Navigating the Real-World Environment of Medical Products

In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into healthcare, describing how she ventured into remote areas to provide support with donated medical devices. This eye-opening experience underscored the critical importance of considering usability and human factors in product design.

Shannon Hoste shares a similar background, transitioning from a more conventional engineering role to human factors engineering after encountering issues related to device usability in post-market settings. Their experiences highlight the vital role of understanding user diversity, technological access, and cultural differences when designing products for a global audience.

The conversation also delves into the pressing need for greater diversity in clinical trials and research projects. Rita and Shannon emphasize the importance of including populations from US territories and underrepresented regions, aiming to create more inclusive and relevant healthcare technologies.

Memorable Quotes:

• “ I remember feeling great satisfaction that we were able to get to a root cause for a particular medical device overheating. So through like a combination of talking to, reaching out to these customers and trending the Complaint data, getting together with the CAPA team, interacting in particular with the design engineer at that time.” - Rita Lin

• “That is one of the things I get excited about with HF is the diversity of the field that we're in and how people are coming into it from different directions with different backgrounds and all of that comes together to better understand. How our end users and the technology we're developing can interact, they're team players.” Shannon Hoste

Transcript:

Outro - 00:00:04: Welcome to The Factor, a global medical device podcast series powered by Agilis by Kymanox. Today's episode is hosted by Shannon Hoste, Vice President of Agilis by Kymanox and assistant professor in the quality education program at Pathway for Patient Health. She's joined by Rita Lin, Director of Human Factors Engineering at Kymanox. Rita's journey into human factors engineering began with her experiences in biomedical engineering, where she witnessed the intersection of technology and user experience during her time abroad in Central America. She had some eye-opening encounters with medical devices in underprivileged hospitals, and today she reflects on the challenges of inclusivity in clinical trials and the need for a deeper understanding of user demographics. So what is the role of empathy in human factors engineering? Let's find out. Here's Rita.

Rita - 00:00:55: I remember in college I had the chance to work with Engineering World Health (EWH) and go abroad with a bunch of other engineering students to work as technicians in hospitals in Costa Rica and Nicaragua with the goal of helping them coordinate the medical devices that were being donated from all over the world to these hospitals. And they were, of course, grateful for all those donations, but oftentimes they came without instructions, without extra repair equipment. If they did have instructions, oftentimes it was written to assume that the user was out of the U.S. Or, you know, EU country. So that was really eye-opening and it was very clear to me that the end user needs to be considered if they're going to get any use out of the device. Because otherwise, the other engineering colleague I was with, every day we would wake up and then go to the hospital and see, we called it the graveyard of medical devices. So there was a huge room. In the back of the hospital where we would just go in and try to tinker and fix as many things. Pieces of equipment as we could with just basic tools like soldering as well. You know, they had given U.S. A little bit of basic engineering technician training to basically work with the field. But yeah, like a lot of other things that we did was also just try to Google and track down a bunch of instructions, manuals for the hospital and translate them if they needed translation into Spanish. So that was, that was just such an awesome experience. And then. Right off college, like I mentioned, I was a quality engineer specifically, in the Post-market realm, and part of my job was to talk with customers of that manufacturing company to figure out what actually happened in the Post-market adverse event or Complaint that they had. Because the company policy was to really try to get to a root cause. And what that meant was that someone had to call the customer at least twice to get more details if they didn't send enough details. So whenever I saw the root cause being use error or user error, I had to get on the phone and call this hospital and get in touch with the nurse that more oftentimes than not, didn't remember what the details of the event were. Or they just said, yeah, like, I don't know. I don't think that it was related to the user. And they were oftentimes blaming the device or vice versa and really not get to the details of what actually might have happened. So that personally was, again, eye-opening and a bit frustrating as a young engineer as well. So I really tried to dig back and look at the process and see what actually was happening and how we could improve the information that we were getting up front. So at that time, I I was making friends with people from the call center and I dug in and tried to see, what their process was for the intake. So I got to sit on a couple of calls and work on the actual intake to basically get more information about what happened during the adverse event. So yeah, just those are two examples of what's really launched me into discovering human factors. And, you know, as you know, I met you at that medical device manufacturer. And I'm grateful that we kept in touch because then eventually I had the chance to join the Human Factors Team at the FDA. And that's, you know, a whole nother adventure of about five years. So, yeah, I'd be happy to also get into the time that we overlapped there too.

Shannon - 00:05:09: Yeah, absolutely. It's interesting. So I came into Human Factors from Post-market issues as well. And I don't know.

Rita - 00:05:19: I remember that, yeah.

