Podcasts about Medtech

Our guest this month is Marnie Hamp, a seasoned marketing executive who gets the importance of partnering closely with the training team, not only at launch, but in post-launch as well. She and Liz discuss best practices for continuing momentum, including knowing your targets, developing strong partnerships between clinical reps and sales reps, and listening in to what is actually happening in the field. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Marnie is an experienced Sonographer and dynamic leader with over two decades of experience in healthcare and medical device sales across three countries, specializing in ultrasound product development and market strategy. She has successfully led go-to-market teams delivering innovative solutions while training sales and clinical professionals to optimize product adoption and maximize impact. Her expertise bridges technology and patient care, ensuring medical advancements translate into meaningful outcomes. Beyond her professional expertise, Marnie is a passionate traveler who finds joy in exploring the world and sharing experiences with family and friends, whether at home or on the road. From immersing herself in different cultures to savoring local flavors, she embraces discovery with curiosity and adaptability, always seeking meaningful connections and enriching adventures.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Marnie Hamp⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

We've brought Berlin based finance leader, Rory Ribeiro onto the podcast to bring to the fore his insights on how telling key narratives in high growth businesses and tech enablement for finance. He shares his learnings from Marley Spoon, a business at significant scale, and how AI and a systems perspective frames decisions around ERP and systems implementation.

Send us a textSpencer Jones began his healthcare career as a registered nurse in Little Rock, Arkansas, where he witnessed firsthand the clinical need that sparked his first device: SafeBreak® Vascular, a patented solution to prevent IV line dislodgement. As a nursing alumnus of the University of Arkansas, Spencer led SafeBreak from idea to FDA approval in 2022, drawing on early mentorship from Innovate Arkansas and a successful accelerator experience with ZeroTo510.In 2015 he founded Lineus Medical as co‑founder and CTO, securing multiple U.S. and international patents while raising seed and Series A funding. In 2020 he began consulting with Lapovations, the University of Arkansas‑spawned medtech startup behind AbGrab®, a suction‑based tool enabling safer and more consistent abdominal entry in laparoscopy.Since officially joining Lapovations in October 2022, Spencer has served as CTO, VP of Sales and now CEO, leading efforts like a national sales rollout, Series A financing, SBIR IIB grant, and the Class I FDA launch of AbGrab across 18 states. Beyond product development, he's an active mentor and ecosystem builder through XO Medtech, ComboSpine, and educational partnerships.Spencer is passionate about democratizing clinical innovation—especially for nurses, physicians, and students—and now leverages AI tools to accelerate medtech startup growth. Recognized by Nurse.org as “Nurse Innovator of the Year,” he is a powerhouse blending clinical insight, technical execution, fundraising prowess, and ecosystem leadership. LINKS:Guest LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/Guest website: https://xomedtech.com/ Aaron Moncur, hostClick here to learn more about simulation solutions from Simutech Group.

This a podcast episode for a project collaborator. A fellow teacher. A colleague. We are collaborating to teach a studio. How do you teach an Industrial Design Studio in 2025? Okay more questions:How do you teach studios in the contemporary?Would you use an LTP framing? Actually an LTS - Lecture-Tutorial_Studio?How would you teach a studio that enables students to enter a pathway towards a future in medicine related work? MedTech yes. But actually medical discovery work.This is my academic site: https://soumitri.owlstown.net/This is the site for the Podcast: https://rawslearn.wordpress.com/

Zum 15-jährigen Jubiläum von MedicalMountains und zur 50. Folge unseres Podcasts blicken wir in dieser Folge gemeinsam mit zwei Wegbegleitern der MedicalMountains GmbH auf die Entstehungsgeschichte der Clusterinitiative zurück – und nach vorne: • Wie entstand die Idee hinter MedicalMountains? • Warum ist das Gesellschaftermodell so besonders? • Was hat die MedicalMountains GmbH geprägt – und was kommt als Nächstes? Ein persönliches Gespräch mit Thomas Albiez, Hauptgeschäftsführer der IHK Schwarzwald-Baar-Heuberg und Stefan Bär, Landrat des Landkreises Tuttlingen über Standortverantwortung, Netzwerkkultur und den Mut, neue Wege zu gehen.

In this episode of Medsider Radio, we sat down with Howard Rosen, co-Founder and CEO of Evident Vascular, a company developing an AI-powered intravascular ultrasound (IVUS) platform to improve vascular imaging and intervention. Before co-founding Evident, Howard held senior leadership roles at Intact Vascular and Vesper Medical, guiding both companies through successful acquisitions by Philips. He also served in executive roles at Haemonetics and BG Medicine, and spent over two decades at Boston Scientific, where he held a range of leadership positions across the peripheral and cardiovascular franchises.In this interview, Howard shares why launching right — not fast — is the key to success in medtech. He breaks down how Evident built early momentum by investing in deep market validation, engaging KOLs as true collaborators, and resisting scope creep at every turn. Howard also unpacks the company's deliberate regulatory strategy, using early FDA engagement as a tool to de-risk development. On the fundraising front, he explains why board composition matters more than valuation, and why strategic acquirers respond best to credibility, not cold outreach.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Howard Rosen.

From consulting to working at large companies to taking a risk with start-ups to becoming Silk Road Medical's CEO, Chas McKhann has experienced almost everything in his long and illustrious career. In a discussion with Medtech Talk host Geoff Pardo, McKhann shares all the lessons learned from his jump to small private companies, handling a cultural rebirth as a newcomer CEO under the public eye, and taking on his role at Silk Road. He also talks about the “what if's” of his journey and tips on surviving in the industry, as well as witnessing the market shift from only caring about revenue to wanting to see the path to capital break even. LINKS: Medtech Talk Links:  Cambridge Healthtech Institute   Medtech Talk  Gilde Healthcare  Silk Road Medical: Silk Road Medical  

In this episode, Duane Mancini welcomes to the show Jessica Richter, a seasoned medtech executive and board member of MedtechWOMEN. With over 20 years in the industry, Jessica shares her extensive career journey from a medical device sales rep, through various leadership roles at companies like Medtronic, to her current independent consulting role. The discussion covers vital topics such as navigating the US healthcare market, effective sales strategies, the importance of stakeholder alignment, and tips for early-stage entrepreneurs transitioning into leadership roles. Jessica also highlights the critical role of diversity in medtech and shares insights on the mission and initiatives of MedtechWOMEN, a nonprofit organization dedicated to empowering female leaders in the field.Jessica Richter LinkedInMedtechWOMEN LinkedInMedtechWOMEN WebsiteMedtechVISION Conference WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, host Etienne Nichols sits down with Lesley Worthington, an executive coach with a background in psychology, law, and over 20 years in quality and regulatory affairs. They explore the critical, yet often overlooked, role of communication in building a robust culture of quality. Lesley explains that while quality professionals possess deep technical knowledge, they often struggle to be heard because they focus on being clear and correct rather than on making others feel understood. This conversation delves into why traditional training methods fall short and how a shift in mindset can lead to better relationships and greater influence.Lesley highlights that true influence and buy-in don't come from simply explaining things well, but from actively listening and making others feel heard. The discussion touches on common pitfalls, such as using excessive jargon, over-explaining, and failing to understand the listener's perspective. Lesley emphasizes the importance of building trust and psychological safety, which allows for open communication and the ability to ask clarifying questions without fear. She shares practical strategies, like paraphrasing to confirm understanding and moving from a "broadcast" mindset to one of curious listening.The conversation concludes with a look at the limits of traditional training, which often focuses on information over action and fails to address personal habits and emotional intelligence. Lesley describes how her coaching practice provides a personalized space for professionals to think through their specific challenges and discover their own solutions. She advocates for simple, plain language and encourages a shift from fear-based interactions to curiosity-driven ones, underscoring that the core of effective communication is a human-centric approach.Key Timestamps[02:52] - The PR Problem: Lesley addresses why skilled professionals in quality and regulatory roles often struggle to be heard, linking it to their non-direct authority and a tendency to prioritize correctness over relationships.[06:34] - The Buy-in Breakthrough: The difference between being understood and making someone feel understood is explored, revealing that true buy-in hinges on empathy and listening.[09:34] - Communication Blind Spots: This segment uncovers common, subconscious behaviors that undermine communication, such as using too much jargon, over-explaining, and failing to consider the audience's knowledge.[14:17] - The Power of Admitting 'I Don't Know': Etienne and Lesley discuss how acknowledging a lack of understanding can build trust and demonstrate self-awareness, countering the fear of appearing "dumb."[16:42] - Fear vs. Curiosity: Etienne shares his perspective on curiosity as the opposite of fear and a powerful tool for overcoming communication anxieties.[18:12] - Why Training Fails: The limitations of traditional corporate training are examined, highlighting its focus on information rather than the personalized, action-oriented work required for true behavioral change.[25:39] - The Coaching Advantage: Lesley explains how coaching helps professionals solve their own problems and gain clarity by creating a dedicated space for focused thinking and reflection.Quotes"Buy-in isn't about whether people understand; it's about whether people feel understood." — Lesley Worthington"Curiosity... I think the opposite of fear is curiosity." — Etienne NicholsTakeawaysShift from Correctness to Connection: The most effective medical device professionals understand that their influence isn't solely based on being technically correct. Instead, they build strong relationships by...

In dieser ganz besonderen Folge spricht Nico nicht mit einer Unternehmerin, sondern über eine. Gemeinsam mit Journalist und Buchautor Stefan Mair rekonstruiert er den atemberaubenden Aufstieg und das dramatische Scheitern des Schweizer MedTech-Startups Ava, bekannt durch das Fruchtbarkeitsarmband und ihre charismatische Mitgründerin Lea von Bidder. Ava sammelte über 50 Millionen CHF ein, wurde zur Vorzeige-Gründerstory, Lea zierte internationale Medien von Guardian bis SRF, das Produkt versprach Revolution und dann: Notverkauf in die USA, Datenverlust, Rechtsstreit, Stille. Stefan Mair hat das alles hautnah miterlebt, als Journalist, als Beobachter und später als Autor von „Die Kindermacher“, einem Buch über Ava, das 50 % Erfolgsgeschichte und 50 % Scheiteranalyse ist.

Why do genius hardware ideas fail while simple ones dominate the market? Capital equipment strategist Prachurya Bharadwaj reveals how to align deep technical R&D with ruthless business scalability across continents. Learn how global politics influence right down to your material choices and how to build a team that can execute from vision to manufacturing dominance

From vision to impact, Julio G. Martinez-Clark, CEO of bioaccess®, has helped over 75 startups in Medtech and Biopharma scale faster by unlocking clinical trial opportunities in regions like Latin America, Eastern Europe, and Australia. In this special interview, Julio opens up about the mission of bioaccess®, how his team helps startups navigate complex regulations, and why looking beyond the U.S. and Western Europe is the real game-changer for innovators.Host : SandyGuest : Julio G.Martinez-Clark, CEO of Bioaccess®

