Podcasts about Medtech

(02:20) Pills that communicate from the stomach could improve medication adherence(07:13) Innovative Solutions for Tracking Medication(10:46) The Technology Behind the Smart Pill(13:42) Conclusion and Future Implications This episode was brought to you by Mouser, our go-to source for electronics parts for any hobby or prototype. Click HERE to learn more about making healthcare smarter with electronics. Become a founding reader of our newsletter: http://read.thenextbyte.com/ As always, you can find these and other interesting & impactful engineering articles on Wevolver.com.

In this episode, Duane Mancini sits down with Katie Brinkman to discuss the nuances of biocompatibility, the critical role of biological evaluation plans, and the evolving regulatory landscape, including the importance of risk assessment. Katie also shares her experience with biocompatibility evaluation during significant regulatory changes such as EU MDR remediation and the 10993 standard updates.Katie Brinkman LinkedInHohenstein WebsiteHohenstein Group LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

Are you wondering why your clinically sound medical device still isn't being adopted—even after pilots, approvals, and glowing data?If you're a clinician founder ready to take your MedTech prototype to market, this episode breaks down the overlooked reason most devices fail to gain traction. It's not the product—it's your go-to-market execution. Learn how behavior change, system fit, and implementation science play a bigger role than your evidence ever will.Discover the #1 mistake clinical founders make after running pilotsLearn how to identify all the “whos” involved in adoption—and why missing one can ruin your rolloutUnderstand how to turn barriers into behavior-changing strategies that scale across bordersPress play to learn the proven system for moving your MedTech device from “great pilot” to international success—without wasting cash or time.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

Howard “Hojo” Johnson is one of the most accomplished commercial leaders in medical device sales, known for being the first hire trusted to build markets from zero and scale teams into category leaders. In this episode of the Chase MedSearch Podcast, Howard shares how he helped launch and grow organizations at Nevro and Axonics—turning early-stage companies into national forces in neuromodulation.We dive into what it takes to build high-performance MedTech sales teams, how to lead people through rapid growth, and why servant leadership and belief drive sustainable results. Howard breaks down his approach to hiring elite talent, developing future leaders, executing go-to-market strategies, and avoiding the common mistakes new managers make.This conversation is essential listening for medical device sales reps, managers, and executives who want to scale markets, build winning cultures, and grow long-term careers in MedTech.RESOURCES:

Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes.In this podcast episode, we provide a structured and practical discussion on:The definition and purpose of a DHFKey differences between FDA QMSR and ISO 13485 requirementsHow the DHF concept is addressed within ISO 13485When DHF remediation becomes unavoidableTypical causes of remediation, including accumulated DHF debtHow to remediate a DHF without creating new compliance risksCommon pitfalls and practices to avoidHow to define a realistic and defensible remediation strategyRegulatory communication considerations with:National Competent AuthoritiesNotified Bodies This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way.If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach.LinksRichie Christian Linkedin: https://www.linkedin.com/in/christianrichie/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

In this episode of Medsider Radio, we sat down with Greg Walters, co-founder & CEO of Excision Medical. Excision is developing a leaflet modification system to enable lifetime management of aortic stenosis.Greg has almost 40 years of experience in cardiovascular devices, holding leadership roles at Kensey Nash Corporation where he led the development of Angio-Seal and several endovascular programs. He later co-founded Essential Medical, which was acquired by Teleflex in 2018, and is an inventor on more than 75 U.S. and European patents.In this interview, Greg discusses why early-stage teams should build to learn rather than to impress, using functional prototypes to generate real feedback and fundraising momentum. He outlines how disciplined safety work — not perfection — defines first-in-human readiness, and what makes a pre-revenue company attractive to strategic acquirers. Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Greg Walters.

