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A testing bed for the development of high-risk medical devices

Periodic Reporting for period 1 - TBMED (A testing bed for the development of high-risk medical devices)

Reporting period: 2019-01-01 to 2020-06-30

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.
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 4-year 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).
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 are being developed:
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 4/5)
c) Hyperthermia treatment for colorectal cancer, based on magnetic nanoparticles and alternating magnetic field. (TRL 3/4 )
The OITB is being developed during the course of the project and will become a commercially available platform after the project’s end, 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.
In this first period, TBMED has developed all the technical an organizational processes that will be followed once the OITB is functioning. A possible administrative and legal structure has been defined and an in-depth market analysis has been performed, taking into account the general trends worldwide as well as the specific characteristics of the European market. The market has been segmented by therapeutic areas and specific niche markets have been found to have the necessary potential as entry markets for the OITB. A competitor analysis is ongoing.
At the same time, TBMED helped the use cases to achieve their objectives while using Quality by Design (QbD) concepts. All use cases were assessed using a Quality Product Target Profile which was then used as a basis to develop their models further by finding their Critical Quality Attributes and Process Parameters. This increase of knowledge regarding the product and the process is already providing an increase in quality, and is helping the more advanced devices such as Glycobone® and the Keratoprosthesis to build the arguments to demonstrate real benefits. Based on the case studies, a user friendly virtual platform specially designed to be applied in the development of medical devices is generated (easyQbD), that will help in the future to apply this methodology in the development of other medical devices.
Additionally, the first safety clinical study is under preparation and will be submitted for approval shortly. Regarding costs, the use of structured Design of Experiments (DoEs) help to minimize the redundancy between tests, causing a direct impact on the development costs.
TBMED (and the future OITB) covers the whole value chain to transform highly innovative MDs from TRL4 to TRL7 to up-scale and develop new high-risk (≥Class IIb) devices. TBMED aims to become a one-stop shop for MedTech companies providing open access at fair conditions to European companies, specially SMEs, and non-EU players interested in testing facilities to ensure compliance with EU regulatory frameworks for their export products to Europe.
TBMED’s potential impact is to provide a cost-effective, innovative service that will bring safe healthcare MDs in compliance with EU safety regulations to the market with a reduced development time, thanks to an earlier determination of the safety profile and the facilitation of subsequent pre-clinical and clinical testing. The reductions on time and costs cannot be quantified yet, however, it is expected to achieve the order of a 30% reduction.
There are also substantial indirect benefits for European citizens' safety and access to new and innovative medical products:
• Better healthcare systems in terms of delivery, outcomes, and reduced costs (thanks to improved and less expensive therapies, better therapy results, lower invalidity rates).
• Better and potentially more personalised therapies, resulting in better quality of life for patients (less side effects, better therapy outcome, which is quite relevant for cancer patients and also blind people).
• A better understanding of the manufacturing processes, which will help on their optimization generating more ecological-friendly processes.
• Generation of qualified employment.