Arturo Gómez Pellín1, José Francisco Pedrero Sánchez1, Salvador Pitarch Corresa1, María Francisca Peydro de Moya1, Carlos Atienza Vicente1y2, José Luis Peris Serra1y2, Giuseppe Caprara1
(1) Instituto de Biomecánica (IBV) Universitat Politècnica de València (Edificio 9C) Camino de Vera s/n (46022) Valencia (Spain)
(2) IBV’s Healhcare Technology Group. CIBER in Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN)
The Instituto de Biomecánica (IBV) is setting up an innovative service for the biomechanical functional assessment and monitoring of daily activity that will make it possible to know the progress of patients with knee prostheses. This service will provide the manufacturers of medical devices with objective and relevant clinical information on the functioning of their products, which will strengthen their post-market surveillance systems. In addition, this service will benefit hospitals by allowing them to objectively measure the effectiveness of their procedures and rehabilitation treatments, thus helping them improve the resource management.
INTRODUCTION
The new European regulation on medical devices (EU) 2017/745 that will become effective as of May 2020 considerably increases the requirements that the manufacturers of medical devices must meet. In particular, one of the aspects that has been toughened with respect to the previous regulatory approach is the post-market surveillance system. Manufacturers will be required to collect and analyze data on the quality, performance and safety of each product throughout their life cycle in an active and systematic manner.
On the other hand, public health care is being questioned due to the continuous increase in the spending. Currently, 80% of the specialized health resources are allocated to meet the care needs of only 20% of the patients treated. This situation brings to light the need to promote a profound transformation in the way health resources are managed, mainly how the impact and effectiveness of clinical procedures are currently measured.
Figure 1. Biomechanical test for gait assessment in a patient with a knee prosthesis
In this context, the IBV is developing a new technological service of biomechanical functional assessment and monitoring of the patient's daily activity based on new technologies to objectively and easily measure the functional progress of a patient with a knee prosthesis (Figure 1). This service will make it possible to respond to the problems that both sectors face:
– It will allow medical device manufacturers to have objective and relevant clinical information on the functioning of their products by recording the functional activity of the patients who wear them.
This tool reinforces the post-market clinical follow-up of the companies, which will help them to meet the demanding new regulatory requirements for the introduction and maintenance of their products in the market and provide them an essential competitive and innovative advantage to continue facing a highly competitive market in constant evolution.
– Heath centers will be able to objectively measure the effectiveness of the health procedures they perform, significantly contributing to a better management of their resources, and promoting the definition of new and more sustainable healthcare processes.
The outcomes project has a duration of three years and involves implant companies from the Valencian Community: Surgival, Industria Médica Alicantina and NelaBioDynamics, as well as the La Fe Polytechnic University Hospital and the General University Hospital of Valencia, which are collaborating in the validation of the tool.
DEVELOPMENT
The service, which is being developed within the outcomes project, includes three levels to monitor the patient's activity over time. This makes it possible to know the patients whose implants are correctly functioning, and those who show functional problems, which will require more exhaustive monitoring and, if necessary, corrective actions to prevent the failure of the prosthesis (Figure 2).
Figure 2. Biomechanical test to assess the movement of going up and down a step in a patient with a knee prosthesis.
The first level involves monitoring the daily activity of the patient (24/7) using portable technologies such as a mobile phone or an actigraph, and advanced algorithms developed by the IBV. This makes it possible to obtain a large amount of information on the patient without performing a laboratory assessment or an evaluation by a healthcare professional, which means cost savings for both the public health system and patients, who know that their clinical progress is correct and do not have to visit the doctor (Figure 3).
Figure 3. Service that is being developed within the framework of the outcomes project to monitor the performance of patients with knee prostheses.
The second level includes simplified biomechanical tests performed at the doctor’s office. Currently, biomechanical tests are performed in sophisticated laboratories using photogrammetry systems for the kinematic study, and dynamometric platforms to record the reaction forces. One of the innovative objectives of the outcomes project is to bring these technologies and procedures to the examination rooms through portable technologies and simplified measurement procedures. This is possible thanks to the use of advanced techniques of analysis and machine learning that allow us to combine the power of laboratory methodologies and measurement systems with the portability, versatility and low cost of inertial sensors.
The third level consists of tests performed in biomechanical laboratories that will allow us to characterize the functional status of the patient in more detail. This is especially useful when a clinical problem has been detected in the patient and a detailed examination of all the biomechanical parameters that characterize the behavior of a knee prosthesis is needed.
Currently, the IBV is conducting two clinical studies in collaboration with La Fe Polytechnic University Hospital and the General University Hospital of Valencia with patients who had a knee prosthesis surgery. Such studies use the different technologies and procedures described to assess the functional progress of these patients from the preoperative phase up to 12 months after the procedure. These studies will make it possible to:
– Demonstrate the sensitivity and efficacy of biomechanical functional assessment techniques to monitor the progress of patients with knee prostheses, comparing them with the current reference standard, which are the clinical scales and questionnaires based on the patient perception and manual clinical examination.
– Analyze the variables that assess the effectiveness of knee prosthesis procedures, as well as rehabilitative treatments, which will help to define more efficient and sustainable healthcare processes.
– Generate a clinical monitoring report for medical device manufacturers which evaluates the functioning of their knee prostheses from a biomechanical functional point of view compared to other products on the market (Figure 4).
Figure 4. Monitoring of the patient's daily activity through portable technologies.
The completion of the clinical studies is scheduled for the end of the year 2020, from which point the service will be available to medical device manufacturers and hospital centers. From then on, the service is expected to include other medical devices such as hip, spine and shoulder implants.
CONCLUSIONS
As a result of the outcomes project, medical device manufacturers will have a new service that will allow them to monitor the performance of their devices based on the recording of the patient's functional activity, which will help to meet the requirements of the new European regulation on medical devices and offer an innovative marketing tool to stand out from the competition.
In addition, hospital centers will have a tool that will allow them to evaluate the effectiveness of their procedures and rehabilitative treatments and help them to define efficient and sustainable healthcare processes.
Finally, it is important to highlight that the funding with regional and European funds for research, development and innovation projects, makes it possible to transform knowledge into an innovative service in our community that generates wealth and quality jobs.
ACKNOWLEDGEMENTS
The companies that cooperate in this project:
• SURGIVAL CO. S.A.U.
• NELA BioDynamics S.L.
• INDUSTRIAL MÉDICA ALICANTINA S.L.
Since 2018, the outcomes project (Ref. IMDEEA/2019/20) has been funded through the grants from the Valencian Institute for Business Competitiveness (IVACE), 50% co-funded by the European Union through the European Regional Development Fund (ERDF).
