Allison Komiyama | Founder, Bluestocking Health | Medtech Hype Woman, Former FDA Reviewer, & Community Advocate

Allison Komiyama, a consultant and senior regulatory strategist at DuVal & Associates and founder of Bluestocking Health, shares her journey from neuroscience and an FDA reviewer role into regulatory affairs and consulting. Allison explains why companies should educate FDA about their device by telling a compelling, respectful story, and discusses why “getting through FDA” is often the starting line. She highlights the post-clearance work of launch, adoption, and promotion while staying within FDA marketing rules. Allison also reflects on leadership, relying on community and advisory boards, her volunteer work, and the moments that affirm her impact when devices reach patients. 

Guest links: https://www.bluestocking.health/ 

Charity supported: Feeding America

Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 

PRODUCTION CREDITS
Host & Editor: Lindsey Dinneen
Producer: Velentium Medical

 

EPISODE TRANSCRIPT
Episode 083 - Allison Komiyama

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] 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.

[00:00:28] 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.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Allison Komiyama. Allison is a consultant focused on getting medical devices to market and helping them stay there. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about the regulatory submissions as a faculty member at SDSU Global Campus.

She received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010 to 2011, received her Regulatory Affairs Certification US in 2014, and became a RAPS Fellow in 2024. Throughout her career, she's been actively involved in hundreds of pre-submissions and pre-market submissions for a wide variety of medical device companies.

She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market. She's also a senior regulatory strategist at DuVal & Associates, where she helps companies navigate the FDA pre-market process. Alright, well, welcome to the show. I'm so glad you're here today.

[00:01:59] Allison Komiyama: Thank you so much. I'm so glad to be here.

[00:02:02] Lindsey Dinneen: Well, I've been looking forward to this conversation very much. I got to meet you, I think it was maybe last fall, and it was after watching a video where I believe you were chopping wood while explaining a medtech concept, I and was like, "I have to meet this person."

[00:02:21] Allison Komiyama: I like that that is how we, we, yeah, that you were introduced to me is through a wood chopping video. But yes, that was me. I love... I am a lumberjill, so yeah.

[00:02:31] Lindsey Dinneen: See? And we will get into this, let's start with just a little intro into who you are, your background, and what led you to medtech.

[00:02:39] Allison Komiyama: Sure. So background's actually biology, neuroscience. Left academia after graduate school and went and worked at FDA. I was just there for a brief period of time, but it was very instrumental in having me understand what I wanted to do with my life. I knew I loved regulatory affairs. I knew that I loved med devices and the intersection of medtech and innovation and regulatory and, and, and, and, and, right? Like, so all the things I was just super excited to be part of this space.

But after leaving FDA, sort of tried to figure out what... You know, did I wanna work at a company? Did I actually wanna be at a specific industry job? Tried that on. Tried that hat on for a little over a year at an IVD company and just sort of missed all the stuff I got to work on at FDA. So I kind of saw it as the second-best thing after FDA is to go into consulting. So really worked with a lot of startups and companies that were bringing their technologies to market, and yeah, never looked back. I did sort of change positions over the years from going from a small consulting company to my own consulting company to a large consulting company, and now I'm sort of back at a, a smaller regulatory law firm. It's not that small, but, you know, 15-some people at DuVal & Associates working with companies that need help with strategy and regulatory support as well.

And also started my passion project, which is Bluestocking Health. It is a medtech hype company, is what I call us. And we really work on helping companies after they've made it through FDA onto what... you know, what does, what does their launch look like? How do they get people to adopt their technologies and not sort of flounder and, and fail, right? So I, I love seeing really cool, nerdy, geeky tech get to market, and I think we all have a sort of inner geek that loves stuff like that, and it's my happy place where I can just kind of talk about those things and share it with patients and caregivers alike.

[00:04:47] Lindsey Dinneen: Amazing. I love that. Yeah, and so much to dive into. But one of the things also I remember, so so I, I watch this video and you're chopping wood, and you're, you're clearly super passionate about medtech. And then I think the next one, were you possibly like baking or doing some sort of maybe chopping?

