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Building Clinical Evidence Around Your Target Market

Building Clinical Evidence Around Your Target Market

Interview with Teal Health CEO Kara Egan

About the Guest

Kara Egan is the founder and CEO of Teal Health, the company behind the first FDA-authorized at-home cervical cancer screening device. Before founding Teal, she worked in healthcare and software investing at .406 Ventures and Emergence Capital, and held product and marketing roles at Zendesk and Stitch Labs. 

Interview Summary

Designed as an alternative to the traditional Pap smear in the clinic, the Teal Wand allows women to complete screening privately at home, with results returned in roughly five days.

Cervical cancer remains highly preventable through screening, yet nearly one in three women in the U.S. are behind on recommended testing. Kara approached the problem less as a diagnostic gap and more as a failure of access and patient experience. Teal built its product around those constraints with a consumer-first design approach focused on the full screening experience — from onboarding to reminders, clear instructions, and home-use realities like small bathroom spaces and unsupervised collection.

To support FDA authorization, Teal conducted a 17-site nationwide comparative clinical study mapped to U.S. census demographics. Rather than pursuing a narrower indication focused only on underscreened populations, the company expanded the study to the general screening population. Patients first self-collected using Teal’s device before completing a physician-collected screening with a speculum, with both samples analyzed using the same Roche Cobas HPV test. The study demonstrated the same 96% sensitivity as the standard of care.

Teal also received formal support from the American College of Obstetricians and Gynecologists (ACOG) and was added to American Cancer Society screening guidelines, helping reinforce institutional trust around self-collection screening.

Founded in 2020, Teal received FDA authorization in 2025 and launched direct-to-consumer across all 50 states within eight months of regulatory approval. The company operates through a B2B2C model combining at-home screening with physician oversight, telehealth support, reimbursement pathways, and clinical follow-up. Currently, insured patients typically pay a $99 kit fee alongside covered telehealth services, while cash-pay pricing is $249. The company reports a 98 NPS score from thousands of users, and broader insurance coverage is expected beginning in 2027 through updated federal preventive care guidelines under the Affordable Care Act.

Top Takeaways

  • At-home care experiences should include support and follow-up. Scheduling friction, unclear instructions, embarrassment, follow-up logistics, and other access challenges compound quickly in preventive care. Devices designed for convenient at-home use are adopted when they address those barriers while fitting into how people already live and navigate care. In unsupervised settings, the product experience has to provide the confidence, guidance, and support patients would usually expect from a clinician.

  • Build clinical evidence around the market you ultimately want. Clinical studies shape far more than FDA clearance. They influence labeling flexibility, physician confidence, payer adoption, guideline inclusion, and long-term positioning. Regulators optimize for safety and approval, while CEOs need to optimize for market creation. Designing studies around the broader commercial opportunity can justify additional complexity and cost upfront.

  • Healthcare adoption depends on stakeholder alignment and trust. Better patient experience alone rarely changes healthcare behavior unless the surrounding stakeholders also benefit. Build follow-up workflows, reimbursement pathways, and institutional partnerships to align stakeholder incentives while understanding who is economically impacted.

  • Investors fund measurable business momentum, not just mission. Healthcare founders often focus on the problem and its patient impact, but investors evaluate companies through metrics like market size, CAC, ROI, growth, and execution consistency. Investor concerns also change by stage and investor type. And remember, the best CEOs are always preparing for the next round.

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