I had a flash of inspiration during lunch with a colleague last Friday.
Our conversation included how difficult it seems to be to set a clear, concise statement of the objective for developing a device (or indeed any product). The conversation drifted from there to the most memorable presentations we’d experienced.
My eureka moment; the power of a story to anchor and clearly describe the objective. I’d like to share with you an experience that I still vividly recall.
There was an AAMI/FDA meeting in early 2012. On the first afternoon, I listened to a series of presentations around the perhaps dry topic of “device clock synchronisation challenges”. After hearing several speakers talk about technicalities, standards and protocols, I still didn’t really appreciate what the pressing issue was. Then James Fackler, MD (The Johns Hopkins University School of Medicine) shared his experience of working in a paediatric ICU…
The first slide was of a large bank of very similar looking devices in an ICU.
The doctor was faced with banks of instruments all humming and bleeping away, all alerting them to their patient’s bodily functions.
Slide two had a graph of an output versus time from one of the instruments.
The chart was explained, then a second graph was added, followed by a third, fourth and fifth; each with a trace from another device in the ICU, potentially covering the same 30 second time period.
The MD then talked about the blips on the traces and what they meant to the healthcare professional.
Then came the shock.
The blips on each of the charts showed failure of a different bodily function. Crucially, the relative timings of these blips meant a different surgical procedure may be needed to save the patient, a child.
It was like a smack on the forehead!
I understood how important the chart accuracy was to the doctor. A decision how to proceed has to be made within that 30 second window, so device clock synchronisation was critical to presenting the correct sequence of blips that pinpointed the next steps. The doctor is wholly reliant on data from all the devices being accurately displayed, at the right time points, in order to select the appropriate treatment.
Device clock synchronisation suddenly became a matter of life and death.
Encapsulating the problem in a story, clearly presented what needed to be solved and why it mattered, in a straightforward and profound way.
As an aside, although there were no hand-outs from this session, it’s the one I recall most readily from the meeting.
Maybe, as you read this post, you reached the same realisation about the life saving importance of device time synchronisation. How powerful it would be if you described your development goals in terms of what it will mean for the eventual user; described them so that everyone understands exactly the imperative you’re working to address.