Podcasts about Medtech

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls. This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems.Timestamps00:04 – Introduction to common FDA compliance issues02:02 – Discussion on FDA's policy of not naming individuals05:45 – Mike Drues challenges the "pre-market" classification of common issues09:20 – Documentation requirements for different device classes11:35 – Mike's take on the most common FDA issues (beyond the presented three)15:40 – Root causes of common compliance problems and industry responsibility20:00 – The role of regulation and FDA's responsibility in clarity27:05 – Deep dive into design change and design creep31:40 – Software changes and the "bug fix" mentality35:45 – Marketing beyond authorized intended use with a real-world example41:00 – Key takeaways and proactive compliance strategiesStandout Quotes"If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules."You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences.Top TakeawaysRegulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges. This distinction is crucial for companies to allocate resources effectively.Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38%), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence (85% of those rejections).Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%), collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas.Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised.Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion.References & LinksEtienne Nichols' LinkedInGreenlight GuruCall to...

Send us a textGenerative AI is transforming the way clinicians interact with technology. In this episode, Dr. Holly Urban, VP of Business Development at Wolters Kluwer, joins John Driscoll to discuss how AI, ambient listening tools, and trusted medical content like UpToDate are improving clinical workflows, easing documentation burdens, and making healthcare delivery more precise, efficient, and human-centered.

In this episode of the Healthy, Wealthy and Smart podcast, host Karen Litzy welcomes Elizabeth Chabe, MBA, MS, CEO of High Touch Group and author of "The Giant's Ladder, The Science Professional's Blueprint for Marketing Success." Elizabeth shares her expertise in marketing within the science and technology sectors, particularly focusing on biotech and MedTech. She discusses the challenges faced by innovators in getting their ideas noticed and provides insights on how to market groundbreaking work effectively. Listeners will gain valuable strategies for building brand awareness and achieving market traction, making this episode a must-listen for health and wellness professionals looking to amplify their impact. Join Tara and Elizabeth as they explore the intersection of science, storytelling, and strategy in marketing. Time Stamps:  [00:01:43] Marketing strategies for science professionals. [00:04:33] CRISPR and corporate strategy. [00:10:58] Fractional wet lab space. [00:12:08] Storytelling in scientific marketing. [00:15:50] Founders and product-market fit. [00:19:24] Selling scientific products effectively. [00:25:20] Business strategy vs. marketing gloss. [00:29:43] Science marketing for founders. [00:34:40] Marketing strategies for researchers. [00:38:04] Philanthropic support for dog rescue. [00:39:19] Importance of mission in business. More About Elizabeth:  ELIZABETH CHABE (MBA, MS) is an author, entrepreneur, and recognized strategic marketing consultant for science, engineering, and technology organizations. Her work has been featured in The New York Times, Popular Science, Entrepreneur, CNBC, Composites World, and 360Dx, among others.   As the founder and CEO of High Touch Group, Elizabeth oversees a team that develops marketing and PR strategies for advanced science, engineering, and technology organizations. Through High Touch Group's holistic, comprehensive marketing services, clients generate more leads, drive revenue, and elevate their brands into the global B2B space.  Her work as a strategic consultant has been instrumental to biotechnology, energy, advanced materials, advanced manufacturing, robotics, and automation companies.  Since her first business venture at the age of nine, Elizabeth has built and overseen countless successful research programs and marketing teams. As the former senior manager of digital and strategic marketing at the Jackson Laboratory (JAX), she developed the marketing strategies for its mouse model portfolio, model generation (CRISPR), and in vivo contract research services.  Prior to joining JAX, she oversaw global communications for the Advanced Structures and Composites Center in Maine. There, she managed projects including the center's offshore wind research program, the largest research and R&D program in Maine's history.  Since 2018, Elizabeth has been a governor-appointed director of the Maine Venture Fund.  An inveterate traveler, she splits her time between the US and developing world communities. She currently resides in Mexico with her husband and rescue dogs.  Resources from this Episode: July 17th Jane Q&A Webinar High Touch Group Elizabeth's Website Elizabeth on LinkedIn Giant's Ladder Book   Jane Sponsorship Information: Book a one-on-one demo here Mention the code LITZY1MO for a free month Follow Dr. Karen Litzy on Social Media: Karen's Twitter Karen's Instagram Karen's LinkedIn Subscribe to Healthy, Wealthy & Smart: YouTube Website Apple Podcast Spotify SoundCloud Stitcher iHeart Radio

This panel was recorded June 26, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at RQMplus.com.SummaryHear leading neurology innovators discuss how to navigate complex regulatory pathways, accelerate approvals, and reduce risk in bringing groundbreaking neurological devices to market.LinkedIn panelist and moderator profiles 

  Background: From IT in India to MedTech in Norway  You have a pretty fascinating background – you studied computer applications/IT back in India and now you're a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)  What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?  And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)  Day-to-Day as a QARA Manager   Let's talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)  It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?  We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?  On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?  (For example, is it challenging that the scope is so broad – one moment you're deep in engineering specs, next moment you're updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)  First MedTech Role at Hy5Pro AS  Let's dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?  (Feel free to explain what Hy5Pro's product was and your role there, e.g. implementing the quality system, getting certifications, etc.)  Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?  (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)  Leading QARA at RemovAid AS   After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?  RemovAid's product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.  (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)  On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?  RemovAid is in women's health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it's about making contraceptive care easier – that's quite impactful.)  Consulting Experience at LINK Medical   Now, currently you're working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?  I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company's project mid-stream.  Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you've learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*  Diversity and International Career Insights   I'd like to touch on diversity and your international experience. You're a woman in the medtech industry and you've built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you've noticed working in Norway compared to India?  The medtech industry, especially in leadership, still isn't very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?  What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)  Rapid-Fire Round   Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I'll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!  Question 1: What's one thing about your job that most people would be surprised to learn?  Question 2: What's the coolest medical device or gadget you've worked on or seen so far?  Question 3: Are you team coffee or tea? (What fuels your workdays?)  Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?  Question 5: If you weren't in QARA, what alternate career could you see yourself in?  Question 6: What's one Norwegian word or phrase you've picked up that you love to use? (Bonus: translate it for us!)*  Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)  (Guest gives rapid-fire answers with laughter and brief commentary.)  Advice and Closing   Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?  (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)  And maybe equally important, what should they not be scared of? People might think “Oh, I'm not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?      Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)  Welcome & Setup  Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?  Career Journey  How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?  What motivated you to switch into medical device regulations, and what were the biggest initial challenges?  In what ways has your IT background helped you excel in QARA?  Day-to-Day Responsibilities  What does a typical day or week look like for you as a QARA Manager?  Which tools or software (QMS systems, document controls, etc.) do you rely on most?  Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it's all paperwork?  Which aspects of QARA do you find most challenging, and which are the most rewarding?  Hy5Pro AS Experience  What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?  Can you share a memorable “learning moment” or funny anecdote from your time there?  RemovAid AS Experience  At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?  Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.  Any unexpected or humorous challenges you overcame in that role?  How did working on a women's health product impact you personally?  LINK Medical Consulting  How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?  What's a standout project or recurring compliance issue you help clients solve?  How do you stay organized when juggling multiple clients and deadlines?  Diversity & International Insights  As a woman in medtech QARA, have you faced any unique challenges or opportunities?  What cultural adjustments did you experience moving from India to Norway?  How can medtech teams become more inclusive, especially in QA/RA?  Rapid-Fire Round  (Answer quickly with the first thing that comes to mind.)  One surprise fact about your job?  Coolest device or gadget you've worked on or seen?  Favorite (or funniest) QARA acronym—what does it mean?  Alternate career you might have chosen?  Norwegian word or phrase you love—translate it for us!  If your career were a movie title, what would it be?  Closing Advice  What practical steps should students or career-changers take to break into QARA?  What misconceptions shouldn't they be afraid of when considering this field?   

Dans cet épisode bouleversant de La Poche Gastrique, les Drs Pierre Garneau et Alexandre Bougie reçoivent Johana Monthuy-Blanc, professeure titulaire à l'Université du Québec à Trois-Rivières, chercheure au CR-IUSMM et spécialiste des troubles de la perception corporelle. Ensemble, ils explorent en profondeur l'impact de l'image de soi avant et après une chirurgie bariatrique.

In this episode, Liz and Rachel dive into the interview with Sarah Keenan about commercial training. They discuss their thoughts on a competency model, how and why to certify (or not), and the benefits of developing a learning culture. The episode ends with a reflection how training starts with trust: without it, your training just won't be effective. 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 commercial training? Contact us at training@cumbyconsulting.com.Related Resources:Sarah Keenan 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.

Edited June 6th, reloaded June 7th. Thursday, June 5th, MBN was On The Road to Delta Township, (SW Lansing metro) as IONETIX Invests $25.75M in Delta Township Facility, Creating 53 High-Tech Jobs and Advancing Lansing's MedTech Leadership Expansion includes new cyclotron, advanced isotope lab, and strengthens Lansing's position as a national MedTech innovation hub In this video remarks are shared by officials and leaders involved ahead of the ribbon cutting ceremony. Please bear with occasional wind noise on the video's audio. Lansing, Mich. (June 6, 2025) — Yesterday, IONETIX, a leader in advanced radiopharmaceutical technologies, is investing $25.75 million to expand its Delta Township facility. The project will add a second cyclotron, and an advanced isotope processing laboratory. The expansion is expected to create 53 high-tech jobs and further accelerate innovation in life sciences and nuclear medicine manufacturing. “IONETIX's expansion is creating high-skill, high-value jobs and elevating the Lansing Region within the global medical technology landscape,” said Bob Trezise, president and CEO of the Lansing Economic Area Partnership (LEAP). “LEAP is proud to support this project and the ecosystem of innovative MedTech companies making our region a destination for biomedical research and economic opportunity.” IONETIX marked the milestone with a community event at its Delta Township facility, bringing together company leaders, regional partners, and officials from across the state. Speakers included representatives from IONETIX, LEAP, the Michigan Economic Development Corporation (MEDC), and Delta Township. Founded in 2009 from technology developed at the MIT Plasma Science and Fusion Center, IONETIX has pioneered the world's first commercial compact superconducting cyclotron, the ION-12SC, which is used to produce N-13 ammonia, one of the most accurate positron emission tomography (PET) imaging agents for detecting coronary artery disease (CAD). The company has also expanded its focus to targeted alpha therapy (TAT), an emerging cancer treatment utilizing high-energy alpha particles to target cancer cells while preserving healthy tissue. "Delta Township and the Lansing region offer the ideal environment for IONETIX's continued growth. The area's highly skilled workforce, robust infrastructure, and strong spirit of public-private collaboration make it the perfect location for our expansion,” said Kevin J. Cameron, Chief Executive Officer of IONETIX. “We are honored to invest in this community and proud that it is in the forefront of creating diagnostic and therapeutic innovations.” This expansion aligns with IONETIX's broader strategy to grow its radiopharmaceutical manufacturing network, advance commercialization of new therapies, and reinforce Michigan's leadership in life sciences and medical technology innovation. The State of Michigan, through the Michigan Business Development Program, awarded IONETIX $750,000 in incentives to support this expansion, ensuring a strong pipeline of skilled talent and continued innovation in the region. We are thrilled with the company's commitment to Michigan and the Lansing community by investing over $25 million to accelerate the efforts to one day cure cancer,” said Matt McCauley, Senior Vice President for Regional Development at the MEDC. "Team Michigan welcomes IONETIX Corporation's expansion, furthering Michigan's leadership in the life sciences and medical technology industries. We applaud the company's vision to Make it in Michigan. » Visit MBN website: www.michiganbusinessnetwork.com/ » Subscribe to MBN's YouTube: www.youtube.com/channel/UCqNX… » Like MBN: www.facebook.com/mibiznetwork » Follow MBN: twitter.com/MIBizNetwork/ » MBN Instagram: www.instagram.com/mibiznetwork/

On this week's episode of Top in Tech, Megan Stagman, Director, UK TMT, is joined by Charlie Norell, Senior Associate in GC's Health & Life Sciences practice, to unpack the UK's recently published 10-Year Health Plan and what it means for the future of healthcare innovation. They explore how the Plan aims to reshape the NHS, with a focus on the government's desired shift from analogue to digital and harnessing the latest technologies. They reflect on next steps for the proposed Single Patient Record, the expanded role of the NHS App, new "Global Institutes" and regional innovation zones, and dig into the political drivers and fiscal considerations behind the Plan. The discussion covers the opportunities this creates for MedTech, life sciences, and digital health, alongside key challenges such as funding gaps and structural reform. Hosted on Acast. See acast.com/privacy for more information.

Thought leader Julio G. Martinez-Clark shares how his company in helping to bring medical innovation to the market sooner by conducting clinic trials in Latin America. About Julio: Julio G. Martinez-Clark stands at the forefront of clinical research transformation as the Ambassador of IAOCR/GCSA in the Americas and CEO of bioaccess®, where he bridges global quality standards with the world's growing MedTech, BioPharma, and Radiopharmaceutical ecosystems. With over two decades of cross-industry leadership spanning healthcare, telecommunications, and venture capital, Martinez-Clark has become the trusted partner for 100+ companies seeking accelerated regulatory approvals and cost-effective clinical trials worldwide. His unique fusion of technical expertise from Johns Hopkins Hospital infrastructure projects, regulatory acumen honed through UNESCO-aligned accreditations, and operational mastery of diverse global clinical trial landscapes positions him as the definitive authority on risk-mitigated medical innovation in emerging markets. Resources: Products discussed in the podcast: ReGelTec: https://regeltec.com/regeltec-chooses-colombia-bioacce-for-first-in-human-clinical-trial-of-hydrafil-system/   Spine Stabilization Technologies (SST): https://thespinemarketgroup.com/spinal-stabilization-technologies-ltd-announces-start-of-lopain-2-clinical-trial-in-south-america-for-lumbar-degenerative-disc-disease/   bioaccessla.com   Show sponsor:  The Cox 8 Table by Haven Medical

A new micro-credential course to encourage sustainability in the medtech, pharma and public sector in Ireland has been launched at University of Galway. The Green Labs initiative has been spearheaded since 2019 by Dr Una FitzGerald, Associate Professor of Biomedical Engineering in the School of Engineering and a Principal Investigator within CÚRAM, the Research Ireland Centre for Medical Devices. Green Labs develop medtech sustainability course The new 10-week microcredential programme is aimed at Ireland's extensive laboratory industry, including medtech and pharma, healthcare and science and the research sector and builds on the success and impact of the Green Labs initiative, which aims to reduce the environmental impact of laboratory practices. Dr Una FitzGerald said: "Once I took on board the considerable contribution that sustainable lab practices can make to global efforts to reduce GHGs and different kinds of waste, I felt compelled to act, because I supervise and teach many different cohorts of students. I feel I have a duty to do all possible to mitigate the climate and biodiversity crisis and feel fortunate that I am in a position to help. "As Ireland's medtech and pharma sectors continue to grow, so too does the responsibility to operate in an environmentally sustainable fashion. Laboratory testing is a crucial part of operations in these organisations, as well as for hospital and environmental testing - just think of how many lab tests are require to diagnose disease or to prove that the water you are drinking is safe. Medical device manufacturers also need lab tests to prove that implantable devices are sterile, and pharma companies use labs characterise the properties of drugs." The green labs journey commenced in 2019 with CÚRAM becoming the first laboratory in Europe certified as 'Green' by American non-profit, My Green Lab. Meeting this standard required raising awareness of the impact of lab work on the environment and prompted efforts to reduce plastic waste, energy and water usage and adopt green principles of synthetic and analytic chemistry. One fact learned was that a single ultra-low temperature freezer, used to store lab samples, uses as much energy as the average household. In 2020, Dr FitzGerald developed a course module for postgraduates on green lab principles and practice, which more than 170 students have taken to date, including online at universities in England, Scotland, Germany and Denmark. On Earth Day in 2022, Irish Green Labs (IGL) was launched by Dr Fitzgerald, in collaboration with Sustainable Energy Association of Ireland and Dublin City University to promote sustainable methods within public and private laboratories on the whole island of Ireland. The new online microcredential programme Green Labs Principles and Practice, will go further to address the lack of awareness of the impact that lab practices and behaviours have on the environment. Employees in corporate and public sector are being targeted through this course and the first 20 places are funded through Springboard. The first students enrol in September. Microcredential courses are short and accredited to meet the demands of learners, enterprise and organisations, created by Irish Universities Association (IUA) partner universities in consultation with industry and enterprise, under the MicroCreds project. Green Labs Principles and Practice will allow employees to examine how the organisation of, and practices in, scientific laboratories can be reformed to reduce their environmental footprint and be established on a more sustainable basis. The Irish Green Labs network is run on a voluntary basis, supporting more than 37 organisations within the public and private sectors, including all the higher education institutes, the Environmental Protection Agency, 10 hospitals and seven companies. Dr Fitzgerald's work in this area ultimately led to inclusion of sustainable lab practices in Taighde Eireann/Research Ireland's Climate...

