Project Medtech

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 LinkedIn

Council Website

Duane Mancini LinkedIn

Project Medtech Website

Project 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...

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 LinkedIn

indieMedTech Website

Duane Mancini LinkedIn

Project Medtech...

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 br...

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 LinkedIn

Giant Shoulders Website

Lindsey Dinneen LinkedIn

Duane Mancini LinkedIn

Project Medtech Website

Project Medtech...

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 LinkedIn

Ward Law Office Website

Duane Mancini LinkedIn

Project Medtech Website<...

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 LinkedIn

Eisner Safety Consultants Website

Impacts on IEC 60601-1 Webinar<...

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 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 LinkedIn

Zapyrus Website

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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 LinkedIn

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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 LinkedIn

StackAware Website

Duane Mancini LinkedIn

Project Medtech Website

Project 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 fo...

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...

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...

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 LinkedIn

PitchBook Website

Duane Mancini 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...

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...

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...

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...

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 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 t...

In this episode, Duane Mancini interviews Joao Rezende-Neto on his remarkable journey through the global landscape of medicine and innovation. From medical training in Brazil to a trauma fellowship in the US, exposure to Boston's cutting-edge medical advancements, and experiences in Canada, this episode explores the unique insights gained from navigating diverse healthcare systems. Discover how these international experiences spurred the drive to bring innovative solutions across borders, adapting ideas from Boston for Brazil and vice versa. We delve into the critical considerations of clinically relevant research, fostering effective collaborations between clinicians and business leaders, and the balance of scientific...

In this episode, Duane Mancini interviews Kelly Collier at LifeX on the dynamic life science startup ecosystem thriving in Pittsburgh. We explore the unique synergy between major academic institutions like the University of Pittsburgh and Carnegie Mellon University, and healthcare giants such as UPMC and Allegheny Health Network. Discover Kelly's entrepreneurial journey and learn how LifeX provides crucial support and programming for emerging life science companies. We also discuss the common pitfalls startups face and the specific advantages Pittsburgh offers to innovators. Tune in to understand the key ingredients fueling Pittsburgh's rise as a life science hub.Kelly Collier LinkedInLifeX...

In this episode, Duane Mancini explores the critical aspects of medtech regulation and product development with Niki Caporali Spaniel and Chad Gibson of CMD Medtech. Niki shares her expertise in post-market clinical follow-up and navigating the complexities of the Medical Device Regulation (MDR). Chad emphasizes the importance of integrating cybersecurity throughout the product lifecycle, rather than treating it as an afterthought. They both discuss the significance of robust design controls, the pitfalls of inadequate planning, and the power of leveraging professional networks. The conversation highlights how regulatory considerations should inform decisions across all business functions, and the crucial role...

In this episode, Duane Mancini delves into the life science ecosystem in Kentucky with Christin Godale, Executive Director at LifeSciKY, and Nicholas Lyktey, Chief of Laboratory Operations at Gravity Diagnostics. Christin discusses the collaborative, bipartisan efforts driving innovation in the Commonwealth, including the launch of strategic initiatives and the benefits available to participating companies. Nicholas shares the remarkable growth story of Gravity Diagnostics, from a startup with 30 employees to a powerhouse of 330, highlighting the challenges and successes of rapid scaling. We also explore the partnership between Project Medtech and LifeSciKY and how it is shaping the future of the...

In this episode, Matt Sokany joins Duane Mancini at Project Medtech to share his extensive experience in the medtech industry, from his time at Ethicon Endosurgery (Johnson & Johnson) to his impactful journey in the startup world. Matt details his strategic approach to building successful companies, including his remarkable exit with New Wave Surgical, which raised less than $3M and sold for $115M. Matt also discusses his leadership at Standard Bariatrics, emphasizing the importance of setting quarterly and two-year goals, fractionalizing key departments like CFO and regulatory/quality, and securing strong legal and board support. He highlights the crucial role...

