#MedicalDevice Software. Can we trust it? FDA Thinks So, But... | Pharma Industry Regulation | Scoop.it

A field safety notice (FSN) is something that health care authorities issue when medicines or medical devices are found to be dangerous.

In the medical device field this is relevant to software development as FDA statistics show that the majority of product recalls are due to defects introduced by software updates after the initial approval.

The FDA, for its part and in spite of having many dedicated employees, has been captured. The 501(k) equivalence route to approval is often the passage-of-choice for well-connected US firms to release sub-standard equipment, typically manufactured overseas, onto the domestic market. Avoiding as it does the more exacting and costly QA of a new device.

One might question how the FDA can consider an entirely new computer control system to be “equivalent” to a device that has no software. But you’d have to ask them that. Get your name on the no-fly list for it.

Sub-Standard Developers = Sub-Standard Software

The kind of software developers that device manufactures hire also leaves a lot to be desired. They tend to rely on externals, mostly unvetted, who are hired on short-term contracts and have no stake in the future of the product. They are typically hired not for their software development experience, but for how they seem on paper.

If the FDA sees “Agile Certified” this is enough for them. “Has one year prior experience as a web developer“, doesn’t sound so good does it? Not exactly a recipe for success. The FDA sees “staff training giving” on the record, unaware that the training course was in the form of a document written in Chinese emailed to developers who only speak Hindi.

Then they put these guys onto writing safety-critical machine control software. Congratulations! You passed your driving test. Now you can come and drive for our Formula One team.