Designing for the Whole Picture — Cala Health’s Deanna Harshbarger

Designing for the Whole Picture — Cala Health’s Deanna Harshbarger
DeviceTalks Podcast Network
Designing for the Whole Picture — Cala Health’s Deanna Harshbarger

Oct 09 2026 | 00:57:06

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Episode • October 09, 2026 • 00:57:06

Hosted By

Kayleen Brown Tom Salemi

Show Notes

Better MedTech requires more than one perspective.

In this episode of the DeviceTalks Women in MedTech podcast, Host Kayleen Brown talks with Deanna Harshbarger, CEO of Cala Health, about designing for the whole picture, from patients’ everyday needs to the people, evidence, and business decisions that bring a technology to market.

A chemical engineer turned business leader, Harshbarger shares lessons from her career at Johnson & Johnson, Boston Scientific, and Medtronic, including helping build Boston Scientific’s deep brain stimulation franchise and gaining experience with connected devices and direct-to-patient care at Medtronic.

Now leading Cala Health, Harshbarger explains how those experiences inform the company’s noninvasive, wrist-worn therapy for action hand tremor in people with essential tremor and Parkinson’s disease. She discusses why clinical effectiveness and usability must go hand in hand, how regulation and reimbursement shape access, and why no single person holds the answer to building a product that works for patients and can scale sustainably. That philosophy also shapes her leadership: removing hurdles, welcoming different perspectives, and ensuring every person knows their voice matters.

Kayleen also welcomes Yvonne Bokelman, Executive Director of MedtechWOMEN, for an in-studio conversation about highlights from MedtechVISION 2026, the organization’s growing mentorship and community programs, and why diverse perspectives are essential to better medical device development.

Thank you to MedtechWOMEN for sponsoring this episode of the Women in MedTech podcast! To learn more about the organization, please visit: https://medtechwomen.org/

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Chapters

  • (00:00:00) - Introduction: Designing for the Whole Picture & Cala Health Milestones
  • (00:03:11) - Interview with In-Studio Guest, Yvonne Bokelman (MedtechWOMEN)
  • (00:16:58) - Start of Keynote Interview with Deanna Harshbarger
  • (00:17:30) - First Job Lessons: From a Bakery to the Chemical Manufacturing Floor
  • (00:22:53) - Finding MedTech: Johnson & Johnson, Cordis & Balanced Regulation
  • (00:30:56) - Boston Scientific: Building Deep Brain Stimulation from the Ground Up
  • (00:39:14) - Medtronic & Connected Health: Serving Patients Directly
  • (00:41:38) - Cala Health: Revolutionizing Tremor Treatment Noninvasively
  • (00:47:13) - From VP to CEO: Scaling Leadership, Team Culture & Mentorship
  • (00:53:58) - Outro: The Whole Picture, MedtechWOMEN & Connected Health Preview
View Full Transcript