In this episode, Tim Grace, Managing Partner at Techstars Columbus, joins Duane Mancini to unpack the dynamic world of startup acceleration and venture funding. Tim shares his journey from a tech background to leading a pivotal Techstars program, and discusses the creation of the LongJump venture fund. We delve into the origins and growth of Techstars Columbus, exploring the successes of its various cohorts and the unique ecosystem it fosters. Tim provides invaluable insights into common startup pitfalls, particularly the critical mistake of neglecting customer validation. We also cover essential strategies for preparing for fundraising, and the key factors...

In this episode, Antony Watson, COO of Xenocor, joins Duane Mancini to share his journey from Medtronic sales rep to startup founder. Antony discusses his experience in the operating room, observing surgical cases firsthand, and how this unique perspective shaped his leadership approach and ultimately prepared him to launch and lead Xenocor. Discover how valuable lessons learned in the field can translate to success in the startup world. Tune in for insights on transitioning from a corporate environment to the challenges and rewards of entrepreneurship in the medtech industry.

Antony Watson LinkedIn

Xenocor LinkedIn

In this episode, Yaky Yanay, CEO at Pluri, joins Duane Mancini to explore the captivating world of regenerative medicine and the unwavering resilience required to lead in the life sciences. We delve into the profound power of cells and how Yaky's deep scientific understanding fuels Pluri's entrepreneurial success. Yaky shares invaluable insights on work-life integration, the gradual discovery of one's authentic CEO voice, and the undeniable truth that a strong management team is a company's greatest asset. We also discuss the crucial role of cultivating long-term relationships and the enduring passion that drives innovation in this vital field. Tune...

In this episode, Tino Chow, CEO and Founder of Giant Shoulders, joins Duane Mancini for a deep dive into the power of branding in the medtech industry. 1 Tino, a "three-headed monster" with experience in the military, industrial design, and business, shares his expertise on building a brand strategy that empowers "on-brand" decisions, even in the absence of leadership. 2 Discover how to leverage your brand as a tool, navigate the different phases of brand development, and connect with your audience on a personal and emotional level. Tune in for valuable insights on scaling your brand internally and externally and creating...

⁠Jana Montgomery LinkedIn

ActiVie LinkedIn

⁠⁠⁠⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

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⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠Midwest Showcase Registration⁠

In this episode, Susan Xu, Principal at WyDus, joins Duane Mancini to unravel the complexities of reimbursement in the digital health landscape. Susan explains how Medtech startups can navigate the system to get paid for their innovations, covering everything from Health IT and wearables to telehealth and AI. Learn about the crucial role of diagnosis and treatment, key codes like RPM, and the importance of clinical data in securing reimbursement. Tune in for expert insights and ensure your digital health venture gets the financial support it deserves.

⁠Susan Xu LinkedIn

⁠⁠⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠...

In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Tino Chow, Founder, and CEO at Giant Shoulders, join Duane Mancini to discuss building a strong Medtech brand without big budgets. Learn how to develop a compelling brand strategy, create a professional website on a shoestring budget, design impactful pitch decks, and maximize your brand's reach with limited resources. Tune in for actionable insights and create a powerful brand identity that sets your Medtech startup apart.

Devon Campbell LinkedIn⁠⁠

Tino Chow LinkedIn

⁠⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠Midwest Showcase Registration⁠

In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Eric O'Dell, Consultant at Project Medtech, join Duane Mancini in a must-listen for bootstrapped Medtech founders! This episode provides a DIY guide to managing your startup's finances without hiring expensive professionals. Learn how to set up bank accounts, choose the right corporate structure, master basic accounting with QuickBooks and spreadsheets, manage your cap table, and navigate taxes. Tune in for actionable advice and build a strong financial foundation for your Medtech venture, even on a limited budget.

