We design and develop medical, e-health and laboratory products that are used in obstetric departments, neonatal units, operating rooms, care homes and laboratories.
User oriented approachDesign and development of medical devices, being it handheld devices and instruments, endovascular devices, orthotic devices, monitoring devices or larger devices like air treatment systems in an operation room environment ask for a user centered approach, smart technology and innovative thinking. We design always in close cooperation with medical staff, patients and development partners.
Together with our clients we develop, run user tests, develop, test, help to run clinical tests and support in obtaining certifications such as FDA, EMC, IEC 60601, Class 1, IIa, IIb MDD.
Product development of medical devices and e-health solutionsThe process of medical product design is very similar to that of designing other products, but there is more attention to user research, testing and validations of solutions with medical teams and multiple stakeholder groups in hospitals or care homes.
The process requires also more research and documentation on norms, certificated materials, coatings, resistance against cleaning chemicals, general sanitation of the product, water-resistance, and safety norms.
User studies and user trials during medical product designIn our medical design projects we involve medical staff as the future users of the products that we design. And also patients, which in some cases use and operate the products as well. We run observations, try out solutions, organize short effective group sessions, make interpretations on user environment and expected use, coming to simple, beautiful and smart medical product design.
In the case of a medical alarm system, very effective sessions with medical staff helped us to understand that the present products were used in a non-intended way, leading to a dangerous situation for patients. These observations and sessions helped us to design a product that was closer to the daily routine of the medical staff, fitted their mental model better and made their work easier, while taking away the danger for the patient.
Support for certification of medical devicesWe work together with several partners to support our clients with the certification of products, both general certifications for CE regarding mechanical and low voltage regulations, as well as EMC / ESD regulations.
Apart from that we can also assist together with partners in the application and testing for specific medical certifications like 93/42/EEC, ICE 60601 or FDA class I or II devices.
For more projects that we did in the field of medical design and design for health, please visit: Design for Health