eConsent by Design
Built in-house. Designed for patients. Compliant without compromise.
Year: 2021–2022
Company: Better Therapeutics
Role: Product Manager
Scope: Product strategy, UX/UI design, Regulatory compliance, Content management
This case study demonstrates my ability to treat regulatory requirements as design drivers rather than obstacles — balancing regulatory constraints with user-centered experiences that created lasting business value.
OVERVIEW
I designed and launched an in-house eConsent product that replaced a third-party vendor for patient consent during Better Therapeutics’ Real World Evidence (RWE) study. The product was fully HIPAA and FDA (21 CFR Part 11) compliant, embedded directly into the existing web enrollment flow, and consented approximately half of the 1,000+ patients enrolled in the study.
THE CHALLENGE
Better Therapeutics was running clinical studies with partner health systems, and per study protocol, every patient had to sign an Informed Consent form before beginning treatment. When the company ran its Pivotal Trial, that process was handled by a third-party vendor. It worked. But it wasn’t good.
MY ROLE
I owned this project end-to-end as the Product Manager -- from scoping through launch. That included:
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Translating HIPAA and FDA compliance requirements into buildable product specs
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Leading UX design explorations with design and engineering
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Defining content management architecture
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Driving QA testing against the regulatory requirements that mattered most