Episode Transcript

Hello and welcome. I’m Kayleen Brown, managing editor for DeviceTalks. And welcome back to another episode of the Women in MedTech podcast, where I try to reverse engineer the making of a MedTech leader. And as promised, next week, we’ll continue to bring you your DeviceTalks weekly. You can expect that on your favorite podcast player. My guest today is Deanna Harshbarger. She’s the CEO of Cala Health. And I have to tell you, from the very first minute of this conversation, I knew it was going to be one of those episodes. Deanna is a chemical engineer turned business leader turned CEO, and she spent the better part of her career in the movement disorder space. She now leads Cala Health, a company building technology that is making an enormous difference for patients living with essential tremor. Now, a lot has happened for Cala Health since I had my conversation with Deanna, and the biggest one of all is in April of this year, Cala Health’s Cala kIQ Plus system was cleared by the FDA. And then today, the day I’m actually recording this introduction with my in studio guest, Cala Health let me know that their Cala kIQ Plus system is now available nationwide. So congratulations to Cala Health, congratulations to Deanna, and congratulations to the Cala Health team. I mean, you did it. I hope you’re enjoying the success of that for our audience. I put the press release about the nationwide announcement in the show notes, as Some other things, Cala Health is actually showcasing Cala kIQ device at the AAN Fall Conference in Las Vegas. That’s gonna be October 9th through the 11th. And there’s a few other things. Cala Health secured $50 million in funding from Trinity Capital. They also have been recognized by the industry. Cala Health was named the best new neurology technology solution in the 2026 MedTech Breakthrough Awards. And my own personal exciting one, I have to say. Deanna was just named a founding member of the Medical Design and Outsourcing MedTech Innovation Board. She is joined alongside R&D and innovation leaders from Medtronic, Boston Scientific, Abbott, Edwards, Life Sciences, and Eli Lilly. And that board is run by my dear friend and managing editor for MDO, Jim Hammerand. So congratulations, Deanna. You are in the best hands. And. And Jim, good get, Deanna rocks. Okay, let’s talk about this episode and this episode’s theme. So throughout my conversation with Deanna, she kept coming back to this idea that to bring something that truly works for the patient, for the people, building it, for the business, bringing it to market, you have to be designing around the whole picture, not just the diagnosis or the clinical data. She brings this idea and this philosophy to how she leads. No single person holds the answer. If you keep pulling perspective from the same voices, you’re gonna miss the path entirely. You’ve heard me talk about this so many times that to build better medical devices, you have to have diversity of perspective. The more diverse you can be, the more we’re building devices that are actually reflective of that population. And I know that my in studio guest, Yvonne Bokelman, executive director of MedtechWOMEN, agrees strongly with. So to talk more about this episode and this episode’s theme, I’d love to invite Yvonne to join me in the studio. Welcome to the studio. Yvonne Bokelman, executive director for MedtechWOMEN. Yvonne, it’s really good to see you. How are you? Good, good. It’s so great to be with you again. Kayleen, such a pleasure to see you. Within, what, two, three weeks? I know not only attended MedtechVISION 2026, had the pleasure of moderating the executive interview with Martha Aronson, CEO of Merit Medical Systems, which was, as you well know, and everybody in the audience and everybody on LinkedIn and strangers on the street, they all know, was an absolute dream of mine. So good to see you and huge congratulations on an amazing event. Thanks. It was. It was such fun. You rocked the executive interview. It was really great. It was one just your passion for wanting to be there and do it and then just to have an excellent camaraderie with Martha. It was really, really good. But the event as a whole, as you know, was sold out. Long waiting list. It was really great. All of the panels and sessions were great. Of course, the vibe is always what makes this meeting so special. And I think once again, we held to our reputation. You’re here. Just a couple things. Yeah, Martha, she’s incredible. And the authentic way that she communicates her life experiences, I feel like, really resonated with everyone in the audience. They all saw themselves in her in those experiences and that’s really special. So a lot thank you for the kind words. And so many people after the fact came up to me and said, you know, it was such a great interview, but I think it really comes down to the fact that if you can have somebody who you identify with, that connects you to our industry and connects you to the people around us more than anything else can. And it’s. You probably heard me say, like, you can’t be what you can’t see. And I think in that moment, everybody could see themselves as Martha Aronson, and that is such a privilege. So, Martha, you rock. And thank you again, Yvonne, for the opportunity. Oh, no problem. And can I tell you, you’re absolutely right on the relatability. One of the things that she talked about, you know, when I can’t remember if it was a question from you or from the audience, talking about like, what gave her these opportunities and how she kind of, you know, took her trajectory. And she said, I always said yes. And I personally, that is what I have always done that has allowed me to have a great career in MedTech as well, is taking on things where you’re like, I have no idea what I’m doing or I can’t imagine that you ask me to do this and. But you say yes because you want to have that chance. And when she said that, it was just like, oh, oh my gosh, that’s exactly right. So, so relatable. So, you know, making you feel right at home and part of her journey and where you could take away for yours. So it was great. It was so great. Agreed. I also wanted to talk about the patient keynote, which is one of my favorite sessions. It’s the perfect way to kick off the event every time. I think it sets the tone and reminds everybody in the audience why we’re part of this incredible, some most days, difficult industry. So it was with Dr. Byo and one of the things that Dr. Byo communicated was a phrase that she inherited from her father and that has been sort of her guiding post was, you know, ask what could be possible. Always ask what could be possible. So what you’re saying right now with Martha saying Yes and then Dr. Byo saying, Ask what could be possible? If you do both of those things, there’s nothing we can’t do in industry and beyond. That’s a pretty great way to start the day. It was, it was. And you know, sort of just organically starting it off with whatever’s possible. Everybody woke that in to the rest of the day and it just, you know, unintentionally intentionally became this very great theme. And the way everyone sort of thought about each topic and their relationship to it, it just really flow so nicely. And yeah, it was. She was a fantastic patient keynote. Fantastic. Talk about passion. Like, I’m getting chills just thinking about it and it’s been weeks. She’s incredible. I don’t know how you select the patient keynotes, but keep it up. That’s all I’ve got to say. No notes. 