DeviceTalks

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.

In the latest episode of AbbottTalks, Abbott Cardiovascular's leaders, Christopher Piorkowski, MD, DVP and Chief Medical Officer of Electrophysiology, and Dan Kaiser, Divisional VP Product Development, Electrophysiology, delve into the vast landscape of electrophysiology and the comprehensive approach Abbott is taking towards atrial fibrillation (AFib) treatment. The conversation highlights a potentially innovative pulsed field ablation (PFA) technology and Abbott's broader AFib portfolio, showcasing a commitment to revolutionizing cardiac arrhythmia management. While the Volt™ Pulsed Field Ablation System could represent a significant leap forward with its unique capabilities for creating precise and tissue-selective lesions, Piorkowski and Kaiser emphasize the diversity and depth of solutions Abbott is developing. This includes advancements in diagnostic tools, patient monitoring, and a range of therapeutic approaches designed to offer customized and effective treatment pathways for individuals with AFib. By focusing on a holistic view of patient care, they discuss how Abbott aims to improve clinical outcomes through technological innovation and enhance patients' quality of life by making treatments more accessible, reducing procedure times, and addressing the broad spectrum of needs within the electrophysiology community. With ongoing clinical trials and research, Abbott is positioned at the forefront of addressing the unmet needs in AFib management, underlining the company's commitment to continuous innovation and patient-centered care. Thank you to Cretex Medical for sponsoring this episode of AbbottTalks. For more information on how Cretex Medical works with medical device companies, visit www.cretexmedical.com. Thank you for listening to the AbbottTalks Podcast. Tune in and subscribe to DeviceTalks on all major podcast channels to never miss an episode.

In this episode of the DeviceTalks Weekly podcast, John Murphy, CEO of Virtual Incision, highlights the headline-grabbing surgical robotics start-up. Virtual Incision followed up a trip to the ISS for a nod from the FDA. What’s next? He talks to Editorial Director, Tom Salemi. But first Shriya Srinivasan, Ph.d, assistant professor at Harvard’s School of Engineering and Applied Sciences, drops some SciFi on Salemi and Chris Newmarker – neuro interfaces, tiny drills that deliver drugs, and much more! Srinivasan will bring her insights to DeviceTalks Boston on May 1! Thanks to DornerWorks for sponsoring this episode. Find out more at DornerWorks.com. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network so you don’t miss a future episode.

In this episode of Ortho Innovation Talks, Nitin Goyal, MD, chief science, technology and innovation officer at Zimmer Biomet (ZB) shares his journey from the OR to the medtech industry. Dr. Goyal oversees ZB’s global innovation, medical education, clinical affairs, and reimbursement strategy. He tells host Tom Salemi about his passion for building solutions to address clinical challenges and improve the surgical experience. Goyal’s own innovations landed him leadership positions at managed care powerhouse, UnitedHealthcare, followed by medtech giant, ZB. Goyal describes how his pursuit of “making an outsized impact” on orthopedic care brought him to ZB, where he leads the global innovation, medical education, and clinical affairs functions. In this talk, he’ll discuss how ZB incorporates smart implants that track and report mobility data, to big data analytics that guide clinical decision-making throughout the episode of care. Goyal explains why he believes we’re at an inflection point in orthopedics and how ZB intends to lead the way. Thank you to our season one sponsors, Millstone Medical and AcuityMD, for supporting this podcast. To learn more about our episode sponsor, Millstone Medical, please visit http://millstonemedical.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 the Ortho Innovation Talks podcast!

In this episode of the DeviceTalks Weekly podcast, we meet the 13 finalists for the MedTech Color Pitch Competition, both general and pediatric categories. Editorial Director Tom Salemi and Managing Editor Kayleen Brown ask each entrepreneur about the problems they’re trying to solve and the solutions they’ve developed. Tom and Kayleen also interview MedTech Color’s new executive director, Katrina Holland. The pitch competition takes place March 15. For the list of finalists and registration information go to MedTechColor.org Thank you for listening to the DeviceTalks Weekly Podcast. Please subscribe to the DeviceTalks Podcast Network on any major podcast player.

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: - Close collaboration with cross-functional teams, including R&D, regulatory, quality, and marketing, is key to the success of clinical trials. - Clinical trials must consider the specific regulatory requirements of the targeted geographical markets. - 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! 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 of the DeviceTalks Weekly Podcast, Co-hosts Tom Salemi and Chris Newmarker interview Brad Estes, CEO of CytexOrtho, the winner of a pitch contest staged by AAOS. The company is developing implants that could serve as an alternative therapy to total hip replacement. In our main interview, Tom interviews David Wilson, CEO of InnovHeart, a multinational startup that’s developing transcatheter mitral valve replacement systems to treat patients with mitral valve disease. Wilson talks about his journey into medtech, his decision to shift from engineering to sales, and how life as a global president of a medical device business differs from being a start-up CEO. Thank you for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network so you don’t miss a future episode.

