
clinical trial endpoints
It's never too soon to embrace a reimbursement mindset for your medical device. With advance planning, you can leverage clinical trials to inform and accelerate your go-to-market strategy.
"Good plans shape good decisions."
- Lester Bittel
Are You Making the Most of Clinical Evidence?
The clinical trial phase is a pivotal time in the product commercialization process. Ideally, trials should set the stage for device reimbursement.
Unfortunately, too often, device manufacturers design clinical studies without carefully considering reimbursement objectives. Instead, they focus on endpoints that lead to FDA approval - which isn't sufficient for reimbursement. As a result, they don't gather adequate real-world evidence to support reimbursement's three essential elements:
- Coverage
- Coding
- Payment
This familiar oversight can delay your product introduction - which in turn, limits your access to revenues. But it doesn't have to be that way.
Design with Reimbursement in Mind
At JR Associates, we specialize in helping you:
- Establish relevant clinical trial benchmarks for coverage, coding and payment
- Identify appropriate data to collect in support of your target metrics
Bottom line - Start with meaningful, specific endpoints, and you'll make the path to reimbursement easier for healthcare providers. This reduces time-to-payment for procedures involving your device, while increasing patient access to your medical technology.
Do you seek a more strategic approach to clinical trials?
Don't make costly mistakes.
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