OVA Solutions bills medical device engineering at $125 per hour. The total for your device is the number of engineering hours it needs, plus costs that no engineering firm controls: components, test labs, FDA fees, clinical work and tooling. This page shows how to build that estimate, what our rate covers and what you pay to others.
The short answer
- Our rate is $125 per hour of engineering time.
- Your budget is hours multiplied by the rate, plus materials, outside testing and regulatory fees.
- 1,000 engineering hours cost $125,000. 3,000 hours cost $375,000.
- The hours depend on the device: its risk class, whether it touches the patient, whether it is wireless, how much software it carries and how many prototype rounds it needs.
- We estimate each phase in hours before it starts, so you approve the number before the work begins.
What the $125 rate covers, and what it does not
| Covered by our hourly rate | Paid separately, usually to others |
|---|---|
| Electronics design: architecture, schematics, PCB layout | Components, PCBs and prototype materials |
| Firmware development | Outside test labs: electrical safety under IEC 60601-1, EMC, biocompatibility |
| Mechanical design and CAD | FDA user fees |
| Prototype assembly and bench testing | Clinical studies and human factors studies |
| Design for manufacturing and transfer to your manufacturer | Tooling, molds and production |
| Design documentation: schematics, Gerber files, firmware, CAD, test reports, design history file records | Regulatory strategy and ownership of the submission |
FDA fees for fiscal year 2027
These fees apply from October 1, 2026 to September 30, 2027. You pay them to FDA, not to an engineering firm. The small business rate is not automatic: FDA has to qualify your company first.
| Fee | Standard | Small business |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| De Novo classification request | $191,020 | $47,755 |
| PMA | $636,732 | $159,183 |
| 513(g) request for information | $8,596 | $4,298 |
| Annual establishment registration | $13,785 | no reduced rate |
Source: FDA, Medical Device User Fee Amendments: Fees.
A public benchmark for comparison
Few firms publish numbers. One that does is StarFish Medical: its guide puts development and engineering for a medium-complexity Class II device built on proven benchtop technology at $2 million to $5 million, and the full path to 510(k) clearance much higher once clinical and regulatory work is added. Source: StarFish Medical, How much does it cost to develop a medical device?, updated August 2026.
Use any benchmark, including ours, the same way: ask how many hours stand behind the figure and what is excluded.
What makes the number go up
- Risk class. A Class II device needs design controls, verification testing and a regulatory submission. A Class III device needs more of each.
- Patient contact. Materials that touch skin or tissue need biocompatibility evidence, and that limits which materials and suppliers you can use.
- Wireless and connectivity. Bluetooth or cellular adds radio certification, coexistence testing and cybersecurity documentation.
- Software. The higher the software safety class under IEC 62304, the more documentation and testing each feature needs.
- Power. Batteries add safety testing and shipping rules, and small batteries force many rounds of power optimization.
- Changing requirements. A requirement that changes after the layout is done costs much more than the same change on paper.
How to read a proposal from an engineering firm
Whoever you hire, check that the proposal answers these questions.
- How many hours, by phase and by discipline: electronics, firmware, mechanics?
- What is delivered at the end of each phase: a demonstrator, a tested design, or files a manufacturer can build from?
- Which assumptions is the estimate built on, and what is excluded?
- Are outside costs listed on their own lines: materials, test labs, certification, FDA fees?
- Who owns the design files, source code and intellectual property, and when do you receive them?
- How are changes approved, and what happens to the budget when a requirement changes?
- What do you get if you stop after the current phase?
How we work on price
We split a project into phases. Each phase gets an estimate in hours and a list of deliverables before it starts. If something we designed does not work, we fix it at our cost.
We are an engineering team. We are not a regulatory consultancy and not a contract manufacturer: we prepare the design documentation and support your manufacturer during transfer, and the regulatory strategy and the submission stay with you or your regulatory consultant. Our work runs under an ISO 13485:2016 certified quality system, described on the quality page.
To get an estimate for your device, book a 30-minute call or write to info@ovasolutions.com.
Common questions
What is OVA Solutions’ hourly rate?
$125 per hour of engineering time.
Why is there no single price for a medical device?
Because the hours depend on the device. A simple wearable sensor and a robotic system differ many times over in engineering hours, testing and documentation. An honest estimate starts from your requirements and is given in hours by phase.
What is the FDA fee for a 510(k) in fiscal year 2027?
$28,653 at the standard rate and $7,163 for a company that FDA has qualified as a small business.
Does the engineering budget include testing and FDA fees?
No. Test labs, certification, FDA fees, clinical studies and tooling are paid separately. A good proposal lists them on their own lines so you can see the full budget.
Who should own the design files?
The client. Ask every firm you talk to, including us, when you receive the native files and source code, and put the answer in the contract.
Sources: FDA user fees for fiscal year 2027 · FDA 510(k) submission process · StarFish Medical cost guide
By Lisa Voronkova, PhD, CEO of OVA Solutions. Updated on October 7, 2026.