A fledgling company works to bring its first product to market He had reached a crossroads in REGULATORY PATHWAYS FOR MEDICAL its development
JUNE 2014 FDA CASE STUDY A fledgling company works to bring its first product to market He had reached a crossroads in REGULATORY PATHWAYS FOR MEDICAL its development; its key features could be designed to operate DEVICES: CIOOSING THE RIGHT ONE electronically or mechanically. . . . . . . Both were appealing. But which THIS FICTIONALIZED CASE STUDY IS THE FIRST IN AN EDUCATIONAL design would make it smoothly SERIES PUBLISHED BY THE U.S. FOOD AND DRUG ADMINISTRATION. through the regulatory process to the marketplace? Which one would For 35 years, Henry Neyhard had more than once. It burned off his succeed? practiced pediatrics in this 1970s capital, and the devices never beige brick building. When he first reached the patients he was trying The Proteges opened his doors, the building to help. A wiry, energetic young woman with seemed hip and modern-a fresh short brown hair stuck her head in start. Exactly what he needed Neyhard’s latest invention: an his office. Sten Laws. Neyhard had After his residency, he had taken a insulin infusion pump. The device hired her to prepare a business plan detour in his career and founded a could deliver insulin at preset rates and help recruit investors for the medical device company, combining with simple user features, allowing development and manufacturing his love for medicine with his patients to adhere to their regimens drive for invention. Where others of the insulin infusion device. Laws with increased compliance. was finishing business school saw problems, he saw solutions. Although the device was intended at the end of the month and had But turning his ideas into reality for adults with diabetes, his eluded him. He struggled to get ultimate goal was to improve the jumped at the chance to get a new venture off the ground. With her his business off the ground, and care of pediatric patients. This was Rush Mooney, a tall, thoughtful funds ran out before his products time, Neyhard thought, would engineering student about to reached the market. He closed the be different. He would design graduate from the same university. company and opened his medical the device right the first time. practice. Neyhard was a gifted pediatrician, and his patients and practice thrived. And yet, almost daily, a medical instrument or piece of equipment disappointed him. He knew he could do better. At night, on his own time and with his own resources, he tinkered. All in all, Neyhard had filed more than 20 patents for medical devices over the years. Each time, he was beaten to market by competitors who were more savvy about product development and marketing. He was forced to redevelop the device, sometimes
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