In this episode of Structural Heart Talks, Joe Nuzzolese, corporate VP of global supply chain and quality at Edwards Lifesciences, shares how the company has built a resilient and responsive supply chain capable of withstanding significant disruptions—pandemic included—without missing a single patient case.

Nuzzolese explains how Edwards takes a "plan, make, source, deliver" approach, and why MedTech supply chains differ from consumer goods with a stronger emphasis on quality and availability. He details how the company strategically leverages dual sourcing, inventory buffering, and global distribution flexibility to maintain operations, even when borders close or suppliers face challenges.

He also unpacks the need for automation and digital integration, explains how Edwards connects employees to patient outcomes to instill purpose, and reveals why fostering innovation readiness is central to their long-term strategy.

Thank you to Daikin America for sponsoring this episode of Structural Heart Talks. To learn more about Daikin America’s products for your medical application visit https://daikin-america.com.

Wait, there’s more! Want to learn more about Daikin America’s new Co-Extrusion technology? Click here for a high resolution image with more detail.

Thank you for listening to the Structural Heart Talks podcast.

Subscribe to Structural Heart Talks or the DeviceTalks Podcast Network wherever you get your podcasts and follow youtube.com/@DeviceTalks on YouTube Podcasts to ensure you never miss an episode.

• (00:00:00) - Structural Heart Talks: Supply Chain Challenges
• (00:00:50) - Fluorochemicals
• (00:05:18) - Edwards on the Medical Device Industry
• (00:07:12) - Exploring the supply chain in the healthcare industry
• (00:08:40) - Life Sciences and the Supply Chain
• (00:09:06) - Comparing electronics and medical devices: the supply chain
• (00:12:54) - Philip Morris on Supply Chain Resiliency
• (00:19:28) - Dr. Matthew Orr
• (00:22:31) - Edwards Life Sciences: COVID
• (00:24:36) - Do you have dual sourcing in your steel?
• (00:25:56) - Manufacturing Locations and Regional Strategy
• (00:26:50) - How Patient-First is the Supply Chain
• (00:29:13) - Employees' morale during COVID
• (00:30:36) - The Challenges of Attracting Talent
• (00:31:26) - Intermediate Supply Chain: Innovation, Digital Connection
• (00:34:12) - The Structural Heart Talks Podcast

In this episode of Structural Heart Talks, Todd Brinton, MD, Chief Scientific Officer & CVP, Advanced Technology at Edwards Lifesciences, discusses Edwards’ vision of future innovative technologies that elevate patient care and expand the possibilities of structural heart therapies. Brinton reflects on his journey from biomedical engineering to pioneering roles in MedTech, including his work at Shockwave Medical, and shares how these experiences shaped his mission to create impactful technologies for patients worldwide.

The conversation dives deep into Edwards’ evolving focus on structural heart failure and non-valvular structural heart therapies, emphasizing investigational programs that challenge traditional approaches and push the boundaries of interventional cardiology. Brinton highlights how Edwards fosters a mission-driven culture of collaboration, uniting engineering, clinical expertise, and market insights to tackle some of the most complex challenges in cardiac care.

The episode also underscores the transformative role of mentorship in Brinton’s career and his commitment to paying it forward by empowering others in the MedTech space. Drawing on personal stories, Brinton illustrates how embracing failure and leveraging diverse perspectives have driven innovation at Edwards, paving the way for new therapies that can improve care for patients globally.

* Please note that this episode was recorded before the sale of Edwards’ Critical Care business unit to BD, which closed on Sept 3, 2024.

Thank you to Integer for sponsoring this episode of Structural Heart Talks. To learn more about how Integer supports medical device companies, visit Integer.net.

Thank you for listening to the Structural Heart Talks podcast. Tune in and subscribe to the Structural Heart Talks podcast and the DeviceTalks Podcast Network wherever you get your podcasts and follow youtube.com/@DeviceTalks or the Structural Heart Talks on YouTube Podcasts to ensure you never miss an episode.

