Dynamics of device innovation: implications for assessing value.

Area of Science:

• Health economics
• Medical device evaluation
• Clinical trial design

Background:

• Growing interest in health and economic impacts of medical devices.
• Payers use cost-effectiveness analyses and value-based purchasing.
• Current analytic approaches are ill-suited for medical devices compared to pharmaceuticals.

Purpose of the Study:

• To highlight unique challenges in medical device trials.
• To examine the evaluation of left ventricular assist devices (LVADs).
• To address challenges in device evaluation and policy-making.

Main Methods:

• Focus on the development and evaluation of left ventricular assist devices (LVADs).
• Comparison of device trials with pharmaceutical trials.
• Analysis of post-introduction innovation and 'learning by using' in devices.

Main Results:

• Medical devices exhibit greater post-introduction innovation than pharmaceuticals.
• The cost-effectiveness ratio for LVADs decreased significantly after initial trials.
• Initial cost-effectiveness was ~$600,000/life year saved, dropping to ~$100,000/life year saved.

Conclusions:

• Device innovation dynamics challenge traditional evaluation methods.
• Policy-making requires adaptation to the evolving nature of medical devices.
• New frameworks are needed for evaluating the value of medical devices.