In this episode, Duane Mancini speaks with Matt Wunzin, a biomedical engineer from Ohio with nearly 20 years of experience in the medtech industry. Matt shares his career journey from earning his degree at the University of Akron to working at various medical device companies, both large and small, and also discusses his transition to consulting with his firm, Five Design and Development. He shares the importance of quality management and documentation in the medtech field, and highlights the opportunities available in Ohio's medtech ecosystem. Matt Wunzin LinkedInFive Design & Development WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from being one of the first IVF babies in the U.S. to navigating life-threatening health complications—and how these experiences shaped her mission to help others lead with authenticity.The conversation centers on the concept of "SOS moments," which Dr. Hoffmann defines as those critical points of distress or crisis that occur in both personal lives and product development. By applying her CEC framework—Curiosity, Empathy, and Connection—leaders can transform these high-pressure moments into stories of strength. This approach is particularly vital in MedTech, where the ultimate goal is to serve patients during their own most vulnerable SOS moments.Etienne and Jenny also explore the intersection of human leadership and emerging technology. While AI continues to streamline technical workflows, Dr. Hoffmann argues that human empathy and curiosity remain irreplaceable assets for innovation. The episode concludes with a practical look at the return on investment (ROI) for "opening up," demonstrating how personal connection leads to higher quality products, better team retention, and the resilience needed to survive the "messy middle" of product development.Key Timestamps00:00 - Introduction of Dr. Jenny Hoffmann and her background in MedTech and innovation.01:28 - Motivation for writing Open Up: Scaling impact through vulnerable storytelling.04:23 - The shift from the "perfectly composed" leader to the vulnerable leader.05:45 - Dr. Hoffmann's personal origin story: Being one of the first IVF babies in the U.S.08:30 - Listening to the "whisper" and the courage required to respond to inner intuition.10:14 - The ROI of Vulnerability: How personal connection drives higher quality and team motivation.14:39 - Defining SOS moments: Turning distress signals into leadership strengths.18:42 - The CEC Method: Breaking down Curiosity, Empathy, and Connection.20:25 - AI in MedTech: Why human empathy is the one thing machines cannot replace.25:57 - Strategic Sharing vs. Oversharing: How to lead by example without losing professional boundaries.28:52 - The power of storytelling for engineers and data-driven professionals.Quotes"The leader is the first one to step out on the bridge that no one's sure if they want to cross. You paint that vision of the bridge, and then you're the first one to step out on it." - Dr. Hoffman"If we can put empathy first and think about how we are each a patient first... then we can uncover the real needs to

Is your medical device vision actually helping you grow - or silently holding you back?If you're a clinician founder with a working prototype but struggling to scale or export your medical device, the problem likely isn't your product — it's your vision. In this episode, Hakeem Adebiyi breaks down why most healthcare innovations stall commercially and how to fix it using a proven, clinician-friendly framework.Here's what you'll learn:Why your current vision might be too generic — and how that's stalling your commercial growthThe DAMP framework: a 4-step system to pressure test your vision for direction, alignment, motivation, and peopleA practical on-the-go exercise to sharpen your vision and guide real business decisions immediately

In this episode of Medsider Radio, we sat down with Jaeson Bang, Founder & CEO of Future Cardia. Future Cardia is developing a subcutaneous heart-failure monitoring platform designed to capture both electrical and mechanical cardiac signals through a simple office-based procedure.Jaeson brings more than two decades of experience building implantable cardiac technologies across Medtronic, CVRx, EBR Systems, and Abiomed. Drawing on that background, he questioned industry assumptions around miniaturization and invasive workflows — and built a device that prioritizes performance, durability, and clinical practicality instead.In this interview, Jaeson shares how challenging a core constraint unlocked a faster development path, why deep domain expertise matters more than thrift in regulated markets, and how raising capital outside traditional VC can preserve leverage and buy time.If you'd rather read than listen, here's a link to the full interview with Jaeson Bang.

