The sooner you begin thinking about your solution’s regulatory strategy, the better. It can be an expensive, cumbersome, and tedious process – but it doesn’t have to be.
While many organizations equate regulation with approval from the U.S. Food and Drug Administration (FDA), that’s only one option. Decimal.health has helped dozens of digital health startups navigate the complex regulatory landscape and attain digital transformation (DTx) or software-as-medical-device (SAMD) certifications and/or clearances or approvals.
We can help you determine which FDA approval pathway is the right route for you – we have guided numerous companies through the FDA registration and/or approval process. Each pathway has different implications for reimbursement potential, clinical workflows, investment requirements, and timelines.
We’re by your side as you build your regulatory claim, ensure it has all the elements necessary, and work with the appropriate regulatory agency as you pursue approval.
No matter how stellar your digital health solution is, your best chance of success lies in incentivizing the clinician on the ground to offer your product to their patients. A solid reimbursement strategy is an important component for doing just that, and digital health reimbursement is a constantly shifting landscape. That’s why forward-thinking companies require an expert partner like Decimal.health to develop a viable reimbursement strategy.
Our service helps founders and funders answer the following key questions:
- Which CPT codes are relevant, and when?
- How much reimbursement should you expect from each code?
- Is a physician required to bill these codes?
- Who bills and when, and what documentation is needed to do so successfully?
- Is a regulatory filing a necessary precursor to getting reimbursement?
- What evidence is required to qualify for a CPT code?
- What effect will the current reimbursement terms and conditions have on your business?
U.S. market entry program for founders and funders:
Organizations wishing to break into the U.S. market can benefit from Decimal.health’s robust support model.
Part community, part academy, it provides digital health entrepreneurs and VCs with a structured curriculum designed to navigate the challenges of building and growing a sustainable health tech company that does business in the U.S. The program includes the following educational modules:
- Introduction to U.S. healthcare
- Pharma, providers, and payers 101
- Navigating the U.S. reimbursement and regulatory landscape
- Understanding value-based care
- Clinical workflows and role of digital health
- Understanding the competitive landscape
- Developing your company’s value proposition
The program also includes mentorship from Decimal.health’s experienced digital health professionals, enabling our team to customize the program for your specific company or product.
Decimal health will establish the foundations for meaningful scale and structures needed for commercial growth. Decimals proven sales leadership can help:
- Recruit and establish sales
- Provide sales enablement through playbooks and training
- Shape approaches and requirements for deal structures
- Secure in-market traction for pilots and deals that can scale
- Open doors to potential customers in your target segments
Due diligence and digital health portfolio management:
Health tech is a highly regulated industry. To capitalize on the opportunities available, you need to be sure that there are no surprises. As health tech experts, we conduct due diligence for each potential partner or investment.
Whether you have a broad fund representing several industry verticals or a healthcare-specific fund with a range of companies represented, Decimal.health offers health-specific expertise to support optimal health tech decision making.