Compliance Driven Modularization: Developing Medical Device Programs based on Modular Platform Architectures

Within the medical domain, manufacturers are challenged with the ability to manage the growing complexity of the regulatory environment while handling the inherent complexity of their product programs. Meanwhile, manufacturers experience a constant increasing demand for launching divergent new medical device variants while public authorities require extensive compliance for new medical device developments and medical devices already launched to the marketplace, which accelerates the pressure on medical manufacturers.

Although, case examples in literature point towards the opportunity for advancing the research area of modularization consider regulatory and compliance matters, a comprehensive literature study by this research found that although significant research has been carried out on modularization, little to no emphasis has been on modelling the regulation and compliance aspects from a modularization point of view.

By applying a mixed research methods approach, reviewing existing theories and by conducting multiple case studies in industry, this thesis explores the concept of compliance driven modularization. This research suggests that medical device manufacturers should concurrently view their product program considering both product and compliance aspects.

In continuation hereof, the research of this thesis suggests the use of the so-called Compliance Architecture Concept Exploration (CACE) tool. This modelling tool emphasizes analysis and synthesis of the product variants based on a concurrent product and compliance view of the medical device program.

The CACE tool offers four uses that support analyzing the program for rationalization and synthesis for new medical device variant creation. Namely, the tool enables (1) traceability and prioritization by analyzing change and effect between the market and program design, (2) discrepancy analysis based on the Delta-Domain Mapping Matrix (ΔDMM), (3) the ability to create and evaluate a modular platform architecture based on compliance driven modularization, and (4) a structural approach to evaluate new medical design proposals – all by its ability to approach the program design from a product and compliance point of view.

An explanatory case study revealed that by applying the CACE modelling tool, a company can gain substantial competitive advantages. In the specific case example, a program of arterial blood gas samplers was analyzed and a proposal for a new modular platform architecture was made using the CACE tool.

Evaluating of the outcome, it was found that the company would achieve significant reduction in resource consumption, lower time-to-market, and higher probability of success, when acting upon the findings of applying the CACE modelling tool.