Shannon Clark | Founder of UserWise | Human Factors Engineering, History, & Her Entrepreneurship Journey

The Leading Difference

Shannon Clark is the founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy-to-use medical devices. In this episode, Shannon discusses her experience founding her company, the importance of human factors engineering, her love of history, and why she's so happy about her recent "demotion."

Guest link: www.UserWiseConsulting.com

Charity supported: Equal Justice Initiative

Interested in being a guest on the show or have feedback to share? Email us at [e-mail].

PRODUCTION CREDITS
Host: Lindsey Dinneen
Editor: Tim Oliphant
Producer: Velentium

SHOW TRANSCRIPT

Episode 006 - Shannon Clark

Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.

Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello and welcome to the Leading Difference Podcast. I'm your host Lindsay, and I am excited to introduce you to my guest today, Shannon Clark.

Shannon is founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy to use medical devices. Before founding UserWise in 2014, Shannon was a human factors engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated from UCLA with a BS in Mechanical Engineering and a technical breadth in technology management. Shannon is additionally a certified professional industrial engineer, holds two patents and has written and published three books. Clearly an absolute rockstar, thank you so much for being here, Shannon.

Shannon Clark: Yeah, thanks for having me.

Lindsey Dinneen: Of course. Well, I would love, if you don't mind just sharing a little bit about your background and maybe how you got to where you are. I know, you've gotten to do some really amazing things. You have an amazing company. I would just love to hear a little bit of that backstory.

Shannon Clark: How far back should we go? I think it's interesting that on my application to USC, I ended up going to UCLA, but I did apply and get into USC, just for the record, and on my application. I said that my dream job, I was 17 years old, would be to run a product design firm in Spain. It's pretty interesting that I kind of ended up there and I kind of had that idea so early on, but I didn't really fall in love with human factors or even know about it until I was working at Abbott Laboratories and I had this unique opportunity to apprentice one of the world's leading experts in human factors named Ed Israelski. He was the Director of Human Factors for Abbott for many years, and laid all the groundwork for the international standards and it informed the FDA guidances around human factors, so it was a really unique opportunity to work for him. And from there I was able to really dive into human factors with that practical experience at Abbott. And I knew that I wanted to run my own company basically. And I think I, I finally made it there in 2014 when I saw some great opportunities to help fledgling companies out of Stanford Biodesign and Fogerty Institute for Innovation. And I started out with just myself consulting, and then from there built a practice and pretty soon it was 30 human factors engineers, recruiters, and operational staff as of 2022.

Lindsey Dinneen: Wow. That is amazing. Congratulations. That's, that is no small accomplishment. That is amazing. So human factors engineering specifically wasn't necessarily, it sounds like, the first intention that you may have had going into school. So it's awesome to hear that having that experience is what sort of led you into your career path, but I'm kind of curious, were you always very technically minded, kind of interested in user experience growing up or what was, even going back a little further, what was the spark that interested you in that field in general?

Shannon Clark: Well, I had actually never heard of engineering. My mom's a lawyer, my dad's an accountant. So I didn't know what engineering was going into college, and so I was gonna, study Latin or Spanish or something. But then I thought I don't really know what I'm gonna do after college if I study that. And I had an uncle who was an engineer who said, "you really should check this out." So I took some coursework and I thought I could probably do this. And to be honest, mechanical engineering was a big struggle for me, having not taken any of the AP courses. I took AP Latin, AP Music Theory, all the APs that you don't need for engineering. So I came into school pretty behind and feeling behind, but I made it through and I kind of had my eye on this goal of making user experiences easier for people. I was going back even further, I was really inspired by my uncle Peter Skillman, who's now with Phillips I think in their Design Center of Excellence. And he worked at IDO at the time and he was 35 years old and contributed to this project that was featured on 60 Minutes to redesign a shopping cart.

And it was really inspiring to me at the age of 10 or seven or however old I was, to watch someone take something so mundane as a shopping cart and uncover all these issues that exist with shopping carts everywhere, and then completely rethink the design and improve it. And rewatching that video I can now kind of see with another lens that they even started on the basis of safety and designed for safety, which I believe is so important when prioritizing design efforts to think about, " well, how many injuries are there to toddlers every year in shopping carts and how can we address this and how can we make it better?" And then just a month ago, I actually had my toddler in a shopping cart and she got stuck because the seatbelt wouldn't unlatch. And then it made me think that's interesting, full circle.

