DiMe has assembled a global team of digital health experts, including S3 Connected Health, to support digital health product developers in pursuing and optimising their regulatory, evidence generation, and business strategies across multiple global markets and regulatory regions.
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The new project ‘International Regulatory Pathways’ will combine the expertise and experience of the project team, with current global digital health product regulations, regulatory science, and industry pathways, to support life science companies looking to achieve accelerated access through multi-market evidence plans for digital health initiatives.
S3 Connected Health will bring its 20+ years of experience in both the development and the commercialisation of a wide range of digital health solutions and digital therapeutics to the project. S3 Connected Health, as part of this project, aims to help guide digital health manufacturers in navigating complex international regulations to ensure compliance and success on a global scale.
Megan Coder, DiMe's vice president for product and policy said: "We're excited to partner with experts like S3 Connected Health as we bring together a global project team of diverse backgrounds and perspectives to dive into DHT clinical evidence requirements within and across critical global markets. A good business strategy should include a good global regulatory strategy. The International Regulatory Pathways project team will develop the resources and guidance needed for companies to build a global strategy that benefits from streamlined clinical studies, expanded market reach, and ultimately, scalable patient impact.”
The work of this project will be split into two streams. The first will consist of collating the different product types, regulatory pathways, and evidentiary requirements in key global markets with the goal of making this information readily available in one place. The second stream will consider the different digital product types, regulatory pathways, and evidentiary requirements across the US and in-scope markets to develop global regulatory pathways map for all in-scope markets, which will initially include selected European and Asia-Pacific countries, and the US.
Commenting on joining this project team, Brian Flatley, VP of consulting services at S3 Connected Health said: “We are delighted to collaborate with an esteemed team of experts on the International Regulatory Pathways project. This type of collaborative project will serve as an invaluable resource for the digital health community as they look to scale products across markets.”
