Posts categorized as“Product Development”

Process Failure Modes and Effects Analysis (PFMEA) can be a powerful tool to identify potential failures in the manufacturing process of medical device, and help prioritize which failures should be improved first. However, the effort required to complete a PFMEA can take many hours, which costs money. Applying PFMEA efficiently will be addressed in this […]

From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Probably a good thing […]

Designing equipment (medical or otherwise) is a complicated process. This complexity is increased when the equipment of choice must either come in contact with biological material, or function within a biological environment. In order for a device to operate as intended, it must be able to withstand the unique conditions that biological fluids impose. Depending […]

Build an Input Pyramid to support your medical device development As a medical device designer, I see clients balancing cost and feedback in a daily struggle to decide when to get clinical feedback, from whom, and how much weight to give that input. KOLs (Key Opinion Leaders) and individual designer experience can take a product well […]