Lindsey Dinneen: Oh, that is interesting. Oh, the irony. Oh my gosh. Okay. Yeah. So designing for safety first. So I'd love to hear the evolution of you just starting this consultancy by yourself. And I mean, so you were literally doing all the things, you were marketing, you were doing the actual consulting, you were doing the accounting, I'm assuming. How did that all evolve and how did your leadership ability evolve as you've grown your business?

Shannon Clark: Well, I started out with no management experience, quite young. I started out with just myself. I hired some contractors here and there in 2015 . 2016, hired my first employee and I gotta tell you, I was the worst manager. And she was like, patient zero, she's now at Intuitive Surgical. But I think overall it was a great step in her career, but good for her for getting through, I think, four years of reporting to me as I was learning to be a manager. And I think over time through trial and error, I became a better manager. That was sort of a learning experience for me. And something that people were always telling me as I was starting my company was, " you should learn on someone else's dime. Don't start a company and then learn these hard lessons on your own dime."

But I'm happy that I didn't listen to them and sure there were a lot of really expensive life lessons, like the time we didn't expense $150,000 of expenses because I didn't realize that someone wasn't doing their job for four months. There's all kinds of things that happen as you're start a company. But you just have to learn from them and then embed processes to address any gaps that you uncover along the way. And so at this point, we're just such a strong company with so many internal processes and trainings and rigor, and it's really exciting to see how much it's matured over the past eight years.

Lindsey Dinneen: Yeah, absolutely. Well, and correct me if I'm wrong, but it seems like you recently, in fact, had a bit of a transition even for yourself, for your role. Is that correct?

Shannon Clark: Yes, we brought in a new CEO. I was able to secure significant private equity investment from a private equity firm called NaviMed. And so we're forming a new umbrella organization called ClariMed. And so that's sort of a broader quality by design thesis where we're bringing together a bunch of like-minded organizations to help support product development, specifically in the medical space. And we're starting that organization with two human factors consultancies. So it started with UserWise, my company, which was acquired in August of 2022. And then in January this year, 2023, we acquired Harvey Medical, which is a seven or eight person human factors consultancy in the UK and the Netherlands. So, that's where we're at today and I'm thrilled. I, I probably put on LinkedIn that I'm thrilled about this quote- unquote "demotion" to Principal Human Factors Engineer, 'cause previously I was Director of Human Resources, CFO, CEO, and Principal Human Factors Engineer, and it was a lot. Yeah. Let's just say I didn't get a maternity leave. But now I'm just really excited for the future and I have a CEO with 17 years experience running and growing a regulatory consultancy. So I, I'm just really excited to report to her and she's an inspiration to me every day, Kelly Kendall.

Lindsey Dinneen: Awesome. That's fantastic. How has the transition been for you? Did it take a lot of transition or did it come easily? How was it for you?

Shannon Clark: It's been a huge transition, cuz Kelly runs the business based on data and I think when you have investors involved, you have to really present a lot of data to them. Whereas before I didn't have to report to anyone or speak to anyone or ask anyone any questions about what I'm doing, which I think we're a lot better off now cause I'm not just making decisions as I go along. I have a, a whole support system to help me through all the decisions on a day-to-day basis. So, that's been really relaxing to share the responsibility and, and have support. But yeah, it's been a lot of work to try to come up with the data. We're trying to integrate Salesforce. We're just kind of like a small company, quickly growing, so there's a lot there to work on.

Lindsey Dinneen: Yeah. Absolutely. I'm curious, is there a particular moment that stands out to you because it kind of clearly confirmed that this was the right career path for you or the correct industry?

Shannon Clark: It just immediately clicked. Back when I was working for Ed Israelski at Abbott and contributing to standards committees and submitting feedback to the FDA and draft guidances on behalf of Abbott, all of that work really created a spark within me, I'd say. And I think I would pinpoint it on one project I worked on, which was to review all recalls of medical devices by the FDA over the course of time that were due to human error. So, for example, an automated external defibrillator that was on the market, I think this was 2009, where there was a low battery indicator that would blink and falsely cause individuals to cease use of the device unnecessarily. So the idea that they were confusing this red indicator light to mean, "oh, this is broken, don't use it," versus "it's just low battery. Change the battery when you have a chance, but you could have resuscitated the patient."