In this episode of The Med-Tech Talent Lab, we sit down with Eric Steuben, Senior Vice President of Operations at Calyxo, a fast-growing company disrupting the treatment of kidney stones with its proprietary C-VAC system.Eric brings over 30 years of experience in MedTech, having held leadership roles at Varian, Align Technology, Procept BioRobotics, and more. He shares his journey from early career rotations in engineering to scaling operations from 13 employees to over 1,500 across five countries.Together, Mitch and Eric dive into:How a strong foundation in people and culture shaped Eric's leadership approachThe leap from individual contributor to first-time manager—and how to get it rightLessons from scaling Align Technology during its hypergrowth phaseWhy he believes no one should stay in a role longer than 3–4 yearsHow to hire for where you're going, not just what you need todayThe critical role of mentorship and choosing the right people to followWhat makes Calyxo's stone removal technology a potential game-changer in urologyWhether you're building a team, scaling a startup, or aiming for executive leadership, Eric's wisdom and experience offer valuable insights for professionals across the MedTech ecosystem.Eric Steuben on LinkedIn: https://www.linkedin.com/in/esteuben/Calyxo on the web: calyxoinc.com

Jessica Richter is a medtech executive and a board member with MedtechWOMEN. Jessica shares her inspiring journey from B2B sales to becoming a leader in the medtech industry, including overseeing a wide range of vital functions such as clinical trial strategy, regulatory affairs, and market access. Jessica provides insightful advice on overcoming common industry challenges, and underscores the value of quality systems, expert team-building, and fostering a supportive network for women through MedtechWOMEN.   Guest links: https://www.linkedin.com/in/jessica-richter-5aa43517/ | https://medtechwomen.org/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 059 - Jessica Richter  [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, Jessica Richter. Jessica is the Executive Vice President and General Manager at Veranex, a global provider of end-to-end solutions that accelerate MedTech innovation through deep expertise and integrated resources. As the leader of Veranex's contract research organization and consulting services business unit, she oversees clinical trial strategy and execution, clinical data services, regulatory affairs, quality and compliance, market access and reimbursement. She also manages operations, client engagement, business development and performance tracking. A seasoned leader in medical devices and diagnostics, Jessica has extensive experience in software as a medical device, surgical innovation, oncology, aesthetics, cardiology and gastroenterology. Her tenure at Medtronic and Becton Dickinson shaped her expertise in commercialization, sales strategy, physician education, patient advocacy, and change management. Beyond her current role, Jessica serves on the boards of medtech, women and UCLA's technology development group. She actively advises startups, accelerators, and universities, including medtech innovator UC Berkeley's Master of Translational Medicine Program, the Mayo Clinic's Executive Steering Committee for the Surgical Innovation Summit, and UCLA BioDesign.   Thank you so much for being here, Jessica. I'm so excited to speak with you. [00:02:15] Jessica Richter: Likewise, Lindsey, thank you so much for having me. [00:02:18] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind sharing a little bit about yourself and your background and what led you to medtech. [00:02:26] Jessica Richter: Awesome. Yeah, happy to. So, I was born and raised in California. I am the youngest of three girls and my entire family is really in the healthcare delivery field. So both my grandfathers were surgeons. My mother is a nurse. Both my sisters are clinical psychologists. And so when I went to school, I had aspirations at one point to get into medicine, and then through a really challenging organic chemistry class, kind of started to realize that maybe the practice of medicine wasn't where I belonged. And so I initially graduated from Berkeley, had my sights set on potentially doing something in communications, and started off in business to business sales in the telecom industry. So as far from medtech as maybe one could think. Had some experience with software, this is when Blackberries were a thing, if you remember those. And then a friend of mine was a recruiter and reached out and said, "Hey, I, I know that you're into medical and into medicine, and that was something you were interested in. Have you ever considered a career in medical device sales?" And frankly I didn't even know that that existed. I mean, this was 20 years ago, so this was before, you know, internet and all of those things existed, obviously, but it wasn't as pervasive as it is now. And so I wasn't even aware that these jobs existed. The fact that you could be working on the delivery of care but not be a healthcare provider was an eyeopening moment. And so I got in and started actually working at a surgical company called Deval. It's part of CR Bard, which is now part of Becton Dickinson, and I cut my teeth in medical device sales. And then I went on to work in a commercial role within other companies Given Imaging, Covidian, Medtronic. I ascended to sales leadership, working with key opinion leaders, working on the patient advocacy side. And then about eight years ago, I had the opportunity through an organization that we'll talk a little bit more about, called MedtechWOMEN, that I was involved in to learn about a consultancy that was looking for a head of business development marketing. It was a small group called Experian Group. I joined them and then within nine months was promoted to Chief Operating Officer, which was a position that I absolutely loved because we were working on the pre-commercial side of things and regulatory quality systems, clinical trials. And I had always had experience in the post commercial side. So eyes open to what happens, everything leading up to commercial. And I got a masterclass from my colleagues there, learning so much about what happens again, pre-commercial. But then one of the other things that came out very quickly is I've always been someone who loves operational efficiency. And I know that's not sexy or cool, but I just like seeing something that isn't working optimally and get it working optimally is something that brings joy. So I had the opportunity to do that within Experian Group, and then really help the organization, which was already very successful, go from a very successful kind of local consultancy to a much larger, broader group with a broader footprint, more global client base. And then we were acquired by the firm that I currently work with called Veranex, and that really exploded capabilities of what was a 50% consultancy to now over a thousand people with a much broader global reach in the US, in Europe, and in India. [00:05:36] Lindsey Dinneen: Wow. That is incredible. Well, first of all, thank you for sharing your story and your background and all the amazing things that led you to where you are right now. That's incredible. So many questions, in a good way. But let's dive in a little bit about, yeah, so, so tell us a little bit more about your role right now, and what are you excited about as this consultancy continues to grow and new opportunities arise. What's on the future for you? [00:06:02] Jessica Richter: So now I lead one of three business units here at Veranex. So I lead our CRO and Consulting Services Business Unit, and that encompasses regulatory, quality, and clinical, as well as commercial strategy, market access reimbursement, things like coding, coverage, payment. So we help mid-size, early stage, and some of the largest strategic medtech companies, as well as some biopharma as well with companion diagnostics, navigate sometimes the tumultuous waters needed to bring a device from inception all the way through to commercialization. Veranex also has two other business units in preclinical as well as extensive design, development and engineering. So there's leaders in each of those capacities. And what we do on CRO and consulting services is really consultative. So we work with clients to develop strategies in all of these areas, and then we roll up our sleeves and work alongside them to make sure that those strategies are actually executable, so to help them along the way. And some of our clients have teams, so it's strategic and we're advisors. Other clients, if they're early, early, may not have extensive expertise or the ability to build out teams in that way. So we go in, or our team goes in, and really provides them that support along the entire continuum. It's interesting, just today, we have a client we've been working with for two years. They're in Switzerland, but they've been working with our US and global team. They just got news from FDA that they obtained FDA clearance. And I'll tell you, I think our team is as excited as theirs because, when you're in a company, it's all that you're living, breathing, doing. When you're consulting, you're a little bit at an arm's length. So when our clients achieve their results, and it's their work, but in concert with ours, the feeling of accomplishment really is just, it's one of those that's explosive. So we've celebrated that. We ring a bell. We'll share a lot, we'll do some marketing around it with this client. But it's really fun. That's the part that really drives not just me, but members of our team as to "How can we help more companies get more products to patients?" [00:07:58] Lindsey Dinneen: I love that. First of all, congratulations, that's exciting, and I'm thrilled for your clients and for you guys because it matters so much and what a great milestone. So that's wonderful. But yeah, so I'm curious, you've seen a lot of different sides to medtech and to the business side of things, and I'm curious what are some potential stumbling blocks that you have seen that companies, especially when they're perhaps a little bit younger or earlier on in the process, what are maybe one or two stumbling blocks that you see that you think, "You know what, hey, if we put a little bit of thought into this, we can overcome this very easily, but we need to be thinking about this from the start." [00:08:36] Jessica Richter: Okay. There's two things. One of them is gonna be a shameless plug, but I swear it's true, and that's quality. I think companies don't focus enough on quality systems 'cause it's just not the fun or sexy thing, but it's literally where we see companies struggle because they think about it too late. They do just in time. They think an EQMS is the answer, and it's not the only answer, it's a component. So quality would be the short answer. The longer answer is people. So what we see is oftentimes, people, especially in a cost constrained environment, which we are today, where fundraising is tough, people do need to be financially astute as far as what they're spending and how they're spending it. But sometimes you get more by spending a little bit more to get the right advice. So for example, if somebody is expert in engineering or expert in regulatory, excellent. Know where your expertise is not, and then supplement. So either hire a consultant or bring on an employee or have a member of your board that can advise them that way. More often than not, we see people trying to just kind of figure it out as they go, which isn't a bad strategy, but there are critical decisions and inflection points along the way. For example, if you're developing a clinical trial, thinking only about your regulatory strategy and not about your commercial goals or the claims you're going to make, you are gonna have to ultimately spend twice as much when you have to do secondary studies that you could have avoided by including that in endpoints. So there's little things like that along the way where if you don't know what you don't know, it's really difficult to see those hurdles. It's helpful to bring in people, even in an advisory capacity, to help you say, "Okay, these are the hurdles that you're gonna face." You're gonna have new hurdles that maybe that you won't know or people won't know, but it's really making sure that you surround yourself with experts in those key areas. [00:10:25] Lindsey Dinneen: Mm. That's great advice. Experts in those key areas. Well, speaking to the advisory point, I'd actually love to talk about your involvement with MedtechWOMEN, and tell us a little bit about that organization and how it serves women in this industry. [00:10:39] Jessica Richter: Absolutely. Thank you for asking. It's something that I could literally talk about for this entire podcast. So, I alluded to it earlier, but MedtechWOMEN, I got, and I say "roped in" lovingly, but I was introduced to this organization, gosh, maybe a decade ago now when I was at Covidian and then Medtronic, and a mentor of mine, Amy Belt Raimundo, was one of the founders of MedtechWOMEN. And she had mentioned to me, because there weren't a lot of female leaders within that section of my business at the time, so I was paired with her and it feels like kismet because she was this spark of like, this is what badass female leadership looks like. She knew her stuff, she was really focused on the issues. She made time and said yes anytime I had a question or wanted to meet. Our conversations were really meaningful and actionable. Sometimes we just talked as friends. It wasn't always so agenda based, but she introduced me to MedtechWOMEN and shared with me that there's this organization. It's all volunteers. It's kind of membership based and it's literally women getting together talking about the issues in our industry. And it wasn't as focused on things like work-life balance, which quite frankly is a challenge, no matter what your gender is. There are great forums for talking about work-life balance and how you prioritize your health and your mental wellbeing, and that is really, really important. But some of the events that I had gone to as far as women in leadership or women in medtech were really focused on those things and that wasn't what I wanted to talk about. I wanted to see incredible pioneers or trailblazers in our industry talking about the things that mattered in industry and sharing their perspectives. And that's exactly really the thesis of MedtechWOMEN. And so it was an organization founded over a decade ago. It started really as just an annual event, this MedtechVISION event, where we brought women together on a podium talking about the issues impacting healthcare today. It evolved. So after a couple of years and a couple of different topics, what we started to see is that there was a real thirst in the community that we had beyond just that individual or that one time a year we got together for the event. And so we developed a kind of MedtechWOMEN 2.0. We brought on an Executive Director. And we essentially launched a much, much grander vision of what MedtechWOMEN was. So it included membership. It included mentorship, so formal pairings. We created a board of directory, kind of a pathway to get to more women on boards. We also have local events, networking events, virtual events in partnership with our sister organizations like MedTech Color and Diversity by Doing. And then of course we still have our annual event. And then just this past month we actually brought on a new executive director. Her name is Yvonne Bokelman. She is a longtime industry veteran, tremendous leader in medtech, and someone who's really passionate about the organization, the mission, the vision. So we're excited to see what she will do in her role here. [00:13:38] Lindsey Dinneen: Yeah. That's incredible. Thank you so much for sharing a little bit about the organization and its history and who it is serving, and it really resonated because I agree with you that there's wonderful platforms for being able to talk about some of the. Some of the topics that tend to come up quite a bit for women, especially women leaders, and I love the fact that you are fully acknowledging that those things are great as well, but that your focus is a little bit different. And so I'm curious, what are some interesting stories or things that have happened maybe unexpectedly from this network of incredible women supporting each other, learning from each other. Can you share a little bit that? [00:14:17] Jessica Richter: Oh yeah, absolutely. And I'll tell you, many of us that have been members for a long period of time will attest to the fact that job opportunities come via this network, learning opportunities, sales and business opportunities. I mean, we network in the same way that we would in any other conference or any other meeting, but deals certainly have gotten done within and at MedtechWOMEN and MedtechVISION events. But most importantly, and one of the things that I always tout, is that MedtechWOMEN is a sisterhood that will take that call. And what I mean by that is if you have a question, if you need to phone a friend-- going back to what we were talking about earlier of that network of you don't know what you don't know, but somebody probably does-- within MedtechWOMEN, someone definitely does. And so what we encourage our members and our mentors and anyone that's a part of the organization to do is reach forward and reach back. And so when I say take that call, if someone calls-- and I just had literally three conversations in the last three weeks-- with more junior people looking for career advice or wanting to have a question about regulatory or their thinking about a decision point in their job, and what should they do? I always take that call and, you know, we're all busy. We all have things to do, but that 30 minute conversation can have a really big difference. And I know for me, likewise, when I have a question, when I'm coming up against something where it's helpful to have a thought partner, sometimes you want that outside of your own company, or outside of your boss, or outside of your team. And so the MedtechWOMEN Network is incredibly powerful and very supportive. And in my experience, and I've tried it both ways, we will always take that call. [00:15:53] Lindsey Dinneen: Oh wow. That's incredible. So, okay, so mentorship and leadership is obviously a key component of your life, something that you're passionate about. From your own experience as a woman in this industry, are there any things that come to mind that you would say, just pieces of advice-- let's say for other women who might be younger in their career and they're looking to grow, they're looking to become leaders, they're looking to become maybe thought leaders, or own their own company, things like that-- what are some things that you might suggest to them from your own experience would be helpful? [00:16:27] Jessica Richter: Oh yeah. It's, it's a great question, Lindsey, because there's a lot of things. I wish we could just mind share. First and foremost, I would tell women to go for it. I think sometimes we self-sabotage