SaMD — Software As a Medical Device
Software as a Service (SaaS) has led to a rapid spread of Software as a [insert thing here]. It's even expanded to Software as a Medical Device.
What Is Software As a Medical Device?
Software as a Medical Device (SaMD) is software intended for medical purposes without being part of hardware. An example of SaMD might be software used to view images from an MRI.
Of course, SaMD can be used alongside hardware as well. In the example above, the software is used alongside the MRI hardware.
SaMD and Safety
Not every engineer understands safety. But when it comes to developing software as a medical device, understanding safety is important.
Safety needs a lot of work from the design stage forwards. And that's true if you're using Agile methods in safety-critical environments, too. 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.
Balancing Quality With Speed in SaMD
"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
It's hard enough for software startups to get into a highly regulated industry. And development tools for quality — including testing and requirements traceability — probably aren't high on their priority lists. But perhaps they should be.
Medical device testing is critical to compliance. And software as a medical device developers aren't exempt from compliance concerns.
Requirements traceability is important in proving compliance, too. Organizations who've relied on Microsoft Word and Excel documents have struggled with medical device compliance.
The only way to balance quality with speed is by using a medical device lifecycle management solution for SaMD.