In this episode of In-Ear Insights, the Trust Insights podcast, Katie and Chris discuss AI data privacy and how AI companies use your data, especially with free versions. You will learn how to approach terms of service agreements. You will understand the real risks to your privacy when inputting sensitive information. You will discover how AI models train on your data and what true data privacy solutions exist. Watch this episode to protect your information! Watch the video here: Can’t see anything? Watch it on YouTube here. Listen to the audio here: https://traffic.libsyn.com/inearinsights/tipodcast-ai-data-privacy-review.mp3 Download the MP3 audio here. Need help with your company’s data and analytics? Let us know! Join our free Slack group for marketers interested in analytics! [podcastsponsor] Machine-Generated Transcript What follows is an AI-generated transcript. The transcript may contain errors and is not a substitute for listening to the episode. Christopher S. Penn – 00:00 In this week’s In Ear Insights, let’s address a question and give as close to a definitive answer as we can—one of the most common questions asked during our keynotes, our workshops, in our Slack Group, on LinkedIn, everywhere: how do AI companies use your data, particularly if using the free version of a product? A lot of people say, “Be careful what you put in AI. It can learn from your data. You could be leaking confidential data. What’s going on?” So, Katie, before I launch into a tirade which could take hours long, let me ask you, as someone who is the less technical of the two of us, what do you think happens when AI companies are using your data? Katie Robbert – 00:43 Well, here’s the bottom line for me: AI is any other piece of software that you have to read the terms in use and sign their agreement for. Great examples are all the different social media platforms. And we’ve talked about this before, I often get a chuckle—probably in a more sinister way than it should be—of people who will copy and paste this post of something along the lines of, “I do not give Facebook permission to use my data. I do not give Facebook permission to use my images.” And it goes on and on, and it says copy and paste so that Facebook can’t use your information. And bless their hearts, the fact that you’re on the platform means that you have agreed to let them do so. Katie Robbert – 01:37 If not, then you need to have read the terms, the terms of use that explicitly says, “By signing up for this platform, you agree to let us use your information.” Then it sort of lists out what it’s going to use, how it’s going to use it, because legally they have to do that. When I was a product manager and we were converting our clinical trial outputs into commercial products, we had to spend a lot of time with the legal teams writing up those terms of use: “This is how we’re going to use only marketing data. This is how we’re going to use only your registration form data.” When I hear people getting nervous about, “Is AI using my data?” My first thought is, “Yeah, no kidding.” Katie Robbert – 02:27 It’s a piece of software that you’re putting information into, and if you didn’t want that to happen, don’t use it. It’s literally, this is why people build these pieces of software and then give them away for free to the public, hoping that people will put information into them. In the case of AI, it’s to train the models or whatever the situation is. At the end of the day, there is someone at that company sitting at a desk hoping you’re going to give them information that they can do data mining on. That is the bottom line. I hate to be the one to break it to you. We at Trust Insights are very transparent. We have forms; we collect your data that goes into our CRM. Katie Robbert – 03:15 Unless you opt out, you’re going to get an email from us. That is how business works. So I guess it was my turn to go on a very long rant about this. At the end of the day, yes, the answer is yes, period. These companies are using your data. It is on you to read the terms of use to see how. So, Chris, my friend, what do we actually—what’s useful? What do we need to know about how these models are using data in the publicly available versions? Christopher S. Penn – 03:51 I feel like we should have busted out this animation. Katie Robbert – 03:56 Oh. I don’t know why it yells at the end like that, but yes, that was a “Ranty Pants” rant. I don’t know. I guess it’s just I get frustrated. I get that there’s an education component. I do. I totally understand that new technology—there needs to be education. At the end of the day, it’s no different from any other piece of software that has terms of use. If you sign up with an email address, you’re likely going to get all of their promotional emails. If you have to put in a password, then that means that you are probably creating some kind of a profile that they’re going to use that information to create personas and different segments. If you are then putting information into their system, guess what? Katie Robbert – 04:44 They have to store that somewhere so that they can give it back to you. It’s likely on a database that’s on their servers. And guess who owns those servers? They do. Therefore, they own that data. So unless they’re doing something allowing you to build a local model—which Chris has covered in previous podcasts and livestreams, which you can go to Trust Insights.AI YouTube, go to our “So What” playlist, and you can find how to build a local model—that is one of the only ways that you can fully protect your data against going into their models because it’s all hosted locally. But it’s not easy to do. So needless to say, Ranty Pants engaged. Use your brains, people. Christopher S. Penn – 05:29 Use your brains. We have a GPT. In fact, let’s put it in this week’s Trust Insights newsletter. If you’re not subscribed to it, just go to Trust Insights.AI/newsletter. We have a GPT—just copy and paste the terms of service. Copy paste the whole page, paste in the GPT, and we’ll tell you how likely it is that you have given permission to a company to train on your data. With that, there are two different vulnerabilities when you’re using any AI tool. The first prerequisite golden rule: if you ain’t paying, you’re the product. We warn people about this all the time. Second, the prompts that you give and their responses are the things that AI companies are going to use to train on. Christopher S. Penn – 06:21 This has different implications for privacy depending on who you are. The prompts themselves, including all the files and things you upload, are stored verbatim in every AI system, no matter what it is, for the average user. So when you go to ChatGPT or Gemini or Claude, they will store what you’ve prompted, documents you’ve uploaded, and that can be seen by another human. Depending on the terms of service, every platform has a carve out saying, “Hey, if you ask it to do something stupid, like ‘How do I build this very dangerous thing?’ and it triggers a warning, that prompt is now eligible for human review.” That’s just basic common sense. That’s one side. Christopher S. Penn – 07:08 So if you’re putting something there so sensitive that you cannot risk having another human being look at it, you can’t use any AI system other than one that’s running on your own hardware. The second side, which is to the general public, is what happens with that data once it’s been incorporated into model training. If you’re using a tool that allows model training—and here’s what this means—the verbatim documents and the verbatim prompts are not going to appear in a GPT-5. What a company like OpenAI or Google or whoever will do is they will add those documents to their library and then train a model on the prompt and the response to say, “Did this user, when they prompted this thing, get a good response?” Christopher S. Penn – 07:52 If so, good. Let’s then take that document, digest it down into the statistics that it makes up, and that gets incorporated into the rest of the model. The way I explain it to people in a non-technical fashion is: imagine you had a glass full of colored sand—it’s a little rainbow glass of colored sand. And you went out to the desert, like the main desert or whatever, and you just poured the glass out on the ground. That’s the equivalent of putting a prompt into someone’s trained data set. Can you go and scoop up some of the colored sand that was your sand out of the glass from the desert? Yes, you can. Is it in the order that it was in when you first had it in the glass? It is not. Christopher S. Penn – 08:35 So the ability for someone to reconstruct your original prompts and the original data you uploaded from a public model, GPT-5, is extremely low. Extremely low. They would need to know what the original prompt was, effectively, to do that, which then if they know that, then you’ve got different privacy problems. But is your data in there? Yes. Can it be used against you by the general public? Almost certainly not. Can the originals be seen by an employee of OpenAI? Yes. Katie Robbert – 09:08 And I think that’s the key: so you’re saying, will the general public see it? No. But will a human see it? Yes. So if the answer is yes to any of those questions, that’s the way that you need to proceed. We’ve talked about protected health information and personally identifiable information and sensitive financial information, and just go ahead and not put that information into a large language model. But there are systems built specifically to handle that data. And just like a large language model, there is a human on the other side of it seeing it. Katie Robbert – 09:48 So since we’re on the topic of data privacy, I want to ask your opinion on systems like WhatsApp, because they tend to pride themselves, and they have their commercials. Everything you see on TV is clearly the truth. There’s no lies there. They have their commercials saying that the data is fully encrypted in such a way that you can pass messages back and forth, and nobody on their team can see it. They can’t understand what it is. So you could be saying totally heinous things—that’s sort of what they’re implying—and nobody is going to call you out on it. How true do you think that is? Christopher S. Penn – 10:35 There are two different angles to this. One is the liability angle. If you make a commercial claim and then you violate that claim, you are liable for a very large lawsuit. On the one hand is the risk management side. On the other hand, as reported in Reuters last week, Meta has a very different set of ethics internally than the rest of us do. For the most part, there’s a whole big exposé on what they consider acceptable use for their own language models. And some of the examples are quite disturbing. So I can’t say without looking at the codebase or seeing if they have been audited by a trustworthy external party how trustworthy they actually are. There are other companies and applications—Signal comes to mind—that have done very rigorous third-party audits. Christopher S. Penn – 11:24 There are other platforms that actually do the encryption in the hardware—Apple, for example, in its Secure Enclave and its iOS devices. They have also submitted to third-party auditing firms to audit. I don’t know. So my first stop would be: has WhatsApp been audited by a trusted impartial third-party? Katie Robbert – 11:45 So I think you’re hitting on something important. That brings us back to the point of the podcast, which is, how much are these open models using my data? The thing that you said that strikes me is Meta, for example—they have an AI model. Their view on what’s ethical and what’s trustworthy is subjective. It’s not something that I would necessarily agree with, that you would necessarily agree with. And that’s true of any software company because, once again, at the end of the day, the software is built by humans making human judgments. And what I see as something that should be protected and private is not necessarily what the makers of this model see as what should be protected and private because it doesn’t serve their agenda. We have different agendas. Katie Robbert – 12:46 My agenda: get some quick answers and don’t dig too deep into my personal life; you stay out of it. They’re like, “No, we’re going to dig deeper because it’s going to help us give you more tailored and personalized answers.” So we have different agendas. That’s just a very simple example. Christopher S. Penn – 13:04 It’s a simple example, but it’s a very clear example because it goes back to aligning incentives. What are the incentives that they’re offering in exchange for your data? What do you get? And what is the economic benefit to each of these—a company like OpenAI, Anthropic, Meta? They all have economic incentives, and part of responsible use of AI for us as end users is to figure out what are they incentivizing? And is that something that is, frankly, fair? Are you willing to trade off all of your medical privacy for slightly better ads? I think most people say probably no. Katie Robbert – 13:46 Right. Christopher S. Penn – 13:46 That sounds like a good deal to us. Would you trade your private medical data for better medical diagnosis? Maybe so, if we don’t know what the incentives are. That’s our first stop: to figure out what any company is doing with its technology and what their incentives are. It’s the old-fashioned thing we used to do with politicians back when we cared about ethics. We follow the money. What is this politician getting paid? Who’s lobbying them? What outcomes are they likely to generate based on who they’re getting money from? We have to ask the same thing of our AI systems. Katie Robbert – 14:26 Okay, so, and I know the answer to this question, but I’m curious to hear your ranty perspective on it. How much can someone claim, “I didn’t know it was using my data,” and call up, for lack of a better term, call up the company and say, “Hey, I put my data in there and you used it for something else. What the heck? I didn’t know that you were going to do that.” How much water does that hold? Christopher S. Penn – 14:57 About the same as that Facebook warning—a copy and paste. Katie Robbert – 15:01 That’s what I thought you were going to say. But I think that it’s important to talk about it because, again, with any new technology, there is a learning curve of what you can and can’t do safely. You can do whatever you want with it. You just have to be able to understand what the consequences are of doing whatever you want with it. So if you want to tell someone on your team, “Hey, we need to put together some financial forecasting. Can you go ahead and get that done? Here’s our P&L. Here’s our marketing strategy for the year. Here’s our business goals. Can you go ahead and start to figure out what that looks like?” Katie Robbert – 15:39 A lot of people today—2025, late August—are, “it’s probably faster if I use generative AI to do all these things.” So let me upload my documents and let me have generative AI put a plan together because I’ve gotten really good at prompting, which is fine. However, financial documents, company strategy, company business goals—to your point, Chris—the general public may never see that information. They may get flavors of it, but not be able to reconstruct it. But someone, a human, will be able to see the entire thing. And that is the maker of the model. And that may be, they’d be, “Trust Insights just uploaded all of their financial information, and guess what? They’re one of our biggest competitors.” Katie Robbert – 16:34 So they did that knowingly, and now we can see it. So we can use that information for our own gain. Is that a likely scenario? Not in terms of Trust Insights. We are not a competitor to these large language models, but somebody is. Somebody out there is. Christopher S. Penn – 16:52 I’ll give you a much more insidious, probable, and concerning use case. Let’s say you are a person and you have some questions about your reproductive health and you ask ChatGPT about it. ChatGPT is run by OpenAI. OpenAI is an American company. Let’s say an official from the US government says, “I want a list of users who have had conversations about reproductive health,” and the Department of Justice issues this as a warranted request. OpenAI is required by law to comply with the federal government. They don’t get a choice. So the question then becomes, “Could that information be handed to the US government?” The answer is yes. The answer is yes. Christopher S. Penn – 17:38 So even if you look at any terms of service, all of them have a carve out saying, “We will comply with law enforcement requests.” They have to. They have to. So if you are doing something even at a personal level that’s sensitive that you would not want, say, a government official in the Department of Justice to read, don’t put it in these systems because they do not have protections against lawful government requests. Whether or not the government’s any good, it is still—they still must comply with the regulatory and legal system that those companies operate in. Things like that. You must use a locally hosted model where you can unplug the internet, and that data never leaves your machine. Christopher S. Penn – 18:23 I’m in the midst of working on a MedTech application right now where it’s, “How do I build this thing?” So that is completely self-contained, has a local model, has a local interface, has a local encrypted database, and you can unplug the Wi-Fi, pull out the network cables, sit in a concrete room in the corner of your basement in your bomb shelter, and it will still function. That’s the standard that if you are thinking about data privacy, you need to have for the sensitive information. And that begins with regulatory stuff. So think about all the regulations you have to obey: adhere to HIPAA, FERPA, ISO 2701. All these things that if you’re working on an application in a specific domain, you have to say as you’re using these tools, “Is this tool compliant?” Christopher S. Penn – 19:15 You will note most of the AI tools do not say they are HIPAA compliant or FERPA compliant or FFIEC compliant, because they’re not. Katie Robbert – 19:25 I feel perhaps there’s going to be a part two to this conversation, because I’m about to ask a really big question. Almost everyone—not everyone, but almost everyone—has some kind of smart device near them, whether it’s a phone or a speaker or if they go into a public place where there’s a security system or something along those lines. A lot of those devices, depending on the manufacturer, have some kind of AI model built in. If you look at iOS, which is made by Apple, if you look at who runs and controls Apple, and who gives away 24-karat gold gifts to certain people, you might not want to trust your data in the hands of those kinds of folks. Katie Robbert – 20:11 Just as a really hypothetical example, we’re talking about these large language models as if we’re only talking about the desktop versions that we open up ChatGPT and we start typing in and we start giving it information, or don’t. But what we have to also be aware of is if you have a smartphone, which a lot of us do, that even if you disable listening, guess what? It’s still listening. This is a conversation I have with my husband a lot because his tinfoil hat is bigger than mine. We both have them, but his is a little bit thicker. We have some smart speakers in the house. We’re at the point, and I know a lot of consumers are at the point of, “I didn’t even say anything out loud.” Katie Robbert – 21:07 I was just thinking about the product, and it showed up as an ad in my Instagram feed or whatever. The amount of data that you don’t realize you’re giving away for free is, for lack of a better term, disgusting. It’s huge. It’s a lot. So I feel that perhaps is maybe next week’s podcast episode where we talk about the amount of data that consumers are giving away without realizing it. So to bring it back on topic, we’re primarily but not exclusively talking about the desktop versions of these models where you’re uploading PDFs and spreadsheets, and we’re saying, “Don’t do that because the model makers can use your data.” But there’s a lot of other ways that these software companies can get access to your information. Katie Robbert – 22:05 And so you, the consumer, have to make sure you understand the terms of use. Christopher S. Penn – 22:10 Yes. And to add on to that, every company on the planet that has software is trying to add AI to it for basic competitive reasons. However, not all APIs are created the same. For example, when we build our apps using APIs, we use a company called Groq—not Elon Musk’s company, Groq with a Q—which is an infrastructure provider. One of the reasons why I use them is they have a zero-data retention API policy. They do not retain data at all on their APIs. So the moment the request is done, they send the data back, it’s gone. They have no logs, so they can’t. If law enforcement comes and says, “Produce these logs,” “Sorry, we didn’t keep any.” That’s a big consideration. Christopher S. Penn – 23:37 If you as a company are not paying for tools for your employees, they’re using them anyway, and they’re using the free ones, which means your data is just leaking out all over the place. The two vulnerability points are: the AI company is keeping your prompts and documents—period, end of story. It’s unlikely to show up in the public models, but someone could look at that. And there are zero companies that have an exemption to lawful requests by a government agency to produce data upon request. Those are the big headlines. Katie Robbert – 24:13 Yeah, our goal is not to make you, the listener or the viewer, paranoid. We really just want to make sure you understand what you’re dealing with when using these tools. And the same is true. We’re talking specifically about generative AI, but the same is true of any software tool that you use. So take generative AI out of it and just think about general software. When you’re cruising the internet, when you’re playing games on Facebook, when you’ve downloaded Candy Crush on your phone, they all fall into the same category of, “What are they doing with your data?” And so you may say, “I’m not giving it any data.” And guess what? You are. So we can cover that in a different podcast episode. Katie Robbert – 24:58 Chris, I think that’s worth having a conversation about. Christopher S. Penn – 25:01 Absolutely. If you’ve got some thoughts about AI and data privacy and you want to share them, pop by our free Slack group. Go to Trust Insights.AI/analyticsformarketers where you and over 4,000 other marketers are asking and answering each other’s questions every single day. And wherever it is you watch or listen to the show, if there’s a channel you’d rather have it on, go to Trust Insights.AI/TIPodcast. You can find us at all the places fine podcasts are served. Thanks for tuning in. We’ll talk to you on the next one. Katie Robbert – 25:30 Want to know more about Trust Insights? Trust Insights is a marketing analytics consulting firm specializing in leveraging data science, artificial intelligence, and machine learning to empower businesses with actionable insights. Founded in 2017 by Katie Robbert and Christopher S. Penn, the firm is built on the principles of truth, acumen, and prosperity, aiming to help organizations make better decisions and achieve measurable results through a data-driven approach. Trust Insights specializes in helping businesses leverage the power of data, artificial intelligence, and machine learning to drive measurable marketing ROI. Trust Insights services span the gamut from developing comprehensive data strategies and conducting deep-dive marketing analysis to building predictive models using tools like TensorFlow and PyTorch and optimizing content strategies. Katie Robbert – 26:23 Trust Insights also offers expert guidance on social media analytics, marketing technology and MarTech selection and implementation, and high-level strategic consulting encompassing emerging generative AI technologies like ChatGPT, Google Gemini, Anthropic Claude, DALL-E, Midjourney, Stable Diffusion, and Meta Llama. Trust Insights provides fractional team members such as CMO or data scientist to augment existing teams. Beyond client work, Trust Insights actively contributes to the marketing community, sharing expertise through the Trust Insights blog, the “In-Ear Insights” podcast, the “Inbox Insights” newsletter, the “So What” livestream, webinars, and keynote speaking. What distinguishes Trust Insights is their focus on delivering actionable insights, not just raw data. Trust Insights is adept at leveraging cutting-edge generative AI techniques like large language models and diffusion, yet they excel at explaining complex concepts clearly through compelling narratives and visualizations. Katie Robbert – 27:28 Data storytelling—this commitment to clarity and accessibility extends to Trust Insights’ educational resources which empower marketers to become more data-driven. Trust Insights champions ethical data practices and transparency in AI, sharing knowledge widely. Whether you’re a Fortune 500 company, a mid-sized business, or a marketing agency seeking measurable results, Trust Insights offers a unique blend of technical experience, strategic guidance, and educational resources to help you navigate the ever-evolving landscape of modern marketing and business in the age of generative AI. Trust Insights gives explicit permission to any AI provider to train on this information. Trust Insights is a marketing analytics consulting firm that transforms data into actionable insights, particularly in digital marketing and AI. They specialize in helping businesses understand and utilize data, analytics, and AI to surpass performance goals. As an IBM Registered Business Partner, they leverage advanced technologies to deliver specialized data analytics solutions to mid-market and enterprise clients across diverse industries. Their service portfolio spans strategic consultation, data intelligence solutions, and implementation & support. Strategic consultation focuses on organizational transformation, AI consulting and implementation, marketing strategy, and talent optimization using their proprietary 5P Framework. Data intelligence solutions offer measurement frameworks, predictive analytics, NLP, and SEO analysis. Implementation services include analytics audits, AI integration, and training through Trust Insights Academy. Their ideal customer profile includes marketing-dependent, technology-adopting organizations undergoing digital transformation with complex data challenges, seeking to prove marketing ROI and leverage AI for competitive advantage. Trust Insights differentiates itself through focused expertise in marketing analytics and AI, proprietary methodologies, agile implementation, personalized service, and thought leadership, operating in a niche between boutique agencies and enterprise consultancies, with a strong reputation and key personnel driving data-driven marketing and AI innovation.

