S1E3 | How do I get funding for a medical device? Video

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. Press Release: Cala announced the national launch and availability of the Cala kIQ Plus 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/ WATCH: *** 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

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

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

In this special episode of the DeviceTalks Women in MedTech podcast, Host Kayleen Brown brings listeners inside the 6th Women in MedTech Breakfast held May 4 at DeviceTalks Minnesota for a powerful keynote panel on “The Art of High-Stakes Decision-Making.” The conversation features Cat Jennings, SVP and President of Vascular Therapies at Boston Scientific; Laura Stoltenberg, President and CEO of Cryosa; and Marcie DeWalt, Chief Human Resources Officer at Provation. Together, they explore what it really takes to lead through uncertainty. From billion-dollar M&A and clinical trial bets to organizational transformations and personal career pivots, the panelists share candid stories about navigating moments where the pressure is real and the outcomes are uncertain. Throughout the discussion, the leaders examine the balance between data and intuition, the importance of stakeholder alignment, and how to develop the conviction to move forward when there is no "undo" button. Whether managing portfolio strategy at a strategic or navigating the growth of a startup, this episode offers practical frameworks for making decisions that shape companies, careers, and patient care. Kayleen also welcomes Heather Hudnut Page and Archana Desai in-studio to discuss the inspiration behind this year’s theme and how the Women in MedTech Breakfast continues creating space for authentic leadership conversations and community-building across the industry. Thank you to Aptyx for sponsoring the Women in MedTech Breakfast at DeviceTalks Minnesota and supporting these essential industry conversations!! Visit https://www.aptyx.com to learn more. Join us May 27-28th at DeviceTalks Boston for the next Women in MedTech Breakfast featuring Dr. Carla Goulart Peron, Chief Medical Officer for Philips to discuss designing MedTech for reality. https://boston.devicetalks.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

In this episode of the DeviceTalks Women in MedTech podcast, Host Kayleen Brown sits down with Gaele Lalahy, Chief Operating Officer at Plexāā, to discuss what it looks like to treat patients as true co-designers, not only in product development, but across the entire pre-surgery experience. Lalahy shares the clinical foundation behind BLOOM⁴³, Plexāā’s wearable, at-home device used the night before breast surgery to increase blood flow and support healing through supraphysiological preconditioning, and explains how Plexāā pairs the device with a holistic app that helps patients feel prepared, informed, and supported before and after surgery. Kayleen also welcomes Tom Salemi, Editorial Director of DeviceTalks, for an in-studio conversation that connects the episode’s theme to the broader MedTech ecosystem, including a look ahead at DeviceTalks Minnesota, May 4 and DeviceTalks Boston, May 27–28. Together, they discuss how listening to the end user shapes better outcomes, better experiences, and better leadership. * Mentioned in the interview * Check out this DeviceTalks Weekly episode featuring Samay's CEO Maria Artunduaga: https://www.devicetalks.com/how-samays-ceo-came-up-with-the-sound-idea-for-a-device-to-battle-copd-win-medtech-innovator/ *** 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