Turning FDA compliance from a barrier into
a platform.

Creative Direction • Brand Strategy • Identity Design • Web Design • Product Strategy • Product Design

While serving as CTO of Science 37, Kelly Chu recognized a major obstacle facing digital health companies: navigating FDA compliance was expensive, manual, and painfully slow.

He developed an automated approach and spun the idea into Sierra Labs. As he exited Science 37, I left shortly after to lead creative for the new company—once again helping transform an ambitious idea into a credible brand and product.

THE CHALLENGE

Regulatory compliance consumed enormous time and resources, yet most companies still relied on consultants, spreadsheets, disconnected software, and manual processes.

Sierra Labs saw an opportunity to make compliance more accessible, automated, and integrated into the way digital health products were built.

THE WORK

As Director of Product Design, I led both brand and product design—from the Sierra Labs identity and visual system to its website, sales materials, and core software platform.

Working closely with Kelly, the compliance team, and engineering, I helped translate a dense regulatory process into a clear, approachable product experience spanning quality management, documentation, workflows, audit readiness, and real-time compliance monitoring.

THE OUTCOME

Sierra Labs grew to more than 20 customers and reached $1.5 million in annual recurring revenue by 2020, demonstrating a real market for a more modern approach to healthcare compliance. www.sierralabs.com

CREATIVE DIRECTOR: Steve Sigler
BRAND STRATEGY & IDENTITY: Steve Sigler
DIRECTOR OF PRODUCT DESIGN: Steve Sigler