• (00:00:00) - Structural Heart Talks: Todd Britton
• (00:01:34) - Intelligent Heart, Integer Ireland Facility Expansion
• (00:02:31) - Integer's capabilities in structural heart
• (00:05:17) - Todd Brinton
• (00:06:22) - Have You Sealed a Mentor?
• (00:09:49) - Choosing Medical School: A Big Decision
• (00:12:20) - The Courage of Med School Applic
• (00:13:46) - Pushing the boundaries of medical innovation
• (00:15:41) - Exploring Shockwave at Edwards
• (00:18:46) - No. 13: Keeping the Idea Alive
• (00:21:14) - What Integer Adds to Full Structural Heart Procedures
• (00:23:38) - Integer's Innovation in Structural Heart
• (00:25:09) - Edwards CEO on the Company's Mission
• (00:27:13) - Edwards Heart Disease: Advanced Technologies
• (00:30:10) - How Do We Accelerate New Ideas?
• (00:34:02) - Ideas for innovation in healthcare
• (00:37:21) - What Was It About Edwards?
• (00:39:18) - Structural Heart Talks

In this episode of Structural Heart Talks, Larry Wood, Corporate VP and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart at Edwards Lifesciences, discusses the transformative journey of transcatheter aortic valve replacement (TAVR) and the SAPIEN valve. Wood reflects on the innovation that enables minimally invasive heart valve replacement, which has become the standard of care for severe aortic stenosis and offers patients faster recovery and greater independence.

The conversation explores Edwards’ efforts to expand access to TAVR, emphasizing the importance of reducing undertreatment and addressing outdated clinical guidelines that delay intervention. Wood also highlights findings from the recent early TAVR study, which challenges long-standing paradigms and advocates for changes to the guidelines to allow earlier treatment of aortic stenosis before symptoms appear.

Tune in to the 2021 episode of DeviceTalks Weekly where Host, Tom Salemi visits with Larry Wood to discuss the “Complete History of the SAPIEN TAVR,” here: www.devicetalks.com/the-complete-history-of-the-sapien-tavr-from-pvts-emerging-idea-to-edwards-lifesciences-success/

Thank you to Confluent Medical Technologies for sponsoring this episode of Structural Heart Talks. To learn more about how Confluent Medical supports medical device companies, visit: www.confluentmedical.com.

Thank you for listening to the Structural Heart Talks podcast. Tune in and subscribe to Structural Heart Talks and the DeviceTalks Podcast Network wherever you get your podcasts and follow youtube.com/@DeviceTalks or the Structural Heart Talks on YouTube Podcasts to ensure you never miss an episode.

• (00:00:00) - Structural Heart Talks: Early TAVR
• (00:01:31) - Confluent Medical: Taking a Nitinol Device From Prototype to
• (00:03:49) - Larry Wood on How He Found His Way to Medtech
• (00:06:15) - Bradley Sapien on the TAVR Story
• (00:07:15) - What is TAVR and its benefits for seniors?
• (00:10:31) - TAVR Therapy: The Technology
• (00:13:01) - Severe Aortic Stenosis: How to treat it
• (00:15:22) - How to manage Aortic Stenosis in the elderly?
• (00:17:32) - What's the Future of Nitinol in Neurovascular Devices
• (00:19:58) - Should we wait for symptoms before performing valve replacement?
• (00:23:01) - Transcatheter Heart Valve Replacement
• (00:31:36) - Tavr versus lung cancer
• (00:32:47) - TAVR Study vs. first trial
• (00:34:11) - Edwards Lifesciences: Structural Heart
• (00:36:04) - Structural Heart Talks

In this episode of Structural Heart Talks, Wayne Markowitz, General Manager and SVP, Surgical Structural Heart at Edwards Lifesciences, discussed the evolving landscape of the structural heart space, emphasizing the sharpened focus at Edwards under new leadership.

Markowitz highlights the importance of the surgical structural heart business, with a strong emphasis on innovation and collaboration with cardiac surgeons. He emphasizes Edwards’ 65-year legacy in innovation driven by partnerships with the surgical community, focusing on addressing unmet patient needs. The conversation also touched on the RESILIA portfolio, featuring surgical valves and conduits, and highlights ongoing clinical trials.

Looking ahead, Markowitz shares his optimism about the future of the surgical structural heart business, emphasizing the need to bring more patients into the treatment system and the potential for growth in emerging markets.

Thank you to Resonetics for sponsoring this episode of Structural Heart Talks. To learn more about how Resonetics supports medical device companies, visit: https://shorturl.at/E1wO8

Thank you for listening to the Structural Heart Talks podcast. Tune in and subscribe to Structural Heart Talks wherever you get your podcasts and follow youtube.com/@DeviceTalks.

Structural Heart Talks is a powered by DeviceTalks, part of the DeviceTalks Podcast Network.

