Enabling Reuse of Documentation in New Medical Device Development: A Systematic Architecting Approach

Medical device companies are continuously challenged with the ability to prove compliance with increasingly complex regulatory frameworks. Operating under heavy regulatory requirements may therefore cause significant delays to the lead time of new medical devices and thus contribute significantly to time-to-market for even simple medical device development projects. In this paper we illustrate how medical device companies can reduce their research and development (R&D) efforts needed to prove compliance when developing new product families by means of platforming and modularization. The results presented in this paper are based on a two-year empirical case study of a European manufacturer of arterial blood gas (ABG) sampling devices. The core contribution of this paper is a systematic architecting approach that applies the concept of a delta-multi-domain matrix (ΔMDM) to support companies in justifying the reuse of verification and validation (V&V) test documentation packages across new product family designs. The paper introduces an approach to aligning product and documentation architectures by architecture mirroring, and emphasizes the need for having a one-to-one mapping between the product and V&V test view. This will allow for V&V-related documentation to follow the product platform, and thereby enable carry-over of test documentation packages from one product family to another. Hence, this approach can provide significant competitive advantages to companies as it increases R&D efficiency while reducing time-to-market for new medical device development.