10 out of 10. Thanks. I always try to find the positive in everything. And I feel like that was a common theme in each panel. Even if we were talking about something that would be difficult, there was still this sort of positive angle. And on the session, leading at the edge, Maggie Dixon, she was saying that it’s the same amount of volatility, it’s just different. And it changed the perspective for me. It did feel, prior to MedtechVISION 2026, it felt like things are worse, but they’re not, they’re just different. And that feels more manageable. Yep, that’s a great takeaway from that. And I, I completely agree and I was glad she put that perspective out there. Cause even in planning you sort of thought about, you know, you don’t want to give this aura of oh my gosh, you know, everything’s crashing around us, when in fact it really isn’t. The challenges are different, the volatility, as you said, is different. But we always have lots of things coming at us. It’s how we choose to lead through them and manage through them that makes all the difference. And I think she, she kind of set that tone and that platform and foundation for us to work from. Perfect. So let’s talk about MedtechWOMEN. MedtechVISION was fantastic. We love it. But I mean, I’m a team. MedtechWOMEN forever. Hashtag Forever. So what can we expect coming out of MedtechWOMEN for the rest of this year? Next year late on us. Yeah, we’re still rolling with the webinars, the content, the activities. I think I shared a map of all the cities across the US where we’re having more and more local in person events. And that’s true in even as we close out this month. I think next week we’ve got something in Philadelphia, San Diego, we have Chicago coming up. So continuing to see our communities expand, get together with regularity. And that’s kind of what this community says they want. They want to be able to network and feed off each other and grow and share stories and so happy to see that growing. Going into next year, we’re going to expand. We’re going to come out with a new topic. And I wish I could kind of have the allure of saying, oh, it’s top secret and I’ll tell later, but we haven’t even decided with what we’re going to do with MedTechFORUM, our quarterly webinar series that has been focused pretty heavily just on women’s health and women’s issues. We’re going to expand that even broader going into next year. We’re going to take some spins around with technology and content around technology. I don’t know if you’re aware, we did this AI hackathon which was a three series event, two webinar, one in person. It was insanely successful and so we’ve been asked to do it, do it again, don’t wait till next September to do it. So we were planning several different kinds of events around that will have an in person component again, knowing how important that is, but will really be around technology and the need to have women engaged. The more I’m having these very different conversations about AI and who’s leading AI and who’s understanding where it can go. And women aren’t always at the forefront of that like we could or should be. And so seeing them engage out of our community and want to expand and make it, you know, something that everyone can grab onto and take where they want to take it is going to be very cool. So we’ll be expanding there. So continued events, continued in person events. Our mentorship program, I’ll just say we just kicked off yesterday a College Edition mentorship program and we have 104 individuals, women involved in it, 52 coming out of the college age group and they’re matching mentors, one for fall, one for spring. It was such an engaged group. We did a kickoff call and here are women in STEM programs, a couple of years of school under their belt and now they get to be paired with leaders and executives of MedTech to help them understand what does it look like? Where can I go? How can I take my career? So that was really very cool. So we’ll continue to expand that program, our regular mentorship program and our CEO and executive circles program. So everything will continue to grow and you know, I’m really looking forward to it. I again the feedback which I take very seriously. I will talk to anyone about what we what is meaningful, what would be helpful. Again, that’s our goal, to provide value to our members and help them be successful in their MedTech career. And and so morphing our programs to match those needs are is what it’s all about. I love that. I’m, I love seeing it on LinkedIn. I love learning more about your programs and for our audience. If you do want to learn more, please go to medtechwomen.org. So Yvonne, let’s talk about the episode a little bit today. Yeah, so this episode is with Deanna Harshbarger. She’s the CEO of Cala Health. I’m sure you’re familiar. Cala has been around for a while. I love what they’re doing. You and I both had the privilege of listening back to that interview. But before we got into the studio today and out of that conversation, I think that we both agreed that the theme of the episode is the whole picture, why better MedTech requires more than one perspective. And I felt like this theme perfectly fits MedtechWOMEN. You have embodied that for as long as I’ve known your organization. So what comes up for you when we talk about diversity and the importance of diversity and perspective in MedTech development? Yes, congrats on that episode. I think it’s great. And look forward to everyone hearing is what we’re kind of founded on, the need to create diversity. We talk a lot about 16 years ago, our co founders were in a meeting and they’re looking at the panels and they’re all men and how we needed to move that. And it’s definitely true. There’s enough data and publications out there to support companies that have diversity do better. And that’s diversity of perspective, of gender, et cetera. So it’s really bringing that to light. We just did a webinar a week ago, moderated by Dr. Carla Peron out of Philips on designing with her in mind, inclusive innovation in MedTech. And that means including all gender, you know, both genders, and being able to think about it from the get go. And they were citing examples of innovation where that wasn’t taken into