Archive | March, 2014

Blog: Are You Sure?

Seven years of engineering, and especially the last two in the medical device space, has taught me that this is the most important question an engineer can ask. It doesn’t matter if you are a design engineer, a manager, or even a quality or testing engineer.

Successful engineering requires you to interact with a complex mix of industry experts in a variety of roles, including quality managers, vendors, coworkers, bosses, partners, suppliers, contractors, and engineers at other companies. In all these cases, you are asking the other party to provide some sort of expertise. And in each of these cases, the success of a project depends on that expertise being real.

There’s nothing insulting about asking someone if they are sure of their opinion. You are asking them to be accountable, to prove that their opinion is actually based on fact. You are challenging them to produce data, past experience or references, which will corroborate the expert’s advice to you. Asking them “are you sure?” means they must back up their claim, and if they can’t, you realize that the opinion they gave you was based on presupposition and/or illusion. In an age where self-promotion is king, where self-assurance is currency, getting beyond bravado is crucial for long-term success.

We’ve had our fair share of this at EMCI. On one project I was leading, our “FDA Expert” turned out to be more of an “FDA Guesser.” His assurances that a clinical trial was not needed for the device and that a bench-top study would be sufficient turned out to be exactly wrong. It delayed market entry by more than a year, and cost us thousands of dollars and hundreds of man-hours in wasted resources. If only we had asked “Are you sure?” when the “FDA Expert” outlined the regulatory path…

More than once, an inventor has come to us with a medical device they think will have a $10 billion/year market and will need little or no further development from the prototype in their briefcase. “It works,” they assure us, “and it costs almost nothing to manufacture.” We have quickly learned that asking “Are you sure?” must be the first three words out of our mouths with these folks.

Machine shops have told me parts aren’t machineable. Coworkers have told me deadlines are impossible. Suppliers have told me lead times are immovable. In all these cases, asking “Are you sure?” quickly tests the passion and reality of their stance.

Asking “Are you sure?” helps an engineer break down dangerous assumptions as well. Thus, constantly asking themselves this question is critically important. For example, I took over a project mid-stream that had been designed by an inventor in collaboration with a machinist. When I took over the project, I was instructed by my manager to get the inventor to stop making design changes so we could wrap up the project quickly. So I did, we closed the design phase, and when we went to the testing phase, the device didn’t work. I’d never asked anyone “Are you sure the design is done?” I’d never asked myself “Are you sure what they came up with is sound engineering?” Because of that, we had to go back and redesign several components of the device. Time, and money, were lost.

Another time, we were told by a distributor that they would be ordering roughly the same amount of product the following year as they had the current one. “Sales are good, we expect only a minor dip,” they told us. And we hoped they knew how to forecast. And our hopes were dashed. Their sales dropped by almost two thirds in the next year.

Certainly, asking “Are you sure” won’t break down every illusion. Once in a while, someone will simply lie to your face. Whether they are malevolent or clueless doesn’t matter, what matters is you have asked them “Are you sure?” and they confidently say “Yes.” And then they turn out to be wrong. So you have to dig. You have to follow up “Are you sure” with a second question: “How are you sure?” Press people until they give up their illusions. Until they admit what was known fact and what was assumption. Then right down the assumptions. These are the things you must test.

For example, we had a device that needed additional certification and the regulatory authority told us the device had failed to meet required specifications. Rather than figure out how to redesign the device and make it compliant, I started by asking the regulatory authority “Are you sure we aren’t compliant?” Then I asked how they were sure. They told me they had referenced a specific document. Reading the document, I realized they had tested our device against the wrong standard. When I pointed this out to them (politely), they agreed, and tested our device against the correct standard. It passed. We estimated redesign and recertification would have taken 6 months and cost at minimum $12-15,000 – and it was saved with two simple questions.

So start asking everyone, especially yourself “Are you sure?” At first others might be annoyed at your constant skepticism (very different, I should point out, from cynicism). But soon enough, those who interact with you daily will learn to come prepared. And they won’t bring any assumptions with them.