Thanks to technologies like 3-D Printing, Virtual Concepting, and Augmented- and Virtual-Reality Prototypes, product iteration can now be done faster, more cost-efficiently, and more frequently. But while that affords obvious benefits, it also presents a conundrum for medical device development teams: how do you resist the urge to iterate endlessly?
The problem is certainly not new, but it has been compounded in recent years as the prototyping tools available to medical device engineers have advanced. in a session on Iterative Design at the MD&M West Conference February 7, experts tackled the topic and shared how they avoid letting great be the enemy of good.
“It’s a really big problem,” explained Mark Wehde, Senior Engineering Manager in the Mayo Clinic’s Division of Engineering. “knowing when you are done is such an important part of an engineering project. if you can’t identify that before you start, you’re not ever going to finish.”
While some engineers take the attitude of “it’s good enough, let’s try it,” others are perfectionists who can’t help but continue to tinker. Customers, too, can contribute to the problem, Wehde said. “They just want more and more.”
The key to avoiding an infinite product development cycle, he added, is “really defining what the user needs are at the very beginning.”
Eric Steuben, Vice President of Operations at Procept Biorobotics, said at his company, it all comes down to starting with a strong initial requirements document and clearly defining what you’re trying to accomplish from the get-go.
“If you define everything up front, we know that once we hit it, we go,” Steuben said.
It’s also critical to rank requirements in terms of importance.
“You have to note the criticality of needs,” Wehde said. Work with stakeholders to determine what features of the device are must-have, nice-to-have, and optional. The latter, he said, are unlikely to make it into the final product unless they require little or no extra work on the part of the team. “The intention is to stop us from gold-plating,” he explained.
Mike Bravo, Director of Preclinical Strategy at NAMSA, summed it up another way. “It’s all scope creep,” he said. “You have to identify the objectives and endpoints, otherwise . . . you have no idea what success is.”