Project Medtech

What does it take to move a medical device from an idea to a solution that reaches patients? In this episode, Edwin Lindsay (Medtech's Guinness Guy) shares how 20+ years in medical devices shaped his hands-on approach to helping startups overcome regulatory, quality, and clinical challenges. He discusses why innovators need more than advice—they need experienced partners who help make decisions, execute strategies, and accelerate progress. Edwin also explores the hurdles facing pediatric device innovation and how his personal connection to the field inspired his mission to support founders and build stronger networks for life-changing technologies.Edwin Lindsay LinkedInCS Life Sciences WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

In this episode, Ethan Drower, co-founder and CEO of CiteMed, shares the story behind Evidence Cloud, an AI-enabled platform transforming how medtech teams approach clinical evidence. Built to simplify complex literature reviews, strengthen regulatory submissions, and create a clear, traceable foundation for clinical claims, Evidence Cloud helps companies navigate one of the most critical steps in bringing innovation to patients. What began as a kitchen-table conversation evolved into a mission to reshape evidence generation and regulatory strategy. In this conversation, Ethan discusses how smarter evidence workflows can improve transparency, accelerate decision-making, and turn clinical evidence from a compliance requirement into a powerful strategic advantage. Ethan Drower LinkedInCiteMed WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

In this episode, Michelle Ottey, President of CIC Campuses and Labs, unpacks what it really takes to build thriving innovation ecosystems and why flexible lab space is only the beginning. Michelle shares her personal journey from genetics and cell biology research into enabling entrepreneurship, and explains how CIC’s “invisible infrastructure” helps life science and medtech founders move faster by reducing operational, regulatory, and capital burdens through plug-and-play wet labs, shared equipment, safety and compliance support, and a deeply staffed community model. The conversation highlights how CIC strategically launches campuses through years of local ecosystem buy-in, why programming and connection points matter as much as square footage, and how CIC’s global footprint helps companies navigate international expansion and business culture.Michelle Ottey LinkedInCIC Philadelphia WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this powerful episode, Laura Corcoran, CEO and Founder of Dignity Care, shares the deeply personal experience that drove her to invent the Miscarriage Collection Cradle, a patented Class I medical device designed to bring practical support and dignity to women managing miscarriage or pregnancy loss. Laura walks through the realities of home miscarriage management, the need for reliable collection for cytogenetic testing, and how gaps in standard care can compound trauma. The conversation explores how she translated an unmet need into a scalable product—rapid NHS adoption, health-economic evidence showing major system savings, and the stakeholder strategy required to drive change from hospitals to Parliament. Laura also discusses FDA clearance and plans for U.S. launch, and closes with advice for innovators: obsess over understanding the problem, and the right solution will follow.Laura Corcoran LinkedInDignity Care Network WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Dr. Malcolm Townes breaks down how WashU is building a more execution-focused commercialization engine through its Gap Fund, designed to advance non-drug, non-therapeutic technologies by funding the technology (not startups) to avoid conflicts and drive sharper development decisions. He shares why hands-on, milestone-based funding and rigorous customer discovery are essential to uncovering “unknown unknowns,” preventing expert blindness, and aligning products with real clinical workflows. The conversation also explores how WashU leverages EIRs and Venture Fellows to add commercialization horsepower, why “coachability” is the strongest predictor of success, and what innovators most often miss: FDA clearance isn’t enough—market access and reimbursement require different proof, data, and strategy.Dr. Malcolm Townes LinkedInWashington University in St. Louis Gap Fund WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Megan Shaw, CEO of the Pittsburgh Life Sciences Alliance, and Will Kaigler, co-founder and CEO of SovaSage, join the Project Medtech