A11. Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices
Tracks
Medical Devices Regulation Summit
| Tuesday, June 3, 2025 |
| 1:30 PM - 2:30 PM |
| C2.2+C2.3 |
Chair & Speakers
Yervant Chijian
Director, MedTech Services
PharmaLex
Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices
Abstract
As innovation progresses rapidly within the medical device sector, regulatory sciences face the dual imperative of harmonizing global frameworks and addressing emerging technologies such as artificial intelligence/machine learning (AI/ML) and quantum computing. This panel session will explore three critical topics:
Global Convergence of Regulatory Frameworks: We will examine advancements and challenges in the alignment of international regulatory pathways, supported by case studies including the ASEAN Medical Device Directive (AMDD) and the International Medical Device Regulators Forum’s (IMDRF) initiatives. These efforts aim at creating a unified regulatory environment that can facilitate smoother deployment of medical devices across different jurisdictions, thus ensuring faster access to innovative healthcare tools globally.
AI/ML-Based Medical Devices: The session will address the complexities involved in regulating adaptive and continuously evolving systems. The discussion will highlight the unique challenges posed by AI/ML technologies, such as ensuring transparency, maintaining safety standards, and providing continuous monitoring and validation of AI systems. Participants will learn about the regulatory strategies employed to manage these challenges and how they can be applied to other AI/ML medical devices.
Regulatory Preparedness for Quantum Computing: We will investigate the potential impacts of quantum technologies on medical devices and assess the adequacy of current regulatory frameworks using predictive analytics in imaging and genomics. Quantum computing promises dramatic improvements in data processing speeds and capabilities, which could revolutionize fields like medical imaging and genetic sequencing. However, its integration into existing regulatory frameworks remains an open question, and this session will delve into foresight strategies to anticipate and mitigate potential issues.
We invite participants to engage in discussions on these case studies, propose practical solutions, and explore how global collaboration can effectively address emerging challenges in regulatory sciences. By fostering an interdisciplinary dialogue, we hope to identify pathways that can support the safe and efficient introduction of cutting-edge technologies into the healthcare system, ultimately benefiting patients worldwide.
Global Convergence of Regulatory Frameworks: We will examine advancements and challenges in the alignment of international regulatory pathways, supported by case studies including the ASEAN Medical Device Directive (AMDD) and the International Medical Device Regulators Forum’s (IMDRF) initiatives. These efforts aim at creating a unified regulatory environment that can facilitate smoother deployment of medical devices across different jurisdictions, thus ensuring faster access to innovative healthcare tools globally.
AI/ML-Based Medical Devices: The session will address the complexities involved in regulating adaptive and continuously evolving systems. The discussion will highlight the unique challenges posed by AI/ML technologies, such as ensuring transparency, maintaining safety standards, and providing continuous monitoring and validation of AI systems. Participants will learn about the regulatory strategies employed to manage these challenges and how they can be applied to other AI/ML medical devices.
Regulatory Preparedness for Quantum Computing: We will investigate the potential impacts of quantum technologies on medical devices and assess the adequacy of current regulatory frameworks using predictive analytics in imaging and genomics. Quantum computing promises dramatic improvements in data processing speeds and capabilities, which could revolutionize fields like medical imaging and genetic sequencing. However, its integration into existing regulatory frameworks remains an open question, and this session will delve into foresight strategies to anticipate and mitigate potential issues.
We invite participants to engage in discussions on these case studies, propose practical solutions, and explore how global collaboration can effectively address emerging challenges in regulatory sciences. By fostering an interdisciplinary dialogue, we hope to identify pathways that can support the safe and efficient introduction of cutting-edge technologies into the healthcare system, ultimately benefiting patients worldwide.
Biography
Yervant Chijian is a seasoned RA/QA consultant specializing in Medical Device regulatory compliance, helping clients achieve efficient market access in major global markets. With over 20 years of experience in the Medical Device industry, Yervant has a strong background in both manufacturing and product development. His expertise encompasses Regulatory Strategic Planning and submissions across key regions, including the United States, Europe, Canada, and Australia. He is particularly skilled in Product Development and Design Controls for software medical devices (SaMDs/SiMDs) as well as a wide range of diagnostic, AI/ML-enabled, imaging, and active devices. Coupled with his experience in Manufacturing Processes, Quality Management Systems (ISO 13485 and MDSAP), and Product Lifecycle Management equips him with a comprehensive skill set to guide clients through diverse regulatory pathways and requirements.