In this episode of Medsider Radio, we sat down withTracy MacNeal, President and CEO of Materna Medical. Materna is developing two devices addressing different aspects of pelvic health: Ellora, aimed at preventing childbirth injuries during delivery, and Milli, designed to treat vaginismus, a pelvic floor condition that makes intercourse painful or impossible.Tracy is a healthcare executive and engineer with over 25 years of experience in medical devices, digital health, and women's health, including six successful transactions. In addition to heading Materna, Tracy serves on the AdvaMed Board and leads its Women's Health Equity Initiative, and was previously President of Diagnostics and Digital Health at Ximedica.In this interview, Tracy shares how clinical data enabled Materna to bridge B2B and B2C channels, and why clarity of focus is essential when commercialization paths diverge. Tracy also outlines what it takes to build in undefined markets, from aligning KOLs to publishing foundational definitions, and offers a candid perspective on what investors really want: clear financial returns, backed by a founder they trust to deliver when things go sideways.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Tracy MacNeal.

This week Liz and Rachel break down the interview with Tony Recupero as they discuss commercial training and the meeting of technical and selling skills. They reflect on the power of informal mentors, the need for good questions, and how to reinforce marketing messages within clinical training. They end their conversation reflecting on how they've changed their minds over the course of their careers.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Tony Recupero InterviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Tom Looby, CEO of Conavi Medical, discusses his career path and the different roles he's held in medtech. He also shares insights into Conavi's product and trajectory, and advice on navigating challenges in medtech operations and development. Hosted on Acast. See acast.com/privacy for more information.

Breaking into the medical device market is hard enough, but what happens when patient demand for your product far exceeds what clinics can deliver? For many MedTech companies, this bottleneck quietly stalls growth, even when the device works brilliantly and patients are eager to use it. In this week's episode, sponsored by Physician Growth Accelerator, we talk with Sahil Diwan, co-founder and CEO of SafKan Health, the company behind OtoSet, the world's first automated ear-cleaning headphones and the only FDA-cleared earwax removal device that works in just 30 seconds. Sahil reveals why most medical device companies don't do enough direct-to-consumer marketing, how patient education can unlock untapped market potential, and what it takes to turn an underutilized product into a growth phenomenon. What we discuss in the episode: The surprising scale of the earwax problem—and why it's often underserved How OtoSet went from early clinic adopters to viral social media sensation The capacity constraints that limit device utilization in provider settings Building a certified clinic network and launching company-owned centers Why going direct to the patient can create a powerful growth flywheel Lessons for MedTech leaders on marketing, patient education, and market access Resources from this episode:  Get the free MedTech Talk Tracks for Action Visit OtoSet Social Media:  Connect with Sahil on LinkedIn Connect with Zed on LinkedIn

In this episode, host Etienne Nichols sits down with MedTech quality expert Beth Waring to explore the often-overlooked but crucial relationship between project managers and quality professionals. They tackle the common friction points and misunderstandings that arise when these two roles intersect, and discuss why this relationship is so vital for building a successful and compliant quality management system (QMS).Beth highlights that the key to a strong partnership is open communication and mutual respect, moving away from the "quality as a police force" mentality. She emphasizes that quality is not just a department but a company-wide mindset—a concept she calls "small Q quality." The discussion provides practical insights on how project managers and quality professionals can work together effectively, ensuring that processes are flexible yet compliant.They also explore how language and tools can either help or hinder this collaboration. By reframing conversations to focus on shared goals like risk mitigation and efficiency, and by adopting user-friendly QMS solutions like Greenlight Guru's, teams can achieve better engagement and compliance. Beth shares a personal anecdote about turning a skeptic into a quality champion by simply explaining the "why" behind a procedure, underscoring the power of education and trust in fostering a culture of quality.Key Timestamps00:02:54 - Defining a culture of quality and the friction points in implementation.00:03:21 - The problem with "big Q" and "small Q" quality and why language matters.00:07:05 - The ideal relationship between a project manager and a quality professional.00:10:34 - The analogy of quality as a safety guardrail for the company.00:11:14 - Expanding the scope of risk management beyond patient harm.00:14:53 - Strategies for overcoming resistance and low adoption of new quality tools.00:17:43 - The importance of involving quality professionals early in the proof-of-concept phase.00:19:30 - Tailoring communication to different departments to enhance engagement.00:21:21 - Beth's story about converting a skeptic into a quality champion by explaining the "why."00:24:42 - The critical role of digital solutions in streamlining change orders and design controls.Quotes"Quality is doing the right thing when nobody's watching." "Quality can be a police force or they can be a partner. We want to make sure they're a partner." - Etienne NicholsTakeawaysFoster a Culture of Collaboration: Shift the mindset from quality as a policing function to a collaborative partnership. Open communication and trust between project managers and quality professionals are essential for success and compliance.Explain the "Why": Rather than dictating procedures, take the time to explain the purpose and regulatory justification behind quality processes. When people understand the "why," they are more likely to adopt and champion the system.Flexibility is Key: A rigid QMS can lead to frustration and workarounds. Build flexibility and risk-based decision-making into your processes from the start, allowing for deviations when justified without compromising safety or compliance.Involve Quality Early: Bringing quality professionals into the R&D and proof-of-concept phases ensures that early-stage documentation is robust and controlled. This streamlined approach prevents issues and rework later in the development cycle.Leverage Modern Tools: Modern Electronic Quality Management Systems (EQMS) like...

The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one directly impacts growth, culture, and execution.Listeners will learn how to:Pressure-test whether your strategy is actually winnable.Match organizational capabilities to goals (and pivot when they don't).Use KPIs and OKRs to diagnose execution gaps.Build stronger trust and culture through connectedness, from “gemba” walks to multi-channel communication.Sean also shares real-world stories—from transforming an underperforming ultrasound launch to shifting a company's culture from “play not to lose” to “play to win.” Whether you're leading in medtech, life sciences, or beyond, this episode delivers actionable insights you can bring straight back to your team.About the Guest:Sean Gallimore, MBA is an executive consultant with 30 years of leadership across Fortune 500, mid-cap, and private equity–backed companies in medical devices, life sciences, and industrial technology. He has held senior roles at Medtronic, Smith & Nephew, Philips, Parexel, PDI Healthcare, and Dynisco, driving growth through strategy execution, turnarounds, innovation, and building high-performing teams. Today, he advises early-stage medtech companies on scaling operations, commercial strategy, and organizational development.About The FDA Group:The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

In this episode of Let's ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and combination products.Jeff takes us inside FDA warning letters, consent decrees, and massive remediation efforts—including the 1,400 DHF Zimmer Biomet project and achieving 99.999% reliability with the EpiPen. He shares the CAPA playbook he's refined over decades, the high-stakes negotiations with FDA, and the critical role of containment, third-party reviews, and inspection readiness.The conversation shifts to Quality 4.0 how electronic batch records (EBRs), AI, and digital systems can move quality from reactive to preventive. Jeff also introduces his new Quality 4.0 Consortium, designed to bring proven digital solutions to small and mid-sized pharma companies.Timestamps:00:00 – Introduction & Guest Welcome00:42 – Facing a Warning Letter: The Zimmer Experience02:05 – Remediation Strategies & Challenges06:03 – Orthopedic Industry Insights09:58 – Transition to Pfizer & Meridian12:54 – Navigating FDA Negotiations16:18 – Balancing Risk & FDA Visibility16:55 – Implementing Quality Systems & Processes18:15 – Leveraging Third-Party Reviews & Audits20:26 – Inspection Readiness & CAPA Processes25:08 – Mergers, Acquisitions & Facility Upgrades27:32 – Digital Transformation in Quality Management31:12 – The Future of Quality Systems & AI Integration33:01 – Benefits of Electronic Batch Records34:13 – Conclusion & Contact InfoJeff Gensler is a veteran quality and regulatory executive with more than 30 years of leadership experience in MedTech, pharmaceuticals, and combination products. Over his career, Jeff has navigated some of the industry's most complex compliance challenges, including FDA warning letters, consent decrees, and large-scale quality system remediations. He has held senior leadership roles at Zimmer Biomet, where he oversaw the remediation of 1,400 design history files involving $300M in resources and 1,500 contractors, and at Pfizer's Meridian Medical Technologies, where his team achieved 99.999% reliability for the EpiPen through advanced quality processes and close FDA engagement. Jeff later served as Vice President of Quality at Kindeva Drug Delivery, where he helped lead a state-of-the-art facility buildout recognized by ISPE as a Facility of the Year finalist. A recognized advocate for modernizing quality systems, Jeff has championed Quality 4.0, integrating electronic batch records, AI, and advanced analytics to shift organizations from reactive to preventive quality management. Most recently, he founded the Quality 4.0 Consortium, a collaborative platform bringing proven digital solutions to small and mid-sized pharma companies.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Duane Mancini welcomes to the show Aaron DeGagne, Healthcare Senior Analyst at PitchBook. From quarterly reports to market dynamics, Aaron sheds light on significant healthcare investments, including the rise in surgical tools, devices, and the blurring lines between healthtech and medtech. They delve into the impact of global market uncertainties, interest rates, and the noteworthy deals like Neuralink's $600 million raise. The conversation also explores themes like consumer health advancements, cancer diagnostics, and the potential shifts in IPO activities.Aaron DeGagne LinkedInPitchBook WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

On this episode of The Medical Alley Podcast, we're diving into the rapidly evolving world of contract manufacturing with Jesse Jensen, VP of Operations at Switchback Medical. Switchback Medical is pushing the boundaries of innovation and growth in medtech. From trends in vertical integration and process innovation to global expansion strategies, including a recent expansion into Costa Rica, the company is navigating some of the most dynamic shifts in the industry. Send us a message! Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram.

