For Investors & Acquirers
Analysis for investors evaluating biomedical deals — regulatory pathways, reimbursement risk, clinical evidence, and the traps that sink deals.
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 ArticleCMS's RAPID pathway, the paused TCET program, and the proposed NTAP repeal are redrawing device reimbursement in 2026. What it means for diligence, and the questions to ask now.
Read MorePrior-round terms — liquidation preferences, SAFE conversions, anti-dilution — move the return waterfall more than the headline valuation.
Read MoreA team from a direct competitor brings deep domain depth — and prior-employer IP, non-compete, and trade-secret exposure. How to diligence both.
Read MoreYour predicate is the most scrutinized early 510(k) decision. How to choose one that holds up in diligence — from public FDA data.
Read MoreA cleared device no one pays for is the silent killer. How to answer the reimbursement question before you raise.
Read MoreAngels probe the same fault lines and decide fast. The pre-raise checklist with what to have ready for each.
Read MoreWhen an investor passes, it's rarely the science — it's a knowable risk that surfaced in diligence. Here are the five they check first, what the public record reveals, and how to close each before it costs you the round.
Read MorePE 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. A leading 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 $2M+ 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 Index 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 "physician-led" 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 MoreIt happens again and again: 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 MoreAnalysis of medical device M&A trends from 2025 and outlook for deal flow, valuation multiples, and strategic priorities in 2026.
Read MoreHealthcare AI raised $18 billion in Q1 2026. But most AI-enabled devices face a critical validation bottleneck that venture capital alone can't solve.
Read MoreMost acquirers underestimate the hidden risk of clinical adoption failure. We analyze the patterns across 50+ failed integrations.
Read MoreThe FDA's Office of Device Evaluation faces capacity constraints that are creating multi-month delays. What this means for your timeline.
Read MoreA comprehensive guide to medical device due diligence covering regulatory, clinical, technical, and commercial risk assessment. Built by a physician executive and biomedical engineer.
Read MoreThe medtech M&A market in early 2026 is running at unprecedented velocity. Large strategics are moving fast—sometimes too fast.
Read MoreThe 510(k) pathway is faster than De Novo or PMA—but only if your predicate device strategy is correct. A wrong choice derails your timeline.
Read MoreCMS's new CPT 99445 code for device setup creates opportunities and requirements for remote patient monitoring device manufacturers. Engineering analysis.
Read MoreCMS's 2025 OPPS changes have devastated skin substitute reimbursement. Analysis of the market impact and what it means for wound care investors.
Read MoreFDA's Accelerated Approval pathway promises faster patient access for serious conditions where surrogate endpoints predict clinical…
Read MoreMedical device clinical trials are not small-molecule pharmaceutical trials. The endpoints, the comparators, the enrollment dynamics,…
Read MoreFDA clearance and CMS coverage are different events with different timelines, different decision criteria, and different stakeholders.…
Read MorePrecision medicine has driven a steady increase in FDA approvals that depend on a paired companion diagnostic test to identify the…
Read MoreEvery digital health company integrates with electronic health records, insurance claims systems, lab data feeds, and patient-facing…
Read MoreThe Inflation Reduction Act of 2022 fundamentally rewired the economics of branded therapeutics in the United States. Direct Medicare…
Read MoreFDA's May 2024 Final Rule on Laboratory-Developed Tests ended a 35-year period of enforcement discretion. Diagnostic developers and the…
Read MoreTechnology transfer—moving manufacturing from a pilot site to a commercial site, or from one CDMO to another, or from one manufacturer…
Read MoreThe Orphan Drug Act of 1983 created powerful incentives for therapeutics developers to pursue rare disease indications: tax credits,…
Read MoreSponsors often generate the clinical evidence FDA requires for approval and then discover that payers want something different. The…
Read MoreFDA approval is not the end of regulatory obligations—it is the beginning of a different set. Post-marketing surveillance commitments,…
Read MoreSoftware as a Medical Device (SaMD) is FDA's term for software intended for medical purposes performed without being part of a hardware…
Read MoreSeries B is where medtech companies prove they can move from
Read MoreMonthly insights on medical device risk, regulatory trends, and commercialization strategy. No spam — just the intelligence that matters.
18 warning signs that flag medical device failure risks — with real examples from our case database. Used by VCs evaluating their first medtech deal.
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