And I wrote this 80 page internal report. All these events that had happened and it really brought to life the importance of the then new FDA focus on human factors. And the fact that you need to really intentionally bake safety into the design of products from the get-go. It's not something you can just add on post-market or even figure out through human factors validation at the end of the process. It's something that you need to think about constantly throughout design, and again, prioritize those design efforts according to risk and safety and according to patient harm and user harm so that you can, at the end, have a product that doesn't result in a recall like that.

So when I saw all that data, it really centered my focus and brought clarity to me that this is something that I wanna do for the rest of my life, 10 years, 20 years. I don't know. I guess I wouldn't say for the rest of my life. But I really was super inspired to do something about it cuz I also read that there were half a million deaths every year due to preventable medical errors in hospitals alone, just in the United States. So we basically have a whole pandemic happening every year in hospitals. And some of that is due to medication errors and hospital processes. But that figure doesn't even capture instances where they amputated the wrong leg. I mean, these are deaths. And so I'm, I'm really dedicating my career to reducing that number of half a million to something lower.

Lindsey Dinneen: Wow. Yeah. That's amazing. I'm so thankful for people like you that are doing that research and like you said, safety first, building it into the design from the very get-go. That's fantastic. Yeah.

Shannon Clark: And I love what Velentium's doing with regards to cybersecurity. I think that definitely follows the same kind of premise of protecting users and ensuring safety.

Lindsey Dinneen: Yeah, absolutely. Yeah. There is so much that goes into it. So any angles that we can take to help protect people is absolutely worth it. So, how would you define leadership or what does leadership mean to you?

Shannon Clark: I think leadership to me is inspiring others to be their best selves and fulfill their own missions, whatever it may be. So sometimes I can spark someone to be inspired to follow my footsteps and become a human factors engineer. Or maybe someone wants to pursue something a little bit different and just letting them uncover their own truths and pursue their dreams. That's probably the main thing I ask in interviews, " what is your dream job?" Because I wanna make sure that you're in your dream job, whatever that may be. So I guess that's what leadership means to me.

Lindsey Dinneen: I love that. Yeah, absolutely. And then what would be your best piece of advice for someone interested in obtaining a leadership role, either within the medtech industry, or very specifically following a similar career path to what you've done? What would you say to someone who that's a goal of theirs?

Shannon Clark: Well, my specific path, I believe, can in fact be replicated, in that, I saw an opportunity to uniquely become an expert in a field that was emergent. And there's many emerging fields that result from regulatory shifts. And in this case, UserWise, came out of the 2011 draft guidance about human factors issued by the Food and Drug Administration that was later published as final in 2016. And so there from my position at Abbott in 2010, 2011, I was able to see that coming down the pike and I saw the huge amount of opportunity at hand, and I saw where industry was and where it would be going. And out of that, I was able to found my consultancy. So I worked tirelessly to transform myself into an expert, not only by working 12 hour days at Abbott and giving them everything I had, but also reading all the textbooks on the syllabus for human factors master's degrees at various universities and had a stack of 20 books that I was working through. So it was all sort of self-taught, but ultimately I saw this opportunity due to a shifting regulatory landscape and things like that happen all the time in all industries. And there's all these opportunities that exist that are just a great opportunity to create a new business around it whether it's consulting or software as a service. Yeah, tons of opportunities out there.

Lindsey Dinneen: So sort of being open to maybe opportunities that you wouldn't have originally pinpointed for yourself, but being aware of various trends and kind of responding to the situation. Is that part of it?

Shannon Clark: Yeah. I mean, ultimately, I guess I'd describe my business model, if it were to be replicated, if you wanted to have success in this manner is to uncover regulatory trends and then find an opportunity, a business opportunity within that. But I guess more generally, if you're looking for a leadership position in the medtech field, I think that expertise certainly is highly valued. And engineering abilities is also highly valued. So, I think you need to go deep before you go broad. I think I do see a lot of like marketing experts, that maybe haven't gone scientifically deep, end up as CEOs of these companies, but I think the best background of all the CEOs that I work with, I always enjoy working with CEOs that have a technical background cuz they can truly understand the ins and outs. And I, I see limitations among some of these CEOs that maybe just have sales backgrounds.

