device makers now must be on the offensive, jockeying for position on the world stage.

Designing and developing medical devices is  challenging. It involves designing for customers, for regulatory approval, and for optimal chances of reimbursement. With healthcare reform and changes at FDA, it is more complicated than ever. There is no single model that industry can follow to ensure its place in the global marketplace. But some companies are placing an increasing emphasis on innovation and looking at new ways  to overcome the challenges. Battelle, an independent research and development organization based in  Columbus, OH, has turned to OhioHealth’s Center for Medical Education + Innovation (CME+I) at Riverside Methodist Hospital to forge a partnership of innovation. Battelle says the five-year-old, state-of-the-art facility for medical training and concept and new product testing serves as the perfect spot to get prototypes into action.

“To effectively advance innovation and be proactive, you must anticipate the future and react ahead of the curve,” says Reade Harpham, manager of the Human Centric Design group in Battelle’s Health and Life Sciences Global Business. “Battelle’s collaboration with CME+I allows us to merge end-user feedback with cutting-edge technology from the inception of an idea.” Harpham says that this approach ensures that the firm’s development teams have an early understanding of the boundaries in which they have to innovate. Such an approach enables Battelle to focus on risk earlier in the development process, allowing new technologies to live up to their potential.

Harpham says FDA has become more stringent than ever on use error on medical devices. He says that while FDA strongly recommends that developers like Battelle incorporate real-world feedback into their designs, increased restrictions in hospitals make it difficult to get early-stage designs of medical devices into those end-use environments.
He also points out that integrating early feedback from end-users is very similar to the benefits of bringing manufacturing in as early as possible during development. “Early insight from all stakeholders allows the development team to anticipate issues before they happen and to take the appropriate action,” he says. “It is much less expensive to find and fix a problem in the very early stages of development than when it is further downstream.”

The collaboration with CME+I enables Battelle to test products with end users in their environments to mitigate problems. “We’re simulating real-world user feedback from almost the inception of the idea without the worry of compromising a patient’s privacy,” says Harpham.

Such early insight can drastically cut down on cost and time for the development of a new medical device. “People partner with Battelle to develop cutting-edge medical devices that are safe, effective, and easy to use,” Harpham said. “Collaborating with CME+I has proven to be a critical aspect of our ability to do just that.” 

So in the battle to remain at the top, U.S. device makers might look to Battelle for a method to spur innovation. Battelle’s program emphasizes early user interaction. “The single most critical element of this program is the ability to get early user insight to our ideas,” notes Harpham. “This insight guides every step of development, ensuring that we deliver a safe, effective, and relevant [products] to impact human health.” Good goals for all device manufacturers.  

Sherrie Conroy
[email protected]