podcast to unpack what it really takes to build, scale, and ultimately create optionality in health tech startups. Megan shares her journey from being the first employee at HemoSonics to launching PLSA in 2024 to accelerate Pittsburgh’s life sciences ecosystem. Will reflects on his experience with multiple startups, and explains how sovaSage is reimagining sleep apnea management to improve outcomes and lower costs. Together, they discuss why customer value—not fixation on an exit—drives success, how to hire the right early team without over-hiring, and why systems and rigorous user discovery can make or break a company. They close with a deep dive into Pittsburgh’s unique strengths and upcoming opportunities to plug into the region’s innovation community.Will Kaigler LinkedInMegan Shaw LinkedInsovaSage WebsitePittsburgh Life Science Alliance WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Mark Domayhn, Partner at JD Lymon Group, joins Duane Mancini to unpack what medtech innovators often miss most: reimbursement isn’t a box to check after FDA—it’s the commercial foundation that determines whether hospitals and physicians can adopt your technology. Drawing on experience across Medtronic, Zimmer, and St. Jude/Abbott, Mark breaks down the “three-legged stool” of coverage, coding, and payment, why clinical evidence must satisfy payer standards (not just FDA), and how to “follow the money” across fragmented U.S. systems. The conversation then dives into the New Technology Add-On Payment (NTAP) program, why it matters for inpatient launches, how breakthrough designation has increased NTAP success, and the major implications of CMS proposing to repeal the alternative pathway—plus what companies can do before the June 9 comment deadline. Mark Domyahn LinkedInJD Lymon Group WebsiteRAPID Coverage Pathway InformationDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, pulmonologist, intensivist, and advanced bronchoscopist Huzaifah Salat joins Duane Manicini to unpack what’s changing in lung cancer care, and why the biggest constraint in MedTech isn’t the FDA, funding, or clinician adoption, but founders building for clinicians instead of with them. Huzaifah shares how robotic bronchoscopy, advanced imaging, and better CT quality are enabling diagnosis of tiny, moving lung nodules, and why the next wave may be non-invasive diagnostics like blood-based, saliva, or bronchial secretion testing. He offers an inside look at serving as a regional medical director and physician voice to the C-suite, where “no margin, no mission” meets patient-first priorities, and explains how diverse frontline perspectives, beyond physicians alone, shape products that truly fit real clinical workflows.Huzaifah Salat LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this kickoff episode of Project Medtech’s “Five Things You Need To Know” miniseries, Duane Mancini is joined by Sean Thompson to break down the essentials of sterile medical device packaging compliance. Sean shares a practical, startup-friendly roadmap anchored in ISO 11607, starting with defining device inputs that drive packaging design decisions (sensitivities, geometry, sterilization method, scalability). He then walks through the four pillars—Make, Ship, Store, and Usability—covering sealing process validation, distribution simulation testing and feasibility testing, shelf-life strategy via accelerated and real-time aging, and the newer focus on usability and aseptic presentation. The episode highlights how missed packaging steps can create costly timeline and commercialization setbacks.Sean Thompson LinkedInPackaging Compliance Labs WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Alicia Wagner shares the deeply personal journey that led her to build Sunra Health after her daughter’s long and traumatic health challenges exposed major gaps in how pediatrics handles chronic conditions. She breaks down Sunra Health as an AI-powered pediatric health platform paired with an at-home cheek-swab genetic test, designed to help families and clinicians move from “guessing” to more personalized, data-informed early childhood wellness decisions. The conversation explores how Sunra aims to function as an FDA-aligned clinical decision support tool, why direct-to-consumer access is a key early strategy, and how AI can responsibly translate complex genetic insights into practical guidance, education, and care planning. Alicia also shares hard-earned founder lessons on resilience, pitching, and educating in a controversial space.Alicia Wagner LinkedInSunra Health WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

