LARA Diagnostics- a new methodology for dignostics of peripheral nerve injury
| Reference number | |
| Coordinator | KUNGLIGA TEKNISKA HÖGSKOLAN - KTH Centrum för teknik i medicin och hälsa |
| Funding from Vinnova | SEK 1 000 000 |
| Project duration | December 2013 - November 2015 |
| Status | Completed |
Purpose and goal
The purpose and goal of the project was to develop a medical device ready for production, develop a intellectual property strategy and file a patent application, carry out technical and clinical validation and to initiate a CE certification process. The project also aimed to further analyze and verify the market and establish a suitable organisation and business model. The majority of the goals have been achieved but due to delays in technical development the clinical trials have not been carried out as planned, instead they will be carried out during 2016 together with CE certification.
Expected results and effects
Apart from the delays in the technical development, the project has progressed well and according to plan with considerable mitigation. Today there are no known obstacles in reaching the market. The product launch is expected to take place in spring 2017, finally contributing to a better and more efficient care of patients with peripheral neuropathy. During the project the market conditions for the product has improved and new products within the same field has been launched on the American market. This further confirms both the need and the business opportunity.
Planned approach and implementation
The setup and implementation of the project have progressed in the expected order. The project has been delayed due to product development and unforseen technical challenges now resolved. The duration of the project has been prolonged due to technical development but has also been more cost efficient. Most of the goals have been achieved and the results strengthen the project. Enough verification and risk mitigation have been attained for a clear road towards the medical device market.