The feasibility assessment has been developed using the Strategic Business Planning Methodology. This methodology has allowed Medfield to progress from the clinical development strategy to the finalisation of the financial and commercialisation targets aligned with an overall business development strategy of the company. The data collected has provided valuable insights into the current trends and opportunities on the market, activities undertaken by the competitors and the recent clinical development results.
Identification of suitable clinical centers to the multicenter is ongoing. Our goal is to enroll at least 3 centers per country in the countries we have planned to launch in and that not has been involved in our earlier studies (i.e. Denmark, Finland, Germany, France, Spain, Italy and Belgium). We aim for well-known and highly scientifically respected centers in respective indication.
Algorithm data collection
Once the device is CE-certified, a med-tech company usually sets up a large-scale, international study to confirm the solutions´ effectiveness in the target medical indication. Afterwards, the CE-certificate can be extended. Medfield Diagnostics has decided to follow this strategy. Thus, Medfield Diagnostics plans to CE certify the MD100 with a performance to detect intracranial haemorrhage 20 ml or larger in 2019 (TBD). The CE-certificate will facilitate conducting the international study that is planned to verify MD100’s capacity to exclude small intracranial bleedings and to validate usability and evaluate safety in a prehospital and hospital setting. After the study, we will apply for extending the claim for our CE-certificate.
Claims/indication verification
To support the device road map to go from model R5 to R6 the claim “Differentiate stroke from healthy persons, detect bleedings >2 ml” needs to be verified. Two large-scale, multicentre clinical trial to gain sufficient clinical data to justify the claim that the MD100 can detect intracranial bleedings 5 ml or smaller need to be conducted. Medfield aim to sponsor and conduct the studies. As such, the clinical trials will deliver the clinical evidence required for a largescale deployment and
commercialization of the MD100:
- Build a patient measurement database to improve and verify the diagnostic precision
- Validate the usability and safety of the device in the prehospital acute stroke and trauma care chain
- Get acceptance from European KOLs within hyper-acute stroke and trauma care
Reference database
A reference database will be built from data acquired during the two clinical trials. The database will be used as training data for the MD100 machine learning algorithm to detect intracranial bleedings. Thereafter, the MD100 system (hardware + software algorithm) will be verified for use as a decision support in a prehospital and hospital settings.