or hold ourselves back if we don't have all of the information or feel like we're a hundred percent qualified. And there's been tons of studies that demonstrate that. So first and foremost, go for it. I had this conversation with one of my mentees who was taking on a new role and I said, "It's okay that you're feeling this way or that way. Do it and do it scared." Like it's okay to not feel like you have all of the confidence, right? And it doesn't mean fake it till you make it, although there's a little bit of that too. But I would say don't let fear hold you back. So that would be the first piece of it. The other piece of it is make sure that you have, really, your own board, meaning advocates, mentors, coaches, thought partners, people that you can reach out to and rely upon. And that has to work both ways. I will tell you, I have learned as much from mentees as I have learned from mentors. And so recognizing that knowledge is shared both ways, no matter what your seniority is. For people that are junior, they have their on the pulse of things that I'm not as privy to, and sometimes I feel, feel that even more strongly. Likewise for people that have been in this industry 40, 50 years, they have institutional knowledge that I only wish that I had. And so, being at this midpoint in my career, I'm sandwiched between both and really appreciate, so I would implore people that are hoping and wanting to pursue leadership, go for it. [00:18:00] Lindsey Dinneen: Yeah. Thank you for that. I, I love that advice. I really appreciate it. So, you have had such an interesting career and going from communication and sales, and then to this new role and Chief Operating Officer, all these cool things. For your own leadership style, what would you say are maybe one or two key things that you have found to be really helpful for you as a leader in the industry in the way that you approach the people that you lead? [00:18:30] Jessica Richter: Another great question, Lindsey. So I would say, well --first maybe I'll share some lessons learned 'cause I've made a ton of mistakes. So I think one of the things that I didn't appreciate early on as a leader that I definitely appreciate now, is that we all have our own lens, our view with which we take on and see the world, and that's the view in which, you know. And so as a leader, initially, my thought was, "Well, everyone kind of sees and feels it this way with their own flavor." That is not true. Everyone has their own view and that's really shaped by their family, their background, their culture, lots of different aspects. And so I think for me, some advice as a leader would be, be humble, take the time to really seek to understand, and then, even if you are heightening your communication, multiply that times three or four and then you're probably scratching the surface, 'cause people need to hear things different ways, multiple times. And it doesn't mean you need to micromanage or drill things down, but when you're leading an organization and bringing people along on a change, especially, it is important that people understand the why, the who, the what, the how come, and that they hear that re repeatedly so that they can understand it, they can buy into it, and that you're creating an environment to make sure that their questions are addressed. So, lesson learned kind of recommendation on the leadership piece. I think the other just piece of advice is that sometimes people aspire to leadership because they think it's glamorous or there's gonna be a lot of money there, or it looks like the leader doesn't have to do that much work, they're just delegating. What I would say is leadership is not glamorous. It's often thankless. It's super hard. I work tons of hours and I love the team that I work with, and so for me the why is that. But if you are not loving that, don't do that. There's plenty of opportunities that you can contribute meaningfully as an individual contributor or a principal or a subject matter expert, and that's great too. So know that if you want to lead people and be involved on that side of leadership, I welcome it. I think it's fantastic. I think there's a lot of people that get into it with a misconception of what it will look like. And I'll tell you it's worthwhile, but it's hard. [00:20:43] Lindsey Dinneen: Yeah, absolutely. Yeah, when you were talking about that it, the glamor side of things, I just remember so vividly and I, I joke about it because I think it's funny-- but very quickly, I used to own my own dance studio and I built that from the ground up. And people would say things to me like, "Oh my goodness. What you're doing, you're living your dream. That's amazing! Oh my gosh, how cool is that?" And inside, I'm like, "Ha, yeah, I mean, I spent the first two hours as the janitor this morning, and then the next two hours as the CEO. And then, you know..." And it's funny, but it's true, you wear a lot of hats as a leader and sometimes your job is literally getting down into the nitty gritty and cleaning up, and that's fine too. So I love that. [00:21:24] Jessica Richter: My quip is always from the janitor to the GM, like, "What needs to get done? There's no task too big or too small." And ultimately, I think that what you described in yourself, and I love that, is servant leadership, right? Like for me, I've always responded well, when a leader isn't above any task and doesn't ask for something that they themselves would not be willing or aren't willing to do along with their team member. And so again, that's, that's not the definition of leadership, but in my eyes, that's a definition of leadership that really resonates with me. [00:21:55] Lindsey Dinneen: Mm-hmm. I agree. Yeah. Well, speaking of stories and those kinds of fun things too, are there any that stand out to you, perhaps along your career or with MedtechWOMEN, or anything really, that just affirm to you that, "Hey, I am in the right industry at the right time, doing what I should be doing?" [00:22:14] Jessica Richter: Oh yes. So there's a couple of different specific examples. So firstly, one of the things that has happened as of late, and I feel like-- not to get too woo or California on you-- but these synchronicities where you'll be thinking about something or remembering something, and suddenly a project and people come together around it-- and again, I think that's part of the power of the network. But there was a friend of mine that I had run into at a conference, we were talking about a specific aspect of their business that was really needing some, some development, and it turned out that after that conversation, literally not a week later, I got a call from a prospective client that was interested in working in this specific space. We were able to connect them with this person that was in need of that exact thing. And it was with software and with AI and so a partnership was forged and now they are literally about to embark in this really explosive and announcement will be forthcoming about it. But there's so many examples of little nuances and synchronicities like that, that again, happen because of staying open, staying curious, that powerful network right place, right time. But I also think it's the magic of our industry. It's really small. People sometimes fail to appreciate because you have these large organizations that are hundreds of thousands of people, but the leaders within the organization are fairly connected and tight. It's really an interconnected ecosystem. So that's just kind of one broad example. There's also other really small examples of the power, I think, of MedtechWOMEN in just how it ignites and how it brings people together, especially across senior and junior roles. So when we do our networking events, we try to do them regionally, just to try to bring different people together. And you can have like the CEO of sometimes a large organization, like Lisa Earnhardt from Abbott is a member and an active participant. She often will come to events talking to someone who's their very first year in medtech. And when you see these examples of sponsors of ours really showing up and demonstrating a commitment to giving back, and you see these people that are junior that may not even know the seniority of the leader that they're speaking to, recognizing that we're all people at the end of the day, trying to really ideally propel healthcare and help patients in their journeys to health and wellness. And so when you see examples of those sparks and those little ignites, it reinforces why we're here, what it is we're doing, and really the power of the organization. [00:24:41] Lindsey Dinneen: Yeah! Well, I think that the more times that you get to see those connection points, and those synergies or whatever we wanna call them, I think that that does impact us in a way that goes, "Yeah, the work that I do matters and it's impacting people's lives and maybe in very different ways." So some of it is, yeah, that end user and that patient, and oh my goodness, what this device can do for them and their quality of life. And sometimes it's the person behind the invention and what does that journey look like for them personally and the impact on their own family and their life. So I love hearing about those connection points. [00:25:16] Jessica Richter: Well, and that's the joy of working also with, I mean, large strategics for sure, but the startup companies, oftentimes it's a physician and engineer. The physician is seeing the unmet need because of the patients coming into their clinic. They're feeling hopeless 'cause they can't address it, but also empowered because they know what to do. So those are the really fun, kind of feel good projects, especially because there is no one better equipped than a clinician, right, to say, "Okay, here's the gap." Engineers can help to design and develop, but oftentimes that's where the teams are sort of left in the lurch to say, "Okay, what do we do from here?" And so it is incredibly powerful to enable these innovators, no matter what their backgrounds are along that journey. And it's not a quick one as you know, being on the manufacturing side. It's not something that's quick or easy. It's not something that is a high success rate. And when it works, there is no better feeling. When you commercialize a device or when you get it through the FDA, that's just the start. When it's actually used in patients and you start to hear those patient advocates and those stories, and you expand indications and are able to help more patients, that's the thing that makes it worthwhile. And when the going gets tough, 'cause it does that, those are the stories, right, that really inspire us to continue. [00:26:33] Lindsey Dinneen: Yes, absolutely. Amen to that. So, okay, so I have so many thoughts swirling around, but I do want to pivot the conversation a little bit just for fun. So imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach? [00:26:53] Jessica Richter: Oh, I love this question. I'll try to make it not about our industry 'cause it's something I've been working on a lot lately, and it's a testament to patience, which is something that I think we could all use more of, but I could definitely use more of. So we rescued a dog in Covid. She's a Doberman pit mix. Her name is Poppy and she's delightful. And she was severely neglected. So when we got her, we knew she was really shut down and that we would have to do work to bring her out of her shell. My husband and I don't have kids. We have a quiet home. I knew that we could take that on. And so while I won't say I am the expert, what I have done in the four years we've now had her, is extensively worked with her on the, what I would call the "Art of the Dog Walk." So we have learned how to really master exercise, training, and discipline as a way to show affection, 'cause for a dog that shut down like that, that's really what she needed to thrive. It was humbling and very educational for me. I've always been a huge animal lover. I used to volunteer when I had a lot more time with an animal rescue. And so I was able to parlay that and work with a trainer really on honing those skills so that Poppy could not just be social in the world, but be less shut down. So it would be so fun to share a masterclass on that 'cause I had so many reflections and learnings on patience. The art of going slow, the art of taking in the world, of just slowing that down, not being on my phone, right, being really present with her. And I sort of joke with my husband, I feel like now when I walk her-- I dunno if you've seen the movie "Avatar"-- but like we connect our avatars and we like go on into this world, and it's meditative. It's our morning practice and it's something that for me has been incredibly rewarding, and challenging, and a huge learning experience that, that I would love to share. [00:28:50] Lindsey Dinneen: Oh, that's wonderful. Oh my goodness. Yes. I am a huge dog lover, so anytime someone's telling me about their dog, it's just instant happiness. [00:28:59] Jessica Richter: Likewise. And for my, my favorite thing that it will always bring a smile to my face is the unlikely animal friends, like if you see like a squirrel a dog or a kookaburra or something, you're like, "Ahh!" [00:29:10] Lindsey Dinneen: It's so cute. It's precious. Yes. I love it. And to me it reinforces, "Hey, we can actually all get along if we try." I mean, I know it's a little different in the animal kingdom, but still, I still love that. Oh my goodness. Great. Well then, how do you wish to be remembered after you leave this world? [00:29:32] Jessica Richter: You know, legacy is something, that I think is important. It's funny, I've been working with my niece on her college essays and college admittance, and reflecting back to my views when I was 18 versus my views today in the world now. And even speaking to my mom about legacy, 'cause it's something, you know, she's approaching her eighties that she thinks more and more about. So it's conversations that we have a lot. I really would love to be remembered as an enabler, as someone who really enables those around me to be successful, to achieve more, to obtain what they want right to, to drive forward. I love being around creative people and innovators and people with really expansive imaginations, and I think my superpower is kind of capturing and enabling those things. So it would be great to be able to enable more people around me. And that's true with patients and healthcare and the clients that we support as well. You know, one of the things that has always been pointed out to me-- and again, my grandfather was a huge proponent of this-- is when things aren't going well in the world, you can focus on what's going wrong or you can look for the helpers. And so, as a surgeon, he was one of those helpers. And so I think he ingrained that in me very early on. And so I'd love to be remembered as someone who is a helpful enabler. [00:30:51] Lindsey Dinneen: Hmm. Yes. That's a beautiful legacy. I love that. [00:30:54] Jessica Richter: I am curious, Lindsey, I know this is like, you're the, you're the interviewer, but how would you like to be remembered? [00:31:02] Lindsey Dinneen: Oh, thank you for asking. First time! You know, there are so many things, so many things that I love doing for other people. But I really actually resonated with your idea of enabling. And I would say mine is very similar. And that is that I love helping people achieve their dreams. And that can look like lots of different things to lots of different people. So it's when I'm working with a company, it always started with one person's idea, right? All these big companies started off as this tiny little one person's idea that became something. And I think just helping that, those sparks, especially when maybe they're eager, but they're not quite ready. They're scared, they're nervous, they're whatever, and helping them see a clear path to achieving those dreams and goals is one of my favorite things. And whether that's just a personal, I wanna run a marathon, I don't even how to know how to get started, or whether it's, I have this great idea for a book, but I am concerned about, like, "Nobody will read it, no one will care." Well, that's not the point. Let's start somewhere. And so I think for me, it's about empowering people to live the life that they want to live and hope that they can live. That's what I would love to be remembered for. [00:32:16] Jessica Richter: Well, that's beautiful. I hope that via this and the other things that you're doing, it seems like you're already on that track. [00:32:22] Lindsey Dinneen: Well, thank you. I appreciate that. I really appreciate you asking me too. Thank you. Well, and then final question, and you've sort of perhaps alluded to this-- I'll see if it's different than your first time-- what is one thing that makes you smile every time you see or think about it? [00:32:37] Jessica Richter: Oh, well, definitely the unlikely animal pairings for sure. [00:32:41] Lindsey Dinneen: Yes. [00:32:42] Jessica Richter: Anytime with family. Family is super important to me. So anytime I can spend time with our family, that is for me, a smile doesn't go off of my face. And also kind of what you said, celebrating other people's wins. And I celebrate my own as well-- I think it's important that we do that-- but there is nothing like, it's a grin, like when someone on our team has an accomplishment, the grin is twice as big, right? Because you just, to see that reflected, that success, that attainment, that win reflected for the people that you work alongside, that brings a smile to my face every time. [00:33:20] Lindsey Dinneen: Yeah, nothing quite like it, and it's so powerful. Yeah, huh. Oh my goodness. Well, this has been an amazing conversation. I don't really want it to end, but I know we have other things we have to get to today, so I just wanna take some time to say thank you so very much for being here with me, Jessica. Thank you for sharing all about your incredible career so far and all the exciting things that are to come, and speaking to MedtechWOMEN and that incredible organization. So I'm really excited for our listeners who might not have been familiar with it to go check it out, lots of opportunity there. And gosh, I just wish you the most continued success as you work to change lives for a better world. [00:34:01] Jessica Richter: Thank you, Lindsey, for hosting and I would encourage anybody who's unfamiliar with MedtechWOMEN, if you're new to industry or if you've been here a while, there is a place for you within MedtechWOMEN. Membership is super low cost. It's $150 for standard membership a year, $75 for junior members. You can follow us on LinkedIn, but highly, highly encourage everyone to join the network. And thank you for the opportunity to share a little bit more about MedtechWOMEN today. [00:34:26] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. 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 share this episode with a colleague or two, and we'll catch you next time. [00:34:57] Jessica Richter: Thanks, Lindsey. [00:34:59] 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.

