Isabella Schmitt | AI & Regulatory Affairs Leader | Strategic Communication, Navigating Pre-Subs, & the Power of Mentorship

Isabella Schmitt is a prominent life science, AI, and regulatory affairs leader, and was recently named one of the top 100 MedTech Leading Voices Worth Following on LinkedIn in 2025. Isabella shares her diverse career journey—from aspirations of neurosurgery to becoming a regulatory expert in MedTech and biotech. She emphasizes the importance of early regulatory involvement, strategic use of pre-submissions, and understanding the voice of the customer in product development. Isabella also discusses the critical role of communication skills in regulatory affairs and offers invaluable advice for aspiring professionals.

 

Guest links: https://www.linkedin.com/in/isabella-j-schmitt/

Charity supported: Polaris Project

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

PRODUCTION CREDITS
Host: Lindsey Dinneen
Editing: Marketing Wise
Producer: Velentium

 

EPISODE TRANSCRIPT

Episode 048 - Isabella Schmitt

[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 am so excited to introduce you to my guest, Isabella Schmitt. Isabella is a life science, artificial intelligence and regulatory affairs leader with expertise in navigating the intersection of science, technology, policy, and innovation.

With a robust background in medtech and biotech regulations, she has contributed to over 200 projects ranging from hardware and software medical devices to AIML products. Isabella holds an MBA from Texas A& M and is pursuing advanced studies in AI management and policy at Purdue University. Known for her engaging communication style, she is a sought after speaker, author, and consultant on AI regulation and innovation.

All right. Well, welcome to the show, Isabella. I'm so excited that you're here.

[00:01:41] Isabella Schmitt: I'm excited to be here. I feel like it's been a long time coming as we just talked about a second ago. We've been needing to connect for a while so I'm glad we're finally getting to do it.

[00:01:50] Lindsey Dinneen: Me too! Well yes. Thank you for taking some time today. And I wonder if you would be willing to start off by sharing a little bit about yourself, your background and actually what led you to medtech.

[00:02:00] Isabella Schmitt: Yeah. So it's an interesting story because I actually have a pretty varied background in general. Like if we start back, back in high school, even so we'll go that far back, I wanted to be a neurosurgeon originally in life, and... well, originally I wanted to be marine biologist, but that was when I was in elementary school. No, I wanted to be a neurosurgeon probably from the time I was like, 14 to like, 21. And then I did a surgical externship and I didn't love it. And so then I had a quarter life crisis where I was just like, "What do I do? This is what I've wanted to do for so long."

And then I found myself going into research, so I did a lot of lab work in primarily healthcare type things. So, with nanomaterials for oncology, you know, specific targeting of tumors and things like that. But then I found with that, I liked the design of the experiments and like the design of new inventions and all of that, but I didn't actually enjoy the lab work. So like the actual part of being a researcher was not fun for me.

And so, I shifted gears, had a little kind of a stray off of the, this normal trajectory, I guess. And I was like, "Oh, well, maybe I want to do veterinary medicine." I love animals, so I did that for a little bit. And then I felt like there was always this drive for me to do something that felt good, aligned with my values, right? But was also intellectually stimulating so that I felt like I was constantly challenged. There was something new. It was very diverse. A little bit of ADHD there, right? So like I need, I need lots of inputs and stimuli. And so I, with veterinary medicine, I felt like I really liked this. It was ticking the sort of values box, but it wasn't really ticking the other boxes for me.

And so then I kind of went back and was like, "Well, maybe I want to go to medical school. I'll revisit that." So I took a job at a pharma company, a midsize biopharma company. And I started off in the clinical research side. I didn't know anything about the industry at this point, 'cause they don't really teach you anything about biopharma or medtech in school. I don't even know what I thought about how products like drugs and devices got to market. I just kind of assumed someone was checking over that, I guess. And so I had no idea and I took the job thinking it was more truly clinical related. Like, I was going to be, I don't know what I thought I was going to be doing, but something clinical, and it was, it was a CRA position.

But what they noticed about me, was that I started trying to analyze the patient data and I unblinded myself in doing that. And so they were like, okay, well, maybe you need to do something that's a little bit, not that there's, you know, that being a CRA is not intellectually stimulating, but not in alignment with exactly where I was. And so they put me towards regulatory affairs. And so I started helping kind of just general regulatory affairs. Then the guy that was running the product side of things, all the manufacturers and getting the product ready, was retiring. And so they promoted me to that position.

