Anchoring of skullbone at open skull surgery

Purpose and goal

The project´s purpose was to develop and commercilize a new, innovative device for cranial fixation: Cranioplug. The goals have been achieved on strategy, regulatory, IP and market-related matters. Design development has been delayed and led to delays also in process development and clinical. Thus, the time plan is pushed forward while the results of other activities in the project mean that the potential of the project over time is maintained.

Expected results and effects

The Cranioplug project has contributed importantly to the development and documentation of the technology and organization, eg by establishing OSSDSIGN´ technology with regulatory authorities and a basis for clearance of subsequent files, eg OSSDSIGN Cranial in USA Jan 2017. Cranioplug is important in the neurosurgery strategy. As the first off-the-shelf product, it complements OSSDSIGN´s existing patient-specific implants and is a tool for growing sales and building customer relations. OSSDSIGN has gone from 7 to 25 employees during the period.

Planned approach and implementation

* In-depth market verification done among international neurosurgeons. * Development plan in place and updated through project. Tollgate development model introduced during project. * Product characterized and validated. * Regulatory plan carried out. Cranioplug has 510(k) clearance in USA and CE in EU. ISO 10993-studies completed. * A histological study with exciting results will be submitted to a scientific journal 2017. * Patent on Cranioplug, eg in USA. * The finalization of the design has been difficult and led to delays in commersialisation.