A note from Kayleen, we'll be back next week!

The evidence doesn’t always point toward the outcome you hoped for. Leadership means acting on it anyway. Leadership means being prepared to act on evidence, even when it points toward a difficult decision. In this episode of the Women in MedTech podcast, Host Kayleen Brown talks with Medtronic’s Linnea Burman, SVP and President of Neurovascular, about her journey from communications and patient storytelling to leading a medtech business. Linnea shares how listening, preparedness, and accountability have shaped her approach to leadership—and why building strong teams and an innovation roadmap are essential to moving technology forward. She also discusses a painful recall decision and what her team learned from it. Kayleen welcomes Skyler Rivera, associate editor across MassDevice, Medical Design & Outsourcing, and DeviceTalks, for an in-studio conversation about accountability and storytelling. They discuss why sharing difficult experiences and what teams learn from them matters, not only for individual leaders, but for the wider MedTech community. Thank you to Orthopedic Technologies Week for sponsoring this episode, register for the free webinar series at:  https://event.on24.com/wcc/mr/7017117/B6E1342D4E6805EE537326E516AAE81D?partnerref=KB *** Enjoy this podcast? Follow Women in MedTech with Kayleen Brown on all major podcast players: https://women-in-medtech.castos.com/subscribe + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:00:00) - Introduction: Acting on Evidence, No Matter How Painful(00:02:09) - Start of In-studio guest interview: Skyler Rivera, Associate Editor, MassDevice, MDO and DeviceTalks(00:08:52) - Accountability, Vulnerability & Learning from Difficult Moments(00:15:45) - Start of Keynote guest interview: Linnea Burman, President, Medtronic Neurovascular(00:26:30) - Patient Stories, Career Growth & the Power of Listening(00:30:13) - Becoming a Business Leader & Taking Accountability(00:36:09) - Leading Medtronic Neurovascular & Building a Team(00:43:13) - Innovation Roadmaps & the Future of Neurovascular Care(00:49:52) - Women in MedTech: Leadership, Community & Connection(00:52:29) - Outro: What Helps You Act on Evidence?

I hope we're still friends. Be back next week, promise!

In this episode of DeviceTalks Weekly, Host Kayleen Brown talks with Joanna Nathan, CEO and Co-Founder of Prana Surgical, about why catching lung nodules earlier requires a right-sized approach to surgical intervention. Nathan explains Prana’s goal of bringing a lumpectomy approach to lung surgery and how the company is developing its technology to localize and remove nodules while preserving surrounding healthy lung tissue. She distinguishes its initial focus on supporting tissue diagnosis from its longer-term vision of potentially treating lung cancer. Nathan also shares lessons from Prana’s first-in-human experience in Australia, including how observing clinicians using the device helped identify design and workflow improvements. Along the way, she discusses her path from bioengineering to entrepreneurship and how lean medtech teams can use AI while maintaining human oversight. In the FOMO interview, Andy Hansen, Global Director of Engineering at ATL Medical, discusses the future of pulsed field ablation and intravascular lithotripsy. We’ll open the episode with this week’s Newsmakers, covering CMR Surgical’s plans following Stryker’s investment, Intuitive’s U.S. procedure growth and quarterly results, Johnson & Johnson’s timeline for its orthopedics spinoff, Abbott’s planned Nutrition business spinoff, and Medtronic’s appointment of a corporate president. Special thanks to ATL Medical for sponsoring this episode of DeviceTalks Weekly. To learn more about how ATL Medical works with medical device companies, visit: ATLMedical.com. *** Enjoy the show? Follow DeviceTalks Weekly on all major podcast players + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:00:00) - Message from Kayleen Brown, DeviceTalks(00:02:26) - Start of Newsmakers(00:21:49) - Start of FOMO with Andy Hansen, Global Director of Engineering, ATL Medical(00:32:32) - Start of Keynote with Joanna Nathan, CEO and Co-Founder, Prana Surgical(00:39:39) - Why Earlier Lung Nodule Detection Calls for Right-Sized Intervention(00:45:30) - Prana’s Goal of Bringing a Lumpectomy Approach to Lung Surgery(00:50:00) - Lessons from First-in-Human Cases and Refining Clinical Workflows(00:55:00) - AI Guardrails for MedTech Teams and What’s Next for Prana

