How do I navigate the clinical affairs process effectively? with Christina Hawley, May Health

In this week’s episode of the DeviceTalks Weekly Podcast, Editorial Director Tom Salemi talks about next week’s DeviceTalks Boston meeting with MedTech Innovator CEO Paul Grand. We also hear interviews done earlier this year with speakers – Bertin Nahum of Quantum Surgical, Kurt Haggstrom of Synchron and Closing Keynote Speaker Rajit Kamal of Medtronic. Anyone interested attending – and meeting a surprise surgical robotics guest – can register at Boston.DeviceTalks.com. Use the code DTWeekly25 to save 25% of the registration fee. Thanks for listening to this episode of the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network.

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: - The integration of market insights from the beginning is crucial for successful medical device commercialization. - Collaborative efforts across various functions are vital to address the comprehensive demands of product development. - 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! https://aptyx.com/ https://catalyzehealthcare.com/ https://confluentmedical.com/ https://www.cretex.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 to MedtechWOMEN Talks!

In this episode, we visit with Rebecca Seidel, president of Medtronic’s cardiac ablation solutions group, about the future of pulsed-field ablation and what it means for the electrophysiology sector. Host Tom Salemi also visits with biomedical researcher Jeff Karp to discuss his new book, LIT: Life Ignition Tools: Use Nature's Playbook to Energize Your Brain, Spark Ideas, and Ignite Action Kindle Edition. Use the code LIT25 to save 25% off the registration price of DeviceTalks Boston and you could win a free copy. Karp will also be at DeviceTalks Boston’s opening reception on April 30. Come meet the author and noted medtech innovator. Finally, we get a #DTBoston2024 speaker preview – Scott Nelson, CEO of FastWave Medical, one of two IVL companies we’ll have at the conference! Thank you to Freudenberg Medical for sponsoring this episode. Go to Freudenbergmedical.com for more information. Thank you for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network

In this episode of StrykerTalks, Spencer Stiles, Group President of Orthopaedics and Spine at Stryker, discusses Stryker's latest advancements shaping the future of orthopedics and spine care, including an update on the significant role of Mako, Stryker’s pioneering robotic arm-assisted system. Additionally, Stiles discusses the expansive reach of these innovations, emphasizing their rapid adoption across global markets, particularly in Asia, where Stryker’s advanced solutions meet diverse clinical needs and operational settings. He shares insights into how these technologies cater to the unique challenges faced in different regions, enhancing Stryker's impact on global healthcare landscapes. The conversation further explores Stryker’s strategic growth initiatives, particularly its approach to mergers and acquisitions. Stiles outlines how these moves are carefully crafted to align with Stryker’s long-term vision, ensuring that each acquisition not only expands their market presence but also complements their existing portfolio. Thank you to DornerWorks for sponsoring this episode. To learn more about how DornerWorks supports medical device companies, visit www.DornerWorks.com. Thank you for listening to the StrykerTalks Podcast. Subscribe to the DeviceTalks Podcast Network on every major podcast platform.

In this episode of DeviceTalks Weekly, Greg Roche, CEO of Distalmotion, explains why smaller profile surgical robotic systems like Dexter have a shot at competing with established soft tissue giants. Just over two weeks to DeviceTalks Boston register now to meet Roche and other surgical robotics executives! Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network.

In this week’s DeviceTalks Weekly podcast episode, Host Tom Salemi talks with Joe Mullings of The Mullings Group about the Karl Storz and Asensus Surgical News as well as Johnson & Johnson's big play for Shockwave Medical. Then, we talk with the leaders of Sovato Health - Yulun Wang, PhD, chairman & co-founder, and Cynthia Perazzo, Co-founder and CEO, about the startup’s plans to build a fiberoptic network to enable remote robotic surgery procedures. Thank you for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network to catch future episodes.

In this week’s DeviceTalks Weekly, Host Tom Salemi thanks the DeviceTalks community for the kindness and support of our podcasts and conferences. He also looks back at our four years and replays Episode 1 where he and Chris Newmarker make some prescient calls on the impact of the pandemic while also showing just how different the world was. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network.

In this week’s DeviceTalks Weekly Podcast, Bridget C. Bagnato, worldwide president of specimen management at BD, gives us a glimpse of phlebotomy’s future – the BD MiniDraw, a blood testing system that can run a wide array of diagnostic tests on the blood drawn from a fingertip. How might this change how and where blood is drawn in the future. Thank you to Aptyx for sponsoring this episode! Listen to our interview with CEO Gregg Tobin and go to Aptyx.com for more information. We also include a portion of an interview Co-Host Tom Salemi did with Nikolai Begg, senior director of portfolio R&D, Robotic Surgical Technologies, Medtronic, in this week’s DeviceTalks Tuesday Surgical Robotics Week. To listen to the entire interview or our other episodes with Intuitive or Virtual Incision go here. https://gateway.on24.com/wcc/experience/elitewtwhmedia/2927718/4415884/devicetalks-tuesdays Also, listen to hear how you can join a unique networking opportunity at Medtronic on April 30 as part of DeviceTalks Boston. We also introduce the new podcast discount code DTWEEKLY25. Use it when you register to attend at DeviceTalks.Boston.com Thanks for listening to the DeviceTalks Weekly Network. Subscribe to the DeviceTalks Podcast Network so you don’t miss a future episode.

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! 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 to MedtechWOMEN Talks!

In this episode of DeviceTalks Weekly Co-Hosts Tom Salemi and Chris Newmarker pay a visit to the Wizard, Joe Mullings of The Mullings Group, to get his take on the disruptive force that is Intuitive’s da Vinci 5. What does this mean to the surgical robotics competitors both big and small? Then Tom Salemi talks with Murali Srivathsa, CEO of Akura Medical, about the company’s aggressive moves to disrupt the thrombectomy. Akura is part of the prolific Shifamed accelerator, so we’ll talk about that innovative powerhouse as well as Srivathasa’s own career. To register for the upcoming DeviceTalks Tuesday Surgical Robotics Week or DeviceTalks Boston go to DeviceTalks.com. Thanks for listening to the DeviceTalks Podcast Network. Subscribe now to the DeviceTalks Podcast Network on any major podcast player.