A methodology to assess sustainability in medical device design

Abstract

The medical device design and development process is highly interdisciplinary and complies with stringent regulatory requirements and safety standards to de-risk the product. Medical device designers generally give considerable attention to functional, performance, and safety requirements during development, while sustainability takes the backstage. In this thesis, we have developed a methodology to incorporate sustainability in medical device development. We offer a set of sustainability evaluation criteria to assess design concepts and develop mitigation strategies to improve the design. A case study on a surgical guide was carried out to demonstrate the usefulness of this methodology. A mini-Delphi study with eight design experts was conducted in Singapore to evaluate the methodology's benefit, effectiveness, interpretability, comprehensiveness, and usability. The results suggest that the methodology is comprehensive and beneficial to the designers in identifying and developing sustainability-impacting design elements and making informed design decisions in incorporating sustainability at the early stage of the medical device design process.