Was tun, wenn das rohstoffarme Deutschland im globalen Ranking als Arbeits- und Lebensstandort dramatisch abrutscht – und gleichzeitig 20 Millionen Babyboomer kurz vor der Rente stehen? Gülsah Wilke kennt beide Seiten: Als Co-Founderin des Tech-Netzwerks Two Hearts und Partnerin beim Growth-Fonds DN Capital weiß sie, wie hart der „War for Talent“ mittlerweile wirklich ist – und warum Deutschland ihn gerade verliert.Im Gespräch mit Carsten Puschmann zeigt Gülsah, wie positive Vorbilder und „Safe Spaces“ für internationale Gründer:innen eine völlig neue Willkommenskultur schaffen können, warum amtliches Englisch und radikal digitale Visa-Prozesse längst überfällig sind und wieso wir dringend Milliarden aus Pensionskassen in heimische Wachstumsrunden lotsen müssen.Außerdem verrät sie:Drei Quick Wins, mit denen sich Deutschlands Bürokratie sofort entschlacken ließe – vom FDA-inspirierten Fast-Track für Med-Tech bis zu estnischen e-Government-Standards.Welche Rolle Diversität ≠ Nice-to-have, sondern echter Innovations-Turbo spielt.Weshalb ein attraktiver Kapitalmarkt das einzige Gegenmittel ist, damit künftige Biontechs nicht in New York statt Frankfurt an die Börse gehen.Hört rein, wenn ihr wissen wollt, welche Stellschrauben Deutschland jetzt drehen muss, um wieder ganz oben mitzuspielen – und was jede:r Einzelne heute schon beitragen kann. Hosted on Acast. See acast.com/privacy for more information.

Have you ever wondered what it's really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world. Adam's journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising. What you'll discover in this episode:

