Article | November 22, 2016

Balancing Technologically Advanced Products and Thrifty Healthcare Consumers

Source: Phillips-Medisize
CLIA – Clinical Laboratory Improvement Amendments

Developers of diagnostics devices are faced with the ever-increasing challenge of balancing the drive to create technologically advanced products with the pressures of today’s thrifty healthcare consumers. During the innovation process, the question often arises as to what level of regulation a diagnostic product needs to be designed, manufactured, and tested to. This article provides a brief overview of the requirements and considerations for the clinical diagnostic innovations.