Dans cet épisode, j'ai rencontré Jonathan Benassaya, qui après avoir cofondé Deezer, se lance un nouveau défi de taille : sauver des vies avec SkinBeat, sa startup dédiée à la détection précoce du cancer de la peau par IA. De ses débuts dans la publicité intégrée aux jeux vidéo à son expérience fondatrice dans la musique en streaming, Jonathan partage les coulisses de la création de Deezer, les défis d'une ambition mondiale, et les raisons pour lesquelles la France n'a pas su faire émerger un « Spotify ».Mais ce podcast est aussi une histoire personnelle : celle d'un mélanome qui aurait pu lui coûter la vie. Ce choc devient le point de départ d'un nouveau combat entrepreneurial. Avec SkinBit, il développe une technologie de scan corporel capable de détecter les anomalies cutanées en quelques secondes, et espère doubler la capacité de diagnostic dermatologique aux États-Unis. SkinBit montre comment l'intelligence artificielle peut transformer la médecine préventive : en répliquant à l'échelle industrielle l'œil expert d'un dermatologue et en libérant du temps médical précieux. Cette approche bouscule le modèle de soin traditionnel avec un jumeau numérique et l'IA, qui promet une réduction des coûts de santé, une meilleure détection des cancers, et une amélioration des conditions de vie pour des millions de personnes.Une conversation lucide, inspirante et nécessaire sur l'entrepreneuriat, la santé, la tech et les choix stratégiques qui peuvent tout changer. Un épisode à ne pas manquer si vous vous intéressez à la MedTech, à l'innovation de rupture, et à l'impact réel des startups sur nos vies. Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.

Dr. Paul Hanona and Dr. Arturo Loaiza-Bonilla discuss how to safely and smartly integrate AI into the clinical workflow and tap its potential to improve patient-centered care, drug development, and access to clinical trials. TRANSCRIPT Dr. Paul Hanona: Hello, I'm Dr. Paul Hanona, your guest host of the ASCO Daily News Podcast today. I am a medical oncologist as well as a content creator @DoctorDiscover, and I'm delighted to be joined today by Dr. Arturo Loaiza-Bonilla, the chief of hematology and oncology at St. Luke's University Health Network. Dr. Bonilla is also the co-founder and chief medical officer at Massive Bio, an AI-driven platform that matches patients with clinical trials and novel therapies. Dr. Loaiza-Bonilla will share his unique perspective on the potential of artificial intelligence to advance precision oncology, especially through clinical trials and research, and other key advancements in AI that are transforming the oncology field. Our full disclosures are available in the transcript of the episode. Dr. Bonilla, it's great to be speaking with you today. Thanks for being here. Dr. Arturo Loaiza-Bonilla: Oh, thank you so much, Dr. Hanona. Paul, it's always great to have a conversation. Looking forward to a great one today. Dr. Paul Hanona: Absolutely. Let's just jump right into it. Let's talk about the way that we see AI being embedded in our clinical workflow as oncologists. What are some practical ways to use AI? Dr. Arturo Loaiza-Bonilla: To me, responsible AI integration in oncology is one of those that's focused on one principle to me, which is clinical purpose is first, instead of the algorithm or whatever technology we're going to be using. If we look at the best models in the world, they're really irrelevant unless we really solve a real day-to-day challenge, either when we're talking to patients in the clinic or in the infusion chair or making decision support. Currently, what I'm doing the most is focusing on solutions that are saving us time to be more productive and spend more time with our patients. So, for example, we're using ambient AI for appropriate documentation in real time with our patients. We're leveraging certain tools to assess for potential admission or readmission of patients who have certain conditions as well. And it's all about combining the listening of physicians like ourselves who are end users, those who create those algorithms, data scientists, and patient advocates, and even regulators, before they even write any single line of code. I felt that on my own, you know, entrepreneurial aspects, but I think it's an ethos that we should all follow. And I think that AI shouldn't be just bolted on later. We always have to look at workflows and try to look, for example, at clinical trial matching, which is something I'm very passionate about. We need to make sure that first, it's easier to access for patients, that oncologists like myself can go into the interface and be able to pull the data in real time when you really need it, and you don't get all this fatigue alerts. To me, that's the responsible way of doing so. Those are like the opportunities, right? So, the challenge is how we can make this happen in a meaningful way – we're just not reacting to like a black box suggestion or something that we have no idea why it came up to be. So, in terms of success – and I can tell you probably two stories of things that we know we're seeing successful – we all work closely with radiation oncologists, right? So, there are now these tools, for example, of automated contouring in radiation oncology, and some of these solutions were brought up in different meetings, including the last ASCO meeting. But overall, we know that transformer-based segmentation tools; transformer is just the specific architecture of the machine learning algorithm that has been able to dramatically reduce the time for colleagues to spend allotting targets for radiation oncology. So, comparing the target versus the normal tissue, which sometimes it takes many hours, now we can optimize things over 60%, sometimes even in minutes. So, this is not just responsible, but it's also an efficiency win, it's a precision win, and we're using it to adapt even mid-course in response to tumor shrinkage. Another success that I think is relevant is, for example, on the clinical trial matching side. We've been working on that and, you know, I don't want to preach to the choir here, but having the ability for us to structure data in real time using these tools, being able to extract information on biomarkers, and then show that multi-agentic AI is superior to what we call zero-shot or just throwing it into ChatGPT or any other algorithm, but using the same tools but just fine-tuned to the point that we can be very efficient and actually reliable to the level of almost like a research coordinator, is not just theory. Now, it can change lives because we can get patients enrolled in clinical trials and be activated in different places wherever the patient may be. I know it's like a long answer on that, but, you know, as we talk about responsible AI, that's important. And in terms of what keeps me up at night on this: data drift and biases, right? So, imaging protocols, all these things change, the lab switch between different vendors, or a patient has issues with new emerging data points. And health systems serve vastly different populations. So, if our models are trained in one context and deployed in another, then the output can be really inaccurate. So, the idea is to become a collaborative approach where we can use federated learning and patient-centricity so we can be much more efficient in developing those models that account for all the populations, and any retraining that is used based on data can be diverse enough that it represents all of us and we can be treated in a very good, appropriate way. So, if a clinician doesn't understand why a recommendation is made, as you probably know, you probably don't trust it, and we shouldn't expect them to. So, I think this is the next wave of the future. We need to make sure that we account for all those things. Dr. Paul Hanona: Absolutely. And even the part about the clinical trials, I want to dive a little bit more into in a few questions. I just kind of wanted to make a quick comment. Like you said, some of the prevalent things that I see are the ambient scribes. It seems like that's really taken off in the last year, and it seems like it's improving at a pretty dramatic speed as well. I wonder how quickly that'll get adopted by the majority of physicians or practitioners in general throughout the country. And you also mentioned things with AI tools regarding helping regulators move things quicker, even the radiation oncologist, helping them in their workflow with contouring and what else they might have to do. And again, the clinical trials thing will be quite interesting to get into. The first question I had subsequent to that is just more so when you have large datasets. And this pertains to two things: the paper that you published recently regarding different ways to use AI in the space of oncology referred to drug development, the way that we look at how we design drugs, specifically anticancer drugs, is pretty cumbersome. The steps that you have to take to design something, to make sure that one chemical will fit into the right chemical or the structure of the molecule, that takes a lot of time to tinker with. What are your thoughts on AI tools to help accelerate drug development? Dr. Arturo Loaiza-Bonilla: Yes, that's the Holy Grail and something that I feel we should dedicate as much time and effort as possible because it relies on multimodality. It cannot be solved by just looking at patient histories. It cannot be solved by just looking at the tissue alone. It's combining all these different datasets and being able to understand the microenvironment, the patient condition and prior treatments, and how dynamic changes that we do through interventions and also exposome – the things that happen outside of the patient's own control – can be leveraged to determine like what's the best next step in terms of drugs. So, the ones that we heard the news the most is, for example, the Nobel Prize-winning [for Chemistry awarded to Demis Hassabis and John Jumper for] AlphaFold, an AI system that predicts protein structures right? So, we solved this very interesting concept of protein folding where, in the past, it would take the history of the known universe, basically – what's called the Levinthal's paradox – to be able to just predict on amino acid structure alone or the sequence alone, the way that three-dimensionally the proteins will fold. So, with that problem being solved and the Nobel Prize being won, the next step is, “Okay, now we know how this protein is there and just by sequence, how can we really understand any new drug that can be used as a candidate and leverage all the data that has been done for many years of testing against a specific protein or a specific gene or knockouts and what not?” So, this is the future of oncology and where we're probably seeing a lot of investments on that. The key challenge here is mostly working on the side of not just looking at pathology, but leveraging this digital pathology with whole slide imaging and identifying the microenvironment of that specific tissue. There's a number of efforts currently being done. One isn't just H&E, like hematoxylin and eosin, slides alone, but with whole imaging, now we can use expression profiles, spatial transcriptomics, and gene whole exome sequencing in the same space and use this transformer technology in a multimodality approach that we know already the slide or the pathology, but can we use that to understand, like, if I knock out this gene, how is the microenvironment going to change to see if an immunotherapy may work better, right? If we can make a microenvironment more reactive towards a cytotoxic T cell profile, for example. So, that is the way where we're really seeing the field moving forward, using multimodality for drug discovery. So, the FDA now seems to be very eager to support those initiatives, so that's of course welcome. And now the key thing is the investment to do this in a meaningful way so we can see those candidates that we're seeing from different companies now being leveraged for rare disease, for things that are going to be almost impossible to collect enough data, and make it efficient by using these algorithms that sometimes, just with multiple masking – basically, what they do is they mask all the features and force the algorithm to find solutions based on the specific inputs or prompts we're doing. So, I'm very excited about that, and I think we're going to be seeing that in the future. Dr. Paul Hanona: So, essentially, in a nutshell, we're saying we have the cancer, which is maybe a dandelion in a field of grass, and we want to see the grass that's surrounding the dandelion, which is the pathology slides. The problem is, to the human eye, it's almost impossible to look at every single piece of grass that's surrounding the dandelion. And so, with tools like AI, we can greatly accelerate our study of the microenvironment or the grass that's surrounding the dandelion and better tailor therapy, come up with therapy. Otherwise, like you said, to truly generate a drug, this would take years and years. We just don't have the throughput to get to answers like that unless we have something like AI to help us. Dr. Arturo Loaiza-Bonilla: Correct. Dr. Paul Hanona: And then, clinical trials. Now, this is an interesting conversation because if you ever look up our national guidelines as oncologists, there's always a mention of, if treatment fails, consider clinical trials. Or in the really aggressive cancers, sometimes you might just start out with clinical trials. You don't even give the standard first-line therapy because of how ineffective it is. There are a few issues with clinical trials that people might not be aware of, but the fact that the majority of patients who should be on clinical trials are never given the chance to be on clinical trials, whether that's because of proximity, right, they might live somewhere that's far from the institution, or for whatever reason, they don't qualify for the clinical trial, they don't meet the strict inclusion criteria.  But a reason you mentioned early on is that it's simply impossible for someone to be aware of every single clinical trial that's out there. And then even if you are aware of those clinical trials, to actually find the sites and put in the time could take hours. And so, how is AI going to revolutionize that? Because in my mind, it's not that we're inventing a new tool. Clinical trials have always been available. We just can't access them. So, if we have a tool that helps with access, wouldn't that be huge? Dr. Arturo Loaiza-Bonilla: Correct. And that has been one of my passions. And for those who know me and follow me and we've spoke about it in different settings, that's something that I think we can solve. This other paradox, which is the clinical trial enrollment paradox, right? We have tens of thousands of clinical trials available with millions of patients eager to learn about trials, but we don't enroll enough and many trials close to accrual because of lack of enrollment. It is completely paradoxical and it's because of that misalignment because patients don't know where to go for trials and sites don't know what patients they can help because they haven't reached their doors yet. So, the solution has to be patient-centric, right? We have to put the patient at the center of the equation. And that was precisely what we had been discussing during the ASCO meeting. There was an ASCO Education Session where we talked about digital prescreening hubs, where we, in a patient-centric manner, the same way we look for Uber, Instacart, any solution that you may think of that you want something that can be leveraged in real time, we can use these real-world data streams from the patient directly, from hospitals, from pathology labs, from genomics companies, to continuously screen patients who can match to the inclusion/exclusion criteria of unique trials. So, when the patient walks into the clinic, the system already knows if there's a trial and alerts the site proactively. The patient can actually also do decentralization. So, there's a number of decentralized clinical trial solutions that are using what I call the “click and mortar” approach, which is basically the patient is checking digitally and then goes to the site to activate. We can also have the click and mortar in the bidirectional way where the patient is engaged in person and then you give the solution like the ones that are being offered on things that we're doing at Massive Bio and beyond, which is having the patient to access all that information and then they make decisions and enroll when the time is right.  As I mentioned earlier, there is this concept drift where clinical trials open and close, the patient line of therapy changes, new approvals come in and out, and sites may not be available at a given time but may be later. So, having that real-time alerts using tools that are able already to extract data from summarization that we already have in different settings and doing this natural language ingestion, we can not only solve this issue with manual chart review, which is extremely cumbersome and takes forever and takes to a lot of one-time assessments with very high screen failures, to a real-time dynamic approach where the patient, as they get closer to that eligibility criteria, they get engaged. And those tools can be built to activate trials, audit trials, and make them better and accessible to patients. And something that we know is, for example, 91%-plus of Americans live close to either a pharmacy or an imaging center. So, imagine that we can potentially activate certain of those trials in those locations. So, there's a number of pharmacies, special pharmacies, Walgreens, and sometimes CVS trying to do some of those efforts. So, I think the sky's the limit in terms of us working together. And we've been talking with corporate groups, they're all interested in those efforts as well, to getting patients digitally enabled and then activate the same way we activate the NCTN network of the corporate groups, that are almost just-in-time. You can activate a trial the patient is eligible for and we get all these breakthroughs from the NIH and NCI, just activate it in my site within a week or so, as long as we have the understanding of the protocol. So, using clinical trial matching in a digitally enabled way and then activate in that same fashion, but not only for NCTN studies, but all the studies that we have available will be the key of the future through those prescreening hubs. So, I think now we're at this very important time where collaboration is the important part and having this silo-breaking approach with interoperability where we can leverage data from any data source and from any electronic medical records and whatnot is going to be essential for us to move forward because now we have the tools to do so with our phones, with our interests, and with the multiple clinical trials that are coming into the pipelines. Dr. Paul Hanona: I just want to point out that the way you described the process involves several variables that practitioners often don't think about. We don't realize the 15 steps that are happening in the background. But just as a clarifier, how much time is it taking now to get one patient enrolled on a clinical trial? Is it on the order of maybe 5 to 10 hours for one patient by the time the manual chart review happens, by the time the matching happens, the calls go out, the sign-up, all this? And how much time do you think a tool that could match those trials quicker and get you enrolled quicker could save? Would it be maybe an hour instead of 15 hours? What's your thought process on that? Dr. Arturo Loaiza-Bonilla: Yeah, exactly. So one is the matching, the other one is the enrollment, which, as you mentioned, is very important. So, it can take, from, as you said, probably between 4 days to sometimes 30 days. Sometimes that's how long it takes for all the things to be parsed out in terms of logistics and things that could be done now agentically. So, we can use agents to solve those different steps that may take multiple individuals. We can just do it as a supply chain approach where all those different steps can be done by a single agent in a simultaneous fashion and then we can get things much faster. With an AI-based solution using these frontier models and multi-agentic AI – and we presented some of this data in ASCO as well – you can do 5,000 patients in an hour, right? So, just enrolling is going to be between an hour and maximum enrollment, it could be 7 days for those 5,000 patients if it was done at scale in a multi-level approach where we have all the trials available. Dr. Paul Hanona: No, definitely a very exciting aspect of our future as oncologists. It's one thing to have really neat, novel mechanisms of treatment, but what good is it if we can't actually get it to people who need it? I'm very much looking for the future of that.  One of the last questions I want to ask you is another prevalent way that people use AI is just simply looking up questions, right? So, traditionally, the workflow for oncologists is maybe going on national guidelines and looking up the stage of the cancer and seeing what treatments are available and then referencing the papers and looking at who was included, who wasn't included, the side effects to be aware of, and sort of coming up with a decision as to how to treat a cancer patient. But now, just in the last few years, we've had several tools become available that make getting questions easier, make getting answers easier, whether that's something like OpenAI's tools or Perplexity or Doximity or OpenEvidence or even ASCO has a Guidelines Assistant as well that is drawing from their own guidelines as to how to treat different cancers. Do you see these replacing traditional sources? Do you see them saving us a lot more time so that we can be more productive in clinic? What do you think is the role that they're going to play with patient care? Dr. Arturo Loaiza-Bonilla: Such a relevant question, particularly at this time, because these AI-enabled query tools, they're coming left and right and becoming increasingly common in our daily workflows and things that we're doing. So, traditionally, when we go and we look for national guidelines, we try to understand the context ourselves and then we make treatment decisions accordingly. But that is a lot of a process that now AI is helping us to solve. So, at face value, it seems like an efficiency win, but in many cases, I personally evaluate platforms as the chief of hem/onc at St. Luke's and also having led the digital engagement things through Massive Bio and trying to put things together, I can tell you this: not all tools are created equal. In cancer care, each data point can mean the difference between cure and progression, so we cannot really take a lot of shortcuts in this case or have unverified output. So, the tools are helpful, but it has to be grounded in truth, in trusted data sources, and they need to be continuously updated with, like, ASCO and NCCN and others. So, the reason why the ASCO Guidelines Assistant, for instance, works is because it builds on all these recommendations, is assessed by end users like ourselves. So, that kind of verification is critical, right? We're entering a phase where even the source material may be AI-generated. So, the role of human expert validation is really actually more important, not less important. You know, generalist LLMs, even when fine-tuned, they may not be enough. You can pull a few API calls from PubMed, etc., but what we need now is specialized, context-aware, agentic tools that can interpret multimodal and real-time clinical inputs. So, something that we are continuing to check on and very relevant to have entities and bodies like ASCO looking into this so they can help us to be really efficient and really help our patients. Dr. Paul Hanona: Dr. Bonilla, what do you want to leave the listener with in terms of the future direction of AI, things that we should be cautious about, and things that we should be optimistic about? Dr. Arturo Loaiza-Bonilla: Looking 5 years ahead, I think there's enormous promise. As you know, I'm an AI enthusiast, but always, there's a few priorities that I think – 3 of them, I think – we need to tackle head-on. First is algorithmic equity. So, most AI tools today are trained on data from academic medical centers but not necessarily from community practices or underrepresented populations, particularly when you're looking at radiology, pathology, and what not. So, those blind spots, they need to be filled, and we can eliminate a lot of disparities in cancer care. So, those frameworks to incentivize while keeping the data sharing using federated models and things that we can optimize is key. The second one is the governance on the lifecycle. So, you know, AI is not really static. So, unlike a drug that is approved and it just, you know, works always, AI changes. So, we need to make sure that we have tools that are able to retrain and recall when things degrade or models drift. So, we need to use up-to-date AI for clinical practice, so we are going to be in constant revalidation and make it really easy to do. And lastly, the human-AI interface. You know, clinicians don't need more noise or we don't need more black boxes. We need decision support that is clear, that we can interpret, and that is actionable. “Why are you using this? Why did we choose this drug? Why this dose? Why now?” So, all these things are going to help us and that allows us to trace evidence with a single click. So, I always call it back to the Moravec's paradox where we say, you know, evolution gave us so much energy to discern in the sensory-neural and dexterity. That's what we're going to be taking care of patients. We can use AI to really be a force to help us to be better clinicians and not to really replace us. So, if we get this right and we decide for transparency with trust, inclusion, etc., it will never replace any of our work, which is so important, as much as we want, we can actually take care of patients and be personalized, timely, and equitable. So, all those things are what get me excited every single day about these conversations on AI. Dr. Paul Hanona: All great thoughts, Dr. Bonilla. I'm very excited to see how this field evolves. I'm excited to see how oncologists really come to this field. I think with technology, there's always a bit of a lag in adopting it, but I think if we jump on board and grow with it, we can do amazing things for the field of oncology in general. Thank you for the advancements that you've made in your own career in the field of AI and oncology and just ultimately with the hopeful outcomes of improving patient care, especially cancer patients. Dr. Arturo Loaiza-Bonilla: Thank you so much, Dr. Hanona. Dr. Paul Hanona: Thanks to our listeners for your time today. If you value the insights that you hear on ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:    Dr. Arturo Loaiza-Bonilla @DrBonillaOnc Dr. Paul Hanona @DoctorDiscover on YouTube Follow ASCO on social media:      @ASCO on Twitter      ASCO on Facebook      ASCO on LinkedIn    ASCO on BlueSky Disclosures: Paul Hanona: No relationships to disclose. Dr. Arturo-Loaiza-Bonilla: Leadership: Massive Bio Stock & Other Ownership Interests: Massive Bio Consulting or Advisory Role: Massive Bio, Bayer, PSI, BrightInsight, CardinalHealth, Pfizer, AstraZeneca, Medscape Speakers' Bureau: Guardant Health, Ipsen, AstraZeneca/Daiichi Sankyo, Natera

