should be excited too.

Dr. Michaela Kauer-Franz: Yeah. So my name is Michaela as you already said, and I'm on the field of usability engineering for medical devices since, almost 20 years now, so quite some time. And I'm head and founder of an own company who's focused on this field so, I have a lot of experience in designing great, intuitive, and safe medical devices. So this is probably something that you could be excited to learn.

Jon Speer: Alright. You haven't heard this story some of the listeners might have heard the story and I'll tell the very short version of it. But there was a moment when I started in med device, it was a job. I didn't want to live with my parents, I needed income, start my own life as an adult. It was fun don't necessarily mean, but I didn't connect the dots. I didn't really emphasize the importance of what I was doing and at the time I was a Product Development Engineer and how that could have an impact on life. But then there was this moment where I was actually present for the first clinical use of a device that I had developed. And I started to freak out, because I realized, oh my, that patient was alive when they came in now, I don't know why they were there, they had something that they were dealing with, but they expect to be alive when they leave and my device is going to be used on this patient. So then I started going through this mental checklist am like, did I do this? What about this? What about? And that changed my perspective. And it really changed my life because that moment I'm like, what I do as a Medical Device Professional has an impact on the quality of life. And I want it to be a positive one.

Dr. Michaela Kauer-Franz: Yes, I totally get that point. You know when I started feasibility engineering, I started in the general field of feasibility engineering. So my first project was the design of a workflow management system. I was really excited and I worked on project almost a year and I was very confident because I had a lot of discussions with my supervisor on the topic and I really liked the results of it. And then we presented it to the users after a year and to the stakeholders when we thought it was perfect. And they just ripped it apart, ever single step of it and that's the moment when I realized, oh my God, oh my God, it's not about me being excited about it, but about the user being excited about it, being able to understand it. And I think this is a very valuable insight, especially when I moved on to the medical device area where it's not about making the work of someone a few seconds faster, but saving the life of someone. That's like a goosebump moment.

Jon Speer: Yeah, I know. And I always try to stress this every time on the podcast when I speak with people, it's like we are Medical Device Professionals. We're making devices products that are going to interact with patients, maybe it's going to save their life, maybe it's going to improve them, but regardless it's being used in a medical capacity. And I really love this quote that I found on your website and the quote is with the development of a medical device, you face the great challenge of developing a device/ software that should support people with health issues and problems. I mean, that's a very profound statement.

Dr. Michaela Kauer-Franz: Yes but I mean, that's what we are working on. You know I think working in the medical device industry is one of the most rewarding activities that I've ever done, because you have so much impact on the quality of life of so many people, you can save life, you can improve life, you can prevent damage if you do your work right. And I think that's so rewarding compared to many other areas where you can work.

Jon Speer: For sure. So I want to get into a little bit about how you got into usability. And I guess I'll share that when I started, so I'm old, but you said you've been in the industry for 20 years. So you've been around for a bit too. But I remember the early days when I started as a Product Development Engineer, I mean at that time, what we know is design controls or the design and development requirements were technically new from a regulatory perspective. And I remember a lot of the colleagues that I was working with, they had been working at the company for quite a few years before I got there and they were kind of grumbling about, oh, we got to document these things, I'm an engineer I don't like documentation, blah. So I kind of like, so I'm an engineer. Does that mean I don't like documentation? And so I'm getting into it and like, but I'm fascinated like, oh wow, design digital controls, like I get to define these requirements and we get to do tests that are showing and demonstrating that the product meets its requirements, hopefully, and all these sorts of things. And then I'll fast forward a few years and it's like, oh, now there's this new discipline called human factors and usability, come on, really? I probably started to sound like one of these old engineers when I started that, ah I hate that stuff. Why is usability so important? And I guess that'll be a first place to start. I'll ask the other question here in a few moments, but why is it so important in your point of view?

Dr. Michaela Kauer-Franz: To be honest, I think if you design something, let it be software, let it be a hardware device, let it be anything that is used by a human. Then there is no way where you can pass by designing the device for the person who is using it, for me it's the essential part. I don't like the idea that you design some automation, some device, and the user has to adapt to the technique, to the technical instrument that he's given. We should design devices and products that are able to support the user in his tasks, that are able to amplify the quality that the expert has on the field instead of step in between and building a barrier because the user has to think about how to work with the device instead, what he needs to do. And usability is the translation from the capacity that an expert or a user has into a device that is being easily used and intuitive understood and say for sure in the medical device industry, but that comes with the point that it's easy and intuitive.

