| Abstract [eng] |
The innovation landscape for medical device manufacturers in the European Union has undergone significant changes since the introduction of the European Union Medical Device Regulation (EU MDR) in 2021. While open innovation practices offer strategic advantages in fostering technological advancement and agility, the need for compliance presents significant barriers to their practical implementation in small and medium-sized enterprises (SMEs). This study examines the interplay between open innovation and MDR compliance through a qualitative single-case study conducted at Spiegelberg GmbH, a Germany-based SME in the medical device industry. The firm specializes in developing and manufacturing neurosurgical devices, operating across more than 70 countries, and is representative of innovation-driven, internationally active SMEs navigating strict regulatory environments. The study's methodology employs semi-structured interviews across multiple functional departments and utilizes thematic analysis to interpret the data. As a result, five major themes emerged: Regulatory burden and innovation constraints, Market access challenges and regulatory risks, Internal organizational adaptations, External collaboration barriers, and Strategic and ethical reflections. Further subcode analysis revealed that documentation complexity, opportunity costs of compliance, and innovation fatigue are dominant internal barriers. At the same time, market access is hindered by regulatory misalignment across multiple markets and bottlenecks imposed by notified bodies. Internally, organizations face a steep learning curve in terms of regulations and fragile knowledge-sharing networks. Externally, selective openness and limited absorptive capacity hinder effective collaboration. Strategic reflections show contradictory insights on balancing innovation needs with regulatory expectations. The findings highlight a systemic misalignment between the iterative, rapid nature of open innovation and the methodological requirements of MDR compliance. SMEs are increasingly internalizing innovative activities to manage regulatory risks. However, structured frameworks that integrate external collaboration with robust compliance strategies can enable firms to retain agility while ensuring adherence to regulatory standards. This study contributes to the growing discourse on innovation management in regulated industries and offers practical recommendations for SME’s seeking to harmonize open innovation practices with compliance obligations. |
