emphasised by Dr. Tomaž Karčnik, Director from the SME company IPD med, Slovenia.
Risk management is key element in medical device development. No harm is the mantra. Substantial part is usability analysis: how does design decisions lead or mislead the end user in device daily use scenarios. Standard IEC 62366:2015 addresses these issues. Class IIb medical devices according to MDD 93/42/EEC, how our cutting edge Insulin patch pump is classified, are devices that could inflict serious harm to the patient in case of malfunction or misuse. In the worst case it may even cause death. Avoiding misuse is therefore one of the most important parts in risk management and device development. Collaboration with the group at JSI partially addresses those issues: the Insulin pump remote controller design needs to be independently evaluated and potential for misuse assessed. JSI group offers the services based on its longtime experience.
TETRACOM enabled us to execute the studies much more in depth and in parallel to other activities. The key outcome is safer and less misuse prone technology where diabetic patients – pumps users will be the most important beneficiaries. In addition, the integration with OPEN Platform for Clinical Nutrition developed by JSI will significantly increase the application of the Insulin patch pump.