Intrinsic properties of medical devices: considerations for economic evaluation

ABSTRACT

Introduction: In recent decades, medical devices (MDs) have increasingly become an integral part of patient care. However, when it comes to designing and appraising economic models, researchers typically follow pharmaceutical templates (e.g. CHEERS) to assess their economic viability. This study evaluates the generalizability of four device-specific criteria, as recommended by the recent MedtechHTA project, of learning curve, incremental innovation, dynamic pricing, and organizational impact with a broader group of MDs including diagnostics and implantables. The purpose was to determine the applicability of these criteria to a broader range of MDs.

Areas Covered: We determined the extent to which these criteria could be applied to each device type and attempted to identify common themes. We performed a literature search using PubMed and Google of a range of devices to understand the clinical significance, operation, and economic viability.

Expert Opinion: Our findings suggest that the four characteristics are not applicable to all device types. Prior evaluation of a device’s intrinsic properties (such as longevity and device location) and its FDA risk classification could help to indicate the applicability of the criteria. Documenting this process when assessing the additional four criteria on the CHEERS checklist would improve the transparency of future economic evaluations.

KEYWORDS:

• Economic evaluation
• medical devices
• intrinsic properties
• risk classification

Acknowledgment

This special report and the research behind it would not have been possible without the continued support of our HEOR colleagues at Medtronic especially Robert Giffin, Hung-lun Chien and Jianying Zhang.

Article Highlights

• Methods for the economic evaluation of medical devices (MDs) have typically mirrored those used for pharmaceuticals. However, there is growing recognition that device-specific aspects are not being fully captured in current economic models of MDs.

• The recent MedtechHTA project proposed four new device-specific criteria to be considered in economic models of MDs: the learning curve associated with the procedure, the incremental innovation process observed with MDs (such as the addition of new features), dynamic pricing of MDs, and any organizational impact associated with the introduction of a new MD. We set out to determine the applicability of these four criteria to a broad range of MDs.

• The applicability of each of the four characteristics depends on the clinical utility, procedure involved, and intensity of resources used in demonstrating the usefulness of MDs.

• There are intrinsic properties/characteristics of the MDs that play a crucial role regarding the relevance of the four characteristics. These properties, along with the risk involved in using the MD, precede the applicability of the four characteristics.

• During the economic evaluation of a MD, documenting the intrinsic properties of the MD as checklist items prior to verifying the four characteristics would improve the transparency of MD economic assessments, and ensure a common approach understood by researchers, reviewers, and decision-makers.

• Further assessment of the practical implications of incorporating the four characteristics into economic models in the future is needed to develop formal methods to ensure uptake by researchers.

Declaration of interest

The authors are salaried employees of Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This paper was not funded.