Podcasts about Medtech

Breaking into the US MedTech market is slow, complex, and often misunderstood. In this episode, we're joined by Brian Hantzis, a US medical device distributor who has built and scaled a specialist distribution business through organic growth and acquisitions. Brian shares an honest, behind-the-scenes look at how distribution really works in the United States and why so many manufacturers struggle to gain traction.We discuss:Why the US market takes years — not months — to crackThe difference between specialist and general distributorsWhat US hospitals actually care about when adopting new productsThe importance of clinical data, studies, and value analysisHow pricing, margins, and fair partnerships really workWhy MedTech distribution is consolidating — and what that means for foundersWatch on YouTube: https://youtu.be/3v8N7F2gGqoListen on Apple Podcast: https://podcasts.apple.com/gb/podcast/hands-on-business-the-h-files-unlocking-growth/id1548129226

Hoe vaak hoor je nu dat een mediabedrijf samengaat met een kernfusiebedrijf? Waarin de sociale media van de president van Amerika fuseert met een kernfusiebedrijf waar wetenschappers werken? Dat hoor je één keer. Vandaag.Trump Media fuseert namelijk met TAE Technologies, een deal goed voor 6 miljard dollar. En daar stopt de invloed van de president op de beurshandel niet. Hij hervormt de cannabismarkt, waardoor investeren in marihuana ineens aantrekkelijker wordt. Aantrekkelijk vinden beleggers Nike dan weer niet. Al jaren wachten ze op de comeback van het bedrijf. Jarenlang neemt de beurskoers én omzet af. De kwartaalcijfers zijn beter dan verwacht, maar Nike is er nog steeds niet. Deze aflevering kijken we wanneer dat herstel er nu wél komt. Kijken we ook naar TikTok. Er is een Amerikaanse deal, een waar de familie Ellison bij betrokken is. Verder hoor je ook meer over de miljadenlening aan Oekraine en de overnamesoap rondom Warner Bros Discovery. Te gast: Errol Keyner, van de Vereniging van Effectenbezitters.See omnystudio.com/listener for privacy information.

Hoe vaak hoor je nu dat een mediabedrijf samengaat met een kernfusiebedrijf? Waarin de sociale media van de president van Amerika fuseert met een kernfusiebedrijf waar wetenschappers werken? Dat hoor je één keer. Vandaag.Trump Media fuseert namelijk met TAE Technologies, een deal goed voor 6 miljard dollar. En daar stopt de invloed van de president op de beurshandel niet. Hij hervormt de cannabismarkt, waardoor investeren in marihuana ineens aantrekkelijker wordt. Aantrekkelijk vinden beleggers Nike dan weer niet. Al jaren wachten ze op de comeback van het bedrijf. Jarenlang neemt de beurskoers én omzet af. De kwartaalcijfers zijn beter dan verwacht, maar Nike is er nog steeds niet. Deze aflevering kijken we wanneer dat herstel er nu wél komt. Kijken we ook naar TikTok. Er is een Amerikaanse deal, een waar de familie Ellison bij betrokken is. Verder hoor je ook meer over de miljadenlening aan Oekraine en de overnamesoap rondom Warner Bros Discovery. Te gast: Errol Keyner, van de Vereniging van Effectenbezitters.See omnystudio.com/listener for privacy information.

ProPhase Labs CEO Ted Karkus joined Steve Darling from Proactive to announce that the company has entered into a non-binding Letter of Intent (LOI) regarding a proposed reverse merger transaction with Advanced Biological Laboratories (ABL), a European biotechnology and MedTech group. Under the proposed structure, Advanced Biological would become the majority owner of the combined public entity, while ProPhase's existing operations would continue as sister companies to a newly formed U.S. subsidiary expected to remain under ProPhase's current management team. Karkus emphasized that the transaction remains subject to the execution of definitive agreements, regulatory approvals, and board authorization. However, the parties have discussed a preliminary, non-binding valuation framework that could imply an enterprise value of up to approximately US$30 million for ProPhase's legacy business. This framework is intended to provide a basis for ongoing negotiations rather than a final valuation. As outlined in the LOI, and subject to applicable law and final documentation, ProPhase Labs may declare a special cash dividend of up to US$10 million payable to shareholders of record on a date to be determined. Importantly, any such dividend would be distributed separately and would not be part of the merged operating company. In addition, all Crown Medical Collections receivables are expected to be carved out and retained exclusively for the benefit of current ProPhase shareholders, further preserving value for existing investors. Advanced Biological Laboratories would contribute its global biotechnology and MedTech infrastructure to the combined company, including advanced health data processing platforms, cloud-based computing capabilities, and access to international financing resources. The combination is intended to create a more diversified healthcare technology platform with expanded global reach, while allowing ProPhase to unlock value for shareholders through potential cash distributions and retained assets. #proactiveinvestors #prophaselabs #nasdaq #prph #biotech #genomics #genomesequencing #ProPhaseLabs #AdvancedBiologicalLaboratories #ReverseMerger #LOI #Biotechnology #MedTech #HealthcareTechnology #StrategicTransaction #ShareholderValue #SpecialDividend #NasdaqListed #GlobalHealthcare #HealthData #CloudComputing #LifeSciences #MergersAndAcquisitions

De Nederlandse sector voor zorgtechnologie heeft een nieuw Groeiplan MedTech gepresenteerd, als aanvulling op het rapport van oud-ASML-topman Peter Wennink. De sector zegt zo'n vijf miljard euro aan publiek-private investeringen nodig te hebben in de komende tien jaar om innovatie in de zorg te versnellen en Nederland bij de wereldtop voor medische technologie te krijgen. Het plan is deze week aangeboden aan de ministeries van Volksgezondheid en Economische Zaken. In BNR Beter bespreken we wat er in het groeiplan staat en wat de investering moet opleveren. De sector zet in op onder meer autonome MRI-systemen, AI-gestuurde en robotondersteunde therapieën en een landelijk netwerk voor zorgdata en patiëntmonitoring. Volgens de initiatiefnemers zijn dit belangrijke ontwikkelingen om zowel de zorg als de economie te versterken. Het groeiplan schetst ook duidelijke randvoorwaarden: betere toegang tot zorgdata en een sterke AI-infrastructuur, snellere opschaling van innovaties van idee naar praktijk, innovatievriendelijkere regelgeving, behoud van hoogwaardige maakindustrie en een stabiel, voorspelbaar overheidsbeleid. Zonder die voorwaarden dreigen start-ups en innovaties te blijven steken in pilots of naar het buitenland te vertrekken. Presentator Rens de Jong praat erover met Roy Jakobs, ceo van Philips, Wiro Niessen, decaan Medische Wetenschappen aan de Rijksuniversiteit Groningen en bestuurder bij het UMCG, en Marjoleine van der Zwan, managing director Health & Work bij TNO. Zij gaan in op de haalbaarheid van het plan, de rol van publiek geld, de knelpunten rond databeschikbaarheid en regelgeving, en het risico dat innovaties en start-ups Nederland verlaten als die randvoorwaarden niet verbeteren. Lees hier meer over het groeiplan van de MedTech-sector.See omnystudio.com/listener for privacy information.

What actually happens after you sell a company for $1.1B and never need to work again?Joe DeVivo is a legendary MedTech CEO who sold InTouch to Teladoc in a $1.1B deal and is now President, CEO, and Chairman of Butterfly Network.Joe has a very specific reputation in the industry. He steps in when companies get stuck. Often at the moment when a founder-led business needs a different kind of leadership to scale. In this episode, Joe breaks down his turnaround playbook step by step, from how he diagnoses what's broken, to who stays, who goes, and how focus gets restored.He also opens up about something that's rarely talked about. What it really feels like after a massive exit. When the money hits, the anxiety leaves your body, and you realize you never have to work again. What does “post-economic” life actually look like, and why do some people still choose to come back?We also trace Joe's path from growing up in a family-run manufacturing business to becoming the CEO boards call in moments of crisis, and why invention and scaling are fundamentally different jobs.LinksButterfly Network: https://www.butterflynetwork.comDr Mustafa Sultan: ⁠⁠⁠https://www.musty.io⁠

Viele Unternehmen der Medizintechnik stehen gerade vor einem historischen Wendepunkt: Die Gründungswelle der 1990er-Jahre erreicht jetzt das Übergabealter – und damit rücken Nachfolgeentscheidungen in zahlreichen Firmen in den Fokus. Doch was macht eine erfolgreiche Nachfolge aus? Und wie gelingt der Spagat zwischen Tradition, Kultur und Zukunftsausrichtung? In dieser Folge spricht Julia Steckeler mit Stefan Drescher, Geschäftsführer von Drescher Consulting über den strategischen Nachfolgeprozess: – Was bedeutet strategische Nachfolge und wie beginnt man den Prozess? – Wie sichern Unternehmen implizites Wissen, Führungskultur und Kundenbeziehungen? – Welche Fehler kann man vermeiden? – Und wie kann das Thema Nachfolge zu einem echten Zukunftsmotor werden? Stefan Drescher begleitet seit vielen Jahren Unternehmen in der Medizintechnik und im Mittelstand bei Strategie-, Veränderungs- und Nachfolgeprozessen. Seine Perspektive verbindet Struktur, Menschlichkeit und Tiefe – perfekt, um dieses komplexe Thema greifbar zu machen.

In this episode of Medsider Radio, we sat down Dr. Adam Kadlec, practicing urologist and co-founder of Rivermark Medical.Rivermark is a clinical-stage company developing FloStent, a first-line, reversible device therapy for benign prostatic hyperplasia (BPH).Before launching Rivermark, Adam built a thriving urological practice in Milwaukee and consulted for several device companies — experiences that ultimately revealed how early true device development begins and why physicians rarely get the chance to influence innovation upstream. Partnering with medtech operator Andy Doraiswamy, Adam transitioned from clinician to CEO and is now leading Rivermark through its pivotal trial.In this interview, Adam shares why workflow integration is one of the most overlooked drivers of adoption, how physician-innovators can build the right decision-making infrastructure, and why understanding who actually enrolls patients at clinical sites can make or break a trial. He also touches on the mindset required to stay resilient through the ups and downs of building a medtech startup.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 Adam Kadlec.

One on One Video Call W/George https://tidycal.com/georgepmonty/60-minute-meetingSupport the show:https://www.paypal.me/Truelifepodcast?locale.x=en_USThe Lila Code: https://orcid.org/0009-0008-4612-3942

Duane Mancini welcomes Ben Fogarty, a design generalist and strategist and founder partner at Council. Ben shares his journey from an art student to leading an independent design practice working with startups and Fortune 500 companies. The conversation delves into the vital role of design thinking in problem-solving, the importance of internal and external brand alignment, and crafting clear, compelling narratives crucial for success in the MedTech industry. Ben Fogarty LinkedInCouncil WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for talent" (many jobs, few candidates) to a market flooded with applicants, often overwhelming internal recruitment teams. This shift, exacerbated by simple application processes like LinkedIn's Easy Apply, makes it challenging for good candidates to cut through the noise and for companies to manage high application volumes.To thrive in this new environment, MedTech professionals, particularly those in Quality Assurance (QA) and Regulatory Affairs (RA), must expand their focus beyond technical competence. Elena stresses the growing importance of transverse skills (the essential human skills like communication, negotiation, and leadership) and, critically, AI literacy. With the pressure on companies to "do more with less," AI is creating an environment where smaller, highly productive teams are favored. This doesn't mean roles will disappear, but professionals must embrace technology to eliminate tedious tasks and focus on high-value, strategic work.Navigating the job market now requires a more intentional and proactive approach, especially to access the hidden job market where the best unadvertised roles reside. Tactics include direct networking with hiring managers and active professional branding. Furthermore, the global regulatory environment's fragmentation—especially between the US (FDA) and EU (MDR/IVDR)—is impacting how companies build their teams, favoring remote work and strategic location choices that factor in the local talent pool and employment laws.Key Timestamps1:50 - The MedTech Talent Shift: From "War for Talent" to a "Reset"4:45 - The impact of high volume and "easy apply" on candidate experience6:15 - Immediate disqualification criteria and "gaming" the application system7:35 - Strategies for accessing the hidden job market (networking and strategy)9:20 - The controversial impact of AI on QA/RA roles and the need for efficiency11:30 - Future-proofing your career: Why leaders and junior professionals must embrace AI13:55 - Understanding transverse skills (soft skills) and business acumen15:40 - The QA/RA role in the age of AI: Focusing on the 30% of high-value expertise17:00 - Tactics for achieving AI literacy: Small wins, experimentation, and habit stacking19:45 - Why the "hidden job market" exists (confidentiality, exclusivity, and pipeline)21:30 - Positioning yourself externally: The power of active contribution on LinkedIn23:45 - The importance of speaking at industry events (e.g., RAPS) to build credibility24:55 - Strategic advice for founders building remote, global teams26:15 - The impact of US vs. EU regulatory fragmentation on talent selectionQuotes“It's not going to be enough to just be good at your job. You're going to need to have a little bit more understanding of how to position yourself, how to brand yourself, how building skills outside of just your technical competency [is important].” - Elena Kyria“This is a massive opportunity... to step up and get started... you can use the technology but then you're focused on strategy, relationships, [and] the human side of it versus the people that are still very manual.” - Elena KyriaTakeawaysPrioritize AI Literacy: MedTech professionals must proactively experiment with AI tools (like note-takers and regulatory intelligence systems) to automate up to 70% of tedious tasks. Waiting for...