Dr Orin Chisholm
Program Director, PMDD Programs
University Of Sydney
Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices
Abstract
As innovation progresses rapidly within the medical device sector, regulatory sciences face the dual imperative of harmonizing global frameworks and addressing emerging technologies such as artificial intelligence/machine learning (AI/ML) and quantum computing. This panel session will explore three critical topics: Global Convergence of Regulatory Frameworks: We will examine advancements and challenges in the alignment of international regulatory pathways, supported by case studies including the ASEAN Medical Device Directive (AMDD) and the International Medical Device Regulators Forum’s (IMDRF) initiatives. These efforts aim at creating a unified regulatory environment that can facilitate smoother deployment of medical devices across different jurisdictions, thus ensuring faster access to innovative healthcare tools globally. AI/ML-Based Medical Devices: The session will address the complexities involved in regulating adaptive and continuously evolving systems. The discussion will highlight the unique challenges posed by AI/ML technologies, such as ensuring transparency, maintaining safety standards, and providing continuous monitoring and validation of AI systems. Participants will learn about the regulatory strategies employed to manage these challenges and how they can be applied to other AI/ML medical devices. Regulatory Preparedness for Quantum Computing: We will investigate the potential impacts of quantum technologies on medical devices and assess the adequacy of current regulatory frameworks using predictive analytics in imaging and genomics. Quantum computing promises dramatic improvements in data processing speeds and capabilities, which could revolutionize fields like medical imaging and genetic sequencing. However, its integration into existing regulatory frameworks remains an open question, and this session will delve into foresight strategies to anticipate and mitigate potential issues. We invite participants to engage in discussions on these case studies, propose practical solutions, and explore how global collaboration can effectively address emerging challenges in regulatory sciences. By fostering an interdisciplinary dialogue, we hope to identify pathways that can support the safe and efficient introduction of cutting-edge technologies into the healthcare system, ultimately benefiting patients worldwide.
Biography
Orin is the program director for the postgraduate programs in Pharmaceutical and Medical Device Development at the University of Sydney. She has academic appointments with UNSW and Arizona State University, USA. Orin has previously spent many years in industry roles and is a consultant in regulatory affairs. She is on the Board of the Association of Graduate Regulatory Educators (USA) and on the editorial advisory committee for the Regulatory Affairs Professionals Society (RAPS) in the USA. Orin received the Organisation for Professionals in Regulatory Affairs (TOPRA), UK award for excellence in regulatory education in 2017; became a Senior Fellow of the Higher Education Academy (UK) in 2018 and was elected a Fellow of RAPS in 2021. Her research focuses on regulatory science, workforce development and pharmaceutical policy.
Dr Lakshmidevi Balakrishnan
Hon. Lecturer
Sydney Pharmacy School, University of Sydney
Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices
Abstract
As innovation progresses rapidly within the medical device sector, regulatory sciences face the dual imperative of harmonizing global frameworks and addressing emerging technologies such as artificial intelligence/machine learning (AI/ML) and quantum computing. This panel session will explore three critical topics: Global Convergence of Regulatory Frameworks: We will examine advancements and challenges in the alignment of international regulatory pathways, supported by case studies including the ASEAN Medical Device Directive (AMDD) and the International Medical Device Regulators Forum’s (IMDRF) initiatives. These efforts aim at creating a unified regulatory environment that can facilitate smoother deployment of medical devices across different jurisdictions, thus ensuring faster access to innovative healthcare tools globally. AI/ML-Based Medical Devices: The session will address the complexities involved in regulating adaptive and continuously evolving systems. The discussion will highlight the unique challenges posed by AI/ML technologies, such as ensuring transparency, maintaining safety standards, and providing continuous monitoring and validation of AI systems. Participants will learn about the regulatory strategies employed to manage these challenges and how they can be applied to other AI/ML medical devices. Regulatory Preparedness for Quantum Computing: We will investigate the potential impacts of quantum technologies on medical devices and assess the adequacy of current regulatory frameworks using predictive analytics in imaging and genomics. Quantum computing promises dramatic improvements in data processing speeds and capabilities, which could revolutionize fields like medical imaging and genetic sequencing. However, its integration into existing regulatory frameworks remains an open question, and this session will delve into foresight strategies to anticipate and mitigate potential issues. We invite participants to engage in discussions on these case studies, propose practical solutions, and explore how global collaboration can effectively address emerging challenges in regulatory sciences. By fostering an interdisciplinary dialogue, we hope to identify pathways that can support the safe and efficient introduction of cutting-edge technologies into the healthcare system, ultimately benefiting patients worldwide.
