In 2001 I landed a job as a design engineer at Alaris Medical Systems (now part f BD). It was there I learned design controls and the Waterfall Design Process that calls out User Needs. It was my good friend, co-founder of Gilero, and then colleague at Alaris, Ted Mosler, who gave me a first lesson in User Needs. My takeaways were this:
1. User Needs and Voice of Customer (VOC)
Who exactly are “users” and “customers” of any product, especially medical devices? Are they Doctors? Nurses? Therapists? Patients? What other needs should be considered? Hospital Administrators? There are many stakeholders to consult. I started substituting “Stakeholder” for “User” and “Customer” … they are the Stakeholder Needs and Voice of Stakeholders.
2. Solution Independence
Ted would say that the user needs should be clear, concise, verifiable, and free of solutions. More on that to come…
In 2006, I started teaching Biomedical Engineering Design at NC State. Taking these two lessons, I implemented a process where students interviewed and shadowed stakeholders and developed a single statement. At the time, I called it The Problem Definition. This was a single sentence (to be clear and concise), needed to include a metric for success (to be verifiable), and was to be free of solutions.
None of this was a secret, but rather well known industry best practices being implemented in a classroom. And I wasn’t alone. In fact, Stanford had recently started a fellowship called Biodesign that was built on a foundation of having diverse teams immersed in clinical settings to identify stakeholder needs and develop innovative solutions. The Stanford Biodesign lexicon became the standard in Biomedical Engineering Education when they published their book by the same name in 2010.
Biodesign highlights a process they coined, Need Statement Development, to compose a single statement that is solution independent. This is the cornerstone of the Biodesign process, and the mantra they’ve coined is, “A well-charactarized need is the DNA of a great invention.”
So from 2006 to 2010 I called this solution free statement, The Problem Definition… and from 2011 to 2016… the Need Statement.
While the results of this methodology are undoubtedly successful, it is not straightforward as an educator to teach what this solution free need statement is.
Over the years I got more specific with the instructions for how to craft a well written need statement. They should be:
- Free of solution
- Free of bias
- No assumptions, inferences, or judgement
- Incorporates a metric of success or indicator of change
- Be pleasant to the ear and clearly understood
In 2017 while serving as a coach for the NIH C3i Program, there was this combination of coaching a nurse from Arizona while being married to a nurse in North Carolina.
My wife and I were sitting at a bar in downtown Raleigh at Trophy Tap & Table where I was describing the challenge I was having teaching Need Statement Development to the Nurse in Arizona.
Abby said, “Can you give me an example?” and when I did…, she followed that up by saying, “Isn’t that an outcome?”
It was meeting with Ty and Scott that triggered what matters.
What Stanford Biodesign calls Need Statement Development is, in my opinion, what Clayton Christensen calls Jobs to be Done…, and what Tony Ulwick calls Outcome-Driven Innovation. Indeed, it was the word “outcome” from Abby that triggered this… Indeed, it was early 20th century economist and Harvard Business School professor, Theodore Levitt, that said, “People don’t want to buy a quarter-inch drill, they want a quarter-inch hole.”
Whether it’s a need statement, job to be done, or outcome… it’s the “WHAT” that matters… not how it’s done. And not only is it the “what” that matters, the “what” has to matter. After all, if the need, job, or outcome has no value, it doesn’t matter, and therefore, it’s not worth doing.
So what I used to call The Problem Definition, and then the Need Statement, is today referred to as the What that Matters (WTM).
More thoughts on what matters in future blog posts… in the meantime, would love to hear your thoughts.
Health & Happiness for All