Katie Bochnowski is the Senior Vice President of Customer Success & Services at NowSecure. Katie shares her journey from studying cyber forensics at Purdue University to becoming an expert in mobile app security and forensics. She discusses the impactful work her team does in securing mobile apps, especially in the medtech industry. Katie also offers valuable advice on building relationships within organizations, the importance of security best practices, and staying curious as a professional.  Guest links: https://www.linkedin.com/in/katiestrzempka/ | https://www.nowsecure.com/ 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 & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 070 - Katie Bochnowski [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am absolutely delighted to introduce you to my guest, Katie Bochnowski. Katie is Senior Vice President of Customer Success and Services at NowSecure co-author of the book, "iPhone and iOS Forensics," and a recognized expert in mobile forensics and app security testing. Katie holds a master's in Cyber Forensics and Bachelor's of Science and Computer Technology from Purdue University. In her current role, Katie oversees customer support, onboarding and success departments, as well as the mobile AppSec Professional Services Organization that is responsible for pen testing, training, and consulting. All right. Well, welcome. Thank you so much for being here. I'm so delighted to speak with you today. [00:01:37] Katie Bochnowski: Awesome. I'm really happy to be here. [00:01:39] Lindsey Dinneen: Excellent. Well, I would love, if you wouldn't mind just starting off by telling us a little bit about yourself, your background, and what led you to medtech. [00:01:48] Katie Bochnowski: Awesome. Sure. So, I'm Katie Bochnowski. I work for a company called NowSecure. My background, dating back many years to school is in computer technology and more specifically cyber forensics. Where I am now is mobile app security. How I got into that industry is, is really from that forensic background. Our company used to do data recovery and forensic investigations on mobile devices, and we kind of quickly realized that mobile apps are storing a lot of data. So we shifted into proactively working with organizations to secure those apps that reside on devices. And in terms of medtech, obviously you can probably make that connection, but we began working closely with first, companies that really care about the data that's being stored, and transmitted on those apps, which absolutely includes medtech industry. [00:02:43] Lindsey Dinneen: Awesome. Okay, so going back a little bit. So when you were first deciding on college paths and career paths and all those lovely things, what drew you to where you ended up? [00:02:55] Katie Bochnowski: You know, I don't have a great, like "aha" moment for this question. It was just one of those things. I grew up, I had a computer in my house. I did Typing Tutor when I was really young on MS Dos, and I just always en enjoyed that. I had a friend in high school and we both got interested in making our own website with HTML. So, it was just enjoying being around computers and also tinkering to figure out what was wrong with something from a technology perspective. Purdue is where I attended. Purdue had a more generic computer technology degree that I didn't have to know exactly what I wanted to do. You could try different paths, so that's kind of what got me into it. It's not like I knew I wanted to do that my whole life, but I never really went back or questioned it. I always just kind of enjoyed it along the way. [00:03:45] Lindsey Dinneen: Yeah. Excellent. Okay, so the phrase cyber forensics is just exciting. So, can you dive a little bit more into exactly what that means and entails and what it looks like? [00:03:57] Katie Bochnowski: Yeah, absolutely. So, it is exciting- -so much so, in fact, that my senior year of college, the very first time they offered this class, it was called Cyber Forensics, it was an elective and it sounded amazing. And, it was amazing. It was really cool. We went through from start to finish, how you collect evidence from a computer and technology perspective, how you keep it pristine, how you collect the data off of it. We even got to work with local law enforcement as part of an internship to do all that, so I was very lucky in that my very last semester of my four years, they offered this and I just really, really liked it. It always was there in the back of my mind. So yeah, cyber forensics is really the collective of all things digital, which is everything, now. I don't do, necessarily, that work anymore, but I can't even imagine all of the data collection off of Alexas and, and all of those devices. But yeah, that's, that's kind of how I got into that. [00:04:56] Lindsey Dinneen: Wow, that's really cool. Yeah. So, okay, so talking about this data collection and all of these things, I'm curious, what are maybe one or two things that just really surprised you when you started getting into the industry and doing the work? [00:05:11] Katie Bochnowski: I know people always said this, and it shouldn't have been a surprise, but when I first started working for NowSecure-- which was actually called Via Forensics back in the day when I first started-- we worked on a lot of individual cases, so people saying, " Can you recover my deleted text messages, and pictures..." and things like that, and the amount of data that really does reside on those devices still after you delete them, going back months, years. So, I don't know if that's still the case now. I don't know if they do a better job of that, but that was surprising to us. What was also surprising was how much apps are storing and transmitting data on those devices when you don't think about it. So a lot of these cases that we would work on, they would focus so much on voicemails, emails, photos, and text messages, but nobody ever said, "Hey, can you go check the Facebook app or the Messenger app you're using?" That was something we realized pretty quickly, and were shocked to see-- this was 15 years ago-- how many apps were storing incredibly sensitive information on those devices. [00:06:20] Lindsey Dinneen: Yeah. And so now that there's more awareness of this and people are maybe, hopefully taking a little bit more ownership of even their own awareness and education with all of it, what do you see are the changes and shifts towards better protection? [00:06:38] Katie Bochnowski: Yeah. Great question. So there's a couple things: One, people are more aware, so they are leveraging the best practices really for these things. So there's places you should and shouldn't store data on devices, and you should use encryption for sensitive information and encryption that can't easily be broken into. The platforms themselves, too--Android, iOS-- have also made improvements in protecting those sandboxes. But, it's not everything, so you absolutely still have to be mindful of that. A lot of organizations like medtech companies and financial organizations do add a lot of those extra protections. But a lot of people don't, still. They're not either, don't think about it as much or aren't aware of it. And then the other thing that we see is everyone could have, you know, a hundred percent perfect intentions in storing and protecting that data, but you make a mistake, or you accidentally leave a debug flag on or something like that, where this information still can be accessed even though developers and security organizations are following the best practices there. [00:07:51] Lindsey Dinneen: Hmm. Yeah. So as you look toward the future of device security in general and cybersecurity, what are you looking forward to in terms of improvements, and hope for the future? Because I know there's a lot of things to worry about, just in life. But, what are some of the things that you're hopeful about? [00:08:11] Katie Bochnowski: Yeah. I'm hopeful for the--I'm going to call it the camaraderie--we're seeing between security and development groups. Not that there was argument or debate between them before-- there probably was a little bit-- but we are seeing a lot more organizations have what they refer to as a Security Champions Program, which brings those groups together. Security used to be seen, and probably in a lot of cases still, is seen as that blocker. Developers are being rushed and pushed to release features quickly. They have deadlines, timelines, and then if security finds an issue, it has to go back to the drawing board to remediate. But, with these programs, we're seeing either a development group that has a security champion there, or just teams kind of melding together a little bit more to build that testing earlier on. That's a trend we're seeing increase more and more. And, I believe that's going to only continue because it's just the right thing to do for everyone all around. [00:09:12] Lindsey Dinneen: Yeah, and that collaboration piece is so critical to eventual success, or hopefully even shorter-term success, like said, so that there's not as many iterations. It's like, "No, let's just integrate and do this from the start well together." Yeah. [00:09:27] Katie Bochnowski: Yep. [00:09:27] Lindsey Dinneen: Cool. Okay, so, you started with NowSecure, and then eventually you got your first medtech client. Could you talk about that experience? [00:09:36] Katie Bochnowski: Yeah, absolutely. Actually, before I even started with NowSecure, I worked for a Fortune 100 company in their security department doing firewall rule management. And, it was all good and everything, but I remember thinking throughout my career, I'm the type of person that likes to do things meaningful, making an impact on people. So, for many years, I was like, "Okay, what am I doing? I'm just executing firewall rules, I'm recovering data..." That's why the forensic work was so appealing to me because you were actually helping assist with investigations that mattered. Then, getting into the mobile app security industry was certainly important, but it took it to a whole new level for me when we got our first medtech client. I remember going on site and seeing some of the things that the apps can do in conjunction with medical devices, implants, et cetera, and thinking, "If you get this wrong, this can impact a human life." That helped bring all of this to a whole new level, and it's something I talk about internally within our organization as well to help people understand how meaningful it is --what we do, what the medtech industry does, and how important it is to get security right. It's just helped me with a new perspective. I love working with our medtech industry clients. It's contagious to be around them and see how much they care about what they do, and, how important it is to their lives --makes an impact on the way I work as well, then. [00:11:06] Lindsey Dinneen: Yeah, I love that. I think that's so true. I get so inspired by even just talking with these incredible founders, their devices and their heart behind why they're doing what they're doing. It's not an easy road so choosing to do so, and then hearing that passion is what drives them sometimes in those crazy late nights, early mornings, hassle in between, you know? So you started getting medtech clients, and now you've developed a niche offering for that group. I'm wondering, what are some of the common themes that you see companies maybe aren't aware to consider when they're starting their development of their devices and apps? And, perhaps just some general advice: What should people be on the lookout for? [00:11:50] Katie Bochnowski: Yeah, so I guess you-- I shouldn't say unique, but specific to organizations like medtech industry or, financial or healthcare and the apps they build-- is that highly sensitive information. And so I guess my advice and the thing I would point out that I see in those types of applications is not only, of course, best security practices and understanding what's unique in mobile is super important because web apps have been developed for many, many years. Mobile apps now have been many years, but people don't necessarily know that it is unique in the way that they are developed and the different attack surface, right? You have the local device attack surface. You have the attack surface of other apps that could be malicious that are installed on that device. So, understanding what those mobile unique security best practices are is my number one piece of advice for developers. Number two would then be multiple layers of security protection. So, developing a secure app is one part of it, and a very important part of it. What we see is a lot of organizations sometimes are dependent on either the protections of the device OS itself--the Android OS protections or iOS protections. And, there are tools out there that offer protections like tamper detection: If you detect the app is being tampered with, don't launch it. If you detect the app is installed on an exploited, rooted, jailbroken device, don't launch it. Or, don't allow login. Those are important, but those can be bypassed and so I say multiple layers of protection. I'm not against those protections. I think they're very important. I think you should do them, but you should also assume in some cases they can be bypassed, and you need to have that foundational security in the way you develop your applications. [00:13:48] Lindsey Dinneen: Yeah. So, you've had a really interesting career so far, and I'm sure you've seen a lot of things over the years. What are some moments that really stand out to you, especially with your medtech clients, as, as hitting home that, "Wow, I am in the right place at the right time, making an impact." [00:14:09] Katie Bochnowski: I think it's hard because it's not like there's one single moment. Because what you want to avoid in this industry is a breach, is something like this "oh my gosh," this big negative moment. And so honestly, it's seeing the organizations we work with, not having that happen. When you do see a breach that might be mobile-specific, I immediately jump in and see, "Okay, what happened? How did they exploit this? What was the actual vulnerability that led to this?" We check for that, and we help our customers test for that and knowing, "Okay, whew. They're covered." And we see that kind of stuff all the time. So I don't have, necessarily, a big moment, but I do have those moments along the way where it's like, you see something in the news, and you are not surprised by the way that was exploited. It's something that is foundational to mobile app security, and you know your customers are protected. [00:15:09] Lindsey Dinneen: Yeah. Well, that's a really good reminder in general because sometimes you get those big, crazy, sort of in-your-face moments that are going, "Yes, okay, I know why I'm here." But then, those don't happen all that much, usually. So having those little encouragements along the way of, "No, you're on the right path, you're doing the right things is incredibly... [00:15:30] Katie Bochnowski: It's funny; it actually reminds me of sometimes we'll work with customers and they'll use our products or services--and, they'll be upset because we haven't found anything in a certain amount of time. Seriously. And they're like, "You must not be testing enough" or " You haven't found anything high risk in six months." Sometimes, we have to remind them that's good. "Green is good," is what we always say. "Green is good." And, of course you want to check and make sure you're doing everything, in depth as possible. But, if you do a full two-week pen test and nothing big is found, that's good. You're doing a great job. So, take the win. Green is good. [00:16:07] Lindsey Dinneen: Green is good. I love it. Words to live by. You have had a really interesting trajectory even through NowSecure, but throughout your career and you've stepped into different kinds of leadership roles. I'm wondering how has that evolution been for you as a leader? What are some of your key takeaways that you've discovered work really well, and maybe some lessons learned? [00:16:29] Katie Bochnowski: Yeah, so I was not the person coming out of college that said, "I want to get my MBA, I want to be a CEO, I want to be, you know, high up in an organization." I just knew I liked computer technology, I liked tinkering--that kind of stuff. So I wanted to do things that were interesting. Via forensics, and now, NowSecure really was amazing for me because I got to do all of that. I got to grow with the company. I was really the first employee with the co-founder here, and as the company grew, I naturally started developing the managerial and the leadership roles as we hired more people and got more clients. So for me, I learned on the job, along the way, and when I think about it, I see people that are very ambitious to be a manager and, that's okay too. The best leaders that I've seen have been leaders that have naturally and organically developed a mutual respect, trust, and collaboration with their teams, seeing them as partners and peers and not someone to delegate things to in an authoritative way. And that's not just necessarily from a managerial perspective, because I see individual contributors, on my team for example, that exhibit amazing leadership skills, developing those relationships with other departments. And when you do that, you get-- I don't mean this in the way it's gonna sound, but you get people to do things for you because they want to, because they want to support you. And so that's what I always like to focus on is, just building those relationships, having empathy for other people. And, of course there's delegation that comes with that, but when you do that, then they want to do that for you or for the organization because you've, you've built that foundation. [00:18:20] Lindsey Dinneen: Yes. That's great advice. I really appreciate that. There were several things in there that, stood out to me. One of them was your comment about even individual contributors can be leaders, so even if you are not technically in a managerial role, or you don't have anyone working underneath you at the moment, doesn't mean you can't develop those skill sets and lead yourself and lead your own direction. So I think that's a really important note. And, something to give a little bit of perhaps inspiration, too. So if you want to be in that leadership role at some point, but you're not there yet, doesn't mean you can't build the skills along the way. [00:18:54] Katie Bochnowski: Yeah, absolutely. And I think about, I, I have heard people in the past say, "Oh, I can't go ask them to do something. I don't have the authority to do that." I hear that a lot. " I'm not their manager. I can't tell them to do that." And then there's people that don't even think that way, and just build that relationship and get others to collaborate and work with them. Those are the natural leaders that managers are going to see and want to promote to be the next manager. Right? So, if I'm gonna give another piece of advice, it would say, never say, "I don't have the authority, or I don't have the power to do that." Or "It's above my pay grade" is something that I'm like, "Oh, don't say that," because nothing is. You just need to learn to work with others to figure out how to do that. [00:19:41] Lindsey Dinneen: Yeah, and I think you're absolutely right about relationship building and collaboration being such a key to success in general. I mean, I think about all of the opportunities that are created and these sort of magical, what feel like magical, synergistic moments that happen, but they're not magical. They're because of intentionally cultivating these relationships. So yeah, I love that. And then helping people come up alongside you. So that's actually a concept I'd love to hear about your experience, either as a mentor or mentee, or anything like that that you've experienced that has really been inspirational to you. [00:20:18] Katie Bochnowski: Yeah. Well, I guess I have maybe two examples. I had someone that was working on my team many years ago and, again, we worked very closely as, I saw him as a partner and he got to a place basically at the organization where I would always tell him, "We could switch jobs, and you could do this and I could report to you and it doesn't matter," because I saw him grow that quickly. And he is now in another position that's probably double my pay and I don't know. But that's... you want to see that. And, some people might be threatened by that, but you shouldn't be, if you are doing the right thing because you want to see people grow into those roles. I don't know if this directly answers your question, but there is a leader who's a CEO of another organization who I have always looked up to, and I just see this is exactly how she leads. You know, everybody respects her. Everybody wants to support her and her mission at her company. Even when you're not working at her company like me, you just see the way she leads and the way she has built relationships throughout all of the employees in her organization. It's just something that I aspire to. [00:21:27] Lindsey Dinneen: Yeah, absolutely. And sometimes it's really helpful 'cause you'll get your share of... well I think most people at least have had the experience of getting their share of people in leadership roles that they would maybe not wish to emulate. So getting to be inspired by the people who are doing it correctly is is lovely. Yeah. Yeah. I love that. What is your number one, if you could boil it down, piece of advice for ordinary folks who are looking to up their own security game and just be more aware. [00:22:04] Katie Bochnowski: Be curious; don't wait for someone to show you or teach you how to do something. Part of what I oversee is managing a group of mobile app pen testers, and the best pen testers that I've seen are not the ones that have tons of experience or skill. It's actually, we've had two interns come straight out of school, come in and just dive into things without being asked, and just go figure it out and learn. And so be curious. Go try online exams and labs, even if you have no clue what you're doing, just try it, research and figure it out, and be curious. And I guess that's my biggest thing. [00:22:45] Lindsey Dinneen: I love it. Yeah. Curiosity gets you far in life. Yeah. I love that. Okay, 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 doesn't have to be in your industry, but it could be. What would you choose to teach? [00:23:07] Katie Bochnowski: Okay, this might take a nerdy turn. [00:23:11] Lindsey Dinneen: Excellent. [00:23:12] Katie Bochnowski: And I would need a lot of education or somebody else who's an expert in this to actually teach the class. But, I've personally gotten really interested the last couple years into brain health, neuroplasticity, managing stress, and the importance of it. And, this is from a personal situation that I went through and not really understanding how just everyday, little stressors--I never saw myself as a highly stressed person. I was actually quite the opposite--but, when you internalize a lot of, just like I said, everyday stressors, doesn't have to be anything big-- arguing with my daughter every morning to get dressed before school has an impact on your body and your brain health. And it started having physical symptoms in me that got scary, right? I don't need to dive into that, but from that, it helped me in meeting with a bunch of health experts and learning that what an impact your brain health really has on you. So if I could go back and teach some of the exercises that I was given--super simple things like these little games on your app that just help work different areas of your brain that you don't normally work. When you get into a routine at work, and every morning you wake up, send your kid to school, sit down at your desk, do the same meetings, emails, you have the same routine every day--you don't have, just a change in your routine, or try new hobbies, things like that, then your brain doesn't grow and, and that affects your health, and your mood, and all of that. I've just learned so much about that, and I remember getting to a point where I was like, "Why isn't this a class, a required class, in high school, college, and beyond. It should be part of onboarding at every job. So I guess that's my answer. I don't think I'm quite qualified to teach it, but I'd love to attend it. [00:25:14] Lindsey Dinneen: There you go. You can facilitate it. How about that? [00:25:16] Katie Bochnowski: Yeah. [00:25:17] Lindsey Dinneen: Excellent. Excellent. Yeah, and how do you wish to be remembered after you leave this world? [00:25:24] Katie Bochnowski: Oh, this is the hard one for me. I think it's probably a cliche answer, but just, you know, caring for others, doing things for others, being kind-- just being a good person... [00:25:38] Lindsey Dinneen: Yeah. [00:25:38] Katie Bochnowski: ...is really all I want. [00:25:40] Lindsey Dinneen: Yeah. Very nice. And then final question. What is one thing that makes you smile every time you see or think about it? [00:25:50] Katie Bochnowski: Oh, this is also gonna be probably a common answer--my daughter, my daughter, who is six, going on 16, very much a teenager, but I remember a friend of mine telling me 'cause I remember asking her, when your child grows up, isn't it so sad that, oh, they're no longer a baby, they're no longer one, like to see them grow up. And she said, "Well, maybe a little bit. Each stage is something so new that you're so proud of, of what they've developed and grown that you don't even really think about that." Oh, and it's so true. It's just seeing her read and seeing her-- she's going to be a future leader. I guarantee it. [00:26:27] Lindsey Dinneen: Yay! [00:26:28] Katie Bochnowski: Just the way I've seen her, and so just seeing that, that pride overcomes any kind of, oh, I miss that one. But, of course, I still miss her when she was a baby. But, yeah, so that makes me smile. That and yoga! [00:26:42] Lindsey Dinneen: Yes. Yoga is so wonderful. I mean. Yeah. And speaking of ways to help de-stress, calm down a bit. Yeah. [00:26:51] Katie Bochnowski: It has helped me dramatically, for sure. So... [00:26:53] Lindsey Dinneen: Excellent. Excellent. Well, it has been a true pleasure and honor to have you here today, Katie. So thank you so much for spending a little bit of time, and 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, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success. [00:27:33] Katie Bochnowski: Thank you for having me. This was awesome. I appreciate it. [00:27:37] Lindsey Dinneen: Awesome. And yeah. Thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you shared an episode with a colleague or two, and we'll catch you next time. [00:27:52] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Superpowers for Good should not be considered investment advice. Seek counsel before making investment decisions. When you purchase an item, launch a campaign or create an investment account after clicking a link here, we may earn a fee. Engage to support our work.Watch the show on television by downloading the e360tv channel app to your Roku, LG or AmazonFireTV. You can also see it on YouTube.Devin: What is your superpower?Justin: What I try to do is…bring that authenticity to our clients in everything that we do.Success in crowdfunding isn't just about having a great product or service—it's about building a community that rallies behind your mission. This idea was central to my conversation with Justin Starbird, CEO of The Aebli Group, in today's episode. Justin highlighted that the real “silver bullet” for a successful crowdfunding campaign is the strength of an engaged community.“From our experience, a lot of times that secret weapon…is the community that they have amassed around their mission,” Justin explained. He emphasized that mission-driven companies often have an edge because their stories resonate deeply with their supporters, creating a foundation for passionate engagement.Justin shared how his team works with companies to authentically communicate their vision and values in ways that connect with people. “It's really important to be able to tell a story that's compelling, that's authentic, that's true to who they are,” he said.Justin and his team recently worked with Organic Transit, a company bringing back its innovative solar-electric bicycle, the ELF. The company's founder, Rob Cotter, turned to crowdfunding after a challenging bankruptcy. With The Aebli Group's help, Organic Transit is now raising funds on Wefunder to scale its ELF 3.0—a modernized, Eco-friendly version of its original product. Justin noted that the campaign's success is rooted in the loyal community Organic Transit had already built, which helped them pre-sell over 800 vehicles and log 10 million miles.Through storytelling, community engagement, and a focus on authenticity, Justin and his team enable mission-driven companies to thrive. “At the end of the day, it's still the mission, the vision, the goal of the company, and their authenticity,” he said.By building campaigns that connect with communities, Justin and The Aebli Group are transforming crowdfunding into a powerful tool for both raising capital and creating meaningful change.tl;dr:Today's episode explores how mission-driven storytelling creates community engagement for crowdfunding success.Guest Justin Starbird shares insights on building authentic marketing campaigns that resonate with investors.Justin describes working with Organic Transit to revive its solar-electric bicycle, the ELF 3.0.The Aebli Group uses authenticity to help startups foster trust and build meaningful connections.Justin's superpower, authenticity, is key to creating campaigns that leave lasting impacts.How to Develop Authenticity As a SuperpowerJustin's superpower is authenticity. He described it as being unafraid to share hard truths with clients and always striving to leave things better than he found them. “What I try to do is…bring that authenticity to our clients in everything that we do,” he explained. Justin emphasized that authenticity fosters trust, builds communities, and ensures long-term success for businesses.Justin shared a personal analogy to explain his approach to authenticity. He recalled hiring a yard-cleaning service and finding a Coke can left in the brush after they finished. Though small, the oversight eroded his confidence in the team's attention to detail. That lesson shaped Justin's ethos at The Aebli Group: always go the extra mile. By doing the “small things” right, like addressing potential blind spots, his team ensures their campaigns resonate with clients and communities.Tips for Developing Authenticity as a Strength:Be Vulnerable: Acknowledge weaknesses and lean into them to foster genuine connections.Address Blind Spots: Identify potential risks or challenges and confront them openly.Focus on Community: Build trust by staying true to your values and mission.Always Go the Extra Mile: Pay attention to small details that demonstrate care and commitment.By following Justin's example and advice, you can make authenticity a skill. With practice and effort, you could make it a superpower that enables you to do more good in the world.Remember, however, that research into success suggests that building on your own superpowers is more important than creating new ones or overcoming weaknesses. You do you!Guest ProfileJustin Starbird (he/him):CEO and Founder, The Aebli Group (pronounced ABE-Lee)About The Aebli Group: At The Aebli Group (TAG), we help innovators, founders, and established companies plan, execute, and optimize crowdfunding campaigns that build community, humanize your brand, and drive sustainable growth. Crowdfunding campaigns require a unique blend of strategy, storytelling, and platform knowledge. Companies choose us because we:Have deep experience navigating crowdfunding platforms and have led multiple successful campaigns by understanding how to leverage each platform's unique audience and dynamics Combine marketing strategy with human-centered engagementHelp clients avoid pitfalls while maximizing funding potentialTurn campaigns into long-term growth engines, not just one-off eventsOur clients have successfully raised millions of dollars, validated new products, generated media coverage, and built lasting communities.Website: aebligroup.comCompany Facebook Page: facebook.com/AebliGroupBiographical Information: Justin Starbird is the CEO and Founder of The Aebli Group (pronounced Abe-Lee), a full-service marketing agency focused on assisting founders in the crowdfunding space. Additionally, TAG is an experienced B2B marketing agency that specializes in the medical device, medical technology, and manufacturing industries. He has built his company into an industry leader by focusing on the details that help push clients to the next level. Most recently, Justin and the TAG Team launched the TAG Awards. The inaugural TAG Awards will spotlight the MedTech and Healthcare sectors, underscoring The Aebli Group's long-standing commitment to driving success in these essential industries. With advancements in medical technology and healthcare delivery shaping the future of patient care, this focused awards program aims to honor the companies, products, and leaders redefining the standards of excellence in these fields.Justin is also dedicated to his community and has been recognized with the prestigious “Spirit of America” and “Local Hero” awards for his volunteerism and philanthropy. Today, Justin lives in Maine with his loving wife, two beautiful daughters, and two dogs.LinkedIn Profile: linkedin.com/in/justinstarbirdPersonal Facebook Profile: facebook.com/justin.starbirdSupport Our SponsorsOur generous sponsors make our work possible, serving impact investors, social entrepreneurs, community builders and diverse founders. Today's advertisers include FundingHope, and BabyQuip. Learn more about advertising with us here.Max-Impact Members(We're grateful for every one of these community champions who make this work possible.)Brian Christie, Brainsy | Cameron Neil, Lend For Good | Carol Fineagan, Independent Consultant | Hiten Sonpal, RISE Robotics | John Berlet, CORE Tax Deeds, LLC. | Justin Starbird, The Aebli Group | Lory Moore, Lory Moore Law | Mark Grimes, Networked Enterprise Development | Matthew Mead, Hempitecture | Michael Pratt, Qnetic | Mike Green, Envirosult | Dr. Nicole Paulk, Siren Biotechnology | Paul Lovejoy, Stakeholder Enterprise | Pearl Wright, Global Changemaker | Scott Thorpe, Philanthropist | Sharon Samjitsingh, Health Care Originals | Add Your Name HereUpcoming SuperCrowd Event CalendarIf a location is not noted, the events below are virtual.Superpowers for Good Live Pitch, December 11, 2025, at 8:00 PM Eastern / 5:00 PM Pacific, will bring together four mission-driven founders—Fran Maier (BabyQuip), Farooq Zama (CureValue), Andrei Evulet (Jetoptera), and Erin Martin (Pump For Joy)—as they present their companies live to a national audience on e360tv, YouTube, and LinkedIn. Hosted by Devin Thorpe, CEO and Founder of The Super Crowd, Inc., this special broadcast showcases entrepreneurs raising capital to solve real-world problems across family travel, healthcare access, disaster response aviation, and maternal health. Viewers are encouraged to watch the live pitches and then continue the experience by joining the Private Investor Session immediately following the broadcast, where attendees can engage directly with founders, ask deeper questions, and explore their active investment offerings in a focused, off-air environment. Whether you are an active investor or simply interested in the future of mission-driven innovation, this event offers a rare opportunity to witness purpose-driven companies in action and connect with them directly after the show.Impact Cherub Club Meeting hosted by The Super Crowd, Inc., a public benefit corporation, on December 16, 2025, at 1:30 PM Eastern. Each month, the Club meets to review new offerings for investment consideration and to conduct due diligence on previously screened deals. To join the Impact Cherub Club, become an Impact Member of the SuperCrowd.SuperCrowdHour, December 17, 2025, at 12:00 PM Eastern, will feature Devin Thorpe, CEO and Founder of The Super Crowd, Inc., leading a session on “Designing a Winning Marketing Strategy for Your Investment Offering.” Drawing on his deep experience in impact crowdfunding and investment storytelling, Devin will break down the essential elements of building a marketing strategy that attracts, engages, and converts potential investors. Participants will learn how to identify and reach the right audience, craft messages that build trust, and develop a promotional plan that supports sustained momentum throughout a raise. Whether you're preparing for your first regulated investment crowdfunding campaign or looking to strengthen an ongoing one, this SuperCrowdHour will provide the insights and practical frameworks you need to elevate your offering and boost investor participation.SuperGreen Live, January 22–24, 2026, livestreaming globally. Organized by Green2Gold and The Super Crowd, Inc., this three-day event will spotlight the intersection of impact crowdfunding, sustainable innovation, and climate solutions. Featuring expert-led panels, interactive workshops, and live pitch sessions, SuperGreen Live brings together entrepreneurs, investors, policymakers, and activists to explore how capital and climate action can work hand in hand. With global livestreaming, VIP networking opportunities, and exclusive content, this event will empower participants to turn bold ideas into real impact. Don't miss your chance to join tens of thousands of changemakers at the largest virtual sustainability event of the year.Community Event CalendarSuccessful Funding with Karl Dakin, Tuesdays at 10:00 AM ET - Click on Events.CfPA President-elect's Vision for 2026 with Brian Belley, December 17 at 2:00 PM ET – reserve your spot now!If you would like to submit an event for us to share with the 10,000+ changemakers, investors and entrepreneurs who are members of the SuperCrowd, click here.We use AI to help us write compelling recaps of each episode. Get full access to Superpowers for Good at www.superpowers4good.com/subscribe

