With the Accountable Care Act, now more lives are covered and the total cost burden
of healthcare is greater. Thus, payers (private and public) are seeking ways to
reduce costs. It is no longer enough to follow the FDA’s design control process
with a sole focus on the physician and patient. The payer’s need for proof of
economic value must also be considered.


Success Tip:

  • Consider the patient, physician and the payer during the “User Needs” phase:
    • Integrate product design, clinical study design and regulatory strategy with a complementary reimbursement strategy
    • Ensure the clinical data plan includes assessments of economic value and clinical outcomes

Resulting benefits include:

  • Patient realizes improved health with innovation
  • Physician benefits from a new treatment option
  • Payer will reward demonstration of improved outcomes at a lower cost

For on demand commercialization and reimbursement leadership, email us at hello@ruckuspartners.com or call 650-743-0059.