Jacqueline Van Druten
CLIN-r+ Ltd,
United Kingdom
Abstract Title: The Future of Cardiology MedTech: Opportunities, Challenges, and Success Strategies
Biography:
Jacqueline van Druten (MICR.CIM.RD) is a seasoned healthcare professional with over two decades of experience, including extensive specialization in MedTech development planning, regulatory submissions, and medical clinical practice. Over the past seven years, her focus has been on leading MedTech development strategies and regulatory submissions, ensuring medical devices achieve CE marking under the stringent EU MDR framework. She has successfully guided the submission of high-risk devices, combining her deep understanding of clinical benefit, innovation profiles, and regulatory compliance. As the Clinical & Regulatory Affairs Director at CLIN-r+, Jacqueline spearheads clinical development planning workflows, including CEPs, CERs, and CDPs, along with post-market surveillance solutions such as PSURs, PMSRs, and SSCPs. Her leadership has enabled fast-track EU MDR submissions, streamlining the pathway for innovative medical devices to achieve regulatory clearance. Previously, as a Consultant Advisor at Elsevier, Jacqueline specialized in IVDR/MDR transitions, contributing to compliant technical documentation and biocompatibility evaluations (ISO 10993). Her ability to align technical, clinical, and market considerations ensures clients' MedTech innovations meet stringent safety and efficacy standards. Jacqueline’s expertise lies in translating clinical research into actionable strategies for MedTech manufacturers, enabling them to secure regulatory clearance, achieve market differentiation, and ultimately improve patient outcomes. Her passion for cardiology, critical care, and sustainability has led to measurable impacts across the healthcare industry. In addition to her professional achievements, Jacqueline has authored research publications, contributed to NICE guidance consultations, and shared her insights at global MedTech conferences, webinars, and podcasts. Her mission is to ensure that MedTech projects adhere to rigorous regulatory standards, delivering robust clinical evidence that supports innovation and enhances patient lives. A strong advocate for sustainability and health, Jacqueline integrates her knowledge of evidence-based nutrition and sustainable practices into her professional and personal life. With a unique blend of humor, transparency, and a big-picture perspective, she engages diverse audiences and fosters meaningful connections in every interaction.
Research Interest:
The cardiology MedTech landscape is evolving rapidly, driven by advancements in technology and heightened regulatory expectations. To succeed, innovators must strategically balance clinical impact, regulatory compliance, and payer expectations. This keynote offers a comprehensive blend of regulatory, clinical, and statistical planning insights, providing attendees with the tools needed to craft an effective Clinical Development Plan (CDP). Key topics will include strategies for aligning payer and patient benefit data with regulatory clearance assurance. The talk will explore how evolving technologies, such as Artificial Intelligence and emerging biomarkers and bio signals, serve as key drivers of future innovation. Usability, now a critical market differentiator, will also be discussed as an essential element for aligning product design with patient safety outcomes, enhancing both clinical effectiveness and market positioning. Attendees will gain actionable insights into harmonizing clinical and regulatory strategies, with a focus on employing advanced statistical approaches such as Bayesian modelling to optimize planning from concept to clinical application. The session will also delve into the evolving regulatory landscape, highlighting the changing expectations for validation testing, including biocompatibility, and the critical preparations required for longterm re-certification. This keynote will emphasize the importance of integrating data-driven insights with stakeholder needs to develop MedTech solutions that resonate with payers, patients, and regulatory bodies alike. By addressing challenges and opportunities at every stage of development, attendees will learn how to craft a CDP that ensures innovation, compliance, and successful market entry. With practical strategies and forward-looking perspectives, this session aims to inspire attendees to lead the next wave of impactful advancements in cardiology MedTech.