[00:05:08] Allison Komiyama: Yes. I do flower arranging, so it might've been that one. I, I-- That's a great idea, though. I love to bake. I love protocol, so I think you're onto something. I need to come up with a video maybe where I'm talking about, like, the de novo process and, like, baking a cake or something. So.

[00:05:27] Lindsey Dinneen: Amazing. And you're right, it was flower arranging, and I was thinking at the time, "Is there anything you don't do?"

[00:05:35] Allison Komiyama: Yes. I-- There's a lot of things I don't do or don't even dare to do. Mostly dangerous sports. I, I'm a rower, so I love to row where no one's touching you. You know, like no one... There's no physical contact. You're just in a boat pulling an oar, and it's quiet and peaceful and, you know, also you're working hard. So, but otherwise, yeah, don't want any contact sports in my life. And but there's a lot of things I don't do, of course. I just have a lot of hobbies and things that I enjoy doing.

[00:06:10] Lindsey Dinneen: Okay. So did the idea for Bluestocking Health come from? I mean, I know you explained a little bit about what the company does and who it helps, but first of all, I'm really curious about the name, and second of all, I'm just curious about, yeah, what made you go, "Gosh, this is the right time for this"?

[00:06:27] Allison Komiyama: Yeah, great question. I-- So Bluestockings were... I'll, I'll go first into the origin story 'cause I think it kind of helps explain why I picked up that name. The Bluestockings were a group of mostly women in the 1700s in England who were, you know, kind of tired of sitting around playing card games and, you know, learning new dance routines-- not that there's anything wrong with that-- I love doing all of those things. But they decided they wanted to pursue some more intellectual and intellectually stimulating conversations with people.

So they would invite women and men into their salons to have these conversations, and they would talk about botany and, yeah, science, art, literature, theater, all of the things that sort of sparked their interest. And they would say, you know, "Don't worry about wearing your black stockings," which were, like, the highly fashionable, expensive stockings of the day. They said, "Just come in your blue stockings. It's fine." You know, which were wool and, you know, cheaper.

And I was like, oh, I love that idea of just people getting together, talking about stuff that they find interesting, and having it be like, "Come as you are. Wear your sweats," you know? "Don't worry about getting fancy." And that resonated with me. And so I thought, you know, what I want to build is something similar to what the Bluestockings had, but have it be more medtech or health-focused, and so hence Bluestocking Health was born.

I, yeah, I really... A-as I said earlier, I saw a lot of companies feel like getting through FDA was the finish line, and I s- you know, I would tell them, like, "No, that's kind of the starting line with a lot of what you're going to now need to build." You know? It's-- I, I think historically FDA was seen as, like, the hardest thing to get through, which isn't always the case, right? The, the 510K program is historically very successful with getting devices cleared. You know, FDA does wanna work with you, and that was my narrative and my mantra always was like, you know, "How do you work with FDA to get through FDA?"

And then once you're through FDA, what's next? And I wanted to have those honest conversations, you know, as these companies were considering the product development, their quality system, their regulatory, and, you know, even reimbursement is also part of that post-market conversation. And I wanted them to also think about, "How are you gonna get patients to know about this? Like, what are ways that you can promote yourself and promote what you're doing without misbranding or mislabeling or adulterating anything, right?"

You wanna stay within FDA's regulations and not do anything wrong marketing-wise. But it's also something to get really excited about, and I think we've often forgotten that a lot of these medtech devices do really, really cool things, do really amazing work to help people, help people s- you know, improve their quality of life. Let-- Help them survive, get them to live longer, let kids actually make it to adulthood, right?

So there's so much good that I wanted to amplify that more. I wanted to get people to not just focus on the negative, right? There is, there is a lot of harm that can come from any sort of drug, device, anything, but there's also a lot of good. And so I think especially right now in the world we need more good things to talk about. Not that I wanna, you know, look at everything through rose-colored glasses. But I do think if we can focus on some of the good that's going on in the world and the things that we have in common, what a great conversation to have.

[00:10:14] Lindsey Dinneen: Oh, yeah, I couldn't agree more. And I love the fact that and you're so much fun. You're helping these companies also get excited too, because I think sometimes it's really easy-- I mean, we need to take our industry seriously. It's a serious industry and real life consequences, good and bad, from innovation...

[00:10:29] Allison Komiyama: Yes.

