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In this episode of Tank Talks, host Matt Cohen is joined by John Ruffolo to dive deep into the rapidly evolving AI landscape, its economic ramifications, and Canada's growing potential as a global tech leader. They discuss pivotal topics, such as energy challenges in AI infrastructure, the rise of AI tokenization, and the impact of government policies on the sector. With a focus on the future of tech, investments, and the role of Canada, this episode offers an insightful look at where the industry is headed.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.AI Energy Demands & Canada's Opportunity (00:04:39)John and Matt discuss the massive demand for compute power in AI and Canada's potential to lead by meeting these energy needs. They highlight the importance of matching energy capacity with data center development to become a global tech leader.The AI CapEx Boom and the Trillion-Dollar Question (00:07:05)The discussion shifts to the booming capital expenditures in AI, with a particular focus on the rising costs of building AI infrastructure and whether this growth is sustainable in the long term.Canada's AI Strategy and Sovereign Identity (00:14:21)The conversation turns to Canada's AI strategy, with a task force focusing on innovation, research, and talent retention. John shares his thoughts on the potential challenges and opportunities for Canada in becoming a key player in the AI space.The SEC's Push for Tokenization in the U.S. (00:19:33)The episode also delves into the SEC's efforts to allow the tokenization of stocks and what this could mean for the financial industry and blockchain adoption.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
Today's guest is Faithe Toomy, Director of Voice of the Customer and Insights at Insulet. Insulet is a medical device company specializing in wearable drug delivery systems for diabetes care, combining engineering, clinical research, and digital health capabilities to develop automated therapeutic solutions. Faithe joins Emerj Editorial Director Matthew DeMello to discuss how data and AI are transforming call center operations while maintaining compliance and customer trust. Faithe also shares practical strategies for training agents, leveraging conversational analytics, and implementing AI tools that enhance workflow efficiency, improve first-contact resolution, and support a more confident, human-centered customer experience. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast!
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.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 Josh Vose.
This week on Taking The Pulse, Heather and Seth record at the NCLifeSci 2025 Annual Meeting with Bobby Patrick, Senior Vice President of Government Affairs at AdvaMed. Bobby shares how the world's largest medical technology association is advocating for expanded Medicare coverage of breakthrough devices, navigating the evolving role of AI in diagnostics, and addressing supply chain and tariff challenges. We also explore how AI is enhancing physician decision-making and how patient trust and data security remain central to innovation. Tune in now for a timely look at the policy and technology shaping the future of medtech.
Morrilton Chamber taking nominations for annual awards; Baby Box installation begins at Med-Tech; Calhoun Scholarship established at UACCM; Atkins Heritage Fest is Saturday; Model T club to visit Morrilton Depot Museum; Dogs fall out of top five; We visit with Michelle Jones and Holly Tramel with the MHS Homecoming Parade Committee
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, Goodnight 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 LinkedInGoodnight 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, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversation highlights the most common mistakes companies make, like treating security as an afterthought and jumping straight into coding without a solid architectural plan.Mohamad Foustok introduces the concept of "zero trust" and the critical importance of designing for security across the entire product lifecycle, from initial concept to post-market surveillance. The discussion clarifies that cybersecurity is not limited to network-connected devices but applies to any medical device with a software function, regardless of its connectivity. They also touch on the historical context of FDA guidance, noting a significant shift in recent years that has raised the regulatory bar and put a greater emphasis on robust cybersecurity documentation.The guests provide actionable advice for MedTech professionals, stressing the value of a balanced approach that integrates security and functionality from day one. They explain that a well-thought-out process, though seemingly slower at the outset, ultimately saves time and resources by preventing costly and time-consuming redesigns later on. This episode serves as a vital guide for anyone looking to build a secure and compliant medical device in today's evolving regulatory landscape.Key Timestamps[01:50] Common pitfalls in developing SaMD, including overlooking regulatory guidance like IEC 62304.[03:20] The critical mistake of treating cybersecurity as an afterthought in product development.[05:00] Who cybersecurity applies to beyond software, including patients, manufacturers, and supply chains.[06:30] The FDA's stance on cybersecurity for any device with a software function, even if not network-connected.[08:00] A discussion on "reasonable assurance of cybersecurity" and what it means for manufacturers.[10:00] The "zero trust" principle and why you should never assume a network is secure.[14:00] How hospitals and other stakeholders are demanding more rigorous cybersecurity standards.[15:40] The ideal process for a "security-first" development lifecycle.[21:00] Why rushing development without a proper architecture can lead to significant delays and cost overruns.[23:00] A brief history of FDA's cybersecurity guidance and the major shift in 2023.Quotes"Software as a medical device ultimately is a medical device, and so you want to be developing it from the get-go with that mindset." — Jose Bohorquez"Security can't be an afterthought. You have to consider security at the inception of your approach to a product." — Mohamed FustokTakeawaysA "Security-First" Mindset is Essential: Integrate cybersecurity from the initial architectural phase of your project. This proactive approach saves significant time and money by avoiding costly redesigns and delays later in the development process or after an FDA submission.Cybersecurity is for All Software-Driven Devices: Don't assume that only cloud-connected devices need cybersecurity documentation. The FDA requires documentation for any device with a software function, including embedded systems and programmable logic, even if it's not connected to a network.Regulatory Compliance is a Process, Not a...
Ofer Shalev is the CEO and founder of Newphase, a MedTech company that has developed a new treatment for advanced cancer patients. Their technology uses tiny particles that target and destroy cancer cells while leaving healthy cells unharmed, offering hope for patients when other treatments have stopped working. Avraham and sat down with Ofer to discuss how their technology works, how he came up with the idea, how he got funded, the challenges he's faced, tips for startup founders and much more. Do you have a great innovation? We'd love to hear from you. Contact us by going to https://jmbdavis.com/startup/contact. Learn more at https://jmbdavis.com and https://jmbdavis.com/startup. Also available at https://soundcloud.com/jmbdavis/ ofer-shalev-of-newphase. Listen to all of the episodes at https://jmbdavis.com/podcast.
In this episode of Tank Talks, host Matt Cohen is joined by John Ruffolo to discuss pivotal developments shaping Canada's economy and tech industry. They cover a range of topics, from Canada's immigration policies in light of changes to the U.S. H1-B visa program to the evolving AI landscape and its economic implications. John provides insights on how Canada could leverage these immigration shifts to attract global talent, while exploring the risks of inflated AI valuations and the potential for an AI bubble.The conversation also delves into the rising vendor financing model in AI, which could contribute to market instability, and examines whether the massive investments in AI infrastructure are sustainable. John reflects on the challenges facing Canadian companies, including the latest news from Constellation Software and its founder, Mark Leonard's resignation. Together, they explore how AI and its financial impact may create headwinds for established companies while offering opportunities for the Canadian tech sector to emerge as a global leader.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.AI CapEx Bubble: A Growing Concern (07:30)The conversation shifts to the massive capital expenditures in AI, with John analyzing the risks associated with overbuilding data center infrastructure and the possibility of a tech bubble.Vendor Financing in AI: A Dot-Com Repeat? (09:52)John draws parallels between current AI financing models and the early 2000s dot-com bubble, exploring whether companies are overexposed in the AI sector.The Future of AI Valuations (15:04)An in-depth discussion on the risks of inflated AI company valuations and the potential economic fallout.Canada's Immigration Advantage: H1-B Visa Adjustments (18:12)John and Matt discuss the implications of recent changes to the U.S. H1-B visa program and how Canada could use this shift to attract top talent.Constellation Software: A Transition and the Role of AI (27:09)John reflects on the recent news of Mark Leonard's resignation from Constellation Software and what this means for the company, especially in light of AI-driven changes.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
Se réconcilier avec sa zone de confort… et en faire une force. Laisser un message vocal S'abonner via votre App Suivre ce podcast via What's App C'était le thème de la dernière soirée Humana de Juin, et c'est exactement ce que Maud Larochette, CFO & DRH en mission dans la MedTech, est venue partager au micro du podcast hrmeetup.© – rubrique Humana. Dans cette courte capsule (4 min), Maud raconte ce que cette soirée lui a apporté : ✨ du fun et de l'énergie collective
In this episode of Tank Talks, host Matt Cohen sits down with Nejeed Kassam, a serial founder, investor, and advocate for positive change. With a journey that spans from launching his first business as a teenager to scaling and selling Keela, a CRM for nonprofits, Nejeed's experience offers valuable insights for entrepreneurs, especially those navigating the challenges of building tech-driven impact companies.Nejeed shares his entrepreneurial beginnings, the lessons he learned growing Keela, and the challenges he faced when taking on external funding. He also discusses his new venture, Rewire Digital Therapeutics, an AI-powered mental health company using gamification to help users manage depression and anxiety.From scaling Keela to navigating a successful exit, Nejeed dives into his journey and the key principles he follows in his entrepreneurial endeavors. Whether you're interested in nonprofit tech, mental health, or financial literacy, Nejeed's story provides inspiration and practical wisdom.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.Nejeed's Early Entrepreneurial Beginnings (08:12)* Starting a business at 14 with his brothers in Vancouver* Learning from early failures and the importance of sales in businessScaling Keela and the Path to Acquisition (15:17)* The journey from building Keela as a side hustle to scaling it into a successful company* The decision-making process behind bringing in external capital and navigating an exit* Insights on the acquisition process and private equity rollupsRewire Digital Therapeutics: Tackling Mental Health with AI (25:34)* How Nejeed's personal experiences with mental health drove him to create Rewire* Leveraging AI and gamification to address mental health issues like depression and anxiety* The future of digital therapeutics and its potential to impact millionsFinancial Literacy: Teaching Kids Money Management (35:11)* How Nejeed teaches his kids about financial literacy* Building the financial literacy platform, Snowball 72, and its impact on Gen Z and Gen Alpha* The importance of creating safe, accessible financial learning environmentsNejeed's Lessons on Building Impactful Businesses (45:23)* The importance of staying committed to solving meaningful problems* Building businesses that balance profit with positive societal impact* The role of resilience and discomfort in entrepreneurshipAbout Nejeed KassamNejeed Kassam is a serial entrepreneur, author, and advocate for positive change. He co-founded Keela, a CRM for nonprofits, which he successfully scaled and sold in 2024. He is now co-founder of Rewire Digital Therapeutics, a company focused on using AI and gamification to help people manage mental health issues like depression and anxiety. In addition to his work in tech, Nejeed is passionate about financial literacy and has launched Snowball 72, a platform aimed at teaching the next generation about money management. Nejeed's entrepreneurial spirit is driven by his desire to solve real-world problems and make a meaningful impact on society.Connect with Nejeed Kassam on LinkedIn: https://www.linkedin.com/in/nejeed/Visit the Keela website: https://www.keela.co/Visit the Rewire Digital Therapeutics website: https://rewiredigitaltherapeutics.com/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
In this episode of Business Ninjas, host Andrew Lippman sits down with Nikhil Rai of QNX, a BlackBerry subsidiary, to explore how their real-time operating system powers the automotive industry — and why the company is expanding into new frontiers like industrial automation, medical devices, and aerospace.From digital cockpits and over-the-air updates to mission-critical systems that demand zero failure, QNX has built its reputation on safety, reliability, and innovation. Now, the company is leveraging its dominance in automotive to become a global leader in embedded software across multiple industries.If you're curious about the future of automotive technology, industrial automation, and the hidden software powering our most critical systems, this conversation is one you don't want to miss.