Jon Speer: So my next question for you is when I started to really understand design controls and I'm like, oh yeah, I get it, it makes sense it's just the flow of information. And with the later stages of your design and development process, it's really about demonstrating that my product works as I designed it, but it also helps solve the problem that I set out to begin with. How is that different from usability?

Dr. Michaela Kauer-Franz: I don't think it's different in some ways.

Jon Speer: I wasn't trying to be a trick question. Let me give you a little bit more context. Sometimes I think like, as these things have evolved over the past couple of decades, I think there are varying interpretations. Like some people say, oh, you need design history file, you need your usability file, you need your risk management file. And I'm like, scratching my head, I'm like aren't they just all the same thing with slightly different points of view.

Dr. Michaela Kauer-Franz: Yes they are. You know I well would love to tell you that usability engineering is something totally unique and has a totally different aim, but it's not, it must be integrated and introduced to all the other things that are there. When for sure you need a usability engineering file, but we try to integrate as much information as possible into other existing files and not start to totally new documentation and to make the burden even higher. But we try to integrate information where it belongs. But for sure, we do have a different perspective, a different point of view when we look at the system because our solution is not technical in first place, but instead our solution is focused, especially in the early phases on the question, what does the user really need? What would help him to make the progress that this person is looking for? And we often start and change the focus and the idea of the device totally compared to the project start when the team comes to us and say, my device will do this and that, but it won't ever do X and Z. And then we start into discussion and you see how the focus shifts because the voice of the user becomes so strong that it's totally clear that you will not have any market chance by doing this. So in some way, I think we are going above the pure insurance of making a safe device and we help if you are a good usability engineer in my perspective, we held to build a marketable device, which has a big chance for success.

Jon Speer: Absolutely, and on that note, I want to take a quick break. I want to remind folks that I'm speaking with Michaela Kauer- Franz and Michaela is the CEO of Custom Medical, and you can learn a lot more about her and her team, which by the way, seems like an awesome team. I was looking at all the bright shining faces on the website and reading a little bit about some of the background of the folks that are on her team. She's got an amazing team, but you can learn more about Custom Medical by going to, it's pretty simple, custom- medical. com and Michaela tell us a little bit more about what Custom Medical does how and when companies should reach out to you and your team and those sorts of things.

Dr. Michaela Kauer-Franz: Okay so let me see. I think it becomes pretty clear that I'm in the field of usability engineering by now. So that's actually the core focus of our company. So if you are a medical device manufacturer, you can come up to us and we will help you with the whole usability engineering process. We start with the user interface design, if you do have an active medical device and we can conduct all your formative studies up to the final summative study, including all the documentation that you need for the usability engineering and that's it.

Jon Speer: Okay, well, that's a lot actually. As we continue on here a few moments, we'll dive into some of those details, but while we're taking this break, I want to remind folks about Greenlight Guru. Greenlight Guru is the only medical device success platform in the medical device industry design, only for the medical device industry by actual medical device professionals. I know I said medical device a lot right there, but in all seriousness, we've built this platform for you because things like documenting your design history file and your risk management activities and maintaining documents and records, including, electronic review and approval and revision history and all those sorts of things and all those post- market quality events that you're going to have to manage and document and investigate things like complaints. Well, good news for you. It's all in the Greenlight Guru medical device success platform, a single source of truth for all of those things. Very simple to learn more about what we do go to www.greenlight.guru, and you can read all about the different software features and functions and workflows and all of our products and services. And if you'd like to have a conversation with our team so that we can understand if your requirements, your needs align with some of the products and services that we offer, we'd love to have a conversation with you. So again, go to www.greenlight.guru to learn a whole bunch more about the success platform from Greenlight Guru. Alright, Michaela, you mentioned summative and informative. I know those are always confusing terms, so maybe spend a moment and talk about each of those. And then where I want to go from there is maybe some of the mistakes or some of the opportunities for improvement, if you will, when that you've observed medical device companies could change as far as their approach and practice when it comes to usability.