consideration. And women physicians might not be able to use products that were designed mostly with men. And so just so many ways that touches and where we can highlight that, where we can support. Support that, where we can bring visibility to the need to create diversity and then have women that we can show our experts on so many topics and experts in leadership and how their views can help. I think that’s kind of what MedtechWOMEN is about. So it definitely speaks to us. I love that. And I actually did a women in MedTech breakfast with Dr. Perone and we talked a little bit about that as well. And it’s. It’s kind of like the Mr. Rogers thing. If it’s mentionable, it’s manageable. So the fact that we’re starting to mention it, we can do something about it, it brings visibility to it. And to do that, you have to have diversity of perspective and gender. Exactly. To your point in the. The interview, Deanna says, and I actually wrote it down because this is, I feel like one of the quote, polls that really resonated with me. She said that her philosophy is we never get to the right answer if we don’t have those different views on it, because my lens is going to be different than your lens. And that just, I think, summarizes it beautifully for what MedtechWOMEN does, for what we try to do and bring attention and visibility to the fact that we need everybody in the room, everybody at the table as we design and build medical devices for patients and you know, doing so really intentionally and thoughtfully. So I think enough about us. Yvonne, again, thank you so much for everything you do and MedtechWOMEN’s as let’s give the audience what they want. Will you please introduce today’s keynote interview? Great. I am delighted to do so. Let’s bring on Deanna Harshbarger, CEO of Cala Health. Deanna Harshbarger, CEO of Cala Health. Welcome to the podcast. Thank you so much for having me. Before I dig into your background and we talk about what is the making of a MedTech leader, I just want to shout out Cala Health. I’ve known Cala Health for quite some time now, and I love what you do and I’m excited to share your story with our audience. But with that in mind, let’s get to know you a little bit better. So what was your very first job, Deanna? And I’m not. It doesn’t have to be a paid job. Just what comes to mind when you think this is my first job? And what did you take from that experience that might influence how you lead today? Yes, I. I love that question. Now you’re making me think back to very, very early years. My very first job was working at a bakery. It was called Grandma’s Bakery, and it was a fantastic job because it was very quiet. I got a lot of homework done in the meantime. But the, I would say the broader leadership takeaway that I got from there was understanding your customer. There was nothing better than living in a small town and having people come in to get their donuts. You understood people’s habits and you also got a chance to really know them because people are really chatty when they’re there for their donuts. That’s so interesting. One, I like how you said it was very quiet. That is, we are, we’re the same. I work from home and I have worked from home for 15 years, way before COVID And it’s because I like the quiet. I’d like to be able to get my homework done. So I really, I get that. So the bakery role was very surprising in the best kind of way. What’s also surprising to me is the fact that you have a chemical engineering degree and then later on got your mba. I don’t normally see an, an engineer, not just an engineer in MedTech, but a chemical engineer who moves into business. So was there a plan in mind or did it just sort of happen? Like walk us through that, that thought process? Yes, so, so it just sort of happened. I actually graduated high school thinking I like chemistry and I like math. And so I’m going to combine those two things together and become a chemical engineer. And it was actually a fantastic place to start my career. One it was very grounding and understanding how you think about problems, how you solve problems. And then even in chemical engineering I went a little untraditional pathway. So you can typically go straight into research and development or you can spend time in production. And I very much like working with things that are tangible, things that you could touch and feel. And so I went into production, which is basically manufacturing. And it was a great learning experience. I worked in massive production facilities, in manufacturing facilities. Since I was chemical engineering, we made things like hydrogen peroxide and plastic. So I got to wear a hard hat and steel toed boots. Very fashionable. And what I found was there weren’t that many women in chemical engineering. So in my undergraduate class it was very small, less than 10% of the class were women. And, and within production and manufacturing, there were not even women’s restrooms on the manufacturing floor. You had to go, yes, you had to go up to the office and I would be the only female out there working with the guys on the line, talking to them about how they should produce, whatever we were working on. And I learned a lot about leadership there. One is really understanding what someone is doing, valuing their views, their opinions. They’re the people that are day in and day out doing that job and also getting to know them as people. And I think that’s really important, especially when you get into MedTech and into healthcare. At the end of the day it’s about people and patients. So it was a fantastic experience. I knew I didn’t want to spend my life in a hard hat and steel toed boots. It was a wonderful experience. But I also loved solving problems for customers. And so that was really my incentive to go to business school. It’s so interesting to me because you have this very rare ability, talent, I’ll even say talent here, where you have the, the, the tactical, technical brain. You love the math, you love the sciences, you love the actual engineering of it. But then you’re also a bridge into communication. And I would Say psychology, so the kind of humanitarian like, or the humanities. So that’s very rare, but I think such an incredible tool for MedTech because to have two sides of your brain working together like that, there’s sort of nothing you can’t accomplish if you’re able to think the way engineers need to think to create medical technology and then able to apply that and communicate that to all of the stakeholders effectively. I mean, that’s probably why you’re a CEO of Cala Health. So let’s, let’s take the following, the bridge idea, let’s take that into MedTech. So I know that you were with Poly One, which is a specialty polymer company, very chemical focused from there. What made you or what turned your head to MedTech? What made you think, oh, well, maybe this is an industry