Regulatory Processes & Innovation Cycles in Times of Digitalization – a Contradiction?

Titelangaben

Konrad, Peter:
Regulatory Processes & Innovation Cycles in Times of Digitalization – a Contradiction?
In: Schmid, Andreas ; Singh, Simone (Hrsg.): Crossing Borders - Innovation in the U.S. Health Care System. - Bayreuth : P.C.O. , 2017 . - S. 163-181 . - (Schriften zur Gesundheitsökonomie ; 84 )
ISBN 978-3-941678-63-7

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Abstract

Digitalization - without a doubt - is the main driver of innovation nowadays. This phenomenon takes place in almost every business, even within the medical device industry digital development is an important driving force. Digitalization allows a broad range of people to create their own mobile applications, as demonstrated by the enormous number of digital products available for mobile devices. While the simplified creation of digital products accelerates innovation in the medical device industry, regulatory processes remain the same yet seem to be necessary to provide a safe market entry. This work examines the influence of digital innovation on medical devices and compares the regulatory processes in the US and Germany. Therefore, a theoretical background of innovation and regulation theory is given. Subsequently, the regulatory systems of medical devices in the US and Germany are analyzed regarding their fit for mobile applications. After describing problems arising due to long and inappropriate regulation systems, recommendations are given by a fictive regulatory system on how regulatory processes can be adjusted to accommodate mobile medical applications.