How do you go from managing a gym to managing trauma cases in the Operating Room?In this episode, we sit down with Roo Cotter, a former personal trainer who made the incredible leap into the high-stakes world of medical device sales. Roo shares her journey of getting recruited by a gym member to work for Stryker Trauma, navigating the chaos of 14-hour days in the O.R., and her recent pivot into the innovative field of cancer diagnostics with Exact Sciences.If you are an athlete, a trainer, or someone looking to break into medical sales but don't know where to start, this conversation is for you. Roo breaks down how she used grit, networking, and the Medical Sales U program to land her dream job in under two months.IN THIS EPISODE, YOU WILL LEARN:- The unlikely path: How working hard at a gym led to a "lucky" break in MedTech.- The reality of Trauma: What it's really like to be on call 24/7 (and why it teaches you resilience).- Ortho vs. Diagnostics: Why Roo transitioned from the "meathead" world of orthopedics to early cancer detection.- Networking Hacks: How to get internal referrals and skip the "ghosting" phase of job applications.- Mental Toughness: Balancing a high-pressure career with the "1000 Hours Outside" challenge.CHAPTERS:0:00 - Intro: From Personal Trainer to the O.R. 1:55 - Why a Finance Major chose Fitness2:45 - Building relationships with doctors at the gym5:40 - Getting scouted: The Story of landing the Stryker job8:37 - The harsh reality of Trauma Sales (and 14-hour days)13:25 - Transitioning to Neuromodulation (Nalu Medical)16:00 - The Pivot to Diagnostics: Joining Exact Sciences19:15 - How Medical Sales U helped speed up the process24:00 - Avoiding Burnout: The "1000 Hours Outside" ChallengeREADY TO BREAK INTO MEDICAL SALES? If you want to fast-track your career like Roo did, check out our program. We help professionals transition into top-tier medical sales roles: medicalsalesu.com/About the Guest: Roo Cotter is a Medical Sales Professional with experience in Trauma, Neuromodulation, and Diagnostics. A Miami University graduate, she combines her background in finance and fitness to bring a unique, disciplined approach to the O.R.#MedicalSales #Stryker #CareerPivot #PersonalTrainer #MedicalDeviceSales #ExactSciences #SalesCoaching #CareerAdvice #OrthoDisclaimer: The views expressed in this video are those of the participants and do not necessarily reflect the official policy or position of any other agency, organization, employer, or company.

In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends."Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli00:00 - Introduction to AI in MedTech05:15 - Discussing AI's deterministic vs. statistical nature12:30 - AI in diagnostics: Radiology, Cardiology, and Neurology20:45 - Wearable health monitors and patient-driven health data28:10 - The role of AI in medical device operations and manufacturing35:00 - AI at the point of care: Enhancing patient and clinician experience42:15 - Regulatory challenges and the future of AI in healthcareKey Takeaways:1. Latest MedTech Trends:The integration of AI in diagnostics is growing, particularly in radiology, cardiology, and neurology, aiding in more accurate and quicker diagnoses.Wearable health monitors are empowering patients to take control of their health data, leading to personalized healthcare solutions.2. Practical Tips for MedTech Enthusiasts:Stay informed about the latest AI advancements and regulatory guidelines to leverage AI effectively in MedTech.Consider the ethical implications and ensure bias mitigation in AI model training and deployment.3. Predictions for the Future:Increased adoption of AI across various healthcare sectors, including surgery and patient care management.Evolution of regulatory frameworks to better accommodate and oversee AI-driven medical devices.References:Ashkon Rasooli on LinkedInashkon@engeniussolutions.comEngenius SolutionsAFDO/RAPS Working GroupEtienne Nichols on LinkedInSponsors:This episode is brought to you by Greenlight Guru, a comprehensive solution designed to streamline MedTech product development and ensure regulatory compliance. Discover how Greenlight Guru can accelerate your projects at www.greenlight.guruShare your thoughts and questions with us at podcast@greenlight.guru