HSBC Innovations is the global bank's financing arm for American and European startups, especially in the healthcare and life sciences industries. The bank's semi-annual Venture Healthcare Reports document trends in the investment market.Key Tech's Andy Rogers welcomes the report's author, HSBC Innovation Managing Director Jon Norris in Episode 43 of the MedTech Speed to Data podcast.Need to know·       Four core market segments — HSBC Innovation's Venture Healthcare Reports cover investments and exits in Biopharma, Dx/Tools, Med Device, and Healthtech.·       Sourcing investment data — Norris enriches Pitchbook data with additional structure and analyses, making the report more relevant to these market segments.·       Sourcing exit data — Norris supplements media and industry publications with market research and conversations with industry leaders.·       An investment data tapestry — The reports provide “an honest picture of what's going on in the market” so investors and innovators alike “can make targeted smart decisions.”The nitty-grittyAndy and Norris discuss the investment market's recent history before exploring drivers of today's investment headwinds.“2021 was a record-setting year,” Norris recalls. “Every record that could be set for deals and dollars was set across all the sectors.” Things changed in 2022 as new BioTech IPOs struggled, prompting investment reprioritizations.“VCs had done all these… frothy valuations,” Norris says. “They had to go back and look at their own portfolios and say, does this company have enough capital? How do you want to put money to work?”Investments rebounded in 2024, but not the number of deals. Investors poured money into their existing portfolios to boost their exit chances, resulting in today's nine-figure megadeals.“Basically, they're smooshing two rounds together and extending the investors coming in to support that round,” Norris says.Headwinds stiffened in 2025 as tariffs, a more litigious competitive space, and other factors amplified business uncertainty.Norris attributes this progression to the psychology of venture capital. “When you think about what makes these folks tick,” Norris explains, “they want to continue to raise new venture funds because they get paid management fees. But in order to raise their new venture funds, they have to show their investors that they've actually gotten returns.”That means reaching an acquisition or IPO. “They're very focused on getting to exit right now. That's why they're so focused on their existing portfolio. And because of that, they haven't been doing as many new investments.”New investments still happen, of course, but the criteria have changed. “While the dollars are actually up in some of these sectors, especially Med Device,” Norris says, “you're seeing that being put to work on later-stage deals because they'd rather get a shorter time to exit.”Data that made the difference:Norris' insights from the HSBC Venture Healthcare Report let him advise startups fighting today's investment headwinds.Adopt a megaround mentality. “Series B has been extremely difficult,” Norris says. “[Raising] sub two million, that's one thing. But if you're looking to raise five million, it's almost better to raise twelve.”Find investors outside the mainstream. “Traditional venture investors don't want to write small checks.” Norris sees angel groups, innovation centers, and other small investors funding these early rounds.Explore acquisition exits, but be careful. “On the device side, most of the corporates have been pretty darn active,” Norris says. However, some litigate to block emerging competition, especially in the Dx/Tools sector. Norris' recommends researching potential acquirers before taking meetings.Download the HSBC Venture Healthcare Report for Norris' complete analysis, and watch the video below for insights into the Medical Device and Dx/Tools sectors, AI's role in MedTech, and more.

