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!

How do I take an approved medical device to market? with YJ Oh, Edwards Lifesciences

Join host Richard Simmons on 'HEAL Security Dispatch Daily Digest' where we dive into the current intersection of healthcare and cybersecurity intelligence. Topics include the Microsoft's cybersecurity strategy overhaul led by Chief Information Security Officer Charlie Bell, Google's reversion of a recent reCaptcha update due to a bug affecting Firefox for Windows, a study revealing significant financial losses for U.S. businesses due to cyber activity, CISA and FBI's alert on path traversal vulnerabilities, the White House's new NSM focusing on critical infrastructure security, scrutiny faced by UnitedHealth Group's CEO over the Change Healthcare cyberattack, a 10-step roadmap for inclusive health chatbots from the University of Westminster, and recent advancements in cystic fibrosis treatments. Tune in to stay updated on the critical developments affecting our digital world. 
healsecurity.com

Securing Healthcare: Navigating Cyber Threats and Innovations

In this episode of DeviceTalks AI, we are joined by Ha Hong, PhD, Chief Artificial Intelligence Officer of Medtronic Endoscopy about integrating AI into Medtronic's endoscopy unit, the impact on healthcare outcomes, patient-centric design, and the future of AI in the medical device industry. Watch or listen to the episode to:

- Discover how Ha's research coincided with the rise of deep learning, a pivotal technology in modern AI, and how it shaped his work in emulating visual perception processing in the brain.
- Better understand Ha's instrumental role in developing the first FDA-approved AI-powered cardiac ultrasound guidance system, a groundbreaking innovation in cardiology.
- Learn about Ha’s move to Medtronic and his vision for integrating AI into endoscopy, highlighting the potential for AI to revolutionize gastrointestinal diagnostics and treatment.
- Gain insights into Ha's philosophy of patient-centric AI design, emphasizing the importance of prioritizing patient needs and safety in AI development for healthcare.

In the episode, we also sit down with Joe Mish, VP of Sales at SmartTRAK to better understand how SmartTRAK is using AI to enhance their market intelligence solutions, combining the traditional robust analysis with advanced algorithms for more nuanced, speedier insights in the medtech industry.

This conversation comes to you courtesy of our episode sponsor, SmartTRAK. To learn more about SmartTRAK, visit www.smarttrak.com.

Please subscribe to DeviceTalks AI on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode. 

Thank you for listening to DeviceTalks AI!

Medtronic Endoscopy's Chief AI Officer on Transforming Dx through AI and Patient-Centric Design

In this episode of StrykerTalks, we welcome back Andy Pierce, Group President of MedSurg and Neurotechnology, to discuss the impact of the Vocera acquisition and how Vocera's dynamic clinical workflow addresses staffing shortages and enhances efficiency. 

Additionally, the episode covers Stryker's new LIFEPAK 35 monitor/defibrillator, advancements in the 1788 visualization platform, and ongoing innovations in the neurovascular space. Pierce also touches on plans for incorporating Vocera into more Stryker products and the company's interest in soft-tissue surgical robotics.

Want more from Andy Pierce? Explore his previous appearances on the DeviceTalks Podcast Network.

Prior appearance on StrykerTalks:
https://www.devicetalks.com/pierce-talks-innovation-vocera-ascs-and-why-nurses-hug-strykers-neptune-waste-management-system/

Prior appearance on DT Weekly:
https://www.devicetalks.com/lobo-and-pierce-talk-wright-cool-tech-robotics-and-the-not-so-secret-plans-to-keep-stryker-growing/

Thank you to S2 Insight, Inc. for sponsoring this episode. To learn more about how S2 Insight, Inc. supports medical device companies, visit https://www.s2insight.com/case-studies. 

Thank you for listening to the StrykerTalks Podcast. 

Subscribe to the DeviceTalks Podcast Network so you don’t miss a future episode.