Shannon - 00:05:20: For me, it was. I was. Working as an engineer, we learn a lot about systems and design, and we're looking at very specific mechanical electrical problems, right? And understanding those. And then in Post-market, you start seeing issues that are use-related. And I know for me as an engineer, I was like, wait a second, there's this whole other factor we're not considering. How do we consider that? So I don't know, is that similar to your experience?

Rita - 00:05:51: Absolutely. Like I said, I experienced this sort of frustration of not. Being able to solve the problem. Well, even before that, figuring out what actually the problem is, I remember feeling great satisfaction that we were able to get to a root cause for a particular medical device overheating. So through like a combination of talking to, reaching out to these customers and trending the Complaint data, getting together with the CAPA team, interacting in particular with the design engineer at that time. Who ended up being a great mentor, you know, I had the chance to actually. Contribute to closing the loop on that particular device issue, which was very satisfying. And it helped pivot me into actually becoming a design engineer and going down that route. Because I wanted to do a little bit more in those projects. I wanted to become the one that then after the root cause was after we had some confidence that there was a root cause that was related to design, then the product engineers at the time who are the design engineers in the Postmarket realm at the company would take it and run with it. Start prototyping and start running tests, go down design verification validation. So that was the, a realm that I thought was very interesting and I wanted to be a part of. So at that point in my career, I pivoted into R&D and had a really great experience there as well. It was a relatively small team that focused on devices that help people with back pain. So it's something I think we can all relate to. The products were really interesting because they're minimally invasive. So that was another chance I had to be exposed to human factors. I remember working on a product that... Um. That interventional radiologists use to access vertebral bodies. But there was an issue with the stylet of the needle popping out. Um, so I. Basically worked with a more senior engineer to come up with a solution. Well, to be fair, most of the solution was already designed. And the junior engineers were there to try to finesse it and get to a final stage. But, you know, through that process, I was exposed to sales reps that had a bunch of customers. Specifically the surgeons that were complaining about this problem. Uh... I think it was really interesting to go out and actually. Talk to the surgeons themselves and do. Initial, you know, formative human factors evaluations with them out in the field with cadavers, and think about it more from the whole totality of, of those surgeons. You know, are they right-handed, left-handed? Are they, you know, are they going to all have the same anatomy to be able to group the stylet? That's the new one that we were proposing. So those characteristics came into play as well. It wasn't always offered up either by the users. You know, I also had to observe and try to think ahead and have these. Possibilities in mind. So that was really wonderful. I think at the time you were trying to start the human factors methods or like in the quality, the QMS of the company.

Shannon - 00:09:55: But yeah. Pounding the drum of human factors.

Rita - 00:09:58: Yeah. Like during those times it was a bit wild west.

Shannon - 00:10:02: It's before the draft guidance even came out probably right around that time.

Rita - 00:10:06: Probably. Yes. Yeah. Yeah. Mm-hmm.

Shannon - 00:10:09: I find it interesting as you talk through your career, you have talked about your engineering and your work with the devices, but you've also referenced from the beginning, from the work you did during. Your studies. On the patients and the people being served by the products. Is that a motivating factor? It sounds like you started in this field very early in your, even your career journey, even in school.

Rita - 00:10:35: Absolutely. I went to school with the intention of, I think I was leaning towards Gordan Medical School and I was doing all of the courses that would lead me there. But that first experience I had referenced with Engineering World Health (EWH). Is something that I always... Will be grateful for and I attribute to that pivot in my decision to stick with engineering and go to grad school actually. And I'm lucky that the professor from that program, shout out to Dr. Malkin, he also was a huge, mentor and and had like a visionary for what it would look like. To help. You know, rural hospitals or third world hospitals. Get up onto their own feet and equip them to continue to serve, equip them, meaning the engineering technicians at these hospitals, to continue to be able to serve the hospitals, you know, even after we left for, for the end of summer, you know. So I think that was, that was awesome. And it was day and night, you know, the hospital that we were at didn't have guaranteed power. So there were sometimes, a couple of times where the power was shut off and we wouldn't run over to the main engineering technician and see if he needed help to get the generator up and running again. And then we also made friends with the anesthesiologist and he had scrubbed in to help a young lady give birth and then the power went out during that time too. Like he actually, well he had let U.S. Scrub in just to be able to observe, you know, like for educational purposes. I was observing how calm the surgical team was during that moment. It was just like day and night, I think, compared to if that had happened in the U.S. They just took it for granted and rolled with it. So again, we talk about use environments. So their use environment of OR, what it's like to be in OR is so different, I think, from maybe other expectations. Yeah, definitely.

Shannon - 00:12:57: I think Health care professionals in general are very resilient folks. I, in my experience, they're really good at rolling with it. But even in extenuating circumstances, that's fine. I guess there's a reason it's called the sharp end of healthcare, right?

Rita - 00:13:17: Literally and figuratively.