for me? Yes. Yeah. So when I was at Poly One, that’s when I was in manufacturing and it was really working with the customer. So at the end of the day, we had to produce plastics polymers for a customer and help them understand how to best use them. And one of my favorite things to do was to actually work with our customer service team, and they were the team that would help solve the problems for the customer, saying, do you have the right product? Is this fitting your need? And I spoke with a lot of different people and said I’d rather be on the customer side of, of the business. So that was my impetus to go on to, to business school. And once I was in business school, I had the fantastic opportunity to do a summer internship at Johnson & Johnson. And I had an amazing time when I was deciding, because the reason you go to business school is typically two things. One, you want to change the industry that you’re in or you want the function that you’re in. And I actually wanted to do both. I really wanted to at the end of the day. And I think you see this with anybody that’s in the healthcare space. I wanted to feel as though I was helping people, making a difference at the end of the day. And it’s not that you’re not. When you’re making plastics, there are great things that come from that. Actually a lot of medical devices, however, I really wanted to get closer to being able to make an impact. And I looked at a lot of different companies throughout business school, a lot of different industries as well too. And when I did that summer internship with Johnson & Johnson, I said, I’ve found my space. One, I liked device because it was very tangible. I loved being in the hospital, whether it was being in the or in the cath lab, really. Even shadowing. I shadowed a cardiologist for a full week, understanding what it was they were doing day in and day out. And I thought, I can do this every day because if I can go to bed every night thinking somebody is better off because of what I did, then that’s a great place to be. So for me getting into healthcare and then specifically endometriol, how lucky I was to have fallen into the perfect career. So before we clicked record, I knew, Deanna, that you and I had an immediate connection. I could just feel it. And I think now I know exactly why that is. We are so lucky to be an industry of service. In my own way, I am helping patients and that is the greatest privilege of my life. So I will never leave this industry and our audience. Who’s listening right now, Bingo cards out. Best industry in the world. There’s one of your squares and one of us. One of us, Deanna. One of us. I feel you. I hear you. So does that. So from internship, was that at Cordis at the time a J&J company and then later sold to Cardinal Health? Yes. Yes. Great. So from internship, did you become a worldwide product director? Was it through that or was that as part of your internship? Then postgraduate school, then I took a full time position at Johnson & Johnson at Cordis. And that was an amazing experience because really then stepping into understanding a multinational corporation, I think it was fantastic training ground. And what I loved about Johnson & Johnson at the time with Cordis, they rotated people through that organization with a variety of different backgrounds. You had people in the business that had backgrounds in pharmaceutical, people that had backgrounds in consumer packaged goods. And then people had that, that had backgrounds in medical device. And then on top of it all, Cordis was actually a startup that was an acquisition by J&J. So the opportunity for learning there was, was fantastic. And meeting an amazing group of people and learning that not all, all leaders look the same, that there are very different ways to lead. And so a lot of those people I still talk to today I can definitely see that because again, in this industry it’s very up, bingo cards ready, very familial, because it really is. And we are part of this family and our roles may change, our company names may change through acquisition or just, you know, shifting focus, but ultimately we’re still connected to one another. So I can absolutely see that. Pre MedTech experience into MedTech, you touched on a few things that are very, very MedTech. But what about being in a very regulated Industry, how was adjusting to that process? Because that could be really difficult. Feeling confined. Yes. And I would say, especially coming from the chemical industry and at the time frame that I was in it, it was refreshing to be in a regulated industry. I think that is one of the pieces that many people miss. I remember sitting in one of my business school classes and people asking, do you think that there should be regulations? And you know, in true business school fashion, most people are like, no, right. We will be able to find our path. I was one of the few people. But I think there’s a balance, right? I think there’s a balance. But I was one of the few people that said, you know, I’ve been in an industry where you’ve seen that if the regulation wasn’t there, people weren’t protected. And so I think I took that into the healthcare and the medical device space from the standpoint that you must always do the best you can for the patient and the regulation is there to help serve. That doesn’t mean it’s always the right regulation, but it is an important aspect because at the end of the day, we have to protect the patient. So going into that was one, it was a great learning experience, but two, having that view of understanding what something more unregulated looked like versus regulated, there’s a way to find that right balance. I love that. I want to touch on one more thing that you said before shifting to the next step of your career. You were talking about leadership and how from your experience as you learned that leaders come in all different shapes and sizes, they look different. How important is diversity of perspective in MedTech from your experience? It’s critical. My philosophy is we never get to the right answer if we don’t have those different views on it. Because my lens is going to be different than your lens. The lens of someone who is actually manufacturing the product is going to be different. If you really want to think about building a product that is efficacious, that meets the needs of the patients, and you can do that on scale and in a profitable manner, no single person has that answer. So that diversity of perspective is critical. Let’s move to the next stage of your career. So you already mentioned Johnson & Johnson. So let’s talk about two other blue chips, Boston Scientific and Medtronic. You could just give us an overview of the roles you held and the scope of the responsibility from each. Sure. So I joined Boston Scientific after Johnson & Johnson, and I really wanted to get experience a little