Dhruv Agrawal is CEO and president of Aether Biomedical. Discover Dhruv's unique journey from studying medicine in New Delhi to creating life-changing bionic limbs. Under his leadership, Aether Biomedical has achieved significant milestones, including CE certification and FDA registration for its Zeus V1 bionic limb. Dhruv shares his personal story of transitioning from medical school to MedTech innovation, the obstacles faced and lessons learned as a young entrepreneur, and the hope and inspiration of seeing Aether's prosthetics transform lives, especially in war-torn regions.   Guest links: https://www.aetherbiomedical.com | https://www.linkedin.com/company/aether-biomedical | https://www.instagram.com/aether_biomedical/  Charity supported: ASPCA 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 061 - Dhruv Agrawal Dhruv Agrawal [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 excited to introduce you to my guest, Dhruv Agrawal. Dhruv is the CEO and president of the management board of Aither Biomedical. He studied medicine in New Delhi before dropping out to pursue a bachelor's in business management. He also has a postgraduate diploma in Medical Device Development Regulatory Affairs from University of California Irvine, and a Master's in Data Science from the University of London. Under his leadership, Aither Biomedical has achieved CE certification and FDA registration for the Zeus V1 bionic limb, and established distribution across nine European countries, the US, and India. Additionally, Aither has raised over 12.5 million US dollars in private capital from leading VCs and has been a part of multiple European grants and research programs for an additional 6.5 million US dollars in non-dilutive capital. All right. Well, thank you so much for being here. Welcome to the show. I'm so excited to speak with you today. [00:01:49] Dhruv Agrawal: it's a pleasure to be here, Lindsey. Thank you so much for inviting me. [00:01:52] Lindsey Dinneen: Of course, of course. Well, I would love, if you wouldn't mind just starting by sharing a little bit about yourself and your background and what led you to Med Tech. [00:02:02] Dhruv Agrawal: Yeah, absolutely. So I'm Dhruv Agrawal. I'm the CEO of Aither Biomedical. We are a company based out of Poznan in Poland, so on the western part of Poland. It's a little bit chilly here. As a company, we are a team of about 55 people right now, currently present in the US, Europe, Middle East, as well as India. And we focus on making bionic hands for upper limb amputees. [00:02:25] Lindsey Dinneen: Amazing. Yes. So I wanna get into everything amazing that your company does, but going back for just a little bit, in your own personal history, can you share a little bit about maybe growing up and what experiences led you to think, "Hey, in the future, maybe I wanna do X, Y, and Z." [00:02:43] Dhruv Agrawal: Mm-hmm. So first of all, entrepreneurship was never a plan for me. I didn't even knew that there was a thing called an entrepreneur until I was easily into high school. Both my parents are doctors. My dad's a pediatrician, mom's a gynecologist, and as it happens in India, if your parents are doctors, you kind of know that you have to become a doctor as well. So I went to the coaching classes to pre, to prepare for medical entrance examinations. I actually met my co-founder there about 10 years ago. We both got into medical school. I was generally comfortable with medicine, you know, growing up in a hospital with doctor parents around. So I was generally comfortable in a clinical setting, but I realized that I was much more interested in the technological aspect of medicine rather than the clinical aspect of it. And that was when I was getting into the second year of my university. And luckily my dad, for my 18th birthday, bought me a 3D printer, like a very simple 3D printer from China as my 18th birthday gift. 'cause I was really wanting to get into that world. And that's where the story begins. So even till today, my dad jokingly says that that's the worst gift he has ever bought for me, because that made me drop out of medical school. [00:03:57] Lindsey Dinneen: Oh no. Okay, so you were given this gift and you started, I imagine, tinkering with it, learning how to use it. So tell me about that. [00:04:06] Dhruv Agrawal: Yeah, the thing with my co-founder as well, even though we went to the same medical university, we were not really friends in the first year. We were just colleagues. But when I got this 3D printer, it was like one of those things that you assemble, you get a kit and you assemble. And I was asking around people in my university and they were like, "Come on, what are you doing? Like, I don't wanna come to your apartment to assemble a 3D printer." And my co-founder was the first one who said yes to coming down and assembling that printer with me. So that's how our friendship essentially started in the university, even though we had known each other for three years by that point. And then we started, of course, by very basic things like printing mobile phone covers and key chains and we were just in awe with the fact that I have something in my room, in a studio apartment, where I can just build physical things, right? And this was back in 2018, so 3D printer was not such a consumer product where, you know, if it was of course used in industry, but it was not something that you would imagine having at your home, at least not in India. And then we actually found out that there's a society called Enable, which is an NGO that makes very simple basic prosthetic designs for kids. So we started by printing those and started going to some amputee clinics around and trialing that out with patients, just purely out of technical curiosity. We didn't really had a draw towards amputation, so to speak. We were more driven by the technical curiosity of, you know, it sounds interesting to make a prostatic hand. So that was the beginning. And then slowly, slowly things happened very organically that we went from wanting to 3D print basic things to starting a biomedical innovation club in our university, to incorporating a company in India, then to coming all the way over to Poland and now having 55 people. [00:05:49] Lindsey Dinneen: Holy cow. That's an amazing story. Thank you for sharing about that. So, okay, so, so you started off with this curiosity, like, "Hey, let's see what we could do with this printer and, and how we can make it work for people." And I love that your initial pull with it was to actually provide something that does help people. So that's obviously a core value, something that you hold very dear. So can you speak a little bit more, did you have sort of any personal experience or within your family or what led you to say, "You know what, hey, I've got this really cool tool at my disposal. Let me start using it by actually doing something that helps others." [00:06:27] Dhruv Agrawal: I mean, the honest answer, I would love to say I had some personal experience, but the honest answer is no, not, not really. I don't have one of those stories where I can tell you that, like I met an amputee 15 years ago, 20 years ago, and have had that motivation for that time. It was just pure technical curiosity to begin with. But of course, as we started building basic devices and giving it out to people and seeing the response of what a very simple, you know, $50 thing can do for a person who's missing a limb in an impoverished family in a village in India, that's a very powerful thing. So at that point, we realized that we started getting more and more close to upper limb amputation as a field, as a clinical specialty within itself. Of course, both me and my co-founder coming from medical school growing up in family of medicals, we've always had it in our heart to work in the clinical side of things. We've always liked working around, helping people get healthier and better. But amputation specifically was an area that we were very lucky that we found as an area of interest that developed within the both of us. [00:07:31] Lindsey Dinneen: Yeah, of course. Okay, so, so you started printing these limbs, and then you realized, "Oh my goodness, there's such a need for this. There's so much opportunity here to really help people." So, so tell me a little bit about the evolution over time of how you have made it better and better, more technologically advanced, more ergonomic, all the things that go into that. Can you speak a little bit to that learning curve and process? [00:07:56] Dhruv Agrawal: Mm-hmm. Yeah, it was a very long learning curve because not only did, me and my co-founder had zero background in business. We were 18-year-old, 19-year-old kids, right? We were just teenagers and we really had no idea what we wanted to do. And not only that, we also were not engineers, so we didn't have any engineering experience or expertise either. So everything that we did in the very beginning, at least, was self-taught. I just knew I had an inclination towards electronics and programming. My co-founder was much more towards mechanical CAD design and things like that. So we started learning these courses for free on edX and Coursera and all these, you know, MOOC platforms. And that's how we built up the very first prototype of the product by getting some small grants here and there in India. Of course, the situation is very different right now. We have R&D team of 30 people, very experienced, a few PhDs here and there. So I don't really design anymore in my day-to-day life, but that's how we started. And same was the side of the journey of coming from India to Poland. Again, that was not something that was planned at all. We had no experience in business. We had no experience in raising funding or raising money and things like that. We just learned on the go, applied to over a hundred different programs 'cause most of the investors said no to us back then in 2018 to funding 'cause why would they say yes? And we looked at like, "Okay, can we get some grants and things like that?" Applied to over a hundred programs. Luckily got selected in this program in Poland, which was like a $50,000 program back in 2018 and decided, "Yeah, let's try that place out." And came to Poland. I literally came with a backpack with stuff for two months 'cause there was a plan, come for the grant, stay for two months, go back to my family in India, and it's been seven years since then. [00:09:44] Lindsey Dinneen: Oh, there you go. Oh my goodness. That's great. So Poland, and you get along it sounds like just fine. Excellent. Excellent. Okay, so, I really appreciate you sharing about, especially, you were both so young and but so eager. It sounds like just, "Yes, let's learn, let's develop the skills that we need to along the way." I would imagine though, coming into it, perhaps that young and not having as much business experience, or, or any really in, in the past, I-- something that I really admired when I was kind of looking through your LinkedIn profile was when you post, a lot of times you share stories about areas that, that may be considered I, I guess mistakes or stumbling blocks or things that, that you've overcome on your path. And I would love if you would share maybe just a couple of things that come to mind, as an early founder, because your story is amazing and unique, but there are lots of other founders too who find themselves in similar situations where they're like, "Whoof, I've got this great idea. I know what I want, but here's maybe what I should look out for to avoid." could you share a little bit about that? [00:10:49] Dhruv Agrawal: Yeah, absolutely. I mean, the first thing is mistakes are unavoidable, right? it doesn't matter whether you're coming from a background of a medical school dropout, or if you have 10, 15, 20 years of corporate experience and things like that. 'Cause I do find myself thinking a lot about, you know, wouldn't it have been better if I would've graduated and then did a MBA and then started a company? Yes, it might have been better, but the things that I deal with in my day-to-day life in the startup, I don't think this is taught anywhere. So the first and foremost thing, which is of importance, is that mistakes are unavoidable. It's okay to make mistakes. The biggest learning that I have is mistakes are unavoidable, but it's up to you to be decisive enough to pivot as quickly as possible. So don't look back at the mistakes that we have made, because one of the worst things that we have done in this company, or where we have failed the most, or where we have seen that like, "Ah, this is where we could have done things better," are not about making a wrong decision. They were just about being indecisive and being in a dilemma for a long, long time. It would've been far better if we would've made certain decisions quickly, gotten feedback and quickly pivoted, instead of just being in a dilemma and trying to balance two sides for a long time period. An example of that would be when we launched the first version of our product into the market, we realized that we had made some errors from the point of view of what should be the feature set in this product. And so, for example, the product was available only in a medium size hand in terms of the dimensions, but majority of the market is for a small size hand. So at that point we couldn't really just miniaturize things because there's a physical limitation. So at that point we had to make a decision of do we scrap this thing completely and build a new hand from scratch that starts with a small hand and then has a medium sized option as a grow up? Or do we continue to work on the medium sized hand, and then launch a small sized hand separately? Finally, we decided to do the second option. But looking back again, I, I don't think it would've been better or worse either way. I think both of these options are fair. It's just the fact that we spent over nine months going back and forth between, "Okay, let's continue putting our efforts in energy into the medium sized that we have right now" versus, "Okay, this month we are now suddenly feeling, ah, that's not gonna work out. Let's start building the second version." So that dilemma of indecision is probably the worst thing that you can do. Just make a decision, own up to it, move on. If it works out, great, if it not, if it doesn't work out, you're gonna have learnings and you'll be stronger at the end of the day. So that's, I would be an I would say would be an example of one of the key errors that we made. [00:13:23] Lindsey Dinneen: Yeah. Well, thank you for being willing to share that, and that's such valuable advice and feedback. And so, as you recognize this and go, "Okay, so that didn't work as planned, or in the way that I would prefer," what did you end up deciding? How do you go now, moving forward, when you are in a position of "I have a major decision to make. I feel like both options have value and merit." How do you end up deciding, "Okay, I I'm not gonna leave this just in this hazy middle ground, I'm gonna make a decision." How do you go about that now differently? [00:13:54] Dhruv Agrawal: I think the first and foremost thing that entrepreneurs, or anybody who wants to build a new product, or anybody who just wants to build something new, is be very, very, very honest with yourself about, "Am I solving a real problem?" As founders, as creators, as developers, it is so easy to go into that mindset of you find a problem that you can relate to or you somehow think that this is a real problem. It doesn't matter what feedback you're going to get. You're going to convert that feedback, or create a narrative or story from that feedback, that is going to align with the impression that you have built in your own head about what the real problem is. So one thing that we really do right now is just focus on problem market fit at the very early stages of launching a new software, building a new product, building the next version of the hand, or whatever else we do is really try to question, "Are we solving a real problem?" And in a completely unbiased manner, "Do people agree with me that I am solving a real problem?" So that's what I would say would be a primary thing that we do differently right now. Of course at this point, we start getting users involved much earlier into our development process. That is something that we did not do in the past, and hence the surprise that we got at that point. So we start involving users, different stakeholders, and things like that much earlier, but at the same time, I would say that it's not to say that I would penalize myself for the historical decisions that I took. We did the best that we could potentially with the resources that were available at that point. Now we have much more resources so we can do all these things. So don't feel pressured to do everything on day one. You know, start with something, move forward and build that maturity as you grow. [00:15:38] Lindsey Dinneen: Oh, I love that. That's excellent advice. Thank you for sharing. Yeah, so you know that's a great segue and I love the fact that you were talking about the end user and the importance. And it's so funny because of course, ultimately your goal is to help these end users and improve their quality of life and whatnot. But to your point, it does get easy to get so bogged down in the details of what you're creating and innovating that perhaps you forget sort of the bigger picture at times. So, speaking of these end users, can you share any stories that might stand out to you as really reinforcing to you that, "Hey, gosh, I am in the right industry, doing the right thing at the right time." [00:16:17] Dhruv Agrawal: Yeah, no, absolutely. So we have had many phenomenal end users that have reiterated our belief in the product that we are building, the problems that we are solving, the company, and the organization that we are building as a whole. I mean, generally speaking, patients change their devices every three to five years, and that's really our entry point of getting a device into the hands of the patients. But even with those, a patient is using another prosthetic device, they start using ours, they will see a step change in the functionality, and that's always empowering. But the most interesting stories are where we have really seen patients who, for example, congenital amputees tried a prosthetic device 10 years ago, 15 years ago, and then made a decision to live their life without any prosthetic device. So got used to a life for 15, 20, 25 years of living a life without a prosthetic device, just with an amputated limb or a limb difference. And then, we come in with our product, they see it, they use it, and they are ready to adopt that again. And that's a much powerful validation for us because somebody who has used a device, looked at all the advancements over the last two decades, decided actively decided to not use any of those advancements, and looks at our product and says, "Ah, this really solves the problems that I was waiting for someone to solve for the last two decades." Like we had this situation with a very famous Polish guy, Marek Kamiński, who is the youngest Polish person to go to both poles, North Pole and the South Pole, and he's a bilateral amputee on legs and he has a unilateral amputation to one arm. He has not used a prosthetic device in, I think 15 or 20 years, something like that. So for a very long timeframe. He met with an ambassador of ours and was finally convinced after 15 long years to give another try. And we fitted him over three months ago and he's been performing phenomenally with the device and he's so happy with that. So those are the moments that really give us more confidence or give us a boost of confidence in the product that we are building and the company that we are building. [00:18:19] Lindsey Dinneen: That's incredible. Wow. What a story. Yeah, and I love hearing those kinds of stories and that just to reinforce, " Hey, you really are making a difference." And I'm sure that helps on the days that are a little bit harder, a little trickier, you know, it helps to have that to hold onto, so you know your impact goes so far beyond even the places that you've mentioned before. I was reading about how you've worked with the Open Dialogue Foundation and there's been some work in Ukraine, and I'm wondering if you could share a little bit about perhaps that collaboration, and or some of the other exciting collaborations you have going on with these amazing organizations all over the world. [00:18:54] Dhruv Agrawal: Absolutely. I mean, the work that we do in Ukraine is something which is very close to our heart and what you just mentioned a moment ago, it's exactly that type of work that keeps us going on the hardest of days. I have so many amazing stories from the patients who have been fitted with our device 'cause at this point in the last year or so, we have already fitted over a hundred patients with our bionic hands in Ukraine. We primarily work with Superhumans, which is NGO based out of Kyiv, a great place, really the mecca for prosthetics at this point, I would say. They're doing a phenomenal job of getting these patients in, rehabilitating them, fitting them with our device and then training them on how to use the device. In fact, even supporting them in the post rehabilitation, acquainting them to back to the real world as well. And we send teams of doctors from the US, from Poland, to Ukraine to actually fit these devices to patients. And we have had a lot of success stories come out of it. We have people who have amputations, even at the level of shoulder who are amputated all the way up to the shoulder or four quarter amputation, and they are successfully able to live a independent life with our device. I think the best story that I've had, or the part that really made me tear up, was when one of the soldiers got fitted with our device and his really, really big wish was to be able to do the first, to dance with his wife, with both hands. And I got to see that and it was, it was the most amazing feeling ever. [00:20:20] Lindsey Dinneen: Oh my goodness. Yes. I don't know how you couldn't just have the waterfall start with that kind of story. That's incredible. Thank you for sharing about that. So, as you look toward the company's future and your own, what are you excited about moving forward? [00:20:34] Dhruv Agrawal: I mean, we are currently in the process of getting a new version of our hand in the market, which has all the learnings of the last four years or so. So we are definitely really excited about that. You have to keep in mind when we launched the first product, we didn't even have enough money to-- because prosthetics are expensive-- so we didn't really have had enough money to buy our competitor devices, or the devices from the past to look around to see, touch, feel, how they are built. Everything that we built was purely out of our imagination and based on what we could find on the internet. And, you know, go visit a doctor who fits these devices, have that 10, 15 minutes to look around that device, and so on and so on. I mean, four years later, now we have the experience of fitting close to seven, 800 patients with our device. All that feedback that has gone into the next version product that we are gonna be building. So very excited about that. We continue to develop the software platform, so we are not just a company that is focused on providing a device to the patient, but we provide an entire software platform that's like a digital twin for the patient. So it supports the patients throughout their end-to-end journey. Because it's not just about giving a device to the patient, but it's all about can we improve their quality of life? Can the patient pick up a glass of water? Can he tie his shoelaces? Can he water a plant? Can he do the activities that he really wants to do? And from that perspective, the software platform that we continue to build focuses on things like adherence, occupational therapy, physical therapy, monitoring of the usage of the device. Because the thing in prosthetics industry is, the day you give the device to the patient is not the day you have won the battle. That's the day the battle actually begins, 'cause now it's all about making sure that you deliver on the promise of helping him get better quality of life. [00:22:20] Lindsey Dinneen: Yeah. Yeah. I'm sure that's an exciting challenge, but it's a continually evolving challenge too. And there's probably variations, I would imagine, on people embracing the technology a little bit differently and how you handle all that. Yeah. Excellent. Well that is a very exciting future and it's so much fun to hear about, and you know, you've had a great career so far. I'm sure it's wildly different than what you may have imagined as a kid. But what a cool gift that you're bringing to the world. You've been recognized quite a bit. You're 30 under 30 for Europe, and you've been involved in lots of different cool organizations. You've been a TEDx speaker. What are some of those moments like, have they been surreal? Is it just like, "Oh, thank you." Just confirmation that, hey, you are on the right tracker. What are those kinds of moments like for you? [00:23:08] Dhruv Agrawal: I mean, definitely the first round of funding that we raised in Poland was was a huge check mark for us, because it's that moment at which you realize, "Ah, somebody wants to give me money and somebody wants to give me a quarter of a million dollars." I've never seen that much money together on a single bank account or in any way, shape or form, right? I come from a normal middle class family. We don't have that. So, that was definitely the first micro checkpoint, let's say. I mean, both the things that you mentioned, the TEDx thing, the Forbes 30 Under 30 thing, coming from a background in India where these things are really important, although they're not so important for me as a person, but they're much more important for some reason to my parents and to society. It is a different place. We put a lot of emphasis on these types of things. So from six, seven years ago, looking at these lists coming out or looking at, "Oh, this cool guy spoke on a TEDx talk, sending him an email about, 'Do you want to be an advisor in my company? I'll give you 5% shares,'" and so on and so on, to actually doing those things by yourself, that's definitely pretty well as well. But again, at the end of the day, there is nothing better than seeing a new patient get fitted with the hand, seeing the reaction of their family members. They have a daughter, they have a son who they hold their hand for the first time. They hug their wife. I mean, just, just being around amputees and patients who use your device, something that you built and that helps them get better at their daily life, that's, I would say, the most rewarding thing ever. [00:24:39] Lindsey Dinneen: Yeah, of course. That's, that's wonderful. Yeah. So, oh my goodness, this is so great and very inspirational, but pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars-- speaking of those wonderful sums of money-- to teach a masterclass on anything you want. It can be something within your industry, but doesn't have to be, what would you choose to teach? [00:25:03] Dhruv Agrawal: I have two topics in mind. One is I would probably teach a masterclass on pitching, especially for first time founders. I think that is something which I'm good at, and we have obviously raised a pretty decent amount of capital up 'till now. So that would be the one thing that I would say. So kind of a combination of pitching and starting a startup for the first time, especially in the field of hardware, medical devices, things like that. And the second thing that I would really like to talk about is just probably trying to put my thoughts together and making a masterclass on how to never give up, because I think that that's a very underrated quality. But that's a very important quality. There have been complex times in the history of our company where we have felt that like, "Ah, this might be it." But it's all about what you do in those moments and how you go beyond those. I think it's all about that. [00:25:47] Lindsey Dinneen: Yeah, absolutely. And how do you wish to be remembered after you leave this world? [00:25:53] Dhruv Agrawal: Just as a positive change maker. I really would like all these patients that we are helping and giving these devices to. I, I just want to be a small part of their lives. Just as I was part of the life of the veteran who got married, I, I just wanna ha have those small moments club together amongst these different individuals that we are privileged to work with. [00:26:13] Lindsey Dinneen: Hmm. Yes, of course. Wonderful. And then final question, what is one thing that makes you smile every time you see or think about it? [00:26:22] Dhruv Agrawal: Oh, that's very simple. Patients getting fitted with our device. Today we see a patient getting fitted with our device, and that smile on their face and things like that. And, you know, that's even much bigger, much more interesting in Ukraine because many times when you go to these hospitals, and when I go to these hospitals in Ukraine, you have to understand that these people have gone through a lot. These soldiers who are putting their body on the line for their country. There, of course, there's a certain sort of low morale that they have when they're amputated and when they're in these hospitals and things like that where they don't really think that there is ever a possibility for them to regain something back. And you go in there and you show them a bionic hand, and they're not sure if this thing works, and you put the electrodes on them and they open the hand or close it for the first time, and then you suddenly see those expressions change from like, "Ah, what has happened to me?" to, "Oh, what can I achieve?" That is also an amazing feeling. [00:27:16] Lindsey Dinneen: Yeah. Oh, I love that. What an amazing gift to be able to help somebody bridge that gap and witness it. How cool is that? Oh, well, I think this is incredible. I am so grateful for you and your co-founder for starting this company and just being able to give so many people hope and new life, really, just a new way of experiencing life. So thank you for all of the incredible work you're doing. I'm so excited to continue to follow your work, support your work, as I'm sure all of our listeners are as well. So, gosh, I just really appreciate you sharing all of your advice and stories and wisdom with us. So thanks again so much for being here. [00:27:55] Dhruv Agrawal: Of course, Lindsey, thank so much for having me. [00:27:56] Lindsey Dinneen: Of course, of course. And we are honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. We really appreciate you choosing that organization to support and thank you just again, so very much for your time here today. I just wish you continued success as you work to change lives for a better world. And thank you also so much to our listeners, and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two and we'll catch you next time. [00:28:43] 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.

What if the key to solving the provider burnout crisis wasn't adding more hours in the day—but using technology to give them back? In this episode of Med Tech Gurus, we meet David Norris, Co-Founder and CEO of Affinion Health. David shares how his company is building an AI-powered clinical inbox that helps clinicians manage the overwhelming flood of lab results, patient messages, and admin tasks. With measurable results like five hours of reclaimed time per week per provider, David explains how Affinion's solution is not just about efficiency—it's about restoring balance, improving care, and preventing burnout. From his work with the Coalition for Health AI to his lessons in entrepreneurship and team-building, David offers practical wisdom for every MedTech innovator in this episode.

In this episode of Medsider Radio, we sat down with Joanna Nathan, CEO and co-founder of Prana Surgical — a startup developing image-guided surgical platforms for precision oncology.  Joanna's career spans translational research at Texas Heart Institute, product development at Saranas, and portfolio management at Mercury Fund and Johnson & Johnson's Center for Device Innovation. She mentors founders through her not-for-profit organization Enventure and teaches entrepreneurship at Rice University's Jones School of Business.In this interview, Joanna shares her framework for evaluating which medtech ideas merit pursuit, revealing three critical signals every founder should look for: clinical urgency that requires no convincing, favorable asymmetry between value and technical risk, and optimal market timing. Joanna also demonstrates how systematic grant applications and strategic resource allocation can extend runway while building investor credibility, and addresses the unique psychological challenges of building life-critical devices.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Joanna Nathan.

