Abstract:

The medical device industry faces stringent regulatory challenges, particularly under the EU Medical Device Regulation (MDR), which have compelled firms to streamline product portfolios. This paper proposes a hierarchical multi-criteria model to evaluate medical device product portfolios in light of these challenges. The model was developed through analysis of recent market impacts of MDR and refined via expert consultations in the field. It comprises four main criteria – regulatory complexity, market potential, strategic significance, and sales model adaptability – broken down into 21 specific sub-criteria for comprehensive assessment. The results offer a structured decision-support tool that helps companies identify which products to retain, invest in, or phase out, balancing compliance demands with business strategy. The model contributes a practical framework for portfolio optimization under regulatory pressure, and the paper discusses its implications, limitations, and the path for future validation through methods like AHP and real-world case studies.