Back at NICTA, and a few Reflections on Medical Device Engineering

In February I moved back to NICTA after what proved to be an interesting sabbatical year working at Saluda Medical.  Saluda is going strong – they have great technology, and very recently closed a $10Mill VC round which will lead towards major clinical trials of their implanted spinal cord stimulator in the US.
I learned a lot working at Saluda, which is always fun – I hadn’t previously worked alongside mechanical engineers on product design, nor alongside electrical engineers doing signal processing, nor thought much about manufacturing process and product validation for manufactured devices. My role included work defining user requirements, system specifications, system architecture, system validation, and system verification. But perhaps the most interesting thing was risk management, which is central to systems engineering and is highly interdisciplinary. The system I was involved with is now undergoing clinical trial in the US. I also contributed to my first (very cool) patent application, and helped co-author a (conference) publication on placement of paddle leads for spinal cord stimulation. There is perhaps another (journal) publication in the works on adverse events for spinal cord stimulation. And I had the opportunity to learn Python, which was fun, and to learn more about Microsoft Word Interop scripting than I ever wanted to know.
The medical device industry has an interesting regulatory environment.  Of course it’s very conscious about risks and ethics. However, there is a surprising amount of flexibility about how companies can choose to engineer medical devices. Nonetheless, when a company has said how they’ll demonstrate safety and/or effectiveness (and having had that plan approved), regulatory monitoring and review is a powerful way of making sure that happens. That’s especially pointed when companies are selling medical devices (which Saluda hasn’t yet started to do).