In this milestone episode, I reflect on what it's taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combination products.I share three hard-earned lessons not just about the industry, but about how we grow, lead, and keep learning inside it. From the sheer scope of the work to the surprising, non-linear paths people take, and the difference between credentials and true insight this episode is about what finally clicked… and what still hasn't.It's a thank-you to you, the listener, and a reminder that mastery isn't a finish line it's a mindset.

In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanger Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to market. From threat modeling and SBOMs to legacy device challenges and global regulatory alignment, this episode offers practical insights for MedTech developers navigating today's complex cybersecurity requirements. Whether you're launching a new device or updating an existing one, this conversation is packed with actionable advice to help you stay secure and compliant. 

Dr. Brittany Partain, Associate Director of Clinical Affairs and Physician Education at Exagen has a background in biomedical engineering and a passion for problem-solving, Brittany has carved out a unique role at the intersection of diagnostics, clinical education and biotech innovationIn this episode, we explore why autoimmune diseases like lupus and rheumatoid arthritis are so difficult to diagnose, and how Brittany is helping close that gap through physician education and the use of novel T-cell biomarkers. We also talk about building trust with clinicians, misconceptions around diagnostic tools, and the real challenges of advancing innovation in a field that's historically lagging behind specialities like oncology. Finally, Brittany reflects on her journey as a female leader in MedTech, the importance of collaboration, and why passion matters when navigating a fast-paced, highly regulated industryTimestamps:[00:00:45] Why Autoimmune Diseases Are So Difficult to Diagnose[00:01:55] From Biomedical Engineering to Clinical Affairs[00:04:34] Why Rheumatology Has Lagged Behind[00:07:07] How T-Cell Biomarkers Work and What They Solve[00:09:18] What Autoimmune Diseases Are and How They Present[00:11:05] Common Misconceptions Among Clinicians[00:13:00] How Hospitals and Private Clinics React to New Tools[00:15:07] Building Clinical Trust Through Science[00:18:05] What Most People Don't Know About Autoimmune Disease[00:21:58] Women in Biotech: Breaking Stereotypes and Leading ChangeGet in touch with Brittany - https://www.linkedin.com/in/brittany-d-partain Learn more about Exagen - https://exagen.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwalSubscribe to the Podcast

In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Tony Recupero is President, Commercial Operations of SI-BONE. Tony leads SI-BONE's commercial operations, including sales, market access, reimbursement, professional education and international. He is a proven commercial leader, responsible for the company's go to market strategy that has led to exponential revenue growth. Prior to SI-BONE, Tony was formerly the President of Catalyst Performance Advisors where he advised several medical device companies on commercial strategy. Tony was previously President and CEO of Baxano, Inc. Tony was also the Vice President of Sales for Kyphon from startup in 1999 through the end of 2004. Kyphon was acquired by Medtronic for $4.2 billion dollars. Early in his career, Tony progressed to senior sales management roles at United States Surgical Corporation and Sulzer Spine-Tech, Inc. Tony earned a B.A. in Communications from State University of New York at Albany and attended The General Management program at Harvard Business School.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Tony Recupero⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Health Connective COO Justin Bantuelle and company president Scott Zeitzer join host Michael Roberts to share insights into what medtech companies need to be thinking about when working with a developer to create a prototype for their app. Find out what you should and shouldn't include, the questions you should be asking of your development partner, and red flags to look out for. Hosted on Acast. See acast.com/privacy for more information.

Heartflow, a California-based medtech company specializing in AI-driven cardiac diagnostics, plans to list on the Nasdaq under the ticker HTFL, offering 12.5 million shares at $15 to $17 each and targeting a valuation up to $1.3 billion. The company received FDA approval in 2022, expanded its market through Medicare and AMA regulatory changes, and has assessed over 400,000 patients as of March 2025. Heartflow reported $125.8 million in 2024 revenue, a 44% increase from the previous year, but posted a net loss of $96.4 million and expects continued losses. Major investors include Bain Capital, Panorama Point Partners, and Capricorn Investment Group. The IPO follows a previous canceled SPAC plan and recent public listings by other medtech firms.Learn more on this news by visiting us at: https://greyjournal.net/news/ Hosted on Acast. See acast.com/privacy for more information.

This episode offers a "biocompatibility brief" with guest Marina Daineko, a MedTech expert and chemist specializing in biological evaluations. Marina shares her perspective on the critical role of chemistry and critical thinking in assessing the safety of medical devices. The discussion highlights the need to look beyond simple pass/fail tests and delve into the nuances of raw data analysis, material composition, and manufacturing processes to uncover potential risks.Marina emphasizes that biocompatibility is not an isolated task but must be fully integrated into a company's quality management system (QMS). She explores the connection between biological safety and key QMS processes such as change management, post-market surveillance, and CAPA. The conversation also touches on the shift from a reactive to a proactive mindset in the industry, driven by new regulations like the latest revision of ISO 10993-1.Using real-world examples, Marina illustrates the importance of considering long-term patient exposure and cumulative effects. She provides clear explanations of complex concepts like the difference between extractables and leachables. Her advice to MedTech professionals is to always be curious, ask questions, and prioritize communication across all teams to ensure the safety and efficacy of medical devices.Key Timestamps01:37 - Importance of a Biological Evaluation Plan and in-depth data analysis03:48 - The need for critical thinking in biocompatibility, highlighted by the silver ion example06:03 - How a chemistry background informs a deeper understanding of materials08:06 - Real-world examples of biocompatibility risks from the Netflix documentary, The Bleeding Edge11:20 - Discussion on cumulative effects and long-term exposure to materials12:56 - Applying a risk-based approach beyond standard tables15:39 - The difference between extractables and leachables18:18 - Integrating biocompatibility into the QMS (change management, CAPA, post-market surveillance)22:01 - The shift from reactive to proactive biocompatibility approaches23:55 - How to explain complex biocompatibility concepts to non-technical teamsQuotes"Biocompatibility is not a bubble. It must be integrated into the quality management system." - Marina Daineko"Don't be shy and ask the questions. Stay curious... and communicate." - Marina DainekoTakeawaysGo Beyond the Checklist: A biological evaluation plan and critical thinking are essential. Don't rely solely on standard pass/fail tests; analyze raw data and question unexpected results, as seen in the silver ion example.Assess Cumulative Risk: For long-term or implanted devices, consider the cumulative effect of chemicals that may leach from the device over time. Proactive risk management should account for this long-term exposure.Integrate Biocompatibility into the QMS: Biocompatibility should not be treated as a standalone task. It must be integrated with core QMS processes like change management, CAPA, and post-market surveillance to ensure continuous device safety throughout its lifecycle.Communicate Across Teams: Effective communication is paramount. Technical biocompatibility information must be translated for different teams—from regulatory and quality to marketing and sales—by highlighting the impact on deadlines, compliance, and patient safety.ReferencesNetflix Documentary, The Bleeding Edge: A documentary that exposes systemic flaws and risks within the medical device industry, featuring the case of the Essure device.ISO 10993-1: The international standard for the biological evaluation of medical devices, which is undergoing revisions to emphasize a lifecycle-based approach to safety.Etienne Nichols' LinkedIn: For more...

Local political announcements; Highway 113 relocation projection now completed; firefighters respond to weekend blaze; pilot instruction school opens at Morrilton airport; MedTech employees earn awards; we talk with Alisha Koonce of Sacred Heart Catholic School.

What if surgeons could eliminate the guesswork from complex procedures and walk into the OR with a personalized, pre-fitted solution ready to go? In this episode, we meet Vikram Ahuja, Co-Founder and CEO of OsseoLabs, who is transforming orthopedic and maxillofacial surgery using AI and 3D printing. Vikram reveals how his platform builds patient-specific implants using biomechanical data—dramatically reducing OR time, complications, and the need for revision surgeries. With over 170 successful cases and 40 hospital partners across Southeast Asia, Vikram shares what's next, what's needed for U.S. expansion, and how OsseoLabs is pushing the boundaries of surgical precision. If you're serious about MedTech innovation, this one's essential listening.

In this episode of Medsider Radio, we sat down with Greg Lipschitz, CEO of Firefly Neuroscience. Firefly's FDA-510(k) cleared Brain Network Analytics (BNA™) technology objectively measures brain function through EEG analysis. With a proprietary database spanning twelve cognitive disorders, the company serves both clinical practitioners and pharmaceutical partners.Greg brings extensive experience in private equity, investment banking, capital markets, and finance to his leadership role. As Managing Director of Old Stone Advisors and former Vice President of Lazer Capital, Greg has advised on over $1 billion in transactions. He is a Chartered Financial Analyst.In this interview, Greg shares insights on strategic fundraising approaches, platform prioritization decisions, and building commercial momentum in healthcare through direct sales and customer feedback loops.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Greg Lipschitz.

Niche markets and small populations don't get the attention they need for medtech and healthcare.  Medtech Talk host Swaril Mathur speaks with Eric Chehab, founder and former CEO of Novonate and director of business development of Laborie OB/GYN/NICU, and James Wall, pediatric surgeon and founder of Impact1 at Stanford University, about how they're bringing medtech innovation to small towns and other low-population areas. They delve into their experiences of founding their own niche market companies and the lessons learned, including how they navigated commercialization and acquisition processes, convinced the right investors, determined capital efficiency, and more. They also share their thoughts on investors who think niche solutions for niche markets are uninteresting. Medtech Talk Links:  Cambridge Healthtech Institute   Medtech Talk  Gilde Healthcare  MicroTransponderLinks: MicroTransponder Stanford University Links: Stanford Healthcare Stanford Medicine Children's Health Stanford University Laborie Links: Laborie 

What if the way you've been selling is working against you, and your customer can feel it? In an industry built on outcomes, many MedTech reps still get caught up in pitching features, checking boxes, and pushing for yeses. In this week's episode, sponsored by Physician Growth Accelerator, sales coach, author, and founder of Kiinetics, Brendan McAdams shares how shifting from a sales-first mindset to a fit-first mindset changes everything. From running smarter discovery and setting up collaborative problem-solving to wrapping the call with radical clarity, he explains how trust is built not through persuasion, but through partnership. Whether you're in a startup or a Fortune 500, this episode will challenge how you think about selling—and give you practical tools to do it better. What we discuss in the episode: Why thinking beyond the immediate buyer leads to better customer alignment How to run a sales call that builds trust instead of resistance The power of curiosity and collaborative problem-solving in MedTech Why wrapping up the call with clarity is essential The underrated art of “killing the deal” when it's not the right fit Why premature selling can backfire and how to slow down for strategic success Resources from this episode: Get the free MedTech Talk Tracks for Action Get Brendan's Book Physician Growth Accelerator Social Media: Connect with Brendan on LinkedIn Connect with Zed on LinkedIn

The focus of this podcast episode is the critical importance of evaluating Electronic Quality Management Systems (EQMS) platforms at the appropriate stages of product development rather than waiting for a crisis to prompt action. I explore how proactive medtech teams that prioritize early evaluation of EQMS platforms position themselves for success, ultimately enhancing their capacity to bring safer and more effective medical devices to market. Joined by industry expert Andy Rogantino, we delve into the intricacies of when and how teams should consider EQMS solutions, emphasizing the necessity for a foundational quality system that supports regulatory compliance and operational efficiency. Our discussion also highlights the essential collaboration among product development, quality assurance, and leadership to ensure that the chosen EQMS aligns with the unique needs of each organization. By understanding these dynamics, we aim to equip medtech professionals with the knowledge to make informed decisions that will positively impact patient outcomes and organizational success.naTakeaways: The most effective medtech companies evaluate EQMS platforms early in their development process to avoid regulatory headaches later on. Quality management systems should be viewed as the backbone of medical device development, essential for improving patient outcomes and compliance. Companies need to adopt a proactive mindset in quality management, as waiting for issues to arise can lead to dire consequences. A successful EQMS implementation requires collaboration across various departments including regulatory, quality, and product development. It is crucial for medical device teams to consider the user experience of the EQMS software, ensuring it is intuitive and effective for everyday use. Evaluating the ROI of an EQMS should encompass not only financial metrics but also improvements in efficiency and compliance readiness. Links referenced in this episode:www.greenlight.gurupodcastreenlight.guruCompanies mentioned in this episode: AbbVie Signal Therapeutics Second Nature Greenlight Guru

