Medical Device Design-Lifecycle Management and Sustainability

Professor, Mechanical Engineering
Aristotle University of Thessaloniki

"Academia Perspective of Sustainable Medical Devices Devices"
Sustainability is rapidly becoming a defining requirement for medical devices, reshaping how academic research and education define high quality design across the full lifecycle, from concept generation and material selection to manufacturing, clinical use, servicing, and end of life. This presentation frames sustainability as a multi objective design problem in which environmental targets must be balanced with safety, performance, usability, regulatory compliance, and cost. Research informed approaches are highlighted for embedding sustainability into design requirements and decision processes, including lifecycle thinking, circularity strategies, and design for X methods adapted to healthcare constraints such as sterility, infection control, traceability, and risk management. Emphasis is placed on material and process choices, reusable versus single use systems, packaging impacts, and the role of digital tools, including data, simulation, and AI assisted design, in quantifying trade offs early and transparently. Additional focus is given to selecting meaningful sustainability indicators and integrating them into verification and validation planning, supplier engagement, and evidence generation. The discussion concludes with priorities for collaboration between academia, industry, healthcare providers, and regulators to accelerate measurable footprint reductions while maintaining patient safety and clinical value.

Bio: Dr. Nikolaos Michailidis is Professor and Director of the Physical Metallurgy Laboratory (PML), School of Mechanical Engineering, Faculty of Engineering, Aristotle University of Thessaloniki (AUTH), Greece and Chair of the Centre for Research & Development οn Advanced Materials – a Joint initiative between TEES and AUTH. He served as Research Professor at Texas A&M University (2018-2024), Materials Science and Engineering Department. He is Board Member of the Federation of European Materials Societies (FEMS), Deputy Board Member of Space Partnership Association for the Competitiveness of Europe (S.P.A.C.E) AISBL (S.P.A.C.E AISBL), and co-founder of PLiN Nanotechnology S.A. (AUTH’s spin-off). He is Fellow of the International Academy for Production Engineering (CIRP), Fellow of International Academy of Engineering and Technology (AET), Editor-in-Chief of the European Journal of Materials by Taylor & Francis and FEMS, Scientific Coordinator of Megaproject 1: Advanced Materials and Manufacturing, Thessaloniki International Technology Center (ThessINTEC), and member of various Scientific Societies and Boards. Served as President of the Hellenic Metallurgical Society (2016-2022), Chair of the Scientific Committee of EUROMAT 2019, Chair of the 73rd CIRP General Assembly ‘24, 18-24 August 2024, Thessaloniki-Greece, and Chair of the 14th European Aeronautics Science Network (EASN) “Innovation in Aviation and Space towards sustainability today & tomorrow”, Thessaloniki-Greece, 9-11 October 2024. He serves as Director of the Interdepartmental Post Graduate Studies Program: “Processes & Technology of Advanced Materials” - AUTH), steering committee member of the Interdepartmental Post Graduate Studies Program: “Biomedical Engineering” at AUTH and Coordinator of the Dual Master’s Program on “Design and Manufacturing of Sustainable Medical Devices”, between AUTH and TAMU. He was Visiting Professor at Fraunhofer Institute for Production Technology (IPT), Aachen-Germany (2008-2009). His research interests include: Additive Manufacturing, Advanced Materials and Composites, Nanotechnology, Biomaterials & Bioengineering, Porous Materials, Coatings and Inspection. 

Nuclear Engineer
Pacific Northwest National Laboratory

"The use of Simulation for Life Cycle Management of a Medical Device"
Simulation tools can be used to aid in the design and development of medical devices. One such tool developed by Pacific Northwest National Laboratory (PNNL) includes PUFFIn (PENELOPE User Friendly Fast Interface). PUFFIn, is designed as a fast and simple Monte Carlo simulation tool for the transport of photons and electrons that can operate with very little compute power making it accessible to a larger audience of technicians, engineers, and scientists. Simulation can be used at all stages of product development to ensure that the design of the device including the materials and packaging meet sterilization requirements. Simulation should be used in the design stage to make sure the proposed materials can be adequately sterilized. A three-dimensional dose map of the proposed product can be created to determine areas of concern that can be addressed prior to the manufacturing of the product. Packaging can be analyzed to ensure proper dose to the product and optimize the amount of packaging. Simulations can be used to show all participants in the product lifestyle that the proper requirements are met.