Dr. Michaela Kauer-Franz: Okay. That's a good question, actually. So start with the definition of the both, I think everybody heard about formative and summative because you can't pass them somehow in the terms, but nobody's explaining you what it means. So formative means simply that while you are developing the product and you're still not sure where to go, what designed to choose, probably which functions to include, or sometimes even earlier what task especially needs to be done and how it needs to be done, that's way you conduct formative evaluations. That means you can simply figure out if you're on the right track with your device, or if you're working in a totally wrong direction. You can, and you should check on the stages if the device is safe and easy to use, but you can also, you don't need to, you can also focus just on the question if the task, right, If it's understandable. So no real requirements on that part. The summative evaluation in contrast that is done with the production units, the first one, or with the production equivalent device. So when you are done with all the development, and that's the place where you show the use of your medical device does not come with any unacceptable risks. So that's more the proof for the safety of use, whereas the other ones are more into the proof of the right direction for your device.

Jon Speer: Right. So what I love about formative, well, I often share stories and sometimes as the stories that I share are mistakes that I've made in my past. I remember some of the early development projects that I worked on. It's fascinating to be able to work with a physician who gives you a cocktail napkin sketch, or an idea, right. This really happens. It's happened many, many times in my career. That's great to have that information on the front end and usually those folks that I work with, I would put them in the category of key opinion leaders. So they were oftentimes cutting edge innovative, folks that are young, trying to be pioneers in some areas of medicine. But what I would did in some of those cases is I take that information, I put my head down, I would go maybe build a prototype or maybe define some user needs or some requirements, but often time it was a solo activity. I was the only one contributing to it. Sometimes I had a couple of other colleagues that would contribute to it. Maybe I would talk to the folks that, were more involved with sales and marketing, because I made this assumption that oh, well they interact with those folks. They can represent that voice of customer but rarely though did I include the actual users and you know, I'm an engineer, I'm smart.

Dr. Michaela Kauer-Franz: You know what to do.

Jon Speer: I know what to do. I can figure this out, and oh, I'll write down all the step by step instructions and the directions for use or a little packet that's going to go with the product. This is going to be easy, right. And then there's a couple times that we get, much later in the process and the users are like, what is this? Or why doesn't I have that? And it's like, oh my gosh, like rookie mistake. I think those who are doing a great job with if medical device product development have formative activities built into the iterative cycle of especially those earlier stages of development, whether they call it that or not. Because I think it's so important, you have to have that user or not a user, but a group of users that voice or those voices represented throughout that process because otherwise what's the point.

Dr. Michaela Kauer-Franz: Definitely. And I think because you ask about the mistakes that we often see, and I think one of the major mistakes that we, I don't know, see a lot, especially in companies who are just starting with the regular usability engineering activities. I mean, to be honest, they weren't that important during the last few decades and they're growing in importance now. So what we often see is that people walk up to us as a service provider and say, Hey, we have this great device, we are almost done, we just need our summative evaluation. Will you be so kind to? And we're like, okay, so cool. Did you do any formative testing upfront? No, no, no. We know what we're doing. So that's a very tricky point because it never works. I always have the comparison. Summative evaluation is the first point where you device meet the user. This is like doing your first driving lesson on a highway with 200 kilometer an hour. It might work. But it's definitely not a good idea.

Jon Speer: Yeah, right.

Dr. Michaela Kauer-Franz: And this is one of the major mistakes just start too late and I think there are multiple reasons for doing this. And one is, as you already said, there are experts in designing. So they are like, I'm an engineer. I know what to do. And it's a hurdle to say, I need the input of someone because often they're afraid that they lose competency or-

Jon Speer: Credibility. I mean, engineers like to be the smartest person in the room and if I have to ask for help then, oh my goodness, I might not be the smartest person in the room.

Dr. Michaela Kauer-Franz: Yes, actually, that's one of the major things. And the second thing is if you're not used to conducting formative evaluations or to conduct interviews, then to be honest, you will often not get any usable results. So it's really about have to have somebody who is able to get the information out of the user and not try to sell the product during the discussion or not try to explain what's happening. That's a real struggle because we talk so often to people, they say, oh, we tried that, that doesn't work. And then we say, okay, have a look at our interviews, let us conduct them and you will see the difference. And they're like, oh my God, this is how they can look like.

Jon Speer: Right. And so Your role is you're removing the bias and providing objectivity.

Dr. Michaela Kauer-Franz: Yes. It's like, you don't have to discuss on your gut feeling, but you get data where you can work on it. Just you say, this is what is needed to make a successful and good product. We just had a customer who was working on a device with us, totally new development. And they decided that they are not going to integrate warnings because it's such a big hurdle in the approval process. But we conducted, I think three formative evaluations on the way. And we brought back every time, the information that all the users we are talking to told us that they need warnings and they will not use and buy the device if there are no warnings included. So the final device has warnings because it won't be marketable without. So...

