OUTCOMES. Development of a support tool for after-sale clinical monitoring of knee prosthetics for medical device manufacturers
Development of a support tool for medical post-market surveillance of knee prosthesis for medical device manufacturers based on ongoing monitoring and biomechanical functional evaluation.
The OUTCOMES_2 project is the second year of a three-year project performed by the knowledge application areas of Body Systems Biomechanics and Human Functions. Specifically, this involves lines of research into clinical indicators (clinical outcomes) and functional evaluation.
Results obtained in previous projects:
The study carried out by IBV in 2018 in the OUTCOMES_1 project enabled wide-ranging knowledge to be gained about procedures for clinically assessing patients with knee prosthesis, biomechanical variables that best detect changes in how they are working, and about the use of inertial sensors technology and the development of algorithms to treat the recorded signals and analyse data that enables such variables to be calculated.
Objectives of the project:
The OUTCOMES_2 project aims to give companies that manufacture medical devices a support tool for medical post-market surveillance of their devices, enabling them to have objective, relevant clinical information about their safety and how well the devices are working. This tool will also enable medical organisations to have objective information about the outcome of their operations, which is essential in making strategic decisions when managing healthcare resources.
To do so, research and development will continue into simple procedures for ongoing monitoring and biomechanical functional evaluation, which may be used as clinical indicators about the state of the lower limb of a patient with knee prosthesis.
The outcomes expected from this second year (OUTCOMES_2) are grouped together as follows:
1. Definition of the structure and content of the clinical report’s proof of concept in keeping with the requirements of the participating companies.
2. Definition and set up of the procedures to record the biomechanical functional activity of patients treated with knee prosthesis via:
a. Traditional methods.
b. Ongoing monitoring.
c. Simplified biomechanical tests.
3. Results from the experimental study, which include:
a. Analysis of the sensitivity of the different technologies used.
b. Analysis of the most relevant variables to check on the progress of patients with knee prosthesis.
4. Validation of the clinical report’s proof of concept by the participating company.
In May 2020 the new European Regulation (EU) 2017/745 on medical devices came into effect. This new regulatory context is intended to strengthen the requirements and controls that such devices must comply with to be allowed onto the market, thereby ensuring European citizens’ safety.
The numerous changes that medical device manufacturers must address in their post-market surveillance system include the need to monitor their devices based on clinical evaluations throughout their lifecycle.
In this context, the OUTCOMES project’s intentions are:
1. To give companies in the Valencia Community region that manufacture medical devices a support tool for medical post-market surveillance of their devices, enabling them to have objective, relevant clinical information about their safety and how well they are working. This tool is intended to significantly help comply with the new, demanding regulatory requirements so as to introduce and maintain their products on the market, while also giving them a competitive, innovative edge that is essential to continue to thrive in a market that is constantly evolving and highly competitive such as the one for medical devices.
2. To give the healthcare industry new technological tools to objectively measure the effectiveness of medical operations that significantly help to take more advantage of healthcare resources and help define new, more sustainable processes for medical assistance within the Valencia region.
This project also responds to the initiative by the ICHOM (International Consortium for Health Outcomes Measurement) in its mission to develop clinical indicator metrics mostly suited to patients with osteoarthritis of the knee throughout the whole period of medical assistance.
This type of initiative opens up possibilities to compare the behaviour of prosthesis more globally, allowing specialists to learn from each other and thus improve clinical assistance for the patient.
Participants and collaborating companies
SURGIVAL CO. S.A.U.
NELA BioDynamics S.L.
INDUSTRIAL MÉDICA ALICANTINA S.L.
Duration and reference no.
Start date: 01-01-2019
End date: 31-12-2019
Project reference no.: IMDEEA/2019/20
Project (IMDEEA/2019/20) funded by the 2019 programme of aid from the Valencia Institute of Business Competitiveness (IVACE) aimed at technological centres in the Valencia Community region to carry out R&D projects of a non-economic nature in cooperation with companies.