Kristy Kennedy

Kristy Kennedy is a commercial leader focused on medical devices and life sciences, with 25+ years spent helping MedTech manufacturers bring regulated products to market. She has led sales, business development, and go-to-market strategy for device and diagnostic launches, and built long-term partnerships with hospital systems, distributors, and OEM channels that ship real product into clinical environments.

At Blue Goat Cyber, Kristy uses that MedTech-native background to help device manufacturers - from pre-submission startups to established Class II and Class III OEMs - scope cybersecurity engagements that fit their FDA pathway (510(k), De Novo, PMA), their product timeline, and their regulatory strategy. Her focus is right-sizing the work: enough evidence to clear review under Section 524B and the Feb 3, 2026 premarket guidance, without pulling engineering off the release critical path.