Encouraging Product Adoption as the Bar Rises for New Technology
BY LAUREN UZDIENSKI, APRIL 1, 2008
In the past decade, the use of intramedullary nails in the treatment of hip fractures has increased substantially, despite a lack of evidence supporting the benefits of their use. Additionally, use of the nails varies by geography, differing more than tenfold among states.
This example illustrates one of the main points Drs. Kevin Bozic and Joshua Jacobs argue in an editorial published this month in JBJS: stronger evidence is needed in support of innovative technologies, but there should also be an effective means of disseminating product information, one which would likely result from collaboration between industry, physicians and other stakeholders. Additionally, the authors identify the particular challenges orthopedics companies face in addressing evolving data requirements and the rising costs of healthcare.
A controlled, randomized clinical trial is often impractical or unethical in the case of a surgical implant, but the authors encourage industry as well as physicians, payers and patients to consider other sources of product data as well. These sources include well-designed observational cohort studies, decision analysis models, medical device registries and administrative databases. At their recent AAOS analyst meeting, Smith & Nephew cited Australian registry data as support for the BHR, offering one recent example of devicemakers sourcing evidence beyond the clinical trial. The expecations for data are also increasing; payers are looking to comparative effectiveness studies in evaluating new technology, and it is advantageous for devicemakers to consider their product's clinical efficacy, safety and cost-effectiveness relative to the gold-standard technology.
The article also suggests that physicians could benefit from additional training on the principles of evidence-based medicine, so they can more effectively interpret and apply the data in clinical decision-making. The article also reminds devicemakers of the nonclinical components that contribute to technology decisions such as local practice norms, perceived ease of use and technical difficulty, relationships with device companies, DTC advertising and financial incentives. As data expectations are increased, with an eye toward industry-wide standards of care, the authors imply that these nonclinical factors may become less prominent.
Diffusion of evidence is key to adoption, and the authors suggest the emphasis on strong data could benefit the practice of orthopedics more broadly; the data could be pooled and used to develop evidence-based clinical practice guidelines, for example. This possibility further conveys that evidence will continue to become more core to clinical decisionmaking, increasing the pressure on new technology not only to perform on its own merits, but to demonstrate its value when considered for comparative and cost effectiveness.