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, Grant Kruger joins Duane Mancini to share his journey from growing up in South Africa to becoming a University of Michigan researcher and medtech entrepreneur. He discusses his roots in electrical engineering and AI-driven manufacturing, the leap to Michigan for a postdoc, and the pivotal shift from automotive-focused research into collaborating with physicians to solve real clinical problems. Grant explains how early pain-research tooling evolved into Veracron Wellness Systems, and how an NIH I-Corps-style customer discovery process reshaped their thesis, revealing clinicians didn’t need better pain intensity scores, but objective, workflow-friendly functional data. He outlines their single-use wearable “functional assessment test kit,” designed to remove clinic burden and support better chronic pain decisions, approvals, and patient satisfaction, plus lessons on team, ecosystem support, and why usability beats perfection.Grant Kruger LinkedInVeracron Wellness Systems WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Tony Mango and Evan Gomez from Orlando Health’s Strategic Innovations team break down how a major nonprofit health system accelerates ideas from its 40,000+ team members into real solutions. They explain Orlando Health’s unique capability to develop medical devices in-house under FDA registration, how they triage innovation disclosures, and when they choose outside-in partnerships versus building internally based on speed, workflow fit, and adoption. The conversation explores the realities of commercialization—reimbursement, CFO-driven purchasing, long U.S. sales cycles, and why great technology can still fail without economic alignment. They also share how Orlando Health uses innovation as a recruitment and retention engine, expands regionally, and builds industry connections through curated clinical immersion sessions. Tony Mango LinkedInEvan Gomez LinkedInOrlando Health WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Ankit (founder of UGen) and Brent (a physical therapist at University Hospitals) about why rehab is primed for innovation, and how UGen is tackling the biggest breakdowns in physical therapy. Ankit shares how his grandfather’s Parkinson’s journey inspired him to apply his electrical engineering and sensor research background to build wearable motion sensors that deliver real-time, multi-sensory feedback at home, while capturing clinician-ready data to improve care decisions. Brent explains the clinical pain points UGen can solve: limited face-to-face time, poor home-exercise compliance, and the “honor system” that leaves therapists guessing, plus how UH’s sports medicine growth and the Haslam Sports Innovation Center create a pathway for tech adoption. They also discuss UGen's presence at the NFL Combine, expansion into neuro and assessment, and founder lessons on hardware difficulty, workflow fit, and building with patient safety in mind.Ankit Shah LinkedInBrent Pekarski LinkedInUGen WebsiteHaslam Sports Innovation Center WebsiteSportsLand WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Cory Criss joins Duane Mancini to share his path from pediatric surgeon to building innovation infrastructure at Nationwide Children’s and helping launch the Midwest Pediatric Device Consortium (MPDC), an FDA-funded Pediatric Device Consortium created to accelerate pediatric device development. The conversation breaks down why pediatrics is uniquely hard—small, fragmented markets and the need for multi-institutional clinical evidence—alongside the stark funding gap, with less than 1% of VC dollars going to pediatric-only companies despite children representing 25% of the population. Corey explains how Nationwide’s Innovation Center de-risks and educates through an innovation fellowship, and how MPDC unites Nationwide, Cincinnati Children’s, Ohio State, Cleveland Clinic Children’s, and others to support pediatric startups nationwide with expert evaluation, hospital access, and non-dilutive funding. They also discuss lessons learned managing multi-institution partnerships, sustainability beyond grant funding, and why clinician and hospital buy-in is critical for international startups entering the U.S. market.Cory Criss LinkedInNationwide Children’s Hospital WebsiteMPDC WebsiteMPDC YouTube ChannelPediatric Device Consortium: Cardiovascular Focus Event Registration Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Brent Lavin shares how two decades in product and portfolio management at GE Healthcare, C.R. Bard, and BD shaped his mission to help Series A and B medtech startups build commercial logic into every stage of innovation. Brent breaks down what surprised him most moving from strategics to early-stage teams and why large companies often operate like startups when resources must be earned through influence, not authority. The conversation dives into how his engineering training powers a structured, “marketing-as-a-science” approach to product management, the most-missed elements of customer discovery, and a concrete example of winning by simplifying a “Cadillac” product into a segmented solution. Brent also unpacks what strategics look for in acquisitions plus lessons from LSI, leadership, and the discipline of endurance running.Brent Lavin LinkedInIronwood Medtech Partners LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Duane Mancini speaks with vascular neurologist Anit Behera about what it takes to improve stroke care from the ER through long-term recovery. Anit shares his path through an MD-PhD in outcomes research, how consulting and clinical trials shaped his innovation mindset, and why stroke care advancement spans four phases: prevention, acute treatment, post-acute care, and rehabilitation. He explains where he sees major opportunity next, pointing to emerging devices and research in post-stroke rehab alongside stronger prevention strategies and better health literacy. The conversation also breaks down how clinicians evaluate new technologies, emphasizing rigorous data, patient safety, and real-world workflow fit, plus the role of key opinion leaders and conferences in driving adoption. Anit Behera LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Jake Ward joins Duane Mancini to break down how startups should think about intellectual property from day one and why smart IP decisions directly impact fundability. Jake shares how Ward Law grew from a three-person boutique to a 35-person, multi-state virtual firm, and why their Midwest roots help deliver high-quality IP services at accessible rates for entrepreneurs. The conversation dives into where to start with patents, then shifts to trademarks and brand strategy and why selecting the right mark early, staying consistent, and timing registration can prevent costly rebrands later. They also tackle AI in legal work, exploring confidentiality concerns, “don’t trust the robot” pitfalls, and how to use AI as a tool without letting it undermine strategy or enforceability.Jake Ward LinkedInWard Law Website Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Jenny Lynn—founder of milkmade and a mom-turned-entrepreneur—shares how a frightening breastfeeding experience, including an undiagnosed tongue tie and the exhausting “weighted feed” routine, sparked the idea for a Smart Nipple Shield that can deliver continuous, actionable insight into infant milk intake. The conversation explores why breastfeeding—despite being the clinical “gold standard”—so often breaks down early, driven by perceived and actual low milk supply, fragmented care, and limited access to lactation support, especially in rural communities. Jenny Lynn also unpacks her path from marketing and health tech into regulated medtech, including patents, pursuing clinical validation, and navigating a Class II De Novo pathway with no predicate. Jenny Lynn Walding LinkedInmilkmade Website“Invisible Women” by Caroline Criado Perez“She Persisted” by Chelsea Clinton & Alexandra Boiger Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Duane Mancini sits down with Sarah to unpack her path from healthcare operator to investor and what founders should know when raising capital today. Sarah shares how her experience as the 10th employee at a digital health startup shaped her empathy for founders and the practical lens she brings to diligence, from ICP and pricing to building durable foundations early. The conversation pulls back the curtain on venture mechanics—how syndication and relationships really work, why fundraising is difficult when LPs demand DPI, and how fund structure, lifecycle, and co-investments can shape outcomes for startups. Sarah also explains Angelini Ventures’ global strategy and thesis-driven focus in areas like cardiology and neurology, and why “exitability” requires forward-looking insight into strategic buyers, technology shifts, and long-term fit.Sarah Fox LinkedInAngelini Ventures WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

