Secret to Success in Human Factors for Medical Product Development
Highlights:
This is the first in a quarterly series podcast. The goal of this podcast is to bring various viewpoints in the medical device and combination product industry that impact the end users.
Shannon is passionate about teaching and building up expertise and expanding knowledge because it opens up opportunities to be responsive as technology and regulations evolve.
Memorable Quotes:
“If you understand the importance of being able to describe human performance and are able to do that to me that's the secret sauce. All things are possible after that.”
“Human factors is about the users, ensuring that they can safely and effectively use the medical product that they are given.”
Transcript:
Sophia Kalita: Welcome to The Factor, a new podcast series by Agilis Consulting Group. I am your host, Sophia Kalita and today we are kicking off our very first podcast. We're launching a podcast because we see this as a great opportunity to join in on some very important conversations, that are happening in the medical device and combination product industry. Conversations that impact the end users.
And so our very first guests to start off our podcast are Pat Patterson and Shannon Hoste. Pat is the Founder and CEO of Agilis Consulting Group, and Shannon is the president of Agilis Consulting Group.
Pat Patterson: Hi Sophia, thank you for inviting me to this first podcast. I think this is pretty exciting.
Shannon Hoste: It's very exciting.
Sophia Kalita: Super exciting! I'm happy to have you both here.
Sophia Kalita: Pat you are the founder and CEO of Agilis and along with this great company that you've created, you've been a Fortune 500 consultant in process improvement and have over 40 years serving as an expert to various industries. Wow.
And Shannon, in addition to being president of Agilis, you're also an Assistant Professor at the Quality Science Education program at Pathway for Patient Health, you serve on several standards and conference committees for medical devices and combination products. And prior to that, you've worked with FDA.
Sophia Kalita: Very impressive for the both of you, and we're gonna get more into your journeys and where you are today in just a moment. Before that, I want to thank you both for being a part of our very first podcast episode. Again, this is very exciting. Together we'll be discussing Agilis history and the importance of human factors for medical products.
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Sophia: Pat, you have a background in instructional design. How did that lead you to start Agilis and come into medical?
Pat Patterson: That's, that's a great question because in looking back, no one would see the connection, looking back, there really was no connection. I got into medical from Fortune 500 because I was put in touch with a client that manufactured complex biomedical test equipment, and they were training their users, medtechs from all around the world, bringing them in for weeks of training, sending them back to their labs with the anticipation that they would then train the other medtechs in their labs.
And they were having huge problems with that. To that client's credit, one of the things they did was they calculated how the loss they were getting on the training, how many questions they were getting. Every time a MedTech would call them about, Well, what about this, what about that? They would say, Well, that was covered in the training.
They, they calculated that each call was costing them money. So they asked me to come in and help them, kind of, reexamine how they were training the MedTechs, which I did. I completely redesigned how they were training the med techs. We actually shortened the training program and improved the results. That was my first exposure to medical and I absolutely, I fell in love with it.
I love the MedTechs. I love the fact that they were so, they were so enthusiastic, so committed to the quality of their training. I had never seen this in any other industry, Automotive, Pulp and Paper, Banking, IT, you had good industrious people, but they didn't have that passion. And so the client who had brought me in there kept moving to different companies and brought me with them.
And eventually, they wound up in a company that manufactured home care medical devices intended for home users, and that's when I got introduced to FDA, and the fact that home users were a new user group in medical. They didn't quite know how to train lay users and they were very skeptical.
The FDA was very skeptical, and can you really train them? And so after that, I just literally fell in love with medical. I literally fell in love with the fact that what we do really matters to people's lives. And I decided that I wanted to conclude my career, 40 years, sounds like a really long time, it is. But I really wanted to conclude my career making a difference.
And I think that's what we've done with Agilis and the terrific people that we have and have had in Agilis and our terrific clients. I think we do make a difference. So it was a stroke of luck, but my background, and this was never an obvious choice.
Sophia Kalita: That is what makes it an incredible journey, So I'm curious now, Shannon, when and how did you come into medical and why is human factors important to you?
Shannon Hoste: Sure. Actually, I think it's interesting as you meet folks in the field of human factors and instructional design in this space, everybody has a slightly different path.
Pat Patterson: They do. They do. Yeah. Yeah.
Shannon Hoste: I actually like that because I think it makes us a very diverse group. We come in with different backgrounds and different areas of expertise, which I think makes us all better.
