Utility Diadora and the Italian startup Medere have introduced a new era, creating anatomical insoles for workers via a dedicated Web App. This service is fast, practical, and compliant, specifically designed to efficiently meet the demands of the safety sector while fully adhering to European Regulation (EU) 2017/745 on Medical Devices. To gain deeper insight into this groundbreaking initiative and its impact, we explored the challenges overcome, the solutions offered, and the tangible benefits of this partnership for worker well-being and the broader safety ecosystem.
How did this project originate, and how does strict adherence to European Regulation (EU) 2017/745 on Medical Devices ensure not only legal compliance but also maximum benefits in terms of customization, comfort, and injury prevention for workers using certified insoles?
Giorgio Pira – Global Sales Director – Diadora Utility: “Utility has always been a pioneering brand in the safety world, committed to innovating with solutions that genuinely improve the lives of those who work. The partnership with Medere was formed precisely to address the increasing focus on individual well-being and injury prevention, which has led to a rising demand for custom orthopedic insoles. In a work environment, however, it’s crucial that these devices are certified by the manufacturer and compatible with safety footwear. This is the only way to ensure full compliance with regulations governing PPE. Using insoles not certified by the manufacturer compromises the validity of safety shoes as Personal Protective Equipment, exposing both workers and companies to legal and health risks.”
Giorgio Salvetti – End User Sales Manager & P.P.E. Trainer Europe
– Diadora Utility: “Thanks to the Web App developed with Medere, we provide employees of our partner companies with a practical, fast, and secure tool. Every worker can obtain custom-made insoles that are certified and perfectly compatible with the main Diadora Utility models, without compromising their PPE validity. Customization isn’t just about comfort; it directly impacts prevention. A custom-made insole helps reduce issues like plantar fasciitis, tendinitis, and postural imbalances, improving stability and reducing fatigue. For Utility, this synergy of safety, ergonomics, and innovation is the result of a concrete commitment:
developing products that not only meet standards but truly protect, because they’re designed with the wearer in mind.”
How have Medere’s experience and advanced expertise in personalized 3D modeling and 3D printing technologies specifically optimized the solution offered in the partnership with Utility Diadora, and how have these capabilities enhanced innovation in the field of personalized medical devices?
Medere, Marco Mannisi Founder Medere: “Medere was founded with the very goal of bringing innovation to the biomedical personalization sector. Thanks to our experience in 3D modeling and additive manufacturing, we’ve developed a system capable of transforming biometric data into functionally and biomechanically optimized digital models. This enables us to design custom insoles with exceptionally high precision, perfectly conforming to the individual foot morphology and specific clinical needs. 3D technology also allows us to adapt the insole’s interior to the typical stresses of work activities, reducing localized loads and improving stability and comfort. All of this occurs within a workflow that complies with regulations for custom-made medical devices, ensuring an effective, safe, and traceable outcome.”
Your system relies on data collection (photos and videos) via an intuitive Web App, operated by personnel who don’t require specific healthcare or technical skills. Considering that this data forms the basis for personalized 3D modeling of a medical device, what algorithms and internal validation processes have you developed and implemented to ensure the extreme precision and accuracy of the acquired biometric measurements, ensuring that the final insole fully meets the medical prescription and maintains compliance as a certified medical device?
Medere, Marco Mannisi Founder Medere: “Our system was designed to ensure full compliance with Regulation (EU) 2017/745 on medical devices, with reference to the requirements of Annex I (General safety and performance requirements) and Annex XIII (Custom-made devices).
The collection of biometric data (photos and videos) happens through a Web App accessible even to unqualified personnel, yet its technical structure is designed to eliminate any margin of error. Each acquisition session includes automated data consistency checks, verifying the metric scale, correct angle, and visual integrity of the uploaded materials. These checks don’t replace a human operator but form a crucial initial quality barrier for data acceptance.
Once the acquisition is complete, the data is transferred to protected servers and analyzed by an in-house team of biomedical engineers and orthopedic technicians.
Three-dimensional modeling is performed using photogrammetric reconstruction algorithms that create an accurate and stable geometric representation of the foot. Every insole is designed based on the individual medical prescription and is accompanied by:
• An individual technical file, documenting the entire design, production, and verification process.
• A Declaration of Conformity for custom-made devices (pursuant to Annex XIII, point 1), signed by the manufacturer. Finally, the device is validated by an orthopedic technician registered in the national registry, and the insole is made with materials and processes compatible with user safety requirements. The entire process is traceable, and documentation is archived in accordance with Article 10 of the MDR.
This approach ensures that each insole reliably, reproducibly, and compliantly addresses both the patient’s clinical needs and the obligations set forth by European regulations.”
Giorgio Salvetti – End User Sales Manager & P.P.E. Trainer Europe
– Diadora Utility: “The service is already active and available. To access it, interested companies simply need to contact Utility Diadora. A dedicated distributor will be assigned to manage the entire process, with no need for specific equipment or in-house training. Both workers and companies can use the free Web App for measurements. The system was designed for maximum ease of adoption and immediate integration into company processes, ensuring complete safety and compliance with current regulations.”
For more information, please contact:
Marco Grego – Diadora Utility – End User Sales Specialist Italy marco.grego@diadora.com
Giorgio Pira – Global Sales Director – Diadora Utility
Marco Mannisi – Fondatore – Medere
Giorgio Salvetti – End User Sales Manager & P.P.E. Trainer Europe – Diadora Utility