And so what was happening at that time was I was getting intellectually stimulated. I was doing well. It had the diversity that I liked where it was ticking the altruistic box and helping people and it's, you know, scientific, it's medical, it's writing, it's reading, it's understanding. And so it was kind of scratching that itch for me, so I didn't go back to school. I well, actually I did, but that's later down the line. But I, I stayed there.

That company got bought by Allergan and I left at that point and I went to a medtech startup company and that was my first foray into medtech. So I moved from biotech to medtech. And, you know, some of those things can translate, right? The cultures between biotech and medtech are very different, but a lot of the foundational knowledge of how you think about things can translate. So at that company, I learned more about medtech, but I could apply the biotech lens to it, which I think ultimately helped me from a strategic standpoint in the medtech world.

And then I left that company and I started at Proxima, which was the company where I first met you. And I was like employee four there, and I ultimately built their regulatory consulting group and that whole kind of department from me to 15 people and over 200 projects. Loved working there. I did a lot of talking, BD, consulting, all kinds of things. I then started running their clinical department as well, and then I left Proxima and now I work at a AIML company as their VP of clinical and regulatory. So I manage all of their suite of products for global submissions and kind of all the clinical collaborations that are ongoing there.

There's a long background, but it's a trajectory and I feel like people feel like they need to know what they're going to do at some point, like early on. And when you go to college, you're like 18, you don't know, and you barely know about what's out there, right? But you feel like 'I should know the answers to all of these things,' and you don't. And sometimes you find yourself in places that you didn't really expect and I know that a lot of people also want to get into regulatory affairs, and it is difficult sometimes to get your foot in the door. It's a competitive type of role largely because it, it is so diverse and stimulating and you have to have a lot of different types of skills to actually be successful in it.

But, you know, what I would suggest people do is look for smaller companies to kind of go towards, because those are the types of companies that'll maybe take a chance on you with leadership that helps and guides you through that transition. So when I was running Proxima, I like to hire people kind of earlier in their career because one reason was selfish. You don't have to reteach or get them out of bad habits, right? And then the other part was I just liked kind of, I liked the, the helping and the molding and the growing of them. And it's really nice to see them be successful there or afterwards as they move on into other places. And we have lifelong relationships now. You know, I've left and I still talk to them and they still come and they ask me for advice about things. And so that's really nice.

[00:08:42] Lindsey Dinneen: Yeah, that's incredible.,Well, first of all, thank you for sharing a little bit about your background. That was really cool to hear about your career trajectory and so many things popped up for, for me right away. But one of the things that really stood out was this idea-- I love how you talked about the fact that you don't have to know at the very beginning of your career or really, I don't know, even in the middle of it, is this what I'm going to do for the rest of my life?

I mean, it's okay to kind of. stumble into a path you didn't expect and see where it leads you. And, I'm curious too, you know, you've had such an interesting, diverse background and you've had all of these different skill sets. So when you first started, I know throughout different places you've been, you've done a lot of business development, but can you share a little bit about the skillsets and the things that you've learned through business development that actually really do translate to... Yeah.

[00:09:35] Isabella Schmitt: So, so business development is... so weirdly I had this sort of side thing where I was doing marketing work kind of just as like a side hustle for a bit. And so at Proxima, I really helped with market. So, business development and marketing, particularly for the consulting side of things reported into me as well. So I did a lot of that work, and I think in those cases, business development and marketing, if you're good at it, is all about communication, right? Like, it is about communicating effectively with other human beings, whether that's through talking to them or through writing. And understanding the audience that you're talking to, whether it's talking to them or through writing.

So, you know, in a conversation, you get good at reading people, right? Like you can kind of hear what they're saying and you start to learn like, okay, this is their pain point. They're saying this one thing, but what I'm getting from it is this other thing that I know a little bit more about that they're not necessarily picking up on. And so you, you start to be able to take on more of an advisory role, I think? There's different approaches to sales and marketing, right? There's the hard sales approach where it's like sell, sell, sell, which is, there's nothing wrong with that. It's just not my approach to business development and marketing. Mine is much more advise, educate, relationship. What is it that you actually need? How can I meet your needs?

