Insights | Vantage Biomedical Partners

Due Diligence · Method

Aug 30, 2026 6 min

How to Verify a Medtech Claim in the Public Record

Six public systems settle most regulatory claims in a biomedical pitch. What each one proves, what it cannot prove, and how to read the silences.

Clinical · Method

Aug 30, 2026 4 min

Reading a ClinicalTrials.gov Record for Diligence

A registry record discloses more through its revision history and its results clock than its summary. How to read both, and what silence does not mean.

Due Diligence · Fund Operations

Aug 30, 2026 9 min

Biomedical Diligence Without a Biomedical Partner

Small funds take biomedical exposure without in-house clinical depth. The three ways they cover diligence, and what each one structurally cannot reach.

Reimbursement · Policy Watch

Sep 2, 2026 7 min

CMS Wants Ten Algorithmic Lab Codes Off the Lab Fee Schedule — What That Does to an AI-Diagnostics Position

The CY2027 Physician Fee Schedule proposes renaming SaaS to Software as a Medical Service and contractor-pricing ten HCPCS codes off the Clinical Laboratory Fee Schedule. Docket CMS-1848-P; comment deadline September 14, 2026.

Reimbursement · Policy Watch

Jul 9, 2026 6 min

Medicare Just Rewired Breakthrough-Device Coverage — What RAPID Means for Diligence

CMS's proposed RAPID pathway, the paused TCET program, and the finalized repeal of NTAP's Breakthrough alternative pathway are redrawing device reimbursement in 2026. What it means for diligence, and the questions to ask now.

Deal Structure

Jul 9, 2026 3 min

The Cap Table Is a Legal Document, Not Just a Math Problem

Prior-round terms — liquidation preferences, SAFE conversions, anti-dilution — move the return waterfall more than the headline valuation.

Team & IP

Jul 9, 2026 3 min

Founders From the Incumbent: An Asset and a Liability

A team from a direct competitor brings deep domain depth — and prior-employer IP, non-compete, and trade-secret exposure. How to diligence both.

Regulatory

Jun 1, 2026 2 min

510(k) Predicate Strategy: How to Pick One That Survives Diligence

How to choose a 510(k) predicate that holds up in diligence, checked against public FDA data.

Reimbursement

Jun 1, 2026 1 min

The Reimbursement Question Every Medtech Founder Should Answer

Coding, coverage and payment, comparable-code reasoning, and linking evidence to coverage, before you raise.

Fundraising

Jun 1, 2026 1 min

Angel & Seed Medtech Due Diligence: A Founder's Pre-Raise Checklist

A founder's pre-raise checklist for angel and seed diligence, with what to have ready for each area.

Fundraising

Jun 1, 2026 3 min

Is Your Series A Medtech Actually Fundable? The 5 Risks Investors Find First

Five risks investors check first in a Series A medtech deal, and what the public record shows about each.

Due Diligence

May 12, 2026 3 min

Platform vs. Bolt-On: Why PE Healthcare Diligence Needs Different Playbooks

Why diligence on a platform acquisition and on a bolt-on asks different questions.

Due Diligence

May 5, 2026 4 min

The Strategic Acquirer's Blind Spot: Clinical and Engineering Risk in Medtech Deals

Financial and strategy advisors cover much of an acquisition. Clinical and device-engineering risk often needs a different read.

Case Insight

Apr 28, 2026 4 min

The TTO Commercialization Scorecard: Prioritizing Technologies That Actually Make It to Market

Why technology transfer offices need a consistent way to assess commercial viability, not just technical novelty.

Case Insight

Apr 20, 2026 4 min

The First 100 Days: What PE Operating Partners Miss in Medtech Acquisitions

Regulatory, clinical and quality milestones a standard 100-day plan can miss after a medtech acquisition.

Due Diligence

Apr 14, 2026 6 min

Investor Readiness for Medical Device Founders: 7 Questions VCs Will Ask

Seven diligence questions investors ask medical device founders, and what to have ready for each.