Join us for a special 250th episode of The Project Medtech Podcast as host Duane Mancini and Director of Marketing and Engagement, Lindsey Dinneen, flip the script. Duane shares the journey from the podcast's inception during the height of COVID-19 to becoming a consulting, networking, and education resource for medtech startups. They delve into the core philosophy of creating value, the realities of team-building, and the exhilarating moments of client success. This episode is a candid reflection on the impact of the Project Medtech mission, the importance of a value-driven approach, and exciting future prospects. Lindsey Dinneen LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Duane Mancini sits down with Louise Yochee Klein to explore the fundamentals of fostering courage and innovation in the MedTech industry. Louise shares her journey from Canada to Philly, co-founding Courage Growth Partners, and emphasizes the importance of understanding and overcoming fear in business. The conversation highlights the critical need for aligning team objectives, adhering to detailed plans, and maintaining positive energy for personal and business success.Louise Yochee Klein LinkedInCourage Growth Partners Website“Courage to Champion” BookDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Duane Mancini welcomes Aileen Helsel, Director of Innovation at Carilion Clinic, to discuss the exciting advancements in healthcare innovation in Roanoke, Virginia. Aileen shares her journey from academia to technology transfer and ultimately to her current role, emphasizing the transition from research to real-world application. They explore Carilion Clinic's unique position serving a diverse population, including rural communities, and how this drives impactful healthcare solutions. Aileen Helsel LinkedInCarilion Clinic InnovationDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Duane Mancini sits down with Stan Glezer, Managing Director at Outcome Capital, to dive deep into the roles of strategic advisory and investment banking in driving innovation within the life sciences sector. Stan elaborates on his multifaceted career, from his beginnings as a physician to leading roles in biopharma and MedTech companies. He discusses the importance of aligning a company's value proposition with market dynamics, the art and science behind M&A deals, and why realistic, transparent goals can unlock transactional success. Stan Glezer LinkedInOutcome Capital WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

