A product's life cycle ranges from initial design through post-launch activities. Princeton Reimbursement Group provides services during all phases of your product's life cycle to greatly enhance your product's opportunities for market success.
Product Definition
Our reimbursement feasibility analysis identifies both opportunities and roadblocks before a new medical product is fully defined.
Product Development
We establish a strategic reimbursement plan and conduct cost modeling early in the product development process to increase a product's chances for success in the marketplace.
Clinical Trials
Our experts can assist in designing clinical trials that will collect data to demonstrate the product's clinical benefits and cost effectiveness versus other treatment options.
We also have experience that can help you achieve reimbursement during clinical trials, which can provide an early revenue stream along with developing a charge history for your product.
Outcomes Studies
Payers will compare your new technology with existing procedures and want an understanding of financial benefits for the healthcare system. Pursuing an outcomes study will generate clinical, economic and quality-of-life data for economic analyses.
Regulatory Submissions
Our reimbursement analysis provides information that can assist in regulatory decisions that adequately address FDA requirements and consider CMS requirements. These agencies have different mandates but both are instrumental in achieving product success. We can assist you with creating an appropriate strategy for your regulatory submission and reimbursement pathway.
Our alliance partner, Horwath Resource Group, is available to support all of your FDA regulatory needs including the preparation and submission of IDEs, 510ks and PMAs for all classes of medical devices.
Market Launch
Through payer advocacy activities and provider assistance programs, we can help introduce a new product to multiple audiences in targeted ways that will determine its ultimate success.
Post Launch
Economic modeling and analyses can be used to expand markets and enhance product sales. In addition, carefully planned, ongoing advocacy and reimbursement education can improve opportunities for long-term product success.