And I think that skill set translates really well into regulatory affairs. There's different types of ways you can be involved in regulatory affairs. If you're doing high level strategy type things, you need to have these communication skills. You need to be able to see the forest and the trees and be able to redesign a forest if you need to. But there's also the very by the book administrative side of regulatory affairs where I think these skills probably aren't as necessary and there's nothing wrong with that. Some people really like that sort of structure.

I'm not that way. So I really like the strategy communication talking aspects of it. And I think the business development and marketing, the crux of it all is the communication aspect. And that is incredibly important when you're pulling together regulatory submissions, and you're engaging with regulators, you need to understand your stakeholder there, who you're talking to, the audience, what they're interested in what they're not interested in and be able to read that in that instance as well because you want to give them enough information, but not too much information about what it is that they need to understand in order to clear or approve your product.

For the people that I would bring in, you know, when they were early in their career, I think them being in a more of a consultative environment was probably beneficial to them in the long term because they had to learn those skills in the context of engaging with clients, right? And so we would do different things, you know, as they were training, I would be on the calls with them, but sometimes we'd do sort of like the mic in the ear thing, but through Teams, I would send them messages like, 'say this, ask them that.'

And then I would explain, you know, or if I said something that seemed unexpected, you know, like that was a different direction from the conversation or they expected me to respond to something that I didn't respond to, I would explain it to them afterwards so that they could learn and kind of absorb those skill sets so that they could then take that forward and apply it whether it's with clients or with regulators, or just with teammates, whomever it is moving forward, they would understand the communication aspect is so incredibly important in the strategic side of regulatory affairs.

[00:13:38] Lindsey Dinneen: Yeah. Yeah. Yes. Thank you for, for sharing more about that. I can absolutely see the critical importance of the communication skills, being able to translate, but, but building those skills. And honestly, it's probably just great advice across the board. You know, anyone, especially young in their career. Those are the skills to build.

[00:13:57] Isabella Schmitt: Yeah.

[00:13:58] Lindsey Dinneen: Yeah.

[00:13:59] Isabella Schmitt: Yeah.

[00:14:00] Lindsey Dinneen: So.

[00:14:01] Isabella Schmitt: Nothing, nothing better than relationship building and communicate and clear communication in your personal life, in your professional life, everywhere. So, yeah. And I think, you know, it's interesting too because there are things about my childhood and growing up that also translated into having a skill set associated with communication and understanding people and dynamics that was like a long term training, you know, from being a little kid to now, which maybe not everybody gets and that's okay, but they can learn it. It's something that, it's learned. It's not innate. You can learn it at any point if you're willing.

[00:14:48] Lindsey Dinneen: Yeah, I, I love that. So, you know, okay, so now you've had all this incredible experience. You've helped a lot of companies and, you know, regulatory affairs is your jam. What kinds of things do you see that are kind of common, perhaps stumbling blocks for, especially smaller medtech companies that are trying this for the first time and this is their big hurrah and it's really exciting, but what are some things that you see that, that maybe we could help mitigate?

[00:15:16] Isabella Schmitt: Mm. Yeah, I think the first things that come to mind and it's kind of like two opposing flavors. One, is... and they're both around pre-subs, right? So pre-subs are the big talking point, I think, all the time, and you will often hear people say like 'just do a pre-sub 100 percent of the time.' I think generally, that's true. There are cases where you don't necessarily need to do a pre sub. But as you go into a pre sub, it's again about communication. You want to make sure that you're not saying something that you can't get yourself out of in the future.

So, like, you know, oversharing or oversharing erroneously too. You can share things that maybe are not particularly relevant to what you need to convey but then can cause a flag that sticks in the minds of the reviewers. So you want to go to a pre sub typically with someone who has done them before successfully, and you probably want to find, if you're an innovative company that's doing this for the first time, someone who works with innovative companies a good bit more on the strategy side, even if they're not the one that's writing the pre sub, but that it is overseeing the sort of process with it.

Like I said, there's, there's a very administrative side to regulatory affairs too, and there are people who can turn, turn, turn submissions out and that's great. But when you're dealing with an innovative type product, that sort of administrative part of it== it's still important, but it becomes less important-- because you're basically navigating a new landscape and you need someone who has done it before, who can kind of understand how the regulators, whether it's FDA or notified body might think about it so that you can convey the information adequately or answer their questions adequately too.