TTO Guide

Apr 7, 2026 3 min

Buying Outside Diligence Through University Procurement: A Guide for TTOs

How university procurement typically handles outside diligence services — purchase orders, approvals and the questions to ask your procurement office.

Due Diligence

Mar 29, 2026 6 min

Manufacturing Due Diligence: The 10 Questions Every Investor Should Ask

From single-source suppliers to quality system gaps: ten manufacturing questions investors should ask.

Regulatory

Mar 22, 2026 7 min

What Founders Get Wrong About Their First FDA Submission

Five common mistakes in a first FDA submission — from choosing the wrong regulatory pathway to underestimating biocompatibility requirements.

Regulatory

Mar 16, 2026 5 min

Cybersecurity in Connected Medical Devices: What FDA Now Requires

Section 524B makes an SBOM, a postmarket vulnerability plan and cybersecurity processes part of every cyber device submission. What it means for investors and founders.

Market Analysis

Mar 8, 2026 5 min

The GLP-1 Device Boom: Due Diligence on Medtech's Hottest Adjacency

The GLP-1 boom is drawing investment into companion devices, but not every 'GLP-1 adjacent' play is investable. How to separate defensible positioning from hype.

Regulatory

Mar 1, 2026 4 min

De Novo vs 510(k): When the Shorter Path Actually Costs More

Founders often default to a 510(k) because it sounds faster, but a weak predicate can cost more than a De Novo request would have. What each pathway gives a company, and how to read the choice.

Regulatory

Feb 13, 2026 4 min

FDA AI Deregulation: What Medical Device Founders Need to Know

What FDA’s January 2026 general wellness and clinical decision support guidances changed for wearables and AI software, and what they did not.

Market Analysis

Feb 7, 2026 3 min

AI in Medical Devices: Separating Hype from Evidence

What FDA authorization does and doesn't show about an AI device, and the data, validation, workflow and reimbursement questions to ask.

Case Insight

Jan 30, 2026 5 min

Anatomy of a Failed Device Launch: An Illustrative Case

An illustrative case of a surgical device launch that stalled on adoption, and the signals a diligence read looks for at Series A.

Regulatory

Jan 23, 2026 3 min

EU MDR Update: What the Latest Extensions Mean for US Companies

The MDR transition deadlines set in 2023, the conditions legacy devices had to meet, and what they mean for US device companies weighing Europe.

Due Diligence

Jan 16, 2026 2 min

Reimbursement Red Flags: The Questions Investors Should Ask

Existing-code claims, Category III reliance, hospital economics, coverage policy and health economics: the reimbursement questions to ask.

Due Diligence

Jan 8, 2026 3 min

The Predicate Trap: When a 510(k) Plan Rests on the Wrong Predicate

How a 510(k) plan can rest on a predicate FDA won't accept, and the diligence questions that surface it early.

Regulatory

Feb 1, 2026 3 min

FDA's 510(k) Modernization: What's Final, What's Still Draft

Which of FDA's recent 510(k) changes are requirements and which are still draft, and what each means for a submission.

TTO & Incubators

February 2026 8 min

From Lab to Market: Why University Spinouts Face Unique Commercialization Challenges

Why university spinouts stall between lab and market, and the questions investors and technology transfer offices can ask about clinical translation, market fit and talent.

M&A Trends

Feb 2026 3 min

The Medical Device M&A Landscape: 2025 in Review and 2026 Outlook

Deal value in 2025, the largest medtech transactions, what they had in common, and what they mean for diligence.

Regulatory

Mar 2026 5 min

The AI Validation Gap: What Funding and FDA Authorization Don't Show

A funding round and an FDA authorization don't show that an AI device holds up across sites and patient groups. The diligence questions that test it.

Clinical Risk

Mar 2026 8 min

The Clinical Adoption Gap

Why acquirers underestimate clinical adoption risk, and the questions that surface it in diligence.

Regulatory

Mar 2026 3 min

FDA Device Review Timing in 2026: What Device Companies and Investors Should Check

Staff cuts, the 2025 shutdown and user-fee reauthorization, and how to check a device timeline against FDA's published review performance.

