In Product Development, Fast and Steady Wins the RaceIn Product Development, Fast and Steady Wins the Race

Moving quickly and moving deliberately might seem like antithetical concepts, but in the world of medical device development, they are inextricably linked. Given the emphasis placed on releasing products as soon as possible, it’s easy to imagine OEMs throwing caution to the wind in a mad dash to market, but in truth, the realities of the device industry mean that the best way to speed up the process is to carefully plan it out.

October 27, 2011

2 Min Read
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biomedevice.jpg“The bottom line here is, speed to market is about eliminating waste and roadblocks, and yet remaining compliant with the current standards and regulations, which is a good balancing act,” says Barry Craner, vice president of quality assurance and regulatory affairs at Stellartech Research Corp. (Amherst, NY). Craner is chairing the presentations scheduled for the second day of BIOMEDevice, which will cover different aspects of designing and developing medical devices from concept to production. According to Craner, careful planning and preparation are central to that process. Manufacturers must determine that there is an actual need and market for the product being designed.

“What we really have to understand is what the customer needs, [and] what the market will need,” Craner says. He cites Ford’s ill-fated Edsel, the 1950s sedan that famously flopped when no one wanted to buy it, as an example of a company moving forward on a product without carefully considering whether there would be a market for it. “They tried to launch a car that looked like [the one that] everybody wanted… but by the time it came out, it wasn’t marketable,” he says.

That’s why it’s important, Craner says, for companies to be fully aware of the market for any potential products, to know exactly what the product would be used for and whether there is any interest in that use. Companies that develop a tight specification for a product early in the design process have “a pretty good chance at a much faster development process,” he says.

san-jose.jpgA company that spends too much time adding features and capabilities to a product may be beaten to market by a competitor offering a simpler design, Craner says. That competitor will successfully brand its product, and by the time the first company is ready to release its more advanced version, the market may have moved on.
Craner says OEMs should have “a process in place that guides you in your analysis, makes sure that you have the right product spec for the right product…”

“You don’t want to be guessing along the way,” he says, “or especially after you have your approved product spec.”

Implementing each step of the design process carefully, with an awareness of the other steps, is key. This mentality holds true for many areas of design and development, such as supplier controls, materials selection, software verification, and complying with standards. Thoughtful and deliberate decisions make the process smoother in the end.

However, Craner says, it’s important not to let an obsession with thoroughness become a drag.

“You have to be careful, but you can’t let unmitigated caution stop you from taking actions that are appropriate,” he says.

—Thomas Blair

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