In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting a professional mindset, passing the first 90-day test, avoiding the 'silent trap,' finding mentors, valuing feedback, mastering systems, and taking responsibility for their careers. Subhi emphasizes that these lessons can significantly accelerate growth and career advancement for newcomers to the industry.Link to course: subhisaadeh.gumroad.com/l/6figurebiomedical00:00 Introduction: Starting Your Career Journey00:54 Lesson 1: Your Role Can Have a Big Impact02:55 Lesson 2: Adopting a Professional Mindset04:06 Lesson 3: The First 90 Days Are Crucial05:09 Lesson 4: Avoiding the Silent Trap06:35 Lesson 5: Finding the Right Mentors07:14 Lesson 6: Embrace Feedback as Fuel07:51 Lesson 7: Mastering the Systems08:47 Lesson 8: Taking Responsibility for Your Career09:19 Conclusion and Additional ResourcesSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Medsider Radio, we had a fascinating chat with Mary Lou Jepsen, founder and Chairman of Openwater, a medtech company developing breakthrough diagnostic and therapeutic wearables for cancer, stroke, mental illness, and beyond. Openwater is rethinking how medical devices are built — not as single-purpose machines, but as flexible platforms that function more like smartphones. A physicist and prolific inventor, Mary Lou holds nearly 300 patents and has launched over 50 products across VR, AR, holography, and consumer electronics. Previously, she led engineering at Intel, Facebook, and Google, taught at MIT, and now serves on the boards of Lear Corporation and Luminar Technologies. She has been named to Time magazine's list of the 100 most influential people. In this interview, Mary Lou explains why the traditional “one disease, one device” model falls short, and how her team is applying consumer electronics and open-source principles to develop scalable, software-driven tools. Backed by renowned investors including Khosla Ventures, Vitalik Buterin, and Esther Dyson, Openwater is aiming to make advanced care more accessible worldwide.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 Mary Lou Jepsen.

Dans cet épisode, j'ai rencontré Jonathan Benassaya, qui après avoir cofondé Deezer, se lance un nouveau défi de taille : sauver des vies avec SkinBeat, sa startup dédiée à la détection précoce du cancer de la peau par IA. De ses débuts dans la publicité intégrée aux jeux vidéo à son expérience fondatrice dans la musique en streaming, Jonathan partage les coulisses de la création de Deezer, les défis d'une ambition mondiale, et les raisons pour lesquelles la France n'a pas su faire émerger un « Spotify ».Mais ce podcast est aussi une histoire personnelle : celle d'un mélanome qui aurait pu lui coûter la vie. Ce choc devient le point de départ d'un nouveau combat entrepreneurial. Avec SkinBit, il développe une technologie de scan corporel capable de détecter les anomalies cutanées en quelques secondes, et espère doubler la capacité de diagnostic dermatologique aux États-Unis. SkinBit montre comment l'intelligence artificielle peut transformer la médecine préventive : en répliquant à l'échelle industrielle l'œil expert d'un dermatologue et en libérant du temps médical précieux. Cette approche bouscule le modèle de soin traditionnel avec un jumeau numérique et l'IA, qui promet une réduction des coûts de santé, une meilleure détection des cancers, et une amélioration des conditions de vie pour des millions de personnes.Une conversation lucide, inspirante et nécessaire sur l'entrepreneuriat, la santé, la tech et les choix stratégiques qui peuvent tout changer. Un épisode à ne pas manquer si vous vous intéressez à la MedTech, à l'innovation de rupture, et à l'impact réel des startups sur nos vies. Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.

Theresa Neil is reshaping the future of healthcare

In this episode, we sit down with Gary Thomas, Senior Vice President of Manufacturing and Product Development at Onkos Surgical, a company delivering breakthrough innovations for musculoskeletal oncology. With over 30 years of experience in MedTech—much of it in the ortho-spine space—Gary shares his remarkable leadership journey, beginning in aerospace and culminating in the fight against cancer-related infections.We cover:How discipline, fitness, and early morning rituals drive high performanceHis transition from aerospace into MedTech—and why he still recruits from that worldLessons from launching high-stakes products under pressureThe moment his career accelerated and the mindset that got him thereThe key differences between directors and VPs—and why some don't make the leapHow he evaluates leadership potential in technical professionalsWhy culture isn't just a buzzword—and how high-performing teams self-correctWhat makes Onkos Surgical's NanoSap™ technology a game-changer for infection preventionGary's practical insights on leadership, talent development, and execution make this a can't-miss episode for anyone aspiring to lead at the highest levels in MedTech.Gary on LinkedIn: https://www.linkedin.com/in/gary-thomas-00a8a533/Onkos Surgical on the web: https://onkossurgical.com/

Martin Witte is Senior Director covering Growth & Innovation topics at TÜV SÜD, driving strategic transformation across global medical device markets. With a career spanning regulatory affairs, sales, marketing, and business development, Martin brings a rare cross-functional lens to leadership in MedTech.He is passionate about shaping future-ready services through customer-centricity, digitalisation, and collaboration. Martin's approach focuses on unlocking team potential and amplifying impact through inclusive leadership, executive sponsorship, and design-driven thinking.In this episode, Martin shares how cross-functional experience shaped his career, why great leadership starts with building trust; and how real innovation happens when you involve the right people early - even in highly regulated environments.Tune in for:- Why healthy friction is essential for team growth (and not something to avoid)- How AI is reshaping MedTech and why soft skills now matter more than ever- Practical ways leaders can create safe spaces for open disagreementAnd much more!Career inspiration, medtech opportunities, hiring solutions, and market insights, all in one place. Find them here - linktr.ee/elemedCareer inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

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

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America. They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standards improve site credibility, de-risk clinical trials, and offer faster pathways for medtech market access. From regulatory advantages to site selection strategies, this episode is essential listening for sponsors, CROs, and MedTech leaders navigating global trials.Key Timestamps00:02 – Introduction to Julio Martinez-Clark and episode overview02:10 – What is GCSA and IAOCR certification?06:00 – Why certification is emerging now: volume, complexity, and patient safety09:42 – Certification structure: site vs. individual requirements13:45 – The Colombian model: First mover in Latin America17:55 – Global harmonization vs. local certification pitfalls21:30 – Measuring ROI of certified vs. non-certified sites26:15 – Future of global site certification and Latin America's role30:00 – Regional differences: speed vs. patient pool in trial site selection36:15 – Final thoughts on FDA trends and LATAM's emerging positionQuotes“It's appalling that in an industry that deals with lives, there was no global standard to certify site or individual competency—until now.”– Julio Martinez-ClarkWhy it matters: This underscores the critical gap in clinical research infrastructure and the urgent need for standards like GCSA.“You can't measure quality without a shared framework. Certification levels the playing field globally.”– Julio Martinez-ClarkWhy it matters: This highlights how global certification allows consistent benchmarking across clinical sites, benefitting sponsors and patients alike.Key TakeawaysGCSA Certification Elevates Site Credibility: Clinical sites with GCSA certification are fast-tracked for sponsor consideration, leading to better trial access and more robust patient recruitment.IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset.Latin America Offers Dual Advantages: With rapid recruitment and cost-effective data generation, LATAM is uniquely positioned to lead in globally certified trials—especially Colombia, which already mandates certification.Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust.The FDA Bottleneck May Shift Market Entry: With regulatory delays in the U.S., more medtech firms may turn to Latin America for first-in-human trials and initial commercialization.ReferencesJulio Martinez-Clark on LinkedInBioaccess LATAMIAOCR – International Accreditation Organization for Clinical ResearchEtienne Nichols on LinkedInMedTech 101: What

Send us a textWhen people talk about clinical trials, they usually think of drugs, but what about the tools that deliver, diagnose, and detect? Medical device Innovation often flies under the radar despite being essential to modern care. In this episode of the HealthBiz Podcast, Jason Monteleone, CEO of Avania, discusses how his firm helps medtech, diagnostics, and digital health companies navigate clinical trials and regulatory hurdles.

In today's MedTech landscape, where technological breakthroughs are redefining what's possible in inpatient care, it's easy to focus solely on the machines, data, and devices driving that change. But behind every innovation - whether it's a surgical robot, a smart implant, or a predictive algorithm - are the people who imagine, build, and continuously improve them. It's this human engine of progress that often determines whether innovation scales, sustains, and ultimately succeeds. At a time when competition for talent is intensifying and industries face increasing disruption, how we develop, support, and continuously upskill our people is no longer a 'nice to have' - it is a defining strategy. Ireland's MedTech leadership has always been grounded in talent, but today, the challenge is evolving. This demands a shift in how we think about talent. It's no longer enough to hire for existing roles. Instead, it is vital to build adaptable and diverse workforces capable of evolving with new tools, technologies, and expectations. Diverse pathways into MedTech Creating a future-ready workforce starts with opening up multiple, accessible routes into the sector, regardless of someone's background, education, or starting point. Not everyone follows a traditional path into a career, which is why flexibility and inclusivity in attracting and developing talent are so important. Apprenticeship models are a powerful example. They offer individuals, including school leavers, career changers, and those re-entering the workforce, the opportunity to gain formal qualifications while contributing directly to real-world projects. At Stryker, we've seen apprentices progress into engineering, operations, and leadership roles. This is proof that talent can emerge from many directions when given the right support and structure. Our programme enables participants to pursue degrees in manufacturing engineering while rotating between academic study and on-site learning. It's not just about gaining a qualification - it's about reshaping career trajectories and unlocking potential that might otherwise go untapped. Equally important are graduate entry pathways, which bring fresh energy and new perspectives into the organisation. Each year, we welcome graduates from a range of disciplines to our nine sites across the island of Ireland. Stryker's graduate programme rotates participants across engineering, finance, and other core functions, giving them exposure to the breadth of the business. It's not just an onboarding tool - it's a way to build a pipeline of future leaders who bring curiosity, adaptability, and cross-functional collaboration to their roles. Together, these pathways - whether through apprenticeships, graduate programmes, or internal mobility - reflect a broader commitment to inclusive growth. By creating multiple entry points into MedTech, including for those coming straight from school or those seeking a new direction mid-career, organisations can tap into a wider talent pool, foster diversity of thought, and build teams that are equipped to lead the future of healthcare. A learning culture Offering training and upskilling opportunities is one thing; embedding a culture of continuous learning is another. That means creating systems, time, and initiatives that make development part of the everyday. Our Training Centre of Excellence in Tullagreen, developed in partnership with IDA Ireland, has been designed to make upskilling a key aspect of transformation. The three-year training initiative, developed with the support of IDA Ireland, will equip employees at Stryker's Tullagreen facility with the agility and skills for the future of work, promote innovative thinking, and embed a culture of continuous improvement, and advance sustainability. But it also reflects something more fundamental: when people feel supported to grow, they stay engaged, motivated, and committed. That support extends beyond formal programmes. Every employee in Stryker Ir...