[00:10:30] Lindsey Dinneen: ...But I think you know, we've, we've talked a lot about this recently, even ar- along amongst just some of my colleagues, is like we're gonna take, we're gonna take our actual work very seriously, of course, but we're gonna not take ourselves super seriously. We're gonna have fun. We're gonna celebrate. We're going to each other why we're here and why we're doing this, 'cause otherwise it can get easy to get kind of bogged down in the, the nitty-gritty.

[00:10:52] Allison Komiyama: Oh, it's so easy to spiral. I-- And I feel like a lot of media allows us a-and, and capitalizes on that doom scroll/spiraling of, "Oh gosh, everything's bad." And I wanna be informed, but I also, as you said, I don't wanna take myself that seriously. Like, I have so many hobbies. I laugh a lot. I have really great conversations with people, and I think that's what I, you know... the legacy I wanna le- leave behind is that I made the world a little better than when I started here. And also that I had a lot of joy to share. So yeah.

[00:11:31] Lindsey Dinneen: Okay. So I-I'm curious, going back to your days at the FDA, what are some of the common things that you saw where perhaps there's either a misconception about the process of approval or just mistakes you might have seen that were kind of common that maybe those who are listening who are trying to, you know, get through it as, as easily as possible could benefit from?

[00:11:54] Allison Komiyama: I think one of the biggest misconceptions and it wasn't anyone's fault, was that FDA are the experts in what you're building. And maybe, maybe folks knew that that wasn't the case. You know, they walk in and they know that they're living and breathing their technology and their device day in and day out. They've been building it for years oftentimes. And so to think that FDA understands your patient population, understands the, the sensor technology or whatever technology you're building understands your software, your materials, all, all the various things that go into a s- a pre-market submission, is a terrible assumption to make, right?

Not that you wanna treat FDA like a bunch of dummies, that you're like, "Oh, you guys don't know anything. I'm gonna have to start from, you know, square one here to really walk you through everything." But you definitely want to communicate and be able to tell a really solid story to FDA about what you're building or what you've built, and why you believe it's either safe and effective, or why you believe it's substantially equivalent, or why you believe the benefits outweigh the risks.

And so I think if you can be that storyteller, if you can really walk FDA through what it is you've built, and why you think it should be, you know, allowed to enter interstate commerce, you've w- you know, you, you're already ahead of the game. So I think any company that really is trying to figure out what's that first interaction they're gonna have with FDA, whether it be at a pre-submission or just straight to pre-market submission, right?

They're just gonna file the, the, the 510K or what have you. Really making sure that you've explained your product and they know why you're there. Otherwise, you are going to cause more questions than answers from FDA, and that's a big concern when you have somebody who doesn't understand what you're doing or why you've built it the way you've built it. That can really set you back.

[00:13:56] Lindsey Dinneen: That's great advice. So, so being really prepared to kindly educate while telling the story, but you know, doing so, of course, in a, like you said, a respectful way. But, but having those answers ready, having the narrative really thought out so that you can walk in with that authority, but also explanation and storytelling. Yeah. Okay.

[00:14:19] Allison Komiyama: Exactly. Yeah. It is. I mean, I always my-- I've actually, I have a podcast that I f- a few of my guests recently, they've all been expert or experts in how we tell stories, which I love even just... I mean, how we tell stories to our children is very different to how you tell a story to a colleague at work or, you know, the... and there's a way that, once you know your audience and once you know what it is you're trying to convey, there's a very clean path that you can follow. I'm still working on it. I have to, I have to confess, I am not a great storyteller. I have a tendency to get sidetracked and off topic, probably like what I'm doing right now. But, but you know, bringing it back and, like, what are, what are we trying to do? What are we trying to accomplish? And that I think that storytelling is really valuable when you have FDA as your audience.

[00:15:15] Lindsey Dinneen: So I know, like you said, you have many hobbies and lots of things that keep you occupied, but you also do a lot of volunteering for boards. And I was wondering if you could share just a little bit about some of that experience and what you're passionate about there.