Lindsey Dinneen: Sure. Yeah, that, that makes a lot of sense to me. I can understand that.

Shannon Clark: I think I'm talking to a salesperson right now, so I hope I haven't offended you.

Lindsey Dinneen: Not at all. I am more on the marketing engagement side of things, but I wouldn't be offended regardless, because you're right, you need both to be successful. So, absolutely.

Shannon Clark: Go deep first and then go broad. That's kind of the advice that was given to me as well and I followed that advice.

Lindsey Dinneen: I like it. I like that a lot. Yeah. Well, so I know from your bio that you are a published author three times. Right? I would love to hear about that and what have you written about and how did that all come about?

Shannon Clark: Well, nothing too impressive, and it's quite off topic, but I really enjoy history. So I authored a history of a local neighborhood, which is actually where UserWise is located in San Jose. And so I wrote this 150 page history book and we sold I think 3000 copies. And all the funding went to fund local farmer's markets as well as ultimately the annual 4th of July parade for San Jose. So I wrote that book and then wrote a follow on, a sequel about parades in the Bay Area, California. Have you ever heard of the Pasadena Tournament of Roses?

Lindsey Dinneen: I have.

Shannon Clark: So, we used to have one of those in Northern California. There's a whole Northern California, Southern California rivalry. That was huge when I went to UCLA. But we used to have our parade and our parade died out with the Great Depression, and we tried to resurrect it in 1960, but it didn't work out. So it was just kind of an interesting forgotten history that I wanted to capture in a book before it got lost forever.

Lindsey Dinneen: Yeah. That is awesome. Very cool.

Shannon Clark: And then the third book is how to get a job in management consulting. It's called "College2Consulting." It's a silly book, but I think it's pretty helpful if you wanna get a job at LEK or some management consultancy. I didn't come up with all the material for that, but I was the ghost writer.

Lindsey Dinneen: Oh, so cool. That's awesome. So what are some interesting industry trends that you are looking forward to as you continue on with UserWise and beyond?

Shannon Clark: I guess when I think of industry trends, I immediately think of what's happening with Europe, with MDR, and where's the FDA headed specifically with regards to human factors cuz that's ultimately what's gonna guide where UserWise is going next. With the FDA, there's been a lot of turnover with their human factors review team over the past five years, and it's created a shift towards requiring more and more. I think that's always the story with regulations where before maybe we didn't submit a full 60 page human factors engineering submission report for a lower risk device and just submit a protocol. These days they're just rejecting a protocol if there's no full backup for all the elements found in a human factors engineering submission report. So I think overall, I guess as always there's just more and more regulations. I do hope to make some progress. I'm headed to the International Standards Committee later this month in Germany, and I hope that I can kind of start socializing some ideas around reducing the burden from an international standards standpoint for human factors.

So, I guess another industry trend that's a little more specific is that we just finished our multi-year study on training decay, whereas in collaboration with the Food and Drug Administration. And to date for combination products, so drug delivery devices, you're basically required to conduct human factors testing with untrained users. And it's created a context where there's some drug delivery devices where if they were pure medical devices, they would easily get clearance. But since they're a combination product, they have a drug, they're reviewed by DMEPA, CDER, a different human factors team. They're just unapprovable because untrained users are not capable of using them successfully. So I'm hopeful that with our research, we can further promote the concept of trained usability testing and invite more devices to the table instead of requiring perfect use for combination products. That's a hope of mine. But again, with more and more regulations we'll see if that comes to fruition.

Lindsey Dinneen: Yeah, of course. Yeah, that sounds like a really good path forward. So it'll be interesting to see, like you said, how the landscape changes over time. So how do you prioritize your own continued learning and growing as a leader these days? I know you mentioned having stacks of textbooks, which I love, but nowadays, how do you continue to develop your own skills and knowledge?