Shannon - 00:13:18: Yeah. Another thing that you had mentioned is you'd mentioned coming into human factors from biomedical engineering. Worked in quality and research and design engineering as well. I think. That is one of the things I get excited about with HF is the diversity of the field that we're in and how people are coming into it from different directions with different backgrounds and all of that comes together to better understand. How our end users and the technology we're developing can interact, they're team players, right? I actually also think something from your background, I think that is very interesting as you're bringing it up is, you know, the of human factors is understanding the technology, but also understanding the people and the situations around it. So like the experiences you just described. I'm picturing you watching this from an ethnographer's lens, right? Understanding that use environment and what those Health care professionals are exposed to. But you've also had experiences, you've lived in a lot of different cultures even, countries, but different cultures. And do you find that your exposure to just living in different areas and understanding different languages and cultures helps you to think through?

Rita - 00:14:48: Yeah, I think it does. I think it gives me, I hope it gives me more empathy and awareness. So I didn't mention another experience I had before joining Agilent. I also worked on a Startup company called Vigor who focuses on people that have COPD and asthma. And partners them with virtual coaches. So before I had joined, I'll be honest, I didn't know that much about COPD. But It is often, and the majority of folks that have it, chronic obstructive pulmonary disease tend to be older and exposed to bad air quality, basically. That could have started happening from an earlier age to, or, you know, a year or two. Earlier career if they had worked at a only at the head. Yeah, that. Bad air quality and chemicals coming out of it. So from the very beginning, you know, these rural folks and people on the lower socioeconomic ends of the spectrum are more likely to have this disease. Um. So I guess I'd always known that fact, but that that's the reality of it. And then same with asthma too. If kids are growing up closer to these environments and their families can't afford to get to live somewhere that has better air quality or aren't educated in that, then they are more likely to grow up with asthma. So it's really sad. And I was pretty encouraged by the team at the Startup to be resilient, as you're saying, to be flexible in terms of the... Product that We ended up. Presenting in. Finding useful to work with these people, basically. So I, yeah, and then at the end of day, instead of, for example, starting with a mobile medical app and kind of more expensive spirometer, we ended up at, OK, let's say we hire coaches that live relatively close, or wouldn't be, wouldn't mind driving 20, 30 minutes to these people, at least for initial setup call. Or set up. In-person visit. And then from there, understand their situation. If they, we actually did run to people that didn't have reliable connections. So reliable phone service, wifi. So it wasn't even a possibility to get on the phone with them reliably. Or ask them to download an app. Maybe they didn't even have a smartphone. We got to the point of mailing out calendars for them to keep track of their diet, their exercise, give them pointers for how to breathe. It was a lot operations-wise, because then on the opposite side of the spectrum, we did have people that were very comfortable with technology that could use our app. That. I think we could be a little bit more hands-off on. But just for the purposes of the pilot, understanding the full spectrum and language plays into it, too. I had the chance to live in Puerto Rico, who, unfortunately, tend to not be a part of the conversation that often in terms of medical devices, even though they're a U.S. Territory, technically. So I think there's quite a few cool and different cultural differences. Over there too compared to mainland U.S.. You know, I could get into it too, you know, if we're talking about real-world evidence, even there's, there's bias there, like, as well, potentially. Or, to be quite honest, if we're discussing human factors testing, I don't think we often talk about. Recruiting in Puerto Rico or Alaska or Hawaii, you know. So yeah, like, I think it's, it's interesting because, yeah, I consider U.S., obviously U.S. Is a country, but it's such a belting pie. Um, and I... I think we try our best to get a good cross-section, but sometimes I wonder if... We could do more. To get like a bigger. Understanding of who our customers are.

Shannon - 00:19:32: Mm-hmm. I think now I have an image in my mind of this research project, at least to characterize the user groups from different areas of the U.S., U.S. Territories.

Rita - 00:19:48: Whenever we have the time.

Shannon - 00:19:53: Sounds interesting. And the other thing is, as you bring that up, I'm... I think on some recent developments that have happened in the clinical trial space. That are really driving higher diversity within clinical trials. It's been very good to see the FDA giving direction and guidance on that front as well.

Rita - 00:20:16: Yeah, I definitely encourage to see that as well.

Shannon - 00:20:19: Yeah.

Outro - 00:20:25: That's where we'll end today. And next time, Rita and Shannon reflect on their recent experiences at the RAPS Convergence in Montreal. You won't want to miss that, so be sure you're subscribed to this podcast on YouTube or wherever you get your podcasts. For more information on what Kymanox offers, visit kymanox.com. That's K-Y-M-A-N-O-X dot com. This episode was edited and produced by Earfluence. Thanks for listening, and we'll talk to you again soon on The Factor.

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