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Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace

Economic Considerations

In today’s dynamic orthopaedic environment, effectively navigating the reimbursement landscape is critical to achieving product success. The general contraction across some segments of the market is in part due to payors developing stricter coverage criteria. Much of a product’s success is determined by effectively proving and communicating the clinical and economic value of a product to payors, physicians, facilities and of course patients. The key to success in this demanding marketplace is credible clinical and economic data. Whether your product is at the idea stage or you are planning for commercialization, be mindful of the following:

  • FDA approval does not mean payor approval.
  • Demonstrating that your product is not inferior to an existing product may gain FDA clearance, but may not be sufficient evidence to achieve payor coverage and payment.
  • Published data in peer-reviewed journals will be required for code applications and payor coverage decisions.
  • Economic data is critical to justify that the benefits of a technology are worth its cost.
  • Long term post clearance data are frequently being requested for orthopaedic and spine devices to establish long term safety and efficacy.
  • Early reimbursement planning is critical to achieve payor acceptance and adequate payment.

Study Design Considerations

The challenges within the regulatory and reimbursement environments lead to a need for convincing clinical evidence. However, designing clinical trials in orthopaedic medicine is a challenge. Prospective, randomized, controlled clinical trials are considered scientifically rigorous; however, historically, these exacting trials represent only a small percentage of the research conducted in orthopaedic medicine. The relatively small number of rigorous clinical trials is due to a host of issues that are somewhat unique to orthopaedic interventions.

Today more than ever we need to carefully evaluate all available study design tools and strategies to ensure that we are maximizing the likelihood of obtaining convincing clinical data. When designing a trial in orthopaedic medicine, researchers must sort through a number of common questions such as:

  • What is the best control?
  • What are the most appropriate primary and secondary endpoints?
  • What is the most efficient method of statistical analysis?