Medical Device Due Diligence

Protecting Your Investment with Clinical Insight

We combine physician expertise with biomedical engineering rigor to evaluate medical devices—identifying opportunities that deliver exceptional returns and risks that don't show up in pitch decks.

Schedule Consultation See Our Process

75%

MedTech Startup Failure Rate

2-3 wk

Typical Turnaround

MD + BME

Dual Expertise

Who We Serve

Tailored Expertise for Your Needs

For Investors

Comprehensive due diligence for VCs and PE firms evaluating medical device investments. De-risk your portfolio decisions with clinical and technical depth.

Explore Services

For Founders

Get investor-ready with objective assessment of your company. Know exactly what VCs will ask—and how to answer—because we do their due diligence.

Explore Services

Depth of Analysis

See What Standard DD Misses

Like a CT scan revealing what lies beneath the surface, our dual-expert analysis penetrates deeper—layer by layer—exposing hidden risks that surface-level review can't detect.

Most Due Diligence Stops at the Surface

Standard VC due diligence relies on generalists reviewing pitch decks, financials, and team bios. They see green lights across the board—because they're not equipped to see what's underneath.

Our physician + engineer team penetrates to the core, revealing clinical adoption barriers, regulatory pathway risks, manufacturing scalability issues, and IP vulnerabilities that only emerge with specialized expertise.

See Our Full Process

01Surface

Standard Due DiligenceMBA / Finance / Legal

✓ Pitch deck ✓ Financials ✓ Team bios ✓ Market size ✓ Cap table

All clear

02Clinical

Clinical AnalysisPhysician (MD) — CMO

✓ Clinical validity ! Trial endpoints ! Workflow fit ✓ Patient safety ! Adoption path

3 risks

03Eng

Engineering AnalysisBiomedical Engineer (BME)

! IP landscape ! BOM / unit cost ! Mfg scalability ✓ Tech feasibility ! Reg pathway

4 risks

04Deep

Converged FindingsMD + BME Consensus

✗ 510(k) pathway blocked ✗ Unit economics fatal ! 3-year delay risk

2 critical

Clear

Risk found

Critical

The Stakes

The Cost of Missing What Matters

Medical device investing carries enormous risk. Without specialized due diligence, most investments fail—and failures are expensive.

75%

US medical device startups fail

30-40%

of VC investments result in total loss

$31M

average cost to bring a 510(k) device to market

3-7 yrs

typical time from concept to market

When Deals Stagnate: The Hidden Carrying Costs

Regulatory Delays

Wrong pathway choice can add 3+ years and require PMA instead of 510(k)—at $94M vs $31M average cost.

Capital Burn

Each month of FDA review delay costs $200K-500K in operational overhead with zero revenue.

Adoption Friction

Hospital budget cycles mean FDA clearance in July = 9-12 months waiting for capital budget allocation.

Manufacturing Scale

Steel tooling costs $45K-80K per mold with 2,500-5,000 unit minimums before proven demand.

Lessons from Failure

What Proper DD Would Have Caught

High-profile failures share common patterns. Here's how specialized clinical + engineering analysis would have identified the red flags early.

Theranos

$700M+ LostBlood Testing

Promised revolutionary blood testing from a finger prick. Raised $700M+ from top VCs and strategic investors including Walgreens. Technology never actually worked—results were run on competitors' machines or fabricated.

What We Would Have Flagged:

No peer-reviewed validation of core claims

Physics limitations of sample volume vs. test accuracy

No clinical lab director oversight of claims

Board lacked medical device expertise

The "Typical" Failed Device Startup

Pattern MatchComposite Example

Great technology built by engineers who don't understand clinical workflows. 510(k) strategy assumes a predicate that FDA won't accept. Unit economics assume scale that manufacturing can't deliver. Physicians won't adopt because it adds 15 minutes to procedures.

Common Red Flags We Identify:

Regulatory pathway based on "similar" device that isn't predicate-eligible

Trial endpoints misaligned with payer coverage criteria

BOM costs incompatible with reimbursement rates

Workflow integration that physicians will reject

Why Vantage

The Dual Lens Advantage

Most due diligence misses what matters. We see medical devices through both clinical and engineering perspectives—catching what others overlook.

Clinical Credibility

Led by a practicing physician with P&T committee experience evaluating real-world device adoption. We know what gets used—and what gets shelved.

Engineering Rigor

Biomedical engineering expertise from Boston Scientific and Axonics in device design, manufacturing scalability, and regulatory pathways.

Air-Gapped Security

Your confidential data never touches cloud APIs. We offer complete network isolation for the most sensitive competitive intelligence work.

Validated Framework

Our 18-category assessment is tested against 30+ real investment outcomes. 85% accuracy predicting failures before they happen.

Our Process

From Pitch Deck to Investment Decision

A structured approach that delivers actionable intelligence in 2-3 weeks.

Intake & Scoping

Define evaluation criteria aligned with your investment thesis and timeline.

Clinical Assessment

Dr. Ravinutala evaluates clinical utility, adoption barriers, and competitive positioning.

Technical Review

Aswini analyzes design, manufacturing, regulatory pathway, and IP landscape.

Joint Validation

Both partners review findings, reconcile perspectives, and deliver unified recommendation.

See Full Process Details

Our Team

The MD + BME Partnership

Two perspectives, one mission: protecting your investment with insight that matters.

Arvind Ravinutala, MD

Chief Medical Officer

Clinical Informatics • Bioethics

Practicing physician and Medical Director at Adventist Health White Memorial. Chairs P&T Committee evaluating device adoption for 150+ physicians.

Connect

Aswini Ravinutala, BME

Chief Technology Officer

Boston Scientific • Axonics

Biomedical engineer with deep industry experience in medical device development, manufacturing, and regulatory pathways.