In this episode of Medsider Radio, we sat down with Andrew Holman, MD, CEO of Inmedix. Inmedix is commercializing CloudHRV, an FDA-cleared diagnostic that quantifies biological stress with clinical precision to guide treatment decisions in autoimmune disease and beyond.Andrew is a practicing rheumatologist in Seattle with 25 years of clinical and research experience. His discoveries linking autonomic dysfunction to autoimmune disease outcomes led to a $10 million patent sale to Boehringer Ingelheim. After a decade in retirement, he returned to found Inmedix and pioneer the field of immuno-autonomics — preparing the market for his technology years before launch.In this interview, Andrew shares how to build a category before commercializing a product, why clinical evidence creates competitive moats that money can't replicate, and how to raise capital from angel investors by understanding what they actually care about.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 Andrew Holman.

Dr. Yuan Li, Director of Medical Business at DQS and a former medical device auditor with deep expertise across orthopaedic manufacturing and regulatory systems.In this episode, we discuss the sweeping regulatory transition coming to the U.S. with the introduction of the Quality Management System Regulation (QMSR), which formally aligns 21 CFR Part 820 with ISO 13485. Yuan unpacks what this shift means for U.S.-based manufacturers, why FDA is phasing out the QSR audit model and why contract manufacturers and software-based device firms are particularly vulnerable if they delay planning.We also explore the growing use of AI in QMS platforms, the pitfalls of template-driven compliance, and why “regulatory fatigue” is no excuse when patients' lives are at stake. From post-market surveillance strategies to paperless QMS migrations and the validation grey zone, Yuan offers pragmatic, deeply informed advice for those navigating FDA audits, ISO certification and international expansionTimestamps[00:02:36] Why QMSR is a Big Deal for U.S. Manufacturers[00:04:09] Key Differences Between 21 CFR 820 and ISO 13485[00:05:09] Why Companies Wait Too Long to Comply[00:07:19] Impact on Contract Manufacturers and Supply Chains[00:08:36] Do You Really Need ISO 13485 Certification?[00:10:18] AI-Generated QMS Systems: Useful or Risky?[00:11:52] Most Memorable Audit Story: Iterative Design Gone Wrong[00:14:46] How to Spot Proactive vs Reactive Post-Market Surveillance[00:17:03] Why Software Companies Struggle with The Regulatory Mindset[00:20:57] What Validation Really Means Under ISO 13485Connect with Yuan - ⁠https://www.linkedin.com/in/yuan-li-phd-3bb14013/Learn more about DQS - ⁠https://www.dqsglobal.com/en/Get in touch with Karandeep Badwal - ⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠Follow Karandeep on YouTube - ⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠Subscribe to the Podcast

Santiago de la Torriente habla en Capital Intereconomía sobre cómo el sector salud viene impulsado por la Inteligencia Artificial, la cuál ya se está utilizando para conseguir diagnósticos más rápidos y precisos y esto ha reactivado el interés de los inversores. Desde Bellevue subrayan las oportunidades en tecnología médica y el renovado optimismo del mercado de cara a los próximos años. En primer lugar, el sector salud ha mostrado un rally muy sólido en las últimas semanas gracias al efecto combinando de la inteligencia artificial, la mejora de la eficiencia en diagnósticos y procedimientos médicos, y un flujo de inversión que vuelve con fuerza. Aun así, desde Bellevue Asset Management insisten en que el recorrido no está agotado: las valoraciones siguen siendo atractivas y existen segmentos, como la tecnología médica y las aseguradoras, que todavía no han expresado todo su potencial. Los acuerdos con la administración estadounidense han demostrado que es posible alcanzar soluciones equilibradas y, sobre todo, que el impacto real será mucho menor del que temía el mercado. El gestor del Bellevue Medtech & Services, Santiago de la Torriente, ha reforzado el mensaje de que más del 90% de los inversores institucionales con los que se reunieron se mostraron alcistas para 2026. De cara a 2026, Bellevue ve un escenario especialmente positivo para la tecnología médica, donde la innovación y la estabilidad del crecimiento superan a buena parte del sector farmacéutico tradicional.

Regulatorik, Geopolitik, Nachhaltigkeit und KI - die Life-Sciences Branche stehen vor einem Strukturwandel. Was heisst das für Marktzugang, Preise und internationale Expansion?

This episode tackles the complex challenge of applying the hardware-centric clauses of ISO 13485 to Software as a Medical Device (SaMD). Adnan Ashfaq, founder of Simply Medica, joins Etienne Nichols to dissect how traditional standards intended for physical manufacturing must be creatively interpreted for the virtual world of software development, where apps update weekly and cloud-based systems evolve in real-time. The conversation zeroes in on the often-muddy areas of production and service provision (Clause 7.5), emphasizing that these clauses are far from non-applicable, requiring a "virtual manufacturing space" mindset.A significant focus is placed on the Software of Unknown Provenance (SOUP), treating these building blocks as purchased components that require robust supplier evaluation and validation, bridging Clause 7.5 (production) with Clause 7.4 (purchasing). The discussion extends to crucial concepts like the Software Bill of Materials (SBoM), the complexity of Agile vs. Waterfall approaches within the standard's framework, and the essential role of the new FDA Computer Software Assurance (CSA) guidance in risk assessment.Beyond production, the experts explore the application of resource management (Clause 6), specifically addressing infrastructure, contamination control (malware/ransomware), and the critical need for a well-documented Design Transfer to Production (Clause 7.3.8) evidenced by a complete software release package, including all 62304 requirements. The episode provides actionable insights for quality and compliance professionals struggling to maintain speed and innovation while strictly adhering to regulatory requirements.Key Timestamps01:45 - The changing landscape: Why traditional MedTech rules struggle with modern software updates.03:50 - Historical context of ISO 13485 and its non-distinction between hardware/software.05:05 - Starting Point: Clause 7.5 (Production and Service Provision) and the "Virtual Manufacturing Space" concept.06:20 - Unpacking Software of Unknown Provenance (SOUP) and its link to Clause 7.4 (Purchasing).08:35 - The necessity of validating the development environment (GitHub/GitLab) and building blocks.11:10 - Applying Clause 4.1.6 (Software Validation) to SOUP items and master validation plans.12:20 - Applicable vs. Non-Applicable Clauses: Sterilization/Cleanliness vs. Installation.13:55 - Clause 4.2.3 (Medical Device File) for SaMD: E-labels, UDI, System Architecture, and SBoM.16:30 - Cybersecurity controls and the manufacturer's responsibility for identifying state-of-the-art standards.17:35 - Defining "Production" for continuously updating software and managing significant vs. non-significant changes.20:15 - Clash of Standards: Agile development, ISO 13485, and the missing documentation for version control risk assessment.21:30 - Clause 6.3 & 6.4 (Resource & Work Environment): Looking at data security, access controls, and contamination (malware/ransomware).24:45 - Clause 7.3.8 (Design Transfer to Production): The need for a formal software release package and the importance of the Software Design Trace Matrix.26:00 - The 16 essential documents needed to meet IEC 62304 requirements.27:10 - Production controls when the user influences the outcome (customizable features,...