bit more in the typical upstream marketing and product space. And so when I joined Boston Scientific, they were a recent acquisition. They were a startup called Advanced Bionics and they had a spinal cord stimulation business. So it was the neuromodulation business. And I joined into a group called Emerging Indications, which was basically opportunity to look at all of the potential that neuromodulation can do. And from a learning standpoint, again, fantastic people. I loved the moxie that comes with the startup. So even though you are acquired by a larger organization, you have again, different mindsets, which I think is fantastic. And the other piece that I loved was it just gave me the opportunity to learn about neuromodulation and electricity as medicine and then realizing that the next opportunity within the neuromodulation business was really starting Deep Brain Stimulation. And so I was able to really, from the ground up, with a team of very intelligent people, begin the Deep Brain stimulation franchise at Boston Scientific. And every year was a different experience. Early on you are learning how to, with very little resources, find a way to build a product that meets, better yet exceeds the needs of the customer, which would be the physicians and the patients. Be able to study that it’s an implantable device, Class 3 implantable. So lots of regulation there. And so where do you do your studies, how do you get the most data and how do you get most efficiently to understanding the potential of what you are building and what countries do you do that in? So I was able to launch the very first product in Boston Scientific and Deep Brain Stimulation internationally. So I spent a lot of time in Europe and then subsequently into APAC, LATAM, every country that you can imagine, and then finally in the United States because we had a very long pivotal study. And again, I think taking that back to what, what I learned from that, the amazing people that I met and the trials and tribulations of really trying to get a business off the ground. So I’m going to, I’m going to hold myself back and I’m just going to ask one follow up question. I did not realize that you launched the first Deep Brain stimulation product out of Boston Scientific. That’s pretty incredible. And then launched it internationally. So I have to imagine that you have a lot of lessons learned. So let’s start with how do you take a product internationally and what skill sets do you feel like you either had or needed to learn to do that effectively? Yeah, absolutely. So I would say, and this is just a very basic skill set is curiosity and knowing that you don’t have the answer. So when you’re going into a new space. You really have to take the time to understand the environment. So what is the regulatory environment in whatever it is, the country, region that you want to be able to enter into? What’s the patient population look like? What is that opportunity? What is the reimbursement environment? Every country is different, so reimbursement is different, I think very exciting in this world of the digital space. It’s also understanding what are the legal laws associated with patient data and patient information, because it’s different in every country. And if you are serving patients, then what is the best way to serve them? What are the channels that actually sit within, within that country? So taking that back to what are the key things you need to understand? It’s. It’s having that curiosity, curiosity and making sure that you are spending time to fully understand the environment that you’re going into because you have to meet the needs of your customer in order to be able to launch. Now then, the second key aspect is working with people and that is people across every range you can imagine. So one, within your organization, so who’s going to be building the product? Two is where are you going? So what channel are you going to be able to get that product through to? And then all of those aspects, the regulatory environment, the legal environment, the reimbursement environment, all of the people within that particular country that run those areas. And so again, going back to having diversity of perspective, you have to be able to have that because if you don’t have someone that can look at it through that lens, you’re not going to be able to find a final solution for it. Very, very well said. I said that I was going to hold myself back. I can’t. So I have a follow up to my single follow up and it’s because you said diversity of perspective again. And I have to wonder, do you feel like being a woman in this space at this time during this launch helped you and how? That is a fascinating question. I guess I always approach whatever situation I’m in of how do we get the job done. I would say it had its positives and negatives. I think again, going back to having worked in an environment where there weren’t even women’s restrooms nearby. I think for me personally I’m comfortable in any environment. I certainly have sat in plenty of boardrooms, meetings externally within the physician base, patient base, and being the only woman in the room, which I am sure so many of your listeners, everyone in the MedTech space is very familiar with. So I would say that regardless of male or female. I just kept an open mind and I was persistent. Was I mistaken for some working for someone when that person actually worked for me often. But I’m not alone in that situation. Well, I really appreciate you sharing that with me and I think just for our audience, what I took from what you said is being comfortable in any environment and sometimes that might just have to be learned. So maybe it’s more being comfortable with knowing you’re going to be uncomfortable and just being okay with that. So just sitting in that and getting comfortable with that and then be persistent. Love that. So we haven’t even gotten to Cala Health, so I’m going to move us forward begrudgingly. So let’s just high level Medtronic. So what did you, what was your time at Medtronic? High level. And then I want to bring us straight to Cala Health. Absolutely. So I was really interested in understanding better the space of direct to consumer as well as connected devices. And so I left Boston Scientific. That was difficult. Amazing group of people. I would say everywhere I’ve worked I’ve met fascinating, talented, amazing people. And then I went to go work at Medtronic in their diabetic division. And I worked in at the time it was a group that was focused on patients that were injecting insulin. So I worked on continuous glucose monitors and, and, and then also with the acquisition of a small startup that was focused on again injecting insulin. So a pen. And I would say from that standpoint, same thing. One of the great things that they did was they rotated people around organizations, so working