Prior to design verification of packaged products, consider the following process-related elements.
This three-part series explains how an all-encompassing testing approach will improve product reliability and secure your bottom line.
Well-written and usable instructions are critical for all users.
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.
Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.