Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills.

Biomanufacturing processes are hard to control, and the products are difficult to define as “identical” from batch to batch. Despite these challenges, biopharmaceuticals are critical to public health because the advantages are significantly greater. Scientific understanding of diseases and the success of biologically manufactured therapies to treat them has increased dramatically. But it can take a decade from design to full production of a biopharmaceutical—not fast enough to meet the needs of all the patients, or to beat competition from overseas.

Robert Rouzer is retired, but he may be busier than ever as a Baldrige volunteer. In recent years, Rouzer has served not only as a Baldrige examiner for the Baldrige Performance Excellence Program, but also as a state-level examiner for two Baldrige-based award programs that are part of the nonprofit Alliance for Performance Excellence. (The Alliance is a network of programs that partner with the Baldrige Performance Excellence Program to help organizations of any size, sector, and state to adopt the Baldrige Excellence Framework to improve their performance.)

Before his retirement in 2015, Rouzer was University of Illinois-Chicago executive associate director of Campus Auxiliary Services and assistant to the vice chancellor for Student Affairs. In the following interview, he describes some of the gratifying experiences that have kept him involved in Baldrige volunteer work year after year.

‘It’s the shoes!” Spike Lee yelled into the camera on the Air Jordan ads.

But it was never the shoes. Michael, Magic, and LeBron would have outplayed their leagues in golf cleats.

It was never the shoes.

But it was us, the salespeople. In our case, the intelligencia that “trains” people to be lean, agile, or whatever.

In companies all over the world, we are convincing people that success lies in the shoes. In huddles or iterations or A3s or DMAIC or story points. All these tools are not even hard tools, like hammers; they are conceptual tools, like voting. We don’t seem to get this.

When someone who has experience looks at these tools, we don’t see the tools; we see the results we’ve enjoyed in the past. We are strangely blind to the failures of deploying them or the near misses (which our brains will inevitably turn into wins). So, when we describe these tools in classes, we describe them with a high degree of certainty that whoever touches them will be successful.

Our classes are so convincing that we, strangely, even convince ourselves.

Even though we always struggle with clients to get them to “just do it.”

The argument for moving toward enterprisewide model-based definition is simple: The way we describe products is increasingly digital, not paper-based. The way we optimize and validate products seems almost entirely digital, except for a few remaining destructive tests. The way our production machines accept design instructions

Transferring our modeling data through simulation and related design iterations to final format and straight to machine production is the logical goal of all software and hardware development. It’s where everything we do as manufacturers and software developers has been heading for decades. I believe that both the hardest and easiest parts of the all-digital effort lie just ahead.