I am sure that all of you are experts in your field, the most common development mistakes are underestimating knowledge and experience of other discipline. Collaboration and sharing of experience between development and regulation department can bring the expected result.
MDM projects involved in gap analyzes in startups and large companies and we are faced with a situation when the certification department was involved in medical development only at the final stage, it harms to the project not only in financial aspect but also a losing time, which is sometimes more important than money.
A start-up company with an innovative device and great market potential, medical devices was implemented for intendance of use “continuous monitoring device”. The device was included WIFI/BLE communication and transmitted real time data to TV nurse station. MDM projects performed a gap analysis and found that the device will be rejected by the FDA because missing build-in information panel. A mistake that could have cost the company half a year of development delay.
The medical device development request compliance to medical certification 60601-1/2, not all specialist has enough experience with medical development design.
Biocompatibility requirements, have you found solutions for your mechanics and plastics, what about sensors that have direct skin contact? What about ESD compliance for sensors? There are many questions that should get answer in first design stage.
Also, one of important requisition for current leakage, and insulation should be implemented in first design stage.
The company developed a medical device for the treatment of Alzheimer disease, the medical device was at 60601 certification stage , medical device failed leakage current test ,the leakage current was more than 350uA, MDM projects has proposed several solutions, the problem MDM projects fixed by adding an external transformer, but this could have been avoided if at the beginning of development the gap analysis was done by expert in regulation requirements.
Another critical area of medical device development is conformity for radiation immunity and emissions.
The company that development home use hair removal device loosed six months in trails to finalize compliance for radiation immunity and emissions because of mistake in first stage design. The problem was solved by adding inlet filters improving traces routing, improving flayback and switching circuit.
During the gap analyzes of the same device MDM projects found non conformity for standby power requirements.
MDM projects believes that one of the most important stages of medical devices development is the initial stage in which specialists from all areas should participate. All issue can be solved by applying