To choose a medical device development firm, ask for three things before you talk about price: a device like yours that the firm took past the prototype stage, the names of the engineers who will do the work, and a list of the files you will own if you leave. Then compare quotes by hours and deliverables, not by hourly rate. I run one of these firms, so check every point below on us too.
Most founders pick a firm the way people pick a contractor for a kitchen: a nice portfolio, a pleasant call, a number that fits the budget. With a kitchen the worst case is ugly tiles. With a Class II device the worst case is a prototype that works on the bench and can’t be manufactured, tested or submitted. Here are seven checks. They take about a week and cost nothing.
The seven checks in one table
| Check | What a good answer looks like | Red flag |
|---|---|---|
| 1. A device like yours | Two projects with the same hard part as yours, what the firm delivered, where the device is now | A wall of logos with no roles |
| 2. The people | The lead engineer is named and talks to you before you sign | Only sales people on the calls |
| 3. The quality system | An ISO 13485 certificate with holder, scope, issuer and dates, plus one redacted example of requirement-to-test traceability | “We write the documentation at the end” |
| 4. The quote | Hours by phase and by discipline, deliverables for each phase, exclusions | “Full development” with testing excluded |
| 5. Outside costs | Materials, test labs and FDA fees on separate lines | One number for everything, or a guaranteed clearance date |
| 6. Ownership | Project IP assigned to you, native files and source code handed over at each phase | PDFs and compiled binaries only |
| 7. Pricing model | A small paid first phase, then scoped phases with estimates | A fixed price on a vague idea |
1. Ask for a device like yours, not a big number
Every firm has a big number. Ours is 220 devices. The number tells you the firm has survived. It doesn’t tell you the firm can build your device.
Ask for two projects that share your hard part: the same kind of sensor, the same patient contact, the same power budget, the same wireless link. Then ask what the firm delivered and where the device is now. “We built the first prototype and the client took it from there” is an honest answer. A logo on a slide is not an answer.
Published engineering detail is a good sign too. If a firm writes about real trade-offs, the way we do in our notes on a wearable knee monitor and a rehabilitation crutch, you can judge the thinking before the first call.
2. Meet the engineers before you sign
You are buying the hours of specific people. Ask who the lead engineer will be and talk to that person for half an hour. A useful question: “What are the three things most likely to break our schedule?” A lead who has built something similar answers in a minute.
Ask also who replaces the lead if they leave the project, and how much of their week is yours.
3. Read the certificate, not the badge
“ISO 13485 certified” on a website tells you very little until you read the certificate. Look at four lines: who holds it, what the scope says, which body issued it and when it expires. The holder may be another company of the same group. That is common and fine, as long as the firm says so. Ours is held by Canyon Medical Inc., a company in our group, and the scope is design and development, production and distribution of medical device prototypes. The details are on our quality page.
Two facts help here. Since February 2, 2026 the FDA Quality Management System Regulation incorporates ISO 13485:2016 by reference, so a design process built on that standard has the structure FDA expects. And FDA says plainly that it does not issue or require ISO 13485 certificates, and that a certificate does not exempt a manufacturer from inspection. A firm that calls itself “FDA certified” is describing something that doesn’t exist.
Then ask for one redacted example of traceability: one requirement, the design output that meets it and the test that proves it. If the answer is “we write the documentation at the end”, the documentation will be fiction.
4. Compare hours, not hourly rates
A lower rate with more hours costs more. $125 per hour for 3,000 hours is $375,000. $90 per hour for 5,000 hours is $450,000.
So ask every firm for the same thing: hours by phase and by discipline, and what you hold in your hands at the end of each phase. “Full development” can mean a demonstrator, a verified design, or a package a manufacturer can build from. These are three different purchases.
Design is also where much of the later trouble is decided. In an analysis of 58,374 FDA recall records from October 2002 to June 2026, device design was the largest identified root cause at 13.0%, and software design added another 5.9%.
5. Budget for what the firm doesn’t control
An engineering quote is one part of the budget. Ask the firm to list the rest on separate lines: components and prototype builds, test labs for electrical safety and EMC, biocompatibility, human factors, tooling and FDA fees.
