Between Innovation and Regulation A Study on New Product Development of Medical Devices

Abstract

The majority of medical device companies fail to generate sufficient returns for their investors and need more efficient, user-oriented, and faster New Product Development (NPD) processes while pressure from regulatory requirements is increasing. In Europe, the Medical Device Regulation has increased the regulatory burden for medical device companies, thereby prolonging the time to market for new devices. At the same time, user needs, regulations, and technologies are continuously changing, increasing the need for flexible, efficient and fast NPD processes. This thesis explores the NPD processes currently employed by medical device companies, the contemporary challenges they face, and the actions used to address these challenges in practice. The study places particular emphasis on fulfilling user needs and shortening time to market while maintaining regulatory compliance. The qualitative interview study is based on 29 semi-structured interviews with practitioners across 15 medical device companies and two consultancy firms active in the medical device sector.

The findings show that a hybrid model, where a governing stage-gate process is combined with agile elements and/or V-model logic between the gates, is the most common approach for NPD of medical devices. The six main challenges identified are: regulatory burden and extensive quality management system, environmental and organizational changes, securing and translating user needs, inefficient and short-term oriented prioritization processes, organizational and cultural barriers, and software-specific complexity. The thesis concludes that medical device companies can improve NPD through six practical recommendations: front-load before design control, organize for cross-functional execution to reduce time to market, keep the quality management system lean, be closer to users and observe behaviors, prioritize in a structured way and protect exploration, and assign responsibility and follow-up on deliverables. This study provides six practical recommendations for balancing innovation and regulation in NPD and for improving user-needs fulfillment and time to market without compromising compliance.