Rick Bente, co-founder and CEO of Indomo, the company behind ClearPen, an investigational at home corticosteroid injection for inflammatory acne. Rick brings over two decades of experience in drug delivery and diagnostics with previous roles at Medtronic, Insulet and YourBio.In this episode we trace Rick's journey from insulin pumps, large volume wearable injectors and remote blood collection to tackling one of the most common yet under-served conditions in medicine: acne. Rick explains why dermatology has seen far less innovation than fields like diabetes, why 40 percent of acne sufferers in the US live with deep inflammatory lesions that topicals simply cannot reach and how ClearPen aims to replicate in-clinic injections safely in the home.We dig into how dermatologists and GPs perceive acne severity, the mental health burden of adult acne and why telehealth has become a critical tool when wait times to see a dermatologist can exceed three months. Rick also unpacks the technical and regulatory complexity of combination products, from tying drug and device design histories together to generating RCT-grade evidence that satisfies regulators, payers and prescribing physicians.Finally, we talk about the realities of building a direct-to-patient model in a regulated market, balancing unmet patient need with the gatekeeping role of clinicians and insurers, and Rick's own transition from corporate engineer to founder. He shares candid lessons on focusing beyond the patient to the full healthcare ecosystem, designing devices that are “hard to misuse” and why turning ideas into reality ultimately requires taking the leap.Timestamps[00:00:21] From insulin pumps and wearables to dermatology and ClearPen[00:02:27] Why acne and dermatology have been under-innovated compared to other MedTech fields[00:05:25] Acne beyond teenagers: genetics, adult breakouts and mental health impact[00:07:16] How dermatologists versus GPs understand acne severity and burden[00:09:27] Typical US acne care pathway and why Accutane was the last big breakthrough[00:11:54] Using telehealth to address three-month dermatologist wait times[00:15:16] Investigational at-home corticosteroid injections and designing for safe use[00:17:21] Biggest technical and regulatory challenges in drug-device combination products[00:19:59] Where founders go wrong with direct-to-patient models in healthcare[00:24:13] Moving from engineer to founder and building around value inflexion pointsConnect with Rick - ⁠⁠⁠https://www.linkedin.com/in/rick-bente/Learn more about Indomo - ⁠⁠⁠https://www.linkedin.com/company/indomotx/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠Subscribe to the Podcast

Fundraising isn't a pitch deck moment—it's a process. And if you treat it like a last-minute sprint, you'll lose more than equity.In this 5 in 5 episode, Hakeem Adebiyi shares five hard-earned lessons every founder needs when raising capital, especially at pre-seed, seed, or early Series A. From avoiding diluted equity to knowing what investors actually care about, this episode helps clinician-founders and MedTech entrepreneurs approach funding with strategy—not desperation.You'll learn how to:Approach fundraising as a structured process, not a one-off eventGet in front of investors without relying on warm introductionsLead with the problem—not the tech—when pitchingAvoid damaging credibility by targeting the wrong investorsUnderstand what investors look for right after they say “yes”Use preparation as your best defence against unnecessary dilutionWhether you're building a medical device, a healthtech platform, or preparing to scale internationally, this episode gives you the mindset and tactics to raise smarter and protect what you've built.

In this episode of the Chase MedSearch Podcast, Jordan Chase sits down with Peter Calabrese — Senior Digital Product Program Manager and longtime neuromodulation leader—to unpack how digital ecosystems, data interoperability, and AI are transforming deep brain and spinal cord stimulation.Peter shares how the next era of neuromodulation will be defined not only by implantable devices, but by the data they generate—and how that data improves outcomes from the PACU to long-term follow-up. He explains the emerging shift toward software-as-a-subscription in MedTech, the growing expectations from payers for interoperability, and why companies are racing to build secure, scalable data “lakes” before deploying front-facing AI tools.Peter also takes us through his personal career arc: 15 years as a high-performing field rep, his fascination with solving complex problems, and the transition to in-house marketing and product development. He shares the real profile of a Medical Device Sales Rep. who should consider this path—and what the first week in marketing feels like after years in the operating room (OR).Whether you're a medical device rep, sales leader, or someone tracking the digital shift in MedTech, this episode delivers key insights into where neuromodulation is going next—and how sales professionals can prepare for the future.RESOURCEShttps://www.linkedin.com/in/peter-a-calabreseBiodesign Courses Recommended by Peter Calabrese:  https://med.stanford.edu/biodesign/programs/stanford-courses.html

