An interactive guide for clinical studies on medical devices

Purpose and goal

The objective of the platform is to provide custom-made feedback during all phases of a clinical investigation. As we face substantial regulatory changes that are expected to entry into force in Q2 2017, the need for regulatory guidance has increased further. The platform´s potential to achieve its ambitious purpose have been confirmed by the parties who have been introduced to the platform as part of this project. However, in order to verify the real value of the platform it must be placed on the market.

Expected results and effects

As the functionality of the platform now can be demonstrated, we have a good position for further business development. We can also refer to the feedback received from the parties that have been introduced to the platform, including the user experience obtained in the clinical pilot project. Currently we have a confidentiality agreement signed with a US based stakeholder and continued follow-up with a second stakeholder that we presented the concept for at the beginning of the project. Our hope is that some of these will act as a partner during the continuing work and launch of the platform.

Planned approach and implementation

The project has developed a beta version of the platform and introduced it to a number of parties. The development has involved a combination of internal and external resources, which has been crucial to get the right expertise and be able to work in parallel with various parts of the project. Other vital factors to be able to complete the project according to schedule has been that the key personnel (internal and external consultant) has been located in the same city and thus have been able to meet frequently, and that the external resources the project has been relying on have been available.