In this feasibility study, SurGuide has refined its go-to-market strategy, validated its business case and proceeded to the next step in product development.
For the go-to-market strategy, SurGuide has mapped and contacted key opinion leaders in oral cancer surgery. The innovation has been discussed with surgeons and pathologists from several European university medical centers. In these discussions, the exact needs were discussed. Overall, the reactions on our solution were very positive.
The major part of this project has been dedicated to business case validation, marketing and reimbursement. In collaboration with a business coach, SurGuide has evaluated the reimbursement system in France, United Kingdom and Germany. This work also enabled us to refine our existing knowledge about the Dutch healthcare system.
A clear overview has been made of the implications of MarginGuide on healthcare budgets and potential route to reimbursement in target countries. Furthermore, the impact on the quality of care and potential cost-effectiveness has been investigated. This gave clear information on the potential reduction of healthcare expenses, which formed the basis for our current pricing model. As a result of the business case validation, SurGuide has a clear vision for its marketing and sales plan in Europe.
As part of this study, SurGuide continued with product development. Several steps have been taken to reduce the costs of goods. As a result, a new prototype could be built that demonstrates functionality and design of the final product. With this prototype, we can easily discuss the actions needed for product finalization.
Alongside product development, a freedom-to-operate (FTO) analysis was performed. Results from the FTO showed no threats to our development. Together with a regulatory and medical affairs specialist, SurGuide has prepared the implementation of a quality management system. A clear report with timing and actions has been made.
As last, SurGuide has set-up a trial design for MarginGuide. This clinical validation is needed for CE-certification. During this project, SurGuide has defined potential product claims. In the future, these claims will be substantiated by means of clinical trials.
With the SME instruments phase I project, SurGuide has clearly defined the next steps to finalize the development and market entry in 2021