In this episode of Medsider Radio, we sat down with Anthony Fernando, President and CEO of Asensus Surgical.Asensus is expanding the role of robotics in the OR with its performance-guided surgery platform — a digital-first, AI-enabled system designed to enhance precision and real-time decision-making. A mechanical engineer by training, Anthony has more than two decades of experience spanning medtech, robotics, and global operations. He joined Asensus in 2015 and previously served as Chief Operating Officer and Chief Technology Officer. Earlier in his career, Anthony held leadership roles at Stryker, Becton Dickinson, PerkinElmer, and Varian, where he focused on advancing automation and medical device innovation across international markets.In this interview, Anthony shares how the Durham, NC–based Asensus navigated uncharted regulatory territory for a first-of-its-kind technology and proactively made the case for acquisition — well before KARL STORZ came to the table.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 Anthony Fernando.

This week Liz is joined by Sarah Keenan, VP of Commercial Excellence, to discuss the importance of building physician and rep competency for commercial success. In their conversation they dive into how to create a learning funnel, assess competency, and partner with hospitals to track training. Listen in for how to create a culture of learning at your organization. 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:Sarah Keenan is a senior commercial executive with over 18 years of experience driving growth, optimizing resources, and building high-performing teams within the medtech space. She specializes in scaling commercial organizations—from early-stage startups to mid-sized multinational companies—by aligning strategy, infrastructure, and talent for sustainable success.Sarah currently serves as Vice President of Commercial Excellence at Route 92, a company pioneering revolutionary procedural advancements to address unmet needs in neurovascular care. In this role, she leads initiatives that equip the commercial team with the tools, insights, and structure needed to thrive in a dynamic and evolving market.Prior to Route 92, Sarah was Vice President of Operations at Magnus Medical, where she established core operational functions to support the launch of the SAINT neuromodulation system for treating major depressive disorder—including manufacturing, installation, and HCP training.Before that, she was Vice President of Commercial Enablement at iRhythm Technologies, where she built the enablement function from the ground up. Her efforts were instrumental in equipping U.S. and international commercial teams with the knowledge and resources needed to scale the organization from a startup into a mid-sized leader in the cardiac monitoring space.Earlier in her career, Sarah held roles at CardioDx, where she launched Corus CAD and scaled sales training capabilities; as well as commercial and sales positions at ThermoFisher Scientific (Phadia AB), Merz Pharmaceuticals, Schering-Plough, and Altria Group.She holds a Bachelor of Science in Business Administration from the University of Illinois Gies College of Business.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: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Sarah Keenan⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

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

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn't cut it. Whether you're a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech.Key Timestamps02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting10:20 – Why software and compliance tools get left out of early budgets14:12 – How missing budget detail impacts product quality and time-to-market19:04 – Red flags investors look for in MedTech startup budgets23:30 – How to improve budgeting accuracy without a CFO28:10 – Critical cost categories MedTech founders often overlook35:55 – Advice for recovering from a budgeting oversight39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more)45:00 – Final advice: why networking trumps isolation for smarter budgetingStandout Quotes"Relying on the status quo is never good. There are always ways to do things better."Jon reminds founders and compliance professionals alike that innovation doesn't stop at the product level—it also applies to budgeting, systems, and team empowerment."Getting a 510(k) through is just the starting point. Budgeting like everything ends there is a massive red flag."This quote highlights the investor's perspective on sustainability and long-term thinking—crucial traits in any fundable founder.Key TakeawaysBroad Budget Buckets Signal InexperienceLumping all compliance-related costs under one line item may look tidy but signals to investors a lack of operational depth. Break out line items for QMS, clinical, regulatory, and software tools.Software and Tools Are Not Optional ExtrasFounders must factor in essential systems—like eQMS, CAD, risk management, and clinical data tools—early in budgeting. Assuming a single hire covers everything is a critical mistake.Budgets Must Reflect Time and Scale RealisticallyFlat budgets over 2–3 years, or those that assume regulatory costs end at market clearance, raise red flags. Investors expect dynamic budgeting that reflects the realities of growth, post-market surveillance, and team evolution.Outsourcing ≠ All-InclusiveMany startups underestimate the actual costs tied to consultants and CROs, assuming “someone else is handling it.” Always clarify what's included—and what's not.Recovery Is Possible—If You Own ItIf your budget's off-track, clear communication with your board and investors, a willingness to revise, and a plan for worst-case scenarios are your best tools for regaining credibility.ReferencesJon Bergsteinsson on LinkedInEtienne Nichols on LinkedInGreenlight Guru – QMS and Clinical platform for MedTech companiesMedTech...

MedTech graveyards are full of clever devices that never made it past the demo. Dr. Tori O'Daniel (OB/GYN, Medical Director, Oklahoma City) walks us through the five adoption pillars that separate shelf-ware from standard-of-care.In This Episode• The “ease-of-use” litmus test every new device must pass• Why education is a FOREVER activity, not a launch event• How to spot (and empower) your Champion-for-Change• Talking cost: shifting the conversation from unit price to total value• Template-driven VAC submissions that save months of back-and-forth

In this episode of the Chase MedSearch Podcast, Joey Eloms shares his journey from NFL defensive back to top-performing medical device sales leader. He reflects on the lessons that shaped him—perseverance, humility, and grit—and opens up about mentorship, servant leadership, and building high-performing teams. Packed with insights on hiring, career pivots, and growth, this is a must-listen for anyone in medical sales or leadership.

Ryan Phelan is a partner and patent attorney at Marshall Gerstein. He discusses his journey from a background in computer science and fintech to becoming a prominent IP attorney serving clients in the MedTech industry and beyond. He shares insights on the importance of protecting intellectual property, especially for startups, and the burgeoning role of AI in medical technology. This succinct yet fascinating conversation highlights the critical intersection of law, technology, and medical innovation. Guest links: https://www.marshallip.com | https://www.patentnext.com/  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 058 - Ryan Phelan [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 I am so looking forward to my conversation today with Ryan Phelan. Ryan is a partner and patent attorney at the Chicago based intellectual property law firm, Marshall Gerstein, where he counsels medtech companies on protecting their valuable IP. Ryan ultimately believes that AI is an important technology to embrace, but cautions medical device and related companies to approach it pragmatically, developing a policy to govern and protect intangible assets and innovation. All right. Well, thank you so much for being here, Ryan. I'm so excited to speak with you today. [00:01:29] Ryan Phelan: Yeah. Thank you for having me. Thank you, Lindsey. [00:01:31] Lindsey Dinneen: Of course. Well, I'd love if you'd start off by sharing a little bit about your background and what led you to medtech. [00:01:39] Ryan Phelan: Sure, absolutely. So I'm an attorney by trade. And I started off in probably a different place than most people in MedTech, but I have a computer science degree and I worked in industry first for Accenture, doing a lot of programming and consulting in the FinTech world. So, high frequency trading and programming some pretty complicated data algorithms in order to trade stocks and bonds and securities, and things like this. That let me see aspects of intellectual property that people were doing with respect to the code I was writing. So I got curious with IP and law, and that led me to law school, Northwestern Law, in pursuing a joint JD, MBA program, which I finished in 2010. And I went into IP law with a passion for technology, pretty much in the computing space. And then in the last decade or so, IP practitioners, not unlike doctors, like to practice in specific areas and one of the ones that I focused on is software medical devices. And so that, that kind of led me into the realm of medtech. [00:02:48] Lindsey Dinneen: Very nice. Okay. So you have had such an interesting career trajectory and I'm wondering, back in the day, say you're a six year old Ryan, could six year old Ryan have predicted that you would be a lawyer and particularly intellectual property? [00:03:04] Ryan Phelan: Absolutely not. I mean, first of all nobody in my family, at least immediate family, was a lawyer. And so going to law school was not on the radar. I grew up in Louisiana in a small town, basically farm life, so certainly technology and stuff like that wasn't available in the city. But I did have a passion for things that were tech. I was certainly a kid that loved to take things apart and put them back together and build all kinds of Legos and stuff like that. So that basic kind of STEM acumen or desire was always there from the beginning. And so, as I, I grew up and got exposed to more things, certainly in college, it became kind of a passion. And so, I ended up doing that. We did have some medical issues in my family, including cardiac and cancer and stuff like that. So, those types of things always hit home with me and you're getting to a chance to kind of lean into medtech, at least on the software side, with medtech devices that include or incorporate medical technology became very interesting to me personally. [00:04:07] Lindsey Dinneen: Yeah, of course. And so going back just a smidgen when you decided to go into law and you know, you've come from this background that was the software engineering and you've got this fintech background and you have all of these amazing skill sets already, what led you specifically to say, "Okay, I want to focus on intellectual property, and so this is going to be my, my sweet spot." [00:04:33] Ryan Phelan: Yeah. So when you go to law school, you get exposed to a lot of different classes. In fact, in your first year law school, you're required to take a bunch of baseline courses like criminal law and all these things. And so you quickly figure out what you like and what you don't like. And so for me, a computer science degree is always kind of the beating heart of what I loved. And so I wanted to, I tended to like, classes that were up that alley, so to speak. And the IP course that I took was definitely there because it was all about technology, inventions, people making things, and how those inventions played out in court. So I found my greatest joy in law school to be in those classes. So I spoke up the most in class and did the best. There's common saying that "you should do things that you love because you never have to work a day in your life" kind of thing. So I always try to think about that, and certainly fun today because I practice in IP and picked that direction. [00:05:27] Lindsey Dinneen: Yeah, absolutely. So, in addition to all of the other credentials you have, you are also a published author and you are a speaker. And I would love if you would share maybe a little bit more about how you got into being a thought leader as well in your industry and how that path has taken you. [00:05:51] Ryan Phelan: Yeah, for sure. It's the same kind of thing. I've always liked to write as well. And I feel that when I write about something, I really get to understand it. And so in my field, there's a lot of stuff happening all the time. Like a court will come out with a new case, an IP and medtech or AI or something like this, and I really like to dig into it to figure out how can I use this court decision as a tool for clients, or how does this change things up? What will clients ask me questions going forward, or how can this be an interesting topic to either write about or to speak about? And so, I try to learn when I'm reading, and then I write it, and that teaches me, and I think and hope that others get a benefit from that too when I publish, so. [00:06:34] Lindsey Dinneen: Yes, of course. Of course. And you are also, if I'm not mistaken, an adjunct professor. So, first of all, do you sleep? And second of all, tell me more about this as well, please. [00:06:47] Ryan Phelan: Yeah, so I'm an adjunct professor at Northwestern Law. I teach a course on patenting software inventions. I do sleep because it's only once a year for a power week. You know, I think it's like three days out of the year. There's the long classes, they're like a few hours each, but we pack in several 30 minute core sessions into a day. So one day, maybe we'll go for three hours or two hours. And, you know, we will get the benefit of several weeks of coursework by doing all of that at once in those three days. And so, I teach on that. We teach fundamentals of patenting softwares and inventions, which includes medtech software devices. For example, the FDA classifies software, medical inventions in, in, in certain ways, like their software as a medical device where you have the software only such as, you have database with medical data and you're either formatting it or storing it or processing in some unique way, or you have software in a medical device where you actually have a physical device. It's a cardiac device where the software is running or at least partially running that device. And so we talk about ways to, to patent those inventions primarily with US law. So. [00:07:59] Lindsey Dinneen: Very nice. So specifically thinking about your medtech clients, because I know you probably have clients in many industries, but specifically in medtech, what are some of the common mistakes you see medtech companies making? Especially say, you know, an earlier startup or something like that, when maybe they haven't thought through an aspect that really should be thought through a little bit earlier in the process. What are some common things that you see that people should be aware of? [00:08:27] Ryan Phelan: Yeah, I mean, easily one of them is not filing a patent application early. And if they are a startup company and they have their biggest selling product, or what they think will be their biggest selling product, and they don't file a patent application on it, that could be bad because you have one year to get to the patent office with that, at least in the U. S. to file something once it's been publicly disclosed. And if you miss that deadline, then effectively you're allowing your competitors to copy it. And if you're a startup company, the last thing you want is for your product to become extremely successful and then a big Fortune 500 company gets wind of it, figures out you don't have a patent, and then just starts making it themselves and it takes away your market share. So that would be, you know, I think that's every inventor of startups like worst nightmare, right? So, getting that patent on file before the deadline is pretty important. [00:09:22] Lindsey Dinneen: Yeah, of course. Now, I noticed you had recently written an article on LinkedIn about when to file this patent. And I know part of maybe some concerns that might arise are, "Well, we don't necessarily want this to be in public awareness yet." So how do you walk that line between "This is our IP, we're really trying to keep it very tight," versus, "But I also need this protection, this legal protection." So how do you navigate things like that? [00:09:54] Ryan Phelan: Yeah, so the point at which you need to make your invention publicly available or to disclose it because you need to, you know, maybe you're going to pitch competition and you need to show your invention on like a PowerPoint deck in front of hundreds of people. Then that's probably a good point to start thinking about filing a patent application if you're still developing it, and it's like in your basement, so to speak, and nobody's seen it. It's still secret then. You don't need to necessarily file a patent application at that point. Although, there's a funny thing in patent law where, if you have an idea, sometimes there's somebody else thinking about it too, and the first one to get the patent office, wins, and so, you certainly don't want to wait around too long and find out years later that you filed your patent application the day after somebody else. This actually happened with Thomas Edison and the light bulb and he had lots of fights about the other person that was claiming the same thing that lost, and we don't remember his name today because of that. So anyway, so that's one thing to keep in mind when you're starting out. [00:10:54] Lindsey Dinneen: Yeah. Well, and speaking of those kinds of stories, are there any that particularly stand out to you as you've worked with all of these incredible clients who have seriously life changing products they're creating. Are there any that really stand out to you in your memory as affirming, "Oh my goodness, this is why I'm here. This is why I'm doing what I'm doing." [00:11:17] Ryan Phelan: Yeah, for sure. One that stands out is one in the opioid or the narcotics market. In my family, we have an individual who is unfortunately affected by this. And so, I had a client that reached out to me to create a VR program that helps to eliminate or to reduce cravings in this field. And that one was really impactful because using technology and non pharmaceutical way in order to reduce cravings for people that are struggling with addiction of some type, I felt to be very important. So I thoroughly enjoyed working with that inventor and helping to, to create that patent application for that invention. [00:11:59] Lindsey Dinneen: Yeah, of course. Yeah. Thank you for sharing about that. I think sometimes those really personal connection kinds of stories are the ones that really stick in your mind because it, it helps to have this moment of realization, like you know that what you do matters, of course, but then having that extra layer of confirmation that "Yes, this is helping somebody who could literally be a family member or a close friend or relative" is really impactful. [00:12:25] Ryan Phelan: Exactly. [00:12:26] Lindsey Dinneen: Yeah. So considering all of the industries that you currently serve, and of course, you have this incredibly varied background, which can only be wonderful to draw on from this rich history and experience of yours. What are some interesting crossovers you see between industries that can be useful in terms of, maybe one industry approaches something in a way that you've seen could actually really benefit folks in medtech or vice versa. Are you seeing trends like that? [00:12:59] Ryan Phelan: Yeah, absolutely. I mean, one of the biggest ones that I can think of now is artificial intelligence coming into play with medtech. I mean, certainly, medtech kind of runs the gamut of, you know, like, like we mentioned before software only to physical devices that incorporate software. And so AI is interesting because you can load it and AI model onto one of these physical devices, or you can have an AI model that's medtech based sitting on a server somewhere that can help doctors look or find particular cause or whatnot like that, based on symptoms that a patient may walk into, or maybe there's a device, like a needle, that allows that has an AI model on it that helps with injection or something like this. And so, these AI tools are becoming smarter. And I think that they help in the field of medtech and they require a different level of expertise with these inventions to not only create them because they're complex, but also to bring them to market because they require specific FDA regulations. Even the FDA right now is trying to figure out AI. They have approved several AI devices, but it usually comes down to, you know, is your AI device going to change in the near future because you're going to update the model? And if so, does that change it enough to require like a new submission? So the fact that AI moves so rapidly doesn't really mix well with the FDA's process of approving the device and having it set in stone at that approval state. [00:14:30] Lindsey Dinneen: Yeah. So where do you anticipate that this will take medical devices? Do you think it'll become so naturally ingrained in many of them that it's just sort of part of our reality, or do you think we'll still have those --what do we want to call them-- not AI functionality devices? [00:14:48] Ryan Phelan: Yeah, I think both will exist. You know, certainly a spectrum of these devices, right? Certainly there's surgical tools that exist now that have hundreds of years, or a hundred years, just in different, maybe better forms. So, those will stay, stick around. The AI assisted ones, I'm sure will find their niche, and live alongside the the existing tools. [00:15:10] Lindsey Dinneen: Yeah, absolutely. If you could narrow it down, what would be maybe your top piece of advice for a MedTech startup founder from your perspective, in your role? [00:15:23] Ryan Phelan: Yeah, I guess the number one would be again to, you know, make sure you're not giving away your crown jewels. Have your patent filed before you step out. If you're trying to raise money, just be careful that you're not sharing information publicly. You have to share with a potential investor, consider an NDA or if they won't sign an NDA, you can file a provisional patent application with the patent office. That shows that you have something on file before you talk to others. And as long as you describe the invention sufficiently in the four corners of your provisional application, then that's often the best way to protect yourself going out. So I think, as an IP attorney, that, that would be the number one advice that I would give a startup company in the medtech space. [00:16:10] Lindsey Dinneen: That's incredible. Thank you for that. That's really appreciated advice. So, it's so interesting because when I was looking at your LinkedIn profile, of course you have all of this incredible experience, and one thing actually really stood out to me, and that was that at least at some point you have been a and --I'm sure you've done this throughout your career multiple times-- but a pro bono lawyer for Lawyers for the Creative Arts. And I was curious about that and how you got involved, and can you share a little bit about that journey? [00:16:40] Ryan Phelan: Yeah. So LCA or Lawyers for the Creative Arts is an organization here in Chicago that deals with artists of limited means. You know, usually they have some type of basic issue that they want handled and it mainly deals with IP. Typically, I work on a different capacity for these because I see them as like kind of fun learning opportunities. I usually work in the copyright space and the clients that I work with need help either filing a copyright for maybe a piece of art that they've created, or maybe have a question about how their IP is being used or sold in some way, and they need to figure out if their IP has been infringed. And so, we'll work with them in a pro bono capacity to help write a letter to a company or to file a copyright registration and things like that. [00:17:28] Lindsey Dinneen: Well, as a, as my side thing as also an artist, I just want to say thank you because it is so great that you're doing things like that for the artist community. It is not always easy. So, oh, that's great, appreciate it. Yeah. So as you look towards your own future, what are you excited about say in the next year or two? [00:17:50] Ryan Phelan: Very excited to see how, I guess, AI is playing out with medtech. You're seeing regulations and guidelines coming out that The United States Patent and Trademark Office and also the Copyright Office about how these laws will impact artists. I've sat on a panel with the Copyright Office and the United States Patent and Trademark Office as they're thinking through these decisions and putting out these guidelines. There is questions about, is the new administration going to change things up with respect to guidance and guidelines that have come out. So, you know, artists are looking at AI is like a tool, like a paintbrush. And the law is kind of looking at it, obviously from the legal perspective and it doesn't seem like those two things are aligned yet. There's common in, in history that the law typically lags the technology by, you know, a decade or two or more. And so that's certainly the case with AI. For example, there is a famous -- I wouldn't call it a case-- but a denial of a copyright registration at the copyright office for a gentleman that had created an AI piece of artwork, won the Colorado state fair, I think in 2022, and tried to file a copyright registration, but was denied. And he told the copyright office, basically he had entered in 500 plus prompts in order to generate, or at least partially generate, this work of art, but was still denied . Not because of his effort, just because of the way the law is written under current copyright statutes. And so, things like that seem to be, at least from a policy perspective, incorrect. And so it'd be great to see exciting how this plays out. Will Congress care enough to change it or how will artists be impacted under these types of laws and policy considerations going forward? [00:19:35] Lindsey Dinneen: Yeah, absolutely. So pivoting the conversation a little bit just for fun, imagine that you were to be offered a million dollars masterclass on anything you want. It can be within your industry or part of your amazing background, or it could be about something entirely different. What would you choose to teach? [00:19:55] Ryan Phelan: Yeah. Wow. You know, I guess I would teach what I'm currently teaching. Cause I, I do enjoy the class I teach now. I'm at Northwestern, my alma mater, which I love. It's down the street from the office, get to go in same place where I went to school and teach the law and things that I do every day, which is patenting software inventions, including the medtech space. If I could get a million dollars to teach what I do now, that would be wonderful, in this hypothetical, so. [00:20:22] Lindsey Dinneen: Right. I love it. Excellent. And how do you wish to be remembered after you leave this world? [00:20:30] Ryan Phelan: Wow. I hope people remember me as someone who was fun loving and enjoyed tech and hopefully brought some information to the world that helped them in some way. [00:20:42] Lindsey Dinneen: Yeah, of course. And final question, what is one thing that makes you smile every time you see or think about it? [00:20:51] Ryan Phelan: Oh, wow. I guess there's a lot of stuff. I also like to do some type of sports. Currently, the ski season is ending, so I certainly enjoy skiing, so when I see or think about that's one of those things, and now coming is the golf season, so I transitioned into that. We're looking forward to some good weather here, finally, in Chicago. It was 80 degrees last week, and it snowed yesterday, so things are changing from golf to ski season, but one of those is always fun, so. [00:21:17] Lindsey Dinneen: That's awesome. That's fantastic. Yeah. If folks who are listening are in a position, would there be a way for them to get in contact with you and then how early should they do that actually? [00:21:31] Ryan Phelan: Yeah. There's multiple stages. They can get in touch with me anytime they want. You can always find me at our firm's website, Marshall Gerstein. Or if you want to, you can go to patentnext.com, just patent and the word next. com. That's my blog that I write on typically, and it has my contact information there, including my email address. [00:21:51] Lindsey Dinneen: Perfect. Well, thank you so much. Well, Ryan, it has been a joy to speak with you today. I really appreciate you sharing a little bit about your career and your insights, your advice, especially appreciate that for MedTech founders who might, you know, not quite know where to start with this whole legal element that they really need to consider. So I really appreciate you sharing kind of when and how to do that. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. And thank you again so much for being here. This has been a wonderful conversation, and I just wish you the most continued success as you work to change lives for a better world. [00:22:41] Ryan Phelan: Thank you, Lindsey. My pleasure. Happy to be here too. Thank you for having me. [00:22:44] Lindsey Dinneen: Of course. And for our listeners, thank you so much for tuning in. If you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time. [00:22:56] 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.