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.

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

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

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

Duane Mancini welcomes Emily Adams, Co-Founder of Leading with Human Design, who shares her remarkable journey from growing up in the Amish culture to becoming a leader in the tech and consulting world. Emily details her escape at 17, her transition into the corporate world, her rapid rise in the automotive manufacturing industry, and her healing journey through therapy and powerlifting, which led her to discover human design. Now, with her tech platform, she helps teams understand their unique working and decision-making styles to improve leadership and team dynamics. Emily Adams LinkedInLeading with Human Design Website“From Choice to Change” BookDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

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

This special episode of the podcast is a recording of a panel discussion that took place at the 2025 Ohio VC Fest powered by @JumpStart Inc. entitled "AI-Driven Healthcare: The Heartland Advantage." Panelists include Michael Dalton (CEO & Founder at @Ovatient), Kaleigh Gallagher (VP of Tech Services & Network Management at @JumpStart), Matthew Zenker (Director of Tech Partnerships & Investments at @University Hospitals Ventures), Jennifer Owens (Senior AI Program Administrator at @Cleveland Clinic), and moderated by Duane Mancini. The conversation dives into the rapidly-growing AI-driven healthcare innovation in the Midwest, exploring the unique advantages the region faces. The discussion covers various topics including talent acquisition, clinical validation, partnerships with healthcare systems, and the role of data in accelerating growth.Michael Dalton LinkedInKaleigh Gallagher LinkedInMatthew Zenker LinkedInJennifer Owens LinkedInJumpStart Inc. WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

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, 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

