Time and Motion Studies: Building Economic Value Messages for Medical Devices

Time and Motion Studies: Building Economic Value Messages for Medical Devices

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.

Traditionally, the value of investing in novel medications is measured in terms of the incremental cost-effectiveness ratio (ICER) compared to SOC. When the ICER falls within an established monetary threshold, the technology is considered cost-effective. This requires robust evidence of both the effectiveness and costs associated with the treatment. Today, a new method of establishing cost-effectiveness is the “Efficiency Frontier,” which does not set a fixed financial threshold against which new treatments are compared and does not demand measures such as quality-adjusted life years (QALYs), which are used to estimate how many healthy years an individual may gain from a treatment. The new approach exemplifies a drive towards a more holistic view on cost-effectiveness, including the explicit notion of efficiency.

In the case of medical devices, economic value is often reflected in efficiency-related outcomes resulting in messages of time and/or cost savings afforded to patients, providers, and healthcare administrators. For example, efficiency is an important dimension of the product’s value profile if the device can simplify or streamline healthcare delivery and reduce total staff time and/or resource allocation compared to SOC.

In this context, Time and Motion (T&M) studies can be employed as a methodology to evaluate and quantify efficiency-related outcomes of interest. A T&M study is a type of observational study that aims to:

  • Quantify the impact of a medical technology on healthcare resource allocation and/or delivery process
  • Identify the specific resources utilized
  • Quantify patient and/or caregiver time

Such evidence of “value” may be used to populate health economic analyses, including models that can quantify facility efficiency, patient throughput, cost-effectiveness, and budget impact. This evidence may be crucial to demonstrating a product’s true economic potential.

Thus, T&M studies can generate robust estimates of process time as well as efficiency-based evidence geared towards different stakeholders, including patients, HCPs, hospital administrators, payer, and government/health technology assessment bodies.

Example outcomes resulting from T&M studies can be expressed as savings in terms of:

  • Staff time
  • Nuclear imaging machine time
  • Operating theatre time
  • Travel time
  • Patient waiting time

These metrics can be provided for either an individual patient or for a centre population. Time savings can be monetized to reflect the opportunity cost of freeing up personnel and/or facility time; in other words, the value of the best available use of the time. The impact of facility time freed up on patient throughput and healthcare facility capacity, including the effect on unit revenue (in a context of fee-for-service funding) can also be quantified. Such derived evidence can serve as crucial inputs for activity-based costing exercises or to inform healthcare management decisions. These studies and the evidence they collect can also help generate economic value messages through micro-costing, efficiency models, or other types of health economic techniques.

Through extensive experience, UBC has developed a step-wise approach for the design of scientifically robust T&M studies that are feasible to conduct. Contact us to start building the value story for your new drug formulation or medical device or attend our upcoming presentation at the NextLevel Medical Device Access Leaders Forum on Wednesday, December 10 at 11:30 a.m.