Hunter Ambrose Leadership Podcast

From Zero to FDA Clearance: Building Products Healthcare Systems Actually Buy with Arvita Tripati, MBA

Nicole Barbano

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Arvita Tripati has guided multiple AI-powered medical devices through FDA clearance, including mobile EKG analysis and COVID testing systems. She's contributed to $2B+ in enterprise healthcare revenue with organizations like NHS, Gilead, and American Red Cross.

In this episode, Arvita shares insights on navigating FDA regulatory pathways, the distinction between customer pain points and market demand, and emerging healthcare challenges, including Candida auris—a drug-resistant fungus spreading in hospitals.

Key topics: FDA review strategies, positioning products for enterprise buyers, understanding willingness to pay, and underserved therapeutic areas.

Connect with Arvita: Vahana Labs AI - https://vahanalabs.ai/

LinkedIn https://www.linkedin.com/in/atripati/ https://vahanalabs.ai/

Learn more about Candida auris: https://www.cdc.gov/candida-auris/index.html

To learn more about Hunter Ambrose, visit us at hunterambrose.com and nicolebarbano.com