A strong pitch deck covers the problem, the solution, the market, the team and early traction. Diligence goes further. When investors dig into a medical device company, the questions that are hardest to answer on the spot tend to be about the regulatory pathway, the evidence the market will need, who pays, whether the product can be made at scale, and how the company will meet its obligations once the device is on the market.
Here are seven questions investors commonly ask, what each one is trying to learn, a common gap in founders' answers, and how to prepare.
Question 1: "What's Your Predicate Strategy, and What Happens If FDA Disagrees?"
What investors are trying to learn: regulatory risk. A delay in clearance can consume runway and affect valuation, so investors want to see that the predicate has been tested, not just identified.
A common gap: the founder can name a predicate but has not thought through what happens if FDA asks for more information or finds the device not substantially equivalent, which can mean new testing, a different predicate or a De Novo request.
How to prepare: document (1) the predicate's 510(k) number and clearance date, (2) why the device is substantially equivalent in intended use and technological characteristics, (3) what could lead FDA to question substantial equivalence, and (4) the plan if FDA sends an additional information request or reaches a not-substantially-equivalent decision. See the predicate trap and De Novo vs 510(k).
Investors do not expect perfect answers about FDA, but they do expect evidence that regulatory risk has been thought through.
Question 2: "What Evidence Will the Market Need Beyond Clearance?"
What investors are trying to learn: the path from clearance to adoption. Clearance is a regulatory milestone, not a purchasing decision, and hospital value analysis committees and payers often look for outcomes or economic data beyond what supported the FDA submission.
A common gap: assuming clearance leads to adoption, with no plan for the evidence hospitals and payers will ask for.
How to prepare: map (1) the outcomes hospitals and payers care about for this device, such as complications, length of stay or cost, (2) the studies or registry data needed to show them, (3) the timeline and cost of generating that evidence, and (4) how it supports adoption. See what payers ask for.
Question 3: "Who Pays for This, and How?"
What investors are trying to learn: the reimbursement path. A device that no one will pay for does not become a business.
A common gap: “Hospitals will buy this because it improves outcomes,” with no answer on price, codes or coverage.
How to prepare: identify (1) the CPT or HCPCS codes likely to be used, (2) Medicare payment for those codes (CMS's Physician Fee Schedule search covers physician services), (3) how commercial payers cover comparable procedures, (4) whether the device will be paid as a supply, within a procedure payment or as capital equipment, and (5) which coverage decisions are needed and on what timeline. See the reimbursement question.
The Answer That Stalls the Conversation
Investor: “Who pays for this?” Founder: “Hospitals will buy it because it saves them money.” That is a hypothesis, not an answer. Investors look for research on codes, Medicare payment and hospital purchasing workflows.
Question 4: "What Happens If Your Contract Manufacturer Can't Scale?"
What investors are trying to learn: manufacturing and supply chain risk. Using a contract manufacturer is normal for an early-stage device company; the question is what happens at commercial volume, or if terms change once the company depends on one supplier.
A common gap: assuming the prototype builder will scale, without a view on single-source risk, design transfer or cost of goods at volume.
How to prepare: set out (1) current cost of goods at prototype volume, (2) projected cost of goods at the volumes in the financial model, (3) the design transfer plan, (4) whether a second source exists, and (5) lead times for ramping production and the safety stock plan. See our manufacturing due diligence questions.
Question 5: "What Protects You Beyond the Core Patent?"
What investors are trying to learn: defensibility. A single patent can be designed around, so investors look at the broader position: additional patents and applications, trade secrets, freedom to operate and the company's position in the market.
A common gap: treating one utility patent as the IP strategy, with no freedom-to-operate view and no plan to protect know-how.
How to prepare: (1) list core patents and applications with filing dates and status, (2) identify continuation applications and design patents, (3) commission a freedom-to-operate analysis, (4) identify trade secrets and how they are protected, and (5) be precise about regulatory status: 510(k) clearance and De Novo classification do not give market exclusivity, and FDA notes that devices classified through De Novo may be used as predicates for future 510(k) submissions by others. Issued patents and published applications can be checked in the USPTO's Patent Public Search.
Question 6: "What Are Your Postmarket Obligations, and How Will You Meet Them?"
What investors are trying to learn: postmarket risk management. Once a device is on the market, its manufacturer must report certain events to FDA: under 21 CFR 803.50, reports of deaths, serious injuries and certain malfunctions are due within 30 calendar days of becoming aware of them. FDA can also order postmarket surveillance of certain Class II and Class III devices under section 522 of the Federal Food, Drug, and Cosmetic Act, generally for up to 36 months.
A common gap: a plan focused entirely on premarket work, with no answer to “what happens if a safety signal appears?”
How to prepare: set out (1) what will be monitored (adverse events, complaints, device failures), (2) how the data will be collected (complaint handling, registries, customer reports), (3) the threshold for investigating a potential signal, (4) who is responsible for regulatory reporting, and (5) how the company would respond to FDA questions. See postmarket surveillance traps.
Question 7: "What Does Your Quality System Look Like?"
What investors are trying to learn: operational maturity. FDA regulates how devices are designed, made, tested and documented, not just the device itself, and quality system problems can lead to warning letters or recalls.
A common gap: a working prototype built without design controls, a design history file or a corrective and preventive action (CAPA) process.
How to prepare: since February 2, 2026, FDA's Quality Management System Regulation (21 CFR Part 820) has incorporated ISO 13485:2016 by reference; third-party ISO 13485 certification is a separate step. Assess (1) where the quality system stands against that standard, (2) whether a design history file documents design decisions and testing, (3) whether suppliers are qualified, (4) whether procedures exist for design changes, testing and risk management, and (5) whether a CAPA process is in place.
What to Bring
For each of the seven questions, a short written answer with its supporting documents is more persuasive than a verbal one. It does not need to be a 50-page manual; it needs to show that regulatory risk, manufacturing, reimbursement and operations have been thought through.
How a Founder Report Helps You Prepare
A Vantage Founder Report ($7,500, delivered in 48 hours) is eight-domain diligence on your own company, reviewed by a physician and a biomedical engineer. It reads the same kinds of public records an investor's team will check, including FDA, clinical trial, patent and CMS sources, so the gaps these questions expose can be found and addressed before the first meeting. It surfaces what the record shows; it does not predict whether investors will fund the company.
The Bottom Line for Founders
A pitch deck, clinical data and team credentials still matter. When investors move into technical diligence, these seven areas are where preparation shows, and written answers backed by documents make that part of the process faster and more credible.
References
- FDA. "Premarket Notification 510(k)." fda.gov
- FDA. "De Novo Classification Request." fda.gov
- 21 CFR 803.50, "Individual adverse event reports; manufacturers." law.cornell.edu
- FDA. "522 Postmarket Surveillance Studies Program." fda.gov
- FDA. "Quality Management System Regulation (QMSR)." fda.gov
- CMS. "Search the Physician Fee Schedule." cms.gov
- USPTO. "Patent Public Search." uspto.gov
Need a Custom Analysis?
Vantage full reports assemble the public record on a company, cite factual claims to their sources, and are reviewed by Arvind Ravinutala, MD, and Aswini Ravinutala, BME. Start with a free 20-minute call.