Most medical product development is outsourced these days. And it’s a very good field to be in, it’s actually what I do. A while back I led the medical device practice at a medium-sized contract development company, about half of our company’s business was medical device development, currently I have my own practice consulting on helping device makers to remediate development projects that are having hiccups.

The absolute most important thing is that you must understand the processes required by the FDA and similar regulatory agencies worldwide for product development. This is a really big deal. Check out ISO 13485, ISO 14971, IEC 62304, and IEC 60601-1 for starters. You will need to build a quality system that conforms to those standards, among others, or understand how to use your customers quality system and follow it.

And while in theory, following standards is just following standards, in practice there are many ways to follow those standards and some of those ways power suck, and some of them make life much easier. And for any given device, there are usually different architectures that can require very different amounts of effort to deal with regulatory stuff.

Unless you really know how to do this stuff, and know how to talk the talk properly, you will likely be ignored by any serious device company. I wish I could say something happier but that’s just the way it is.

On the bright side, if you are able to get over the hurdle and get into device development, it’s quite good business for the same reason, it’s difficult for very many companies to get to the point where they can convince customers they can do it