perspective on design validation
I’m tired. And I’ve been working late. And I’m frustrated with Mexico and ready to get through this product launch and take a vacation. These are the kinds of days that you really need to see things like this:
A Phoenix area newspaper this week.
Normally unremarkable. A woman with a baby. Cord blood donation for minorities (which, by the way, is a huge need right now). But I count at least two Bard products in the picture, one of which I’ve worked with (never mind that it’s being used incorrectly….). Perspective.
There’s little that’s more rewarding than seeing your product in use. Doubly so when that product directly affects health and well-being of its users. Couple that with the fact that 80% of ideas are killed before they see the light of the marketplace (anecdotally, that holds to be true, but everyone seems to have their thoughts on the actual statistic), and I know that I’m lucky to be launching my first major new product so early in my career.
As we go through launch plans and wrap up our final build documentation and testing, one of the things that’s weighing heavily on me is Design Validation. For those that aren’t familiar, design verification is the answer to the question “did we build it right?” It’s why I’ve spent time at the molder and the manufacturing plant, done all sorts of testing. Design validation is the answer to the question “did we build the right thing?” That’s a little bit trickier to answer.
In a procedures-based environment, we are constantly designing to user tasks - what is it that a surgeon or internist wants to do? How can we help them do it faster, better, cheaper? Design validation, then, seems most natural in clinical trials, or simulated use tests. But with sample size requirements, IRB protocols, access to clinical sites, and targeted patient populations, that’s not always practical to get that in-depth. Sometimes, it makes more sense to release the product with an understanding of how it’s going to be used (safely and efficaciously, of course) and let the market decide for you if it’s the “right product”.
In school I always struggled with the idea that we need to release products quickly. It seemed like such an “industry” thing to say, to release faster and make more money. And while it’s true that faster launches do mean more revenue, they also mean that patients get their hands on things faster.
When I look at a picture like the one in the newspaper, I remember what validation feels like. It’s seeing a smile on a mom’s face to know her infant is healthy. It’s hearing a grandchild tell you thank you for making sure her Nana’s medication got to her in time. It’s seeing a patient start to exercise again after a mitral valve repair surgery.