Arecor Therapeutics PLC (AIM:AREC) CEO Sarah Howell talked with Proactive's Stephen Gunnion about the company's strategic updates, including a key partnership with Sequel Med Tech and a new royalty financing agreement with Ligand Pharmaceuticals. Howell explained that Arecor has partnered with Sequel, a US-based insulin pump device company, to advance its lead program AT278, described as “the only ultra-concentrated, ultra-rapid acting insulin in development.” Together, the companies will co-develop AT278 in combination with Sequel's twiist automated insulin delivery system, with phase 2 clinical trial preparations already underway. Each party has committed up to $1.3 million to fund development, with trial readiness targeted for 2026. Discussing the rationale for the partnership, Howell said Sequel “really bring innovation to the table, significant experience in terms of patient need, the market and also clearly commercialisation.” She noted the potential for AT278 and the Twist system to extend insulin pump wear times and support future miniaturisation, expanding access for people with diabetes. In addition, Arecor announced a royalty financing deal with Ligand Pharmaceuticals, securing up to $11 million in non-dilutive funding linked to partnered products using its Arestat technology. Howell said this extends the company's cash runway into the first half of 2027, while supporting development of AT278 and its oral peptide delivery platform. For more interviews and updates, visit Proactive's YouTube channel. Don't forget to like this video, subscribe to the channel, and enable notifications for future content. #ArecorTherapeutics #AT278 #DiabetesCare #InsulinPump #SequelMedTech #TwistSystem #DiabetesTechnology #BiotechNews #PharmaUpdates #ClinicalTrials
How Efficiency in Import and Distribution Logistics Drives Global Success?Efficient importation and distribution are no longer operational afterthoughts, they are strategic imperatives for pharmaceutical and MedTech companies seeking global expansion. But what are the hidden risks, and how can companies truly optimize their logistics while remaining compliant?In this episode of International Pharma Talks, Dr. Diogo Sousa-Martins, Founder and President of ELS Group, explores how mastering the complexities of global import and distribution logistics is key to regulatory compliance, operational efficiency, and patient safety.From navigating regulatory mazes to mitigating supply chain risks, we'll break down what separates companies that scale globally from those that stumble at the border.You'll learn more about:How regulatory compliance shapes logistics strategies across multiple marketsThe key certifications that open doors to international tradeCommon challenges in customs clearance and how to overcome themHow to prevent product recalls, supply interruptions, and reputational damageWhy robust quality systems and traceability are essential in combatting counterfeitsHow smaller companies can scale efficiently through strategic logistics planningIn a market where a single delay can cost millions, or put lives at risk, companies cannot afford inefficiency. Supply chains must be proactive, compliant, and resilient.Tune in now to understand how optimizing your import and distribution operations can drive faster market entry, reduce costs, and safeguard both your product and your patients.Learn more at els-solutions.comThis episode was recorded in 2025. Some of the data discussed may have changed since then. This podcast has been prepared using various bibliographic sources. The opinions expressed reflect the professional experiences of ELS members and referenced material.
Was macht das Innovation Forum Medizintechnik - veranstaltet von MedicalMountains GmbH, TechnologyMountains e.V. und IHK Schwarzwald-Baar-Heuberg - zu einem der wichtigsten Branchentreffs in Deutschland? Wer entscheidet über die Keynotes, wie laufen Planung und Organisation im Hintergrund – und welche Geschichten passieren abseits der Bühne? In dieser Folge von MedTalk on Air nimmt euch Julia Steckeler mit hinter die Kulissen eines Events, das mehr ist als Messe und mehr als Kongress. Zu Gast sind Britta Norwat, verantwortlich für Programm und Inhalte, sowie Marena Rothermund, die die Ausstellung und das Ausstellererlebnis mitgestaltet. Gemeinsam geben sie exklusive Einblicke in Planung, Teamarbeit und kleine Geheimnisse rund um das Forum. Themen sind u. a.: • Was das Innovation Forum auszeichnet – und für wen es gemacht ist • Wie das Programm entsteht – von der ersten Idee bis zur Keynote-Zusage • Warum die Ausstellung inzwischen innerhalb von 24 Stunden ausgebucht ist • Was hinter den Kulissen wirklich passiert – inklusive Anekdoten • Persönliche Highlights und Vorfreude auf 2025 Tipp: Das Innovation Forum 2025 findet am 23. Oktober in Tuttlingen statt. Infos & Tickets unter https://medicalmountains.de/innovation-forum-medizintechnik/
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Ahmed Elmouelhi, CEO of TRiCares. TRiCares is developing Topaz, the first purpose-built transcatheter tricuspid valve replacement system — a technology designed specifically for the right side of the heart, where complex anatomy has made durable solutions elusive.Ahmed is a 20-year medtech veteran with leadership experience across electrophysiology, men's health, neuromodulation, and structural heart. Before joining TRiCares, he helped build multiple businesses at AtriCure and held key roles at Medtronic during the early days of TAVR. He also serves as Chairman of the American Heart Association in Minnesota.In this interview, Ahmed shares why adoption — not added complexity — is the ultimate measure of medtech innovation, how a small group of physician champions can accelerate clinical studies faster than internal resources alone, and why treating your board like collaborators in the “sandbox” leads to stronger partnerships and better outcomes.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 Ahmed Elmouelhi.
Oakley Meta took center stage at Vision Expo West, where the Defocus Media team toured the EssilorLuxottica booth to see how AI, smart eyewear, and next-gen lenses can raise the bar on real-world patient care. Alongside Ray-Ban Meta and Nuance Audio, the team explored how design, fit, battery life, and everyday usability come together to help eye care professionals deliver better conversations in the exam lane and better outcomes in everyday life.
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
This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, defining the front end as the crucial period between applied science and new product development, where teams identify unmet clinical needs and shape a product concept. This conversation offers a clear roadmap for balancing creativity with structure, using the Design Council's Double Diamond model and Stuart's 10 key insights for observing user behavior.Stuart Grant's discussion on the front end of innovation highlights the importance of deeply understanding the user and the environment in which a device will be used. He introduces a number of tools and techniques, such as the Pugh Matrix and the NVivo software, to help teams transition from a broad exploration of ideas to a focused, viable product concept. Stuart explains that while the front end may seem "fuzzy," it can be a systematic process that uncovers the true clinical and market needs that will determine a product's success. He emphasizes that the most successful devices aren't just incrementally better, but are born from a deep understanding of customer insights.This episode is an essential guide for anyone involved in MedTech innovation, from academic researchers to seasoned engineers. Stuart's insights challenge the conventional reliance on key opinion leaders and provide a framework for a more holistic, user-centric approach. He outlines how to identify and interpret subtle user behaviors, from workarounds and unconventional uses to unspoken frustrations, all of which are critical for developing a truly impactful and user-friendly medical device. Whether you're at the very beginning of a project or looking to improve your current innovation process, this episode provides actionable strategies to bridge the gap between a great idea and a marketable product.Key Timestamps(2:00) Defining the "Front End": Stuart explains what the front end of innovation is and why its name has evolved from the "fuzzy front end."(8:00) The Double Diamond Model: An explanation of the UK Design Council's Double Diamond, illustrating the divergent and convergent phases of problem-solving.(12:30) Common Pitfalls: Discussing the three critical questions to answer: Is there a market (viability)? Is the technology possible (feasibility)? Do users want it (desirability)?(15:00) Balancing Creativity and Structure: The roles of different team members and how to manage the creative (divergent) and critical (convergent) phases of innovation.(21:00) 10 Ways to Find User Insights: Stuart breaks down the specific techniques and red flags to look for when observing users, including workarounds, affordances, and areas of disjuncture.(26:00) The Problem with KOLs: Why relying solely on key opinion leaders can be a mistake and the importance of observing a wider range of users.(30:00) Triggers of Use: How unconventional uses of a device can reveal new product opportunities.Standout Quotes"A craftsman will build you exactly what you ask for. An artist will build you what you didn't know you need." - Etienne Nichols"You don't just do what the customer says because that could lead to a terrible product." - Stuart GrantTakeawaysObservation is Key: Go beyond interviews. The most valuable insights come from observing users in their natural environment,...
Invitée : - Joana Cartocci,Cofondatrice de Robeauté Hébergé par Audiomeans. Visitez audiomeans.fr/politique-de-confidentialite pour plus d'informations.
Invitée : - Joana Cartocci,Cofondatrice de Robeauté Hébergé par Audiomeans. Visitez audiomeans.fr/politique-de-confidentialite pour plus d'informations.
Hur vänder man ett personligt trauma till en samhällsförändrande innovation? I det här starka avsnittet av Med målet i sikte möter vi Cissi Nilsson – grundare av Safety By Cilia – som delar med sig av sin resa från kris till kraft och hur hon idag bygger teknik som räddar liv. När tryggheten rämnade i Cissis liv föddes en idé som skulle visa sig få långt större betydelse än hon först anade. I det här avsnittet berättar hon om vägen till att starta företaget Safety By Cilia och om hur hennes egna erfarenheter format visionen att skapa ett tryggare samhälle för kvinnor. Det är en berättelse om mod, innovation och drivkraften att förändra. Med målet i sikte är en podd från Iris Hadar AB.www.iris.se
Welcome back to Let's Talk Medtech, where we're joined by returning guest Paul Grand, CEO of MedTech Innovator, for an essential conversation on securing capital in the medical technology space.In this value-packed episode, Paul reveals why successful fundraising requires a comprehensive, holistic approach rather than a narrow focus. He maps out proven strategies for medtech startups to attract and secure investment at various stages of development, drawing from his extensive experience in the industry.Paul also shares remarkable insights into how MedTech Innovator has successfully connected over 700 promising companies with investors, helping transform innovative ideas into market-ready healthcare solutions.Whether you're a medtech entrepreneur seeking funding, an investor looking for opportunities, or simply interested in the business of medical innovation, this episode delivers actionable wisdom from one of the industry's most respected voices.Subscribe to Let's Talk Medtech for more expert conversations on navigating the complex world of medical technology development and commercialization.
Dr. Adam Power, co-founder and Chief Medical Officer at Front Line Medical Technologies, shares his fascinating journey from a background in vascular surgery to developing COBRA-OS, a groundbreaking device for hemorrhage control. He discusses the challenges and milestones in bringing this life-saving technology to market, the impact of the device in trauma and emergency care, and innovative future applications, including its unexpected use in non-traumatic cardiac arrest. Guest links: https://frontlinemedtech.com/ Charity supported: Canadian Cancer Society 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 064 - Dr. Adam Power [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Dr. Adam Power. Dr. Power is a leader in innovative medical devices for trauma and emergency care that is committed to lowering the barriers and bleeding control and resuscitation. Dr. Power was instrumental in the development of COBRA-OS, drawing on his unique clinical viewpoint and expertise to ensure utmost patient safety and assist with the company's global expansion. In addition to his current role as co-founder and Chief Medical Officer at Front Line Medical Technologies Incorporated, Dr. Adam Power is a vascular surgeon in the division of vascular surgery at Western University, which he joined in the fall of 2012, and he is involved in all aspects of academics and clinical care. Also, Front Line was just named the 2025 Medical Device Technology Company of the Year, so I definitely wanted to highlight that too. All right. Well, thank you so much for being here today, Adam. I'm so delighted to speak with you. [00:01:55] Dr. Adam Power: Yes, it's a pleasure to be here. Thank you. [00:01:57] Lindsey Dinneen: Of course. Well, I'd love if you would start by sharing a little bit about yourself, your background, and what led you to what you're doing today. [00:02:05] Dr. Adam Power: Sure, I'd love to. So I'm a Canadian. I grew up on the east coast of Canada and was always interested in science and math and those types of things. I think, importantly, I grew up with an identical twin brother as well. So we really didn't know what we wanted to do with our lives, and ultimately we're good in science and math and ended up in medicine. And then both of us, when we got into medicine, we weren't sure exactly what we wanted to do in medicine, and ultimately both of us became surgeons. He became a urology surgeon, and I became a vascular surgeon, where we joke that we're both plumbers. I deal with the red stuff and he's the yellow stuff. But I did my initial medical school out on the east coast of Canada and then I did my general surgery training, which also involved trauma training, and then did a Master's of Bioscience Enterprise, which was basically biotech business from the University of Cambridge in the UK. When I finished my general surgery training, I continued on and did vascular surgery training at Mayo Clinic down in the US, and since that time after graduating from there, I've been at Western University in London, Ontario, Canada, for the past 13 years practicing as a vascular surgeon and an academic vascular surgeon. But when I was here at Western, I was always interested in innovation. I filed my first patent as a resident way back when, and have filed many over the years. But ultimately, if I was ever gonna see anything that came outta my head and was actually used in a patient or I could actually use in a patient, I figured I'd have to do it. I knew that I couldn't do it by myself. And so, I was very fortunate to meet my co-founder Dr. Asha Parekh. She's a PhD, biomedical engineer, extremely smart jack of all trades, and we teamed up now about eight years ago. We met here at Western, teamed up and really took an idea right out of our heads and patented it and raised money for it, prototyped it, brought it all through the regulatory steps to approvals, built a quality system and ultimately got it out onto the market in Canada, US, Europe, now Australia, and more to come. So the commercialization piece is what we've been focusing on over the past three years. And it's been really fun, but very exhausting but very rewarding as well. I think I'll stop there because I've been blathering on, but... [00:04:39] Lindsey Dinneen: No, it's fantastic. I really appreciate it. Plus, it's really fun to hear about your trajectory and so, okay, so you've teased us a little bit about this company of yours and this innovation of yours. Can you now share a little bit more about that and the development of it over time? [00:04:55] Dr. Adam Power: Yes, of course. Well, I mean, thing that we recognized early on is, and I'll just explain how I normally explain it, is if you have bleeding, it's a hemorrhage control device. And so if you have bleeding in your extremities, then you can often either put pressure on it or you can put a tourniquet on it. The problem when you have