How to certify custom-made orthopedic insoles? Here is the solution

The growing focus on individual well-being and injury prevention has led to an increased demand for custom-made orthopedic insoles. However, not everyone may be aware that the use of orthopedic insoles that are not specifically certified together with safety footwear can compromise the validity of the certification as Personal Protective Equipment (PPE).

To overcome this problem, Utility Diadora, together with the start-up Medere, has developed a service for the production of custom-made insoles that are fully compliant with regulations. Thanks to a free and intuitive web app, partner companies are offered a fast and efficient service for the production of certified custom-made insoles, directly in-house and without the need for external travel.

Data collection (photos and videos) is just a technical upload phase and is guided, simple, and secure. No health or technical skills are required on the part of the operator performing the scan: the system has been designed to be accessible and compliant for everyone to use.

 To explore the topic further, we asked the key players involved in the initiative a few questions. Giorgio Pira, Global Sales Director at Diadora Utility; Giorgio Salvetti, End User Sales Manager & P.P.E. Trainer Europe at Diadora Utility; and Marco Mannisi, founder of Medere, provided their responses.

Is the proposal for customized orthopedic insoles only for those with specific problems, or could it be of interest to all workers in order to improve comfort and prevent any musculoskeletal problems related to the type of work?

Giorgio Pira: “In the professional sphere, the use of insoles that are not certified by the manufacturer compromises the validity of safety shoes as Personal Protective Equipment, exposing workers and companies to legal and health risks. The proposal developed by Utility Diadora in collaboration with Medere stems from a concrete need: to offer all workers, not only those with specific pathologies, the possibility of using manufacturer-certified, custom-made orthopedic insoles to improve daily comfort and posture and promote the prevention of musculoskeletal disorders. If there is a medically certified condition, an insole certified as a medical device is made. If there is no prescription but there are still issues that affect working conditions, a custom-made comfort insole can still be created that does not alter the PPE certification of the footwear and will be useful for specific problems that generic insoles cannot solve”.

How did the idea for the app come about and how does it work, particularly with regard to data collection?

Giorgio Salvetti: “The web app was created to respond to the growing demand for custom-made orthopedic insoles, including for use at work, offering an innovative and fast alternative to the traditional clinical process, which is often complex, lengthy, and difficult to access. Together with Medere, we have developed this intuitive and free tool that allows the necessary data to be collected directly in the workplace in just 15-20 minutes, without requiring any technical or medical expertise.

It is very simple to use: all you need is a smartphone and a sheet of A4 paper. Guided by video tutorials, the user takes six photos and records a short video for each foot, using the A4 sheet to check the correct foot size. The Web App verifies the quality of the data shared with internal processes that eliminate the possibility of error. The data, automatically sent to the Medere team, will be used for the analysis phase and the subsequent 3D processing and modeling of the insole based on the morphology of the foot, the medical prescription, and the results of the specific analysis”.

How is compliance with PPE regulations ensured?

Giorgio Pira and Giorgio Salvetti: “The system is based on the strict application of the new EU Regulation No. 2017/745 (MDR), which introduced significant changes to the rules governing the manufacture and marketing of medical devices. Each certified insole is made to a valid medical prescription and its construction is entrusted to a specialized team that includes orthopedic technicians and biomedical engineers.

The process involves the preparation of an individual technical file for each insole, validation by the orthopedic technician, and the manufacturer’s signature. A Declaration of Conformity is also issued, certifying that the device has been manufactured in full compliance with the parameters of the Medical Device Regulation. All documentation, including the medical prescription, is archived for at least ten years, as required by law.

Medere certified insoles are compatible with most Diadora Utility models, for which full integration between the orthotic and the shoe has been verified. In this way, the footwear retains its PPE certification even when fitted with a customized insole. The entire process, from data collection via the Web App to delivery of the insole, has been designed to comply with every regulatory step and ensure maximum safety for the end user”.

What materials are used to make custom insoles?

Marco Mannisi: “Medere insoles are made of TPU (thermoplastic polyurethane), a material selected for its advanced biomechanical properties. TPU guarantees:

• high flexibility, which allows dynamic adaptation to the phases of the step;

• mechanical and wear resistance, even under prolonged use;

• controlled elastic return, useful for supporting propulsive thrust and absorbing impact with the ground;

• biocompatibility, important for reducing skin risks or allergic reactions.

Each insole is designed with a customized internal geometry (thickness, density, and reinforcement zones) based on the morphology of the foot, the biomechanical needs of the user, and the type of task performed. This allows us to offer an ideal balance between comfort, support, and protection, actively contributing to the prevention of musculoskeletal injuries and improving overall ergonomics. The material used is tracked and validated in the technical file in accordance with the requirements of Regulation (EU) 2017/745”.

When was Medere founded and who are its founders? What expertise do they have in the biomedical and regulatory fields?

Marco Mannisi: “Medere was founded in 2018 by a group of biomedical engineers and researchers with a clear vision: to bring digital customization to the world of medical devices. The founders have expertise in:

• CAD design and parametric 3D modeling;

• applied biomechanics and gait analysis;

• medical 3D printing and certified additive manufacturing;

• regulatory compliance and technical file development according to MDR.

The team has collaborated with public research centers, hospitals, universities, and companies in the orthopedic sector, including the Istituto Superiore di Sanità, the Politecnico di Milano, and the Vivitop network. In addition, Medere draws on the expertise of external partners for the management of legal, intellectual property protection, and regulatory aspects. This network of expertise has enabled Medere to develop a solid, multidisciplinary approach that combines technology, clinical practice, and regulatory requirements in a single platform. The focus has always been on the end user, with the aim of offering truly effective, safe, and certified devices”.

When is the official launch of the project scheduled?

Giorgio Salvetti: “The service is already up and running. Interested companies can contact Utility Diadora to find out who their local distributor is. No investment in equipment, licenses, or complex training courses is required: the Web App is free and can be used immediately in production contexts. The solution is ready to use and designed for rapid adoption, even on a large scale.”