Inside the Cold Calculus of the Problem-Solving Engineer

The general public doesn't get engineers. Maybe it is time they should.

Chris Newmarker

It is an argument heard from time to time: an apparently cold-hearted or negligent company knew about a safety problem with a product and didn't do enough. 

Medtech has seen such accusations during billions of dollars worth of lawsuits involving faulty metal-on-metal hip implants and vaginal meshes. A special type of endoscope called a duodenoscope that is linked to deadly superbug outbreaks could be next.

But what if the public perception is wrong? What if the problem lies in the fact that most people don't think like engineers--but maybe they should?

"Engineers have a grievance. They think we should think more like them. They are not wrong." Malcolm Gladwell wrote last month in a New Yorker piece entitled "The Engineer's Lament."

Gladwell's piece focuses on the automotive industry, but it is easy to also draw conclusions from it when it comes to medtech, another highly regulated industry that is heavily reliant on engineers. 

At one point in the article, Gladwell uses a joke to illustrate why it is hard for an average person to understand an engineer's point of view. It goes something like the following...  A priest, a doctor, and an engineer are playing golf and ask a grounds keeper why the group ahead is taking so long to play. The grounds keeper explains the group ahead is a bunch of blind firefighters. They saved the clubhouse a few years back, but were blinded in the process. The course lets them play for free.

The priest says he will pray for the firefighters. The doctor says he might have a specialist friend who could help them out. 

The engineer? The engineer says: "Why can't they play at night?"

The engineer's answer seems really callous. Gladwell, though, explains that it really isn't. The engineer is simply trying to rationally figure out the easiest solution to the problem. 

Much of Gladwell's article focuses on Denny Gioia, who now chairs Penn State's management and organization department but back in the 1970s was a Ford safety official who made decisions revolving around the Pinto, which became the poster child for unsafe, potentially deadly cars because of the reputation it gained as a car that caught fire in rear end collisions. (Gladwell pokes a lot of holes in the perception of the Pinto, too.)

"Now that he is no longer an engineer, even he finds it easy to criticize his former self," Gladwell says.

Gioia tells Gladwell that he thinks he might have made a huge difference in the Pinto case. If Ford's management had known about it earlier, the crisis that followed may have been less. Still, Gioia also remembers what it was like to work in the recall office back then, with such a flood of cases, many complex and ambiguous. Gioia and his coworkers were engineers who relied on numbers to tell them what needed to be brought to the attention of Ford management. 

The sight of a burnt out Pinto in Ford's "chamber of horrors" was enough to cause Gioia to raise issues about the car with his coworkers. But in the end, he agreed with them that he was getting emotional and that there was simply not enough cases and evidence to run the issue up the chain. 

"I had bigger fish to fry," Gioia recalls. "Bigger, more immediate problems to take care of."

When it comes to serious medical device recalls, one has to wonder how many times a similar scenario has played out at a device company. It would help if the public could do a better job at thinking like an engineer. It is often simplistic to think of a product as either wholly faulty or faultless. Engineering a product inevitably involves some tradeoffs.

Let's dig into the notion that duodenoscopes are causing superbug outbreaks--that they are simply an unsafe product with little business being on the market.

Sold in the United States by manufacturers including Fujifilm, Olympus, and Pentax, duodenoscopes are threaded down through the digestive tract and into the small intestine. The device's pros and cons truly reflect the positives and negatives an engineer would weigh. The duodenoscopes' movable "elevator" mechanism at the tip improves efficiency and effectiveness, which is important because duodenoscopes provide the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. But the devices are also challenging to disinfect.

The duodenscope's disinfection challenges may have seemed acceptable to engineers and others with similar mindsets--because of the therapeutic advantages of the technology. But they have proved truly alarming for the public. Unclean scopes have been linked to superbug outbreaks in Los Angeles, Seattle, and Chicago. Lawsuits claim Olympus redesigned its TJF-Q180V duodenoscope last year, but provided hospitals and doctors with cleaning instructions for an older model.

FDA has been criticized for not pulling the scopes from the market. 

And yet how many more people might be harmed if duodenoscopes were not available and patients had to go through more invasive surgical procedures?

"It is impossible to guarantee that a product is 100% safe. While it is a noble thing to want to prevent infections, how do we measure how many people don't have access to a valuable product because we've raised the regulatory burden to the point that companies decide it's not worth it to bring that device to market?" Michael Drues, PhD, president of Vascular Sciences (Boston) recently told Qmed.

Gladwell wonders in the New Yorker whether the U.S. federal government might make driving a lot safer if it tackled problems such as speeding (including using speeding cameras), distracted driving, and lack of seatbelt wearing, versus nitpicking engineering problems at car companies.

With all of the inefficiencies in the healthcare system, one has to ask whether it is time for a similar approach with medical devices, too.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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