The Regulatory Pathway Your CTO Mapped Out Is Based on the Wrong Device Classification
Misclassifying your medical device early costs far more than a filing fee. Here's how deep tech founders get device classification wrong and what to fix.
W. Osei
Lab to Launch
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Lab to Launch covers lab-to-market, startup commercialization, scrappy deep tech. We publish original analysis, frameworks, and commentary for practitioners and decision-makers.
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W. OseiThe Patent License Your Startup Is Building On Was Never Actually Validated
Most deep tech founders assume a university patent license equals protected IP. It rarely does. Here's what you're actually signing and why it matters.
W. OseiThe Insurance Coverage Your Hospital Pilot Requires Will Blindside Your Budget and Your Timeline
Hospital pilots demand insurance coverage most deep tech startups don't have and can't get quickly. Here's what's actually required and how to plan for it.
W. OseiThe Quality Management System Your Contract Manufacturer Insisted On Will Bury You in Paper and Miss Every Real Problem
Most deep tech startups implement QMS requirements from their contract manufacturer without realizing the system is designed for their vendor's audits, not your product quality.
W. OseiThe FDA Pre-Submission Meeting You're Skipping Will Cost You Eighteen Months
Skipping an FDA pre-submission meeting feels like saving time. It usually costs 18+ months. Here's what founders get wrong and how to fix it.
W. OseiThe Vendor Contract Your CRO Sent You Was Written to Protect Them, Not Your Data
Most deep tech founders sign CRO contracts without reading the IP and data ownership clauses. Here's what you're actually giving away.
W. Osei