[00:15:29] Allison Komiyama: Yeah. I think I've always been a big fan of volunteering. I think it's one of the ways that I I meet new people, I get involved in s- things that are outside medtech, which I think is extremely valuable. There's so many voices that even if it's not directly in medtech, everyone's impacted by medtech in some way, right? Like I always say, "You're either gonna start in a hospital or end in a hospital, and you're probably gonna go into a hospital at many different times or use a medical device, whether it be on your phone or, well, while you sleep or," you know, for any-- I don't know, there's a million purposes that people use medical devices.

And I wanted to have more voices around me that that are, that are helping humanity, but in a different way. So, one of the boards that's always been near and dear to my heart, of course, my rowing club. I love... It's the oldest women's rowing club in the world. It's called Slack Rowing Club, based here in San Diego, and I help with a lot of the programs, but also fundraising, membership, and just, you know, having this really dynamic group of 400 women that some of them row, some of them are just there to be part of a community and help each other, which is pretty marvelous.

And we do a lot of actually talks. Like we'll have a speaker series and we'll bring in physicians or we'll bring in people who are talking about sleep and perimenopause and menopause or, you know, various topics that definitely impact our our cohort. It, it's actually kind of similar to Bluestockings, like the original Bluestockings, where we'll have someone come in and talk about architecture. Like there's various things. So I love doing that. It's also-- They're-- The members are from like 12 years old to 102 years old. It's pretty amazing, and just, like, this great dynamic group of women who are fun to volunteer with and also sit in a boat with.

The other one that I've joined last year was the International Relief Teams, which works on helping bring some sort of relief to an emergency situation, whether it be floods or fires or famine or war. Like, there's, They partner-- We partner with different organizations that are, like, boots on the ground in those areas to either build houses or get m- meals or get water to where it needs to be in an emergency. So IRT is fantastic. They get, like, one of the highest ratings of nonprofits.

The other one is Indy Medtech. Really cool. That's a very medtech-based one. It's a virtual board, but it is building a community of medtech suppliers and people who are just needing support from each other or you know, either hiring or, "Hey, I have a question. Can someone help answer this 'cause I don't know where to go to get the answer to this?" So really cool, and they, they're doing a podcast as well. I love it.

And then last but not least is the San Diego Regulatory Affairs Network. So I have been in San Diego, moved here back here, I should -- i'm from San Diego-- but moved back here in 2011, 2012, and I joined the San Diego Regulatory Affairs Network. It's the SoCal... Like, there's a similar one in Orange County, the Orange County Regulatory Affairs, so OCRA, and then there's also, of course, RAPS, and there's a Southern California chapter. And it's just a group of regulatory folks that love to meet up, love to support each other. "Hey, I have this job opening coming up. Hey is there a mentee that would like a mentor?"

And so I'm now the VP of programs for that, and once a month we try to have a speaker either virtually or in person. There's gonna be some in-person ones. And I love it. It's just a great way to network, to support each other, and also to learn more cool stuff going on in regulatory. So yeah, that's a smattering of the ones that I'm part of. So, you know, as, as you said, like, it's kind of like they're all over the place, but it definitely makes me feel more connected with humans, with our-- you know, like, and, and not doomscroll. I'm, I'm too busy to doomscroll. So.

[00:19:44] Lindsey Dinneen: That's, that's a good thing, I feel like. So, I love that. Okay. Those are g- those are such cool organizations. Thank you for sharing a bit about them.

[00:19:51] Allison Komiyama: Yeah. Thanks for asking.

[00:19:52] Lindsey Dinneen: Yeah. So all right, I'm curious. Going back, could eight-year-old Allison have ever imagined what you're doing now?

[00:20:02] Allison Komiyama: Never in a million years. Yeah, I think I, I knew I loved biology and bugs and science at a very young age, so I knew that I was probably on that trajectory. But if you asked eight-year-old-- or actually, I-- if you asked five-year-old Alison what she wanted to be, the first was hummingbird, and I did... That did not pan out.

[00:20:29] Lindsey Dinneen: Dang it.

