Risk mitigation always has been a salient requirement for the design, development and manufacture of medical devices that are safe and effective for their intended use. The tools employed in the pursuit of effective risk management, however, have varied significantly.

When teaching failure mode and effects analysis (FMEA), I start by determining who in the class has participated in creating one. Typically, more than half of the students raise their hands. Next, I ask how useful or accurate their FMEAs were. Responses usually include grumbling, a few shrugged shoulders and at least one thumbs-down. Rarely do I receive a positive response. Finally, I ask how much fun the FMEAs were. This question always produces a round of laughter and more thumbs-downs.

Everyone is talking about technology advancements. References to the cloud, mobile, big data, the Internet of things (IoT)—used as central talking points or tangential nuggets that bounce in and out of conversation—are nearly ubiquitous across manufacturing industries. Most professionals seem to understand, at least on some level, where technological trends are headed for operations.

Compliance has become one of the biggest challenges facing businesses today. Failing to have the right controls and culture in place could mean forking out millions in fines. So how can businesses get it right? Look no further than the newly published ISO 19600:2014 for guidelines on compliance management systems.