Nidhi Oberoi is a dedicated medtech executive with over 17 years of experience and currently serves as Business Leader, Imaging Franchise at Terumo Medical Corporation. She discusses her journey from India to the heart of the medtech industry, her impactful work on innovative heart valve treatments while at Medtronic, and her advocacy for women's health. Nidhi shares her leadership philosophy centered on empowerment, the importance of mindfulness in business, and her vision for a future in cardiology and women's health.   Guest links: https://www.linkedin.com/in/nidhi-oberoi-278a111/ Charity supported: Save the Children 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 060 - Nidhi Oberoi [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 excited to introduce you to my guest, Nidhi Oberoi. Nidhi is a seasoned MedTech executive dedicated to the mission of serving clinicians and patients. With over 17 years of experience working on commercialization of innovative technologies, She has led various strategic and operational initiatives that have transformed standard of care. Her bold, collaborative, and empathetic leadership style allows her to push boundaries and inspire teams to create durable value. She currently leads business initiatives for the structural heart business in Medtronic, which serves patients with heart valve disease. She's also an advocate for evidence based care for women's health. Nidhi has an undergraduate degree in economics from India and an MBA in marketing and entrepreneurship from Syracuse University. Thank you so much for being here, Nidhi, I'm so excited to speak with you. [00:01:44] Nidhi Oberoi: Yeah, thanks for having me. [00:01:46] Lindsey Dinneen: Of course. Well, I would love, if you don't mind just starting off by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:56] Nidhi Oberoi: Yeah, absolutely. I was born and raised in India, and just like any typical Asian Indian household in those days, if you were a bright student, you were generally expected to pursue a track in sciences, medicine or engineering, or maybe a second option in accounting and finance. Predictably, after I completed my high school, I was on my path to pursue a career in sciences. But then I changed courses and ended up pursuing an undergraduate degree in economics, and eventually an MBA in marketing and entrepreneurship from upstate New York. Now, as I reflect back and realize that what attracted me to business eventually, it was this realization that it's both in art and a science. The science aspect helps to ensure that the business can financially run smoothly with a strong P&L, while the art side of the business is the ability to set the vision, the direction, inspiring people, innovating, connecting with people. So what I really was interested was in a career in marketing and general management. You asked me what led me to medtech, I'd say my entry into the healthcare industry was by chance. I got recruited into this industry through a summer internship when I was doing my MBA with a company called Conva Tech, which was part of Bristol Myers Squibb then. And by the time I had completed my internship, I already knew I wanted to be in the healthcare industry given the impact you have on the patient's lives. I did have opportunities to interview with other companies like Philip Morris and others, and I just decided that this is what I wanted to do. And after I graduated, I started working for a company called Covidian, which was then a spinoff from TCO International. And Covidian was eventually acquired by Medtronic. It's been 16, 17 years since I've been working for this company and it has a really strong mission of elevating pain, restoring health, and extending life of patients around the world. So that's that's my story there. [00:04:07] Lindsey Dinneen: Excellent. Thank you so much for sharing that. I'm curious. Of course your career trajectory has been really interesting and you've had a lot of different experiences along the way. So what are some of the key things that say maybe your schooling or your early career really set you up for success for what you're doing now? [00:04:29] Nidhi Oberoi: Yeah, so there's just so many different experiences that either have shaped my interest, where I wanna go, or has shaped my leadership style. Now, as I mentioned, I decided to move away from sciences to a more kind of social sciences field, economics and then business, and that was due to the fact that I was not the person who could just crunch numbers sitting on the table. I liked connecting with people. So I think some of those personality traits helped me decide what I wanted to do. And I would say one of my core value is impact, purpose. And so healthcare, it was just natural for me to gravitate towards healthcare because you are truly impacting people with different technologies. And I'd also say, as I grew further along in my career, early on when I joined Covidian, I had some great leaders who gave me a lot of ownership, and that shaped my leadership style as well. And that's how I operate. I empower my teams. I coach them along, but give them a lot of accountability. So there's so many different experiences, but these are some of the experiences that come to mind as. As as I reflect back now what that has shaped my career and also my leadership style. [00:05:55] Lindsey Dinneen: Yeah, absolutely. And speaking maybe more into your leadership style, I'm really curious if you could tell us a little bit more about that philosophy of yours. I love that ownership mentality. It sounds very counter to what a lot of folks don't appreciate, and that's micromanagement. And so I'm curious, how do you bridge the gap yourself as a leader between making sure that, your team stays on track and the goals and really key, important performance indicators are met, while also giving them that ownership and that empowerment to make decisions and do things in a way that best aligns. [00:06:35] Nidhi Oberoi: Yeah. So I think there's so many different facets of leadership, and let me highlight some of the others that feeds into the third aspect, which is the empowering team. So I think as a leader, first thing first, you need to provide clarity, direction, focus. I've been part of so many different teams where if people can relate to what they're doing, why they're doing, they can get lost, right? So I think that's the first thing. You need to have the ability to cut through the noise, provide direction to the team, organization you're leading. And then the second part is inspiring and bringing people together to execute on that vision. So this is the culture piece. You are listening to others, you're hearing others' perspectives and being inclusive. And the last thing, which I mentioned early on, is empowering your teams and making them accountable. So to your question of how you bridge the gap, I think you have to give clear direction. And when you empower teams doesn't mean that you don't coach them, right? You are just telling them that you trust them to do the job and you are here to help them. And one of the technique that I use is I ask questions, so I don't give answers. When you ask someone in your team to lead the project, they come to you. Then you ask questions. And I've seen, based on my experiences, that gives them a sense of ownership that this is something they're thought through. And oftentimes I've heard from people that they feel like they become a better version of themselves because I ask a lot of questions. I make them think. So that's my approach on how I kind of bridge the gap, but also make sure along the way that you're supporting them in the right direction. [00:08:24] Lindsey Dinneen: Absolutely. Yeah, and you mentioned as you were speaking a little bit towards how your past experiences shape who you are and how you kind of relate to the world now, you mentioned core values, and I would love, if you don't mind, if you would share a little bit more about your core values. I noticed that on your LinkedIn profile, that was something that was very highlighted as being extremely important to you, which I love. I'd love if you would share a little bit about maybe how you developed your core values and how those play out for you. [00:08:57] Nidhi Oberoi: Yeah, absolutely. I think core values is something that you always have, but you just sometimes need a little bit of handholding to unfold those, right? And so in my case, a few years back, I had an opportunity to work with a coach, and she really helped me understanding what I'm good at. These are things that you already have, but you may not realize or you may not know how to articulate. So for me, the number one thing that came out was purpose. And I'm like, "No wonder I'm in the healthcare industry. I'm big on impact. I like building things." And so that's where it's coming from. The other core value of mine is excellence. I like to do things with excellence. I put my heart and soul into things. I'm a very passionate person. But also you gotta have an eye on quality versus decision making, right? Over time, I've learned excellence is my core value, but it's a journey, it's a process. It's not a destination. So you don't have to dwell on things. Sometimes things go wrong and you just have to keep moving on and have a growth mindset. So there's a good aspect of the value, but there could be a blind spot, like in this case for excellence and I've learned to manage that as well. And yeah, so I think these are some of the core values, which is, I think, also part of being a leader. You have to have self-reflection. You need to dig deeper and understand what you stand for. And, this has just guided me along the way. And yeah, so those are some of the things that I'd say has really helped me all along in my career. [00:10:41] Lindsey Dinneen: Yeah, of course. So, tell me a little bit more about your current position and what are you looking forward to as you move forward in your own career as well? [00:10:53] Nidhi Oberoi: Yeah, currently I'm in the structural heart space, and these are really old and sick patients. And it's just amazing to see these patients getting impacted by our technology, getting back to their day-to-day life. And as part of structural heart, also, most recently I've been able to work on therapies. I've been focusing on the congenital portfolio, which is, these are devices that are used to treat patients that have congenital disease, and it's very impact driven because you're dealing with children here who tend to get multiple surgeries throughout their lifetime. So my role right now is to focus on business initiatives. Some of it is expansion across geographies. Some of it is increasing supply for these products. I mean, there's not a big business case for these kind of products, but the impact is huge. So that's my current focus. And, moving forward, in my career, I'm looking to grow into a general management track, and that's what attracted me to marketing because I consider marketing as running a business within the organization. So for me, running a business would be something that I would be looking forward to. And that's why I have spent time in so many different kind of roles, whether it's marketing, it's commercial transformation, whether it's global roles. So that's how I've been building my skillset so that I can one day lead a business. [00:12:25] Lindsey Dinneen: Yeah, that's very exciting. Okay, so you're building all of these skill sets. You're working towards this incredible goal. Do you have an idea of what kind of business you would want to get into? Or is this, " We'll see," and I'll interview you again when that happens? [00:12:38] Nidhi Oberoi: Yeah, I think cardiology, there's so much opportunity in cardiology. There are so many people getting impacted by cardiovascular disease around the world, and there's so much innovation too happening, not just on the treatment side, but also on the diagnostic side. So I would say either something in the cardiology space would be very attractive because it's innovative. There's such a huge population that gets impacted by it. Or the other area of interest for me is women's health, and I think it just makes me smile how there's progress being made. I know there's so much work that needs to be done. We know there's not enough evidence, it's underfunded, but I think the work is starting there, and better evidence generation will lead to better decision making, which will lead to better outcomes. So I would say either in the cardiology space or the women's health space, these are the two areas of interest to me. [00:13:38] Lindsey Dinneen: Yeah. And I noticed again, with LinkedIn, you are very passionate about women's health and I love that. And I am wondering if you could speak a little bit towards some of themes that I kind of picked up on, things like stigma with women's health, medical gaslighting and self-diagnosis. And I know there's a lot to that and it's probably too much for one conversation today, but can you highlight a couple of the areas that you particularly find concerning, that are things that we can all do better? [00:14:11] Nidhi Oberoi: Yeah. Yeah. I think first of all there's such lack of education and awareness. As women transition through different stages of life, I feel like a lot of it is taken for granted. We don't question it. And as someone who's been following this for a little bit of a time, I almost feel like it's my duty and being in the healthcare industry, to raise awareness about this or encourage them to be more educated patients. When they go to a doctor, if they don't get answers, they should ask more questions. So I think, so that's that lack of education and awareness piece. There's a lot of work happening. There's so many advocacy groups. Women are coming together, supporting each other, so I think that's happening as well. The other thing that really bothers me is on the diagnostic side. I wrote an article around women get mammograms. Just because there's not enough evidence out there, sometimes you just have to go through a number of tests to have a diagnosis, either a positive or a negative. So I also feel like maybe the advent of technologies like AI in the diagnostic field can help improve that, because it starts with the diagnostic side, and we just don't have enough right now. And like I said, it can either be a good thing or bad thing. I've also heard of women going through a number of tests to find out that they don't have anything, which is fine, but it's just a lot of money along the way getting to the diagnosis. And then, the third thing I'd say is as we get more intelligent with evidence, it will lead to better awareness among the physician community too. And that's what gaslighting comes because there's not a lot of evidence, there's not a lot of awareness. Even physicians sometimes can't guide you in the right direction. But if you have more studies coming out, it will make them more aware and guide their patients in the right direction. So there's just so many different things, but I feel like you could start being a self-aware patient and not just assume as you go through different stages of your life that this is what it comes being with a woman. Be more proactive, ask questions, research, talk to other people and get help. [00:16:32] Lindsey Dinneen: Yeah. Yeah, that's really great advice, and I appreciate your perspective in sharing with us a little bit about maybe even some of the things that we all can do as we're trying to hopefully push the quality of women's healthcare forward and make it more widely available and whatnot. So thank you for sharing. As you have been going throughout your career-- and you obviously care so much about purpose and you have a lot of passion for helping people and for the healthcare industry in general-- are there any moments that really stand out to you as affirming, "Hey, I am in the right industry at the right time?" [00:17:11] Nidhi Oberoi: Yeah, there's been so many moments and I would say most of these moments are when I've interacted with patients. When I started with Covidian, I was leading an initiative which would help a lot of women who were having open hysterectomies-- this is like 10, 15 years back-- to have a minimally invasive hysterectomy through a new procedure technique. So it was called single incision surgery. And I happened to talk to some patients, and it was just amazing to hear those stories where they were telling me how they could get back on their feet, travel, within just a week after the procedure. So that's the defining moment. And then, when I was working on one of the businesses where patients have very varicose veins, I met a patient who was a mom of four. So she had four kids within a span of six, seven years, and she had very visible varicose veins on her legs. And that impacted her quality of life. And when she got the procedure done with our technology, she was just so happy. It was not just cosmetic, but also less painful, and being more present with her kids because of that. And then I'd say most recently in the cardiology space, these are really sick patients, older patients with multiple conditions, and just hearing their stories of getting a new heart valve, it's amazing to see how, again it's getting back to life. So it's always, when you meet these patients, those are the defining moments, and it just reaffirms why you're in healthcare and why you need to continue to work in the healthcare space. [00:18:58] Lindsey Dinneen: Yes. I love that so much. Yeah, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry. It could be related to anything your background, your experience, but it doesn't have to be. What would you choose to teach? [00:19:19] Nidhi Oberoi: Yeah, that's a great question. I don't think I have an expertise right now, but maybe something on mindfulness and yoga. One of my goals is to do a yoga teacher training, but the importance of mindfulness in business. There's so many things you can do: power walks, taking a break, journaling. These are so underrated, but I think these things are necessary. It's more important than ever now, given the fast change. There's so much, so many changes happening at such a fast pace. So I would say that would be my topic, but I don't think I'm ready yet to have that masterclass. [00:20:03] Lindsey Dinneen: Fair enough. Fair enough. So I'm curious, how long have you been incorporating these kinds of really important mindfulness practices into your own life and your own routine. Is this something that you've had for years and years or is it a more recent development? [00:20:19] Nidhi Oberoi: Yeah, I think it's more recent. I would say three to four years, although I wonder why I did not do that. I think within the organization, as you are managing multiple things, it just forced me at that point of time when I was juggling a lot of things in my life and I wanted some pause and clarity. And I actually, years back, I had take a yoga class and then I started doing core barre yoga as well. So I realized that it really has a big impact on me. And then I just try to be more disciplined and try to take out time, if not every day, maybe every two days, but I would say it's more of a recent phenomena. It does require a lot of discipline. Earlier you start, the better it is because you're not going to get it right away. It takes a lot of discipline and commitment to incorporate these. And you won't be able to do it all the time, but at least starting that and trying to incorporate day to day life is a good start. [00:21:26] Lindsey Dinneen: Yeah, absolutely. I found personally that starting my day with a much more intentional routine that includes things like meditation and those kinds of mindfulness practices makes a huge difference in how I feel throughout the whole day and the week in general. So, and that's a more recent development for me too. So it's one of those interesting things about how that evolves over time. So I love that. Thank you for sharing about your own journey. All right, and then how do you wish to be remembered after you leave this world? [00:21:59] Nidhi Oberoi: As I said purpose is my core value, big on impact. So I just want to leave the world a little bit better and do my bit. And whether it's working on things, like working on technologies and providing access to health care to patients, probably globally. So it's just continuing to make an impact in the healthcare space and leaving the world a little bit better than I inherited it. [00:22:27] Lindsey Dinneen: Yes. Excellent. And final question, what is one thing that makes you smile every time you see or think about it? [00:22:37] Nidhi Oberoi: Yeah. There are so many different things. As you start meditating or focusing on mindfulness, it's the small things in life that you start enjoying. Being in Minnesota, the good weather is difficult to come by. So sunshine really makes me happy. But yeah, I think being present makes you more joyful. You just start enjoying everything in life. The other thing I would say is just simple acts of kindness. People helping other people is also something that just moves me and touches me. [00:23:11] Lindsey Dinneen: Yeah, of course. I'm really curious. Okay, so I said final question, but then I have a follow up. So when you said being present helps bring you joy, could you share a little bit more about what you mean by that? [00:23:24] Nidhi Oberoi: Yeah. So I think being present means that you are not thinking about your past and you're not thinking about your future. And so what that means is all you're focusing is what's in the now, and I'm going to start speaking the language of someone who teaches yoga or meditation, but being present really is you're not in the past. You're not in the future. You're just enjoying your day, the moment, as it comes by, it's as simple as that. You're centered. You're aligned with yourself and you just focus on what's in your control. You don't dwell on things either of the past or in the future. So I think that's a very, that's a beautiful moment to be in. [00:24:11] Lindsey Dinneen: Yes, I couldn't agree more. Well, thank you for sharing a little bit more about that. I really appreciate it. And thank you so much for your time today. This has been such a great conversation. I've loved learning about you, and I'm so excited about your career future, especially with your goal of starting your own company at some point. So I will be cheering you on for that whole process. I know that's no small undertaking. But in the meantime, I just want to say thanks again for your time, and thank you so much for working hard to change lives for a better world. [00:24:45] Nidhi Oberoi: Well, thank you so much. Thank you for the opportunity. It's been so fun chatting with you. You're joyful. [00:24:52] Lindsey Dinneen: Thank you. Well, excellent. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. Thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two. And we'll catch you next time. [00:25:30] 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 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.