The National Standards Authority of Ireland (NSAI) has published its 2024 Year in Review, highlighting a transformative year of progress in areas critical to Ireland's future, including housing innovation, digital resilience, and sustainability. In a year of global uncertainty and rapid advances in areas like cybersecurity, NSAI played a pivotal role in supporting business competitiveness and advancing Ireland's strategic ambitions under Housing for All, the Climate Action Plan, and the Digital Europe Programme. Minister of State with responsibility for Employment, Small Business and Retail, Alan Dillon TD said: "The NSAI plays a vital role in strengthening Ireland's business ecosystem. From enabling housing innovation through Modern Methods of Construction (MMC) and Building Information Modelling (BIM) to advancing cybersecurity and sustainability, NSAI's Year in Review displays how the organisation supports our industries to grow safely, smartly, and compete internationally. The Year in Review reflects the important role NSAI plays in supporting Irish businesses and setting and maintaining world-class standards, measurement services and certification systems." In 2024, NSAI advanced key pillars of its Strategic Plan 2022-2026 in the areas of housing, digital transformation, climate and MedTech through standards, metrology and certification that directly support Ireland's Programme for Government and economic growth. Geraldine Larkin, NSAI CEO, said: "NSAI is committed to supporting businesses to enable growth, competitiveness and long-term success. We're proud to act as a bridge between innovation and assurance, empowering Irish businesses of all sizes to operate with confidence, integrity, and international credibility. Whether it's bringing a new MMC housing system to market or achieving ISO certification in information security, we ensure companies can move faster, meet expectations, and lead by example." Key highlights from the report include: Supporting housing innovation: With 80 new MMC enquiries and 48 new applications received in 2024, NSAI's MMC department is supporting faster, safer and more efficient construction outcomes. NSAI's Sustainability and Built Environment department approved 1,132 construction products last year and NSAI established a dedicated Building Information Modelling department before Christmas. Agrément certification is specifically aimed at products or systems that are new or innovative. The KORE group in Cavan, for example, achieved MMC Agrément certification through NSAI for its insulated concrete formwork system and its insulated foundation system. Caroline Ashe Brady, Commercial Director with the Kore Group said: "NSAI's rigorous assessment process has been crucial in enabling us to bring next-generation construction solutions to market with confidence. MMC Agrément certification helps manufacturers in the construction industry, like ours, to meet both compliance requirements and sustainability goals." Cybersecurity at the forefront: In September 2024, NSAI was appointed lead co-ordinator for the EU TrustBoost programme, aimed at strengthening cybersecurity certification across the EU. With threats to data privacy and digital infrastructure on the rise, this initiative under the Digital Europe Programme is helping to develop new technologies and tools to create a more secure digital ecosystem for Europe. Separately, NSAI developed a new certification readiness tool for Irish SMEs around information security. Innovation and excellence through standards: As Ireland prepares to take over the presidency of the Council of the EU in July 2026, NSAI continues to take a leading on the role of standards in support of the single market. This is a vital role at national and European level. In 2024: 1,467 standards were published 286,209 standards were accessed 200 new members joined technical committees (there are now over 2,400 national committee members) Precise measuring for trade: NSAI's Nati...

As drug abuse rises globally, organizations and governments are turning to preventive solutions. With over 450 active accounts across 24 countries, Intelligent Bio Solutions (Nasdaq: INBS) is making a significant impact through its Intelligent Fingerprinting Drug Screening System.In this interview, Doug Heath, VP of Global Sales, and Anna Turkington, VP of Marketing, discuss how the company is advancing portable, rapid, and pain-free drug testing using its fingerprint-based screening technology.They also share insights into Intelligent Bio Solutions' business model, growth outlook, market opportunity, and global expansion strategy.Find out more: https://ibs.inc/Watch the full YouTube interview here: https://youtu.be/qHeVoWcBU_U And follow us to stay updated: https://www.youtube.com/@GlobalOneMedia?sub_confirmation=1

In this episode of Medsider Radio, we had a really engaging conversation with James (Jim) Corbett, CEO of AVITA Medical.AVITA Medical's RECELL system uses Spray-On Skin Cell technology to accelerate healing for patients with severe burns and wounds.  Jim brings nearly 40 years of medical device leadership experience to AVITA Medical. His career spans global commercial and operational roles, including President of Boston Scientific and General Manager of Scimed Life Systems. Jim has served as CEO of six companies, including three publicly traded entities — Microtherapeutics, ev3, and Alphatec Spine — as well as CathWorks, Home Diagnostics, and Vertos Medical.In this interview, Jim shares lessons from a career spanning global medtech leadership positions — including the importance of hands-on fundraising, adapting sales strategies as products mature, and how generating clinical evidence beyond FDA requirements serves commercial adoption.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 Jim Corbett.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're highlighting comments made by FDA representatives at an event about the most common premarket review issues they see in submissions. First, there is some discussion regarding whether the issues are truly premarket or postmarket concerns. Then, we look at what these are, why they are likely so common, examples of them, and how to avoid running into these issues yourself. During this conversation, the following questions are addressed:Recently, three medical device senior operations officers from FDA's Office of Inspections and Investigations spoke at a conference about the most common “issues” FDA encounters during the premarketing review of medical devices. Can you give a recap of what they said?In your 30+ years of experience working in the medical device industry, would you agree with FDA that these are the three most common issues?Before discussing the three specific common problems individually, what do you think is the “root cause” of these problems?Can you provide some examples?How can design change and design creep get companies in trouble with FDA?What does “marketing beyond authorized intended use” mean?Do you have suggestions and/or best practices to avoid running into problems around these issues?What else is important?What are today's takeaways?Listen to this discussion and see if you've run into these issues yourself. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com andSend us a textFor more medtech news and information, visit https://www.mpomag.com.

Irish Manufacturing Research (IMR) and AMBER, the Research Ireland Centre for Advanced Materials and BioEngineering Research, have officially launched the European Space Agency (ESA) Phi-Lab Ireland - a pioneering six-year programme designed to drive innovation in space technologies within companies in Ireland. Ireland, as a global leader in advanced manufacturing and materials science, will address the thematic area of space-optimised hardware. Phi-Lab Ireland will fund cutting-edge research across the entire life-cycle from materials discovery and testing, to the scaled production of components optimised for the unique and challenging environment of space. Benefiting from the combined capabilities of two of Ireland's leading research organisations, Phi-Lab Ireland will also offer access to expert mentorship and training programmes, state-of-the-art research infrastructure, comprehensive networking opportunities, and significant seed funding for projects up to 24-months. Welcoming the expansion of the European Space Agency's Phi-Lab network to Ireland, Minister for Enterprise, Tourism and Employment, Peter Burke, said "the launch of ESA's Phi-Lab Ireland offers Irish companies a great opportunity to further develop in the areas of advanced manufacturing and materials innovation. Available to space active companies and to companies who up to now haven't considering entering into this market, Phi-Lab Ireland will offer expert mentoring and training programmes, access to state of the art research infrastructure and critical seed funding up to €400k. Working in partnership with ESA, IMR and AMBER, two of Ireland's leading research organisations, will strengthen the capability of the growing Irish space eco-system and I look forward to Irish companies taking their place in the globally competitive space sector. I am particularly pleased to see this degree of endeavour and innovation taking place here in Mullingar in my own constituency". "The establishment of ESA's Phi-Lab in Ireland marks a pivotal moment in our journey to position Ireland at the forefront of space innovation. The initiative reflects our continuing partnership with the European Space Agency and our shared ambition to harness cutting-edge technologies for economic growth and global impact. Phi-Lab Ireland will empower Irish companies to lead in the development of transformative advanced manufacturing technologies, unlocking new markets and creating high-value opportunities for the future" said Minister of State for Small Businesses and Retail, Alan Dillon, on the launch of Phi-Lab Ireland as part of the expanding ESA Phi-Lab network. Phi-Lab Ireland's first funding call for research project proposals from Irish companies seeking to grow in Ireland's developing space ecosystem is now open. Unique to Phi-Lab Ireland, projects are welcome from companies who in the past may have never considered their products for the space sector, and also current space-active companies seeking to advance their position in this market and/or bring their innovations to larger terrestrial markets. Commenting on the launch of Phi-Lab Ireland's first funding call, Dr. Ken Horan, Director of Technology Innovation and Entrepreneurship at IMR and Head of ESA Phi-Lab Ireland said "ESA Phi-Lab Ireland is a unique opportunity for Irish SMEs, start-ups, and researchers to become leaders in space-focused innovation. Today the Space sector offers opportunities akin to those presented by the MedTech sector a few decades ago and before that, ICT manufacturing. These have become cornerstones of the Irish economy. We want to see Ireland equivalently recognised as a global leader in the Space sector and are building a national competence centre to advance this ambition". Prof. Mick Morris, Director of the AMBER Centre added "AMBER are delighted to partner with IMR to support Irish industry and researchers in exploring new commercial opportunities in the space sector. This activity will build on our...