Ever wondered what happens behind the scenes when a surgical kit arrives in the operating theatre- complete, sterile, and right on time? Meet Charisse Pulfer, our guest mentor for this episode, who's spent over 18 years ensuring that surgeries go off without a hitch. Charisse is a Loan Kit Coordinator and operations specialist who's seen it all: high-pressure logistics, last-minute emergencies, and the daily dedication it takes to keep patients safe and surgical teams supported. In this episode, she shares real-world stories, practical insights, and the mindset you need to thrive in one of healthcare's most critical (and often overlooked) roles. Tune in to discover:

Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.In this podcast episode, we explore:

In this episode of Medsider Radio, we sat down with Colby Holtshouse, President and CEO of May Health.May Health is developing a minimally invasive ovarian ablation therapy designed to restore ovulation in women with polycystic ovary syndrome (PCOS) and PCOS-related infertility.Before May Health, Colby served as Global Medtech Commercial Lead at Organon, overseeing the worldwide launch of the Jada System following Organon's acquisition of Alydia Health, where she held roles including COO, Interim CEO, and VP of Marketing. She has also held leadership positions at Pelvalon, AccessClosure, Medtronic, and Guidant.In this discussion, Colby shares why early clinical evidence should be built in focused layers rather than oversized, all-at-once trials. She explains how a small, deliberate early launch can reveal the workflow nuances and real-world expectations no study ever captures. And she outlines why founders should define the raise first — and how clarity, preparation, and a deep understanding of strategic partners can dramatically accelerate the fundraising process.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 Colby Holtshouse.

Recently I sat down with two true pioneers of the medical device industry — Gregory L. Peel and David “Dino” Harris Jr. — to talk about the book that's already inspiring the next generation of MedTech talent.Greg's new book, The Pivot Point, captures the stories of 16 African-American trailblazers who built careers in an industry almost no one knew existed when they started. Their stories of grit, door-knocking, resilience, and career pivots are pure gold for anyone in (or trying to break into) medical device sales.In this episode we talk about:• How pioneers navigated being the first in a territory• Why most people still don't know this industry exists• The Mayo Stand test — the real scoreboard for reps• The “door-knock theory” and why rejection is a skill• Why you must build multiple income streams• How a single career pivot can change an entire life trajectoryWhether you're a junior rep, a veteran leader, a transitioning athlete or veteran, or someone trying to break into medical sales — this conversation is a roadmap.RESOURCES

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways.They discuss:- The hidden costs of regulatory failure and how to avoid them- Why early engagement with regulatory agencies is critical- Global regulatory models, including emerging markets like China and the UAE- A clear explanation of UDI and serialization- How regulatory impacts extend beyond compliance teams- The role of LinkedIn and storytelling in regulatory careers- Steven's experience running for the European Parliament and what it taught him about policyTimestamps00:00 – Introduction and Guest Welcome00:38 – The Hidden Costs of Regulatory Failure03:47 – Engaging with Regulators Early05:26 – Global Regulatory Models and Emerging Markets10:07 – Understanding UDI and Serialization15:16 – The Power of LinkedIn and Personal Stories17:11 – Running for European Parliament and Policy Insights21:18 – Conclusion and Contact InformationConnect with Steven O'RourkeWebsite: https://clarifi.fiLinkedIn: https://linkedin.com/in/sorourkdeSubscribe to Let's Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy.Stephen O'Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety.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.

With a background spanning Boston Consulting Group, Novartis and Silicon Valley, Michelle Wu is a leader at the forefront of AI in MedTech. Today, she's the co-founder and CEO of NyquistAI and recognised as one of the top 100 women in AI globally.Michelle believes that successful AI adoption has far less to do with the technology, and far more to do with people. Mindset, culture and clarity matter more than tools - and the companies who get this right will move fastest.With a career shaped by data, strategy and innovation, Michelle offers an honest look at what AI can (and can't) do for regulatory affairs, and how leaders can turn ambition into real impact.Tune in for:Why 86% of leaders are struggling with AIThe three factors every company needs for real adoptionHow to avoid AI fatigue and overloadWhat AI will really change in regulatory careersWhy mindset, structure and data matter more than hypeAnd much more!Want to build real GenAI capability in RA? Apply for elemed's AI Accelerator 2026: a focused programme where RA leaders pilot one workflow inside real work and measure the impact. Request access

In this episode of NucleCast, host Adam Lowther engages in a thought-provoking conversation with Rob Kittinger, a seasoned expert from Sandia National Labs. They delve into the critical role of human factors in nuclear safety and explore the intriguing dynamics of the AI race between the US and China. From the potential pitfalls of human error to the strategic implications of AI advancements, this episode offers a deep dive into the challenges and opportunities shaping our nuclear future. "Other examples of color vision affecting job safety can be found here: https://waggonerdiagnostics.com/pages/law-enforcement "Robert Kittinger, Ph.D. is a Senior Fellow at the National Institute for Deterrence Studies (NIDS). He spent nearly 10 years at Sandia National Laboratories, culminating in the Nuclear Threat Science department and working in Nuclear Emergency Support and Counterterrorism & Counter-Proliferation (CTCP). During his time at Sandia, he was also a 2017 graduate of the prestigious Weapon Intern Program (WIP).Before joining Sandia, Dr. Kittinger spent over five years as a civilian in the U.S. Navy and was part of a five-person tech startup, BookLamp, which was acquired by Apple in 2013. Following his tenure at Sandia, he served as a senior researcher at Amazon and currently holds the role of Chief Research Officer at a MedTech company.Socials:Follow on Twitter at @NucleCastFollow on LinkedIn: https://linkedin.com/company/nuclecastpodcastSubscribe RSS Feed: https://rss.com/podcasts/nuclecast-podcast/Rate: https://podcasts.apple.com/us/podcast/nuclecast/id1644921278Email comments and topic/guest suggestions to NucleCast@anwadeter.org

In this episode, Duane Mancini chats with Holly Cotter, a seasoned regulatory quality and clinical consulting expert in MedTech and co-founder of indieMedTech. Holly discusses the inception of indieMedTech, a platform designed to support MedTech professionals, especially independent consultants and startups, with a robust community and marketplace. The conversation delves into Holly's background in biomedical engineering, her hands-on experiences with regulatory submissions, quality management, and clinical trials, and the significance of community and networking within the MedTech space.Holly Cotter LinkedInindieMedTech WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram and the episode's focus[00:05:15] Discussion on the challenges and opportunities of new regulations[00:10:40] Insights into the importance of confidence and adaptability in the regulatory field[00:15:20] Kavetha's journey and advice for emerging professionals[00:25:00] The role of innovation and collaboration in MedTech advancements[00:35:10] Strategies for professionals to stay relevant and proactiveQuotes:"Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram"Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols"Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha RamKey Takeaways:Insights into MedTech Trends:Regulatory changes are both a challenge and an opportunity for innovation.Practical Tips for MedTech Enthusiasts:Stay updated with regulatory changes and understand their implications.Engage in continuous learning and skill development.Foster collaboration across disciplines to enhance innovation.References:Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight GuruQuestions for the Audience:"What advice do you have for budding Regulatory Affairs professionals?"Reach out to us and let us know what you thought of the episode at podcast@greenlight.guruAlso, if you enjoyed this episode, please leave us a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Greenlight Guru's platform streamlines product development and compliance, making the process more efficient and less risky. Discover how Greenlight Guru can accelerate your product development at www.greenlight.guru.

Send us a textFew people enter the MedTech world because of a personal experience with the technology itself—but for Brent Lavin, that's exactly where it began. At just 23 years old, a CT scan that revealed an urgent medical issue also sparked a lifelong passion for medical technology and its power to save lives. That moment became the foundation of a career devoted to driving innovation in healthcare.Brent's early engineering work revealed an exceptional talent for connecting technical possibility with human need. Over the next two decades, he would lead cross-functional teams through more than 20 successful product launches, three mergers and acquisitions, and hundreds of millions of dollars in portfolio growth. His leadership—marked by curiosity, clarity, and conviction—has earned him accolades such as BD's Director of the Year and the CEO Excellence Award.Today, as Director of Strategic Growth at BD, Brent is responsible for identifying high-impact opportunities for both organic development and targeted acquisitions. Previously, he served as Director of Marketing and Product Management, where he led global teams across multiple disease states to record-breaking revenue growth, even in the face of pandemic-era supply chain challenges.Before joining BD, Brent spent years at GE Healthcare, where he honed his product management and global commercialization expertise, launching next-generation ultrasound systems that achieved over 200% year-over-year growth. His career reflects a rare blend of technical grounding, marketing strategy, and human-centered leadership—built on a mission to deliver meaningful innovation to clinicians and patients worldwide.Beyond the numbers, Brent is known for building high-performing teams and mentoring leaders who thrive in complex environments. Whether he's shaping go-to-market strategies, integrating newly acquired companies, or guiding engineers toward greater clarity and impact, his approach is grounded in purpose: to help people and teams reach their full potential while bringing life-changing technologies to market. LINKS:Guest LinkedIn: https://www.linkedin.com/in/brent-lavin/ Aaron Moncur, hostDownload the Essential Guide to Designing Test Fixtures: https://pipelinemedialab.beehiiv.com/test-fixtureAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us