Devon Campbell LinkedIn⁠

Eric O'Dell LinkedIn

In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Tom Morgan, Chief Scientific Officer at myBiometry, join Duane Mancini for a practical discussion on optimizing early development for Medtech startups.
Devon and Tom highlight the crucial role of organization, process, and software in driving efficiency and success, even before a startup officially launches. They delve into the importance of defining direction, utilizing tools like Lucid, Coggle, Monday, and Notion, and implementing robust ELNs.
Learn how to foster a culture of quality and compliance from the outset, while remaining scrappy and resourceful. Gain valuable insights...

In this episode, Simon Malpas, CEO of Kitea Health, joins Duane Mancini to share his incredible journey from blood pressure researcher to Medtech CEO. Simon details Kitea Health's innovative brain pressure implant, revealing the challenges and triumphs of navigating clinical trials and the FDA's PMA process as a startup.
Hear firsthand accounts of Kitea's dedication – from attending every surgery during their pilot study to building a strong company culture. Simon discusses the critical role of fundraising, strategic planning, and execution in achieving success in the Medtech industry. Tune in for invaluable insights into leadership, perseverance, and the future of...

In this episode, Kirk Petyo at Talent Factory Recruiting and Duane Mancini discusses his background in recruiting, how startups attract talent, the biggest mistakes companies make in hiring, managing company culture, implementing a successful onboarding process, and so much more.

Kirk Petyo LinkedIn

Talent Factory Recruiting LinkedIn

Talent Factory Website

⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠Midwest Showcase Registration

In this episode, Shalabh Gupta at Unicycive Therapeutics and Duane Mancini discuss going from a practicing physician to a biotech entrepreneur, why he made the switch, lessons learned in his career, how to think about your career long term and not short term, how he took his company public, measuring success, his best advice and so much more.

Shalabh Gupta LinkedIn

Unicycive Therapeutics LinkedIn

Unicycive Therapeutics Website

⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠

Midwest Showcase Registration

In this episode, Eric Eskey at Dark Horse Works and Duane Mancini discuss his background as an engineer, understanding what your customer wants, recommended books about innovation, behavioral economics, early adopters vs. laggers, common mistakes, his best advice to entrepreneurs, and so much more.

Eric Eskey LinkedIn

Dark Horse Works LinkedIn

Dark Horse Works Website

⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠Beginski Wegner & CO⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠Rook Quality Systems⁠⁠⁠⁠⁠⁠

In this episode, Staci Miller at Gen UX Consulting and Duane Mancini discusses her background as a fashion designer, cognitive psychology, how she got into human factors testing, what she learned from her time with Medtronic and Abbott, and so much more.

Staci Miller LinkedIn

Gen UX Consulting LinkedIn

Gen UX Consulting Website

Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠Beginski Wegner & CO⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠Rook Quality Systems⁠⁠⁠⁠⁠⁠

Kymanox

In this episode, Emma Scharfenberger Off at CincyTech and Duane Mancini discuss her background as an M&A lawyer, who is CincyTech and what they are focused on, how to leverage your board, decision-making within startup companies, bridge rounds, how to create value and so much more.⁠⁠⁠⁠⁠

⁠Emma Scharfenberger Off LinkedIn⁠

⁠CincyTech LinkedIn⁠

⁠CincyTech Website⁠

⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠Beginski Wegner & CO⁠

⁠⁠⁠⁠⁠⁠⁠Rook Quality Systems⁠⁠⁠⁠⁠⁠

⁠⁠In this episode, Aaron TenHuisen, Jamie Easterling, and Rich Mazzola at Project Medtech and Duane Mancini discuss the growth at Project Medtech, the growth of the commercial consulting group, our expansion into talent and quality support, and so much

⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠

⁠Aaron TenHuisen LinkedIn⁠

⁠Rich Mazzola LinkedIn⁠

⁠Jamie Easterling LinkedIn⁠

⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠Rook Quality Systems⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠Beginski Wegner & CO⁠

