SaaMD - Software as a Medical Device
(Doesn't everyone need a "Saa..." abbreviation to be cool these days?!)
I've just been reading an interesting article about the role of software in medical devices. A lot of sensible comments are made by the various contributors and a couple stood out for me:
"Only a small portion of software engineers understand safety" (Quentin Ochem, Adacore) which is probably very true. Safety needs a lot of work from the design stage forwards. I've heard others talking about the role of Agile methods in safety-critical environments. There are things that can be done during design and development though which are important to building safety into the application development process. Change control, visibility and traceability are obviously key.
"For new companies, there may not be enough equity and therefore there is pressure to create revenue before the money runs out. For established companies, there is pressure to bring products to market on time. Added to this, even minor changes to the software can result in huge expenses when it comes to testing." (Fergus Duncan, Bitwise). I can imagine that it's hard enough for software startups to get into a highly regulated industry and development tools for quality including testing and version management probably aren't high on their priority lists but perhaps should be. The concerns about minor changes that could result in huge expenses is also true but good management of the variances between versions (of software and hardware) could actually be a benefit rather than a liability - wouldn't it be attractive to be able to offer subtly different versions of a system or application that's more tailored to a specific customer environment if you can manage those differences effectively?
Perforce has a lot of experience in these areas. Independent analysis of the use of Perforce at Cardinal Health showed dramatic improvements in developer and tester productivity with associated cost savings and reduced time to market. It's well worth taking a look at the Cardinal Health ROI report.