• (00:00:00) - Structural Heart Talks
• (00:01:05) - Interview
• (00:04:35) - Structural Heart Talks
• (00:05:04) - Interviews with the Pioneers of Medtech
• (00:05:53) - Top Executives: Bringing the Medtech Industry to Life
• (00:06:54) - Wonders of the World: Working Abroad
• (00:08:49) - Edwards Surgery Structural Heart
• (00:10:56) - Nitinol in extremity implants
• (00:12:13) - Nitinol Heart Devices
• (00:13:36) - Edwards CEO on Innovation in Structural Heart
• (00:16:24) - Edwards Structural Heart: The Future
• (00:18:31) - Edwards Surgery: What's Up for Structural Heart
• (00:20:27) - Edwards CEO on the Surgery Division's future
• (00:21:35) - Making It Possible: Structural Heart Talks Podcast

In the inaugural episode of our newest podcast, Structural Heart Talks, we sit down with Daveen Chopra, Corporate VP and GM of Transcatheter Mitral and Tricuspid Therapies (TMTT) at Edwards Lifesciences. In the episode, Chopra discusses the unique challenges of advancing therapies for the mitral and tricuspid valves, which have historically been more difficult to treat than the aortic valve due to their complex and varied nature. He details Edwards Lifesciences’ efforts to innovate in this space with technologies like the PASCAL valve repair system and the EVOQUE tricuspid valve replacement system, the first transcatheter tricuspid valve replacement approved in both the US and Europe.

Later, Chopra explains the importance of a focused approach at Edwards Lifesciences, where the company’s specialization in structural heart disease enables deeper knowledge and more targeted innovation. The conversation also explores the intricate process of planning and executing these advanced procedures, which require close collaboration between interventional cardiologists and echocardiographers. Chopra underscores the ongoing commitment to clinical evidence and real-world outcomes as key drivers of future success in this rapidly evolving field. Looking ahead, he emphasizes the need to increase awareness, diagnosis, and treatment rates for valve diseases, noting that many patients still go untreated due to a lack of awareness.

Thank you to Resonetics for sponsoring this episode of Structural Heart Talks. To learn more about how Resonetics supports medical device companies, visit: https://shorturl.at/E1wO8

Thank you for listening to the Structural Heart Talks podcast. Tune in and subscribe to the DeviceTalks Podcast Network wherever you get your podcasts and follow youtube.com/@DeviceTalks or the Structural Heart Talks on YouTube Podcasts to ensure you never miss an episode.

• (00:00:00) - Structural Heart Talks
• (00:00:54) - Andy Pegganau Discusses New Nitinol Lab at Res
• (00:04:39) - How Did I Find My Way into Medtech?
• (00:05:50) - What was it about joining the industry that resonated with you?
• (00:06:26) - Former Medtronic CEO Mike Masalam on Edwards
• (00:09:05) - Transcatheter, Mitral and Tricuspid Valve Therapy
• (00:10:03) - Tricuspid Valve and the Aortic Valve
• (00:12:30) - Valves
• (00:13:27) - Heart Valve Replacement, Safety and Innovation
• (00:14:31) - Interventional Cardiology: The Role of Echo-guided Imaging
• (00:15:30) - Heart Surgery 4, Cardiac Valve Imaging
• (00:19:15) - Nitinol in extremity implants
• (00:20:26) - Nitinol Device Design and Manufacturing Challenges
• (00:21:52) - Edwards Cardiac Surgery: Structural Heart
• (00:25:52) - Heart disease, 13 of 100, mitral and tricusp
• (00:28:44) - Heart Valve Replacement: The Journey
• (00:31:33) - When do you know when the valve is the right valve?
• (00:32:47) - Inventors Push the Innovation in Vascular Valve
• (00:33:25) - John Edwards on Mitral and Tricuspid
• (00:36:27) - The Structural Heart Talks Podcast

Nearly 70 years ago, engineer Miles Lowell Edwards and surgeon Dr. Albert Starr launched a company and an industry by developing the first commercially available artificial heart valve. Today, Edwards Lifesciences is focusing its attention on developing life-saving and groundbreaking devices that can help patients with heart disease. Hosted by Tom Salemi, Editorial Director of DeviceTalks, and with the support of Edwards Lifesciences, we sit down with the Edwards Lifesciences leaders who are adding to this great MedTech story. Filmed onsite at Edwards Lifesciences' headquarters in Irvine, CA. Welcome to the Structural Heart Talks video podcast. This podcast is powered by DeviceTalks and is part of the DeviceTalks Podcast Network.

• (00:00:05) - Breaking Down Structural Heart Surgery