internal bleeding in the torso is that you can't actually put direct pressure on it, and there's no tourniquet that necessarily works for intraabdominal, intrathoracic bleeding. And when people bleed to death before coming to hospital, I mean, they're bleeding in these areas. You can empty almost your entire blood volume into your chest or into your abdomen. And this does account for a significant number of fatalities in all environments, basically in the trauma environment. That's military, that's pre-hospital, that's any time that that people are bleeding from internal organs. And so, because this is such a problem, the old fashioned way to fix it is to open up someone's chest and put a clamp on the aorta. So what does that do? Is it basically above the clamp, keeps blood flowing. The remaining blood in the body keeps blood flowing to the brain and the heart, keep you alive. And then below the clamp, it stops sort of the hemorrhaging from the spleen or the liver or whatever. So there's two things going on. One above the clamp and two below the clamp. But opening up somebody's chest in, you know, side of the road or in the emergency department really is impossible. You need highly skilled people like vascular surgeons like myself to be able to do this. And even if we were at the side of the road, we don't have the resources available to keep a patient alive. So there is this idea that we could do this minimally invasively, sort of accomplish this through minimally invasive means. And this, the idea of doing REBOA, which is an acronym-- Resuscitative Endovascular Balloon Occlusion of the Aorta-- came into being. This was probably 15, 20 years ago now. It wasn't necessarily a new idea. It had been done since the Korean War. There was somebody actually put a balloon up into someone's aorta to stop bleeding, but it came back again and was starting to be used a little bit more because. And so really the idea is to, through the femoral artery in your groin where you can feel a pulse, you introduce initially a sheath, which is your access point, and then you place the device up through the sheath, up into the aorta and inflate a balloon in the aorta. So instead of an external clamp, it's an internal balloon clamp that keeps blood flowing above the balloon and stops the blood flowing from below the balloon. Initially these devices were as big as my baby finger, like they were massive. And so if you put them in and you took it out, there was a big hole in the artery, had to cut down on the artery and repair the artery. But as it got more and more advanced and technology advanced, they become smaller and smaller. So that's really where we came in. The initial devices were 12 French, about the size of my baby finger. And then it advanced to Seven French and all of a sudden Seven French-- and these are diameter, French sizes are basically diameter-- and so when it went from 12 to seven French, now we could start doing it through the skin without actually cutting down on the artery. But that Seven French size was still very large and you're putting this in the hands of people that don't do this all the time. And so, we had the idea to bring it down even further now to Four French. And so this is essentially the size of an IV. And so you put a tiny little IV in somebody's femoral artery. And lots of different people can do that. And then you advance the device up in, inflate the balloon and you can magically occlude the aorta. In our first study that we did, the first inhuman study, we averaged about just over a minute to occlude someone's aorta, which was really fast to be able to get that amount of control that quickly. So that, that was really been the advancement is to decrease the access size, make this whole procedure simpler so that so that we can essentially save more lives. [00:09:08] Lindsey Dinneen: Okay, so thank you so much for sharing a little bit about that. Can you tell me about the beginnings of this innovation and how you brought it to market? Because it's really wonderful to hear all the success, and I'm so excited to hear that it's spreading, you have presence all over the place now. But you know, that's not an easy pathway. And I'm curious if you could walk us through a little bit about that decision to go, "You know what? We have a solution to a known problem, we can make this happen." And then how did you actually go about doing that? [00:09:42] Dr. Adam Power: Yeah. I think, I mean, I make it sound fairly straightforward, like a nice story, but it certainly was not that. I mean, we were very lucky I would say, that we had a lot of great advisors and mentors that we figured that we try not to fail early, fail fast. We wanted to make this one as successful as possible. So before we made any decision, we often would consult our mentors. And I'm a surgeon. I like to shoot first, ask questions later. My partner is not. And so I think we, we strike an excellent balance between not just the engineering and clinical side of things, but also from driving a business forward, getting all the information, but helping to get decisions made and moving forward. You know, starting out, we really had to choose the right sort of fit for what we wanted to pursue. We like to say it checked all the boxes. It checked all the boxes as far as even where we are. We're in Canada, we're not in a tech triangle where there's tons of funding opportunities. We knew we would be limited from a funding perspective, so we couldn't choose something that necessarily required a hundred million dollars to start up. So, you know, we had this device that we knew that we could fundraise for it. And then once it was fundraised, it was simple enough that we could get it manufactured. We chose to go the OEM route for the original equipment manufacturer, so we didn't have to build a manufacturing facilities ourselves. And then really from there, and building a quality system in the regulatory, we did work with a lot of consultants, that was both positive and negative experience. We had great consultants. We had not so great consultants. But really what our our goal was, is to learn the process ourselves. And so there's always manuals for things, even from the FDA perspective. They give out great documentation about what is supposed to go into an FDA application. And we dug into that. We really tried to understand. We did not trust anyone. That's one of my rules in surgery is, "don't trust anyone, not even myself." So we really didn't trust our consultants, and we tried to double check and triple check everything so that we didn't make mistakes. And of course, we did make mistakes and had to go back to the drawing board a few times. But as much as we wanted to get this out there, we really did wanna learn the process and know the process because ultimately we're the ones that are responsible to the patients in the end, and we needed to make sure that we had a handle on each and every step of the way. We, of course, because of that, were maybe not as quick as we could have been but in other places we became more efficient because, as we learned the process, getting feedback back and doing it right the first time, it really made a difference. So. [00:12:39] Lindsey Dinneen: Yeah, absolutely. Of course. Yeah, and I appreciate you going into a little bit more of the nitty gritty details 'cause it is so fun to hear the success stories, but of course, as you go along, there's that pathway to success. And it's helpful to understand that yeah, it's gonna be potentially a long road, sometimes windy, sometimes weird, but at the same time that it is possible. So as you look to the future with your company, what are you thinking of in terms of the future? Are you going to continue down this pathway and continue with iterations of this device? Are you thinking of new devices to introduce as well? Or, what are your thoughts for the future? [00:13:18] Dr. Adam Power: Yeah. And I have to be very careful what I say here, obviously. I can share generically what our thoughts are. We love this. Ultimately there was no better feeling than to use-- I mean, I've used my device to save a patient. And, you know, I would say that Asha, who's my co-founder, she cares. I'm a physician, but she cares about the patients just as much as I do, as does everyone in our company, which is really quite rewarding. But the future, what does the future hold? We really want this to get to everywhere. Yes, we're in lots of different countries ,have commercialized really all around the globe, but we really wanna go deeper into a lot of these geographies and really help as many people as possible. We realize that we can't do it on our own and are gonna need help. And so that's, we're in a growth phase right now of our company and we're looking for strategic collaboration. We're looking for those opportunities to deepen our ties and in all the different geographies. That being said, we are inventors and of course we have an idea every day about what we could improve on. But as far as the pipeline goes for our company, we are focusing on some very specific up and coming applications that we hope to have in the next couple of years. And I also wanna say that, I talked about trauma and bleeding, but the more exciting side of aortic occlusion has really been the applications. And you'd think, okay, it makes sense for trauma to be able to stop blood flow and stop bleeding. But some of our recent successes have been through postpartum hemorrhage. And there is this really, terrible condition called placenta accreta, where the placenta grows into the uterus and when you deliver the baby either by C-section or by delivery, and then the placenta attempts to be delivered, it tears, and you can have torrential bleeding. And, and so our device is being used in these women who are pregnant when inflicted with this condition and helping to decrease blood transfusions, helping to save a mother's life. So that's been really amazing. And then next on the horizon is strangely there's, it's not even a bleeding application. We've done some research and there's research going on globally about using aortic, minimally invasive aortic occlusion for non-traumatic cardiac arrest. And so if, which is really, again, it's like, "Oh my gosh, does this thing do everything? It might make your supper tonight if you're not careful." So it, so what happens there is that if somebody drops dead basically in front of you, and you start CPR, if you start pushing on their chest and pushing on their heart, you're pushing blood to the whole body. And the way you get someone back to life is if you can get the heart muscle oxygenated again. So if you put an aortic occlusion balloon up close to the heart, every time you push, you're directing blood right into the coronary arteries and right into the brain as well. And so what we're seeing is that there's increased return of spontaneous circulation rates when you do this with CPR. And there are different trials around the world that if this shows that there's an increase in survival or in better neurological survival, this will be the first time that we've really changed the script on cardiac arrest since advanced cardiac life support came out many years ago. So this, again, is very exciting for a simple device to be able to make that much impact in all these different areas. So, you know, we have a lot to focus on right now, even growing into the future because some of these, like cardiac arrest, are quite early on. So we don't wanna lose sight of this great original product, but we do think all the time about different pipeline ideas that could help other patients. [00:17:18] Lindsey Dinneen: Yeah, but, and to your point, even the amazing other use cases for this incredible device, like you said-- maybe it's gonna make us dinner next-- but the idea being that, who knows? I mean, there's so much more to discover even now, which makes me excited just to think about how many more use cases you could have for it and how many more people you could save. So, speaking of that, are there any stories that kind of stand out to you, moments that you've had where, you know, either through your day job, so to speak, being a vascular surgeon, but also being the co-founder of this company that really sort of affirmed to you that, "You know what? I am in the right place at the right time, in the right industry." Just those moments that really stick with you. [00:18:05] Dr. Adam Power: Yeah, I mean, it obviously all stems back to the patient and what patients are impacted. And I remember, the first time that the device was used at our hospital, one of the radiologists called me in and said, " We need to use one of these balloon occlusion devices for a patient that's been in an accident." And so I went in and I said, "I actually have the device that my partner and I created. We can use this for the patient." And so we started using it for the lady that was involved in a very serious accident, had a pelvic fracture, and she was a Jane Doe at that particular time. She was anonymous. And anyway, we noticed that she had actually had some vascular surgery done based on her angiograms, and I leaned over and I-- so she was sedated, but she was awake-- I said, "Have you had vascular surgery? Who's your vascular surgeon?" And she said, "It's Dr. Power. He's such a nice man." And so I was actually helping one of my patients. That was pretty crazy. [00:19:04] Lindsey Dinneen: Oh. [00:19:05] Dr. Adam Power: Also from my hospital, when I heard one of my junior residents was able to save someone's life. So, you know, junior residents are often good, but they're not trained surgeons. And so to have a simplistic device that one of my residents could actually place and help someone, that's pretty amazing too. There's also been times where like even the postpartum hemorrhage, we hear the first cases in the States of saving mother and baby. That's pretty incredible. Or that we donated some devices to the Ukraine conflict as well, and we heard that it saved some soldiers' lives as well. And there's different military groups that, that use our device and save soldiers. So it's all back to the patient. And hearing those success stories and hearing about somebody alive because of this particular device, because of all this effort that we've put in. I mean, it's really makes it worthwhile. It sounds kind of corny, but as a surgeon, I can help one person at a time, but as somebody involved in industry and medical device industry, I don't even have to be there. You know, this device can help long after I'm gone. The tricky part of it, being the Chief Medical Officer is, I usually only have to worry about my patients. Now I have to worry about everybody worldwide and the device being used. That was a little hard to wrap my head around initially, but yeah. [00:20:28] Lindsey Dinneen: Yeah, of course. But the ripple, the ripples, the impact that you get to have because of this device and because of your diligence getting it to market, because it isn't an easy path, and that's incredible. So thank you for doing the work that you're doing. That's not easy and it's very appreciated. This is incredible. So, yeah. So, okay. When you were growing up, let's say 8-year-old, Adam-- you know, you're having a good time doing whatever you like to do-- could you possibly have pictured yourself where you are now? [00:21:08] Dr. Adam Power: No, I don't think so. I mean, I, I. I came from a very small, like, small upbringing and, you know, in my family I had absolutely lovely family members, but they really, apart from my aunt, they weren't overly educated. And so I really didn't know what it took to be successful in life, really. I had work ethic from my parents, that's for sure. And so that's what they bred into me. And all I knew is that I was gonna work as hard as I could, and I figured that as long as I keep working-- and I was lucky to have some brains as well-- then I figured things would fall into place. They honestly haven't fallen into place exactly how I pictured them as I grew older and what it would look like. But I'm certainly thankful for where I am right now, and what is the next five years or 10 years gonna look like? I have no idea. And I guess I just don't even picture it. I have goals, but I also know that those goals change depending on circumstances. And you need, as I'm growing into middle age-- I think I'm beyond middle age now-- I'm thinking about midlife crisis and things like that. I get into philosophy and there's like telic and atelic things and so, it's sounds, again, it's about the path and the journey. It's not about the ultimate goal because, having reached a lot of these successes, that good feeling lasts for maybe a day or half a day. And you