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Overview Reimbursement


Challenges for Medical Device Makers


When medical device entrepreneur Kelvin Ning started working in Silicon Valley 13 years ago, no one talked very much about reimbursement for new devices. “Just know what they [competitors] are charging for their device—and that’s what you’ll get,” he recalls his colleagues telling him. Ten, three years ago, when the medical device company he worked for was hav-


ing problems with reimbursement, Ning decided to school himself on the subject. He realized there were deficiencies in the firm’s clinical data, and that the company had to play catch-up to solve the problem. “At the end it all comes down to the very beginning,” says Ning, who currently


is associate director of business and technical development for BioAccel (Phoenix, AZ), a nonprofit that helps commercialize late-stage biomedical research. In other words, according to Ning and reimbursement and supply chain experts interviewed for this article, manufacturers of the 5000–8000 medical devices in the


How medical OEMs can best prepare for running the approval gauntlet—and the consequences of falling short.


Robust data will help a medical device maker get his product into the supply chain and, ultimately, into the hands of users for the benefit of patients.


United States are wise to plot strategies to collect meaningful data while their ideas are still in the research and development stage. Tey also say that planning early and enlisting the aid of experts, in addition to actually collecting the data, cannot only smooth the road to commercialization for a device newly approved by the Food and Drug Administration (FDA), but also add value to the product.


Ilene Wolff Contributing Editor


Medical Manufacturing 2013 19


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