Fractional Product & Development Leadership for Medical Device Companies
Snow Cloud Ventures partners with medical device companies to lead product development, navigate FDA regulatory pathways, and bring proprietary devices to market. No full-time executive overhead required.
What We Do
Fractional Product Leadership
Embedded senior-level product and development leadership on a part-time, flexible basis. Ideal for companies that need executive depth to lead cross-functional teams, manage development programs, and drive product strategy. No full-time hire required.
Contract Manufacturer Management
Vendor selection, contract negotiation, design collaboration, and cost governance for hardware development programs. Structured to protect your IP and cost targets while maintaining a productive partner relationship through full product development lifecycle.
Medical Device Development
End-to-end product development from concept through commercial launch. This includes defining product requirements, managing contract design and manufacturing partners, leading design control processes, and coordinating verification and validation activities. All structured to meet ISO 13485 and 21 CFR Part 820 requirements.
Regulatory and Reimbursement Strategy
FDA 510(k) pathway planning, QMS implementation support, PDAC and CMS submissions, and HCPCS code strategy. For software-enabled devices, experience navigating SaMD and SiMD classification under FDA's current guidance framework.
WHO WE WORK WITH
Medical device and DME companies that need senior product leadership but are not ready for a full-time executive hire. Typically, clients are transitioning to proprietary devices, preparing for their first 510(k), or managing multiple development programs without a VP of Product in place.
ABOUT US
Snow Cloud Ventures was founded by Drew Mayer, a product and development executive with over a decade of experience building healthcare technology companies, including co-founder and C-suite roles across medical device, digital health, and health tech ventures.
Drew holds an MBA from the McCombs School of Business at UT Austin and a BA in Mathematics from Colorado College. His work spans the full product development lifecycle: from early requirements definition and design controls through FDA regulatory submissions, contract manufacturing, and commercial launch.
Current and past work includes medical device development under ISO 13485 and 21 CFR Part 820, 510(k) submission strategy, SaMD/SiMD software classification, PDAC and CMS reimbursement submissions, Bluetooth-enabled device development, and clinical study coordination with major research institutions.
Snow Cloud Ventures operates as a fractional practice, providing senior executive engagement without the cost structure of a full-time hire. Engagements are structured around your development stage, timeline, and team.
Based in Grand Junction, Colorado. Serving clients nationally.
Let’s Talk
If you're building medical devices and need experienced product leadership, reach out to start a conversation. Engagements are typically structured as part-time monthly retainers, scoped to your needs.