⁠Kymanox LinkedIn

⁠In this episode, Aaron TenHuisen, Jamie Easterling, and Rich Mazzola at Project Medtech and Duane Mancini discuss the growth at Project Medtech, the growth of the commercial consulting group, our expansion into talent and quality support, and so much

Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠

Aaron TenHuisen LinkedIn

Rich Mazzola LinkedIn

Jamie Easterling LinkedIn

⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠

⁠⁠⁠⁠Mittal Consulting ⁠⁠⁠⁠

⁠⁠⁠⁠Rook Quality Systems⁠⁠⁠⁠

⁠⁠⁠⁠Beginski Wegner & CO

Kymanox LinkedIn

In this episode, Rebecca McManus at Amethyst Care and Duane Mancini discusses the technology she is working on out of Trinity College of Dublin, their next 18 months, the innovation scene in Dublin, Ireland, her interest in Northeast Ohio, Adapt Research Center, lessons learned so far, how she overcame the anxiety of how long everything takes in Medtech, and so much more.

Rebecca McManus LinkedIn

⁠Amethyst Care Start Up Project LinkedIn

⁠⁠Amethyst Care Start Up Project Website⁠

⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠

⁠⁠⁠⁠Mittal Consulting ⁠⁠⁠⁠

⁠⁠⁠⁠Rook Quality Systems⁠⁠⁠⁠

⁠⁠⁠⁠Beginski Wegner

In this episode, Crystal Weber at Group 31 and Duane Mancini discuss her second career as a marketing expert, how her first career as a nurse prepared her for this role, the importance of tailoring messaging to investors, how to position your product in the healthcare system, and so much more.

Crystal Weber LinkedIn

Group 31 Communications LinkedIn⁠

⁠Group 31 Communications Website

⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠

⁠⁠⁠Mittal Consulting ⁠⁠⁠

⁠⁠⁠Rook Quality Systems⁠⁠⁠

⁠⁠⁠Beginski Wegner & CO

In this episode, Todd Ponsky at Cincinnati Children's and Duane Mancini discuss his background as a pediatric surgeon, his startup company that he launched around education, the changes to the innovation and venture arm of Cincinnati Children's, the importance of having a supportive hospital leadership team for the innovation department, and so much more.

Todd Ponsky LinkedIn

Cincinnati Children's LinkedIn

Cincinnati Children's Website

⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠

⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠

⁠⁠Mittal Consulting ⁠⁠

⁠⁠Rook Quality Systems⁠⁠

⁠⁠Beginski Wegner & CO

In this episode, Dylan Horvath at Cortex Design and Duane Mancini discusses how he founded his company, features vs. innovations, lessons learned, common mistakes, and so much more.

Dylan Horvath LinkedIn

Cortex Design LinkedIn

Cortex Design Website

Duane Mancini LinkedIn⁠⁠⁠⁠

⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠

⁠⁠⁠⁠Project Medtech Website ⁠

⁠Mittal Consulting ⁠

⁠Rook Quality Systems⁠

⁠Beginski Wegner & CO

In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the globe, common mistakes and so much more.

Don Pohl LinkedIn

Sheri Krajewski LinkedIn

NAMSA LinkedIn

NAMSA Website

Duane Mancini LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech Website

Mittal Consulting

Rook...

In this episode, Omar Khateeb at Khateeb & Co. and Duane Mancini discuss carrying the bag, growth marketing, talking to investors, meeting with early adopters, his podcast The State of Medtech, speed learning, building loyal customers and so much more.

Omar Khateeb LinkedIn

Khateeb & Co. Website

State of Medtech Podcast

⁠Duane Mancini LinkedIn⁠⁠

⁠⁠Project Medtech LinkedIn⁠⁠

⁠⁠Project Medtech Website

In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneurs, and so much more.