[00:20:29] Allison Komiyama: But and then I would say florist 'cause I love flower arranging, so that is something that I've s- I've kept up with, as you said, like you saw the video of me arranging flowers. I still love doing that. I, I enjoy that creative outlet. But not in regulatory. I didn't really know that regulatory affairs existed as a career especially until I was 26. I mean, which is crazy to think, like I was in grad school, and I took a course on the history of FDA, and I was like, "What is this? This is so exciting, so interesting." And I knew that was something, that something along those lines is what I wanted to do with using my biology and, and neuroscience background, but also how do I maybe get closer to medicine in a certain way? Like, I, I didn't wanna be a medical doctor, but I knew I wanted to help people. Like, I think most people wanna help people. And that was, that was the right pivot for me at that point.

[00:21:32] Lindsey Dinneen: Amazing. So, all right. So you've had a bunch of different leadership positions now over the years. And of course, you have led your own company now a couple different iterations, I suppose, of, of what you've been doing. But what has that leadership journey been like for you, especially perhaps how different it is between working for another company where you might be in a leadership role versus leading yourself and your company?

[00:21:56] Allison Komiyama: Great question. I-- what was it, what's it been like? I would say there's like equal parts fearlessness, excitement, and terror. I don't know, like I-- maybe those are all kind of, of the same like ilk of those, those feelings. My daughter always says, she's like, "I'm nervous and I'm excited," like before she goes on stage in the talent show, and she's like, "I'm nerve-cited." And I, I, I use that a lot now too 'cause, you know, before I give a talk or before I you know, go on a podcast like this, I'm like, "I'm nerve-cited," 'cause it's gonna be something that I haven't done before, right? Every day is a little different and... But it's also exciting to do. I

Yeah. I, I feel like it was not always easy. Like, people are like, "Oh, you made it look so easy and, and just, you know, seamless." And oof, there were moments that I really struggled. It's... You know, there have been times that I really relied on my family, on therapy, on my friends to really help me. And even just, you know, something as simple as I had a friend who made my first website for me. He was like, "You're so busy and stressed," like, "Let me help you." And so I think calling on others and really having people be your community that you've built, right? Like, I think sometimes we try and go it alone, and maybe that's the worst thing to do when you're building something 'cause you really need to rely on others to help you out. And so I've had, you know, I've, I've, I've worked really hard on my network and to build the friends and colleagues that I want to surround myself with, and then I have reached out to them when I knew I need them.

So I, for example, I think with Bluestocking Health, I... When I was-- Before I launched in last year, so September of 2025, I called a bunch of folks that I really trusted to tell me if I was going off course or to also help me build stuff. And my advisory board for Bluestocking Health is amazing. Like, they're not all in regulatory, 'cause that's not what I wanted to build. They're in media. They're in quality system, reimbursement, business strategy. Like, there's such a diverse group of folks that will also help be my sounding board, right?

Like, I had a couple medical doctors that I reached out to that are on the advisory board that I was like, "I'm thinking of doing this. Can you give me, like, your thoughts pro/con?" And they always are so willing to help, right, if they have the time. It's been extremely rewarding. So I would say that leadership journey, again, not the easiest at times, but also when it gets hard calling on those friends to really support me has been really marvelous.

[00:24:49] Lindsey Dinneen: Yeah. You know, that's such an interesting thing because this has come up a lot, especially in the last few episodes and just conversations I've had in the industry of the importance of community and mentorship and surrounding yourself with those good people who you can call and go, "Okay, I have this, I have this, I think maybe crazy idea. What do you think?" Or just, "Hey, life is a little tough right now. Can we just, can we just talk?" So that's...

[00:25:15] Allison Komiyama: Yeah.

[00:25:15] Lindsey Dinneen: ...Really cool.

[00:25:17] Allison Komiyama: Yeah. Absolutely

[00:25:19] Lindsey Dinneen: Yeah. Okay. So as you've gone through your career, and especially within the medtech industry, which seems like you've really just, you know, fell in love with and, and stayed, so that's wonderful. Are there any moments that stand out to you as really affirming that, "Yes, I am in the right place at the right time"?

[00:25:40] Allison Komiyama: I think every clearance De Novo granting that I've ever been part of, even if my name's not on the file, has been one of those moments where, oh, it feels so good. It feels so great to see those companies make it through FDA. And then also, you know, to the next point or d- you know once they are selling and they're, they're helping patients, I've had clients reach out to me and say, "I just got this amazing testimonial from somebody and I wanted to share it with you because you were part of that journey." And oftentimes I'll say, "Can I share that with the FDA reviewer that helped us 'cause they're still there and I really think that they would value that, that piece of information, just that commentary and that validation."

