This white paper was written in collaboration with Fierce Healthcare. Additional contributions came from Todd Greenwood, director of digital connected health at ZS.
Today’s digital health firms creating next-generation software-as-a-medical-device (SaMD) products and digital therapeutics regularly confront a conflict between rapid software development life cycles and methodical evidence generation procedures. Both processes are vital to successful product development and commercialization, but this conflict can be difficult to manage, especially for firms with little experience running clinical trials or seeking regulatory approvals.
Striking a balance between the two processes requires adopting a strategic, integrated approach to evidence generation that aligns the clearly defined phases of clinical research with the milestones of iterative software development. This close alignment between evidence generation and business goals helps forward-thinking firms conduct more valuable studies in less time while using fewer resources, generating evidence that brings greater value to the firm and its potential pharmaceutical and medical technology partners. As healthtech funding shrinks, it’s becoming more critical than ever for firms to get evidence generation right—the success of the digital health revolution depends on this.
Download this white paper to learn:
- How to address the inherent conflict between software development practices and evidence generation workflows
- The case for integrating evidence planning with digital health product development
- What integrated evidence planning looks like for companies developing digital therapeutics
- Perspectives on evidence generation from digital health company leaders
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