Are you picturing your global launch, but unsure how to position your product across different regulatory requirements?

Do you want to unlock reimbursement possibilities for your users?

Blue circular traffic signs with white arrows pointing left and right, mounted on a white wall. FemTech regulatory consulting.

The challenge:

Regulatory requirements vary between the US, EU, Canada, and other markets. Time is money, and you need a regulatory strategy that gets you to market as fast as possible, while mitigating regulatory risk. You’d also like your users to be able to unlock healthcare reimbursement.

The approach:

  1. Assess multiple geographies to identify the least burdensome route to market

  2. Plan your design and development activities to make future authorizations easier (FDA, MDR, TGA…)

  3. Map reimbursement possibilities and requirements to make sure you are collecting the right data, now.

  4. Unlock possible quick wins for health account spending (USA)

Real-world KPIs:

  1. Strong documentation to justify ‘borderline’ devices as wellness products (faster market entry)

  2. Bench and user testing plans to satisfy FDA and MDR requirements: 100% approval of FDA 510(k) submissions

  3. Listing devices for FSA-HSA reimbursement (USA) with less than 2 month turnaround

Benefits:

  1. Get your product into the hands of real users, fast, with wellness device positioning

  2. A clear testing and development plan means less unnecessary spending and faster time to submission

  3. FSA-HSA reimbursement can differentiate your product from competitors and means cost savings for your users (USA only)