Standardizing the patient-specific medical device design process via a paper-based pro-forma

Purpose/audience: this study targets designers, clinicians and biomedical engineers who are involved in digital surgical planning and patient-specific medical device design, either in hospitals, universities or companies. A commonly accepted, standardized design process does not exist in this specialized but highly variable field, and this can make regulatory compliance via the implementation of quality standards more difficult. Methodology/approach: an article-based design pro-forma was created based on needs identified in previous work. It was structured in order to broadly standardize the design process; consolidate planning and modelling behaviours into discrete clusters; anticipate decision-making on key product requirements; facilitate focused discussion with clients (surgeons); create a pleasurable experience for the designer; and encourage detailed reporting of design decisions and therefore to lower barriers to Quality Management System (QMS) implementation and adherence. The performance of the pro-forma was verified using observation, simultaneous verbalization and semi-structured interviews. Three participants across two contexts were observed designing without and then with the pro-forma. Their behaviours and comments were recorded, their designed outcomes evaluated and their quality compliance assessed. Findings: The design workflow was shown to be segmented and contained within distinct and repeatable steps when using the pro-forma. Reported participant confidence increased and stress decreased. Contact time between participants and clients was consolidated. Designed outputs and documented records successfully complied with generaliz-able aspects of the International Organization for Standardization (ISO) 13485 standard. However, it did not, and by definition could never, wholly implement a complete certifiable QMS, which must be tailored to a specific organization. Implications for practice, society or research: as demand for patient-specific devices continues to rise, and as regulatory requirements about QMS adherence extend to cover all contexts, organizations will need to react accordingly. This pro-forma offers a clear direction for how to introduce evidence-based best practices, and a starting point for full QMS certification. Originality/value: this research marks the first attempt to standardize this highly specialized design process across users, tools and contexts.