think you know, I spent all these years coming with the, with our device, getting our device to market and getting FDA approval and like, oh my gosh, like, you'd think, I'd feel so great about that. And it did. It felt great, but you wake up the next day and you gotta keep going. So you have to enjoy the journey and that's really what it's the wisdom that comes with age is trying to enjoy the journey as much as possible and not focus too much beyond that. [00:23:09] Lindsey Dinneen: Yeah. Yeah, and I think that's really good advice too, in that it is because the daily life isn't usually all the celebration and successes. I mean, that does happen and those are good moments, but because the vast majority of our life is spent on the journey component of it, and going through those peaks and valleys, it is important to find something you love and feel that you can make an impact in. So I'm so thankful that this is what you've chosen to do. So pivoting the conversation a little bit just for fun, imagine that you're to be offered a million dollars to teach a masterclass on anything you want. Could be within your industry, but it doesn't have to be. What would you choose to teach? [00:23:55] Dr. Adam Power: And would that mean that I was an expert in it? [00:23:58] Lindsey Dinneen: Well, certainly if you're getting paid a million dollars, somebody has decided you aren't an expert at it. How about that? [00:24:05] Dr. Adam Power: Okay. Well. Can I pretend like I'm an expert in it? There's something that I really love, but I'm not I'm probably not an expert in it. It would be, I would teach a masterclass in DJing. Isn't that strange? I know it's so random. [00:24:21] Lindsey Dinneen: Oh my goodness! Tell me more! [00:24:23] Dr. Adam Power: Well, I mean, I love music. I've, I grew up playing lots of sports and never was involved in music. And, and I've always appreciated music and art, but I was never able to do it. And, you know, growing up I did love sort of all types of music and then even electronic music and it just somehow talked to me. So I started DJing electronic music basically when I was around med school and have always loved it now, and when I was over in England, I DJ'ed on the campus radio and also DJ'd in a club. It was really fun and it sounds pretty silly to be talking about this when I have these other things that are on the go. But honestly, being able to share space with other human beings these days, and actually having a good time and having it not be stressful and having it be only, you know, everybody's wishing others to have a good time. There's not many people that go out sort of dancing into electronic music that are thinking bad things about other people. Really they're just out for a good time. And so being able to steer that whole music and scene is pretty awesome. And I do love it. And I don't DJ as much as I used to, but I still do different events, usually Christmas parties for the operating room. I'll do the typically wedding sort of DJ, but then they always, 'cause they know me, they let me do an hour long electronic set, which is like hardcore electronic. But then I go back to the regular stuff. But I would want to teach a masterclass in DJing. [00:25:56] Lindsey Dinneen: That is awesome. How exciting. Oh my gosh, I love that. And I think you're right. Music brings us together and it's a wonderful way to, to share a little bit of joy. [00:26:07] Dr. Adam Power: Yeah. [00:26:08] Lindsey Dinneen: Yeah. Okay. And then how do you wish to be remembered after you leave this world? [00:26:15] Dr. Adam Power: I, so number one is I don't, again, with my midlife crisis, I've actually been trying to eliminate my ego as much as possible. And so when people talk about legacy, it actually gives me the hives these days to be quite honest, because I don't like that because I think you're focused a lot on yourself. In my opinion, a lot of legacy is all about you. The way that I would wanna be remembered, though, is truly that I was kind and compassionate to everyone that I met, and that I stood for something, and that I left the world a better place. [00:26:57] Lindsey Dinneen: Yeah, those are wonderful things to want to be remembered for, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it? [00:27:09] Dr. Adam Power: My kids. My son Kai and my daughter Saoirse. They are the light of my life. And I, you would think that with how busy I am ,you know, those things would deprioritize, but they truly are the one thing in my life that makes me smile when I get up in the morning. [00:27:30] Lindsey Dinneen: Oh, that's wonderful. Well, that is absolutely incredible. I loved getting to meet you and speak with you a little bit today. Thank you so much for sharing about your journey. Thank you for sharing about your incredible device and your bits of wisdom along the way. The idea of we've gotta enjoy the experience, the path, the journey. And I just really appreciate you spending some time with us. So thank you for everything you're doing to change lives for a better world. [00:27:59] Dr. Adam Power: Oh, well, thank you for giving me the opportunity to speak with you. It was absolutely lovely chatting with you today. [00:28:05] Lindsey Dinneen: Wonderful. Well, thank you again so much. Thank you also to listeners who are tuning in, and if you're as inspired as I am, I would love it if you would share this episode with a colleague or two and we'll catch you next time. [00:28:20] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
In this episode of Tank Talks, host Matt Cohen is joined by Christian Weedbrook, Founder and CEO of Xanadu, a groundbreaking Canadian company leading the charge in photonic quantum computing. With over $250 million raised, Xanadu is on track to revolutionize industries through its cutting-edge quantum technologies.Christian discusses his transition from academia to entrepreneurship, the challenges of building a quantum company, and the potential for quantum computing to reshape industries like AI, drug discovery, and materials science. He shares his insights on Canada's role in the future of quantum tech, how quantum's “ChatGPT moment” will likely change the game, and why error correction is the key to scalable quantum applications.Christian also dives into Xanadu's ambitious plans for a quantum data center in Toronto, aiming to leverage room-temperature photonic computing to create the world's first fault-tolerant quantum computing environment by 2029. From AI-driven innovation to material science breakthroughs, this episode is packed with insights on how the future of computing is being redefined.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.Christian's Journey from Quantum Physics to Entrepreneurial Vision (08:15)* The transition from academia to founding Xanadu.* Early quantum research and turning theory into a business.Quantum's "ChatGPT Moment" (13:10)* How quantum computing's breakthrough will mirror AI's rise.* The promise of quantum in industries like AI and drug discovery.The Challenges of Quantum Capital and Investment (16:20)* The hurdles of fundraising and dealing with investors unfamiliar with quantum technology.Xanadu's Recent Breakthrough in Photonic Error Correction (18:47)* How solving error correction will pave the way for real-world quantum applications.* Quantum advantage in practical settings.Canada's Advantage in Quantum and Xanadu's Global Impact (22:01)* Why Christian chose to build Xanadu in Toronto.* How Canada can lead the quantum revolution and avoid the pitfalls faced by the AI sector.The Future of Quantum Chemistry and Material Science (39:10)* The role of quantum computing in next-gen battery and solar cell development.* Why quantum chemistry is the next big frontier.About Christian WeedbrookChristian Weedbrook is the Founder and CEO of Xanadu, a leading quantum computing company based in Toronto, specializing in photonic quantum technologies. With a PhD in quantum computing, Christian has held postdoctoral positions at MIT and the University of Toronto, contributing to groundbreaking work in the field. He founded Xanadu in 2016, aiming to make quantum computing scalable and commercially viable. Under his leadership, the company has raised over $250 million and is on track to build the world's first fault-tolerant quantum data center by 2029. Christian is dedicated to positioning Canada as a global leader in quantum computing and helping to unlock its potential across industries like AI, drug discovery, and material science.Connect with Christian Weedbrook on LinkedIn: https://www.linkedin.com/in/christianweedbrook/Visit the Xanadu website: https://www.xanadu.ai/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
From Surgeon to CEO: Prof. Marc Possover's Inspiring Journey in Medical Innovation The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension of his life's mission: to improve patient outcomes and expand access to advanced treatments in pelvic neurosurgery. In this exclusive episode of the Medical Device Made Easy Podcast, host Monir El Azzouzi invites Prof. Possover to share his story—one that blends clinical excellence, entrepreneurial vision, and a deep commitment to education. A Career Built on Medical Breakthroughs Prof. Possover is internationally recognized as a pioneer in neuropelveology, a specialty dedicated to treating complex pelvic nerve disorders. Over the years, he has developed innovative procedures that offer hope to patients suffering from chronic pain and dysfunctions once considered untreatable. But his ambition has always reached beyond the operating room. By founding his own medical company, he sought to transform groundbreaking surgical techniques into accessible, reproducible therapies that benefit patients worldwide. Why a Surgeon Became a CEO Moving from the precision of surgery to the strategic demands of business might seem like a dramatic shift, but for Prof. Possover it was a continuation of his mission. Becoming a CEO meant taking responsibility not only for individual patients but for the future of the treatments themselves. Leadership allowed him to guide product development, secure resources, and create an ecosystem where new therapies could flourish well beyond his own practice. As he explains in the podcast, “At some point I will retire—or die—but what will remain are the colleagues I trained.” His decision to lead a company ensures that his techniques will survive and continue to evolve, creating impact that outlasts any single career. Patient Education as a Driving Force Throughout the conversation, Prof. Possover emphasizes the vital role of patient education. When patients are aware of new treatment options, they actively seek qualified specialists, creating a natural demand for innovation. This patient-driven movement pressures the medical community to adopt cutting-edge solutions and ensures that life-changing therapies reach those who need them most. By offering information sessions and open discussions, he empowers patients to become advocates for their own health—transforming the doctor–patient relationship into a true partnership. Building a Global Legacy Through Training Prof. Possover's passion for teaching is at the heart of his work. Through the International School of Neuropelveology (ISNP), he trains surgeons from around the world in these advanced procedures. Every surgeon he educates becomes a multiplier of knowledge, capable of treating patients in regions far beyond his own reach. This dedication reflects a philosophy that medicine's greatest achievements are collective. A breakthrough is only meaningful if it can be shared, replicated, and improved upon by future generations. Lessons for Medical Professionals and Entrepreneurs This conversation is more than an inspiring personal story—it is a roadmap for anyone seeking to combine medicine, innovation, and business. Clinical expertise can fuel entrepreneurship when paired with strategic thinking. Patient awareness accelerates adoption, creating a powerful feedback loop between innovation and demand. Education builds permanence, ensuring that treatments survive beyond the careers of their pioneers. Whether you are a surgeon curious about entrepreneurship, a MedTech innovator looking for guidance, or a healthcare professional eager to create lasting change, Prof. Possover's journey demonstrates that the skills learned in medicine—discipline, precision, and empathy—are the very qualities that can drive successful leadership. In this podcast, Monir El Azzouzi and Prof. Marc Possover invite you to reflect on the future of healthcare. Their discussion shows that true medical progress lies not only in discovering new treatments, but also in ensuring that knowledge is shared, patients are informed, and innovations continue to thrive long after their creators have left the stage. Links INSP Link: https://isnp.possover.com/index neurogyn: https://neurogyn.com/ Possover: https://www.possover.com/en/ Youtube: https://www.youtube.com/results?search_query=marc+possover Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
What if you could cut your product development time in half—and avoid the regulatory landmines that derail most startups? In this episode of Med Tech Gurus, Marcel Botha, CEO and Founder of 10XBeta, reveals how his Brooklyn-based venture studio helps innovators turn bold ideas into compliant, fundable, and scalable medical technologies. With deep expertise in design, engineering, and regulatory strategy, Marcel shares how 10XBeta supports founders in navigating the critical—and capital-intensive—first mile of MedTech development. From pandemic-driven ventilator designs to launching 50+ products, Marcel delivers powerful lessons on speed, structure, and investor alignment. Gurus, if you're building in the deep end of innovation, this episode is your blueprint.
In this episode of Tank Talks, host Matt Cohen is joined by John Ruffolo to dive into a wide range of topics affecting Canada's economy, from energy and tech to blockchain. They discuss the government's announcement of major projects like LNG Canada's expansion and the critical need for nuclear energy. The conversation also touches on Canada's role in the global energy market, especially with the growing importance of renewables and the challenges of balancing carbon-based energy.The episode shifts to AI and blockchain, exploring how Canada can stay competitive in the tech race. They also dive into the rise of stablecoins in Canada with Tetra Digital Group's new Canadian peg stablecoin aimed at transforming B2B payments. Lastly, the episode examines the increasing presence of Canadian executives in U.S. tech companies and the risks of overvaluation in the AI startup space.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.LNG, Nuclear & Energy Future: Canada's Next Big Steps (00:07:13)Matt and John discuss the announcement of major energy projects in Canada, including LNG Canada's expansion and the importance of investing in nuclear energy for the future.Stablecoin Innovation: The Canadian Peg Stablecoin (00:15:01)Tetra Digital Group in Calgary launches a Canadian peg stablecoin set to revolutionize B2B payments. John and Matt explore how it could impact Canada's financial landscape.Opendoor's New CEO: Canadian Leadership in U.S. Tech (00:18:25)Opendoor appoints a Canadian executive as CEO, sparking a conversation about the growing influence of Canadian tech talent in major U.S. companies.AI Valuations: Are We Heading for a Tech Crash? (00:25:39)With the AI boom in full swing, Matt and John examine the potential for overvaluation and the risks of an AI bubble, echoing insights from Vinod Khosla on market “carnage.”AI's Future: Innovation or Overhype? (00:26:15)Matt and John delve into the power law of investing, discussing how capital is flowing into AI and why only a few companies will win big while many others will fail.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Marc Penna, CEO of Voyager Biomedical. Voyager is a clinical-stage company tackling one of the most persistent challenges in dialysis care: reliable vascular access. Marc has more than 20 years of experience leading clinical research and regulatory programs across cardiology, vascular disease, and oncology. Since 2014, he has focused on early-stage ventures, with leadership roles at Intact Vascular and Vesper Medical — both acquired by Philips — as well as senior positions at Edwards Lifesciences, Boston Scientific, and AngioDynamics.In this interview, Marc shares how to pressure-test new medtech ideas, why collaboration with regulators and trial sites builds lasting credibility, and how disciplined fundraising and smart exit planning can set startups apart.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 Marc Penna.
Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of Let's Combinate, Subhi Saadeh sits down with Dominick Romano, founder of Drainpipe.io, to unpack the future of AI in pharma, medtech, and drug/device regulation. The conversation goes deep into how AI could reshape dossier preparation, regulatory submissions, and quality oversight — and what strategies regulators and companies need to make sure speed doesn't come at the cost of trust.We explore:- Why pharma's unique risk profile makes AI regulation different from other industries-How ICH guidelines and process validation can be applied to AI systems-What “combinatorial problem sets” mean for pharma and AI models-The role of AI in regulatory affairs and dossier preparation-How regulators may use AI to accelerate reviews and approvals-The balance between speed, accuracy, and zero hallucinations in regulatory contexts-The future of AI in quality control, biologics, and beyondIf you work in pharma, medtech, or drug/device combination products, this episode will give you a clear look at how AI could change your world and what needs to happen before it earns the regulator's trust.Episode Chapters00:00 Introduction: Regulating AI in Pharma/MedTech01:01 Pharma's Unique Risk Profile02:14 AI in Regulatory Affairs03:44 Combinatorial Problem Sets in Pharma04:24 ICH Guidelines and AI Regulation08:22 Process Validation in AI10:20 AI in Regulatory Submissions15:54 Ensuring Accuracy and Consistency17:02 Regulatory Agencies and AI18:28 Accelerating Drug Approval with AI21:36 Time Savings in Dossier Formation25:44 AI in Quality Control for Biologics27:42 Challenges in AI Integration29:25 The Future of Pharma & MedTech with AI30:40 Where to Find Dominick RomanoDominick Romano is the founder and CEO of Drainpipe.io, focused on building trustworthy AI systems for regulated industries like pharma and medtech. A graduate of Full Sail University in video game development, his career spans game design, programmatic advertising, and voice applications before moving into AI. He was named one of Technology Innovators' Top 50 AI CEOs and has contributed to global initiatives such as the WHO/ITU AI for Health program. Today, he helps organizations explore how AI can be validated and integrated without compromising compliance or trust.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.
Timestamps:02:02 — Why Eric quit finance to create instead of comply.04:20 — Investor Brain as a Founder: 70+ angel deals, stakeholder management, and Switzerland's funding “missing middle.”12:50 — Flow > Busywork: How Eric engineers flow states to work efficiently16:25 — Why Holistic exists: Root-cause care for chronic conditions vs. longevity/prevention hype.27:40 — A business model that scales, willingness to pay, and going global via telehealth + group programs.This episode was sponsored by Google Cloud. Join their Founder's Story event on September 24th to hear directly from visionary founders in the transportation industry discussing the seismic shift in mobility, from ownership to on-demand access, and the pivotal role of AI and cloud technologies in driving this transformation.The cover portrait was edited by www.smartportrait.io.Episode summary:Eric Laudet is the CEO and Founder of Holistiq, a medtech startup aiming to establish the gold standard for scalable root-cause medicine and build the world's leading AI-powered holistic health platform, community, and brand. He holds a Masters in Management from ESCP Business School. In his conversation with Merle, Eric opens up about leaving corporate finance to build, not comply. He shares how his perspective as an investor reshaped his approach to fundraising, why Swiss founders must navigate a “missing middle” between angels and VC, and his system to create real leverage and flow states in his work.He then goes deep on Holistiq, the online clinic for root-cause care of chronic conditions (gut, metabolic, hormonal, and ADHD). Eric explains why willingness-to-pay concentrates where pain is real (not in shiny longevity products), how Holistiq blends labs, telemedicine, and group programs into their offering, and why focusing narrowly (gut health, menopause, ADHD) beats spraying features across the whole wellness map. It's a playbook on building scalable healthcare while staying radically customer-centric.Don't forget to give us a follow on Instagram, Linkedin, TikTok, and Youtube so you can always stay up to date with our latest initiatives. That way, there's no excuse for missing out on live shows, weekly giveaways or founders' dinners.
This week, Liz and Rachel discuss the interview with Marnie Hamp and the importance of staying relevant post-launch. In their conversation, they focus on the need for training, marketing, and sales to all have ears in the field and strong collaboration among departments so that the needs of the reps and the customers can be met. In addition, they discuss the need to cross-train clinical reps and sales reps while maintaining clear roles and responsibilities.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Marnie Hamp InterviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: Cumby ConsultingRachel MedeirosLiz CumbyAbout Cumby Consulting: Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.
Desde la llegada de Trump a la Casa Blanca los mercados han reaccionado con un repunte de la volatilidad. Los aranceles han sido la causa principal. Sin embargo, la nueva administración también ha promovido medidas que afectan a sectores más específicos. Es, por ejemplo, el caso del sector salud. Blanca Gómez de Agüero, Directora de Ventas Iberia J. SAFRA SARASIN, analiza esta situación en el Foro de la Inversión de Capital Intereconomía. El sector salud ha estado en el.de mira de la administración Trump ya que, se esperan recortes en Medicaid, en el programa de seguros de salud para los ciudadanos estadounidenses. Además, según comenta la invitada “se siguen barajando aranceles para el sector médico, que desde Safra creemos que no serán muy agresivos”. Es por ello que identifican el sector salud de forma muy atractiva. Desde su visión el sector sanitario es uno de los más heterogéneos y, por tanto, con rentabilidades muy dispares. “No es lo mismo invertir en servicios hospitalarios o medicamentos, que están más expuestos al foco político y a los recortes de gasto en Estados Unidos, que hacerlo en tecnología médica”, explica. ¿Qué diferencia a la tecnología médica del resto del sector salud? Blanca señala que “MedTech incluye implantes, dispositivos de uso externo y equipos médicos. Se trata de soluciones que no solo escapan en gran medida de la presión política, sino que además ayudan a reducir costes del sistema sanitario, ya que permiten cirugías menos invasivas y hospitalizaciones más cortas”. También cuenta que “En Estados Unidos, la tecnología médica representa apenas un 16% del gasto público, frente al 70% que absorben hospitales, servicios y fármacos. Eso hace que esté mucho menos expuesta a las medidas de la administración Trump”, apunta la invitada.
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, host Etienne Nichols sits down with seasoned MedTech entrepreneur Steve Bell to discuss the critical lessons for starting and scaling a medical device company. With over 30 years of global experience, Steve shares insights from his work with major corporations like Johnson & Johnson and his role in building Europe's largest MedTech unicorn. He reveals how a conversation with his wife led him to develop an extensive course and a new MedTech AI tool to help founders navigate the complex and often unforgiving startup landscape.Steve emphasizes the importance of moving beyond a great idea to build a viable business. He outlines the foundational mistakes that sink over 75% of startups, from emotional attachment to non-viable concepts to underestimating the time and financial commitment required. He introduces his “greenhouse score” system, an objective, data-driven tool designed to help founders evaluate their business idea against global competition, urging them to "kill their ideas early" if they aren't built for success.The conversation also touches on the unique challenges facing first-time founders, including the critical decision of who should lead the company. Steve advises against a "have-a-go-hero" mentality and highlights the value of bringing in experienced leadership to avoid costly mistakes. He stresses that true success lies in being "needs-based, not product-based," focusing on solving a core problem rather than becoming overly attached to a specific solution. The episode concludes with a warning about protecting intellectual property (IP) and the costly mistake of sharing proprietary information prematurely.Key Timestamps00:02:13 The origin story of Steve's MedTech startup course.00:04:58 The #1 reason MedTech startups fail: A good idea isn't always a good business.00:08:54 The greenhouse score and MedTech AI advisor for objective business idea validation.00:11:09 Why entrepreneurship is a "wide open field" and how to find a path.00:12:00 The importance of "Location, Location, Location" for MedTech startups.00:13:58 The MedTech Survival Guide book and life lessons learned.00:17:02 Should a first-time founder be the CEO?00:18:10 How to find and compensate an experienced CEO.00:20:45 Why you must be needs-based, not product-based.00:22:47 The difference between a business and an orphan or philanthropic project.00:23:53 The risk of destroying your IP before you even get started.Quotes"Every idea is good, but not every idea is a good business... some of them are just really interesting tech that's trying to look for a home." - Steve Bell"Most likely thing for most companies is the idea you go in with is not the idea you come out with... You need to be needs-based, not product-based." - Steve BellTakeawaysValidate Your Idea Objectively: Don't rely on gut feelings. Use data-driven tools to assess your business idea's viability. If your "greenhouse score" is low, don't abandon the need—pivot the solution or fix the weaknesses.Stack the Deck in Your Favor: Simple, logical choices can significantly increase your odds of success. This includes selecting a strategic business location and prioritizing a strong team over a lone "have-a-go-hero" founder.Hire Experienced Leadership: A first-time founder should rarely be the CEO. Bringing in a seasoned professional with C-suite experience can save millions of dollars and years of development, as they bring invaluable scar tissue and a network of investors.Protect Your...
In this episode of Tank Talks, host Matt Cohen sits down with Nikunj Kothari, Partner at FPV Ventures, to explore his journey from product leader at LinkedIn, Opendoor, and Meter to early-stage investor. Nikunj shares candid insights on why the best companies thrive under benevolent dictatorships, how AI is reshaping SaaS pricing models, and what makes founders truly exceptional.From his early years growing up in India to becoming one of the most thoughtful voices in venture, Nikunj opens up about his decision to leave operating roles, his angel investing beginnings, and his transition to VC at storied firm Khosla Ventures before joining FPV. He also dives deep into evaluating founders, navigating hypergrowth, and why outcome-based pricing may define the next decade of SaaS.Whether you're a founder looking to scale, an investor trying to spot the next breakout company, or simply curious about how AI is rewriting business models, this episode is packed with hard-earned lessons and bold ideas.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.From India to Silicon Valley: Nikunj's Early Journey (00:08:21)How his blend of engineering, design, and business led him to product management at LinkedIn and startups.Learning From Hypergrowth at LinkedIn and Opendoor (00:011:23)Why talent density and ambitious missions drive scaling organizations.The Investor's Lens: Spotting Latitude in Founders (00:013:32)Nikunj's framework for evaluating founder vision and depth at the earliest stages.Why the Best Companies Are Benevolent Dictatorships (00:015:39)How companies like Shopify and Coinbase thrive under strong, opinionated leaders.The Tension for Non-Founders in Dictatorship Environments (00:21:09)Nikunj's personal lessons as a PM executing a founder's vision.The Pivot to Investing: From Angel Checks to Khosla Ventures (00:23:26)Why he left operating roles, and what he had to unlearn as he became a VC.Joining FPV Ventures and Betting on Founder POVs (00:27:18)How FPV approaches concentrated early-stage investing with diligence and conviction.Gross Margins, Kingmaking, and the VC Trap (00:32:09)Why focusing on revenue quality matters more than chasing top-line growth.AI and the Future of SaaS Pricing Models (00:39:31)How outcome-based and usage-based pricing will disrupt per-seat SaaS models.Navigating Enterprise AI Adoption (00:44:22)The role of champions in enterprise sales and lessons from scar tissue in early adoption.Competing in Crowded Markets: The Series A Challenge (00:47:31)Why exceptional founders and market depth matter more than being first.Hot Takes: Solo Founders in the AI Era and the Future of IPOs (00:54:24)Nikunj's contrarian views on solo founders and whether Canva will go public.About Nikunj KothariNikunj Kothari is a Partner at FPV Ventures, where he focuses on early-stage investments with a founder-first approach. Previously, he was a product leader at LinkedIn, Opendoor, and Meter, where he helped scale hypergrowth startups and navigate tough product challenges. Nikunj began angel investing while at Opendoor and later joined Khosla Ventures, before moving to FPV to pursue concentrated, high-conviction seed and Series A investments. Known for his sharp writing on venture and product strategy, Nikunj has become a leading voice on topics ranging from benevolent dictatorships to the future of SaaS pricing.Connect with Nikunj Kothari on LinkedIn: https://www.linkedin.com/in/nikunjkVisit the FPV Ventures website: https://fpvventures.com/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're speaking about a recent Editor's Letter I wrote for MPO that gave reasons why placing a warning label on wellness devices about their status as an FDA regulated medical device would be a good idea. Does Mike agree? Do you agree that patients should be provided with an explanation that a wellness product does not get reviewed or approved by the FDA? During this conversation, the following questions are addressed:My editorial is about wellness products. Before discussing further, can you remind us what a wellness product is?Why did you write this column and given wellness devices have been “formally recognized” by FDA since 2016, why did you write it now?In your title, you use Wellness Products vs. Wellness Devices. Why?You point out in your editorial that general wellness devices are low risk devices. In fact, that's part of the title of the guidance. But is it correct to say, “General wellness devices are low-risk devices”?Let's discuss the example from my editorial (SaltAir by Halosense).Should wellness devices be required to have a disclaimer regarding their lack of FDA review, or should it be the consumer's responsibility to research and find out more about the product on their own?If a disclaimer is recommended (maybe not required), what should the disclaimer say?What else is important?What are today's takeaways?Listen to this discussion and see if you think wellness products should get a warning. If you'Send us a textFor more medtech news and information, visit https://www.mpomag.com.
