Frequently Asked Questions

We cover the full spectrum of medical devices across all FDA classifications and therapeutic areas, including:

• Class II and III therapeutic devices
• Diagnostic and monitoring devices
• Surgical instruments and robotics
• Implantables (cardiovascular, orthopedic, neuro)
• AI/ML-enabled medical devices
• Digital health and Software as a Medical Device (SaMD)
• Combination products (drug-device, biologic-device)

Our team's clinical and engineering background allows us to evaluate devices across specialties with equal rigor.

Our comprehensive due diligence typically covers:

• Technical Assessment: Device design, engineering fundamentals, manufacturing readiness
• Clinical Evaluation: Clinical evidence, unmet need validation, physician adoption likelihood
• Regulatory Analysis: Pathway assessment, predicate strategy, timeline and risk evaluation
• IP Review: Patent landscape, freedom-to-operate considerations, competitive positioning
• Market & Reimbursement: Competitive dynamics, payer landscape, economic viability
• Team Assessment: Experience, capability gaps, execution risk

We deliver a comprehensive report with our proprietary Vantage Score and specific recommendations.

Timeline depends on scope and complexity:

• Rapid Assessment: 5-7 business days for focused technical review
• Standard Due Diligence: 2-3 weeks for comprehensive analysis
• Deep Dive: 4-6 weeks for complex devices or extensive competitive analysis

We can accommodate expedited timelines when deal timing requires—just let us know your constraints.

We provide rigorous analysis and our assessment of technical, clinical, and regulatory risk—but we do not make investment recommendations. Our role is to arm you with the specialized insight needed to make informed decisions.

Our Vantage Score provides a standardized framework for comparing opportunities, and we clearly identify red flags, yellow flags, and areas of strength. The investment decision remains yours.

Yes. Our team is structured to handle multiple concurrent engagements. For VC/PE clients with ongoing deal flow, we offer retainer arrangements that provide priority access and preferred pricing.

We maintain strict information barriers between engagements to protect confidentiality.

We take conflicts seriously. Before any engagement, we conduct a conflict check and disclose any relevant relationships. We do not:

• Hold equity positions in companies we evaluate
• Accept success fees tied to investment outcomes
• Share information between competing engagements
• Provide due diligence on companies where we have advisory relationships

Our business model is built on being a trusted, independent voice.

Smart founders get ahead of investor concerns by identifying and addressing gaps before they become deal issues. Our founder services help you:

• Identify weaknesses before investors do
• Strengthen your regulatory and clinical story
• Prepare data room materials that withstand scrutiny
• Anticipate and prepare for tough technical questions
• Build credibility with sophisticated healthcare investors

Think of it as a pre-flight check before you hit the fundraising runway.

Our primary role is assessment and strategic guidance. We identify issues and recommend approaches, but we don't typically serve as ongoing consultants or fractional executives.

However, we can provide targeted advisory support for specific workstreams and can refer you to specialists in our network for implementation work.

Confidentiality is foundational to our business. We employ:

• Standard NDAs executed before any engagement
• Encrypted communication and file transfer
• Access controls limiting information to engaged team members
• Secure document management and retention policies
• Information barriers between concurrent engagements

For highly sensitive engagements, we offer air-gapped analysis environments where your data never touches cloud infrastructure or internet-connected systems. This includes:

• Isolated local computing environment
• No cloud storage or transmission of sensitive materials
• Physical security controls
• Secure handoff protocols

This is particularly relevant for pre-IPO companies, highly competitive situations, or engagements involving trade secrets.

We offer several engagement models:

• Project-Based: Fixed fee for defined scope of work
• Retainer: Monthly commitment for ongoing access and priority scheduling
• Hourly: For targeted advisory or follow-up work

Pricing varies based on scope, complexity, and timeline. We provide detailed proposals after an initial scoping conversation. Contact us for a quote.

Simple:

• Reach out via our contact form or email
• We'll schedule a brief call to understand your needs
• We'll provide a proposal with scope, timeline, and pricing
• Upon agreement, we execute NDA and engagement letter
• We begin work immediately

Most engagements can kick off within days of initial contact.

Our methodology is validated against our proprietary database of documented medical device outcomes curated from SEC filings, FDA records, and clinical literature with 96% historical accuracy. Our team brings decades of direct experience:

• Dr. Ravinutala chairs a hospital P&T committee evaluating device adoption for 150+ physicians
• Aswini Ravinutala was part of the Axonics operations engineering team through Boston Scientific's $4.1B acquisition, working across design controls, manufacturing scale-up, and quality systems
• Our Senior Advisor Rinda Sama has overseen two successful Boston Scientific acquisitions as COO

Internal teams typically excel at financial and market analysis but miss clinical adoption barriers, manufacturing scalability risks, and regulatory pathway nuances. Standard due diligence misses approximately 60% of the failure patterns we identify. Our dual MD + BME methodology catches risks in parallel:

• The physician identifies clinical workflow barriers, reimbursement gaps, and adoption friction
• The engineer evaluates manufacturing readiness, design controls, and regulatory pathway viability

At $30K for a full assessment vs. assembling separate clinical, regulatory, and engineering consultants at $50-100K+, we deliver more depth in less time.