In this episode of DeviceTalks Weekly, Host Kayleen Brown welcomes back Rocco De Bernardis, Global President for Soft Tissue Robotic Surgery at Johnson & Johnson, to discuss the company’s OTTAVA™ Robotic Surgical System. De Bernardis explains why OTTAVA’s four robotic arms are integrated into the operating table and how the system’s smaller footprint could give surgical teams more room to work while helping hospitals bring robotic surgery to additional operating rooms. He also shares what Johnson & Johnson learned from OTTAVA’s clinical trial, including how the system performed in different operating-room environments and what the company’s FDA authorization means as it prepares for a commercial rollout with selected U.S. customers. The conversation also explores the technology behind OTTAVA, including its automated setup and docking, surgical instrumentation, and Polyphonic™, an open digital ecosystem designed to connect data from devices and systems across the operating room. De Bernardis discusses how these technologies could improve workflow, support surgical teams and create a foundation for the future of robotic surgery. Catch the 2023 interview with De Bernardis here: https://www.devicetalks.com/hear-why-j-a-vc-discusses-the-impact-of-glp-1-drugs/  Special thanks to this episode's sponsor, Harmonic Drive. To learn more about how Harmonic Drive works with medical device companies, visit harmonicdrive.net. *** Enjoy the show? Follow DeviceTalks Weekly on all major podcast players + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:00:00) - Message from Kayleen Brown, Managing Editor, DeviceTalks(00:03:35) - Start of interview with Lee Ginter, Sales Engineering Manager, Harmonic Drive(00:09:01) - Keynote Interview with Rocco De Bernardis, Global President for Soft Tissue Robotic Surgery, Johnson & Johnson(00:09:52) - Why OTTAVA™ Integrates Robotic Arms Into the Operating Table(00:13:35) - What Johnson & Johnson Learned From OTTAVA’s Clinical Trial(00:14:47) - OTTAVA’s Smaller Footprint and Automated Setup(00:21:59) - Designing Surgical Instruments for Greater Efficiency(00:26:21) - Polyphonic™ and the Future of Connected Robotic Surgery

Better MedTech requires more than one perspective. In this episode of the DeviceTalks Women in MedTech podcast, Host Kayleen Brown talks with Deanna Harshbarger, CEO of Cala Health, about designing for the whole picture, from patients’ everyday needs to the people, evidence, and business decisions that bring a technology to market. A chemical engineer turned business leader, Harshbarger shares lessons from her career at Johnson & Johnson, Boston Scientific, and Medtronic, including helping build Boston Scientific’s deep brain stimulation franchise and gaining experience with connected devices and direct-to-patient care at Medtronic. Now leading Cala Health, Harshbarger explains how those experiences inform the company’s noninvasive, wrist-worn therapy for action hand tremor in people with essential tremor and Parkinson’s disease. She discusses why clinical effectiveness and usability must go hand in hand, how regulation and reimbursement shape access, and why no single person holds the answer to building a product that works for patients and can scale sustainably. That philosophy also shapes her leadership: removing hurdles, welcoming different perspectives, and ensuring every person knows their voice matters. Kayleen also welcomes Yvonne Bokelman, Executive Director of MedtechWOMEN, for an in-studio conversation about highlights from MedtechVISION 2026, the organization’s growing mentorship and community programs, and why diverse perspectives are essential to better medical device development. Thank you to MedtechWOMEN for sponsoring this episode of the Women in MedTech podcast! To learn more about the organization, please visit: https://medtechwomen.org/ *** Enjoy this podcast? Follow Women in MedTech with Kayleen Brown on all major podcast players: https://women-in-medtech.castos.com/subscribe + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:00:00) - Introduction: Designing for the Whole Picture & Cala Health Milestones(00:03:11) - Interview with In-Studio Guest, Yvonne Bokelman (MedtechWOMEN)(00:16:58) - Start of Keynote Interview with Deanna Harshbarger(00:17:30) - First Job Lessons: From a Bakery to the Chemical Manufacturing Floor(00:22:53) - Finding MedTech: Johnson & Johnson, Cordis & Balanced Regulation(00:30:56) - Boston Scientific: Building Deep Brain Stimulation from the Ground Up(00:39:14) - Medtronic & Connected Health: Serving Patients Directly(00:41:38) - Cala Health: Revolutionizing Tremor Treatment Noninvasively(00:47:13) - From VP to CEO: Scaling Leadership, Team Culture & Mentorship(00:53:58) - Outro: The Whole Picture, MedtechWOMEN & Connected Health Preview