Stryker’s Pierce updates on Vocera, 1788, Neuro, & interest in soft-tissue surgical robotics system

In this episode of AbbottTalks, Matthew Fishler, PhD, Chief Engineer & Senior Director, Product Development, Cardiac Rhythm Management at Abbott Cardiovascular, shares his experience helping to develop the revolutionary dual-chamber leadless pacemaker system, taking us through the significant challenges and triumphs of creating a device that ensures precise coordination between the heart’s atrial and ventricular chambers without traditional leads. 

Fishler recounts the meticulous development process, from initial concept testing using rudimentary "submarines" in saline tanks to achieving FDA approval. He highlights the deliberate approach taken to ensure safety and effectiveness, resulting in a device that now benefits patients with more comprehensive cardiac support. Lastly, he explains the innovative i2i communication technology, which uses electrical impulses to enable seamless device interaction, a concept likened to a “moonshot” due to its unprecedented nature.

Thank you to ProMed for sponsoring this episode of AbbottTalks. To learn more about ProMed’s prototype services, visit: https://promedmolding.com/capabilities/prototyping/

Thank you for listening to the AbbottTalks Podcast. Tune in and subscribe to DeviceTalks on all major podcast channels to never miss an episode.

Abbott’s Fishler on Dual Chamber Leadless Pacemaker from “submarine” tests to FDA approval

In this episode of DeviceTalks AI, host Kayleen Brown sits down with Eigil Samset, PhD, General Manager for Cardiology Care at GE HealthCare. Dr. Samset takes us through his vast experience stretching over nearly three decades and discusses the transformative role of AI in advancing healthcare, particularly how GE HealthCare is leveraging AI to streamline and enhance cardiology care pathways. 

In the episode, Dr. Samset gives us the backstory of the 2023 Caption Health acquisition and provides insights into the inspiration behind Caption AI for use in Vscan, which democratizes cardiac assessments by making them accessible to less experienced users. The conversation touches on the regulatory challenges, the importance of multi-disciplinary collaboration, and GE HealthCare's strategic approach to integrating AI – aiming to improve patient outcomes and care pathways significantly.

This conversation comes to you courtesy of our episode sponsor, DeviceTalks West. Listen to the episode for 25% OFF the registration rate: West.DeviceTalks.com.

Please subscribe to DeviceTalks AI on all major podcast channels and subscribe to DeviceTalks on YouTube to ensure you never miss an episode.

Thank you for listening to DeviceTalks AI!

GE HealthCare’s Samset on how deal led to building Caption AI for Vscan and securing FDA approval

In this episode of AbbottTalks, Jennifer Jones-McMeans, PhD, Divisional VP of Global Clinical Affairs at Abbott and Brian DeRubertis, MD, Chief, Division of Vascular & Endovascular Surgery at Weill Cornell Medical Center tackle the complexities of treating peripheral arterial disease (PAD) below the knee, particularly chronic limb-threatening ischemia (CLTI), a severe form of PAD that drastically impacts patients' quality of life and longevity.

In the episode, the two discuss Abbott's Esprit BTK System, the first-and-only FDA-approved drug-eluting resorbable scaffold for infrapopliteal CLTI. Dr. Jones-McMeans explains how Esprit BTK works by releasing a drug that prevents artery re-narrowing, crucial for maintaining sustained blood flow and promoting wound healing. 

Later, they walk us through the pivotal LIFE-BTK trial, a significant milestone that demonstrated Esprit's efficacy and led to its FDA approval. They also highlight the importance of including diverse patient populations in clinical trials, particularly those disproportionately affected by PAD, such as African Americans, Latinos, Native Americans, and women. This inclusive approach not only ensures the treatment's effectiveness across varied demographics but also sets a precedent for future trials.

Thank you to Freudenberg Medical for sponsoring this episode of AbbottTalks. For more information on how Freudenberg Medical works with medical device companies, visit www.freudenbergmedical.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.

Abbott’s Jones-McMeans and Dr DeRubertis on PAD below-the-knee, LIFE-BTK trial & Esprit BTK approval

This episode is sponsored by Becton, Dickinson and Company (BD).

Sylvie Lombardi, senior R&D director at BD, discusses her journey in biomedical engineering and the rewarding impact her work has on physicians and patients in this episode of Diverse. 