Shannon Clark: Well, I think I mentioned earlier that I am thrilled to report to Kelly Kendall, CEO of our company. And so I learned from her every week by watching the way she runs the company, the way she makes decisions. I've just learned a ton. It's been drinking through a fire hose with regards to key performance indicators and everything to do with running a business in a more formal manner. Cuz I ran my business based purely on intuition and not really on data. And when you really get a grasp of all the data associated with a business, like she says, it's about turning knobs up and down and adjusting and fine tuning once you know what the knobs are. And so, I feel like myself professionally, I've grown so much just having a mentor continuously working with me. I have in the past had executive coaching, but that, that, pales in comparison to what I'm now able to experience having a seasoned and experienced CEO to report to.

Lindsey Dinneen: Yeah, and it's completely a hundred percent relevant to you and your business, which is awesome that you get that experience. Very cool. Okay, so just for fun, imagine that someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry. What would you choose to teach and why?

Shannon Clark: Well, I think the answer that I might be supposed to say is moderating. So I have a lot of experience moderating usability testing and minimizing bias for participants so that you can extract truth. So basically, as a moderator, you don't wanna get in the way of the truth of what a participant is experiencing or feeling or demonstrating through their interaction with a product. So we just launched a moderator course, which I'm really excited about. But I guess after having done all that work for the past months to launch that course, I need a break. So if I could teach a masterclass, I guess it would be on the history of the Maya, which right now I'm trying to learn Mayan hieroglyphs. And I have an interest in archeology. And to be honest, I know nothing about the Maya, but maybe I have a kind of a crazy overconfidence going on where I feel that I wanna learn everything about it. And I, I feel like I've done this in a couple of areas of my life where I'll learn everything about a subject and then kind of become like an expert. And so that's kinda my next side hobby. I have some ideas there about what I'm gonna do.

Lindsey Dinneen: Oh, that's awesome. So what sparked your interest specifically in that?

Shannon Clark: I think in part it's because I've been to Mexico a number of times. I speak Spanish. And then I have an aunt who's Mayan who was involved in kind of raising me at an early age. So, that definitely sparked my interest. And then I've been honestly, like watching a lot of TV about Ancient Apocalypse and all those shows. I don't know if you've seen them, but I was just like, oh yeah, this is so cool.

Lindsey Dinneen: I love it. Yes. Isn't it great to have something outside of your main, day-to-day job life focus that just kind of brings you this other level of passion and joy-- I'll just put it, put it that way.

Shannon Clark: Yeah. This is certainly, it really stems out of being able to share the burden of running a company with others namely my boss Kelly, and it opens up my time to actually think about other things. And that has been a focus for me since the transaction in August. It's something I'm excited about just to have some extra hours in my week to think about things that aren't related to work.

Lindsey Dinneen: Yeah. That's fantastic. So what is the one thing you wish to be remembered for after you leave this world?

Shannon Clark: I guess being a good mom and that's really all I care about. I have one daughter, her name is Emily, and she is 22 months old. And she's great. So that's definitely my focus to be a great mom. And it'd be cool to be remembered as a good contributor to the industry of human factors, but I think more importantly, I wanna be a good mom.

Lindsey Dinneen: Yeah. Yeah. Absolutely. Aww. Oh my gosh. I love it. What is one thing that makes you smile every time you see or think about it?

Shannon Clark: Well, my daughter Emily, obviously, lemme try to come up with a different answer.

Lindsey Dinneen: Ok, it's a great answer though.

Shannon Clark: Yeah, that's gotta be my answer, sorry.

Lindsey Dinneen: No, that's fantastic. Well, I just want to say thank you so much for sharing a little bit about your background, about your company, about the industry, where you think things are going, and your advice. I just really appreciate your time today, and I love hearing the why behind how you got into this and what makes you tick. So, thank you. And plus, it's really fun to hear about your hobbies outside of work too. And Emily, and course Emily. So, we are honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So Shannon, thank you so much for picking that organization to support today. Thank you so much for your time. We wish you continued success as you work to change lives for a better world.

Shannon Clark: Thanks so much. Thanks for having me.

Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two, and we will catch you next time.

The Leading Difference podcast is brought to you by Velentium.

Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.

Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.

Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.

Visit velentium.com to explore your next step in medical device development.