For fiscal year 2027 a 510(k) costs $28,653, or $7,163 if FDA has qualified your company as a small business. A De Novo request costs $191,020, or $47,755 for a small business.
Be careful with dates too. FDA’s goal for a 510(k) decision is 90 FDA days. The clock stops while you answer a request for additional information, and you have up to 180 calendar days to answer. No engineering firm controls that clock. A firm that guarantees a clearance date is guaranteeing someone else’s work.
For scale: StarFish Medical, one of the few firms that publishes figures, puts development and engineering for a medium-complexity Class II device at $2 million to $5 million. Your device may need far less. What matters is knowing which line of the budget each number sits on. We publish our own rate and what it covers on the cost page.
6. Own your files from the first phase
Ask one question: “If we stop next month, what exactly do we receive?” The answer should include native CAD, schematics and PCB files, firmware source code with build instructions, the bill of materials, test protocols and reports, and the design history file records. PDFs and compiled binaries are not a design. They are photographs of one.
Put in the contract that intellectual property created in the project is assigned to your company, and that any technology the firm brought with it is licensed to you, so another team or manufacturer can maintain the product.
If you are a physician or work at a university, read your employment agreement first. Your employer may have rights to the invention.
7. Match the pricing model to the uncertainty
Time and materials fits early work, when nobody knows yet whether the sensor will be accurate enough. Fixed price fits work with a clear scope and a measurable acceptance test.
A fixed price doesn’t remove uncertainty. It decides who pays for it. A firm that takes that risk will price it in or recover it through change orders.
The arrangement I would choose as a client: a small paid first phase with a clear output (architecture, risk list, test plan, estimate for the next phases), and a decision to continue or stop after it.
A one-week process
- Write one brief: intended use, users, what exists today, target markets, expected volumes.
- Send it to three firms and ask all three for the same scope.
- Talk to the lead engineer at each firm.
- Ask for the certificate, one redacted traceability example and two references. One reference should be from a project that had problems.
- Compare hours and deliverables by phase.
- Buy the first phase only.
What OVA does here, and where our responsibility ends
OVA Solutions is a full-cycle hardware engineering team: electronics, firmware, mechanics, prototypes, design for manufacturing and transfer to production. We bill $125 per hour and work under an ISO 13485:2016 certified quality system. We are not a regulatory consultancy and not a contract manufacturer. We prepare the design documentation. The regulatory strategy and the submission belong to you or your regulatory consultant, and production is done by manufacturing partners.
Common questions
How much does a medical device development firm charge per hour?
Most firms don’t publish a rate. Ours is $125 per hour. Directories such as Clutch show the range each firm declares. Compare total hours and deliverables, because a lower rate with more hours costs more.
Does a development firm need ISO 13485 certification?
FDA doesn’t require the certificate itself. But since February 2026 FDA’s quality regulation incorporates ISO 13485:2016, and a certified firm has had its design process audited by a third party. Read the holder and the scope on the certificate.
Who owns the IP when you hire a development firm?
Whoever the contract says. It should say you: project IP assigned to your company, and a license to any technology the firm brought with it.
How long does FDA take to review a 510(k)?
FDA’s goal is a decision within 90 FDA days. The clock stops while you answer requests for additional information, so calendar time is longer.
Should a startup hire a firm or build its own team?
Build a team when hardware is your long-term core and you can hire electronics, firmware, mechanical and quality engineers at once. Hire a firm when you need one device built and tested and can’t wait a year to assemble the team.
Sources: FDA, Quality Management System Regulation · FDA, QMSR frequently asked questions · FDA user fees for fiscal year 2027 · FDA 510(k) submission process · MedDeviceGuide analysis of FDA recall records, 2026 · StarFish Medical cost guide, 2026
Lisa Voronkova, PhD, is a medical device development expert and CEO of OVA Solutions, a New York engineering group of 62 engineers that has developed 220 devices. She holds a PhD in applied mathematics and wrote Hardware Bible: Build a Medical Device from Scratch.
If you are choosing a firm now, we are glad to be one of the three you compare. Grab a slot on Lisa’s calendar at calendly.com/lisa-voronkova/30min, and if nothing there works, write to lisa@ovasolutions.com.
More on this topic: Cost, Funding & Market