In this episode, host Etienne Nichols sits down with Josh Eckelberry, Principal at Solas BioVentures, for an illuminating conversation about venture capital in the MedTech and life sciences sectors. Josh shares his journey from a medical background to a career in venture capital, driven by a passion for creating "leveraged change" by helping innovative technologies reach a broader patient population. He explains how this approach allows for a greater impact than what's possible in one-on-one clinical care.Josh delves into the unique investment philosophy of Solas BioVentures, which is an operator-led firm that provides hands-on guidance to early-stage startups. He introduces the firm's core "dote, goat, float, and moat" framework, which evaluates a company's therapeutic efficacy, management team, economic viability, and intellectual property. The discussion provides a candid look at how venture capitalists assess risk and make investment decisions, highlighting the importance of building a strong, emotionally intelligent team and demonstrating a clear path to market.The conversation also explores practical strategies for startups to de-risk their investment proposition. Josh offers insights on how companies can use a pre-submission to get crucial feedback from the FDA, and how leveraging the right advisory board can instill confidence in potential investors. He explains the value of bringing in key opinion leaders and how a well-structured clinical trial, with thoughtfully designed inclusion and exclusion criteria, is essential for proving a technology's safety and efficacy.Key Timestamps1:02 - Josh's transition from medicine to venture capital.7:27 - The unique, operator-led investment approach of Solus Bio Ventures.12:47 - The "dote, goat, float, moat" framework for evaluating startups.15:02 - What makes a great management team ("the goat").24:43 - De-risking strategies for early-stage MedTech companies.27:55 - The importance of regulatory discussions with the FDA.30:13 - Building and compensating a strong advisory board.Quotes"I call that leveraged change. I try to change that fulcrum of not just one patient at a time like I felt like in clinical medicine, but advocating and changing the lives of hundreds of people by getting these drugs and devices to market." - Joshua EckelberryTakeawaysFocus on the team: Investors, particularly at the early stage, place significant emphasis on the management team's experience, emotional intelligence, and ability to navigate challenges. Past success and a positive, collaborative culture are key indicators of future performance.De-risk early and strategically: To attract early-stage capital, companies must proactively address key risks. This includes securing strong intellectual property, proving therapeutic efficacy, and engaging with regulatory bodies like the FDA through pre-submissions to gain confidence.Build a knowledgeable advisory board: A well-vetted board of advisors with a strong reputation and deep industry knowledge—particularly in areas like reimbursement and regulatory affairs—can be a major confidence booster for investors.Understand the "Dote, Goat, Float, Moat" framework: Companies should be prepared to address these four pillars: Dote (therapeutic efficacy), Goat (management team), Float (economics/reimbursement), and Moat (intellectual property).Embrace the conversation: Early-stage investors are often more accessible than founders might assume. Reaching out and engaging with...
Josh Cohn, Chief Commercial Officer of EndoSound, joins Test. Optimize. Scale. to share how his team is changing access to GI procedures through innovative medical technology and equity crowdfunding. With 17 years of experience in the medical device industry, Josh has built a track record of leading teams ranked #1 in revenue, percent to plan, and conversion dollars year after year. In this episode, Josh explains why EndoSound is gaining national attention from investors, physicians, and surgical centers. He breaks down how their technology lowers costs for patients, expands access to care in underserved communities, and opens new opportunities for doctors and facilities. Josh also talks about the company's Reg CF campaign on Wefunder, how they attracted hundreds of investors, and why he believes crowdfunding is essential to the future of MedTech. Whether you're a founder, investor, or curious about medical device innovation, you'll hear real insights into testing, optimizing, and scaling a healthcare startup.
Morgan Evans is a biomechanical engineer, serial medtech entrepreneur, and angel investor. She shares her journey from aspirations of becoming a doctor, to working in mergers and acquisitions at Medtronic, to co-founding/founding six companies, including Agitated Solutions and Avio Medtech Consulting. Morgan discusses the importance of supporting startups in accelerating market entry, the challenges and opportunities with innovative medtech development, and the value of servant leadership. Guest links: www.aviomedtech.com Charity supported: Polaris Project 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 EPISODE TRANSCRIPT Episode 063 - Morgan Evans [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Morgan Evans. Morgan is a serial medtech entrepreneur and investor, which means her passion is launching new businesses. She's a biomechanical engineer by training, went to business school and worked for Medtronic in corporate development before jumping fully into the world of startups. Over the past 10 years, she has founded or co-founded six companies: two medical device companies, two medtech accelerators, and two venture investing vehicles. She spends most of her time with Agitated Solutions, which is developing several innovations related to contrast and ultrasound, and Avio Medtech Consulting, which helps lower the barriers to entry for new ideas and new medtech companies. All right. Well thank you so much for joining us today, Morgan. I'm so excited to speak with you. [00:01:42] Morgan Evans: Thank you again for having me. Pleasure to be here. [00:01:45] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to medtech. [00:01:53] Morgan Evans: Sure, of course. Originally from Houston, I went to school in the Bay Area and studied to be a biomechanical engineer. I originally thought that I was gonna be a doctor, and wanted to start in heart lung transplant of all things. Did an internship between my freshman and sophomore year and quickly learned two things. One is that I love people a bit too much to distance myself emotionally, so it would've really been a hard career for me, I think being on the front lines with that. But the second important thing I learned as well was there was a lot of technologies that existed in the medtech side of the world, just trying to buy people time and give options. And so I fell in love with medtech as a career relatively early. Started working for my first startup in the neuromodulation space before I even graduated undergrad, and loved that. Wore a ton of hats ranging from engineering, clinical commercial. I did some vertical line integrations in there and I started before we were even at 10 employees, left at 55. Thought it was massive 'cause we had middle management. Then toward the tail end of that, started studying to go to business school 'cause I realized I was getting further and further away from my engineering degree. And then I went to Kellogg at Northwestern and when I was there, co-founded my first startup with a clinician that had a great idea, didn't really know how to navigate the regulatory side of the world, and we co-founded that company together. And toward the tail end of that, was recruiting for formal kind of post-business school. Where am I gonna land? What am I gonna do? And decided to go to Medtronic and do mergers and acquisitions within the corporate development team. Did that for about two years. Loved it, learned a lot. The team was great. But big company was a huge change, especially as I just mentioned, you know, I thought 55 was large with middle management. And then you go to 90,000 at the time and deal teams of that. And kind of felt like my calling was going back to startups, so left in 2016 and have been innovating and building companies ever since. [00:03:53] Lindsey Dinneen: Wow. Okay. Well, thank you for sharing a little bit about your background and everything that's led you to where you are today. I really appreciate it, and so I am so intrigued. Okay, so you were on track in, in theory, initially to be a doctor and to go that route and then decided, "Okay, well, maybe this isn't for me," which is so great that you learned earlier rather than later, of course. But so as you were processing through making this transition into medtech and going, "Oh my goodness, there's actually a whole lot here." Were there any particular things that really stood out as being the most intriguing? Were you just kind of interested in the industry as a whole, or were there specific things where you thought, "Oh gosh, I really wanna learn about X, Y, and Z." [00:04:37] Morgan Evans: Yeah. Two things happened in relatively short order that I think landed me in my love, right? The first is, when I was doing this internship, they actually had some preclinical research going on in the basement of the hospital. And I, it's a long story, but I randomly ended up wandering into this place and figuring out it existed, and saw some of the early preclinical research happening live where they actually had a pig that they were trying to induce a heart attack in to then do a treatment for. And this pig actually coded in the middle of the procedure and they literally come out with paddles. And I'm just like, "This is the coolest thing in the world, this is actually how innovation is done and people learn." So that kind of, "Oh, cardiovascular sounds really interesting," was where I originally started. And then, at the time when I was at Stanford, I was playing on the basketball team as well, and I went to a event with some supporters of the program. And the person at my table was Chairman of the Board of a neuromodulation startup, autonomic technologies. And the one thing I at least love that I'm not afraid to ask questions. And so I just was like peppering him with like, "What is this? How does that work?" And that actually led to my first job. And it's kind of fortuitous that you're in the right place at the right time, but then just get exposure, and that was in pain and pain's a hard space. The type of treatment we were doing was treating condition that was known as a suicide headache. And so I think that was helpful to see the impact of the work we can do so early on. And then I, like I said, I've been hooked ever since. [00:06:05] Lindsey Dinneen: Yeah. Yeah, that's great. And those are great stories. I love the synchronicity and how those moments sometimes just play out perfectly and lead you to your next right step. So now you are in a position where you are advising startups, but you have lots of things going on. I feel like when I was looking at your LinkedIn, there were multiple different organizations you're a part of and participating in. So could you share just a little bit about all the wonderful things you're up to these days? [00:06:31] Morgan Evans: Yeah, for sure. So my day job, as I call it, but where I spend by far majority of my time is I am co-founder and CEO of a company called Agitated Solutions. And we say that we're unlocking the potential of diagnostic ultrasound. So we have multiple products that include a contrast agent that's revolutionary and that it has a temporary micro bubble, looking for holes or flaps known as a patent foramen ovale in the heart that's highly associated with cryptogenic stroke. So we have contrast side, and then we also have some software as a way to have better prediction of what our high risk shunts and what could cause stroke. That had a company spin out of it called Moonshot Medical that is more of a traditional incubator where we put all of the IP and ideas that weren't quite ready to be full-blown companies, but we knew there were some things there that I also technically lead. So those are the two that I'm CEO of. I founded a company called Avio, that I'm very passionate about, that is really focused on trying to help get these medical technologies to market faster. The work we do is on the backend of medtech, so quality systems, regulatory, R&D project management. But just in the theory that there's so much paperwork that is behind any innovation, like how do we get better at that paperwork so that we can keep innovators doing what they do best. And then we're just really that helping hand alongside. I joke, all of the things I'm involved in, this was my happy accident. I felt like I was building what I needed for my own startups. Literally no intent of anyone else ever seeing this or offering that as a service. And I just remember distinctly, I woke up one day shortly before my son was born and I was like, "Oh, I think there's actually a business here. Maybe I should run it like one." So that's another one. And then passionate about angel investing in early stage as well. When I fundraised for the first time, I was 29. I'm now 37. I get asked that a lot, although you're not supposed to ask a woman her age. When I fundraised for the first time, especially in these early stage rounds, no one looked like me, both in gender or age. And so I'm one of those believers, "Put your own money where your mouth is," even if they were baby checks to start, they were something. And that's been another area that I also spend some time. [00:08:48] Lindsey Dinneen: Yeah. Wow. Okay. So you've got a lot going on to, put it mildly, which is fantastic. You mentioned something that really stood out to me. You're trying to help these startups bring their medical technology to market faster. And I'm curious, are there maybe one or two things that you see a lot of startup companies perhaps either accidentally overlook, or delay too long, or something like that, where, at the beginning, if they had done X, Y, and Z, they could have gotten their technology to market faster. [00:09:21] Morgan Evans: Yeah, a couple thoughts. One is I think people underestimate the amount of time that it takes to formally document all of the things that go into getting your device compliant and on the market. For example, I've had a client before that came to us that had a product that was working. He had tested it, he'd done all these things and it was a software, and ready to go, and submit to the FDA. And then you're like, "Well, we need user needs and product requirements, and your design schema," which, you know, there is a reason that these processes exist and I think they can make you have a better product at the end of it. But I think, you know, people assume, "Let's build the right product first and then worry how to document it." And then you forget sometimes why certain decisions were made or you know, is this actual requirement or was that done because it was an off the shelf thing? And so there is a lot of learning that I think can be lost by waiting. Now all that said, the other part of it would be that if people kind of shore up too fast, so you overbuild the team, you have a quality person, a regulatory person day one that feel like they need to be doing all of the things and justify their full-time job, then you end up documenting and revising. So there is some healthy balance and tension between the two. So it's not easy to get it perfect. But I would say those are the two areas that come to mind. [00:10:37] Lindsey Dinneen: Yeah, that makes a lot of sense. And I can see where the polar opposites could be challenging. So staying happily in the middle, working with an expert such as yourself, is a really wonderful way to go about that. You mentioned angel investing and being passionate about helping. It sounded like based on your own experience, you're very passionate about helping the next generation of leaders and entrepreneurs in this space create the products and bring what they envision to market. As you've gone about this, and even as you learned for yourself how to fundraise, maybe feeling like, "Hey, nobody else looks like me, is my age," or whatever, what are some learning lessons that you've experienced that you would suggest for somebody who's maybe in a similar situation that you were in? [00:11:28] Morgan Evans: Yeah. Some of it is just to be a little bit fearless, I would say. There's a lot of people that have told me over the years, "Pick one. I don't understand how you do all these things." My least favorite question I've ever gotten is, "Do you ever see your kids?" Yeah. But people ask you that, you know? And I think it's easy to let other people tell you what you should be or what your product should look like or your path should be. And I think I have been fortunate to find some wonderful mentors that empowered me to be my own version. I didn't have an example of someone that had built the things in the way that I had built them or that had a couple of them at one time. But I also knew very confidently that I wasn't dropping a ball and I was doing the right thing by the companies I was building and supporting. And it was helpful to have the army behind me that just loved me for me and supported me in that, in developing it. And I think that next generation of entrepreneur, if you can find the