Charu Roy, Chief Product Officer at Enlil, shares her extensive journey in the software industry, which began in the late 1980s and evolved into her leadership role in medtech. Charu discusses her role at Enlil, where she oversees the development of an AI-powered platform to enhance medical device lifecycle management. She emphasizes the importance of understanding customer needs, fostering team potential, and ensuring cybersecurity in medtech software solutions. With profound insights on her career growth, leadership style, and the technological advancements propelling the industry forward, Charu's story is an inspiring tale of innovation and dedication to improving lives.  Guest links: https://enlil.com/ |  https://www.linkedin.com/company/enlil-inc/ 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 069 - Charu Roy [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 absolutely delighted to introduce you to Charu Roy. Charu is the Chief Product Officer at Enlil, where she leads product strategy, vision, and execution for the company's AI powered medtech development platform. With over two decades of experience building and scaling enterprise software products, Charu brings deep industry expertise in product management, user-centered design, and go to market leadership. Before Enlil, she held senior product roles at industry leaders, including Epicor, Oracle, I-2 Technologies slash Aspect Development, HP and Agile Software, where she drove software innovation across enterprise cloud SaaS and data driven solutions. Known for her ability to align customer needs with business strategy, she is passionate about delivering products that transform complex industries and enable measurable impact. Well, welcome, Charu, to the conversation today. I'm so excited to be speaking with you. [00:01:54] Charu Roy: Thank you so much for having me. I'm very really excited about being here on this podcast. [00:02:00] Lindsey Dinneen: Oh, awesome. Yeah. Well, I would love, if you wouldn't mind starting off by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:10] Charu Roy: Sure. As every other sort of person who gets into the software world, I came in a while back in 1987 to 89, where I did Master's in Computer Science at University of Louisiana. That was my first introduction to America, really. And computer science brought me to the Bay Area where I worked at HP, Hewlett Packard. In those days, it was called Scientific Instruments Division in Palo Alto. And there I programmed robotic hands to, to sort of move that, the vial from samples, drug samples from athletes so that they could get tested for drugs. So, I didn't know the importance of all this. It was my first job. I enjoyed myself seven years, you know, software programming, really, and understood how a large company works. And then slowly I started getting a little bored. So I went on to my next startup and was involved in the same kind of principles that drive things today. So I just sort of built my way up. In terms of the software, I joined different groups, ran consulting services, ran engineering, and sort of worked myself up through the ranks and into sort of more decision making capabilities, and you know, continued to join companies and learn new things and leave them for some better opportunities. So I moved from Hewlett Packard to a startup that was called Aspect Development, which got sold to I-2 Technologies for $9.3 billion in those days. So, you know, I went through that acquisition, trying to understand the market, what kind of software triggers buying, you know-- so sort of just the software aspects of how to sell software, how to develop software, how to deploy it. So in general, I was learning all of the ropes until I came to Agile PLM, which is a company which, very popular company which made it very sort of easy to deploy software, especially software called Product Lifecycle Management. So I was -- here, I was in and out of companies, learning and understanding the world of software until I fell into med device companies being my customers. So med device being our customers meant, you know, a lot more strictness, a lot more process, with the software itself. So here I was trying to now go through those kind of features, trying to understand what med device needed when they were building products. So, from Agile, I went to Conformia. Again, it was the same, it was regulatory product for wine, spirits and pharma --very adjacent to med device. But again, it was the same thing about how to be provide, how to provide a traceable platform where our customers can trace there, the make of the wine or make of the spirit, or make of a pharma drug or make off of med device. All the principles underlying it are the same because it's a regulated product at the end of the day, but so that's how I kind of fell into it, and I enjoyed every bit of that until I got acquired by Oracle. And so I continued at Oracle doing the same thing over and over again; rebuilt the same products again at Oracle in the clouds, and I was managing the old Agile products. So it's an interesting journey where I was, you know, started off as a software programmer. And I didn't know anything about, you know, the use cases until the time I sort of joined Oracle and understood my customers better. And that's how I came in there. And of course I was at Epicor and finally I made my way to Enlil, which is a very small company, and I'm doing the same thing again. It's just with a different set of customers, very small to medium sized companies. So that's how my career sort of spanned 30 years. [00:06:11] Lindsey Dinneen: Wow. Oh my goodness. Well, there is so much to dive into all of that. Thank you for sharing. It's so cool to hear about all of the winding paths that lead us to maybe, you know, where we're meant to be in, in any given season. And yeah, I just love learning about it. So, okay. So I'm curious, you know, way back when did you like growing up, did you always have an interest in computers and computer science? Is this something you knew you wanted to get into? [00:06:40] Charu Roy: Not at all, actually it was a suggestion, and in those days, parents kind of suggested that you be a engineer or a doctor or a chartered accountant. The choices were very limited. And so my father said, "you will do computer science." And I said, "okay." And there I was and there was no, no sort of emotional attachment to any of those professions. And, I liked it well enough to continue, and I found it was easy enough to understand the principles and work at it. So yeah, there was no-- you know, in these days I think kids are training themselves like by seven or eight to program. And I'm seeing, you know, machine language I mean AI, ML, LLMs being taught to seven year olds and sort of trying to shape them, but in those days it was just some very simple choices, I guess. So, yeah, not a very romantic story. I was never programming younger in my younger days, but I think you know, compared to all the choices youngsters have these days, but just fell into it. [00:07:44] Lindsey Dinneen: Sure. Oh, how fun. You know, even though, yes, it was somewhat prescribed for you, at least originally, and I'm so glad that you fell in love and it ended up being a happy place for you because... [00:07:57] Charu Roy: Yeah, and I think I fell in love with the customer, how customers reacted to the software. I didn't fall in love with the software delivery process or anything else, but it was just the way customers said, "oh, I like that. It's gonna make it easier for me to do something. I'm having a tough time tracking it on paper. I just hate it what I'm doing right now, and your software will help." So I think that's a part that makes me feel really pleased that okay it's going into some good hands and it's going to be used. [00:08:30] Lindsey Dinneen: Yes, by people who really appreciate and value what you can contribute, what maybe comes --at this point, I guess-- naturally to you. And so it's, you're able to translate somebody's ideas or dreams into a really tangible solution. [00:08:48] Charu Roy: Yeah. And in fact, somebody's pain points, like they're really sort of, trying their best to use little resources they might have, wasting a lot of time on either tracking something on paper or in emails. And I think those are the kind of pain points that I really like to understand and say, "Hey, will the software help really help your day to day life? Will it make it easier to find things?" I think that's where I find my sort of biggest thrill of when a customer says, "Yes, you shaved off three hours of my time by giving me this efficient system." [00:09:26] Lindsey Dinneen: Nice. Yeah. Oh my goodness. Yes , and the products that you're making are indeed life impacting and make a difference. And that is rewarding because you know that the work you --do all work is important, but it's really fun when you get to know personally the impact that you get to have. [00:09:45] Charu Roy: Right, right. [00:09:46] Lindsey Dinneen: Yeah. Yeah. So, okay, so I'm, I'd love to dive in a little bit more to your current company and role and learn about that, and how you're helping, you're still helping people you know, win through this. [00:10:00] Charu Roy: So, yes, absolutely. Enlil is part of Shifamed, the portfolio. Shifamed invests in med device devices typically, so ophthalmology devices or cardio devices. Enlil came about as an enterprise software company within the portfolio because they realized that they needed some software to throw all their data into, right? So they had early designs, prototype data. They might have had some user requirements, what kind of standards they might have to follow. So all those were floating about, again, in emails and paper. Enlil came in saying that we can store this data more successfully, more cleanly in a structured fashion so that our users can find that data. And this becomes really important as the med device company moves on and tries to apply for regulatory approval at that time, they need all that history and the data behind the device. And they wanna be able to find it easily and present it to auditors. So, Enlil's a structured way of describing all the data that the customer has and being able to find it easily and then run their audits using the data. So it's a very crucial part of their lifecycle, their product lifecycle. And so it's really important for us to be secure, reliable, available, 24/7. All of that applies to us and basically defines how they go about driving their product lifecycle. [00:11:34] Lindsey Dinneen: Yeah. Well, and you know, one thing that stood out to me when you were talking about that was of course the security aspect. And as we all know, we're, we're probably much more so than in the past, hyper aware of the critical need for cybersecurity and the role it plays specifically in medical device technology. And I'm curious if you could speak a little bit more to that particular element. [00:11:55] Charu Roy: Yeah, we have a lot of layers of security, you know, right from the folks who are accessing the software. The software is hosted in a well-known, reputable cloud service environment. So apart from them providing us cybersecurity and access control and everything else, we have another set of layers on top of that. So our users are vetted and they all have a password. People can be invited and not just sort of show up. So, there's a lot of control of what they can see and can do. Every button sort of, you know, has a role behind it or a layer of control. So not everyone can do everything and press any and all buttons. So, security is at many levels. And we also have a lot of audit trails, e-signatures, and so on. So everything is done to protect the data, and audits are run regularly by them and by us to make sure that nobody who's supposed to be, you know, people who are not supposed to see the data, don't see the data. [00:13:01] Lindsey Dinneen: Yeah. Excellent. Yeah, I know that's just something that is, should be at least, on the forefront, especially of startups' minds as they're thinking about this and working towards having a really secure device. So it sounds like you've built in all of that safeguarding really well and really intentionally. So, so, okay, so I know that -- well, there's a few things that really stood out to me on your LinkedIn profile, and I'm just curious if we could dive into a couple things. One was, I love how you said that you're "passionate about teams and people delivering to their full potential," and I was wondering if you could speak a little bit more to that. [00:13:42] Charu Roy: Yeah, so, you know, along the years I've noticed that people in my team, the team members, they're there, they're working hard, but I do like to understand what's making them tick, what might they be wanting to do, which they haven't got gotten to do yet. Can we unlock some potential, some skill, some talent? And I think that comes about by sort of just talking about it , trying to give them openings about, "Hey, look, I've got this cool project or this cool feature. Any thoughts on that?" Just to understand, are they happy doing what they're doing, or is there something more they could do? And so I think that human touch, you know, is -- it was given to me, or at least it was taught to me by some mentors along the way. And I think that's a part that I really like to explore and see how can teams do better, not just in a numbers, not just turnaround features and releases on time, but are they happy doing it? Did they contribute something meaningful along the way? Did they feel they grew in the process? Did they feel they were recognized for some new responsibilities that they may not have stepped up for in some other companies? So that's a feeling I'm trying to always give them and sort of hoping that we contribute to their growth, not just the company and the bottom line. [00:15:02] Lindsey Dinneen: Yeah, that's critical and key,, and really speaks to who you are as a leader. And I'm actually very curious, you know, you mentioned earlier having kind of worked your way up at HP and then, you know, that may be opening some doors for you for of course, your future opportunities, and I'm curious, what has your own leadership journey looked like? Has, does leadership come naturally to you? Have you spent a lot of, you know, time and resources, whatever, developing those skill sets or how did that work for you? [00:15:29] Charu Roy: I think I was thrown into the deep end of the pool several times, you know, like, so I kicked into the pool, so to learn to swim. So similarly I was made to take on responsibility pretty much the very beginning. So I kind of knew that there were certain things expected that I should be doing, can be doing and then this introspection saying that, did I give the right amount of energy to that particular responsibility and did I do well? So just a lot of introspection and being able to understand, did I do well as a leader? But I've been honing it, honing skills. I mean, nothing out of an MBA school, nothing out of, you know, college that helped me. I think it was just about pure interest in psychology, pure interest in humans, you know, just being able to connect and how did I make them feel? How did they make me feel in those interactions? And is that, was that good? Was there something we could do to incorporate more people to get that feeling of ownership or anything? So it wasn't a, you know, by rote or something that I learned in a school. It was more of just sort of. Being thrown into situations where I had to come out of it somewhat gracefully and some somewhat feeling like I had also learned along the way. [00:16:46] Lindsey Dinneen: Yeah. Yeah, that, that's wonderful and incredible. And I think, you know, you mentioned learning along the way, and one thing also that stood out to me was, the recommendations on your profiles are so lovely for you. And two things stood out: they, one thing was somebody mentioned you're always learning, which is a gift in and of itself. And then the other thing was you're always letting others succeed. And that's such a beautiful gift and I'm wondering if you could talk more about both of those as well. [00:17:16] Charu Roy: Yeah, I think it's not about just me being sort of the boss and being able to tell people what to do, though I think success comes from enabling or encouraging the teams to again contribute without any barriers, any levels, or politics. I love the fact that we are in a small company, and I can say safely that, you know, politics --in larger companies there are politics. People are always trying to sort of be showing that they are very valuable. But in a small startup, it's very quickly apparent that there are certain valuable players there and startups, everybody is valuable, right? So I think being able to encourage the team members to do what they think is best for the problem to solve it. And of course, there are reasons why you can't sometimes accept the solution, but the fact that they're thinking about it and the fact they're able to openly express their opinions and say, "No, you're wrong, Charu." I think this is the way to do it. I love that. I think, somebody disagrees with me in a meeting, I just think that's the best thing that could have happened as a style of management. Because I'm not, you know, insecure in that sense. I don't sulk afterwards. I have had bosses and so on who don't like that kind of, you know, disagreements in public. And I think that's a part where I beg to differ, and I want to have people say what they think, what are they feeling, what are the problems, really the truth, and fix it, really. So I think it's less waste of a time when people are honest, and get to the point, and we are able to solve it together rather than hide behind, you know, facades, I guess. [00:19:01] Lindsey Dinneen: Yeah, that's beautiful. And yeah, I've often said for me personally, that, you know, more heads are better than one. I mean, I could have a, an opinion on whatever it is that we're talking about, but really, until we collaborate and start sharing those ideas and those thoughts and opinions , all of a sudden those kinds of sparks happen where, you know, you start with one thing and then it, and then somebody else catches that and they take it even to the next level and it just keeps going. And it's so cool to see the creativity and problem solving and innovation that comes from allowing those conversations. [00:19:36] Charu Roy: Yes, exactly. Creativity and innovation. You've said it so well. That comes with smart people being in the same room, arguing, not agreeing, and then something comes out of that, right? I mean, either your thoughts get clearer because you've seen every side of the coin and you're able to say, "Okay, I know the pros and cons and we can go this way, knowing the full effect of what we are going to do." So I think surrounding myself with smart people who have varied opinions, I think that's a beauty and a blessing really. [00:20:12] Lindsey Dinneen: Yes it is, and you've nailed it with varying opinions. You know, it's easy to get yourself into a situation-- and not necessarily intentionally-- but just it's easy to give into a situation where you've surrounded yourself with people who all kind of have the same opinions on things. And so inviting those conversations to take place that might be difficult, might be challenging, might be frustrating at times, but allowing for that and being open to other points of view and experience. I mean, that's the beauty of a really good collaborative environment is all of those varying opinions that don't necessarily match yours. [00:20:50] Charu Roy: Yes, exactly. Exactly. [00:20:52] Lindsey Dinneen: Yeah. Yeah. So, okay, so looking back, could 10-year-old you have ever imagined where you'd end up today? [00:21:00] Charu Roy: No, absolutely not. I thought I wanted to be a doctor or something vague. 10-year-old me was climbing trees and eating guavas off the trees in Delhi. So it was really crazy childhood. And you know, it wasn't filled with studies and rules and stuff. So I think coming to this, a country when I was young, being able to absorb everything, the culture, the of course the education itself and being able to sort of grow within the companies that I joined, i, I think that was the journey that I was sort of a pointing more towards rather than the childhood me. The childhood me was horrible, I think. [00:21:46] Lindsey Dinneen: Oh man. Honest reflection right there. That's awesome. Yeah, okay. Are there any moments that really stand out to you, perhaps with your current position or, you know, something in your past where you really thought, "Wow, what I'm doing makes a difference. I am in the right industry, at the right time, in the right place." [00:22:07] Charu Roy: I think it's the technology now that, you know, speaking from a technical viewpoint of shipping software, meaning full software, more easily, the time is now. I feel that the culmination of everything I've learned about pain points and users and customers, all of that's culminating in in the product that I'm managing right now, using new technologies, having the right technologies to choose from and being able to propel that software forward to our users. I feel that, "Wow, what a time to be a product officer really, when we have so many choices and being able to be able to apply that to real world problems and real pain points." I had the same pain points 20 years ago, even 30 years ago, but we couldn't do much. We had to, you know, write painful programs. We had to write database queries and, you know, things like that. It was quite painful, I would say. And then now to see all the tools where we can create things overnight and be able to ship it to customers, just hitting the nail on the head. We had to experiment a lot in the old days but I think the time now is is really special. We are on an sort of an industrial revolution or a computer science revolution here with the AI, MML, the LLMs, being able to do so much with probably less resources than before. So. [00:23:39] Lindsey Dinneen: Yeah. So seeing the impact of the work and getting to not have it be so painful. [00:23:45] Charu Roy: Yes. It used be very painful and now I'm thinking, I think we're at the right time, right place now with this product. And it's not just about the products. It's the kind of help we are getting as software professionals to help deliver software and support our users. I think that's really special and I, we are still learning, we're still trying to understand all the technologies that are available to us and how can we make our lives easier and our customers feel that we've solved some problems for them. [00:24:14] Lindsey Dinneen: Yeah, absolutely. And I think that there's just, it is really wonderful again-- just to, to circle back to this kind of been a running theme of getting to be able to experience for the end user or with the end user, that moment of, "Oh wow, I needed this is so helpful and it's gonna make a difference." [00:24:36] Charu Roy: Yeah. I remember in my past, same sort of software tracking wine being made. And that software was pretty cool. It, it used to track where the wine sat and which barrel for how long. And so the pleasure of talking to wine makers, and being able to show them how the software track the progress of the wine and being able to print out a label at the very end for them, saying that "this wine sat in these bottles or these barrels for a while," and that technology application for a simple, naive user, I thought that was it. That was the, you know, the culmination of all the learnings that I had over the years to be able to explain the software so easily to a end user who might be a distiller or a winemaker or somebody, a farmer. I thought that was pretty cool. And that since then, of course, technology has changed, but I think we're beginning to see the effect on a naive user, which we couldn't do, you know, 30 years ago. [00:25:37] Lindsey Dinneen: Yeah, absolutely. Oh my goodness. That is, it is so cool. And I love the work you're doing and just learning all about your history so far and just exciting to see where it's gonna end up too, and as you continue along your career path, but 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, could be within your area of expertise, it doesn't have to be. What would you choose to teach? [00:26:06] Charu Roy: I would probably think about teaching psychology of the individual. I don't have a PhD or a even basic courses in psychology, but I just love the fact that, you know, you can apply psychology, figure out how a user might or somebody might react to something that you say, do, think so I, if it was a master class and I'd be teaching you know, teaching more about life interactions, you know, ordinary interactions. How can they be made more meaningful, more fruitful, using psychological tricks or phrases? I don't know all of those things, but I would really think that I could teach that based on, you know, facial expressions, body mannerisms, or body-- what do they call it, sort of, you know, criminal stories. They read your mind based on certain mannerisms of flutter viol. So yes, psychology is a masterclass I would teach, but more applied to daily interactions, maybe work situations and being able to use psychology better to improve your own work relationships with people and even just general interactions. Yeah, so that would be my attempt at being a psychologist and eventually be a criminal psychologist. [00:27:28] Lindsey Dinneen: Yes. Oh my goodness. That would be so interesting. Yeah, I love that idea. And the masterclass sounds fabulous, so I'm signing up whenever you do it. [00:27:37] Charu Roy: Okay, I'll go get my degrees for it then. [00:27:40] Lindsey Dinneen: Right, right, right. Yeah. Ah, details. Awesome. How do you wish to be remembered after you leave this world? [00:27:50] Charu Roy: This is something that I've always felt deeply about. It's not what you say or what you do, it's how you make people feel, that Maya Angelo said that this much nicer than what I'm saying, but and I've had a few people say this to me, saying that, "We worked together 30 years ago, but that day you made me feel good." And I don't even remember what I said, what I did, but the fact that they remember me for what I made them feel. The fact that somebody also told me that they "don't avoid me when I'm walking up to them because, because I make them feel like things are okay, things are good, however bad the problem is." So they say that with other people they would duck and, you know, go away in the opposite direction. But with me they're waiting for me to come up to them. I'd like to continue that, that feeling that somebody feels like, "Hey, you are coming up to them and you just make them feel good in some fashion." Nothing else. I think that feeling, if I could evoke in people, they say, "Oh yeah, she made me feel good that day. I don't know what she said, but she made me feel good." That's enough. [00:29:01] Lindsey Dinneen: Yeah, that, yes, that is more than enough. What a beautiful legacy. Yeah, and then final question, what is one thing that makes you smile every time you see or think about it? [00:29:15] Charu Roy: I think my dogs smile. I would say he's got missing teeth and so when he looks at me when I first come, you know, come back home and he is smiling almost, and he is sniffling and, you know, trying to sneeze and smile at the same time. Oh my God, what kind of a character dog this is? So that makes me smile and laugh the whole time, especially the missing teeth. Poor thing. He doesn't understand that his teeth are missing because of me, and yet he's smiling at me, so. [00:29:50] Lindsey Dinneen: That is so sweet and cute. Oh my goodness. I love, I know somebody at one point said, "You know, dogs don't actually smile." I don't believe them. They smile. [00:30:00] Charu Roy: They smile and they choke while they smile because my dog has a small nose, I guess. So he chokes when he smiles, and so he is choking, and he is smiling, and this missing teeth there. I was like, "Oh my God." [00:30:16] Lindsey Dinneen: Oh my goodness. Yes. I mean, that would just I, yes, I can just sort of picture this. I love, love dogs and so I'm just picturing this and I, that would bring me joy every single day, definitely. Excellent. Well, this has been such a wonderful time spent with you today. Thank you for sharing your stories and your journey and your advice, and I really appreciate some of those in particular, your leadership advice, and the impact that you can have as a leader, inviting the collaboration, having conversations that encourage people to have varying opinions and maybe outright disagree with you. I love what you're wanting to, you know, wanting your legacy to be, and so that's how you're intentionally showing up in the world. And so I just wanna thank you so, so very much for being here. We're really grateful to have you. [00:31:10] Charu Roy: Thank you, and thank you so much for your intelligent questions and insightful questions that go above and beyond just you know, a company and it's gold. It's there, there's something so human about your questions-- and I love when I'm like, "Oh my goodness, this is so, so interesting to see in this day and age, somebody taking the time to ask such questions" and I really appreciate you for that. [00:31:36] Lindsey Dinneen: Oh, thank you. Well, I really appreciate that feedback too, because it's, you know, you come up with an idea-- speaking of sometimes echo chambers, you come up with an idea and you think, "Oh, this is how I'd like to go about this, but does it resonate with somebody else?" So that's delightful to hear. [00:31:51] Charu Roy: Fantastic, thank you, thank you for having me. [00:31:54] Lindsey Dinneen: And we're so 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. So thank you for choosing that organization to support Thank you so much, and gosh, I just wish you the most continued success as you work to change lives for a better world. And to all of our listeners for tuning in, I wanna thank you for being here as well. 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. [00:32:31] Charu Roy: Thank you. [00:32:32] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.Will we need to retest everything?Is this a complete game-changer, or just an evolution?How will Notified Bodies and the FDA react?In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi hosts Marina Daineko, biocompatibility consultant at Intrinsic Medical Group, to unpack what's really coming.This episode covers:The background and current status of the ISO 10993-1 revisionWhy the new version is best seen as an evolution, not a revolutionHow the standard pushes further into a risk-based, scientifically justified approachThe link with ISO 14971 and lifecycle thinkingChanges in contact categorization and cumulative exposureThe industry trend toward reducing animal testing through in vitro methods and data-driven justificationHow to conduct a gap analysis once the new standard is publishedPractical advice on how to prioritize updates without freezing projects or panickingReal-world examples where process chemicals, not base materials, changed the risk pictureHow Intrinsic Medical Group supports companies with biological evaluation, cleanliness, sterilization and reusable devices

