Ch 14 Managing Medical Devices within a Regulatory Framework

What is it about?

Historically limited scientific data collection for medical devices represents a global problem that has come to the fore based on various studies that indicate the poor quality of evidence used to determine medical device safety and effectiveness. National regulatory agencies have addressed the problem with increased guidance and standards regarding the conduct of clinical trials both pre- and postmarketing. Current limitations on personnel and budgets suggests that increasing the levels of scientific evidence throughout the total product life cycle (TPLC) can be achieved through the integration of Clinical and Biomedical Engineering Technology earlier in the TPLC prior to regulatory approval and with the development of standardized data anticipated to be generated from this approach. The objective of this modification to introduce CE into clinical trials is founded on their capacity to use biometric and physiological indicators as well as engineering capacity to offset the potential for adverse events in patient-device interfaces. The suggested use of biometrics measured in situ simulation to evaluate important characteristics of health benefits and value of new technology could become additional data fields from which to draw short- and long-term assessments throughout the TPLC.

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Why is it important?

The study identifies important regulation and health technology basics to support the recommendation.