Biography
Olivia Reeves
Director, Device Specialist Evaluation Section
TGA
Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices
Abstract
As innovation progresses rapidly within the medical devices sector, regulatory sciences face the dual imperative of harmonising global frameworks and addressing emerging technologies such as artificial intelligence/machine learning (AI/ML) and quantum computing. This panel session will explore three critical topics:
Global Convergence of Regulatory Frameworks: We will examine advancements and challenges in the alignment of international regulatory pathways, supported by case studies including the ASEAN Medical Device Directive (AMDD) and the International Medical Device Regulators Forum’s (IMDRF) initiatives. These efforts aim at creating a unified regulatory environment that can facilitate smoother deployment of medical devices across different jurisdictions, thus ensuring faster access to innovative healthcare tools globally.
AI/ML-Based Medical Devices: The session will address the complexities involved in regulating adaptive and continuously evolving systems. The discussion will highlight the unique challenges posed by AI/ML technologies, such as ensuring transparency, maintaining safety standards, and providing continuous monitoring and validation of AI systems. Participants will learn about the regulatory strategies employed to manage these challenges and how they can be applied to other AI/ML medical devices.
Regulatory Preparedness for Quantum Computing: We will investigate the potential impacts of quantum technologies on medical devices and assess the adequacy of current regulatory frameworks using predictive analytics in imaging and genomics. Quantum computing promises dramatic improvements in data processing speeds and capabilities, which could revolutionise fields like medical imaging and genetic sequencing. However, its integration into existing regulatory frameworks remains an open question, and this session will delve into foresight strategies to anticipate and mitigate potential issues.
We invite participants to engage in discussions on these case studies, propose practical solutions, and explore how global collaboration can effectively address emerging challenges in regulatory sciences. By fostering an interdisciplinary dialogue, we hope to identify pathways that can support the safe and efficient introduction of cutting-edge technologies into the healthcare system, ultimately benefiting patients worldwide.
Global Convergence of Regulatory Frameworks: We will examine advancements and challenges in the alignment of international regulatory pathways, supported by case studies including the ASEAN Medical Device Directive (AMDD) and the International Medical Device Regulators Forum’s (IMDRF) initiatives. These efforts aim at creating a unified regulatory environment that can facilitate smoother deployment of medical devices across different jurisdictions, thus ensuring faster access to innovative healthcare tools globally.
AI/ML-Based Medical Devices: The session will address the complexities involved in regulating adaptive and continuously evolving systems. The discussion will highlight the unique challenges posed by AI/ML technologies, such as ensuring transparency, maintaining safety standards, and providing continuous monitoring and validation of AI systems. Participants will learn about the regulatory strategies employed to manage these challenges and how they can be applied to other AI/ML medical devices.
Regulatory Preparedness for Quantum Computing: We will investigate the potential impacts of quantum technologies on medical devices and assess the adequacy of current regulatory frameworks using predictive analytics in imaging and genomics. Quantum computing promises dramatic improvements in data processing speeds and capabilities, which could revolutionise fields like medical imaging and genetic sequencing. However, its integration into existing regulatory frameworks remains an open question, and this session will delve into foresight strategies to anticipate and mitigate potential issues.
We invite participants to engage in discussions on these case studies, propose practical solutions, and explore how global collaboration can effectively address emerging challenges in regulatory sciences. By fostering an interdisciplinary dialogue, we hope to identify pathways that can support the safe and efficient introduction of cutting-edge technologies into the healthcare system, ultimately benefiting patients worldwide.
Biography
Olivia holds Bachelors degrees in both Science and Systems Engineering, specialising in molecular biology and mechatronics, alongside a Masters of Applied Cybernetics from the Australian National University. Olivia has extensive experience within both the TGA in the regulation of high risk medical devices, and the Digital Transformation Agency with a focus on enabling better digital services delivered by government.
She is currently a director in the Medical Devices Authorisation Branch, responsible for the team that assesses the safety and efficacy of medical device software, including those incorporating AI and ML.