In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale. Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of compliance by starting small and planning ahead. If you're navigating regulatory requirements while trying to stay innovative, this episode is your roadmap to smarter, leaner quality.Key Timestamps00:02 – Introduction to Greenlight Guru and medtech process integration01:15 – QMS evolution from startup to commercialization03:00 – Phase-based product development overview (Phases 0–6)06:35 – Why QMS should follow product needs, not just regulatory triggers09:10 – Agile vs. proceduralism in quality systems11:50 – Building a quality culture during the feasibility phase15:25 – When to implement QMS controls and how to prepare for “enforcement points”18:40 – Investor-driven and regulatory QMS triggers21:10 – How early QMS planning saves time and reduces future remediation26:20 – Ashkon's final advice for startups: start small and stay proactiveStandout Quotes"You've got to take the BS—being burdensome—out of QMS."Ashkon Rasooli redefines QMS as a project management tool, challenging the notion that compliance must be a burden. This quote encapsulates his philosophy of proactive, phased implementation that actually enhances product development."Start small and do a little bit at a time—it won't seem like a burden."A practical mantra for startups, this advice underscores how a gradual, well-aligned QMS rollout can prevent last-minute fire drills and wasted effort.Top TakeawaysUse the "Phase 0–6" Model to Guide QMS Rollout – Align QMS implementation with the stages of product development to ensure each step supports the next.Don't Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations.Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech's safety responsibilities, rather than formal procedures.Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective.Regulatory Strategy = Investor Strategy – QMS maturity is increasingly scrutinized during due diligence. Treat it as a value driver, not just a cost.ReferencesAshkon Rasooli on LinkedInGreenlight Guru – Quality management software for medical devicesEtienne Nichols on LinkedIn – Connect with the hostISO 13485 vs. ISO 9001 – Explains how medical device quality systems build on general standardsISO 14155 Overview – Relevant for clinical validation proceduresMedTech 101: What Are “Enforcement Points”?In the context of QMS, enforcement points are moments when external stakeholders (regulators or investors) require proof of formalized processes. Think of it like a driver's license checkpoint—you may be cruising just fine, but at that moment, you must prove you're compliant. The earlier you prep for them, the smoother your...

Listen in as four outstanding MedTech leaders dive into the real-life challenges and mindset shifts that come with working in startup environments. In this special Future Leader Sessions episode of Career Diaries, our panel shares insights on:Speaking the CEO's languageBalancing long-term vision with day-to-day executionLeading through uncertaintyHear honest stories and practical advice on: ✔️ Getting CEO buy-in on quality and regulatory priorities ✔️ Communicating risk to non-technical executives ✔️ Maintaining strategic focus amid daily fires ✔️ Building a strong quality culture in fast-moving startups ✔️ Making the leap from technical expert to strategic leaderOur expert panel features: 

Listen & subscribe on Apple, Spotify, YouTube, and other platforms.   Welcome everyone to the weekly San Diego Tech News!    I'm Neal Bloom from Fresh Brewed Tech, the Tacos and Tech Podcast, and Interlock Capital. My co-host in this episode is Fred Grier, journalist and author of The Business of San Diego substack. He covers the ins-and-outs of the startup world including breaking news, IPOs, fundraising rounds, and M&A through his newsletter.  Before we dive in, we wanted to thank and ask our listeners to help us grow the show, leave a review and share with one other person who should be more plugged in with the SD Tech Scene. Thank you for the support and for helping us build the San Diego Startup Community!   June 20 Recent events debrief: MedTech, AI, GP/LP  BIO in Boston Startup activity in SD Recent Carta funding data in relation to San Diego and by stage Fundings Retrorate - podcast & Seaside Equity raises $723M for two funds   Cadre AI coming out of stealth Qualcomm acquisition of AlphaWave Semi for $2.4B   Curated Events List – For full list – check The Social Coyote July 1 - SD Tech Founders with Andy Ballester, GoFundMe and Eyepop AI co-founder July 4 - Founders Hike  July 8 - Afternoon Founders Hike July 29 - Dev & Data x CTO Talks: Healthtech Night  

In this episode, Liz and Rachel discuss Liz's interview with Sandy Waugh Ruggles on the importance of developing a go-to market strategy with specific physician targets. They share best practices for getting specific on who to target first, and how that information impacts the training process. 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:Sandy's 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.

Julio Martinez-Clark, Co-Founder and CEO of Bioaccess, a Latin American MedTech CRO that works with US-based medtech and biopharma startups to conduct their first-in-human trials outside the US to accelerate development and recruitment. Data from overseas clinical trials conducted to international standards is considered valid and can support conversations with investors, strategic partners, and the FDA. Drawing on resources in the Balkans, Latin America, and Australia, clinical trials can get faster approvals, more easily recruit patients, and benefit those living in the communities where clinical trials are conducted.   Julio explains, "The mission is to accelerate global clinical trials, and the type of clients is mostly us. Occasionally, we have European clients, but they're mostly San Francisco-based, Boston-based, San Diego-based, Minnesota-based, or Boston-based companies that are looking to execute a first-in-human clinical study outside of the United States. And for many reasons, Latin America is an obvious choice, at least for the exploratory phase. When they're looking for different countries, they usually explore Eastern Europe, Australia, and Latin America. And we help these companies, which have been predominantly US-based MedTech startups. More recently, we have expanded to biopharma as well. But let's talk with the conversation on MedTech startups, and their struggle to conduct these first inhuman trials in the United States. They seek help when they want to go overseas, and they call for us to help them find investigators and to recruit patients and to get past approvals, etc." "There is one single thing, which is that these companies are startups. Getting this type of trial approved is really, really difficult and expensive. And the timeline to get them approved is really uncertain. So when you have a startup that has investors backing the company and they have a business plan, they have some milestones, it is difficult to predict when you're going to hit these milestones, and you need to keep the investors happy. So if you don't have a solid business plan, then you are not going to be able to raise more funds to continue your operation and development."  #BioAccess #GlobalTrialAccelerators #DigitalHealth #PrecisionMedicine #LATAMTrials #BalkansClinicalResearch #AustraliaCTN #AANVISA #ALIMS #MINSA #TrialAcceleration #FirstinHumanTrials #ClinicalTrials #MedTechInnovation #Biopharma #MedTech #PatientRecruitment #CRO bioaccessla.com Download the transcript here

Julio Martinez-Clark, Co-Founder and CEO of Bioaccess, a Latin American MedTech CRO that works with US-based medtech and biopharma startups to conduct their first-in-human trials outside the US to accelerate development and recruitment. Data from overseas clinical trials conducted to international standards is considered valid and can support conversations with investors, strategic partners, and the FDA. Drawing on resources in the Balkans, Latin America, and Australia, clinical trials can get faster approvals, more easily recruit patients, and benefit those living in the communities where clinical trials are conducted.   Julio explains, "The mission is to accelerate global clinical trials, and the type of clients is mostly us. Occasionally, we have European clients, but they're mostly San Francisco-based, Boston-based, San Diego-based, Minnesota-based, or Boston-based companies that are looking to execute a first-in-human clinical study outside of the United States. And for many reasons, Latin America is an obvious choice, at least for the exploratory phase. When they're looking for different countries, they usually explore Eastern Europe, Australia, and Latin America. And we help these companies, which have been predominantly US-based MedTech startups. More recently, we have expanded to biopharma as well. But let's talk with the conversation on MedTech startups, and their struggle to conduct these first inhuman trials in the United States. They seek help when they want to go overseas, and they call for us to help them find investigators and to recruit patients and to get past approvals, etc." "There is one single thing, which is that these companies are startups. Getting this type of trial approved is really, really difficult and expensive. And the timeline to get them approved is really uncertain. So when you have a startup that has investors backing the company and they have a business plan, they have some milestones, it is difficult to predict when you're going to hit these milestones, and you need to keep the investors happy. So if you don't have a solid business plan, then you are not going to be able to raise more funds to continue your operation and development."   #BioAccess #GlobalTrialAccelerators #DigitalHealth #PrecisionMedicine #LATAMTrials #BalkansClinicalResearch #AustraliaCTN #AANVISA #ALIMS #MINSA #TrialAcceleration #FirstinHumanTrials #ClinicalTrials #MedTechInnovation #Biopharma #MedTech #PatientRecruitment #CRO bioaccessla.com Listen to the podcast here  

Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval. From navigating state-specific registration, sales tax laws, and distribution logistics to choosing between direct and distributor-based strategies, Adam shares hard-earned insights for avoiding the "second valley of death" post-clearance. Whether you're a domestic startup or an international company entering the U.S., this episode arms you with a tactical understanding of compliance landmines and scalable go-to-market strategies.Key Timestamps00:02 – Intro: The real MedTech “valley of death” after FDA clearance04:45 – Why U.S. state-level registration is misunderstood and overlooked08:15 – State-level definitions of medical devices and why they differ11:20 – Strategic go-to-market options: Distribution vs. Direct17:00 – How regulations vary drastically by state (CA, TX, etc.)21:50 – The real risks of noncompliance: lawsuits, bad PR, and due diligence failures26:15 – Why distribution agreements can stall your growth (and how to avoid it)34:30 – Sales tax & use tax: The hidden compliance trap39:10 – Logistics, warehousing, and long-term liabilities in contracts44:55 – Overlooked pitfalls: Secretary of State filings and income tax in 36+ states51:15 – Software as a Medical Device (SaMD): U.S. compliance still applies55:30 – Selling to the U.S. government vs. private sector buyers59:20 – Veterinary devices and why they still need regulatory controls1:03:10 – What a winning go-to-market strategy actually looks like1:10:25 – Adam's final advice to MedTech startups (foreign and domestic)Standout Quotes"You're not entering one country—you're entering 50 states and D.C. Each with its own rules, definitions, and tax laws."—Adam Steadman explains why U.S. MedTech entry requires a state-by-state strategy, especially for international companies."None of the strategics want your warehouse management system—they want your product, your sales, and your proof of market fit."—Steadman on why building non-core infrastructure slows down commercialization and valuation.Top 5 TakeawaysFDA Clearance ≠ Market Readiness – State-level registrations, sales tax laws, and pharmacy board definitions often delay or block commercialization.Distribution Isn't Always a Shortcut – National distributors may have misaligned incentives and can lock you into exclusivity that hinders growth.Sales Tax is a Regulatory Minefield – 46 states require separate sales tax registration, exemptions tracking, and monthly filings—even if you're tax-exempt.Beware of Long-Term Contracts – Logistics and distribution contracts often lock companies into rigid terms that prevent pivots or acquisitions.Speed to Market Is Strategic – Getting to market fast is often the difference between becoming #1 or #3—and #3 often gets nothing.MedTech 101What Is “Nexus” and Why It Matters for Sales Tax?“Nexus” refers to the minimum level of economic activity that triggers tax obligations in a given state. For example, selling $100,000 of devices or 200 transactions may establish nexus, requiring you to register for sales tax. Unlike VAT in Europe, U.S. sales tax laws are state-specific, making this a major compliance hurdle for MedTech companies.References & Resources

In this thoughtful conversation, we explore the transformative role of AI in healthcare. From over a thousand FDA-approved AI-enabled medical devices to breakthroughs in medical imaging, the discussion highlights the importance of trust, transparency, and bias mitigation. Join Tracy Ring, Chief Data Officer and Global Generative AI Lead for Life Sciences; Tom Kawalec, Managing Director for Life Sciences Practice at Accenture; and Shaye Mandle, Executive Director of Digital Health Tech at AdvaMed, as they delve into AI's future in personalized care and its potential to reduce healthcare costs.

Every year, the Fierce Medtech team highlights 15 standout companies that are pushing the boundaries of innovation in medical technology. From reinventing diagnostics and surgical tools to advancing AI and biological research, this year’s Fierce 15 is full of startups rethinking what care should look like—and improving on what came before. In this episode of "The Top Line," Fierce Medtech Senior Editor Conor Hale breaks down the themes and standout trends from this year’s list, offering a closer look at the ideas and technologies reshaping the healthcare landscape. To learn more about the topics in this episode: Introducing Fierce Medtech's Fierce 15 This episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

In this episode of Medsider Radio, we sat down with Todd Usen, CEO of Adagio Medical.Adagio specializes in catheter-based ablation technologies for the treatment of cardiac arrhythmias, with a focus on ventricular tachycardia (VT).  Todd has over three decades of leadership experience in the medical technology industry, with particular expertise in commercial strategy, operational performance, and business transformation. Before joining Adagio, Todd served as CEO of Minerva Surgical, a women's health company, and as CEO of Activ Surgical, a digital surgery startup. Todd has also served in executive positions at Olympus, United States Orthopedics, Smith and Nephew, and Boston Scientific.In this interview, Todd shares insights on making usability central to commercialization strategy, leveraging breakthrough designation beyond regulatory validation, and assembling effective boards by carefully selecting both investor and independent members who bring operational expertise.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 Todd Usen.

Credibility isn't what you think it is — it's not what you believe, it's what your customers and colleagues experience. And in today's high-stakes MedTech environment, skipping the small details or ignoring key feedback can quietly erode trust, stall deals, and block innovation. In this episode, sponsored by Physician Growth Accelerator, we talk with Bill Facteau, President and CEO of Earlens, about how credibility shapes every level of success, from individual sales calls to boardroom pivots. Bill shares lessons from leading multiple MedTech startups, why great products still fail without the right strategy, and how Earlens' creation of Virsono Hearing Centers offers a new model for delivering better hearing care. What we discuss in the episode: Why credibility depends on how others perceive you, not how you see yourself The overlooked role of preparation and discipline in winning (or losing) sales trust How feedback loops between sales and leadership drive better pivots and strategies Why even world-class MedTech products fail without the right business model and market fit Lessons from Earlens' creation of Virsono Hearing Centers and how they reshaped hearing care delivery Resources from this episode:  Get the free MedTech Talk Tracks for Action Physician Growth Accelerator Earlens Social Media:  Connect with Bill on LinkedIn Connect with Zed on LinkedIn