Dans cet épisode sincère et éclairant d'Au-delà de la thèse avec Papa PhD, David Mendes reçoit Marc-André Hachey, ingénieur mécanique et ancien doctorant en micro-fabrication. Marc-André partage avec authenticité son cheminement académique, les réflexions qui l'ont conduit à quitter son doctorat, et comment il a trouvé un nouvel élan professionnel dans le secteur de la MedTech. Ensemble, ils abordent des thèmes essentiels pour la communauté des chercheurs : le syndrome de l'imposteur, la santé mentale aux cycles supérieurs, la quête de sens dans les études, et la transition vers l'industrie. Un épisode riche en conseils pour celles et ceux qui envisagent une réorientation après le doctorat.

This week Liz is joined by Trey Morton, Senior Director, Professional Education and Sales Training, and, as his LinkedIn rightly proclaims, "All-around Awesome Guy." Liz and Trey discuss what companies need to consider about training their sales forces as they add products to their portfolios. They discuss when to pull sales reps out of the field for in-person training, the balance between clinical training and sales training, and the importance of aligning and setting expectations with senior leadership. Listen in and get ready for your next product launch!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:Trey Morton is the Senior Director of Education in the life sciences industry. His passion for training began as a Combat Infantry Officer in the US Army, where he learned a cycle of “learn, do, teach.” Combining that experience with various roles in sales management and marketing led him to an outcomes-focused training philosophy.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: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Trey Morton⁠⁠⁠⁠⁠Cumby 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.

This week Liz and Rachel dive into their conversation with Trey Morton on building training programs for your expanding product portfolio. They discuss the benefit of utilizing physicians to teach this new content to both physicians and reps as well as important watchouts to ensure it remains authentic and effective. In addition, they look at when, why, and how to pull reps from the field for training, and creative solutions to meet the needs of already busy reps.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:Interview with Trey MortonSubscribe 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.

The UK Investor Magazine was thrilled to welcome Dan Daly, Founder & CEO of Occuity, and CCO Mark Jenkins to delve into Occuity's eye scanning disease detection technology.Find out more about Occuity on Republic here.Occuity is developing handheld, non-contact devices that use the eye as a window to the body's health.The company's patented optical technology already addresses glaucoma and myopia, while future products will target disease screening and, ultimately, a non-invasive glucose meter for diabetes monitoring.Occuity enables screening of glaucoma, myopia and diabetes through optical MedTech backed by 15 patents and £4 million in grant funding. Its first product is selling globally through 19 distributors. The company has established a proven platform with a strategic pipeline of products in development.The company has been busy forging commercial partnerships and is well placed to push forward with its growth strategy on the completion of their current fundraising round. Hosted on Acast. See acast.com/privacy for more information.

In this episode, Duane Mancini interviews Allison Komiyama, a former FDA reviewer turned successful entrepreneur, who shares her journey from her early passion for biology, through her academic achievements in molecular cell biology and neuroscience, to landing a role at the FDA. She recounts the challenges and lessons learned starting her own regulatory consulting business and scaling it to a successful acquisition. The conversation delves into her latest venture, Bluestocking Health, a medtech hype company aimed at educating the public and professionals about medical technology. They discuss the importance of understanding the FDA's role, navigating the complexities of bringing new tech to market, and the significance of promoting and celebrating medtech innovations.Allison Komiyama LinkedInBluestocking Health LinkedInBluestocking Health Website“Your Life Depends on It” Book by Talya Miron-Shatz, PhDDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes, manage project risks, and drive innovation to enhance patient care.Key Timestamps:00:00:15 - Introduction of Perry Parendo and the episode's focus00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles00:12:20 - Agile methodologies vs. traditional project management in MedTech00:22:35 - The importance of risk management and Monte Carlo simulation in project planning00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities00:45:55 - Strategies for efficient and effective product development processesQuotes:"We're so focused from a compliance point of view on patient and health risk, we're not focused on project risk. And when I worked in the defense industry, we were hugely focused on project risk," Perry Parendo"There's waterfall, there's agile, there's Toyota, there's set based design, and there's APQP in the automotive industry. They're all a blend. There's no organization that's doing purely the theoretical of any one of those processes," Perry ParendoTakeawaysInsights on MedTech Trends:The convergence of agile and traditional methodologies tailored to MedTech's unique demands.The rising importance of advanced risk management techniques, like Monte Carlo simulations, in navigating project uncertainties.A call for innovation that transcends regulatory compliance to genuinely benefit patient care.Practical Tips for Listeners:Adopt a flexible approach to project management by integrating various methodologies based on project needs.Prioritize risk management early in the development process to foresee and mitigate potential challenges.Always align product development objectives with the ultimate goal of improving patient outcomes.Questions for Future Developments:How will evolving regulatory standards shape the next generation of medical devices?What role will patient feedback play in the design and development of future MedTech innovations?Can MedTech sustain its pace of innovation while ensuring safety and compliance?References:Perry Parendo on LinkedInEtienne Nichols on LinkedInBehavioral Grooves podcast with Annie Duke - Thinking in BetsBook - Someday is Today, Ron RichardYoutube video - the Heartbeat of New Product DevelopmentQuality Culture for Product Design SuccessDesign News Columns

Chris DuPont, a seasoned MedTech engineer, entrepreneur, and co-founder of Galen Data, which was acquired by Matrix One in late 2024. With a background in aerospace software from NASA and a career dedicated to medical device connectivity, Chris shares a rare behind-the-scenes look at starting a cloud platform with just $600, scaling it into an FDA compliant infrastructure solution and navigating both technical and financial risk.In this episode, we dive into the unexpected similarities between outer space and inner space, how “Twiddler Syndrome” inspired a connected care solution and why the future of SaMD relies on proactive, cybersecure, cloud native design. Chris opens up about managing through the SVB collapse, regulatory war stories from his days at Cyberonics, and what he learned about entrepreneurship that no incubator can teach. From minimal viable features to medical-grade quality systems, this episode is packed with real lessons from a founder who's seen it all.Timestamps[00:01:05] From Space Station Freedom to Inner Space: NASA to MedTech[00:02:56] Launching Galen Data with Just $600[00:06:21] Why They Built Their Own Incubator[00:08:36] Fundraising in a Non-VC Town (Houston)[00:11:33] The Silicon Valley Bank Collapse and Business Risk[00:16:25] Twiddler Syndrome and the Birth of a Connected Platform[00:19:35] Cybersecurity and Compliance in the Cloud[00:22:20] FDA Approval Without Reimbursement: A Regulatory War Story[00:24:32] Why Not Every Feature Deserves to Ship[00:29:13] “You Can't Fake Science”: Betting on Yourself in MedTechConnect with Chris - https://www.linkedin.com/in/chris-dupont-38b5ba15/Learn more about MatrixOne - https://matrixone.health/ Get in touch with Karandeep Badwal - ⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠Follow Karandeep on YouTube - ⁠https://www.youtube.com/@KarandeepBadwal⁠Subscribe to the Podcast

