Green Sun Medical and other innovative life science companies in Colorado recognize the necessity of incorporating patient input in the development and design of their products. And they’re not alone. The influential journal Health Affairs declared patient engagement “the blockbuster drug” of the twenty-first cen- tury, noting the evi- dence-based view that involving patients in their care often leads to better outcomes. In recent years, there has been a shift in how drug and device com- panies engage patients and look to them as partners in research and development. The value of patient input is reflected at the FDA through initiatives like Patient-Focused Drug Development and the Patient Preference Initiative launched through FDA’s Center for Devices and Radiological Health. Successful legislative proposals like the 21st Century Cures Act also emphasize the need for patient engage- ment, with provisions designed to define and standardize the use of patient experience data in regulatory decision making. Green Sun Medical CEO Jamie Haggard said the company quickly realized that getting input about the brace from those who would wear it was a must. “Thereisnodoubtthatbiomechanicallywehavea bracethatisgoingtoknockitoutoftheparkfor80 percent of these kids,” he said. But biomechanics alone wouldn’t ensure suc- cesswith10-to14-year-old girls, who are about seven times more likely than boys to have scoliosis. “We wanted to find out what they didn’t like about the brace – what would make them take it off,” Haggard said. “We told them, ʻIf you’re too nice we’re not going to be able to help you. We need to know everything that’s wrong [with the brace], even the littlest things.’” Anna Bowman liked that the Dynamic Brace made it easier to move, but she had plenty of suggestions for improvement. The first version took too long to put on, she told Haggard and Thompson, and it had three thick, uncomfort- able layers. It had a fin-like part that poked out in back. The brace pinched her ribs and hips when she sat down. A shirt over the brace went up to the neck, an invitation to unwelcome questions. “I didn’t want anyone saying, ʻHey, what’s that?’” Anna said. “Patients don’t want anyone to know they’re wearing a brace,” Thompson acknowledged. The company went back to the drawing board and addressed those issues with fixes like additional padding on the brace rings, thinner fabric and more. “It’s now less obvious than a thin plastic brace,” Thompson said. Incorporating a patient or consumer viewpoint is also vital to industry problem solving. On a mid-February morning, a lifesaving operation quietly hummed in an unlikely space: an office building in the shadow of the foothills over Golden, Colorado. Blood donors lay comfortably in recliners at the Vitalant™ Denver West donation center, one of the organization’s eight blood-collection facili- ties in Colorado. Hospitals and other providers dependonthesedonorstomeetshiftingdemand for precious blood supplies. “Having enough blood products to go around is a constant battle,” said Liz Lambert, a marketing and communications specialist for Vitalant. She noted that in Colorado, Vitalant’s base of apher- esis donors – those who supply red blood cells, platelets and plasma separated from blood that is then returned to their bodies – has hovered for several years at around 3,100. Donors of platelets, proud to protect bioscience innovations The Rocky Mountain Region’s largest intellectual property firm and proud member of the Colorado Bioscience Association. sheridanross.com 303.863.9700 Denver / Broomfield patent / trademark / copyright / litigation Anna Bowman of Virginia 14 BIOSCIENCECOLORADO / / 2019-2020