Women in MedTech With Kayleen Brown

Empathy is more than a leadership trait—it’s a business advantage. In this season opener of Women in MedTech,host Kayleen Brown talks and Medtronic’s Nina Goodheart, SVP & President of Structural Heart & Aortic talk about Medtronic's focus on women's heart health and make the business case for empathy in MedTech. Kayleen also welcomes Beth Harrison Meyer, SVP of Global Marketing at Aptyx, to unpack what empathy looks like inside companies and why it’s critical to innovation and culture. Thank you to Aptyx for your support. Visit ➡ https://www.aptyx.com Referenced in this episode: – Medtronic’s Letter to My Mother campaign: https://www.medtronic.com/en-us/c/patients-caregivers/pan-cardiovascular/letter-to-my-mother.html – Kayleen’s article in Medical Design & Outsourcing: https://www.medicaldesignandoutsourcing.com/medtronic-nina-goodheart-cardiovascular-deaths-women-rwe-smart-trial/ Enjoy this episode? Follow Women in MedTech → https://women-in-medtech.castos.com/subscribe and subscribe on YouTube → https://YouTube.com/@DeviceTalks to catch every conversation. Access the full DeviceTalks Podcast Network → https://devicetalks.castos.com/subscribe Chapters (00:00:00) - Empathy to Self, Empathy to Ecosystem(00:02:45) - The Power of Mentorship and Sponsorship(00:05:30) - Building the Aptyx Culture of Collaboration(00:10:15) - Insights into the Keynote Interview with Nina Goodheartt(00:17:00) - What Empathy Looks Like in Product Development(00:22:15) - Designing for Equity: Who Are We Not Treating Yet?(00:27:10) - The Business Case for Empathy in MedTech(00:28:17) - Start of Interview with Medtronic's Nina Goodheart(00:36:30) - Using AI to Advance Health Equity (The ALERT Study)(00:49:30) - Medtronic's Letter to My Mother: Women’s Heart Health Awareness(00:55:15) - Redefining Leadership — Empathy as Smart Business

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** In the final episode of MedtechWOMEN Talks season one, we are joined by YJ Oh, SVP US Sales, Marketing and Commercial Operations at Edwards Lifesciences, who takes us through the intricate process of medical device commercialization. Starting with her unique entry into the medtech industry, YJ shares her comprehensive journey from sales to global marketing, emphasizing the significant role of upstream marketing in shaping product development and downstream efforts in executing commercial strategies. In the discussion, YJ highlights the criticality of understanding market needs right from the inception of a product idea, ensuring that every development phase aligns with customer insights and real-world applicability. She provides a glimpse into the key collaborations across various departments and touches on the essential feedback mechanisms in place, ensuring devices meet the stringent requirements and expectations set forth by both regulatory bodies and the end-users, primarily physicians. Her insights extend into the strategic considerations for global market penetration, discussing how different regulatory landscapes affect the accessibility and success of medical devices across borders. TL;DR – Key Takeaways: 1. The integration of market insights from the beginning is crucial for successful medical device commercialization. 2. Collaborative efforts across various functions are vital to address the comprehensive demands of product development. 3. Strategic global considerations are imperative to navigate varying regulatory and market conditions effectively. Thank you to our season one sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical! Thank you for listening!   *** 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

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** In the latest episode of MedtechWOMEN Talks, Rebecca Whitney, SVP, Global Spine President, ZimVie dives deep into what it takes to bring innovative medical solutions to market in a large medtech OEM, weighing the benefits of internal product development against strategic external partnerships. ​ The episode shines a light on the diligent process behind medical device product development, taking into consideration global market nuances, regulatory challenges, and the balance between in-house innovations and external collaborations. Whitney underscores the value of rigorous review stages, which sometimes require difficult decisions like ceasing investment in long-term, costly projects. Key Takeaways: - Tough decisions, like halting a project, are necessary for the betterment of patient care and resource allocation. - Product development incorporates feedback from patients, surgeons, and salesforces to ensure that solutions are practical and market-appropriate. - Strategic external partnerships can optimize development by leveraging outside expertise, allowing large medtechs like ZimVie to focus on their core strengths. Thank you to our season one sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical! https://aptyx.com/ https://catalyzehealthcare.com/ https://confluentmedical.com/ https://www.cretexmedical.com Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode. Thank you for listening! *** 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

