Diadora Utility / MEDERE orthopaedic insoles: Certified Comfort

Diadora Utility, in collaboration with Italian start-up MEDERE, presents a new solution specially conceived to improve worker wellbeing: custom-made orthopaedic insoles, designed to ensure comfort, support, and accident prevention during long days on one’s feet.

This is a highly innovative product, not only in terms of effectiveness, but also on account of the cutting-edge technological and regulatory process used to manufacture it.

New regulatory framework for medical devices

A new European Directive, Regulation (EU) 2017/745 (MDR), which became mandatory on 26 May 2021, has introduced new rules for the safety of medical devices, including custom-made orthopaedic insoles.

The new regulation has raised quality standards and redefined the responsibilities of all players in the supply chain – from manufacturers to technicians to physicians – in order to ensure the safety, traceability and conformity of each and every device put on the market.

In the case of orthopaedic insoles, two figures play a key role in the manufacturing process:

  • The physician who is responsible for prescribing the device and certifying its clinical necessity;
  • The orthopaedic technician, who must validate the orthopaedic insole, sign the declaration of conformity, and make sure that the product is manufactured in full compliance with the applicable regulations.

Orthopaedic insoles: when are they needed?

Working long hours in a standing position, lifting heavy loads, or maintaining a static posture for prolonged periods can cause widespread problems, such as:

  • Foot pain;
  • Plantar fasciitis;
  • Tendinitis;
  • Muscle, tendon and postural problems.

In addition to compromising the wellbeing of workers, these disorders can also limit their operational capacity and increase the risk of accidents. Custom-made orthopaedic insoles are an effective response to such issues, offering: :

  • Enhanced comfort on the job;
  • Reduced pressure on the sole of the foot;
  • Better support for the arch of the foot;
  • Stability when walking and handling loads.

Customised orthopaedic insoles: 3D technology

Besides the quality of the materials used – breathable, shock-absorbing, and designed to ensure high tolerability during prolonged use –, what truly sets apart the orthopaedic insoles developed by Diadora Utility in collaboration with MEDERE is their design and production process that is highly innovative and focused on customisation.

Thanks to a cutting-edge technological approach, arising from research and development conducted by MEDERE, the orthopaedic insole is not adapted to a standard model, but is custom-made based on the specific shape of each worker's foot. Besides achieving a significant increase in comfort during use, this permits targeted intervention in the event of postural misalignments or biomechanical problems, thereby tangibly improving the wellbeing of an individual in their workplace.

The process begins in an extremely simple manner, which makes it accessible even to those who are not familiar with complex technological tools. Workers can download a dedicated App to their smartphone free of charge. The app guides them step by step through the process of capturing images and videos of their feet, to serve as the basis for a morphological foot analysis. They can also download the medical prescription from the same digital platform. This document is essential to start the production of custom-made medical devices in accordance with current European legislation.

Once the information has been obtained, MEDERE's specialised team of orthopaedic technicians and biomedical engineers gets to work. The data collected is processed to accurately determine all the design measurements needed to develop a truly personalised insole. While maintaining high clinical and technical standards, the entire process is carried out quickly thanks to digital integration between the data gathering and the design phases.

The insole is then manufactured using a patented 3D printing technology, validated and optimised to ensure maximum precision and reliability in the production of orthopaedic devices.

The result is a custom-made insole that respects the morphology of the foot, ensuring a perfect fit and targeted support. Once the device is finished, the customer receives it directly, ready for use.

From the practical standpoint, the insole is easily inserted into the main safety shoes available on the market, without requiring any further adjustments. As a result, workers can immediately benefit from an orthopaedic support specially designed for their needs. This ensures a better day-to-day experience in the workplace, improving comfort, accident prevention, and stability.

This synergy between Diadora Utility and MEDERE is a concrete example of technological innovation applied to orthopaedics. The integration of specialist skills and compliance with the applicable regulations enables us to create effective, customised solutions. The outcome is a safe support, designed to protect workers' health.

For further information, write to marketing@lanzigroup.com