In this episode, I was lucky enough to interview Det Ansinn, the founder of Brick Simple LLC, serial entrepreneur with four successful exits, and current CEO of MedTech company Neuralert. Det shares his journey from pumping gas at the Doylestown Airport to building multiple innovative ventures, emphasizing the value of authentic connections, strong team culture, and pursuing projects that excite him over purely profit-driven motives. From creating Brick Simple's first product to developing apps for Xbox Live and navigating the post-dot-com era, Det reflects on how his experiences shaped his approach to entrepreneurship and leadership.Det also delves into his current work at Neuralert, a breakthrough stroke detection company, where he stepped in as CEO following the previous leader's unexpected passing. Det discusses the unique challenges of leading a company he didn't found, the importance of building resilient teams, and his dedication to making a meaningful impact in healthcare. He also shares insights on the Bucks County startup ecosystem, balancing professional intensity with personal passions like motorcycling, and maintaining perspective through mental health practices. Step inside Det Ansinn's world and discover a career fueled by curiosity, innovation, and purposeful action in this insightful episode of The First Customer!Guest Info:BrickSimple LLChttp://bricksimple.comNeuralert Technologieshttps://neuralert.coDet Ansinn's  LinkedInhttps://www.linkedin.com/in/detansinn/Connect with Jay on LinkedInhttps://www.linkedin.com/in/jayaigner/The First Customer Youtube Channelhttps://www.youtube.com/@thefirstcustomerpodcastThe First Customer podcast websitehttps://www.firstcustomerpodcast.comFollow The First Customer on LinkedInhttp://www.linkedin.com/company/the-first-customer-podcast/

Join Glenn Hunzinger and James Woods as they discuss what to expect for medtech dealmaking in 2026, including why buyers are poised to return, how technology is reshaping portfolios, and where investors are focusing to drive future growth.Discussion highlights:Medtech M&A is expected to rebound in 2026 as market conditions improve and capital remains availableBuyers are staying selective, prioritizing assets that support durable growthTechnology and data enabled solutions are key drivers of deal activityTuck in and bolt on acquisitions continue to dominate, with private equity playing an active roleSurgical robotics, AI, cardiovascular, and diagnostics remain areas of strong interestSpeakers:Glenn Hunzinger, US Health Industries Leader, PwCJames Woods, US Medtech Deals Leader, PwCLinked materials:https://www.pwc.com/us/en/industries/health-industries/library/pharma-life-sciences-deals-outlook.htmlhttps://www.pwc.com/us/en/industries/health-industries/library/medtech-deals-outlook.htmlhttps://www.pwc.com/us/en/industries/health-industries/library/health-services-deals-outlook.htmlFor more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.

Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams.In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better.Throughout the discussion, we cover:A clear, simple explanation of Verification vs. ValidationWhy V&V must span the entire development lifecycleHow poor requirements create downstream V&V failuresThe risks of starting V&V planning too lateHow to simplify test methods without losing rigorPractical strategies for handling failed testsHow to think about traceability without fearThe future of V&V as software and AI become more prevalentThis episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes.Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Social Media to follow Aaron Joseph Linkedin: https://www.linkedin.com/in/ajosephprofile/Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