So, I came into medical as a mechanical engineer, working in product development and contract R&D. So I was working across the continuum from initial concepts, doing a lot of systems engineering work, the requirements engineering, risk management and so forth. And then some sustaining work. So kind of working across the life cycle continuum. And I was seeing field failures that I couldn't understand and it turns out people were lubricating their devices because they thought the force wasn't quite consistent enough and so they were lubricating their devices with butter and motor oil.
Pat Patterson: Are you serious?
Shannon Hoste: Yes. yes. Found that out by scanning the surfaces. I couldn't figure out, I was running, finite element analysis and all these things to figure out why the parts are fracturing and couldn't figure it out. It turns out that those materials were on the surface and oils and plastics don't get along they get brittle and fracture. So I was, was paralyzed because I was trying to write requirements and do risk management for my next product. And, I was thinking, well, people could do anything. How do I predict that? So, that led me into discovering the cognitive systems program over at Ohio State and started taking classes on that front and understanding how people and technology work together. And, so this Pat lining up our timelines, this was probably right about the same time that you were working in the instructional design space.
This was the mid to late nineties, right? And, so at that time it wasn't on the radar like Pat was saying. And so, I would mention to folks what I was studying and what I was learning, and they would look at me and say, “Well, we don't do that.” And I'm like, “You don't design things that people use!”
So I started journeying then and kind of moving a little bit around some, to some different companies, to build up, not only the practice within systems engineering space for medical device, but also the human factor space.
The interesting thing, Pat, to your point, I love medical device and combination products, pharmaceutical space, because everybody's passionate about what we're doing, how we’re doing it to better the human experience. We're improving people's lives. That is very motivational. You put a lot of effort into your jobs and careers, and it's very rewarding.
One thing I did notice though, when I went out to Battelle to Intel and I was working at a digital health group there at Intel where they were spinning up new technologies, this would've been in the early 2000s. And one the thing I noticed was while the medical device was saying, “We don't know if we do that.” I mean, in all fairness, they were just figuring out design controls. Late 90s. But, I got out to Intel and they were, they're a component manufacturer.
And they had this like army of ethnographers, understanding what was needed in the digital health landscape. From the consumer standpoint, they were seeing the value in some of this research. And so it was interesting to then take that and apply that to the development of what we were working on, home health products. And kind of understand that model from the consumer standpoint and how it can improve product safety and performance in the medical device landscape and then carry that forward.
Shannon Hoste: So I have a question though for you Pat. You came out to Battelle with Bob North and did a presentation. We met in the early 2000s, somewhere there. And, I was just curious as you were starting and working in Agilis, I know we had interfaced quite a bit early on within that journey and at a few fronts, and they were fronts that were critical to me in my career development and the products I was working on.
One was a presentation with you and Bob North on, how to do the task and use error analysis and then how to build your framework and what to base your efforts on, what's important. Subsequently your work with Mary Brady and Dr. Daryle Jean Gardner-Bonneau on home health on labeling and development and accessibility. And I believe you also worked with Molly Story early on, I was curious to know, how those relationships came about and what were your opportunities to work with those folks early on?
Pat Patterson: One of the things when I came into this profession, I barely knew what FDA was and, I had the good fortune of meeting Dr. Bob North. I had published an article called Home Alone. Which I still think is a great title for an article about home use devices. And his client saw the article and said to Bob, Do you know this person, Bob?
Bob knows everybody. So he found me and we ended up having a really long conversation on the phone, and he said to me, he said, You don't sound like any training person I've ever met. And I said, Well, you've been talking to the wrong training people. And at that point we realized that the foundation of good instructional design is a sound task analysis.
And not all training people took that approach. But that's the approach I took as a performance-based instructional design. And so when we realized that we both start from the same foundation, it became, it just became kismet that, of course, I belong here. I belong in this profession.
I met Mary Brady as a function of writing that article. I interviewed her and learned that she was very into home healthcare. She had been a home healthcare nurse in her earlier career, and so I became associated with working with her and FDA in the home healthcare initiative that she launched in 2010.
Part of that I became then involved in Amy and Dr. Daryle Jean Gardner-Bonneau. That woman was phenomenal. She was absolutely phenomenal. I knew nothing about writing, or information for this industry, and Daryle knew all about that. We served the home healthcare committee together, and she helped me through that.
