102nd Meeting of the EURO Working Group in Multiple Criteria Decision Aiding

Designing What to Assess in Safe and Sustainable by Design (SSbD): A Governed Pathway Builder for Healthcare

Not scheduled

20m

Siemens Auditorium (HIT E 51) (ETH Zürich)

Discussion Paper

Speaker

Marco Cinelli (Leiden University)

Description

The European Commission's Safe-and-Sustainable-by-Design (SSbD) framework formally distinguishes a (re)design phase from assessment. In practice, however, SSbD efforts — including those emerging in healthcare — tend to start from a pre-selected shortlist of options and focus on evaluating them, rather than on structuring how options are generated and governed. This can lead to narrowly framed choices and technology lock-ins, not unlike the way premature optimisation in system design can entrench architectural decisions that are costly to reverse.
This contribution presents the development of the Pathway Builder, a governance-aware morphological methodology developed within the EU IHI ENKORE project (https://enkoreecohealthcare.eu/), designed to fill this gap. The tool operates across three analytical levels: a macro level scoping the lifecycle architecture and organisational domains; a meso level structuring design levers and their options into a morphological design space; and a micro level integrating stakeholders’ governance mapping and multi-type constraints (technical, regulatory, organisational, operational) to prune infeasible combinations and produce a portfolio of governed, assessment-ready pathways.
The methodology will be tested across five real-use cases spanning medical devices and packaging materials — including single-use injection devices, dialysers, and associated packaging — implemented as a spreadsheet-based prototype. Even conservative parameterisation yields a large combinatorial space; constraint-based pruning delivers a manageable portfolio that respects sterility, compliance, and logistical boundaries while making explicit which stakeholders must be involved at each decision point.
Rather than selecting optimal designs, the Pathway Builder structures transparent, implementable pathways that can subsequently feed life cycle, risk, or SSbD assessment workflows — concretely bringing the design back into SSbD practice.