DEMCON has all the competencies in-house to address unexpected challenges in medical product development. One product of this kind is the Heat and Moisture Exchanger (HME) booster for artificial respiration equipment with accessories developed and produced by Medisize. DEMCON was contracted to redesign an existing product to further improve its performance. Following the successful redesign, DEMCON now looks after the product’s serial production.
Humidifying and heating the air for artificial respiration is intended to prevent dehydration of the patient. In order to stimulate the heating, the humidifying unit (a membrane filter fitted in the supply tube) is fitted with an extra heating element, the HME booster. In fact, this is a heating element with a small electronic switch for control and safety. Through heating, moisture evaporates, and with the water vapour, moisture and heat are added to the breathing air. The contact of the HME booster with the water vapour that the patient inhales imposes high demands on biocompatibility. DEMCON studied the choice of materials and selected suitable materials with the correct certificates and the accompanying means of production.
Another compatibility problem involved the installed base of ventilation filters. The new HME booster had to be compatible with all filters in the field, which show a substantial production spread in terms of dimensions for the booster-filter connection.
DEMCON provided the entire design and supported Medisize in the certification process. The electronics for the compact device took the form of a flex circuit board and were naturally tested for EMC compatibility. Thanks to the well-designed casing, heat and moisture did not create any issues in relation to the electronics. For simple control of the heating, the original design was retained. DEMCON did devote a great deal of attention to the safety aspect, in order to prevent overheating. On the basis of an in-house risk analysis, a number of new solutions for secure control were implemented.
Finally, DEMCON arranged the production of the plastic parts, in close coordination with the supplier of the moulds and the injection moulder. The assembly, testing and clean packaging takes place at DEMCON. This guarantees the traceability of each individual product.