with people with a variety of different experiences. But what I loved the most about that business was understanding durable medical equipment which was serving patients direct to patients. And so these are devices that get prescribed but then are purchased directly by the patient and served through whatever payer it is. And it’s also a world where you really see digital health combined with traditional device. And I thought this is where our world is really going. Right. We have this ability to collect all of this data about ourselves. Why can’t that be used to treat ourselves better? And so that was a fantastic learning ground. I just feel the need to recap your journey thus far. So from chemicals, well, let’s talk from bakery to chemicals to heart health to neuromodulation, now to diabetes, slash direct to consumer. So I have to assume that that suggestion, suggestion you made earlier about being curious, you must be a very curious person. Yes, yes, absolutely. The world wouldn’t be so fun if we didn’t look around and see what was going on. I also absolutely was very excited when I then got a call from Cala Health. I was having a great time in the diabetic space, but I saw what Cala was doing and I thought, I really sat down and thought to myself, I would be ridiculous to turn down an opportunity to work at a place where one, I got back into neuromodulation because I fundamentally believe in electricity as medicine. Two, to work with movement disorder patients again and the amazing physicians that treat them. I’ve never met a group of physicians that are so dedicated to holistically looking at treating their patients. And then three, last but not least, the opportunity to treat patients non invasively. So again, having spent a significant amount of time in deep brain stimulation, knowing the value that patients receive from that, but also knowing that the majority of patients, whether they’re candidates or not, will not go for that level of surgery and to have a treatment option for them. And then on top of that, knowing what neurostimulation can do, how unique our brain is than the potential that even sits on top of that. And I told my husband, I’m like, this is crazy. How can I not take this job? That’s. I think what started my, my interest in Cala Health was this idea of a non invasive neuromodulation company. And I went, wait, what? Like, those two puzzle pieces don’t necessarily make sense. So can you help us just understand what is the problem that Cala Health was really trying to solve and how is that different from other tremor treatments? So I would be remiss, not to mention our amazing founder, Kate Rosenbluth, who is a brain beyond that you can imagine, that developed this technology that really started out. And you know, I love, I think you’ve heard her story as well too. The fact that she Yes, I love Kate. Yes. And she sat in a DBS case and thought to herself, why are we doing it this way? And so I think, and we, we joke about this, that we were probably sitting in some of the same cases together and didn’t even know it. And so just what CALA can do. The, the problem to solve was you have a significant number of patients that don’t have great treatment options. There are few. And it doesn’t mean that some of those aren’t effective. It really means that you’re dealing with a patient group that has a neurodegenerative disease that gets worse and worse over time. And we’ve offered them very few treatment options. And many of those treatment options don’t work for them. And Calla is then solving the problem. To say one is you deserve to be treated at any point in your disease state. You deserve to be able to do the things that we all take for granted, like being able to drink a cup of coffee without spilling it on yourself, being able to feed yourself, being able to get dressed in the morning, being able to put your arms through the sleeves of a sweater. And how to do that where you’re also treating patients in their home so there’s nothing else to be done. You are able to non invasively wear what looks like a watch, a device that can then treat your tremor. Just circling back really quickly. And then I want to come right back to this. What would you say the disease state is? So is it Parkinson’s disease? What is it that you’re treating? We are treating essential tremor as well as action tremor within Parkinson’s. Thank you for that clarification. We are in MedTech. It is very regulated as discussed. So I want to make sure that we narrowed in on that. You mentioned the device that was similar to a watch. Can you walk us through that device? So it’s a device that is worn on the wrist like a watch. And what we are doing is actually we are being able to access the area in the brain that’s treated for deep brain stimulation that’s used to treat tremor through the peripheral nervous system. So we’re sending signals to the brain and a patient simply has to put it on. And we are very focused on ensuring that it fits very easily into the lifestyle of a patient as well too. So when you have tremor, something that is extremely easy to put on, be able to push a button and to be able to reduce your tremor. I feel like that must be really important to you as an engineer to make sure that the technology doesn’t just do what it’s supposed to do, but can actually be used by the end user. Yes, absolutely. I want to talk more about leadership and your roles. And what was really intriguing is your progression in Cala Health. I find very intriguing. So you started as VP of product, medical affairs and customer success, and then from there you are co president and chief product officer and now you hold the role of CEO. So why that progression and why were you the right person to keep moving forward or moving up or moving forward, however you want to define that? Yes, yes. So I really think it just goes back to having the ability to understand the customer, understand our patients, and then having, I think, the unique background of having taken different products through their entire life cycle from clinical studies, pivotals through approvals into commercialization across the globe. And having done that with in the movement disorder space, so with the same customer base as well and having had experience within durable medical equipment. And so again the digital health and the direct to consumer. And so again I feel like I am lucky to wake up every morning and to be able to get to lead an amazing group of dedicated people that every day think how do we help patients get access to CalaTherapy that deserve the access. Love that so much. You said the key word here, lead. So let’s talk through that. When you reflect on your current role and your previous roles, do you employ different strategies as a leader today than you did before? Have you had to evolve your leadership strategy? Yes, absolutely. And again, I