Creanova’s product engineers were asked to make the project feasible and manufacturable according to medical regulations and with the goal to realize the product as in the client’s mind. We supported the client through the product development in respecting the medical regulations and requirements.

The engineering refinement led to the optimization of the recorder unit’s details:

• Battery compartment cap is reviewed to automatically lift when it is turned and opened
• An easy-to-deploy solution was found to ensure the electronic contact with the battery, during sleep and each daytime activity
• The connection mechanism, which links the holter with the recorder unit, is optimized
• To meet technical requirements of injection molding, our engineers worked on the directions of removal from the mold, on draft angles, on plastics thickness, all to enhance the project and the device aesthetics

The engineering refinement resulted in a 3D model with very strict tolerances and small thicknesses, slightly different from the starting project also in design.

Much attention was paid to the material, as intended to make up a wearable. The recorder unit can stay in contact with the skin for more days and ISO 10993 indications had to be followed to respect the criteria of cytotoxicity, sensitivity and irritation.