The flip side of it is... so do a pre sub, but do it smartly. The flip side of that is don't do too many pre subs. So one of my friends in the industry and I were just talking recently about ' death by pre sub,' where you do so many pre subs that you've kind of painted yourself into this corner and you maybe don't want to be in that corner and you have to figure out a way to kind of claw yourself out of it. It, it can become very restrictive. So if you go, you know, if you're on pre sub eight, you're probably too far, too far or too deep in at that point. So you want to be smart about the pre-subs and generally speaking, I think that was the first comment, death by pre-subs is usually if you're not being smart about the pre-subs.

And then I think people go in maybe without a pre-subs at all thinking that, "Oh, I have a 510 K. It's straightforward." Maybe they're using a predicate. If your predicate's really old, they may have changed their thinking on it, so you probably still want to do a pre-sub even if it seems straightforward. Those are the things that I think are are probably major pitfalls.

I'd also say companies not involving someone with regulatory expertise early enough on, so even if you're not engaging with FDA, companies can get kind of stuck in a perpetual loop of product changing and advancement to the point that is detrimental and that a lot of that doesn't actually help in the long run, from a regulatory standpoint, understand your minimal viable product. And then from there, once you understand what that is, right, then you should really start engaging someone who has regulatory expertise. Or maybe you need someone to help you figure out what the minimal viable product is through, you know, some sort of regulatory lens as well. But I wouldn't spend 10 years going through design iterations and all of that before you get someone in to level set with where you are from a regulatory standpoint,

[00:19:31] Lindsey Dinneen: Mm hmm.

[00:19:32] Isabella Schmitt: And then I think shifting a little bit from regulatory, also involving regulatory and clinical, is understanding the voice of the customer. You design a product, you kind of want to design a product that people want and will use, because you can get through regulatory right? But if nobody wants that product, you've wasted years developing it, and a lot of money, and so getting with whoever the, the end user is going to be and understanding what their actual needs are and having them kind of look and touch and feel the product is, I think, incredibly important, even in the earliest stages, because you don't want to spin your wheels, designing something that nobody ultimately wants or can use.

[00:20:19] Lindsey Dinneen: Yeah, absolutely. So design with the end user in mind, talk to the end user in mind, and then talk to an expert such as yourself to really help guide you through that regulatory process. And it sounds like the earlier the better just to start that process going so you have an idea of where you need to head.

[00:20:39] Isabella Schmitt: Exactly, yeah. That's exactly right. Yeah.

[00:20:41] Lindsey Dinneen: Yeah, excellent. So, you know, you have had such a very cool diverse background and, you know, you've been honored a lot. You're, you know, a Houston Woman to Watch. You have gotten a business award, multiple ones. You just recently got named to MedTech Leading Voices, you know, 100 MedTech Leading Voices. That was really cool. So congratulations.

[00:21:02] Isabella Schmitt: LinkedIn's been blowing up from that. I was like, yeah,

[00:21:06] Lindsey Dinneen: That's awesome. Yeah.

[00:21:07] Isabella Schmitt: I haven't looked at it on my own LinkedIn yet. And it's, I opened it today. I wasn't on it all weekend and I had like 50...

[00:21:14] Lindsey Dinneen: Oh!

[00:21:14] Isabella Schmitt: ...requests. I was like, what? So yeah.

[00:21:17] Lindsey Dinneen: Amazing. Well, congratulations! That's really exciting!

[00:21:21] Isabella Schmitt: Yeah.

[00:21:21] Lindsey Dinneen: You know, like, just looking back, could 10 year old Isabella have ever anticipated this is where you would be right now?

[00:21:29] Isabella Schmitt: No. Well, you know, not exactly, but I was Student of the Year when I was 10, so maybe that was an early hint, I guess.

[00:21:42] Lindsey Dinneen: I love it.

[00:21:43] Isabella Schmitt: Yeah.

[00:21:44] Lindsey Dinneen: Yeah.

[00:21:45] Isabella Schmitt: Yeah, 10 year old Isabella I don't know. 10 was a weird age.

[00:21:51] Lindsey Dinneen: Yeah. Fair enough. Fair enough.

[00:21:54] Isabella Schmitt: I definitely wouldn't have seen myself in this industry and even, you know, 18 year old Isabella wouldn't have seen myself, because I didn't know it existed,

[00:22:03] Lindsey Dinneen: Right.

