Life Sciences In Focus podcast takes a reflective turn. Instead of welcoming a new

guest, hosts Karen Tkaczyk and María Mateos sit down for a holiday special to look

back at the conversations that shaped 2025 and to share what they see on the

horizon for 2026. Their discussion offers a warm, candid look at the themes, people,

and ideas that defined an eventful year in life sciences.

00:00 - Welcome to the holiday special

0:44 - Themes from 2025 webinars and podcast episodes

01:30 - Amplifying patient voices and engaging non English speakers

02:46 - Clinical research insights with Jonathan Gardo

03:28 - Regulatory trends and expert conversations

05:27 - Mentorship in regulatory affairs with Angelina Lisa

07:59 - Therapeutic area spotlight, ophthalmology in 2025

11:59 - Looking ahead to 2026 and closing reflections

About Life Sciences - In Focus

Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.

About Vistatec

We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com

Social Media:

LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

Regulatory expert Andrei Ninu joins Host María Mateos in this episode of Life Sciences - In Focus to discuss one of the most complex challenges facing the medical device industry today: navigating the dual requirements of the EU Medical Device Regulation (MDR) and the newly enacted EU AI Act.Ninu, who specializes in functional and software safety, as well as AI applications in healthcare, offered a practical and grounded perspective on what these overlapping regulations mean for manufacturers, particularly those developing AI-powered medical technologies.00:00 - Meet Andrei Ninu: Regulatory Expert in AI and Medical Devices01:41 - MDR vs. EU AI Act: Understanding the Dual Compliance Landscape03:59 - Why 80% of MDR Documentation Helps with AI Act Compliance08:11 - AI Model Training10:45 - Compliance Tips for Small and Mid-Sized MedTech Companies14:35 - Real-World Example: Data Partitioning and Clinical Relevance19:58 - Going Beyond Accuracy: Metrics that Truly Matter in AI Evaluation25:03 - Final Advice: Engage Early with Notified Bodies for SuccessAbout Life Sciences - In Focus Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.About Vistatec We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.comSocial Media:LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

Host Karen Tkaczyk speaks with Michael Young, Principal and Founder of biomedwoRx, for a rich discussion that blended personal history, professional insight, and a forward-looking take on the industry. Michael’s career spans over three decades in the life sciences, and his path reveals not only technical expertise but also a deep sense of mission.From First-Generation Roots to Global StrategyMichael describes himself as mission-driven, and that thread runs through his story. Raised in Ohio by immigrant parents, his mother a practicing OB-GYN and his father a structural engineer, he was encouraged toward professional excellence from the start. At Kenyon College, he pursued both English and biochemistry, setting the foundation for what would become his lifelong goal: communicating science in ways that improve patient outcomes.That dual focus on science and communication has shaped his work across patient advocacy, clinical development, and now his consultancy, biomedwoRx.00:00 - Welcome and Guest Introduction00:37 - biomedwoRx and the origin story prompt01:43 - Immigrant roots, assimilation, and voice03:13 - Dual major at Kenyon, mission to communicate science05:11 - Global launches, 22 NCEs, and AI platform work06:56 - Strategy across the product lifecycle and LOE planning09:29 - Cultural competence in practice, translation pitfalls16:18 - JEDI in clinical trials, diversity as better scienceAbout Life Sciences - In Focus Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.About Vistatec We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.comSocial Media:LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences