Guiding you through the world of device development and commercialization.

"Image of a medical device environment. Includes headline: Get In-Step With Government Guidelines"

policy alignment

How well does your medical innovation comply with state and federal requirements? Where are your weakest links? Avoid costly pitfalls - let reimbursement experts guide your strategy.

Recognize and Respond to Relevant Regulations

It doesn't take an industry expert to know that U.S. healthcare policies are complex and fluid. But in this challenging environment, insight and experience can make a big difference in advancing your device technology. Let us show you how.

Don't be Blindsided

Many device manufacturers focus solely on winning FDA approval. True - it's a key to selling medical technology. But FDA approval isn't the only hurdle. Why?

The FDA focuses on safety and efficacy, rather than patient outcomes. Yet increasingly, payers consider treatment results in their coverage decisions. Bottom line - if clinical evidence doesn't demonstrate improved patient outcomes, coverage is likely to be jeopardized.

We'll Keep Your Plan on Track

Missteps are common - but not with JR Associates by your side.

We continuously monitor legislative and health policy regulations. We know how to keep your FDA approval pathway aligned with other regulations and coverage policies. In addition, we maintain ongoing relationships with payers and governing institutions.

     Alignment Process

  • Investigate relevant prevailing standards
  • Assess the potential for coverage within today's regulatory scheme
  • Address gaps by modifying device positioning to follow existing coverage (if appropriate)
  • Consider trends that might shift coverage in your favor (or pose a threat)
  • Clarify steps for proactive advocacy among policy makers, payers and other players

Let's talk about how to strengthen your regulatory strategy...
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