I mean, w- I've had ones where the testimonial was like, "Because of this device, my kid is alive today. My kid would have been-- would have died two years ago if it hadn't been for this product." And like, I even just got chills. Like I-- honestly, it feels like even though I'm not a medical doctor, even though I was, you know, integral maybe in putting their 510K together or their submission together, and I've never touched the device necessarily, I feel so rewarded that it's like, we did it. We did it together, right? And I, I wanna share that with others.

I think that's part of what I'm trying to do with Bluestocking Health is like we all are part of this community, and it's not that we just like clock in and we, you know, do document control or, you know, work on our risk assessments and, you know, clock out for the day. It's like, no, we, we do all help save lives, right? What a, what a powerful thing to be part of and to know that that's, that's something that you helped do. I don't know. I, I-- maybe that sounds again a little too like look how great we are. Like how, you know, look at, look at how amazing this space is, but oh, it is. It 100% is, so.

[00:27:43] Lindsey Dinneen: No, I could not agree with you more. I've, I've always felt the same way of just like, "Okay, I'm, I'm not the scientist, I'm not the engineer, I'm not the regulatory affairs person. I, you know, I play a very small role. I, I help talk about the devices." I sh- you know, the marketing...

[00:27:59] Allison Komiyama: Yes.

[00:28:00] Lindsey Dinneen: ...And that's, you know, that's, that's not the biggest component of bringing these devices to market by any stretch of the imagination. But I do get to play a role, and I think that is the coolest thing ever. Yeah.

[00:28:12] Allison Komiyama: Yeah. Well, and think of-- I mean, I'm gonna be your hype woman for a second because think of all the people who learn about that tech or understand, "Hey, this might be something right for me or my loved one, and if I hadn't learned about it or if I hadn't you know, been exposed to this idea or even knowing that this is in clinical trials, okay, now I'm gonna go look into the clinical trial." Like, that information sharing and even just talking to people or talking to laypeople, like, there's such an important piece of the marketing and the strategy around that, that it's huge. I-- you know, like, directly or indirectly, you've saved a life, right? How cool is that?

[00:28:56] Lindsey Dinneen: Yeah, exactly. How cool is that? It's, it's remarkable. Okay. So, all right. Pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want.

[00:29:09] Allison Komiyama: Ooh, yes.

[00:29:10] Lindsey Dinneen: What would you choose?

[00:29:10] Allison Komiyama: I mean, all of the things in my header, I think at LinkedIn. So I lo- but I'll, I'll give you a real answer in a second. I think, I mean, all of the... I love my creative outlets. So I love flower arranging, I love face painting, I love chopping wood. I love cross-stitch and needlepoint, and my daughter and I just started doing crocheting together. So I feel all of those things are so I... Not that I'm a master in any of those things, but maybe it's being willing to try new things or having that, I don't feel, I don't consider myself to be a totally fearless person, but maybe channeling some of that fearlessness and a willingness to try new things, and where do we find that and how do we kinda overcome some of that activation energy sometimes to get to try those new things?

And I think innovators have that in spades, right? So a lot of the companies that we work with, they're like, "I have an idea, and I don't know if this is gonna work, but I'm gonna go for it." And I think a lot of those cre- it, it's a creative outlet for them as well, right? They're trying something new. And so maybe it's giving people more more support or more confidence that they can try new things. I feel like I don't love change. Like I, I, as a child, I like, I liked the things that just stay the same. But when you look at my arc and my, my origin story, it has been all about very unsettling moments or, you know, like where I was felt, feeling very unsettled or like trying something new, and I'm so grateful for all of those things, and I'm also really grateful that I did it, right?

So a- and again, it came down to a lot of my community, my friends, my family that supported me and said, "Yeah, you can do this," right? Having those hype people to help me. So maybe a masterclass in just like being the hype person for people who wanna try new things and try leadership, right? Or try a new path that they hadn't thought about yet.

