Certified Specialist Programme in Biomedical Device Planning
Published on June 27, 2025
About this Podcast
HOST: Welcome to our podcast, today I'm thrilled to be joined by Dr. Samantha Jones, an expert in Biomedical Device Planning and the lead instructor for the Certified Specialist Programme in Biomedical Device Planning. Dr. Jones, welcome! GUEST: Thank you for having me! I'm excited to be here. HOST: Let's dive right in. Can you share your experiences working in this field and how it led you to create this course? GUEST: Of course. I've been a biomedical engineer for over 15 years, and I've seen firsthand how crucial it is to have a solid understanding of design control, risk management, and regulatory pathways. I wanted to create a programme that would equip professionals with these essential skills. HOST: That's fantastic. And speaking of essential skills, what are some current industry trends that are especially relevant to your course? GUEST: There are a few key trends. First, the increasing focus on personalized medicine, which poses unique challenges in device design and regulation. Second, the growing importance of digital health technologies, such as wearables and AI-powered devices, which require new approaches to risk management and clinical evaluation. HOST: Those are fascinating developments. Now, what are some challenges that professionals might face when learning or teaching this subject matter? GUEST: One challenge is the ever-evolving regulatory landscape. It can be difficult to stay up-to-date with the latest rules and guidelines. Another challenge is the interdisciplinary nature of biomedical device planning. Engineers, regulatory affairs professionals, and product managers need to work together closely, which requires strong communication and collaboration skills. HOST: Absolutely. As we look to the future, what do you see as the most significant opportunities and challenges in this field? GUEST: The biggest opportunity is the potential for biomedical devices to transform healthcare and improve patient outcomes. However, this also presents challenges, such as ensuring the safety and efficacy of these devices and navigating complex regulatory requirements. HOST: Dr. Jones, thank you so much for sharing your insights and giving us a glimpse into the Certified Specialist Programme in Biomedical Device Planning. It's clear that this course will provide valuable knowledge and skills for professionals in this exciting and rapidly evolving field. GUEST: Thank you for having me! It's been a pleasure discussing these important topics with you.
