Quality Engineers and R&D – A Match Made for Innovation

There are two figures that David Amor points to when talking about the role of quality engineers (QEs) - Tony Stark (Iron Man), and MacGyver. He says that, like Tony Stark, QE s need to be very technically savyy, “Technically, quality engineers need to be just as good as development folks.” Yet, like MacGyver, they also have to be versatile. In fact, one of the best things a manufacturer can do for its QEs is to “make sure they're involved in the clinical aspect of things.” The key is to create synergy between QEs and R&D, with the ultimate aim of creating better products.

In a talk on Feb. 13, at MD&M West, “Innovating with Quality in Mind,” David Amor, design quality engineer at St. Jude Medical and his colleague Madhavi Ayyalasomayajula, senior design assurance engineer at St. Jude, both pointed out that there is always room for innovation – but only when QE and R&D are working together. They both cite examples in their experience in which a lack of communication between these two groups resulted in significant issues for a product. A sterile pouch product was delayed three months because QE and R&D miscommunicated as to whether the inner or outer layer of the pouch should be sterile. Another product failed leak testing six months after rollout because the R&D team tested it using a unique method instead of the ISO standard method QE wanted. On the flipside, QE and R&D collaboration early on in the development stage of a catheter product resulted in the catheter being a much safer product. “Eliminating Risk is an innovation in itself,” Amor says.

“Today QEs are facing increasing burdens from additional regulatory pressures, increased job scope, and an aging medtech engineer sector,” says Amor. “As a result they are often seen as a barrier to progress [by R&D].” But Amor and Ayyalasomayajula agree that this need not be the case. With product design and manufacturing contributing to more than half of adverse event reports it is crucial that QEs and R&D have a comprehensive understanding of each other.

A big part of achieving that, they stress, is to never go with a “gut feeling” or to continue with a system because “that's just the way it's done” or because “its always worked before.” QEs and R&D should be able to answer the whys of every step of their process and thinking – always providing objective evidence. “You as a QE should be able to provide the same sort of justification you would expect from an R&D,” Ayyalasomayajula says.

She adds that QEs need to “think hypothetically, but act practically” and the step toward creating this synergistic relationship is in proper QE training. Among various training methods Amor and Ayyalasomayajula suggest role reversals - having QEs spend time actually building a product as R&D does, having QEs become experts on standard operating procedures, and pairing with senior QEs to establish a “trust but verify” relationship. If QEs and R&D feel free and comfortable to communicate in order to constantly, constructively question one another – each with the goal of making sure the other understands the process – the result, Amor and Ayyalasomayajula say, will be better overall product quality. “Bring quality engineers in early and often,” Amor says. Doing this will turn them from an obstacle, to a vital and appreciated part of the product development cycle.

-Chris Wiltz is the Associate Editor of MD+DI  

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