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** In this episode of MedtechWOMEN Talks, Christina Hawley, Sr. Director, of Clinical Operations at May Health helps to unravel the clinical trial process for medical devices, emphasizing the non-linear path from early feasibility to pivotal trials and post-market studies; and delves into the meticulous process of gaining FDA approval and even the nuanced differences between clinical affairs and regulatory affairs. ​ TL;DR – Key takeaways: 1. Close collaboration with cross-functional teams, including R&D, regulatory, quality, and marketing, is key to the success of clinical trials. 2. Clinical trials must consider the specific regulatory requirements of the targeted geographical markets. 3. There is no standardized approach to any of the different clinical trials, each must Tune in to gain insights into the complex and surprisingly creative world of clinical research in the medical device industry. Thank you to our season one sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical! *** 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

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** In the latest episode of MedtechWOMEN Talks, Nicole Osmer, Founder & CEO at Health+Commerce, shares her expertise on the role of branding, media relations, and public relations in the medical device product development cycle from the perspective of “The Publicist.” In the episode, Osmer shares the significance of establishing a strong brand right from a company's inception. Attention to detail in messaging, brand presence, and even the subtleties like an area code on a contact page are pivotal. A central theme revolves around structuring communication effectively through traditional and emerging media channels to make significant market impacts. Osmer's insights on press releases, direct media outreach, and the role of digital platforms offer valuable takeaways on modern medtech marketing. The episode covers not only the 'what' but also the 'how' of successful medtech communications. TL;DR – Key takeaways: 1. Establishing a strong brand from the early stages and maintaining it throughout the lifecycle of a medtech company is crucial for lasting success. 2. Clear, concise messaging and being prepared for media opportunities with key story elements is essential in PR and branding. 3. Press releases remain a relevant tool for communication, especially when they are concise, impactful, and include a compelling headline. 4. Collaboration across various company functions, such as marketing, clinical teams, and investor relations, is integral to a coherent communication strategy. Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical for providing vital support. Thank you for listening! *** 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.

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** In the latest episode of MedtechWOMEN Talks, Vivian Golfin, MD, Senior Associate at Intuitive Ventures, shares her expertise on the role of venture capitalists in the medical device product development cycle from the perspective of "The Venture Capitalist." In the episode, Dr. Golfin discusses the significance of early engagement with venture capital firms for startups and how Intuitive Ventures acts as a strategic partner rather than just a financier. She emphasizes the detailed due diligence process, focusing on understanding the risks and potential of medical device startups. Key topics include the importance of milestones like first-in-human trials, early pilot results, and the necessity of feedback in the development process. Dr. Golfin also addresses the evolving role of AI and ML in medical devices and the importance of data diversity. Her insights highlight the need for proactive communication, networking, and leveraging AI for health equity. Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical for providing vital support. *** 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

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** In the second episode of MedtechWOMEN Talks, our guest Kathryn Rieger, PhD, Sr. Director, Human Factors & User Research at Intuitive, shares her insights on the medical device product development cycle from the perspective of "The Engineer." Drawing from her unique background in military tech and auto tech and her extensive experience in medtech, Dr. Rieger shares insights into how engineers influence the essential stages of the medical device product development cycle. In the episode, Dr. Rieger emphasizes the rigorous nature of verification and validation processes in medtech, underlining the importance of document control and thorough testing to ensure device safety and functionality. She also highlights the role of clinical studies in pre-market validation, underlining the significance of balancing safety considerations with regulatory compliance. Additionally, Dr. Rieger discusses the growing role of AI and machine learning in optimizing development processes while prioritizing user needs and safety. TL;DR - Key takeaways: 1. Integrating user experience and safety is crucial in medical device development. 2. A multidisciplinary approach to medtech product development is key. 3. Effective collaboration and communication are critical to successful product launches. Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical for providing vital support. *** 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  

**Season Two has rebranded to "Women in MedTech With Kayleen Brown** In the first episode of the newest series from the DeviceTalks Podcast Network, our guest Kirsten Carroll, CEO of Kandu Health shares her insights on the medical device product development cycle from the perspective of "The Product Director." With more than a decade and a half in product management for Boston Scientific and Stryker Neurovascular, Kirsten discusses the roles of product management, design verification, and design validation in ensuring a successful product launch. She also highlights the significance of generating clinical evidence and tailoring it to different stakeholders. Kirsten's key message is the value of effective communication and collaboration in developing and launching medical devices. Thank you to our sponsors Aptyx, Catalyze Healthcare, Confluent, and Cretex Medical for providing vital support.  Thank you for listening.  *** Enjoy this podcast? Follow OlympusTalks 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