This episode of AI Meets Life Sci offers a comprehensive look at the ways AI is poised to upend the pharmaceutical industry. It features an in-depth keynote interview with Helen Merianos, Head of Sanofi's R&D Portfolio Strategy, who provides an inside look into Sanofi's commitment to go "all-in" on AI and data science. Merianos discusses the use of Sanofi's proprietary plai app – an AI-enabled smartphone app that draws from over a billion data points – and its role in establishing a data-driven culture across the company. Additionally, the episode features Michelle Longmire, MD, Co-Founder and CEO of Medable, who discusses the use of generative AI in automating and accelerating clinical trial technology deployment timelines. These applications could cut some timelines in half. Longmire envisions AI's potential to drastically accelerate a development process. “Say there's 10,000 uncured or poorly suboptimally treated human diseases.” At the current pace of drug development, it might take about 200 years to create treatments for those conditions. “Imagine if we could 10x that,” Longmire says. Join us for the next episode of AI Meets Life Sci, where we sit down with Ha Hong, PhD, Chief Artificial Intelligence Officer, Endoscopy at Medtronic. Thank you to our sponsors Catalyze Healthcare and SmartTRAK Business Intelligence, for providing invaluable support. catalyzehealthcare.com smarttrak.com Tune in and subscribe to AI Meets Life Sci on all major podcast channels and follow youtube.com/@DeviceTalks or AI Meets Life Sci YouTube Podcast to ensure you never miss an episode. WATCH, LISTEN, and READ: https://www.drugdiscoverytrends.com/when-will-drug-development-have-its-chatgpt-moment-inside-ambitious-ai-initiatives-at-sanofi-and-medable/ Thank you for supporting AI Meets Life Sci!

In this week’s episode, Procyrion CEO Eric Fain details the next steps for the startup’s ambitious plans to secure FDA approval for Aortix, a percutaneous mechanical circulatory support (pMCS) device being developed for patients with acute decompensated heart failure (ADHF) who remain congested despite standard medical therapy (cardiorenal syndrome or CRS). Fain will talk about raising the company’s recent $57.7 million round. He’ll also share some lessons from his successful career as an executive at larger medical device companies. In the opening discussion, Co-Hosts Tom Salemi and Chris Newmarker talk with Santosh Iyer, CEO and Founder of Moonshot, a summer program for high school students interested in learning how the Medtech industry uses cool tech to save lives. For more information visit Moonshot.school. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network.

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. 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.

This week’s DeviceTalks Weekly is a bit of a retrospective on Medtronic’s Symplicity Spiral Renal Denervation System. It obviously ends on a happy note, and we’ll catch up with Jason Weidman, SVP and president of Medtronic’s Coronary and Renal Denervation business in an interview conducted in January. Thank you to AcuityMD for sponsoring this podcast. www.acuityMD.com. Weidman talked with Co-Host Tom Salemi last month to recap a bit of a history of the program including the dramatic – and successful – conclustion at the FDA. We also draw from an earlier interview Weidman gave to our MedtronicTalks Podcast in 2021. Together, these clips and interviews reflect the time and dedication that ambitious medtech programs require. In the current interview, Weidman also give a glimpse of renal denervation’s future. Other resources Medtech Talk Podcast - https://medtechmvp.com/media/medtech-talk-podcast/Mark-Gelfand-Howard-Levin-Discuss-Coridea-Ardian-and-How-They-re-Innovating-Medtech-Innovation 2021 MedtronicTalks Podcast with Jason Weidman - https://www.devicetalks.com/weidman-talks-us-through-the-long-road-to-ge Co-Host Chris Newmarker, executive editor of MassDevice, also discusses his new article – 10 Surgical Robotic Companies that You Need to Know. https://www.massdevice.com/10-surgical-robotics-companies-you-need-to-know-2024/ Thank you for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network on any major podcast player.

We’ll open this week’s episode with Paul Grand, CEO of the MedTech Innovator. Grand issued a last call for medical device entrepreneurs to apply to be part of this year’s program. Lots of good stuff come with it. Listen to the episode and apply at MedTechInnovator.org. Then Co-Hosts Tom Salemi and Chris Newmarker interview successful startup CEO Bill Gruber about his new book, The Leadership Blueprint. Gruber shares some experiences and lessons, but entrepreneurs are encouraged to buy the book on Amazon. Finally, Tom Salemi interviews Ahmet Tezel, Company Group Chairman and Global Head of J&J MedTech Innovation and R&D about his path into medtech and what the future holds for Johnson & Johnson and the medical device industry. Thank you to the sponsor of this episode – Tecan. Here’s a message - Tecan brings all the healthcare OEM pieces together with fully integrated solutions across the entire MedTech and life sciences spectrum from idea to implementation. Partner with us to revolutionize the way you develop medical technology with the Emphysys approach and turn your visionary ideas into a tangible reality in a matter of months, not years. www.emphysys.com/ Thank you for listening to the DeviceTalks Podcast Network. Subscribe now to the DeviceTalks Podcast Network.