Originally Published
MX September/October 2006
BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT
Increased Demand
For a variety of reasons, medical device manufacturers are seeing an increased demand for clinical data, both to fulfill regulatory requirements and their own internal business strategies. Reasons for this increased demand include the following.
Development of more complex devices that are classified as Class III or complex Class II devices. These devices require clinical data for marketing clearance or approval.
Increased competition. Such pressure requires more-sophisticated marketing strategies, including the ability to promote a device based on clinical data that differentiates the device from competitor products, as well as the need to effect labeling changes after a device is cleared or approved for marketing.
Increased demand for economic data to support more-stringent reimbursement and pricing scrutiny.
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