Cost-containment pressures in healthcare have led to more stringent requirements to demonstrate evidence of incremental value versus standard of care (SOC) by regulators and payers alike. Real-world evidence related to patterns and outcomes of care that complement traditional efficacy and safety data is increasingly warranted to ensure successful market access and product uptake, not only for biopharmaceutical products, but also for medical devices.
Efficiency, in addition to effectiveness, is a major value driver for many health care interventions. Time and Motion (T&M) studies are observational studies aiming to quantify time for a process by disaggregating it into its constituting parts to measure task durations.
As the evidence needs of diverse stakeholder groups increase, real-world evidence becomes invaluable to decision-making. The differentiating feature of novel medications, medical supplies, and devices, may be related to increased treatment or healthcare process efficiency as opposed to clinical outcomes.