TB-MED

The European MedTech sector has around 27.000 companies, 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.

Being the MD’s sector a highly innovative one, with an average lifecycle per product of 18-24 months, this scenario represents several challenges, especially for high-tech SMEs.

TBMED is a 4-year-long project coordinated by CIDETEC Nanomedicine that has 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 will 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).

Fig. 1 Services covered by TBMED.

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, 3 use cases in different TRL stages will be used:

a) Keratoprosthesis: a biocompatible and flexible synthetic cornea (TRL 3)
b) Glycobone: an injectable ready-to-use hydrogel tailored for oral bone defect reconstruction to be developed for 2 different indications (TRL 4/6)
c) Hyperthermia treatment for colorectal cancer, based on magnetic nanoparticles and alternating magnetic field. (TRL 3/4 )

The OITB will be developed during the course of the project and will become a commercially available platform after the project is finished providing services in areas such as technology development, business support and financing.

A consortium consisting of 5 Research groups, 5 SMEs, 1 industry and 2 hospitals, all of them with significant track record in knowledge creation and innovation in their respective domains, guarantee the successful implementation of this project and the creation of the OITB as a separate legal entity afterwards.