She held my hand. She taught me how to learn how to be in this industry. She taught me human factors for medical. I just owe her so, so much. And Dr. Molly Story, we worked with her early. And she was one of the few people including Daryle and Bob, who understood the role, the potential role that user instructional material has when it's considered part of the user interface.
So I would say without Bob, without Molly, without Daryle, and without Mary, none of this would would've been possible. So, I'm very grateful to them and, and their encouragement and guidance and patience. A lot of patience.
Shannon Hoste: Actually, it's been my experience too, it's the people I've met that really, made the difference. And I love those relationships that you work together and you both are achieving things that you hadn't even imagined. That's why I'm so excited about this podcast, and as we bring folks in and have a chance to hear from them, I mean these are the opportunities to share.
Pat Patterson: Absolutely. And I used to make it a habit when I would meet with clients and meet with their engineering team, I would ask them how did they come into medical field. What drew them into medical? And some of them it was a job. It was just the next job in their career path. But a lot of them had that same passion.
The folks that had that passion, some of them are still in this profession. It really is infectious. It is absolutely infectious. We matter. We make a difference in people's lives in a way a lot of professions just don't. That's a cool place to be.
Shannon Hoste: Yes.
Sophia Kalita: So what I find interesting about what I heard you both say is, you’re both in a sense pioneers, but that pioneering involved knowing certain people that taught you guys, then you took that knowledge and you took it forward and you have taught and you're continuing to teach.
And, where I'm curious now and want you guys to talk about, how did you meet each other? Cause in this new realm of being in the same company, you're continuing forward. But your meeting was sort of a very important piece to get to where we are today.
Pat Patterson: Yeah. I'll let Shannon take that one.
Shannon Hoste: Sure. So, as I mentioned, I was working and trying to understand cognitive systems or human factors in medical device development. I was understanding the concepts and seeing the importance and trying to work through practically how do you implement them. And that's when, Pat Patterson and Bob North had come out to Battelle to do a presentation, on task and use error analysis. And I was like a kid in a candy store in that presentation. I thought: This is how you do it! And I cornered them promptly after the presentation.
Pat Patterson: Very politely though.
Shannon Hoste: Pat and Bob were accessible to reach out and ask questions, and bounce some ideas off of. So, I could start implementing, what I was seeing within companies. And then as I moved over to Intel and worked more in the Home Health, that's where a lot of the work that you were doing and Dr. Daryle was doing, was so pivotal to optimizing the design for home health. What happens when you send systems home so that the patient at home can communicate back to the clinician?
This is a lot of work, that honestly, has just now come to fruition with, the changes with Covid that removed some of the barriers to home health.
Pat Patterson: Yeah. And one of the things that weren’t really considered back then is, because in some cases it was just assuming you're teaching people how to use a medical device, but there is a whole emotional component to a medical device that doesn't exist with a game or online shopping or something like that. There's a whole emotional component. And Daryle and Mary Brady were really articulate in making and helping the industry understand that, this emotional component is very real and very tangible.
Shannon Hoste: Yes. And I think we crossed paths again at an FDA live meeting, around labeling for medical device. It was awesome to have Pat in my career as I was journeying, and I went from home health into surgical, at Stryker and establishing the best practices and how to execute them. Even so when I moved into, for example, with Stryker, but I've seen this with other companies as well. When you're looking to build human factors within an organization, some of your first allies are the folks in the tech. groups and the folks that are in the labeling groups. They're kind of stuck dealing with any usability issues because they have to explain the user and work around any of those. So as human factors was growing in this field there was a natural synergy.
Pat Patterson: Yeah, very much so. And again, what was amazing is to discover that it really does come down to that task analysis, the ability to describe human performance. Some training, people can do that, some cannot. And some engineers can do that. Some engineers cannot.
But if you understand the importance of being able to describe human performance and are able to do that to me that's the secret sauce. All things are possible after that.
Shannon Hoste: And, and what that tool gives you is a framework to understand where you need more information. So as I'm laying out that task and use error analysis. I start to understand what I don't know. And then I can go out and do research and use different research methodologies, to gather that information, Ethnography, As I start to build out my design I can do cognitive walkthroughs and then simulated use. Then depending on what I need to learn and to come back and understand that task use error analysis.
Pat Patterson: Yes. It's cool. It is. It is fun!