Due Diligence

Apr 3, 2026 12 min

Medical Device Due Diligence: A Framework for Investors and Acquirers

The questions to ask across four areas of medical device diligence, and the public records that help answer them.

M&A Trends

Mar 13, 2026 4 min

Medtech M&A in 2026: What Compressed Diligence Can Miss

When medtech deals move quickly, diligence can compress around the easy questions. Where the long-tail risks hide.

Regulatory

Feb 2026 3 min

Predicate Device Strategy: How FDA Reads Predicates, Reference Devices and Indications

Primary and multiple predicates, reference devices, split predicates and indications for use: the FDA rules a predicate argument can be checked against.

Digital Health

Feb 2026 4 min

RPM's 2026 CPT Codes: Engineering Implications for Device Manufacturers

Medicare's 2026 remote patient monitoring codes, read as engineering inputs for connected devices.

Reimbursement

Feb 2026 3 min

The Skin Substitute Payment Reset: What Medicare Changed in 2026

What Medicare changed for skin substitutes in 2026, why, and the diligence questions for wound care companies.

Regulatory

Dec 2025 3 min

The Accelerated Approval Risk: When Speed Costs You the Asset

Accelerated approval trades earlier approval for a confirmatory-trial obligation: what FDORA changed, what recent cases show, and what to check.

Regulatory

Jun 2025 3 min

Clinical Trial Design for Medical Devices: Where Programs Go Wrong

How device trials differ from drug trials: endpoints, controls, sample size, enrollment, operator learning curves and early FDA feedback.

Reimbursement

Jul 2025 2 min

CMS Coverage Determination Guide: From NCD to LCD to Real Reimbursement

How Medicare coverage is decided, from NCDs and LCDs to MolDX, outpatient payment and NTAP.

Regulatory

Jan 2026 3 min

The Companion Diagnostic Risk: When Your Drug Depends on a Test You Don't Control

When a drug’s labeling depends on a companion diagnostic, the test becomes part of the asset, and part of the diligence.

Market Analysis

Nov 2025 3 min

Interoperability Debt: The Hidden Liability in Digital Health Acquisitions

How one-off integrations become a hidden liability in digital health deals, and the signs to look for in diligence.

Market Analysis

Nov 2025 3 min

IRA Drug Price Negotiation: What Therapeutics Investors Need to Model

How Medicare drug price negotiation works, which drugs become eligible and when, and what therapeutics investors should model.

Regulatory

2026 4 min

The LDT Rule, Vacated: What Changed for Diagnostic Diligence

A federal court vacated FDA's 2024 rule on laboratory-developed tests in March 2025, and FDA rescinded it in September 2025. Why an LDT's regulatory status still matters in diligence.

Due Diligence

May 2025 3 min

Manufacturing Technology Transfer: What a Class III Site Move Involves

What moving device manufacturing to a new site involves, and why Class III transfers need PMA supplements in the plan.

Regulatory

Feb 2026 3 min

Orphan Drug Exclusivity: The Strategy That Cuts Both Ways

What orphan exclusivity blocks after the 2026 change, how orphan status interacts with Medicare negotiation, and what diligence should check.

Reimbursement

Jul 2025 2 min

Payer Evidence Requirements: What Coverage Decisions Actually Demand

The evidence that gets a product cleared or approved is not always the evidence that gets it covered, and what to check in an evidence plan.

Regulatory

Sep 2025 3 min

Post-Marketing Surveillance: The Obligation That Outlasts the Acquisition

Post-approval studies, 522 orders, device reports and corrections: the postmarket obligations an acquirer inherits, and how to diligence them.

Regulatory

Feb 2026 3 min

SaMD Misclassification: When Your Software Is a Medical Device and You Didn't Know

When software meets the legal definition of a medical device, what FDA's January 2026 guidance changed, and the classification questions to ask in diligence.

Due Diligence

Aug 2025 2 min

Series B Medtech Milestones: What Has to Be True Before You Raise

What has to be true before a medtech company raises a Series B.