Jon Speer: And when it suck to get all the way to the end, making this decision that, oh, we don't need warnings because the hurdles or the barriers or, or whatever, the reason, and then you launch and people like that product sucks. It doesn't have warnings. That would be a terrible time to find that out.

Dr. Michaela Kauer-Franz: Yeah. To be honest, that's the time when we meet a lot of our first time customers.

Jon Speer: I can imagine. So kind of wrapping things up today, what tips or pointers or advice would you like to leave listeners with on the topic of usability?

Dr. Michaela Kauer-Franz: The first advice is see usability as something that you have to do constantly. It's not a one time activity that you do once in the lifetime.

Jon Speer: It's a total life cycle process.

Dr. Michaela Kauer-Franz: Permanently. The second thing is, allow your engineers, your usability engineers, whatever to be the experts on the design and the process and get feedback of the experts of the task. So getting the users, getting the feedback, and I think the most relevant hint for everything is listen to them.

Jon Speer: Right. Document the observations and make informed decisions based on that data.

Dr. Michaela Kauer-Franz: Definitely.

Jon Speer: You know, one other tip that I like to throw out on this topic is I mentioned getting the cocktail napkin sketch from like the key opinion leader at the pioneer. Sometimes working with folks like that, it's awesome, don't mishear me, but it could be tricky when it comes to usability because sometimes leading edge or sometimes bleeding edge, they're at the forefront of where things are going from that procedure or this type of product, they don't necessarily represent the majority of the users for this type of product. So my advice to folks is when you're doing formative activities, certainly listen to your key opinion leader, but don't put all your weight in that key opinion leader. You've got to have a group of folks that represents the majority or wider variety of the user base. So just factor that in and I'm guessing your processes consider those types of situations.

Dr. Michaela Kauer-Franz: Definitely. And may I take this advice and bring it even one step forward?

Jon Speer: Oh sure. Absolutely.

Dr. Michaela Kauer-Franz: Because you talked about the key opinion leader and the drawing that they make when tip to work with it, take the opinion of your users, not only the key opinion leader, but the user group that you're talking to and aiming for, but don't take the drawings in exactly the same way they are not the designers. They are no design experts, but they are task experts. So it's your task as a designer and usability engineer to make the thing usable and to figure out how to integrate this function, how to integrate this workflow. And it's not their task to do it. They will tell you what they need but to be honest, they can't tell you how to do it. So-

Jon Speer: Absolutely. I'm so glad you brought that up because it, again, it reminds me of yet another story where one time I took the little sketch, actually I think in this case, the doctor actually had built a really, really crude prototype from the parts and pieces that he was able to get his hands on. And I basically replicated that, but in a way that could be manufactured, but not necessarily in a way that was factoring in usability. So I take humans in, especially those humans who are fixers and problem solvers, the way they communicate the problem is through a potential solution. But it doesn't mean it is the best potential solution. It's just a way that they've hacked together to solve the problem. If that's the product that you take and go to market with, you missed it, you just missed it folks, you missed it. So great tip. I'm glad you brought that up. Well, I have one other question or request from you and we can tackle this another time, but Michaela this was fun. And I would love to have you come back and do another episode at some point in time in the future. There's so many things that are just, buzzing through my head on the topic of usability, it's such an important topic. I think it always has been, but I think it's more important now than it ever has been. So will you come back and be a guest in the future on The Global Medical Device podcast?

Dr. Michaela Kauer-Franz: I would love to. It was so much fun.

Jon Speer: Alright, ladies and gentlemen, Michaela Kauer- Franz with Custom Medical. Again, you can find a lot more about their products and services by simply visiting www.custom-medical.com. They're here to help they're experts when it comes to usability. They have contact information on their websites. So, reach out to them. There's phone numbers, there's emails, all that sort of thing, they're here to help. Folks thank you so much for listening to The Global Medical Device Podcasts. As many of you probably know, it is the number one podcast in the medical device industry. And how does that happen? Well, it requires listeners and that's you. So thank you for continuing to tune in and spread the word and sharing The Global Medical Device Podcast with your friends and colleagues. Hopefully by now you've discovered we're also on YouTube. You can watch the episodes as well as listen to them. So thank you so much. I'm very grateful for this and until next time, this is your host and founder of Greenlight Guru, Jon Speer and you have been listening to 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.

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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