Hear how Lombardi’s childhood dreams of becoming a doctor influenced her path in STEM, her advice for aspiring engineers in the medical technology space, and the growth opportunities that BD provided throughout her career.

Ep 287: Making an Impact in Medical Technology With Sylvie Lombardi of BD

This episode is sponsored by Becton, Dickinson and Company (BD).

Emma Quentin, vice president of urology critical care and surgery at BD, shares her inspiring journey from chemical engineer to global health care leader in this episode of Diverse.

In conversation with Larry Guthrie, director of content strategy at SWE, Quentin discusses the role curiosity plays in both engineering and leadership and the pivotal moments when others believed in her potential before she did. 

Hear how to overcome "superwoman syndrome," why leaders must prioritize the mental health of their teams, and advice for embracing imperfection and growth throughout your STEM career.

Ep 293: Curiosity, Courage, and Leading With Impact With Emma Quentin of BD

Mr. Kedziora is the co-founder of Estenda Solutions, a leading company specializing in custom software development, data analysis, and AI for healthcare and medical companies. With a remarkable journey spanning over 30 years, he possesses a deep understanding of designing, developing, and deploying successful projects. His extensive experience enables him to provide valuable guidance and innovative insights, resulting in cost-effective solutions that improve patient outcomes.

Mr. Kedziora received his M.B.A. from West Chester University and a Bachelor of Science in Computer Science from Duquesne University where he received the Excellence in Computer Science Award. He has spoken at numerous technical and healthcare conferences on a variety of topics and written or co-authored multiple articles focused on healthcare information technology, several published in peer-reviewed scientific journals. His work with clients has won multiple awards including a HIMSS Davies Award in 2017 and he recently received the Health 2.0 Outstanding Leadership Award.

RJ Kedziora, co-founder of Estenda Solutions

The Daily HEAL Security Dispatch Podcast is a leading source for up-to-the-minute news and deep insights in the realm of healthcare cybersecurity and threat intelligence. 

At the heart of HEAL Security's vision is the commitment to equipping organizations and individuals with rapid, contextually rich cybersecurity updates, establishing itself as a pivotal force in unifying practice and data against the ingenious tactics of criminal and malicious entities. HEAL Security is fervently devoted to constructing a robust resource and community that champions the defense of the healthcare sector against the growing cyber threats from organized crime groups and antagonistic nation-states. Our core focus encompasses the protection of vital IT infrastructures, the security of sensitive patient and clinical information, the safeguarding of critical healthcare systems, and the assurance of continuous, undisturbed patient care services.

Welcome to Diverse, a podcast by the Society of Women Engineers. SWE gives women engineers a unique place and voice within the engineering community. On Diverse, we highlight incredible thought leaders and personalities in the STEM community and discover who they are at home, at work and in between.

The Health Design Podcast brought to you by the Journal of Health Design(www.journalofhealthdesign.com). Features interviews with the world's leading health design experts including clinicians, designers, patients, authors and researchers. Better health by design.

The DeviceTalks Podcast Network delivers news, insights and commentary from MedTech industry leaders, primarily from the largest OEMs in healthcare. Our podcasts will inspire MedTech professionals to create better MedTech devices and companies.

Explore the DeviceTalks Podcast Network, home to more than 11 podcasts:

• DeviceTalks Weekly
• AbbottTalks
• Boston Scientific Talks
• DeviceTalks AI
• IntuitiveTalks
• MedtechWOMEN Talks
• MedtronicTalks
• Neuro Innovation Talks: J&J MedTech Neuro
• Structural Heart Talks: Edwards Lifesciences
• Ortho Innovation Talks: Zimmer Biomet
• StrykerTalks

WATCH our video podcasts on www.youtube.com/@DeviceTalks

Connect with the hosts:
Tom Salemi, Editorial Director, DeviceTalks https://www.linkedin.com/in/tom-salemi-7118948/
Kayleen Brown, Managing Editor, DeviceTalks https://www.linkedin.com/in/kayleenbrown/

Learn more about DeviceTalks - Podcasts • Conferences • Webinars - www.devicetalks.com

New tracks tagged #MedicalTechnology