Ch 17 Managing Medical Devices within a Regulatory Framework

What is it about?

The dynamic circumstances in the health system, healthcare delivery, and the envelopment of digital health continue to redefine the definition of health technology management (HTM). This chapter reviews traditional HTM and encapsulates how emerging technologies—remote patient monitoring (RPM), open software interfaces, and biomaterial development, impact the future of HTM. Further, we suggest that HTM personnel can optimize existing information to address problems with technology transfer and interoperability by becoming more familiar with the business product development process (PDP), the National Library of Medicine’s Universal Medical Language Systems, and opening collaborative channels for funding and subject matter expertise that expedite regulatory approval and reimbursement.

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