The regulatory process has always been fairly difficult to translate and formalize into one general best practice. Over the past decade, federal agencies (such as CMS, FDA, ONC, and others) have moved from their independent silos
to a more coordinated regulatory process. This has
created a more complex terrain to navigate for
As former authors and directors of federal regulations and programs, our experts at Elevation support regulatory coordination. However, we have quickly realized the barriers companies face in conducting regulatory due diligence. Elevation was uniquely created with a strategic combination of regulatory expertise and real-world operators.
We provide health technology companies with regulatory due diligence for the most important and highly impactful national policy verticals
Companies must steer through these verticals to thrive in today's heavily regulated healthcare market.
Translating available payment codes into sustainable health tech business models that align with real world health delivery workflows.
Understanding the intent behind federal, state, and private payer policies to create product strategies that accounts for current and emerging reimbursement options.
Design your product and services to optimize the data collection necessary to support required documentation for various payment models.
Tailor the application and implementation of available payment codes to match provider workflows and ensure a return of investment in your health tech products.
Align to the right approval pathway in the midst of evolving FDA policies and programs to maximize R&D budgets and accelerate go-to-market timelines and compete at the highest of levels.
Evaluate the capabilities and intended use of your products against FDA regulatory requirements and capitalize on FDA programs intended to streamline the device approval process.