Duane Mancini chats with Michael Challenor to discuss his entrepreneurial journey in the medtech industry, starting from his early passion for invention through his pivotal experiences in the Stanford Biodesign program in Perth, to co-founding Vital Trace. He highlights his current venture, Innovate Medtech, which supports medtech startups with grants, fundraising, and product development. Michael shares valuable insights into the Australian medtech ecosystem, the significance of team and culture, and offers crucial advice for aspiring medtech entrepreneurs. Michael Challenor LinkedInInnovate MedtechAusMedtech 2026Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.Key Timestamps:[00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.[00:03:30] Jennifer's origin story in quality and regulatory roles.[00:07:15] The pivotal learning moments in quality management and regulatory affairs.[00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.[00:16:30] The significance of human factors in product design and learning from end-user feedback.[00:21:50] Project management skills for quality and regulatory professionals.[00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.[00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.Quotes:"A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor"It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-TudorMedTech Trends:An emphasis on proactive quality management to ensure patient safety and product efficacy.The rising importance of human factors and user-centered design in medical device development.The shift towards integrating software and digital solutions in medical devices.Practical Tips:Quality and regulatory professionals should hone their project management skills.Communication and storytelling are key in influencing business decisions and leadership.Always present solutions and alternatives when addressing compliance challenges.References:JMT Compliance ConsultingJennifer Mascioli-Tudor on LinkedInEtienne Nichols on LinkedInGreenlight Guru's platform for Quality Management & Clinical InvestigationsQuestions for the Audience:Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"Feedback:Love the episode? Have suggestions or topics you'd like to hear about? Email us at podcast@greenlight.guru and leave 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. Streamline your process and foster innovation with Greenlight Guru's intuitive platform!

Duane Mancini interviews Spencer Jones, a registered nurse turned medtech entrepreneur. Spencer recounts his journey from bedside nursing to founding two medtech companies, sharing valuable advice on navigating the often complex medtech landscape, including the critical role of thorough customer discovery and strategic vendor relationships in mitigating commercial risks. He also introduces XO MedTech, a training and community platform for medtech innovators, and MedTech Vendors, an AI-driven platform designed to connect medtech teams with ideal service providers. Spencer Jones LinkedInXO MedtechMedtech VendorsDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running.The conversation dives deep into the "Great Rewiring" of the medical device industry. Michelle outlines how we have moved past the initial phase of AI skepticism and "AI fatigue" into a period of hyper-acceleration. With the introduction of the FDA's ELSA and the implementation of the EU AI Act, the industry has reached a point where AI is no longer a side project but a fundamental requirement for operational longevity.Finally, the episode provides a roadmap for both organizations and individual contributors. Michelle introduces her "Holy Trinity" framework for AI implementation—Data, Workflow, and Agents—and explains why the next two years will be defined by the "Invisible Colleague" or AI copilot. For junior professionals, the message is clear: knowledge is now a commodity, and the real value lies in the ability to ask high-quality, strategic questions.Key Timestamps00:00 – Introduction and Michelle Wu's background in MedTech and AI.03:45 – A founder's perspective: Michelle's personal experience in the OR seeing her clients' devices.08:12 – The 2025 Inflection Point: FDA ELSA, EU AI Act, and global AI expectations.11:50 – From billable hours to value-based output: How AI is disrupting the consulting business model.15:35 – Micro-timestamp: 2026 Predictions. The shift toward universal AI Copilots and Agents for every MedTech role.18:22 – The Holy Trinity of AI: Breaking down Data Layers, Workflow Automation, and AI Agents.22:10 – Case Study: How a top-tier MedTech company automated 17,000 quality and regulatory tasks.27:45 – The 56.8% Salary Premium: Why AI literacy is the most important skill for young RAQA professionals.31:15 – Shifting from memorization to "Clarity of Mind" and high-quality inquiry.Quotes"Knowledge is a commodity now. Previously, regulatory consultants or professionals stood out by their knowledge. Now, with AI leveling the field, the capability lies in those who can ask high-quality questions." - Michelle Wu, Nyquist AITakeawaysAI Literacy is a Financial Multiplier: LinkedIn data shows that non-engineering knowledge workers with AI literacy can command a salary premium of up to 56.8%.The 80/20 Rule of Automation: Approximately 80% of current RAQA tasks are tedious, manual, or administrative. Successful teams are using AI to automate that 80%, allowing humans to focus on the 20% that is strategic and high-value.The Three-Layer AI Strategy: To effectively implement AI, companies should look at the Data Layer (intelligence), the Workflow Layer (automation of specific tasks), and the Agent Layer (autonomous "employees").Value-Based Billing: As AI reduces the time required for regulatory submissions and gap analyses, the industry is moving away from the "billable hour" toward pricing based on the value and quality of the output.ReferencesNyquist AI: Michelle Wu's platform specializing in global regulatory intelligence and AI-driven workflow automation for MedTech.FDA ELSA: The...