[00:22:04] Isabella Schmitt: But, you know, being highly on the business side of things too, because regulatory is very deeply integrated with all should be with all aspects of a product, right? And so I have to understand the voice of customer and I have to understand if there's a market for this and I have to understand the engineering and be able to translate all that information and, you know, and then on the other side of it with Proxima, I built the actual business. So, you know, I had to design pricing strategy and marketing stuff.

And so I never really saw myself being so heavily involved in the business world and that may have like honestly come from, not to get all political or whatever, but like a lens of sort of my vision of business person was male, you know, and so I just didn't have a lot of exposure to women in, in business roles and I don't, I don't think I ever had imposter syndrome because I always felt pretty confident in my abilities. I felt more like the world of business was male dominated, which it largely probably still is. But, but I think that kind of maybe held me from having that vision. And I mean, surgeons are male dominated too, but I was thinking I was going to be a surgeon. So, so, but I also had a vision of the business world as being more like Wall Street kind of world.

And you grow up, you know, and you learn new things and get exposed to new people. I'm very thankful for the people that I have met who have given me opportunities to, to shine, I guess who have trusted me, like Kevin with Proxima trusted me to build the department. The company that I work for now basically trusts me to do all the regulatory stuff. Obviously, hundreds of clients have trusted me with their regulatory, with their babies.

So it's one of those things where it's a combination of your own aptitude, but also other people. And, and I think for me, and that's why I wanted to also bring in, you know, green people who are coming new into the industry, to give those people opportunities to live up to their potential too, because a lot of it is having the opportunity and having someone trust you in order to, to show what you can do or can't do, I guess, but you learn either way, right? Failures are learning opportunities too. So.

[00:24:40] Lindsey Dinneen: Yeah. Well, I love that because you, you saw people, you know, 'cause sometimes it feels, especially as a job seeker, if you're young, or you don't have the industry experience, it just feels so invisible. So I love the fact that you were willing to do that. And then mentorship sounds like a really strong pull for you. Like, you very much care about that and helping the next generation of folks...

[00:25:02] Isabella Schmitt: Yeah, yeah.

[00:25:02] Lindsey Dinneen: ...find their footing too. So I love that.

[00:25:05] Isabella Schmitt: I, I love doing that. And I was teaching at Rice. I would teach a lecture a semester at Rice when I was at Proxima, maybe I'm going to do it now, I don't know. And then A&M a little bit too, and so even just kind of meeting students, I just, I like to give people opportunities, so if people are listening to this and they want to understand how to get into regulatory affairs or really anything, I am happy to have a conversation. Lindsey will tell you that I might reschedule it, but I will have the conversation.

[00:25:40] Lindsey Dinneen: I can attest to this. She will, she will. Absolutely.

[00:25:43] Isabella Schmitt: I do want to do it. It's just, yeah.

[00:25:49] Lindsey Dinneen: MedTech has become sort of, at least it sounds like your calling, for lack of a better word. And so I'm curious, you know, you are obviously very passionate. You are one of the leading voices in the industry. You are a thought leader. Along the way have there been moments where you just thought, "Wow, this really cinches it for me. I am in the right place at the right time doing the right thing."

[00:26:11] Isabella Schmitt: I mean, I think, in general, I feel that way. I, I'm the type of person who, though, is kind of always looking to grow and advance and more and more and more. And so I think it's, it's always kind of a learning experience. I think I will stay in this industry till I die, but for for a long time and it kind of just like, it clicks in my brain. Like, it just, it sort of makes sense with how my brain works.

But, you know, I have also expanded a little bit into AI kind of generally speaking as well. So, I work at an AI company now and I've worked with many AI products before. But I also am in a master's for AI, and I've been doing some policy work with it. So I, I try to, I try to go deep and broad at the same time, which I think is hard and maybe tends towards workaholism, workaholicism? But, but it keeps me stimulated and feeling like I'm productive and moving forward. And so, you know, I, I guess, to answer your question succinctly, I do think I've found a place that I really love.

I think that I will continuously look to expand and grow, just how I am, whether that's in specific with regulatory affairs or whether it's spinning off another consulting company or whatever, you know, my own product company one day, whatever it might be. I think this space is what I like. And I, I like growth personally, and I like growing people and I like growing businesses.

So I think all of that, I guess if there was a moment, honestly, Proxima. My experience at Proxima with growing, growing there, myself, the company, clients, employees, marketing, whatever it was that, that probably sealed the deal for me staying and not kind of looking to do something else. There was a short stint where I was very confused again before I started at Proxima. I was like, "I don't know if this is right for me."

