The Elusive Moose
I have a game I have been playing with my 3-year-old granddaughter. This started a year ago when my wife and I vacationed in the US state, Maine. Maine, for those that don’t know, is the northeastern most state in the US, and is known for its scenic beauty that includes rocky coastlines, unending forests, majestic waterfalls, and abundant wildlife. One member of that abundant wildlife is the Moose. The moose population in Maine is estimated at 60,000 to 70,000. That was of particular interest because I have never seen a moose in the “wild,” and I was intent on finding one. We also have a children’s book about moose that I read to my granddaughter on occasion.
I had told my granddaughter that we were going to look for Moose while in Maine, so she asked on the phone several times, “Poppy, have you seen a moose?” Well, we hadn’t … and we didn’t … in fact, we did not see a moose the whole trip! Disappointing. After many hikes, both in early morning and early evening, we struck out.
However, I decided to purchase a small, plastic statue-type moose and for many months since our vacation, I have been taking photos of the plastic moose and sending the photos to my granddaughter. “I saw the moose!!”, my text message reads. Of course, this has been fun, and I am often trying to get more creative on where I travel with the moose to photograph it! The photo below was from a recent surf fishing excursion near where I live (Honeymoon Island, Dunedin, FL). Can you find the moose? :)
As I think about the “elusive” moose, I cannot help but draw an analogy to software quality. Software quality seems to be equally elusive. I have been working with software quality for over 35 years and think about this topic often … Why so many recalls? … Why so many open bugs? … Why can’t we design more bug-free software?
Off-The-Shelf Software and SOUP
Certainly there are many factors that could be discussed but one factor that is now becoming more significant to me, is the prolific use of OTS / SOUP in medical devices and HealthIT software. Unless it is a small embedded project (which are fewer and fewer), today’s software developers are using more and more OTS / SOUP. I find that many developers, while they may not directly say it, give the impression that they believe the OTS/SOUP is higher quality than they software they write. Yipes! What? This underlies their belief that the OTS / SOUP creators are expending great efforts at software quality. Not necessarily … and not in my experience.
I wonder if much of the effort in software quality that is currently focused on software design (“design in quality”) for custom software, should now shift the emphasis to, “how do you know your OTS/SOUP is working properly?” How do you know? Well, we don't totally know - we must design-in:
- Strategies, methods, and techniques to flush out integration level bugs arising from “gluing” together many different types of OTS / SOUP
- Firewall type risk control measures that aim to keep the OTS / SOUP “between the ditches.”
- Process risk controls that stress, bend, and squish out bugs in OTS / SOUP
- Don't get fixated on "happy path" testing of OTS / SOUP - challenge it!
- And more
Remain skeptical of OTS / SOUP my friend. And I hope you are getting closer to finding the moose.
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SoftwareCPR® Public Training
62304 Training
Our 62304 and Emerging Standards Impacting Medical Device and HealthIT software training course provides a clear understanding of the 62304 standard for medical device software, FDA expectations for software, and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment between them. In addition, participants will learn other standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).
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Learn more: https://www.softwarecpr.com/2020/10/agile-methods-for-medical-device-software-training-course-ireland/
Questions about training? Email: training@softwarecpr.com
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