⁠Kristen Mittal LinkedIn⁠

⁠Mridul Mittal LinkedIn⁠

⁠Mittal Consulting LinkedIn⁠

⁠Mittal Consulting Website ⁠

⁠Duane Mancini LinkedIn⁠

⁠Project Medtech LinkedIn⁠

⁠Project Medtech Website

In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneurs, and so much more.

Kristen Mittal LinkedIn

Mridul Mittal LinkedIn

Mittal Consulting LinkedIn

Mittal Consulting Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Monica Vajani at mHUB and Duane Mancini discuss her background at Abbott and Medtronic, carrying the bag, early adopters vs. laggers, mHUB, the next cohort of companies for their medtech accelerator, and so much more.

Monica Vajani LinkedIn

mHub Medtech Accelerator Application

mHub LinkedIn

mHub Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Craig Misrach at UpLyft and Duane Mancini discuss what has changed since his last appearance on the podcast, choosing and changing your contract manufacturer based on the commercialization stage, the importance of quality, creative ways to finance your startup, and so much more.

Craig Misrach LinkedIn

UpLyft LinkedIn

UpLyft Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Hilary Swan at Rebel Scout Consulting and Duane Mancini discuss her background in the medtech space, inside sales vs. outside sales, tips for selling into a hospital, the user journey, the importance of implementation and so much more.

Hilary Swan LinkedIn

Rebel Scout LinkedIn

Rebel Scout Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Megan Doberstein at Ignite Medtech and Duane Mancini discuss her background in the medical device space, marketing for a direct to consumer medical device, understanding all your customer profiles, strategically marketing to all of those customers and so much more.

Megan Doberstein LinkedIn

Ignite Medtech LinkedIn

Ignite Medtech Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Tim Lucas at The NeuroTech Institute and Duane Mancini discuss why Universities have historically struggled to commercialize innovation, the Broad Institute, how he modeled the NeuroTech Institute after it, achieving clinical adoption, and so much more.

Tim Lucas LinkedIn

The NeuroTech Institute Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Kathryn Dougherty at KCD and Duane Mancini discuss her background in the medtech space, the intersection of finance and marketing, upstream and downstream marketing, the difficulties of being an entrepreneur, her best advice for medtech startup companies and so much more.

In this episode, Matthew Schonauer and Anthony Tomusko at UB Greensfelder and Duane Mancini discuss what led them into being life science-focused IP attornies, the process of engaging an IP attorney, the intangibles an IP attorney can bring to the team, freedom to operate and so much more.

In this episode, Simon Mason at NEST and Duane Mancini discuss the NEST program with the FDA, real-world evidence and so much more.

In this episode, Matt Iorio at Neuros Medical and Duane Mancini discuss his background in the Medtech space, the collection of clinical data, the importance of clinical data for regulatory and commercial purposes, and so much more.

In this episode, Rick Geoffrion at Cyrano Therapeutics and Chip Hance at Regatta Medical and Duane Mancini discuss history of the Early Feasibility Studies (EFS) Program at the @FDA, the importance of it, how @MDIC supported mission and so much more.

In this episode, Andrew Fish and Joseph Sapiente at Medical Device Innovation Consortium (MDIC) and Duane Mancini discuss the mission of MDIC, the various initiatives and programs, how to engage MDIC and so much more.

In this episode, Brittani Ritchie at Project Medtech and Duane Mancini discuss her background in the Medtech industry, making quality a part of your culture, what to expect in an FDA audit and so much more.

In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.

In this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.

In this episode, Kevin Saem at Zapyrus and Duane Mancini discuss what Zapyrus does, their 2023 Medtech report on the industry and so much more.

In this episode, Katrina Holland at MedTech Color and Duane Mancini discuss her new role at MedTech Color, closing the diversity gap in Medtech, her short, medium and long term vision of Medtech Color, and so much more.

In this episode, Ken Callahan at The Hargan Group and Duane Mancini discuss his background with HHS, what startups need to know about the department, what are the biggest policy decisions being discussed right now, how the upcoming election could affect those policies, big issues coming up in 2025 and beyond, and so much more.