It means we evaluate whether physicians will actually use the device in their daily practice — not just whether it works in a clinical trial. We assess:

• Workflow integration
• Procedure time impact
• Learning curve
• Reimbursement alignment
• Competitive alternatives

All from the perspective of practicing clinicians. Many technically excellent devices fail commercially because they add 15 minutes to a procedure, require new billing codes, or compete with established workflows. Our physician co-founder sees these barriers firsthand as a hospital P&T Committee chair.

If our assessment doesn't identify at least one material risk — clinical, regulatory, engineering, or commercial — that your existing diligence process overlooked, we refund the engagement in full. This applies to all assessment tiers. We're confident enough in the depth of our proprietary framework to put our fee behind it, because the clinical adoption barriers, manufacturing scalability gaps, and regulatory pathway risks we evaluate are systematically missed by traditional analysis.

Yes. We routinely work under client NDAs and can accommodate most standard legal frameworks. For maximum confidentiality, we offer air-gapped processing where all analysis happens on encrypted local hardware with zero cloud data transmission. Our infrastructure includes:

• HIPAA-aligned security protocols
• AES-256 encryption
• DoD 5220.22-M deletion standards
• Zero-data-retention agreement with any API providers used for edge-case verification

No. We maintain complete independence — no equity positions, no success fees, no finder's fees, and no deal flow curation. Our assessment serves truth about commercial viability, not deal momentum. We require conflict disclosure before every engagement and will decline work where a conflict exists. This independence is fundamental to the credibility of our analysis.

We serve PE healthcare funds and corporate/strategic acquirers with dedicated service tiers:

PE Services:

• Platform Due Diligence ($105K)
• Bolt-On Assessment ($60K)
• Portfolio Triage (custom pricing)
• Annual Retainers ($210K/year)

Corporate Acquirer Services:

• Acquisition Due Diligence ($90K)
• Strategic Deep-Dives ($150K)
• M&A Advisory Retainers ($300K/year)

Visit our PE Healthcare and Corporate Acquirer pages for full details.

Yes — this is one of the most valuable things you can do. Your initial assessment establishes a detailed baseline across all proprietary categories. When you return after addressing flagged gaps, pivoting strategy, or hitting a new milestone, we re-score against that existing foundation. The turnaround is faster (5-7 business days vs. 2-3 weeks) and the cost is 40% less because the analytical baseline is already built. Your before-and-after Vantage Score comparison becomes a powerful fundraising and board communication asset.

Specific milestones that warrant a re-assessment:

• After FDA feedback: 510(k) response, pre-submission meeting outcome, or classification change
• After a pivot: New indication, new predicate strategy, or market repositioning
• After new clinical data: Pilot results, pivotal trial interim analysis, or real-world evidence
• After a competitive entry: New entrant in your category, predicate device update, or reimbursement policy change
• Before your next fundraise: Updated Vantage Score as a diligence-ready asset for investor conversations
• After an acquisition close: 90-day integration checkpoint to validate thesis assumptions against reality

Each re-assessment benefits from your established baseline — the analysis is faster, sharper, and 40% less than a new engagement because the Vantage Intelligence Platform already has your risk signature, competitive landscape, and category benchmarks.

Every assessment refines the Vantage Intelligence Platform. New risk patterns are validated against documented outcomes, category-specific benchmarks become more precise, and early-warning thresholds sharpen with each data point. This compounding intelligence means:

• For returning clients: Your second assessment is not just cheaper — it is better. We already have your baseline, your competitive landscape, and your risk signature.
• For portfolio investors: Each company you send us improves our intelligence for all your companies in adjacent categories. After 5 assessments, we know your portfolio's risk fingerprint.
• For incubators: Cohort assessments surface cross-technology patterns. When spin-outs graduate, their Vantage Scores travel with them into investor conversations — a credibility asset that compounds with every milestone.

We do. If you refer a founder, investor, or institution that completes a Vantage engagement, you receive a credit toward your next assessment or advisory session. Investor clients who refer portfolio companies for founder assessments can also arrange priority scheduling and courtesy pricing for those referrals. Contact us for specifics — we structure these on a case-by-case basis.

Absolutely. Your Vantage Score report is yours to use — in pitch decks, investor data rooms, IC memos, LP reports, and board materials. There are no additional licensing or distribution fees. Many of our clients find that sharing their Vantage Score with stakeholders is one of the highest-ROI uses of the assessment.