There are more than 33,000 medical technology companies in Europe, 95% of which are SMEs. These companies need to demonstrate not only safety and performance over the entire life cycle of a product, but also tangible benefits for the patients and the healthcare system.
Since the Medical Device (MD) sector is highly innovative, with an average lifecycle per product of 18-24 months, this scenario represents several challenges, especially for high-tech SMEs.
TBMED is a close to 5 years project coordinated by CIDETEC Nanomedicine that received funding from the European Union’s Horizon 2020 research and innovation programme. Its aim is to increase the access of high-risk medical devices to patients, by helping SMEs to minimize the market approval and reimbursement process time, optimizing the process of transforming a prototype (TRL4) into a valuable innovative MD (TRL7).
TBMED was set out to establish an Open Innovation Test Bed (OITB) consisting of a connected network of labs providing a single-entry point to services along the whole value chain, from preclinical development to clinical testing, based on Quality-by-Design (QbD).
The objectives of the service platform are:
a) Increase the quality and reduce the risk of MDs and facilitate subsequent clinical testing
b) Build the arguments to demonstrate real benefits (value/final outcomes) of the new devices to increase their success in entering the market
c) Reduce cost and variability of the manufacturing process and the speed of product release to the market by carrying out statistically DoE for process validation.
In order to develop the platform 7 case studies were included in the project.
The OITB was developed during the course of the project and became a commercially available platform after the project’s end, providing services in areas such as technology development, business support and financing.