Shannon Hoste: I love my job. So, when I started, when I decided to move into consulting, Pat was one of the first people I called, to better understand that. And then I joined Agilis.
Pat Patterson: And that was a happy, happy day for me and a happy, happy day for Agilis. We were really fortunate. We've known each other for 15 years or more than that. But we were kind of circling around each other, never really working together. So this is the first time we're actually working together, which is really pretty amazing.
Sophia Kalita: That's awesome. Maybe you can touch on, Shannon in terms of the passion that you're describing that you have for human factors, which I think is evident in what you do and how you do it.
Now being a part of Agilis how do you see the two tying together? What’s your vision, your expectations moving forward?
Shannon Hoste: Yeah, absolutely. I was just at a conference and what I'm excited to see and have seen happening over the last 20 years is the evolution of this practice, use-related safety and performance within the medical device and pharmaceutical sector. Saw it evolving in industry and within my time at the FDA, with regards to the quality of submissions coming in and the quality of human factors being done. And I see it continuing today to evolve and develop. You know, folks talking about when they're talking about risk management, they're identifying the use-related risk components of it.When they're talking about quality management systems, they're identifying how that use factor plays into their quality management systems.
So it's exciting to see it coming to the forefront because it is so critical. At the end of the day we can design excellent systems and we can do our engineering and engineer as many features as we want to within a system. But at the end of the day, someone will be using that and is it going to serve their needs or not? So it's exciting to see that focus also being built into that development picture.
Pat Patterson: I think it's worth remembering in the beginning you mentioned human factors to someone, they looked at you like a deer in the headlights and they would say, you mean human resources? And would say: No, no, no Human Factors. So that kind of change in 20 years, that's pretty phenomenal.
Shannon Hoste: It is. Yeah. And, what I'm excited about what we're doing at Agilis and where we're going as a whole, is not only helping clients and helping, companies with human factors within their products. But what I'm really excited about is, is building up new folks within the field of human factors and instructional design, building up expertise, within our staff, within other colleagues in the industry.
That's part of why I love teaching the quality science curriculum with Pathway for Patient Health as well. Because it's working with, at that point, college students but college students and early career professionals to further the skills that can take this even further down the road. It's exciting.
Sophia Kalita: So, there’s something you said Pat which segues to another thought or question that I have. Human factors and the deer and headlight, and being labeled human resources. So to me, that's a misconception, right? From, when human factors were starting to surface and the importance and foundation was being laid. What other common misconceptions have you seen as you have been in this space?
Pat Patterson: Well, kind of just on the on the name thing in addition to human factors being confused with human resources, I think I may have been the first person in this industry to use the term instructional design and people would say: You mean industrial design? And I would say no Instructional design. And so we would go through that whole conversation.
I think in the beginning, human factors was just, it was a total unknown. Shannon mentioned earlier about the educational piece. I mean, education was so critical. Clients who, I've always been a consultant, so I'm pretty familiar being in a consulting role with clients, but they would have a hard time understanding how human factors research studies, fit in compared to clinical studies. They're completely familiar with clinical studies. They've been doing them for a thousand years.
How does it fit in with marketing research studies? Again, they're completely familiar with marketing research studies. And so part of the struggle in the early years was helping clients understand human factors is a science.
It is a science of observation, but it does use qualitative data. A lot of clients had confusion over that. But how does human factor studies fit in with the clinical studies? No, we're not clinical. How does it fit in with marketing? No, we're not marketing research. But we are equally important.
And so there was a lot of education that went on, with helping clients understand the role that human factors study and human factors data produces. And one of my favorite things, always has been being with a client. The first time when they're in that observation room, the first time, they see a real live human being interacting with their device, being allowed to do what they're going to do.
And, having the client look at that and say, Oh my gosh, I've never seen that before. It's pretty astounding and amazing, thing to see clients go through that transformation. And it's interesting, once they go through that, they never go back. They never become, you know, confused about human factors versus the other kinds of studies, they get it, they get it pretty quickly.
Sophia Kalita: And what about the task in user error analysis? So you both talked about that. Can you talk about any misconceptions that you've seen in the early days of Agilis or the early days of your work and the sort of responses around that and any challenges you face explaining it?