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

In this episode, Duane Mancini sits down with Amy Rinaldo, Partner at Ward Law Office, to discuss the strategic intricacies of intellectual property in the medtech industry. Amy shares her extensive experience in patent and trademark law, exploring the intersection of IP strategy with regulatory compliance and commercialization. The conversation covers the importance of comprehensive IP planning, the nuances of patents, trademarks, copyrights, and trade secrets, as well as global IP considerations for medtech startups. Amy Rinaldo LinkedInWard Law Office WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini sits downs with Leo Eisner, a seasoned expert in medical device safety and compliance, as he shares his extensive experience and knowledge on the IEC 60601 standards. With a career spanning over 40 years, Leo talks about his beginnings at NASA, his role in the development of medical safety standards, and the intricacies of compliance testing. Discover the complexities of the IEC 60601 updates, the importance of staying informed, and practical advice for medical device manufacturers.Leo Eisner LinkedInEisner Safety Consultants WebsiteImpacts on IEC 60601-1 WebinarDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini chats with Logan McKnight, a seasoned professional with a vast background in medtech. Logan shares her journey from starting in medical services and neuromonitoring to leadership roles, culminating in the establishment of her consulting firm, GoodKnight Consulting. The conversation dives into the nuances of managing corporate and field leaders, the importance of transparency, communication, and trust in leadership, and the complexities of managing people. Logan also highlights the benefits of feedback mechanisms like 360 reviews and underscores the significance of self-awareness and mindset in effective leadership.Logan McKnight LinkedInGoodKnight Consulting Website“Mindset: The New Psychology of Success” by Carol Dweck “The Culture Code: The Secrets of Highly Successful Groups” by Daniel CoyleDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini welcomes back Kevin Saem, Managing Director of Zapyrus, for an enlightening discussion on the future of the MedTech industry. The episode delves into the latest trends in medtech funding, highlighting a significant increase in investments outside the U.S., the pivotal role of diagnostic technologies, and the importance of clinical data over revenue for attracting investments. Kevin shares groundbreaking advancements in data analytics and predictive machine learning applications, helping medtech companies and service providers enhance their commercialization strategies and efficiency. Kevin Saem LinkedInZapyrus WebsiteZapyrus H1/Q2 2025 MedTech Financial ReportDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini chats with Lisa Jacobs, US President of eCential Robotics and Founder of STRIPES. With over 20 years of experience in orthopedics, robotics, and spine, Lisa delves into her motivations, challenges, and significant career milestones, including her personal connection to orthopedics through her brother's medical condition. The conversation covers her leadership style, emphasizing hands-on mentorship and the importance of not rushing commercialization efforts in startups. Lisa also discusses her organization, STRIPES, a women-focused networking group in medtech offering mentorship and support to help break industry barriers.Lisa Jacobs LinkedInSTRIPES Network Website eCential Robotics WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini sits down with Walter Haydock, founder of StackAware and former Marine Corps intelligence officer, to explore the intersection of AI, cybersecurity, and startup leadership in the healthcare and life sciences sectors. Walter shares how his military background informs his approach to risk, decision-making, and company building, and offers practical strategies for navigating regulatory challenges, implementing effective AI governance, and avoiding common pitfalls as a healthtech founder. Walter Haydock LinkedInStackAware WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini welcomes to the show Eduardo Palma, a senior analyst at 415 Capital, a VC firm specializing in cardiovascular medtech investments. Eduardo shares insights on his background, the emergence of Portugal as a VC hub, and the strategic advantages of their Munich base. The conversation explores 415 Capital’s origin, investment thesis, and their unique focus on clinical-stage PMA-track devices. Highlights include the critical role of clinical data, strategies for effective fundraising, and the importance of teamwork between VCs and startups. Eduardo also discusses the challenges and learning experiences of raising a second fund, offering invaluable advice for startups aiming to stand out in their pitches.Eduardo Palma LinkedIn415 Capital LinkedIn415 Capital WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

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

In this episode, Duane Mancini welcomes to the show Dasha Tyshlek, Founder & Chief Strategic Officer of StratCraft. An innovator who's bridging the gap between groundbreaking research and market-ready technologies, Dasha shares her fascinating journey from a science-loving student to a leader in the medtech, biotech, and defense industries. Learn how her experiences at Bridgewater Associates and Micro-Ant have shaped her approach to strategic planning and commercialization, discover the mission behind her consulting firm, StratCraft, and the impact of her Biomedical Frontiers podcast. Plus, get an inside look at the upcoming Disrupt Health conference in Jacksonville, where real-world case studies and innovative discussions promise to elevate the industry.Dasha Tyshlek LinkedInStratCraft WebsiteDisrupt Health Event WebsiteBiomedical Frontiers Podcast“Principles: Life & Work” by Ray DalioDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

