Business Issue
Verily Life Sciences, a subsidiary of Alphabet Inc., sought Andy Strunk’s expertise to commercialize a Class II regulated software medical device, requiring a rigorous approach to legal, regulatory, and compliance strategy across both product development and go-to-market execution.
Given the complexity of selling into highly regulated industries, including federal government health insurance programs, the commercial organization needed marketing materials and sales enablement tools that adhered to strict intended use labeling, regulatory guidelines, and legal constraints.
Additionally, Verily aimed to expand its channel partnerships while ensuring full regulatory alignment in messaging and execution.
Action Taken
Mr. Strunk implemented a cross-functional legal, regulatory, and compliance-driven approach to support Verily’s commercial growth and product utilization while ensuring adherence to industry regulations:
- Regulatory & Legal Strategy Integration: Partnered with legal, compliance, and regulatory SMEs to embed regulatory considerations into the product development roadmap, ensuring alignment with FDA guidelines and federal procurement requirements.
- Sales & Marketing Enablement for a Regulated Device: Developed direct and channel marketing materials that conformed to intended use labels, balancing regulatory compliance with commercial effectiveness to support new bookings and utilization growth.
- Federal Government Sales & Channel Partnerships Execution: Supported public-sector sales strategies, ensuring marketing materials and messaging complied with federal acquisition regulations, enabling effective channel partnerships in government and enterprise healthcare markets.
Impact Delivered
By successfully integrating legal, regulatory, and compliance strategy into both product development and commercial execution, Verily achieved:
- Regulatory-aligned marketing and sales enablement, ensuring all materials met intended use labeling and legal standards while driving product adoption.
- Expanded federal sales and channel partnerships, positioning Verily’s regulated medical software device for growth in government and enterprise healthcare markets.
- Proven operational success in a highly regulated industry, demonstrating transferable expertise applicable to green tech, biotech, medtech, and pharmaceutical development.
By navigating complex regulatory landscapes while driving commercialization, Verily successfully expanded its market presence in highly regulated industries. This case underscores Mr. Strunk’s ability to effectively operate within and scale products in compliance-driven sectors, offering strategic insights applicable across a range of regulated industries.