Mit einer Unternehmensbewertung von über 4 Milliarden Euro ging Ottobock im Oktober 2025 erfolgreich an die Börse und erreichte damit einen bedeutenden Meilenstein in der Geschichte des weltweit führenden Unternehmens für Prothetik, Orthetik und Exoskelette. Diese Folge wurde noch vor dem Börsengang aufgenommen, der einen Blick hinter die Unternehmens-Kulissen jetzt aber umso spannender macht: Martin Böhm, Chief Experience Officer bei Ottobock, berichtet, wie sich das traditionelle, familiengeführte Unternehmen zu einem digital getriebenen MedTech-Anbieter transformiert hat. Seit über 100 Jahren ermöglicht Ottobock Menschen mit körperlichen Einschränkungen mehr Lebensqualität und Mobilität und widmet sich heute Zukunftstechnologien wie neuronaler Steuerung, KI-gestützten Prozessen und Virtual Reality in der Prothetik und Orthetik. Wie schafft es das Unternehmen, Patient:innen, Ärzt:innen, Sanitätshäuser und Krankenkassen in einem komplexen Ökosystem zusammenzuführen und dabei den Menschen in den Mittelpunkt zu stellen? Martin Böhm gibt spannende Einblicke in innovative Plattformen, digitale Hightech-Prothesen und -Orthesen und Patient:innen-Engagement. Das Gespräch im Überblick: (1:20) Martin Böhm stellt sich vor (5:00) Einblicke in Hightech-Prothetik & -Orthetik (12:10) Marktdynamiken & Wachstumstreiber (15:03) Entscheidungs- & Kaufprozesse im MedTech-Umfeld (28:26) Digitale Plattform-Ökonomie & KI (42:30) Next Level MedTech: 3-Druck, Patient:innen-Engagement & Mental Health

In this episode of Medsider Radio, we sat down with Kaitlin Maier, co-founder and CEO of Reia. Reia has developed a self-managed pessary — a collapsible device that empowers women to treat pelvic organ prolapse comfortably and independently. A mechanical engineering graduate of Dartmouth, Kaitlin previously worked at Sherpa Technology Group, developing patent strategies for leading life science and technology firms. In this conversation, Kaitlin shares how she and her co-founders turned a student project into an FDA-cleared product using resource constraints as a design advantage. She explains how to turn FDA feedback into forward momentum, why running an NIH-funded randomized controlled trial (RCT) strengthened both credibility and confidence, and how non-dilutive funding can buy the time and control founders need to build on their own terms.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 Kaitlin Maier.

Meeting the right people can completely change the trajectory of one's career. In this episode of Medtech Talk, host Geoff Pardo speaks with Stacy Enxing Seng, independent director and venture partner, about her journey from Harvard Business School to SciMed to ev3 and beyond. She delves into the lessons learned, the challenges, and—most importantly—the people that have impacted her illustrious career. She also shares advice on why soft skills are key to acquisitions and integrations, the importance of transparency, and determining the difference between a CEO who isn't the right fit versus a CEO who has room to grow. Medtech Talk Links:  Cambridge Healthtech Institute   Medtech Talk  Gilde Healthcare  Corza Medical Lightstone Ventures   

Join Liz and Rachel as they debrief the conversation with Becky Lai on the journey to standard of care. They dive into best practices for using training to drive adoption, engage KOLs, and create a respected brand.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:https://open.spotify.com/episode/7DjeuGhXtiKaOM0qRoWC46?si=_wI8T6TkQ--ZsIoG2MgzmgSubscribe 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.

In this episode, Duane Mancini, Tino Chow, and Lindsey Dinneen dive into the intricacies of pitching, focusing on both the technical and emotional aspects. The conversation highlights the importance of authenticity, building relationships, and the critical role a cohesive and credible team plays in attracting investors. They share strategies for maintaining consistency across your brand and various pitching scenarios, whether it's a pitch competition or casual networking. Tino Chow LinkedInGiant Shoulders WebsiteLindsey Dinneen LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode of the Global Medical Device Podcast, we're joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding.Quotes"If you're not talking about the value that you add, how is anybody going to know what impact you're having?" - Elena Kyria"Everything's uncertain really, isn't it? What you've got to have is a clear sense of forwards and just have a goal." - Elena Kyria"Nobody goes to the gym and looks at the weights and gets fit. You have to do the reps." - Elena KyriaTakeawaysNetworking is Key: It's not just what you know, but who knows you and what they know you're doing.Visibility of Achievements: Share your successes within your company; if you don't, others may not recognize your contributions.Defining Success: Success doesn't always mean reaching the VP level; it's about personal satisfaction and contribution.Strengths and Weaknesses: Focus on your strengths but be aware of your weaknesses and compensate with your team.Career Paths: Understand the different career paths (leadership, expert, generalist) and what they entail for growth.Communication Skills: Strong communication skills are paramount for leadership and for translating technical details to a broader audience.Continuous Learning: Always seek new knowledge and experiences, no matter where you are in your career.Adaptability: Be prepared to pivot and adapt to changes within the industry and your career.Take Action: Don't just reflect on advice; apply it to make actual changes in your career approach.Reference Links:Elena Kyria's LinkedInElemedWorking GeniusGreenlight GuruEtienne Nichols' LinkedInRemember to engage with the hosts and guests on LinkedIn for feedback and further discussions. Don't forget to leave a review on iTunes!*Interested in sponsoring an episode? Use this form and let us know!

In this powerful first part of a two-part series, host Sharna Southan sits down with Kirsten Karchmer, health tech pioneer, women's health expert, and founder & CEO of Conceivable Technologies. About Our Guest Kirsten is revolutionising women's health through technology. Conceivable was named one of the most innovative health tech startups by MedTech in 2015 and Best Fertility App by Healthline in 2016. She's been featured in TechCrunch, Fox News, and Huffington Post, and recognized as one of the top female startup founders to watch. What You'll Learn in Part 1 Kirsten's Transformation Story: How being diagnosed with MS led her to discover acupuncture and Chinese medicine Her journey from linguistics professor to becoming a fertility acupuncturist Working with over 10,000 women across three clinics over 20 years Your Period as a Health Diagnostic Tool: Why every symptom of your menstrual cycle tells a story about your health How blood color, consistency, volume, and cycle length reveal fertility potential The connection between period health and ability to conceive and stay pregnant The Three Key Factors for Staying Pregnant: Energy levels - Why you need an 8/10 energy level (without caffeine or exercise) Body temperature - The critical temperature threshold after ovulation that most women don't know about Menstrual flow - What healthy bleeding should look like and why clots matter Why Current Medical Approaches Fall Short: The limitations of jumping straight to fertility treatments without addressing root causes How medications like Clomid and letrozole can impact long-term fertility Why the medical system isn't equipped to provide comprehensive reproductive health support Key Takeaways Your menstrual cycle is a monthly report card on your overall health Getting pregnant isn't enough - your body needs to be prepared to stay pregnant Many fertility issues can be addressed through understanding and optimizing your cycle Technology can democratize access to fertility knowledge previously only available to a few Resources Mentioned Conceivable Technologies app Kirsten's book "Seeing Red" The Institute of Healing Through Pregnancy Loss Pregnancy Loss Practitioner Certification Program Don't miss Part 2 where we dive deeper into practical solutions and how technology is changing the fertility landscape. Connect with our guest: Kirsten Karchmer, Conceivable Technologies: www.conceivable.com TikTok @yourfertilityexpert Stan store: HERE IG: @conciveable.official Connect with Sharna: ** Grab the FREE Loss to Purpose Masterclass if you want to learn how to turn your experience into your expertise: https://www.sharnasouthan.com/loss-to-purpose-masterclass ** Apply for the Certification: HERE IG: @instituteofhealing_pl IG: @pregnancylosscertification IG: Podcast: @pregnancyloss_podcast LinkedIn: @sharnasouthan Share screenshots and tag us to show what resonated DM for conversation and support Check show notes for Pregnancy Loss Practitioner Certification application Important Note: This podcast is for educational purposes only and does not constitute medical advice. Please consult with your healthcare provider for personalized medical guidance. Listen on: Apple Podcasts | Spotify For those seeking guidance and support, this episode is a reminder that you are not alone, and there are resources and communities ready to help you through your healing journey. Thank you for tuning in, and if you found this episode valuable, please leave a review on Apple Podcasts. We look forward to supporting you in the next episode.

In this episode of Medsider Radio, we sat down with Somer Baburek, CEO and co-founder of Hera Biotech. Hera is developing AI-driven tissue diagnostics for conditions that disproportionately affect women, including endometriosis and cervical cancer.Before launching Hera, Somer spent nearly a decade in venture capital, where she evaluated early-stage medtech startups and learned what separates the survivors from the rest.In this conversation, Somer explains how Hera designed global clinical pathways that balance cost and credibility, why boutique CROs can outperform big names, and how a pre-commercial startup completed three strategic acquisitions using equity and brand trust rather than cash.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 Somer Baburek.

In this episode of The Lebanese Physicians Podcast, co-hosts Dr. Khalil Diab and Dr. Hamad Ali sit down with Dr. Firas Mahdi, Partner at LEK Consulting in Singapore, to explore the intersection of strategy, technology, and innovation in healthcare across Asia and the Middle East. From his beginnings in clinical medicine at AUBMC to leadership roles at GE Healthcare, Medtronic, and now LEK, Dr. Mahdi shares a remarkable global journey spanning Lebanon, the Gulf, and Southeast Asia. We discuss: How Singapore's hybrid public–private healthcare model achieves world-class outcomes Lessons for Middle Eastern health systems in value-based care and operational excellence The evolving role of MedTech and AI in shaping the future of healthcare Building purpose-driven careers and navigating non-clinical paths in medicine A rich conversation about healthcare transformation, professional reinvention, and the future of global health strategy — where East truly meets Middle East.  

Fixation on Histology: From Professional to Patient, A Med Tech's Organ Donation Journey Written based on the NSH Laboratory Webinar- When Worlds Collide Through Organ Donation To Read the Blog, Click Here. 

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation's stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is that existing international certifications (like ISO and IEC) do not guarantee compliance, requiring local type testing and adherence to specific national standards.The conversation addresses how global medical device companies can structure their strategy amid ongoing geopolitical shifts and the "China for China" policy, which favors domestic products through initiatives like the Volume-Based Procurement (VBP). Strategies such as the dual-strategy approach—localizing low-consumable manufacturing while protecting high-technology IP through joint ventures or careful CMO/CDMO selection—are explored as pragmatic ways to secure market presence and margin. Understanding the regulatory landscape, particularly the NMPA's 2021 overhaul, is crucial for success.Finally, Elaine provides practical guidance for regulatory professionals intimidated by the market. This includes understanding the specific regulatory and clinical pathways, performing a gap analysis against Chinese standards (Product Technical Requirements or PTR), and the critical process of selecting and qualifying a local partner/agent. Elaine reveals a specific, often overlooked hurdle: the agent must possess an NMPA-approved CA (Certification Authorization) USB key to electronically submit registration files on behalf of the foreign manufacturer, a critical piece of the submission puzzle. The discussion also touches on leveraging special zones, like the Hainan Free Trade Zone, for crucial real-world data collection applicable to the Chinese population.Key Timestamps[02:40] Introduction to Elaine Tan, MedTech Chopsticks, and the show's focus on the China market.[05:05] High-level risks and rewards: complexity, lengthy registration, local testing requirements, and IP concerns.[08:08] Discussing the NMPA's 2021 regulatory overhaul and the geopolitical shift toward "China for China."[11:00] The Dual Strategy approach: balancing low-end localization with protecting high-tech IP.[14:48] Using CDMOs/CMOs for pilot projects to manage financial investment risk.[16:20] Leveraging the Hainan Free Trade Zone (Bo'ao region) for pre-market clinical data collection and urgent needs product access.[18:42] Ethological differences and their impact on clinical data justification (e.g., Pulse Oximeters).[20:17] NMPA predicate search: The importance of using the Chinese Classification Catalog to find registered, local predicate devices.[23:00] Guidance for overwhelmed regulatory professionals entering the China market: Clinical strategy and Product Technical Requirements (PTR).[25:52] Pitfalls in partner selection: The necessity of the NMPA-approved CA (Certification Authorization) USB key for submissions.[29:30] Partner qualification: Ensuring the agent can support Post-Market Surveillance (PMS) and QMS self-inspection requirements.[30:52] Final pitfall: International compliance (ISO/IEC) does not automatically ensure China...

Medtech is a $900 billion industry transforming how we treat, diagnose, and prevent disease—but its innovation engine is slowing. Vikram Aggarwal, global leader of BCG's medical technology work, explains what's behind the slowdown and how leaders can rethink regulation, software, and talent to re-accelerate breakthroughs. Learn More: Vikram Aggarwal: https://on.bcg.com/4osjpc6 BCG on Medtech: https://on.bcg.com/3LlJ6MC How Medtech Leaders Are Revving Up Their Innovation Engines: https://on.bcg.com/4op2Rl8 Chapters 00:00-01:25 Introduction/Vikram's ‘So What' 01:26-02:10 What is medtech? 02:11-03:46 Where are some of the most exciting innovations happening in medtech? 03:47-05:36 What areas get the most attention? 05:37-07:33 What are the barriers to innovation? 07:34-08:36 How do software and hardware innovation compare? 08:37-09:58 Software in a medical device vs software as a medical device 09:59-11:40 Is there a lag between innovation in software vs hardware? 11:41-13:41 What is the ideal innovation environment for medtech? 13:42-15:13 How do we fix the STEM skills shortage? 15:14-17:46 What will bring the most value over the next decade? 17:47-19:04 What is happening at startups vs established companies? 19:05 – 20:01 Vikram's ‘Now What' 20:02-20:15 Outro This podcast uses the following third-party services for analysis: Podtrac - https://analytics.podtrac.com/privacy-policy-gdrp