The digital health market exceeded $142B in 2020 and is projected to grow at over 17% per year through 2027. Digital health has the potential to redefine healthcare and improve lives, but with so many products in the market today, it can be difficult to know which ones are evidence-based and safe for use. Digital health innovators are just as confused as consumers.
Regulatory strategy can be a differentiator for digital solutions providers in the market. With support for your regulatory strategy decisions, you can pursue the appropriate path for your products and stand out from the competition.
Regulations don’t have to be daunting. DiMe’s Digital Health Regulatory Pathways project team is developing tools that will make it easier for you to know which pathways exist, if you need them, and how to pursue them so you can go to market faster. You can save time, money, and resources just by figuring out the right regulatory pathway for your products.
We are proud to be working alongside the following industry leaders and regulators to create new regulatory science resources for the field.
We want to help you seek regulation when appropriate and open your door to market access opportunities to better serve patients.
Creating action-oriented tools to support digital health innovators in knowing what it means to be regulated, what pathways exist, and the requirements and value of each option
Develop an interactive, open-source, public-facing regulatory science tool by defining key questions and explaining differences in pathways.
Create resources to enable commercial success while speeding the passage of high-quality digital health products to market.
Earn the trust of regulators, payers, clinicians, and patients to drive their appropriate use of digital health products.
How do I know if FDA regulations apply to my product?
How will regulatory strategy inform my commercial success?
This is just a preview of what’s to come.
These resources will be available in Q1 2023.