think it goes to what is it that you’re trying to accomplish? So when you work in a large multinational, you have a significant amount of resources available to you and also you can take missteps. And if you take those missteps, they’re typically you’re still funded, you still live another day. Your program may not be, but I think those are different characteristics. When you work in a large organization versus being in a startup and I would say the evolution is one, you’re still motivating people, right? You still want everybody to work towards that common goal. So that piece doesn’t change. But I think how you think about the business is different. You have a finite amount of time, you have a finite amount of resources and that’s it. Within a startup versus within a division in a large corporation, there’s typically time, additional funding, and so thinking about how you have your team performing at their best as soon as possible, as fast as possible, is a little different. Skew, as an engineer and a marketer and a business leader, what are some practical steps that our audience can take to grow their own MedTech leadership role? Yes, absolutely. I think it’s critical to learn from other leaders and I know that’s easier said than done. It’s making that space and that time to reach out to others that you admire, things that you’ve learned from them and spend the time with them. I think it’s really important too as you go through your career, it’s not just great leaders that you’ve loved. We all know those couple people that you walk through fire for. But it’s also what did you learn from someone that maybe was not the best leader? And what can you take from that? Because I think those are often lessons. We sit in a place where we experience the good and the bad of every single role that we’re in. Learn from both of them. Well, I’d be remiss not to ask what’s one thing that you’ve had to unlearn or you’ve seen that you. You are glad you did not take with you? I think this one, I think this one is fairly standard. That again, women in MedTech see, it’s, it’s not valuing everybody’s input and getting that different perspective if you take it from the same people each time or you are biased to think that only these people have this perspective. And I think that throughout my career, you start early on taking immediately from the people that you see. But as you get farther up in your career, you understand that if I don’t take these full perspectives, we’re not going to find the right path. Very, very well said. So you said just a second ago, people you were inspired by. So speaking of people you are inspired by, are there any female MedTech leaders that we should know about? So I have a little different spin on this one. And you let me know if this is okay. I am extremely impressed. She is within really more of the serving space. So her name is Dr. Kelly Lyons. She is a researcher and president of the International Essential Tremor Foundation. And I really am always humbled by the perspective that she takes of focusing on being an advocate for patients and so ensuring that there’s proper research to continue to advance essential tremor, which has not had as much time in the limelight as other indications. And also being a true advocate for patients. And you typically don’t get that view when you’re in industry. You’re focused on industry. But those I think are the moments where you take pause because somebody that’s dedicated their life to it is amazing. So it is a shout out to Dr. Kelly Lyons. That was a beautiful shout out. Deanna Harshbarger, CEO of Cala Health, thank you so much for joining me on the podcast. I loved it. Same. Thank you. And that’s a wrap on another episode of the Women in MedTech podcast. In my opening with my in studio guest, Yvonne Bokelman, I quoted Deanna Harshbarger and I’m going to do it again. She said we never get to the right answer if we don’t have those different views on it. My lens is going to be different than your lens. The lens of someone who is actually manufacturing the product is going to be different. Deanna was talking about building something that actually works and understanding that if you’re not bringing the whole picture into the room. You’re going to design something that misses the mark for the people you’re trying to serve. And that, to me, is what makes Deanna a remarkable leader. It’s practical, it’s principled, and it shows up in everything and how Cala Health designs our technology for patients, real lives, and in how she built a culture where every single person in the organization knows that their voice matters. So a huge heartfelt thank you to Deanna for sharing her time and her whole self with us today. Now I’m so excited for what Cala Health is building. Again. Congratulations. So please check out that press Release. Please explore www.CalaHealth.com to learn more about the Cala kIQ system and a huge mega thank you to MedtechWOMEN for sponsoring this episode of the Women in MedTech Podcast. Yvonne Bokelman is somebody who I’ve had the joy of getting to know over the last couple of years, and there is just no one better to bring MedtechWOMEN into its next stage of success. I love what you do. Keep doing what you do. It is so very important. Please I encourage you to visit medtechwomen.org and connect with that community. Once again, thank you so much for joining me on today’s episode of the Women in MedTech podcast. I can’t let you go without asking the question now, what does it look like in your world to design around the whole picture, Whether that’s the product you’re building, the team you’re leading, or the career that you’re carving out. Find me on LinkedIn and tell me. I’m Kayleen Brown, Managing Editor for DeviceTalks. Send me a message. And while you’re there, please follow DeviceTalks and the DeviceTalks Podcast Network. Follow the Women in MedTech podcast with me, Kayleen Brown. We keep bringing you some great, great MedTech conversations. Next week’s DeviceTalks weekly will be no exception to that. And before I let you go, I just wanted to invite you to join me next week for DeviceTalks Connected Health series. It’ll be Tuesday through Thursday, October 13th through the 15th, and we’ll be featuring presentations from three giants of healthcare BD, Karl Stortz and Philips, senior leaders from each company will explore how they’re leveraging data, employing spatial computing and building clinical intelligence. Make sure to go to device talks.com to register for free. The webinar series is brought to you by our sponsors, Jabil Healthcare, S3 Connected Health and Terumo Neuro. So see you next week and thank you again to our sponsors of the DeviceTalks Connected Health series. Once again, I’m Kayleen Brown, managing editor for DeviceTalks. And until next time, thank you for listening.

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