Insights built for action

Articles, talks, and frameworks on FDA strategy, clinical development, fundraising, and commercialization — from the team behind 200+ medical innovations brought to market. Built for MedTech and Biotech founders who need precision, not platitudes.

Free White Paper

From Prototype to FDA Clearance

If you’re building a medical device or health technology company for the first time, this one’s for you. This white paper lays out what the regulatory and FDA process actually looks like for early-stage founders, and when you should start the process.

Inside, you’ll find:      

Talks, podcasts & media

Watch and listen – keynotes, conference sessions, and podcast conversations on regulatory strategy, clinical evidence, and commercialization.

Shaherah Yancy Research Lifecycle Solutions

Shaherah Speaks at LSI '25

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I'm at least a year from needing Regulatory

FDA Regulatory Strategy: Why Startups Fail Before Launch

Clinical Evidence: The Key to Market Adoption

Pressure-test your pathway in one call

Bring your device, your current status, and your assumptions to a focused 60-minute strategy session. You’ll leave knowing whether your classification logic holds, what FDA will ask in your pre-sub or market submission, and whether a study is likely — clarity before you spend against the wrong pathway.

$500 / 60 minutes

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Practical insights on FDA strategy, clinical development, and capital-efficient commercialization – written for founders, not for compliance departments. No noise, unsubscribe anytime.

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Don't just read about strategy - let's build one

If you’re serious about getting to market, we’ll help you chart the course – tailored to your product, pathway, and budget.