The IBV is developing a methodology for the semi-automatic personalised design of implants and orthoses

The new Medical Device Regulation (EU) 2017/745, better known as MDR, has brought about the biggest change in the regulatory framework applicable to medical devices in the last 25 years, affecting all phases of their life cycle and all actors involved in their marketing. The complexity and stringent nature of the new requirements of this European regulation have created a major challenge for companies in the sector to bring their products into line with the new legislation .

Faced with this situation, the Instituto de Biomecánica (IBV) has developed the LIFEMED project, currently in its second year, to respond to the challenges currently facing the industry by addressing the entire life cycle of medical devices in order to generate new knowledge in relation to their design, verification, clinical evaluation, certification and post-marketing surveillance. To this end, it works with leading companies in the sector, both in terms of their track record and experience, and in terms of their innovative nature.

The improvement of current processes for the design and development of personalised orthoses and implants is one of the main lines of research of the project. Specifically, the IBV has developed a semi-automatic personalised design methodology that simplifies and streamlines the adaptation of the basic design of a medical device to the specific anatomy of the patient, while maintaining its main characteristics and operating principle. During the project, the methodology has already been validated for the design of wrist and arm orthoses and maxillofacial implants, and its application can be extended to other types of implants and orthoses.

According to Carlos Atienza, Director of the Health Market Area at the IBV, “this new methodology makes it possible to generate the design of a product in a semi-automatic way. The only input data required is the morphology of the patient’s area of interest, obtained by means of a 3D scan (for example, a scan of the arm or jaw), and a limited number of design parameters that can be adjusted according to the patient’s characteristics, the clinical assessment of the orthopaedic surgeon and/or the preferences of the designer or manufacturer of the product”.

Methodologies focused on increasing value for patients and companies

Another of the LIFEMED lines of research, focused on the verification phase of medical devices, has led to the creation of a new AI-based medical image segmentation methodology capable of automatically quantifying the amount of bone osseointegrated with a given implant. According to Atienza, “This new methodology significantly streamlines the procedures currently used to verify the effectiveness of osseointegration, and as such is a significant improvement for implant and coating manufacturers.

In order to improve the post-market surveillance of medical devices, we have also developed methodologies that make it easier for joint replacement manufacturers to monitor their products in patients with implants, allowing them to gather objective information about their performance with less effort. Specifically, they allow manufacturers and professionals to assess the correct postoperative functioning of patients’ knee prostheses in a non-intrusive way by using videos recorded by patients themselves, autonomously and in non-hospital settings, such as their homes. These methodologies can be extended to all types of joint prostheses, such as hip and shoulder replacements, etc., and represent an improvement for patients as well as for manufacturers and clinicians in that they provide objective information on the functionality and effectiveness of the prosthesis in a fast, simple and economical way.

Collaboration with leading companies in the sector

The LIFEMED project has been developed in collaboration with companies known for their track record and experience in the medical device sector. These include SURGIVAL, BIO-VAC ESPAÑA, FRESDENTAL, Especialidades Médico Ortopédicas (EMO) and CELESTICA VALENCIA.

The participation of these companies “enhances the identification of needs and adds particular value to the transfer of the results of this research to the business community and actors in the sector, as well as to society in general, given that this is a project of particular relevance due to its impact on the health sector”, concluded Atienza.

Finally, the LIFEMED project is supported by the Department of Innovation, Industry, Commerce and Tourism of the Autonomous Government of Valencia, through the IVACE+i programme, and receives funding from the European Union through the FEDER Community of Valencia 2021- 2027 Programme (IMDEEA/2024/15).