McDonald said Ximedica tries to make enough changes in the prototype during the formative process to avoid any surprises during human factors validation testing.

In-house or contracted out
The process is fairly similar for device manufacturers that choose to have in-house staff take on the design process.

During a panel on medical device development at MD&M East in New York City in June, in-house designers from Medtronic and Ethicon, a Johnson & Johnson company, noted that their companies also relied on clinical observation when beginning the design process, using 3D-printed parts and even virtual reality tools to quickly make prototypes for clinicians to test out.

Boutet of EPAM Continuum explained that the manufacturers who contract out their design process usually have decided to focus their resources on engineering, computer programming and marketing.

“We often provide a different perspective and a different approach than some of these companies would take,” Boutet said. The manufacturer is “focused on the engineering and technology and getting it into the box, and we’re focused on the people and their needs.”

Kevin Fitzgerald, senior manager within R&D at Medtronic, said his company designs and develops most of its products, including surgical instruments and software, in house, while partnering with outside companies on certain projects. For example, Medtronic partnered with Farm when it began developing its StealthStation S8 surgical navigation system, with Farm helping to provide an initial framework for the design that included some of the elements of consumer electronics that people use every day.

“When we want to make sure we’re aligned with the present-day best practices and take advantage of what people already know on their consumer electronics, that’s when we’ll consider seeking external help,” Fitzgerald said. “We want to make sure our products are modern and cutting edge.”

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