The strongest MedTech innovation doesn't begin with technology in search of an application. It begins with a problem that matters enough to solve. In this episode of the Women in MedTech podcast, Host Kayleen Brown talks with Melaine DiLuzio, Vice President of U.S. Sales for Enabling Technologies within Medtronic’s Cranial & Spinal Technologies (CST) unit, about purposeful innovation—and the responsibility to connect every technology investment to a meaningful clinical need. Melaine shares how more than two decades in MedTech sales, including her progression from associate sales representative to executive leadership, have shaped her approach to purpose, preparation, and building teams that can lead through change. Melaine also unpacks how the CST division approaches enabling technologies: the connected tools for surgical planning, imaging, navigation, robotics, and execution that support cranial and spine procedures. She discusses the importance of designing technology around the realities of clinical workflow, adoption, and long-term utility—and why the most vital question innovators can ask remains: What problem are we solving with this technology? Kayleen also welcomes Caryn Mills, Medical Device Sales Director at HID Global, about how Radio-Frequency Identification (RFID) can support purposeful innovation throughout the medical device lifecycle. Caryn explains how RFID helps OEMs address challenges involving authentication, calibration, traceability, lifecycle management, workflow, and patient safety—and why teams should consider those needs early in the design process. Join us October 22nd and in December to learn more about RFID in two upcoming MDO webinars. Register for free here: https://gateway.on24.com/wcc/experience/elitewtwhmedia/2927718/4415899/medical-design-outsourcing  Thank you to HID Global for supporting this episode of the DeviceTalks Women in MedTech podcast. To learn more about how HID Global works with medical device companies, visit: https://www.hidglobal.com/  *** Enjoy this podcast? Follow Women in MedTech with Kayleen Brown on all major podcast players: https://women-in-medtech.castos.com/subscribe + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:00:00) - Intro: A Note From Kayleen(00:02:00) - In-Studio Guest Caryn Mills, HID Global(00:08:27) - Why RFID Must Be Considered Early in Device Design(00:14:35) - Start of Keynote Interview: Melaine DiLuzio, Medtronic CST(00:15:02) - Purpose in MedTech: The Patient Story That Stays With You(00:31:39) - Why Sales Experience Builds Stronger Leaders(00:37:43) - What Enabling Technologies Make Possible in Cranial & Spine Care(00:39:36) - Stealth AxIS: Connecting Planning, Navigation, Robotics & Data(00:44:16) - Making Technology Adoption Stick: Workflow, ROI & Partnership(00:48:07) - Enabling Technologies and the Move to ASCs

In this episode of DeviceTalks Weekly, Host Tom Salemi talks with Preceptis Medical CEO Dave Carey about his path from MedTech sales to the corner office. Carey shares lessons from launching disruptive technologies at Boston Scientific, Medtronic, Stryker and Pristine Surgical, including what he looks for when hiring salespeople and what it takes to change established clinical workflows. Carey also explains why his new role at Preceptis is personal. After his daughter experienced emergence delirium following anesthesia for an ear tube procedure, Carey was drawn to Hummingbird, Preceptis’ technology for moving ear tube procedures out of the OR and into the physician’s office without general anesthesia. He explains how Preceptis is working with ENTs, pediatricians and parents to drive adoption and why changing even a five-minute procedure requires more than selling a medical device. For more information, visit https://www.hummingbirdeartubes.com  We’ll open the episode with Newmarker’s Newsmakers featuring Mindray, Boston Scientific, Medtronic and Johnson & Johnson MedTech. This episode is sponsored by DeviceTalks Tuesdays Connected Health Series. Register at DeviceTalks.com.  *** Enjoy the show? Follow DeviceTalks Weekly on all major podcast players + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:01:13) - A bit of news from Tom Salemi(00:06:18) - Medtronic hires former Recor CEO to run interventional cardiology group(00:08:15) - Mindray looks to fill hospital ventilator gap left by Philips’ exit(00:09:39) - Medtronic strengthens robotic surgery position with Cornerstone deal, analysts say(00:11:15) - Citi downgrades Boston Scientific as cyberattack recovery compounds competitive pressure(00:14:25) - Johnson & Johnson drops LAA assets following suspended pivotal study(00:17:55) - Keynote Interview: Dave Carey, CEO, Preceptis Medical

