Objectives

TBMED is an EU-funded collaborative research project which aims to increase patients’ access to high-risk medical devices, by helping SMEs to minimize time-to-market and the reimbursement process time, thus optimizing the process of transforming a prototype into a valuable innovative MD.

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. The entire process is based on a Quality-by-Design (QbD) concept.

The objectives of the project are:

• Increase the quality and reduce the risk of the MDs and facilitate subsequent clinical testing
• Build the arguments to demonstrate real benefits (value/final outcomes) of the new devices to increase their success in entering the market.
• Reduce cost and variability of the manufacturing process and the speed of product release to the market by carrying out statistically designed experiments for process validation.