Breaking into the US healthcare market is one of the toughest challenges for medtech and healthtech founders and most underestimate just how slow, disciplined, and evidence-driven it really is. In this 5 in 5 from The H-Files episode, I share five hard-earned lessons from working with companies trying to scale into the US. In just five minutes, you'll learn why speed doesn't equal success, how the wrong distributor can quietly kill momentum, and why clinical data and cash flow matter more than optimism.This episode covers:Why the US healthcare market rewards preparation, not speedHow to spot weak or generalist distributorsWhy clinical proof is non-negotiable in US salesThe real cash realities of US distributionHow to avoid partnerships that look good early but fail laterIf you're a medtech founder, healthtech leader, or healthcare startup planning US expansion, this episode will help you avoid costly mistakes and build a strategy that actually works. Comment or message which action you took and what surprised you. Listen to Full Episode: https://youtu.be/3v8N7F2gGqoListen on Apple Podcasts: https://podcasts.apple.com/gb/podcast/hands-on-business-the-h-files-unlocking-growth/id1548129226 Join the mailing list to get the show notes for every episode here: https://thesalesaccelerationformula.com/podcast-show-notes #healthcare #us #usmarket #5in5 #podcast #hfiles #medtech

Renato (Ren) Circi, co-founder of SAVA, a London based MedTech company building a new generation of minimally invasive continuous glucose monitors and molecular wearables.In this episode we rewind to the underground labs at Imperial College London where Ren and his co-founder Raph first immersed themselves in biosensors and began questioning the status quo of health monitoring. Ren explains how their shared obsession with measuring the body more effortlessly led to SAVA's founding and what it really looks like to push through years of scientific failure in order to build a complex medical device platform.We dive into why SAVA manufactures everything in-house, how their micro sensor architecture differs from traditional filament based CGMs and why controlling every layer from chemistry to algorithms is essential if you want to iterate fast on performance. Ren sets out SAVA's long term vision of continuous molecular tracking for everyone, not just people with diabetes, and what could be unlocked once you can monitor many molecules in real time from a single patch.We also talk about regulatory expectations for CGMs, the reality of one way product decisions in medical devices and the difficulty of fundraising for a consumer facing yet highly regulated deep tech company. Ren closes with candid reflections on what he would do differently, how he protects time for family and why working on a problem you truly care about with people you genuinely like is the only way to survive the journey.Timestamps[00:00:21] Origins at Imperial and discovering biosensors[00:01:59] Long horizons, repeated failure and staying in the game[00:03:56] Why SAVA manufactures everything in-house[00:06:46] How SAVA's micro sensor CGM platform actually works[00:09:36] From diabetes to universal molecular health monitoring[00:12:02] Patient experience and CGM adoption in healthcare systems[00:13:43] When CGMs become cheaper than finger-pricks[00:15:15] Misconceptions about CGM and continuous molecular sensing[00:17:21] Why building CGMs is one of the hardest engineering challenges[00:22:54] Fundraising in unconventional deep tech MedTech and advice for foundersConnect with Ren - ⁠⁠https://www.linkedin.com/in/circi/⁠Learn more about Sava - ⁠⁠https://www.sava.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

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.

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

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

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.

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

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.

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