I was thinking about leaving the industry and going and doing psychology and all of that. And, I got the job at Proxima, it just kind of checked everything for me. And so I think that, that, you know, if you're a person that likes a lot of diversity, I think getting into a strategic regulatory affairs role, particularly if you're able to work with multiple companies is, is the sweet spot. But yeah, that was one of the best places I've ever worked, one of the best experiences I've ever had.

[00:29:02] Lindsey Dinneen: That's incredible. Well, great. I'm so glad and thank you for sharing about that experience. Yeah, that's wonderful. So, okay, 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. It can be in your industry, doesn't have to be at all. What would you teach?

[00:29:21] Isabella Schmitt: would I would probably teach AI policy with specific towards regulated industries. So meaning, obviously, medtech, biotech to o, aviation, aerospace defense. So I kind of want to take it, sort of a broad approach, of how we think about regulatory with regards to AI, and the differences in regulating that type of product versus more standard types of products. So, that would probably be what I would would like to do if I were teaching a master course.

[00:30:06] Lindsey Dinneen: That sounds incredible and very needed, very timely.

[00:30:10] Isabella Schmitt: Yeah,

[00:30:11] Lindsey Dinneen: Yeah. Excellent. How do you wish to be remembered after you leave this world?

[00:30:18] Isabella Schmitt: That's a big question. So, and it's a tough question. I want to have made an impact on the industry, on people's lives, on an industry because, you know, with AI, it could be multiple industries, I guess, too. Probably sticking closely with medtech. It's what I like, and it feels like the best again, like value kind of.

I think if I were to like make up this dream scenario of where I ended up, eventually I would have my own product company. I would sell that off. I would probably start another consulting company that I helped people with still. And then I would do like philanthropic things with money. And largely focused probably on pediatric type devices, rare diseases and conditions, and probably veterinary medicine, which those areas I don't think get enough attention.

I have a lot of experience with with pediatrics in particular and I think I would like to be able to work closely with getting more of those products to market. They're, you know, difficult funding opportunities there because such a small, still large burden, but such a small group of patients that the ROI is not typical of what you would see, you know, a lot of VCs investing in. So something like that, I think, and being remembered for those, those things, I think, would be great to me.

[00:31:50] Lindsey Dinneen: Yeah.

[00:31:51] Isabella Schmitt: Also, if I influenced policy in some kind of way that was fundamental, I think that would be pretty cool too.

[00:31:57] Lindsey Dinneen: Absolutely. Yeah. Very cool. And then final question. What is one thing that makes you smile every time you see or think about it?

[00:32:06] Isabella Schmitt: Oh, that's a good question. Not work related or work related?

[00:32:10] Lindsey Dinneen: Oh, both, either.

[00:32:12] Isabella Schmitt: I, probably my dogs would be, that's an easy not work related answer, although sometimes they drive me nuts too. So there's a spectrum of emotion with them, but generally dogs. Dogs are just the best. I'm, I'm a dog person. They're just so loving and understanding.

Work wise, obviously, anytime I have a successful submission, or there's an exit, any success, it always makes me smile. So, and then, you know, I also really like-- I haven't been to many over the last year, just with the change and the dynamics of my world-- I love networking events. So, like, thinking about networking events, I just, I really enjoy those types of interactions. They've always been really fun. I've been thinking about going to them just for fun, just to see people again because it's been a while.

And I used to love, like, my favorite thing was Medtech Innovator. So I'm answering this question, and I'm thinking of the answers I'm talking about. So MedTech Innovator, I love MedTech Innovator. It was almost like when you're a kid, and you go, and you have the summer off, and you don't see anybody or any of your friends, and then you go back to school, and you're sort of excited to see them again. That's what that community felt like, really to know the people there so well. So MedTech Innovator, that's my answer.

[00:33:35] Lindsey Dinneen: I love it. Great answer. Great answer. Fantastic. Well, oh my word, this has been so much fun. Thank you so much for taking some time today just to share with me about your life and your experience and all the wonderful things that you're bringing to the world. I just really appreciate it. And, just thank you for your time.

[00:33:56] Isabella Schmitt: 'Course, thanks for having me.

[00:33:58] Lindsey Dinneen: Yeah, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support, and I just wish you the most continued success as you continue to work to change lives for a better world. And just also thanks to our listeners for tuning in. And if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.

[00:34:36] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.