same, that's willing to lean in just for you and there's no ulterior motive other than just to see you be successful, hold on with both hands and then pay it forward to the next one. [00:12:38] Lindsey Dinneen: Yeah. Yes. That's great advice and insight. So when you're thinking about your own career and the companies you're leading, what are some things that you're looking forward to in the future as you yourself continue to evolve and develop your own skill sets and whatnot, and also for your companies that you're leading? What are you excited about? [00:12:59] Morgan Evans: Yeah, I think for me, I'm excited about building that next generation of entrepreneur, which we've talked about a little bit. And how do I influence and build and develop those things without me being the one actively leading them? That's been a new learning that I'm continuing to kind of dabble in and grow personally, which is leading through the art of board work or questions or advising, which is different than leading a company by physically being the head of that company. And thinking about how to train and develop and give people enough of a leash to go and run and be them, but yet have that support system that you're still within their appropriate guardrails that-- I'm kind of mixing metaphors, but I think you get it. You know, it's an art, not a science, and one that I'm enjoying learning and growing and developing in this next phase too. [00:13:53] Lindsey Dinneen: Yeah. Well, and speaking to that in general, so I'm sure you've had a mixture as most of us have had, of good experiences with leadership and poor experiences with leadership, and I'm curious how that has shaped your own leadership style now, especially as you're in this new phase of further developing your leadership skills to look a little different than perhaps they have in the past. But what do you draw from and what's your inspiration when you've developed your own leadership style? [00:14:23] Morgan Evans: Yeah. As I mentioned earlier, I've had a wonderful network of mentors that I think have really leaned in and and done it in the right way for the right reason. And I hope to emulate that myself, of being there to grow people and the technologies and the businesses that you're doing and giving them those chances to shine. As a leader, I believe very much in servant leadership. I never want someone to work a weekend that I'm not working as well. But then you kind of realize that isn't always feasible and can feel uncomfortable sometimes. And how I've evolved to give other people those opportunities, but recognize I'm not gonna be in the weeds enough to help them in the same way, it's a journey. I'd love to say I'm at the destination. I'm one of those, I love iterative improvement. I don't think I'm ever at a destination. But just really trying to lead through the art of question, for example, as opposed to coming with thoughts and opinions, has been a big one for me in the last couple months in particular. [00:15:20] Lindsey Dinneen: Yeah. So approaching with curiosity, it sounds like in an effort to understand and or provoke even perhaps that person taking additional ownership or responsibility in their own creative solutions to perhaps what they're coming up with. Are there particular questions you've found that are really helpful as you're shaping these conversations, helping people understand their next right step? [00:15:46] Morgan Evans: Yeah, I, it's funny because one of my mentors that's been coaching me on this is, she's kind of had that progression of learning to shift from, in the absence of leadership, lead, to leading someone else through that. I actually text her periodically and ask her for guidance of, "Hey, they came to me with... This is what I would normally say. How do I frame this in a question such that I'm giving them enough direction, but not leading the horse to water." So it the art of the question is in, in fact, itself an art. In general, I would think about asking something in the framework of, "Have you thought about the ramifications of?" or, " What is the key thing that we should focus on this week?" It's almost trying to pick out what I would focus as being the main thematic issue or next step, and giving them enough of a carrot that they can get there, but not quite telling them exactly how it should be done. [00:16:44] Lindsey Dinneen: Okay. Yeah. So in general those sort of probing questions that might suggest, "Hey, have you thought about X, Y, and Z? Or, what are your thoughts about X, Y, and Z related to this?" And letting them continue to take ownership and responsibility for that. That's really great. One thing I noticed, and I don't know if this is something you currently still do or not, but I was noticing on your LinkedIn that at least at one point you had a Medtech Startup CEO Bootcamp, which just sounds awesome and I would love, if you don't mind, sharing a little bit more about that and what that looks like. [00:17:17] Morgan Evans: Well, the good news is we are doing it, we're doing another one, I think in June. I'm happy to say I don't know the exact date 'cause that means I'm not in it enough to know exactly the dates. So in the spirit of me trying to take myself up a level -- success. But no, it's interesting because I had worked in medtech for five years before business school, went and got a traditional, you know, learning in all things business, right? Graduated, went to Medtronic, did M&A, and then came and did my first startup. And I remember day one it was like, "Do I form an LLC or C corp?" No one had taught me that. And it's funny because, now you can understand the nuance of the question, but I can't imagine how much money I spent on the first attorney. And yes, there's pass through income, but you know, is that appropriate for investors for me to take a disproportionate loss or there's 1202 tax code and all these other nuance. So I started realizing that a lot of just taking the first step where things that you have to learn on your own or find a really awesome board member, advisor, et cetera, to lean in and help you too. Other examples would be, you know, "How much stock options do you normally give your board?" Or, " Should I do a convertible note or a safe? What is a quality system," right? I knew entrepreneurs that had no idea what those things were. So the thought was, "How do I give enough detail to these other entrepreneurs, so where they at least feel that they can ask the right question?" Because to think that I can teach someone the nuance of verification, of validation strategy in an hour or four, versus someone that has done nothing but R&D for 15 years, right? That's not gonna happen. But if you could teach them enough to then say, "Hey, my CTO or contract design partner, should we dry run this test first? Or what test should we dry run?" Right? If we can give those people just enough there to phone a friend, that was the goal of the program. So just giving people that lay of the land and enough of a roadmap. And a lot of this too, like we literally have an acronym sheet because medtech is full of acronyms, and it's funny that like our acronyms can mean something completely different in other people's spaces. And so just even learning the lingo day one, like what's an SOP or CMO or CDO? [00:19:40] Lindsey Dinneen: That's incredible. I love that. That's so great that you have a cheat sheet because I remember that being such a learning curve when I first got into the industry of, " You just said an entire paragraph worth of acronyms and I would love to understand what you're talking about, but I don't yet." so learning how to decipher all of that was great. I'm thankful for it, but yeah, that's wonderful. A cheat sheet sounds fantastic. You know, it's interesting 'cause you mentioned, with this bootcamp, first of all, I'd love that you offer that. What a fantastic offering for anyone in that position who's just needing that support and that extra guidance, and having something that's so specific to the industry is great. Do we just go to your website for details if anyone's interested in that? [00:20:24] Morgan Evans: Yeah, it would be on the aviomedtech.com website. And then I believe there's a tab that is regard to the bootcamp. And yeah, like I said, it's all the stuff that I wish I would have learned or I learned. It took me way too much time and money, that I just want people to know where the landmines are that I had to step on. And if we can just accelerate that learning and that s-curve for the next entrepreneur, we can get these products to market a lot faster. [00:20:50] Lindsey Dinneen: Yes. I love that you offer that. You've gotten to have an amazing career where you've been diving into the industry itself and working for other people, and then of course being a leader in your own companies now as well. I'm wondering if there are any stories that stand out to you as really just affirming, "You know, I really am in the right place at the right time in the right industry"? [00:21:12] Morgan Evans: Yeah, it's funny. I don't get to reflect on this very often, but I co-founded Agitated Solutions and I founded Avio within one week of each other. I didn't know, again, that I was building what I was building on Avio's side. But what's been so much fun is that as I build and grow this awesome company, that's being an entrepreneur myself, being able to take learnings where I see them and try to pull them thematically into Avio so that you kind of have that flywheel effect. So I'm learning that I enjoy both operating within these technology companies, but also trying to figure out what of the system, or the process, doesn't make sense. Like I know other people might do it this way, but why? And, being able to innovate on the system and the output at the same time has been super fulfilling for me. And like I said, it's kind of a little bit of coincidence that it was within one week of each other, but that's part of where I've learned for myself that I don't think I'm fulfilled by just being in one company or one thing fully, and in fact, me being in something else is part of what makes me better at the other thing. So I feel really fortunate to have found that and to know where my passion lies. [00:22:41] Lindsey Dinneen: Yes. That's very cool. And definitely a gift. And you know how things sort of translate into each other-- I was thinking about this earlier because-- I noticed, and you also mentioned that basketball was, and is as my understanding, a core part of your life. And so you've been both a player, you've been a coach. How has basketball played a role in either life lessons, life skills that you've drawn from it, and or how does it just incorporate into your life? [00:23:11] Morgan Evans: You know, it's actually a really fitting question. So first of all, as an athlete, it taught me I cannot stand to be the weakest link on a team. And when you think about that servant leadership, or that hustle or that grit, I was tall, but I was not the most naturally gifted athlete. And so a lot of where I excelled in basketball was on fundamentals, just solid, putting in the time and doing it. And then I got to the point in my career where I could not outwork other people. I could put all the time in the world in there and I was not going-- like I played behind All American Centers when I was at Stanford, and everybody was an All American coming in to play basketball. And it was a good evolution for me to learn a little bit of "How else can I then play a role if I'm not the most gifted athlete?" and to recognize that a team can function well with all those pieces regardless, right? So I don't need to be the leading score to still have an impact on the team was kind of a good mental awareness of how talent gets pulled together to make effective teams. The other thing on the coaching side, so I actually had career ending surgeries between my junior and senior year. And basketball was, and still is, a big love of my life. And to then have my playing days over unexpectedly was a big transition, and I got to see basketball from the sidelines my senior year. And my job then was to make the other players more effective, to study scouting report, to teach, to try to do what I could to get the team ready, knowing I would never step foot on the court. And if you think about some of the parallels we've already just talked about, which is leading through the art of question or being able to lead and guide, but not being able to be out there, running around with everybody else in and of, in itself is a very similar transition to what I'm going through and continue to go through. I coach young women. I did except for this last year. It's been hard with two kiddos, in particular on my husband, especially, you know, we would do travel tournaments and things like that. But coaching young women too, and realizing it's the end result, but it's also wanting them to be good people and life lessons and skills through it. And how do you have them help respond in adversity? All of that, I think, makes me a better leader, and there's a lot of parallels to the working place, for sure. [00:25:35] Lindsey Dinneen: Yeah. Yeah, that's wonderful. And having a gift like that, even when it looks different and morphs over time, I love that you've been able to draw from it such inspiration and application to other areas of life. I think that's really special. Such a cool aspect of being an athlete. So yeah, thank you for sharing about that. [00:25:51] Morgan Evans: Of course. [00:25:53] Lindsey Dinneen: So, pivoting the conversation a little bit just for fun. Imagine that you are to be offered a million dollars to teach a masterclass on anything you want-- could be within your industry, doesn't have to be-- what would you choose to teach? [00:26:07] Morgan Evans: I would teach something on scrappiness. From my experience, I think there's a lot of people that would know the industry really well, but the how to get things done atypically for less money faster. And that's some of the thematic elements that I hope I'm-- not for a million dollars-- but, you know, starting to teach in our bootcamp. Some of the belief that I think sometimes you get these companies in medtech in particular that are kind of overbuilt, too much too soon. And now they have a really high burn rate and everybody has to leave, essentially a unicorn exit or bust. And how can you burn down and mitigate risk with little dollars and making sure you're spending your dollars in the right places early on? I continue to learn from others in that too, I should mention, but I think it's an area with a lot of impact. [00:26:59] Lindsey Dinneen: Yeah, absolutely. And so relevant and helpful for startups that have no choice but to be scrappy and learn how to be creative on a dime. I think that's fantastic. Great. And then how do you wish to be remembered after you leave this world? [00:27:16] Morgan Evans: Yeah. I hope it's something to do with innovating on technologies that improve and help patients, but also innovating with people and process, that hopefully on all of this, that we're leaving the world a little better than we found it. [00:27:33] Lindsey Dinneen: Yeah. Yeah, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it? [00:27:42] Morgan Evans: Definitely my family. I have two kiddos, Marley and Mason. So my daughter's three months, my son is three. And then my husband Matt. It's hard to do all the things that I do without having an amazing support system. And, you know, you can have the hardest, most stressful day and you come home and my son's like, "Do you wanna play with me?" Or, "Let's play hide and seek" or something. And it's just funny how instantly all that stress kind of melts away. Very grateful for my family. [00:28:10] Lindsey Dinneen: Yeah, family is such a gift. Wonderful. Well, this has been such a great conversation, Morgan. I really appreciate you spending some time with us today, and thank you for sharing about your life and your story and your advice. I am excited to see how you could just continue to grow and thrive. I love the fact that you are just a total boss with all the things that you're doing. So thank you for contributing your gifts to the world, and gosh, I just wish you the most continued success as you work to change lives for a better world. [00:28:42] Morgan Evans: Thank you again for having me. I appreciate you. [00:28:45] Lindsey Dinneen: Of course, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support. 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'd share this with a colleague or two, and we'll catch you next time. [00:29:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Christopher Haig, co-founder and CEO of Efemoral Medical. Efemoral is developing bioresorbable scaffold technology for peripheral arterial disease. Chris has over 25 years of experience in cardiovascular devices, holding leadership roles at strategics including Guidant Corporation and Abbott Vascular, and driving growth at startups such as Calypso Medical and QT Vascular, where he built commercial infrastructure and launched multiple products ahead of its $55 million IPO.In this interview, Chris shares how bioresorbable scaffold technology found new life for peripheral arterial disease — and the lessons on matching tech to significant needs and choosing trial sites for lasting data.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 Christopher Haig.