In this episode, MassDevice Editor Chris Newmarker interviews Shan Jegatheeswaran, Global President, Polyphonic, Johnson & Johnson MedTech, about what’s to come after the transformation brought to the operating room by digital surgery and robotics. Jegatheeswaran reports that a new wave of surgical intelligence could take that transformation much further by connecting devices, data, AI and clinicians across the entire perioperative pathway. Jegatheeswaran explains why the biggest challenges may no longer be technological. Interoperability, economic incentives, governance, change management and trust all have to evolve alongside AI and connected medical devices. We’ll open the episode with this week’s Newmarker’s Newsmakers – Petal Surgical, Boston Scientific, Medtronic, Zimmer Biomet and Abbott. This episode is sponsored by DeviceTalks West. Go to west.devicetalks.com. *** Enjoy the show? Follow DeviceTalks Weekly on all major podcast players + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:09:55) - Petal Surgical says its first-in-human incisionless surgery is coming soon and offers a first glimpse of its system(00:12:10) - Boston Scientific could miss guidance over cybersecurity incident(00:15:02) - Medtronic veteran joins Teleflex’s board(00:17:14) - Zimmer Biomet lets go of former Nevro CEO amid leadership restructuring(00:19:32) - Abbott earns FDA approval for new dual-energy ablation catheter(00:22:46) - Shan Jegatheeswaran, Global President, Polyphonic, Johnson & Johnson MedTech

In this episode, Host Tom Salemi sits down with Eliane Schutte, CEO of Xeltis, to discuss a remarkable biomaterial designed to help the body grow its own living blood vessels. Schutte explains how the technology is being used for dialysis patients today and how it could eventually transform coronary bypass surgery, peripheral vascular care and even heart valve replacement. In the FOMO studio, Tom speaks with Katie Grant, VP of MR at Siemens Healthineers North America, about the global helium supply and why the MRI industry is working to reduce its reliance on the increasingly precious gas. They explore how new magnet designs could make MRI systems lighter, more accessible and easier to install in new locations. As always, we’ll open the podcast with the top stories from MassDevice in Newmarker’s Newsmakers, delivered by MassDevice Editor Chris Newmarker. This week, Chris covers Medtronic’s major investment in surgical robotics, Enovis’ acquisition of eCential Robotics, Stryker’s move to strengthen its shoulder portfolio, the rebranding of Johnson & Johnson MedTech, and job shifts at Zoll Medical. *** Enjoy the show? Follow DeviceTalks Weekly on all major podcast players + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe Chapters (00:04:35) - Zoll Medical is closing a California facility(00:07:33) - Stryker to acquire ZuriMed to boost shoulder offerings(00:09:35) - Enovis to acquire eCential Robotics for €155 million, plans to bring surgical robot to market(00:11:58) - J&J MedTech is rebranding Shockwave Medical(00:14:06) - Medtronic invests $780M in two companies amid Street-beating Q2(00:17:10) - FOMO – The State of Helium in MR – Katie Clark, Siemens Healthineers(00:31:38) - Keynote Interview – Eliane Schutte, CEO, Xeltis

The best leaders do more than set a vision. They know what good looks like—and can help others build toward it. In this episode of the Women in MedTech podcast, Host Kayleen Brown talks with Jaime LaMontagne, Chief Marketing Officer of Astrin Biosciences, about the leadership skills behind effective MedTech marketing. Jaime reflects on her 18 years at Medtronic, where she held a series of marketing and leadership roles across urology, neuromodulation, cardiac rhythm, and perfusion. She shares how that experience—along with her work at Smiths Medical and Exact Sciences—shaped her approach to communication, commercial strategy, and leading through change. Jaime explains why marketers must practice situational leadership: adapting messages for sales teams, physicians, engineers, executives, and patients while grounding every claim in evidence. She also discusses Astrin Biosciences’ work to advance breast cancer detection for women with dense breasts, including the promise behind Certitude, Astrin’s blood-based test in development. As she reflects on moving from large organizations to startup life, Jaime shares the episode’s defining insight: experience gives leaders a clear picture of what good looks like. The work is then to break that vision into practical steps, build the right foundation, and create momentum alongside the people who will bring it to life. *Editors note: This interview was recorded before the Certitude Blood Test launched. Certitude is now available, visit www.certitudetest.com to learn more and follow Certitude test on Facebook or Instagram. Thank you to MedtechWOMEN for sponsoring this episode of the DeviceTalks Women in MedTech podcast, to learn more about MedtechVISION 2026 visit https://medtechwomen.org/. *** Enjoy this podcast? Follow Women in MedTech with Kayleen Brown on all major podcast players: https://women-in-medtech.castos.com/subscribe + Follow us on YouTube.com/@DeviceTalks to ensure you never miss an episode. Want access to the complete DeviceTalks Podcast Network (DTPN)? Follow us today at https://devicetalks.castos.com/subscribe