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

In this episode, Duane Mancini welcomes Bob Roda, President and CEO of HemoSonics, to discuss the essential components of building a successful and purpose-driven career in the medical device industry. The conversation explores Bob's formative experiences at Johnson & Johnson and Becton Dickson, the critical need for purpose as a guiding principle, and the continuous process of learning and absorbing information. They delve into practical strategies for building brand equity, the intricacies of the selling process, and the thinking behind acquisition strategy and innovation, including his commercial due diligence on CareFusion. The episode also introduces the value of context and being humbled, highlighting how vulnerability creates connection and why adapting your communication style like a "chameleon" is crucial for impactful leadership.Bob Roda LinkedInHemoSonics WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini welcomes Brian Morley, CMO of Native Orthopaedics, and returning guest Tino Chow, CEO and Founder at Giant Shoulders, to discuss the critical aspects of building and growing a medtech brand. The conversation explores Brian's journey into Native Orthopaedics, the importance of a clear, operationalized vision for startups, and how to effectively balance creative ideation with execution. They delve into practical strategies for achieving brand alignment, identifying when a rebrand is necessary, and leveraging the digital age for reach. The episode also introduces the valuable concept of visionary and integrator roles, highlighting how a strong brand can serve as an integrator to connect a company's vision with its team and partners.Brian Morley LinkedInNative Orthopaedics WebsiteTino Chow LinkedInGiant Shoulders WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini reconnects with Joseph Mocanu, Managing Partner at Verge HealthTec Fund, for a follow-up to their insightful conversation in episode 103. Joseph shares the significant milestones Verge HealthTec Fund has achieved since their last discussion and offers a glimpse into what we can anticipate in the coming years. The conversation takes a critical look at the venture capital landscape, exploring what needs to change and addressing the often-broken feedback loop between startups and investors. We delve into the importance of developing technologies with a global impact, the strategic advantages of a global approach to collecting clinical data, and navigating the complexities of various healthcare systems across the world. Tune in for a thought-provoking discussion on the future of healthtech investment and innovation.Joseph MocanuVerve HealthTech FundDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini is joined by Harrison Lands, Director of Translational Sciences at UPMC Enterprises. Harrison brings a unique perspective, shaped by his background as a physician, MBA, consultant, and now investor. We delve into the workings of UPMC Enterprises, exploring their investment thesis – the who, what, how much, when, and how their fund operates. Harrison also sheds light on the powerful advantages of UPMC's payer/provider integrated medical system and its impact on fostering innovation. The conversation touches on the vibrant Pittsburgh life science community, Harrison's time at the University of Virginia, and insights from CvilleBioHub. Tune in to understand how a major integrated health system strategically invests and drives translational science forward.Harrison Lands LinkedInUPMC Enterprises WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini sits down with Isaiah Kaiser, Co-Founder and CEO of Auxilium Health, and Elyse Ball, Vice President of Programming at Bounce Innovation Hub. Fresh off Auxilium Health's exciting $1.5M oversubscribed pre-seed round and new office at Cleveland Clinic, Isaiah returns to share their journey since his first appearance in episode 147. Elyse discusses the vital role of Bounce Innovation Hub in supporting startups and how her journalism background aids in her work. Together, they delve into navigating the regional iCorp program and the JumpStart accelerator, offering invaluable advice for raising capital and maneuvering the startup landscape. Tune in to hear their insights and get a glimpse into Auxilium Health's next major milestones.Isaiah Kaiser LinkedInElyse Ball LinkedInDuane Mancini LinkedInAuxilium Health WebsiteBounce Innovation Hub WebsiteProject Medtech WebsiteProject Medtech LinkedIn

In this episode, Duane Mancini interviews Devon Campbell, Christie Johnson, and Dan Tipaldo to continue the theme from episodes 207, 208, and 209 about how startups can effectively 'do it yourself' when budgets are tight, this episode tackles the next frontier: Artificial Intelligence. We acknowledge that resource-strapped startups need to be resourceful, but how can AI help avoid costly mistakes and actually accelerate progress? Join us as we explore practical ways startups can leverage various types of AI – often at low or no cost – to improve internal processes, support essential tasks, and ultimately keep moving the needle forward without breaking the bank. Tune in to learn how AI can become a powerful tool in your startup's DIY toolkit.Devon Campbell LinkedInChristie Johnson LinkedInDan Tipaldo LinkedInDuane Mancini LinkedInProdct WebsiteProject Medtech WebsiteProject Medtech LinkedIn