In this episode, Tim Boire and Geoff Lucks at VenoStent and Duane Mancini discuss their background in the Medtech space, how they founded VenoStent, their clinical trial, fundraising strategy, and its correlation to achieving milestones and so much more.

In this episode, Ronan O'Hagan at Bectas Therapeutics and Duane Mancini discuss the overlap between pharma and medtech, what can a medtech company learn from a pharma startup, the importance of communicating science in a digestable manner, building your team, fundraising strategy and so much more.

In this episode, Matt Eisendrath at Full Spectrum Software and Duane Mancini discusses his background in the medtech space, software as a medical device vs. digital therapeutics, what excites him about the future of Medtech and so much more.

In this episode, Angelica Maestas at Healthtech Rx and Duane Mancini discuss her time in the Medtech space, health economics and reimbursement, her obsession with data analytics, taking a company through an exit, her passion for ending health inequities and so much more.

In this episode, Eric Horesnyi at Matrix Requirements and Duane Mancini discuss his background as an entrepreneur, quality management systems and the importance of quality as a key pillar for culture, and so much more.

In this episode, Ryan Confer at Genprex and Duane Mancini discuss his background in startup companies, the importance of understanding finances in an early-stage company, why they took Genprex public, and so much more.

In this episode, Mark Dybul at Renovaro Biosciences and Duane Mancini discusses his background in the US government, what they are working on at Renovaro Biosciences, the importance of being able to communicate complex problems in an easy-to-understand way, and so much more.

In this episode, Anish Kaushal at Amplitude Ventures and Duane Mancini discuss his background in the medtech space, his transition from being a medical doctor to venture capitalist, his new book and so much more.

In this episode, Jeffrey Sirek at PRIA Healthcare and Duane Mancini discuss the importance of health economics and reimbursement, scaling a medtech service company, the culture of a growing company, and so much more.

In this episode, Scott Filer at ProMedix and Duane Mancini discuss his background as a green beret, the problem with diagnosing sepsis, what he has learned in his entrepreneurial journey, and so much more. Scott Filer LinkedIn ProMedix Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Tosan Ugbeye at ScopeMed and Duane Mancini discuss his background as a clinician, the evolution of Scope Med, what he has learned so far, and so much more. Tosan Ugbeye LinkedIn Scope Med Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Karen Zaderej at Axogen and Duane Mancini discuss her background in the medtech space, the story of Axogen, how they are revolutionizing nerve repair and so much more. Karen Zaderej LinkedIn AxoGen Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Shawnnah Monterrey at BeanStock Ventures and Duane Mancini discuss Grassroots Dx, 3rd party review accreditation for FDA, software in Medtech, digital health and so much more. Shawnnah Monterrey LinkedIn BeanStock Ventures Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Howie Chan at Healthy Brand Consulting and Duane Mancini discuss brand development throughout the various stages of a Medtech startup company and so much more. Howie Chan LinkedIn Health Brand Consulting Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Randy Armstrong at Velentium and Duane Mancini discuss innovations, breakthroughs, and challenges in IPG development and so much more. Randy Armstrong LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Dan Purvis at Velentium and Duane Mancini discuss his background in the Medtech industry, how and why he founded Velentium, the importance of why and who, culture and so much more. Dan Purvis LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Susan Xu at WyDus and Duane Mancini discuss healthcare in the United States and its reimbursement maze, reimbursement of digital health products, what payers look for, and so much more. Susan Xu LinkedIn Link to Book by Susan Xu Project Medtech Website Duane Mancini LinkedIn

