Periodic Reporting for period 3 - TBMED (A testing bed for the development of high-risk medical devices)
Período documentado: 2022-01-01 hasta 2023-08-31
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.
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.
The TBMED consortium shaped the future OITB and defined internal processes and services to fulfill future customers’ expectations. In addition to the three case studies that were included initially in the project, four new case studies were included through open calls.
The partners provided services on market analysis, QbD, counselling sessions with experts, biomaterials synthesis and characterization, scale up and manufacturing process development, in-vitro and in vivo testing, and clinical trial design.
Additionally, different tutorials were produced and are available on the website (https://tbmed.eu) that include interesting information on Quality by Design, Tips on Health Technology assessment (HTA), a webinar on HTA and Risk analysis based on ISO 14971.
Finally, go.Med the commercial result of the project is live and can be found at https://gomed.tbmed.eu/
The partners provided services on market analysis, QbD, counselling sessions with experts, biomaterials synthesis and characterization, scale up and manufacturing process development, in-vitro and in vivo testing, and clinical trial design.
Additionally, different tutorials were produced and are available on the website (https://tbmed.eu) that include interesting information on Quality by Design, Tips on Health Technology assessment (HTA), a webinar on HTA and Risk analysis based on ISO 14971.
Finally, go.Med the commercial result of the project is live and can be found at https://gomed.tbmed.eu/
TBMED provides a customer validated (7 cases studies included) Open Innovation Test Bed -go.Med - specialized in the development of high-risk medical devices.
Within TBMED, 3 clinical studies were designed: A Clinical Proof of Concept for a spine surgery robot was completed, a post market study for a bone regeneration hydrogel is conducted in parallel in three clinical sites and two countries and finally, a third device was submitted for a Clinical Proof of Concept, a bone regeneration hydrogel to be used for sinus lift augmentation.
In addition, 3 new products were optimized (i) a new keratoprosthesis that is currently undergoing preclinical validation, (ii) a biodegradable membrane to be used for alveolar reconstruction and (iii) magnetic nanoparticles for hyperthermia treatment.
Furthermore, two in vitro diagnostics systems for COVID-19 were given regulatory advice to continue their path towards the market.
Finally, a SaaS platform is now available for the development of medical devices applying the Quality by Design (QbD) methodology (EasyQbD).
Within TBMED, 3 clinical studies were designed: A Clinical Proof of Concept for a spine surgery robot was completed, a post market study for a bone regeneration hydrogel is conducted in parallel in three clinical sites and two countries and finally, a third device was submitted for a Clinical Proof of Concept, a bone regeneration hydrogel to be used for sinus lift augmentation.
In addition, 3 new products were optimized (i) a new keratoprosthesis that is currently undergoing preclinical validation, (ii) a biodegradable membrane to be used for alveolar reconstruction and (iii) magnetic nanoparticles for hyperthermia treatment.
Furthermore, two in vitro diagnostics systems for COVID-19 were given regulatory advice to continue their path towards the market.
Finally, a SaaS platform is now available for the development of medical devices applying the Quality by Design (QbD) methodology (EasyQbD).