Bio: Randolph Schwarz is a nuclear engineer working for Pacific Northwest National Laboratory. He is the developer of the PUFFIn simulation software. He has worked both in private industry and in the government developing Graphical User Interfaces for nuclear applications for the past 30 years.  Randolph has an M.S. from the University of Washington in Nuclear Engineering and a second M.S in Computer Science from Washington State University.

CEO
RESBED

"CEO Perspectives on Medical Device Sustainability & Lifecycle Management"
Sustainability and lifecycle management are emerging as strategic priorities for medical device companies navigating evolving regulatory expectations, environmental responsibilities, and market demands. From a CEO perspective, sustainable device innovation must balance environmental stewardship with profitability, operational efficiency, and shareholder value. While sustainability initiatives emphasize design for durability, responsible material selection, supply chain optimization, energy efficiency, and end-of-life management, executive leadership must simultaneously address financial performance, market competitiveness, and return on investment often creating tensions between long-term sustainability goals and short-term business metrics. This perspective examines how CEOs integrate environmental, economic, and patient-centered value across the medical device lifecycle from concept development and manufacturing to clinical use and disposal while managing trade-offs between sustainability investments and core business objectives. It also explores the influence of regulatory frameworks from organizations such as FDA & EU, stakeholder expectations, and circular economy principles in shaping corporate strategy. By aligning sustainability initiatives with financial and operational performance, healthcare leaders seek to drive long-term value creation while advancing healthcare system resilience and environmental responsibility.

Bio: Jeff Summers is growth-focused executive leader in the medical device industry. He is an experienced Med Tech veteran with 30 years of medical device experience across all disciplines, including Executive Management roles as President, as well as Operations, Engineering, and Quality/Regulatory in Class II and Class III medical devices across the cardiovascular, vascular access, general hospital, ophthalmology, and cosmetic surgery markets. He specializes in navigating novel ideas from product development into successful commercialization and sales and is skilled in building and maintaining high performing leaders and teams, focused on growth and profit acceleration. He is currently the CEO of RESBED, a Med Tech start-up, with prior experience as the President of Quest Medical. He serves on Engineering Advisory Boards at both Texas A&M University and Rice University. He maintains advisory positions with TMC Innovation Factory and as an adjunct Professor of Innovation at ENMED, both located in the largest medical center in the world in Houston, Texas.

Chief Scientist for Materials Aging & Detection
Pacific Northwest National Laboratory

"Opportunities for Medical Device Sustainability"
Large volumes of single-use plastic waste are generated in healthcare facilities each year. Significant contributions to the embodied energy in each device include materials and energy of manufacture, packaging, transport, and sterilization. Medical devices present special challenges for reuse and recycling like privacy, decontamination, logistical, and regulatory hurdles that may not exist for products in other industries. Design of devices and packaging with manufacturing, sterilization, and end of life in mind can enable real reductions in total chemical, material, and energy use. Designing products for sterilization versatility, for example, can enable selection of optimal sterilization method based on market factors that may change after the device is in production. The U.S. Department of Energy’s National Nuclear Security Administration Office of Radiological Security is funding Team Nablo, an international industry collaboration, to reduce education and data gap barriers to the use of electron beam and X-ray accelerator technologies as alternates to radioisotope-based cobalt-60 gamma radiation for medical device sterilization.

Bio: Leo Fifield is a Chief Materials Scientist at the Pacific Northwest National Laboratory in Richland, Washington, where he manages the Materials Aging and Detection Science Laboratory. His research seeks to understand effects of composition and exposure history on material properties. Through the U.S. Department of Energy-funded Team Nablo, he partners with industry collaborators to overcome barriers to use of electron beam and X-ray technologies for medical device sterilization.

Professor of Practice Biomedical Engineering
Texas A&M University

Bio: Dr. Saurabh Biswas brings more than two decades of combined experience in medical technology innovation, technology commercialization and venture investment around medical device innovations.  He is presently Professor of Practice in the Department of Biomedical Engineering and Executive Director Technology Transition at Texas A&M Engineering. His primary interests are design and development of medicals devices in cardiology, neurovascular and pulmonary health. He has also served in various leadership roles at Texas A&M University System over last 20 years as Executive Director of Commercialization, Director of New Ventures where he led all aspects of new venture creation, investments in start-ups, translational programs and technology transfer.  He also leads the Texas A&M NSF I-Corps Innovation Hub and has been a key participant in the National Innovation Network from its inception in 2012. He is Senior member of National Academy of Inventors, holds 24 patents and co-founder of five health care startups where he has served in management roles at formation as CEO & CTO.  He holds a PhD in biomedical Engineering and completed the Executive Program in Finance from Sloan School at MIT.