[00:31:24] Lindsey Dinneen: Like, I think to your point too, the more that you're willing to do that and kind of step a little bit outside of your comfort zone and have that potential for quote unquote "failure." But, you know, first of all, the more you do that, the more resilient you get, which means it's easier and easier and easier to take those first steps, right, into something new.

[00:31:43] Allison Komiyama: Yes.

[00:31:44] Lindsey Dinneen: But I also think-- I, I often think about it in terms of if you can frame those kinds of moments as "I am exploring, this is an exploration" and not like pass-fail, if you're exploring, there's, there's no chance of failure, right? You can, you can explore something and go, "Ugh, not for me," or you can go, "Oh, I actually love this, but it's hard and I'm gonna have to keep working at it." But I think if you can like kind of maybe take it in a slightly different mental direction, that also helps, you know?

[00:32:13] Allison Komiyama: Ooh, I like that. Yeah. Like reframing. This is not, this is not something that's gonna, you know, end in failure, 'cause I agree with you. You know, I've called it failure in the past where it's like, "I'm gonna try things. If this fails, then I'll go do something else," right, which then it's not really a failure. You learned something. But it is being able to change directions. It is the ability to say, "Okay, I figured out that I something from that, and then what am I, what am I gonna do with that information?" So I love that.

[00:32:48] Lindsey Dinneen: Oh, that'll be a masterclass. I can't wait. okay. And how do you wish to be remembered after you leave this world?

[00:32:55] Allison Komiyama: Oof. I hope I... It's, oof. I, I, I hope to be remembered. Yeah. What does my dash look like? Isn't that what they say? Like, what is the dash between the, the birth year and your the year of your death? I definitely wanna be remembered for, like, what my kids are doing, 'cause I'm pretty proud of, like, how badass both of those girls are. But back to your question. I would like to be remembered as somebody who helped innovators and people who were building in the medtech space to grow their brand, to get their message out there, and to really bring awareness to the benefits of medtech.

I think it's so easy, as I said earlier, it's very easy for us to get caught up in the bad and the negative, and here are the risks, and we really are so nervous about the risks of things, as we should be. We should be a res- risk-averse population. Like, they-- I don't wanna be walking towards something that's gonna cause me harm. And at the same time, there's a lot of benefit to what we're doing, and I think if we can I guess what we were just talking about, reframe a little bit and say, "Yes, there's risk. There's inevitable things that are gonna happen, but here's the potential benefit," and how do we h- in a human way, weigh those things so that we can get other people to also see that this is something that could benefit them.

So it's sharing that message. I wanna know, be, you know, considered somebody who also didn't take herself too seriously, made people laugh. You know, maybe they showed their, their kid a, a video of me doing something silly, but also maybe there's some kid out there that's like, "Oh, she was talking about regulatory affairs. What's that? Maybe I should look into that as a career option." So, yeah, I hope some of it is inspiring to others.

[00:34:48] Lindsey Dinneen: Okay. That's, that's great. And then final question: What's one thing that makes you smile every time you see or think about it?

[00:34:59] Allison Komiyama: I wanna say my kids, but really it's probably hummingbirds. I have never lost the total fascination with hummingbirds. They are so interesting. They're so beautiful. There's a lot of them here in San Diego where I live, and I kid you not, last year, a mother hummingbird built her nest right outside of our front door. And so we'd have-- we told our guests, like, "Come through the, the side gate 'cause do not walk close to, to our sweet hummingbird." And she laid two eggs, and I was able to watch these two little hummingbirds grow and fledge. And I... It was just one of-- again, it makes me smile every time I think about it. Every time I see a hummingbird, I'm like, "That might be our girl that, that had, that had her nest right here." So yeah, I think that whimsy, the, the, the fun and just how gorgeous they are. They always bring... sparks me joy, for sure.

[00:35:58] Lindsey Dinneen: Absolutely. Me too. I adore hummingbirds. One of my favorites. Yeah, love that. Oh my goodness. Well, this has been an amazing conversation. Allison, thank you so much for taking time today to speak with me, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. Oh my gosh, and just thank you so much for everything you're doing to change lives for a better world. We're grateful for you.

[00:36:42] Allison Komiyama: Thank you. It's so nice to be here. Thank you so much for having me on.

[00:36:45] Lindsey Dinneen: Absolutely. Until next time.

[00:36:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.