Shannon Hoste: I have! One way I’ve thought about it and talked about it with different organizations in the past. Again, as I mentioned, that task and use error analysis becomes kind of that framework to hang this information on and to understand where you need more. I know earlier on I had faced, you lay out the human factors recommendations, maybe heuristics to say, here's how this user interface, some rules of thumb on this user interface. And it would basically be, well that's your opinion. I’m a human. This is my opinion.
So, thinking of it more as a design opinion rather than the research practice like Pat was describing. And, one way I like to think about it is, you know, within product development, I'm going engineer speak here, you would develop and you would do your design FMEAs.
And so you would get all of your design folks in, whether it's electrical, mechanical, whatever, and say: Well, here's all the things that can go wrong in the design. And you're representing if I have an electromechanical product, I have mechanical engineers, electrical engineers, process engineers probably. And then if I'm doing a process FMEA, I have all of my manufacturing folks in the room, right? As I start to evaluate a use FMEA, I don't have users in the room, right? I have those same engineers that I had in my design FMEA and my process FMEA in the room? Who's there speaking for the user? Well, that's the role of human factors.
The reason the task and use error analysis is so important is because it drives them to go out and do that research so that they can come back into that room and represent the user. So that research is helping them to understand what are the true challenges for use error? They can bring that back in the room and then you can start to evaluate what can go wrong.
Sophia Kalita: Yeah, I think that from an engineering standpoint, that makes perfect sense to me!
Pat Patterson: Well that's because you're a biomedical engineer, Sophia Kalita, and you have been for a long time. But what's interesting about that, again, in the very early years, in the very early days when you would talk about a task analysis, the engineers would say: Oh, we already do that. But what they were doing was the process task. They were saying: Here's what happens to the device. And we were trying to help them understand, but the user's not involved in this.
What we are doing is involving the user. What does the user have to do? What do they have to know? Push, touch here, feel, smell in order for that. And they were like: Oh, we never thought of that!
Or again, it wasn't something that they considered. I think the other thing, as Shannon talks about engineers, is the engineers are smart people. I've worked with engineers for 40 years, way before medical, all different kinds of engineers. You tend to be very smart, very analytical, very numbers kinds of people.
Your users on medical devices are often not that way, and so for the engineers to try to get into the head of the users by themselves. You can't do it. It's daunting. You can't do it. You can't imagine what it's like for someone looking at numbers who doesn't understand what they're looking at or looking at different kinds of output that they're not familiar with.
Plus again, it's a medical device. There's an anxiety level that isn't associated with other kinds of tools that they might be using. So, human factors for a lot of the engineers gave them this eye-opening experience and it was like, Wow, this is really, really cool. And as you know, Sophia Kalita, we have engineers who just fell in love with human factors. And said, I wanna be in the human factors.. It's a very amazing experience and an amazing science. I love, I love human factors. It's fabulous.
Shannon Hoste: That's funny, Pat, that was my AHA moment back when I first talked about the failure mode that I was trying to investigate when I discovered cognitive systems and human factors. Was that one, there's a systematic way to think about it, the task use error analysis. And two, there's a whole field of research on human performance and research methodologies to understand what that user is facing, I can systematically and scientifically start to understand what this means for my product design. It's not some infinite variety of things that can happen out there. There's patterns in research to support the field.
Pat Patterson: I think for me, who, is kind of seeing this from the beginning, as has Shannon, but being older than Shannon, I don't expect to see as much in the future as she will and you will and others will. I think what's so exciting about this whole field is it's still in its infancy. We've really only been doing this, FDA published its final guidance in 2016. That's not a long time ago. And every day new technologies are being introduced. Every day, new devices and new combination products and new medicines are being introduced.
So everything is always new and exciting and very challenging. This industry is nowhere near some other industries like Aviation, Semiconductor, some others where you can say, Oh, we've always done it.
This. We've never, always done anything anyway, because we're students, we're so young and we're so dynamic. It's, it's a very hot place to be, if I was a young person today, I would be lining up to human factors in medical.
Shannon Hoste: Part of the reason I'm so passionate about building up expertise in the community. To expand knowledge and be even more responsive because as technologies evolve, as regulatory science evolves, being able to answer all of the important questions, takes more eyes, it takes more diversity, as I mentioned earlier. And just the skill set to evolve with that. I'm excited to see that, see that grow.
Sophia Kalita: Super exciting! To summarize, human factors is about the users, ensuring that they can safely and effectively use the medical product that they are being given. Thank you both so much.
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