Human-Centred MedTech Design: Embedding Ethics, Law, and Social Values in Innovation

Recorded: February 24, 2026

Time: 11-12pm

Speakers: Katina Michael, Joseph Carvalko

Introduction: Professor Ross Vlahos

Convenor: Professor Evangelos Pappas Abstract: MedTech innovation is increasingly shaped by data-driven systems, AI-enabled decision support, and connected medical devices, raising ethical, legal, and social implications (ELSI) that directly affect trust, adoption, and scalability. For early-stage startups, these issues are often treated as downstream compliance risks rather than upstream design opportunities. Startups that design for ethics, law, and social impact early, build products that earn trust faster, navigate regulation more smoothly, and scale with fewer downstream risks. This presentation positions the embedding of ELSI into the MedTech design process from the outset as essential for building technologies that are safe, trusted, and investment-ready. Drawing on sociotechnical design, responsible innovation, and health governance perspectives, the presentation frames MedTech products as value-laden systems whose design choices influence accountability, equity, transparency, and patient agency. We propose a practical, design-integrated approach that supports founders in identifying and addressing ethical risks, regulatory expectations, and social context during ideation, prototyping, and iteration. This requires what is known as foresight planning. Key considerations include data stewardship, bias and fairness, explainability, responsibility allocation, and protections for vulnerable users. By shifting ELSI from a compliance checklist to a design capability, the presentation demonstrates how ethics is a driver of product quality, market credibility, and long-term impact, especially for complex MedTech innovations such as biomedical devices.

About the Speakers:

Katina Michael is the inaugural program director of the MBA (Technology and Digital Strategy) at The University of Sydney Business School. She is professor of Strategy, Innovation and Technology. She connects technical, policy, and public audiences, raising awareness of socio-technical challenges and how to address them through human-centered design. Joseph Carvalko Jr is an American technologist, academic, patent lawyer and writer. As an inventor and engineer, Carvalko has been awarded eighteen U.S. patents in various fields, including computer technology, biomedical, fuel purification, and financial systems. He has authored academic books and articles throughout his career. He is Chair Emeritus of the Technology and Ethics Working Group, Interdisciplinary Center for Bioethics, Yale University having led the group from 2019-2025.