Medical devices were some of my earliest toys, since my father was going to medical school while I was an infant. Stethoscopes, otoscopes, surgical scissors, reflex-testing hammers. I could not get over how my reflexing knees jerked like beheaded chickens, or how loudly my heartbeat came in through a stethoscope. As a kid, I liked using large syringes (minus the needles) as water cannons. As a teen, I made jewelry by using forceps to bend wire. 

I suppose medical device manufacturers should not rule out the possibility that some of their more basic medical devices will be used as toys by somebody, somewhere. Not even toys; adaptive tools. I hated using nail clippers as a small child, but surgical scissors where much less traumatic. I’m not sure that you’re supposed to “localize” regulated tools in this way, change their whole usage according to your needs, but we did.

For more standard types of localization, things are a little more predictable. Sometimes, it’s the predictable things that are the most challenging. Predictable things require heightened levels of rigor; there is no ambiguity to hide behind. No legal assumption that the tools will merely be used as toys, for example.

Instead, there are regulations to consider, terminology entries to access. New technology means new products, potentially expanding the definition of medical devices. New medical device mergers — becoming ever-more common — present their own set of potential headaches.

If these are things you’ve considered, this issue should be able to help. And if you ever lose your sense of wonder over medical devices, I suggest you borrow a stethoscope and show the youngest member of your family what a heartbeat sounds like.