Insights & Analysis
Regulatory updates, market analysis, and due diligence insights from the front lines of medical device investing.
The diligence landscape has shifted. Investors are moving beyond financial metrics to demand clinical adoption evidence, reimbursement pathway validation, and manufacturing scalability data. Here's what the best-prepared companies are bringing to the table.
Read ArticlePE healthcare funds evaluate platforms and bolt-ons completely differently — but most diligence processes use the same playbook for both. That's where value destruction starts.
Read MoreBig 4 firms bring financial analysts and strategy associates. What they don't bring: anyone who has designed a medical device or navigated an FDA submission.
Read MoreAUTM data shows only 5-10% of licensed technologies generate meaningful revenue. TTOs need a systematic framework for assessing commercial viability, not just technical novelty.
Read MoreThe standard PE 100-day playbook misses critical regulatory and clinical milestones. In our experience, the #1 cause of delayed value creation is internal quality issues not surfaced during diligence.
Read MoreMost founders nail the pitch deck. But when VCs dig into diligence, they ask 7 questions that kill deals — and most founders haven't prepared answers.
Read MoreUniversity procurement is notoriously slow. Here's exactly how to navigate sole-source justifications, PO requirements, and budget approvals — with ready-to-use language.
Read MoreManufacturing risk is the silent killer of medical device investments. From single-source suppliers to quality system gaps, here are the 10 questions that separate informed investors from expensive lessons.
Read MoreFive costly mistakes we see repeatedly in founder assessments — from choosing the wrong regulatory pathway to underestimating biocompatibility requirements. Each one can add $500K+ and 12+ months to your timeline.
Read MorePost-PATCH Act, cybersecurity is no longer optional for connected devices. FDA now requires SBOMs, threat modeling, and coordinated vulnerability disclosure. Here's what investors and founders need to know.
Read MoreThe GLP-1 revolution is creating a $15B+ companion device opportunity. But not every 'GLP-1 adjacent' play is investable. Here's how to separate defensible positioning from hype.
Read MoreFounders default to 510(k) because it sounds faster. But forcing a weak predicate can cost more than De Novo would have. Here's the decision framework for choosing the right regulatory pathway.
Read MoreFrom Exactech's bankruptcy to Butterfly Network's stalled growth, we map 9 real-world medtech failures to our proprietary Vantage Score framework.
Read MoreThe Trump administration's executive orders signal major shifts in FDA oversight of AI devices. We analyze what's actually changing versus political posturing.
Read MoreEvery pitch deck now features "AI-powered" somewhere. But which AI medical device plays are actually defensible? We break down the regulatory realities.
Read MoreAn anonymized deep-dive into how a well-funded surgical device company missed every adoption signal. The warning signs were there at Series A.
Read MoreThe EU MDR timeline continues to shift. We analyze the latest guidance and what it means for US device companies planning European market entry.
Read MoreClinical efficacy means nothing if payers won't cover it. We outline the reimbursement diligence framework that separates fundable opportunities.
Read MoreWe've seen it too many times: a promising device company builds their entire regulatory strategy on a predicate that was never appropriate.
Read MoreThe FDA's updated 510(k) guidance introduces significant changes to predicate device selection and clinical data requirements. Here's what founders and investors need to understand.
Read MoreMost medical device failures aren't technology failures — they're adoption failures. This analysis examines the structural reasons physicians resist new devices and how founders can assess adoption risk before committing capital to clinical trials.
Read MoreChoosing the wrong predicate device is the single most expensive regulatory error in medtech. We break down how to evaluate predicate risk, when De Novo is actually the faster path, and what the FDA's recent classification trends mean for your submission strategy.
Read MoreWe analyzed patterns across successful university-backed medical device companies to identify what separated them from the 90% that didn't reach commercialization. The findings point to three critical factors that most TTOs underweight in their portfolio decisions.
Read MoreMonthly insights on medical device risk, regulatory trends, and commercialization strategy. No spam — just the intelligence that matters.
18 warning signs that predict medical device failure — with real examples from our case database. Used by VCs evaluating their first medtech deal.
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