To create a safe and effective medical device, you need to consider the many nuances. We will tell you about it using the example of a medical lamp.
First of all, the development conducts taking into account the sales markets where the product appears. In the European Union, medical products are CE marked, and medical device manufacturing standards are in accordance with ISO 13485. In addition, competition is growing in this region. As well, next year, it is planned to start MDR, which will increase requirements for the safety and performance of medical devices.
Industrial design is one of the processes included in the standard. It is impossible to create a high-quality and safe product without compliance with standards. In medical development, ID is responsible for the most important function – the interface for interaction with staff and the patient. Dealing with the issue of usability is a major challenge.
Not every development team has the necessary resources, qualification, equipment and, in general, the ability to perform such work in accordance with the ISO 13485 standard. This standard, as well as the MDD/MDR, imposes requirements on design development service providers that are critical for manufacturers of medical products. Therefore, today, medical device manufacturers want to work only with highly qualified developers.
Design projects in the medical field are subject to requirements for the implementation of residual risks. The process of working is regulated by ISO 14971. Working with risk management forms an additional amount of work to create alternative solutions and constant assessments:
- Work scenarios and identification of hazard types;
- Situations of occurrence of hazards;
- The nature of the alleged harm;
- The severity of the consequences.
The result of the work is not only a completed design project in the form of a design album, 3D model, prototype, and also documents confirming the work with an assessment of residual risks, which are included in the product file.
In development, we rely on the expertise of teams in the field of medical device promotion.
We know about the problems of getting products to market. Thus, we can bring the start of sales closer.
Today, an effective way to create products goes beyond the knowledge and competence of one team. Joint projects with cross-competency models show the best effect.