A consortium led by the Digital Medicine Society (DiMe) is addressing the challenge faced by digital health product (DHP) developers in bringing their products to market in a commercially sustainable manner. The consortium, consisting of digital health and tech companies, pharma groups, government agencies, and patient organisations, aims to create an integrated evidence plan (IEP) model for DHPs.
This initiative comes in response to the rapid development of DHPs in recent years, where some pioneers in the sector have struggled to establish a market for their products. The IEP project, stemming from a survey conducted by DiMe, focuses on improving regulatory and commercial prospects by aligning evidence generation with both regulatory requirements and market realities.
The goal is to increase the chances of commercial success while reducing the cost and timelines of evidence generation for DHPs. DiMe's partners include Peterson Health Technology Institute, ZS Associates, and pharma companies such as Astellas, Genentech, Otsuka, and Takeda. The hope is that IEPs will facilitate more efficient and effective studies that address the needs of regulators, payers, purchasers, and end users of digital health products.
Previous projects by DiMe include initiatives for inclusivity in clinical trials and the development of digital endpoints for therapeutics development.
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