Objectives

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

TBMED strove 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. The entire process was based on a Quality-by-Design (QbD) concept, which introduces quality assessment as early as possible in the product lifecycle (design phase). If used properly, a QbD approach can help address issues early in the product development process and prevent failures at an advanced state of development.

The objectives of the project were:

• 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.