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 DeviceTalks AI 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 DeviceTalks AI, 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 DeviceTalks AI on all major podcast channels and follow youtube.com/@DeviceTalks 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 DeviceTalks AI!

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.

This episode of DeviceTalks AI emphasizes the prognostic and point-of-care decision-making power of AI in oncology while addressing real-world implementation issues from regulation and liability to clinician trust and adoption, through conversations with leaders at GE HealthCare and Catalyze Healthcare. In the first segment, Ben Newton, General Manager of Oncology at GE HealthCare describes likely future advances in multimodal computing, which could parse diverse datasets from pathology, imaging, genomics and other domains to predict likely outcomes in given treatment scenarios. Newton also emphasized AI's ability to help overwhelmed physicians by alleviating workflow bottlenecks and assisting with point-of-care decision making. Despite the promise, he underscored that such advances rely on incorporating clinicians’ valuable perspective when developing these AI systems and partnerships with other industry stakeholders, such as cloud partners like AWS and academic centers or hospitals, to access data and create foundation models. In the second segment, Haley Schwartz, CEO at Catalyze Healthcare, highlights the potential of using AI for screening applications as an initial stepping stone to build trust and adoption. She also notes that potential headwinds for hospital adoption of AI are questions related to legal liability and reimbursement impacts. In addition, Schwartz emphasizes the importance of physician involvement, especially during the early stages of AI integration into healthcare. Join us for the next episode of DeviceTalks AI, featuring a keynote interview with Helen Merianos, Head of Sanofi’s R&D Portfolio Strategy. Thank you to our sponsors, some of whom include Catalyze Healthcare and SmartTRAK Business Intelligence, for providing invaluable support. www.catalyzehealthcare.com www.smarttrak.com Tune in and subscribe to DeviceTalks AI on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode. WATCH, LISTEN, and READ. Thank you for supporting DeviceTalks AI! Read Now: https://www.medicaldesignandoutsourcing.com/ai-holy-grail-devices-disease-digital-healthcare/ Watch Now: youtu.be/XtGbJ-2Jyro

In this podcast we’ll talk with two CEOs scaling tall Medtech mountains. First, co-hosts Chris Newsmarker and Tom Salemi chat with Jan De Backer, CEO of Fluidda, developer of a novel new diagnostic tool for respiratory health. De Backer explains how his company is trying to bypass hospitals and build a new commercial path to patients. Then, Salemi talks with Scott Nelson, CEO of FastWave Medical, an innovative new company developing a new intravascular lithotripsy device. How does the start-up intend to compete with market leader Shockwave Medical? Thank you for listening to this episode of the DeviceTalks Weekly Podcast Don’t miss a future episode. Subscribe to the DeviceTalks Podcast Network.