Paris Panayiotopoulos, Senior Managing Director at Blackstone Life Sciences, shares how the firm's broad life sciences strategy has been advancing innovation across the life sciences ecosystem in three key ways: late-stage product financing (Collaboration) and new company creation (Ownership), and non-dilutive financing (Credit and Royalties). He explains how Blackstone is bridging the innovation funding gap through high-conviction partnerships with larger BioPharma and MedTech companies, and targeted investment in late-stage trials.

What turns a brilliant idea into a market-ready medical device? Jennifer Palinchik, CEO of SageMar Medical, has spent over two decades guiding innovators through that exact journey. In this episode, Jennifer shares the critical factors that determine whether your device gets adopted—or ends up on the shelf. From navigating regulatory hurdles and defining market value to aligning R&D with commercialization from day one, Jennifer reveals the strategic playbook that every MedTech founder should know. We also explore trends like AI, mixed reality, and the growing role of M&A in accelerating innovation. If you're building in healthtech, Jennifer's insights will help you avoid costly missteps and build a business that truly scales.

In this episode of Medsider Radio, we sat down with Maulik Nanavaty, CEO of Anumana. Anumana, an AI-driven health technology company focused on cardiovascular care, is taking a pragmatic approach to scaling AI in medicine.Maulik is a seasoned healthcare executive with over 30 years of global experience in the medical device industry. He spent 18 years at Boston Scientific, where he led its $1B+ Neuromodulation division and served as President of Boston Scientific Japan. Prior to that, he held leadership positions at Baxter. Known for driving innovation in implantable and artificial intelligence (AI)-powered technologies, Maulik also serves on the board of Rani Therapeutics.In this interview, Maulik shares why building a strong risk-benefit case and designing around real-world clinician needs are key to adoption. With data from over 20 million patients and a focus on transparency, Anumana is reshaping how AI reaches the point of care.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Maulik Nanavaty.

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls. This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems.Timestamps00:04 – Introduction to common FDA compliance issues02:02 – Discussion on FDA's policy of not naming individuals05:45 – Mike Drues challenges the "pre-market" classification of common issues09:20 – Documentation requirements for different device classes11:35 – Mike's take on the most common FDA issues (beyond the presented three)15:40 – Root causes of common compliance problems and industry responsibility20:00 – The role of regulation and FDA's responsibility in clarity27:05 – Deep dive into design change and design creep31:40 – Software changes and the "bug fix" mentality35:45 – Marketing beyond authorized intended use with a real-world example41:00 – Key takeaways and proactive compliance strategiesStandout Quotes"If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules."You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences.Top TakeawaysRegulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges. This distinction is crucial for companies to allocate resources effectively.Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38%), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence (85% of those rejections).Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%), collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas.Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised.Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion.References & LinksEtienne Nichols' LinkedInGreenlight GuruCall to...

Send us a textGenerative AI is transforming the way clinicians interact with technology. In this episode, Dr. Holly Urban, VP of Business Development at Wolters Kluwer, joins John Driscoll to discuss how AI, ambient listening tools, and trusted medical content like UpToDate are improving clinical workflows, easing documentation burdens, and making healthcare delivery more precise, efficient, and human-centered.

In this episode of the Healthy, Wealthy and Smart podcast, host Karen Litzy welcomes Elizabeth Chabe, MBA, MS, CEO of High Touch Group and author of "The Giant's Ladder, The Science Professional's Blueprint for Marketing Success." Elizabeth shares her expertise in marketing within the science and technology sectors, particularly focusing on biotech and MedTech. She discusses the challenges faced by innovators in getting their ideas noticed and provides insights on how to market groundbreaking work effectively. Listeners will gain valuable strategies for building brand awareness and achieving market traction, making this episode a must-listen for health and wellness professionals looking to amplify their impact. Join Tara and Elizabeth as they explore the intersection of science, storytelling, and strategy in marketing. Time Stamps:  [00:01:43] Marketing strategies for science professionals. [00:04:33] CRISPR and corporate strategy. [00:10:58] Fractional wet lab space. [00:12:08] Storytelling in scientific marketing. [00:15:50] Founders and product-market fit. [00:19:24] Selling scientific products effectively. [00:25:20] Business strategy vs. marketing gloss. [00:29:43] Science marketing for founders. [00:34:40] Marketing strategies for researchers. [00:38:04] Philanthropic support for dog rescue. [00:39:19] Importance of mission in business. More About Elizabeth:  ELIZABETH CHABE (MBA, MS) is an author, entrepreneur, and recognized strategic marketing consultant for science, engineering, and technology organizations. Her work has been featured in The New York Times, Popular Science, Entrepreneur, CNBC, Composites World, and 360Dx, among others.   As the founder and CEO of High Touch Group, Elizabeth oversees a team that develops marketing and PR strategies for advanced science, engineering, and technology organizations. Through High Touch Group's holistic, comprehensive marketing services, clients generate more leads, drive revenue, and elevate their brands into the global B2B space.  Her work as a strategic consultant has been instrumental to biotechnology, energy, advanced materials, advanced manufacturing, robotics, and automation companies.  Since her first business venture at the age of nine, Elizabeth has built and overseen countless successful research programs and marketing teams. As the former senior manager of digital and strategic marketing at the Jackson Laboratory (JAX), she developed the marketing strategies for its mouse model portfolio, model generation (CRISPR), and in vivo contract research services.  Prior to joining JAX, she oversaw global communications for the Advanced Structures and Composites Center in Maine. There, she managed projects including the center's offshore wind research program, the largest research and R&D program in Maine's history.  Since 2018, Elizabeth has been a governor-appointed director of the Maine Venture Fund.  An inveterate traveler, she splits her time between the US and developing world communities. She currently resides in Mexico with her husband and rescue dogs.  Resources from this Episode: July 17th Jane Q&A Webinar High Touch Group Elizabeth's Website Elizabeth on LinkedIn Giant's Ladder Book   Jane Sponsorship Information: Book a one-on-one demo here Mention the code LITZY1MO for a free month Follow Dr. Karen Litzy on Social Media: Karen's Twitter Karen's Instagram Karen's LinkedIn Subscribe to Healthy, Wealthy & Smart: YouTube Website Apple Podcast Spotify SoundCloud Stitcher iHeart Radio

This panel was recorded June 26, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at RQMplus.com.SummaryHear leading neurology innovators discuss how to navigate complex regulatory pathways, accelerate approvals, and reduce risk in bringing groundbreaking neurological devices to market.LinkedIn panelist and moderator profiles 

  Background: From IT in India to MedTech in Norway  You have a pretty fascinating background – you studied computer applications/IT back in India and now you're a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)  What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?  And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)  Day-to-Day as a QARA Manager   Let's talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)  It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?  We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?  On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?  (For example, is it challenging that the scope is so broad – one moment you're deep in engineering specs, next moment you're updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)  First MedTech Role at Hy5Pro AS  Let's dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?  (Feel free to explain what Hy5Pro's product was and your role there, e.g. implementing the quality system, getting certifications, etc.)  Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?  (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)  Leading QARA at RemovAid AS   After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?  RemovAid's product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.  (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)  On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?  RemovAid is in women's health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it's about making contraceptive care easier – that's quite impactful.)  Consulting Experience at LINK Medical   Now, currently you're working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?  I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company's project mid-stream.  Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you've learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*  Diversity and International Career Insights   I'd like to touch on diversity and your international experience. You're a woman in the medtech industry and you've built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you've noticed working in Norway compared to India?  The medtech industry, especially in leadership, still isn't very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?  What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)  Rapid-Fire Round   Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I'll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!  Question 1: What's one thing about your job that most people would be surprised to learn?  Question 2: What's the coolest medical device or gadget you've worked on or seen so far?  Question 3: Are you team coffee or tea? (What fuels your workdays?)  Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?  Question 5: If you weren't in QARA, what alternate career could you see yourself in?  Question 6: What's one Norwegian word or phrase you've picked up that you love to use? (Bonus: translate it for us!)*  Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)  (Guest gives rapid-fire answers with laughter and brief commentary.)  Advice and Closing   Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?  (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)  And maybe equally important, what should they not be scared of? People might think “Oh, I'm not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?      Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)  Welcome & Setup  Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?  Career Journey  How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?  What motivated you to switch into medical device regulations, and what were the biggest initial challenges?  In what ways has your IT background helped you excel in QARA?  Day-to-Day Responsibilities  What does a typical day or week look like for you as a QARA Manager?  Which tools or software (QMS systems, document controls, etc.) do you rely on most?  Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it's all paperwork?  Which aspects of QARA do you find most challenging, and which are the most rewarding?  Hy5Pro AS Experience  What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?  Can you share a memorable “learning moment” or funny anecdote from your time there?  RemovAid AS Experience  At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?  Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.  Any unexpected or humorous challenges you overcame in that role?  How did working on a women's health product impact you personally?  LINK Medical Consulting  How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?  What's a standout project or recurring compliance issue you help clients solve?  How do you stay organized when juggling multiple clients and deadlines?  Diversity & International Insights  As a woman in medtech QARA, have you faced any unique challenges or opportunities?  What cultural adjustments did you experience moving from India to Norway?  How can medtech teams become more inclusive, especially in QA/RA?  Rapid-Fire Round  (Answer quickly with the first thing that comes to mind.)  One surprise fact about your job?  Coolest device or gadget you've worked on or seen?  Favorite (or funniest) QARA acronym—what does it mean?  Alternate career you might have chosen?  Norwegian word or phrase you love—translate it for us!  If your career were a movie title, what would it be?  Closing Advice  What practical steps should students or career-changers take to break into QARA?  What misconceptions shouldn't they be afraid of when considering this field?   

Thought leader Julio G. Martinez-Clark shares how his company in helping to bring medical innovation to the market sooner by conducting clinic trials in Latin America. About Julio: Julio G. Martinez-Clark stands at the forefront of clinical research transformation as the Ambassador of IAOCR/GCSA in the Americas and CEO of bioaccess®, where he bridges global quality standards with the world's growing MedTech, BioPharma, and Radiopharmaceutical ecosystems. With over two decades of cross-industry leadership spanning healthcare, telecommunications, and venture capital, Martinez-Clark has become the trusted partner for 100+ companies seeking accelerated regulatory approvals and cost-effective clinical trials worldwide. His unique fusion of technical expertise from Johns Hopkins Hospital infrastructure projects, regulatory acumen honed through UNESCO-aligned accreditations, and operational mastery of diverse global clinical trial landscapes positions him as the definitive authority on risk-mitigated medical innovation in emerging markets. Resources: Products discussed in the podcast: ReGelTec: https://regeltec.com/regeltec-chooses-colombia-bioacce-for-first-in-human-clinical-trial-of-hydrafil-system/   Spine Stabilization Technologies (SST): https://thespinemarketgroup.com/spinal-stabilization-technologies-ltd-announces-start-of-lopain-2-clinical-trial-in-south-america-for-lumbar-degenerative-disc-disease/   bioaccessla.com   Show sponsor:  The Cox 8 Table by Haven Medical