Why FDA 510(k) Clearance Matters

Sahil outlines the decision to pursue FDA clearance, its competitive value, and how the device standardizes ear cleaning.

Play episode from 03:46

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Episode notes

When Sahil and his brother started Otoset in their mid-20s, they had no idea their FDA-cleared ear cleaning device would generate over 1 billion social media views and force them to completely pivot their business model.

In this episode, Sahil shares the unexpected journey from building a B2B medical device company to creating "the front door to ear care", a direct-to-consumer healthcare network serving 40 million Americans with chronic ear wax issues.

🔑 KEY TAKEAWAYS:

→ How they became some of the youngest founders to get FDA 510(k) clearance

→ The unexpected social media virality that changed everything

→ Why they pivoted from partner clinics to owning their own locations

→ Marketing strategies: organic content, influencers, and patient education

→ The critical role of FDA clearance as a competitive differentiator

→ Building credibility before scaling consumer marketing

→ Finding the right mentors in healthcare entrepreneurship

💡 WHO THIS IS FOR:

✓ HealthTech & MedTech founders navigating FDA pathways

✓ Startups exploring direct-to-consumer healthcare models

✓ Entrepreneurs learning to leverage social media for medical products