Abstract
Since the 1990s regulation has been relatively unchanged in the world’s second largest medical technology sector, the European Union. However, recent medical device-related incidents involving breast implants and hip replacements have prompted urgent regulatory and compliance reforms. Against the background of increasing global healthcare costs and an aging population, medical devices including spinal devices are about to undergo one of the industry’s most transformational regulatory changes. What does this mean for current and potential innovators of new medical device technologies and their beneficiaries? What will future reimbursement and regulatory frameworks look like, and what will be their impact on medical device technology investment? Navigating the complex requirements of innovative medical device development such as increasing regulatory burden and a multitude of differing payer uncertainties can often be the hurdle to sustained device innovation for many companies.
NB: this work is not related to the views or opinions of Prism Surgical
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Young, E. (2019). Effects of Reimbursement and Regulation on the Delivery of Spinal Device Innovation and Technology: An Industry Perspective. In: Cheng, B. (eds) Handbook of Spine Technology. Springer, Cham. https://doi.org/10.1007/978-3-319-33037-2_95-1
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DOI: https://doi.org/10.1007/978-3-319-33037-2_95-1
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