Our guest this month is Marnie Hamp, a seasoned marketing executive who gets the importance of partnering closely with the training team, not only at launch, but in post-launch as well. She and Liz discuss best practices for continuing momentum, including knowing your targets, developing strong partnerships between clinical reps and sales reps, and listening in to what is actually happening in the field. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Marnie is an experienced Sonographer and dynamic leader with over two decades of experience in healthcare and medical device sales across three countries, specializing in ultrasound product development and market strategy. She has successfully led go-to-market teams delivering innovative solutions while training sales and clinical professionals to optimize product adoption and maximize impact. Her expertise bridges technology and patient care, ensuring medical advancements translate into meaningful outcomes. Beyond her professional expertise, Marnie is a passionate traveler who finds joy in exploring the world and sharing experiences with family and friends, whether at home or on the road. From immersing herself in different cultures to savoring local flavors, she embraces discovery with curiosity and adaptability, always seeking meaningful connections and enriching adventures.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: Marnie HampCumby ConsultingRachel MedeirosLiz CumbyAbout Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.
Even the most driven professionals can find themselves stuck working harder but not moving forward. The culprit? Not market conditions, not product fit, but what bestselling author and executive coach Dr. Noah St. John calls head trash. In this episode, sponsored by Physician Growth Accelerator, Dr. St. John joins Zed Williamson to explore how subconscious limitations cap performance, even for top MedTech reps and leaders. With a track record of helping clients add over $3 billion in revenue, he reveals why traditional goal-setting isn't enough, how to identify the “yeah buts” that sabotage progress, and how to replace time-wasting habits with high-leverage actions. What we discuss in the episode: Why head trash is more than negative thinking—it's any limitation keeping you stuck. The hidden cost of doing $10/hour work as a $10K/hour performer Why humans avoid pain more than they pursue pleasure Real-world case studies where removing head trash unlocked exponential growth How MedTech professionals can recognize and address limitations in themselves and their customers Why a system-driven approach to success outperforms personality-driven motivation Resources from this episode: Get the free MedTech Talk Tracks for Action Visit Dr. Noah's Website Subscribe to Dr. Noah's YouTube Channel Social Media: Connect with Dr. Noah on LinkedIn Connect with Zed on LinkedIn Connect with Clark on LinkedIn
It Happened To Me: A Rare Disease and Medical Challenges Podcast
Join us as we delve into the evolving landscape of clinical trials in Latin America with Julio G. Martinez-Clark, CEO of BioAccess. Discover how his company is pioneering pathways for medtech innovators and shaping the future of medical device innovation in emerging markets. Bioaccess® is a trailblazing company that's helped over 100 Medtech innovators navigate global clinical trials, and he currently serves as Ambassador of International Accrediting Organization for Clinical Research in the Americas. With a career that spans healthcare infrastructure, telecommunications, and regulatory strategy, Julio is a leading voice in the field of medical device innovation in emerging markets. From his early days at Johns Hopkins Hospital to his current role in shaping ethical and efficient trial systems across Latin America, Julio's mission is clear: to expand access to high-quality research for patients and sponsors alike. He's also the host of the Global Trial Accelerators™ podcast, where he dives into trends in Medtech, Biopharma, Radiopharma and clinical trial innovation. We unpack what makes Latin America a strategic region for clinical trials, especially for rare diseases, and explore how improving trial access can speed innovation, and change lives. Episode Discussion Topics: Introduction to Julio G. Martinez-Clark and his role at BioAccess. The clinical trial landscape in Latin America and its strategic importance. Julio's career journey from Johns Hopkins Hospital to BioAccess. The impact of cultural competence and community engagement on clinical trials. Challenges and solutions for conducting clinical trials during the pandemic. The role of artificial intelligence and digital tools in clinical trials. The future of clinical research in Latin America, including radiopharmaceuticals and theranostics. The importance of international standards and certifications for clinical research sites. Success stories and innovative approaches in clinical trials. Julio's podcast, Global Trial Innovators, and its focus on industry education. During the episode a blog post on bioaccess' website was referenced that highlights academic papers that talk about the higher recruitment and retention rates in Latin America, here it is: https://www.bioaccessla.com/blog/the-latin-american-advantage-why-clinical-trial-recruitment-and-retention-outpace-the-us-and-europe Connect With Us: Stay tuned for the next new episode of “It Happened To Me”! In the meantime, you can listen to our previous episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “It Happened To Me”. “It Happened To Me” is created and hosted by Cathy Gildenhorn and Beth Glassman. DNA Today's Kira Dineen is our executive producer and marketing lead. Amanda Andreoli is our associate producer. Ashlyn Enokian is our graphic designer. See what else we are up to on Twitter, Instagram, Facebook, YouTube and our website, ItHappenedToMePod.com. Questions/inquiries can be sent to ItHappenedToMePod@gmail.com.
Send us a textSpencer Jones began his healthcare career as a registered nurse in Little Rock, Arkansas, where he witnessed firsthand the clinical need that sparked his first device: SafeBreak® Vascular, a patented solution to prevent IV line dislodgement. As a nursing alumnus of the University of Arkansas, Spencer led SafeBreak from idea to FDA approval in 2022, drawing on early mentorship from Innovate Arkansas and a successful accelerator experience with ZeroTo510.In 2015 he founded Lineus Medical as co‑founder and CTO, securing multiple U.S. and international patents while raising seed and Series A funding. In 2020 he began consulting with Lapovations, the University of Arkansas‑spawned medtech startup behind AbGrab®, a suction‑based tool enabling safer and more consistent abdominal entry in laparoscopy.Since officially joining Lapovations in October 2022, Spencer has served as CTO, VP of Sales and now CEO, leading efforts like a national sales rollout, Series A financing, SBIR IIB grant, and the Class I FDA launch of AbGrab across 18 states. Beyond product development, he's an active mentor and ecosystem builder through XO Medtech, ComboSpine, and educational partnerships.Spencer is passionate about democratizing clinical innovation—especially for nurses, physicians, and students—and now leverages AI tools to accelerate medtech startup growth. Recognized by Nurse.org as “Nurse Innovator of the Year,” he is a powerhouse blending clinical insight, technical execution, fundraising prowess, and ecosystem leadership. LINKS:Guest LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/Guest website: https://xomedtech.com/ Aaron Moncur, hostClick here to learn more about simulation solutions from Simutech Group.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Howard Rosen, co-Founder and CEO of Evident Vascular, a company developing an AI-powered intravascular ultrasound (IVUS) platform to improve vascular imaging and intervention. Before co-founding Evident, Howard held senior leadership roles at Intact Vascular and Vesper Medical, guiding both companies through successful acquisitions by Philips. He also served in executive roles at Haemonetics and BG Medicine, and spent over two decades at Boston Scientific, where he held a range of leadership positions across the peripheral and cardiovascular franchises.In this interview, Howard shares why launching right — not fast — is the key to success in medtech. He breaks down how Evident built early momentum by investing in deep market validation, engaging KOLs as true collaborators, and resisting scope creep at every turn. Howard also unpacks the company's deliberate regulatory strategy, using early FDA engagement as a tool to de-risk development. On the fundraising front, he explains why board composition matters more than valuation, and why strategic acquirers respond best to credibility, not cold outreach.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Howard Rosen.
From consulting to working at large companies to taking a risk with start-ups to becoming Silk Road Medical's CEO, Chas McKhann has experienced almost everything in his long and illustrious career. In a discussion with Medtech Talk host Geoff Pardo, McKhann shares all the lessons learned from his jump to small private companies, handling a cultural rebirth as a newcomer CEO under the public eye, and taking on his role at Silk Road. He also talks about the “what if's” of his journey and tips on surviving in the industry, as well as witnessing the market shift from only caring about revenue to wanting to see the path to capital break even. LINKS: Medtech Talk Links: Cambridge Healthtech Institute Medtech Talk Gilde Healthcare Silk Road Medical: Silk Road Medical
In this episode, Duane Mancini welcomes to the show Jessica Richter, a seasoned medtech executive and board member of MedtechWOMEN. With over 20 years in the industry, Jessica shares her extensive career journey from a medical device sales rep, through various leadership roles at companies like Medtronic, to her current independent consulting role. The discussion covers vital topics such as navigating the US healthcare market, effective sales strategies, the importance of stakeholder alignment, and tips for early-stage entrepreneurs transitioning into leadership roles. Jessica also highlights the critical role of diversity in medtech and shares insights on the mission and initiatives of MedtechWOMEN, a nonprofit organization dedicated to empowering female leaders in the field.Jessica Richter LinkedInMedtechWOMEN LinkedInMedtechWOMEN WebsiteMedtechVISION Conference WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
In this episode, host Etienne Nichols sits down with Lesley Worthington, an executive coach with a background in psychology, law, and over 20 years in quality and regulatory affairs. They explore the critical, yet often overlooked, role of communication in building a robust culture of quality. Lesley explains that while quality professionals possess deep technical knowledge, they often struggle to be heard because they focus on being clear and correct rather than on making others feel understood. This conversation delves into why traditional training methods fall short and how a shift in mindset can lead to better relationships and greater influence.Lesley highlights that true influence and buy-in don't come from simply explaining things well, but from actively listening and making others feel heard. The discussion touches on common pitfalls, such as using excessive jargon, over-explaining, and failing to understand the listener's perspective. Lesley emphasizes the importance of building trust and psychological safety, which allows for open communication and the ability to ask clarifying questions without fear. She shares practical strategies, like paraphrasing to confirm understanding and moving from a "broadcast" mindset to one of curious listening.The conversation concludes with a look at the limits of traditional training, which often focuses on information over action and fails to address personal habits and emotional intelligence. Lesley describes how her coaching practice provides a personalized space for professionals to think through their specific challenges and discover their own solutions. She advocates for simple, plain language and encourages a shift from fear-based interactions to curiosity-driven ones, underscoring that the core of effective communication is a human-centric approach.Key Timestamps[02:52] - The PR Problem: Lesley addresses why skilled professionals in quality and regulatory roles often struggle to be heard, linking it to their non-direct authority and a tendency to prioritize correctness over relationships.[06:34] - The Buy-in Breakthrough: The difference between being understood and making someone feel understood is explored, revealing that true buy-in hinges on empathy and listening.[09:34] - Communication Blind Spots: This segment uncovers common, subconscious behaviors that undermine communication, such as using too much jargon, over-explaining, and failing to consider the audience's knowledge.[14:17] - The Power of Admitting 'I Don't Know': Etienne and Lesley discuss how acknowledging a lack of understanding can build trust and demonstrate self-awareness, countering the fear of appearing "dumb."[16:42] - Fear vs. Curiosity: Etienne shares his perspective on curiosity as the opposite of fear and a powerful tool for overcoming communication anxieties.[18:12] - Why Training Fails: The limitations of traditional corporate training are examined, highlighting its focus on information rather than the personalized, action-oriented work required for true behavioral change.[25:39] - The Coaching Advantage: Lesley explains how coaching helps professionals solve their own problems and gain clarity by creating a dedicated space for focused thinking and reflection.Quotes"Buy-in isn't about whether people understand; it's about whether people feel understood." — Lesley Worthington"Curiosity... I think the opposite of fear is curiosity." — Etienne NicholsTakeawaysShift from Correctness to Connection: The most effective medical device professionals understand that their influence isn't solely based on being technically correct. Instead, they build strong relationships by...
Why do genius hardware ideas fail while simple ones dominate the market? Capital equipment strategist Prachurya Bharadwaj reveals how to align deep technical R&D with ruthless business scalability across continents. Learn how global politics influence right down to your material choices and how to build a team that can execute from vision to manufacturing dominance