Diligence-Grade Intelligence

Due Diligence in 2026: What Healthcare Investors Are Actually Looking For

How to Verify a Medtech Claim in the Public Record

Reading a ClinicalTrials.gov Record for Diligence

Biomedical Diligence Without a Biomedical Partner

CMS Wants Ten Algorithmic Lab Codes Off the Lab Fee Schedule — What That Does to an AI-Diagnostics Position

Medicare Just Rewired Breakthrough-Device Coverage — What RAPID Means for Diligence

The Cap Table Is a Legal Document, Not Just a Math Problem

Founders From the Incumbent: An Asset and a Liability

510(k) Predicate Strategy: How to Pick One That Survives Diligence

The Reimbursement Question Every Medtech Founder Should Answer

Angel & Seed Medtech Due Diligence: A Founder's Pre-Raise Checklist

Is Your Series A Medtech Actually Fundable? The 5 Risks Investors Find First

Platform vs. Bolt-On: Why PE Healthcare Diligence Needs Different Playbooks

The Strategic Acquirer's Blind Spot: Clinical and Engineering Risk in Medtech Deals

The TTO Commercialization Scorecard: Prioritizing Technologies That Actually Make It to Market

The First 100 Days: What PE Operating Partners Miss in Medtech Acquisitions

Investor Readiness for Medical Device Founders: 7 Questions VCs Will Ask

Buying Outside Diligence Through University Procurement: A Guide for TTOs

Manufacturing Due Diligence: The 10 Questions Every Investor Should Ask

What Founders Get Wrong About Their First FDA Submission

Cybersecurity in Connected Medical Devices: What FDA Now Requires

The GLP-1 Device Boom: Due Diligence on Medtech's Hottest Adjacency

De Novo vs 510(k): When the Shorter Path Actually Costs More

FDA AI Deregulation: What Medical Device Founders Need to Know

AI in Medical Devices: Separating Hype from Evidence

Anatomy of a Failed Device Launch: An Illustrative Case

EU MDR Update: What the Latest Extensions Mean for US Companies

Reimbursement Red Flags: The Questions Investors Should Ask

The Predicate Trap: When a 510(k) Plan Rests on the Wrong Predicate

FDA's 510(k) Modernization: What's Final, What's Still Draft

From Lab to Market: Why University Spinouts Face Unique Commercialization Challenges

The Medical Device M&A Landscape: 2025 in Review and 2026 Outlook

The AI Validation Gap: What Funding and FDA Authorization Don't Show

The Clinical Adoption Gap

FDA Device Review Timing in 2026: What Device Companies and Investors Should Check

Medical Device Due Diligence: A Framework for Investors and Acquirers

Medtech M&A in 2026: What Compressed Diligence Can Miss

Predicate Device Strategy: How FDA Reads Predicates, Reference Devices and Indications

RPM's 2026 CPT Codes: Engineering Implications for Device Manufacturers

The Skin Substitute Payment Reset: What Medicare Changed in 2026

The Accelerated Approval Risk: When Speed Costs You the Asset

Clinical Trial Design for Medical Devices: Where Programs Go Wrong

CMS Coverage Determination Guide: From NCD to LCD to Real Reimbursement

The Companion Diagnostic Risk: When Your Drug Depends on a Test You Don't Control

Interoperability Debt: The Hidden Liability in Digital Health Acquisitions

IRA Drug Price Negotiation: What Therapeutics Investors Need to Model

The LDT Rule, Vacated: What Changed for Diagnostic Diligence

Manufacturing Technology Transfer: What a Class III Site Move Involves

Orphan Drug Exclusivity: The Strategy That Cuts Both Ways

Payer Evidence Requirements: What Coverage Decisions Actually Demand

Post-Marketing Surveillance: The Obligation That Outlasts the Acquisition

SaMD Misclassification: When Your Software Is a Medical Device and You Didn't Know

Series B Medtech Milestones: What Has to Be True Before You Raise

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