In this episode, Christopher Gates at Velentium and Duane Mancini discuss embedded cybersecurity for medical devices, the importance of addressing cybersecurity early, hackers, and so much more. Christopher Gates LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Chris Hanna at Pacific Therapy Access, Kathleen O'Neill at Pacific Therapy Access and Duane Mancini discuss the reimbursement process of medical technologies in the United States, the coding system, why reimbursement pathway is so important and so much more. Chris Hanna LinkedIn Kathleen O'Neill LinkedIn Pacific Therapy Access Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Brendan Boland at Loci Orthopaedics, Fionn Lahart at LUMA Vision, Gerard Insley at PBCbiomed and Duane Mancini discuss what each one of them are working on, the Medtech ecosystem in Ireland, what makes the ecosystem so strong, their favorite Irish Whiskey and so much more. Brendan Boland LinkedIn Loci Orthopaedics Website Fionn Lahart LinkedIn LUMA Vision Website Gerard Insley LinkedIn PBCbiomed Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Rich Mazzola and Duane Mancini discuss Rich's background in the Medtech space, what we can expect from him as host of the Medtech Money podcast series and so much more. Rich Mazzola LinkedIn Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Giovanni Lauricella and Duane Mancini discuss Giovanni's time as the @medtech money podcast host, what he learned, the connections he made along the way and so much more. Giovanni Lauricella LinkedIn Lifeblood Capital Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Devon Campbell and Duane Mancini discuss the due diligence process, what you need to be prepared to answer as a startup company, common errors, recommendations, and so much more. Devon Campbell LinkedIn Prodct Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Edward Steakley, Devon Campbell and Duane Mancini discuss intellectual property, patents, trade secrets, overall strategy around these topics, why they are important, and so much more. Edward Steakley LinkedIn Devon Campbell LinkedIn Cognition IP Website Prodct Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Nikki Batista, Devon Campbell and Duane Mancini discuss the merger of regulatory and business strategy, allowing business to lead decisions not regulatory, global regulatory strategy, how to communicate with the FDA, and so much more. Nikki Batista LinkedIn Devon Campbell LinkedIn MCRA Website Prodct Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Sean McKibben, Stefan Agamanolis, Rich Mazzola, Aaron TenHuisen and Duane Mancini discuss the problem they saw in the industry, the mission of Project Medtech, the growth and expansion of Project Medtech's consulting and advisory services and so much more. Sean McKibben LinkedIn Stefan Agamanolis LinkedIn Rich Mazzola LinkedIn Aaron TenHuisen LinkedIn Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Lissa Tallman and Duane Mancini discuss market research, when you should think about doing market research, the different kinds of market research, AI and Machine Learning in Market Research and so much more. Lissa Tallman LinkedIn Flashfield Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Salvatore Buscemi and Duane Mancini discuss his new book called “Investing Legacy: How the .001% invests”, family offices and how they evaluate opportunities and so much more. Salvatore Buscemi LinkedIn HRN Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Isaiah Kaiser and Duane Mancini discuss the technology they spun out of University of Akron, how his PhD helped him with his entrepreneurial skills, finding non-dilutive capital, their experience with the iCorp program, working with the University so that both parties win, what he has learned so far during his early journey of entrepreneurship, and so much more. Isaiah Kiser LinkedIn Auxilium Health Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Neal Piper and Duane Mancini discuss his personal tie to the problem they are solving, the importance of culture, the focus on team and problem, advice for raising capital, not delaying hard conversations, and so much more. Neal Piper LinkedIn Luminoah Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Katrina Rogers and Duane Mancini discuss the ecosystem in the Pacific Northwest of the United States, the new innovation cluster she is leading, her experience in quality and so much more. Katrina Rogers LinkedIn Evergreen Bioscience Innovation Cluster Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

In this episode, Meg Powell, Travis Manasco and Duane Mancini discuss 501 Ventures, Bio54, why don't we see more physicians take the lead at startup companies, the importance of talent for early stage Medtech companies, the growth in research triangle park (RTP) and what makes the ecosystem great, their best pieces of advice for startups, and so much more. Meg Powell LinkedIn Travis Manasco LinkedIn Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn