Answer six questions and see what the engineering for your device is likely to cost, phase by phase. The hours come from 35 estimates OVA Solutions sent to clients from 2024 to 2026 and from finished projects; the cost applies our current published rate of $125 per hour to those hours. The result is an approximate range, not a quote: a real estimate comes after a short call, in hours by phase, and you approve each phase before it starts.
The calculator needs JavaScript. Typical ranges are in the table below.
Typical ranges
For a Class II device that reads body signals, runs on a battery, talks over Bluetooth and needs 3 to 5 prototypes, the calculator gives these ranges:
| Starting point and goal | Engineering hours | Cost at $125 per hour | Months |
|---|---|---|---|
| Idea to a demo prototype | 560 to 830 | $70k to $105k | 1 to 2 |
| Idea to a few working prototypes | 1,890 to 2,660 | $235k to $335k | 3 to 5 |
| Proof of concept to working prototypes | 1,360 to 1,950 | $170k to $245k | 2 to 4 |
| Working prototype to units for verification and clinical testing | 2,050 to 2,860 | $255k to $360k | 3 to 6 |
| Proof of concept to a production-ready design | 3,450 to 4,820 | $430k to $605k | 5 to 10 |
| Idea to a production-ready design | 4,340 to 6,040 | $545k to $755k | 6 to 12 |
| Device on the market to a redesigned prototype batch | 1,210 to 1,740 | $150k to $220k | 2 to 3 |
The full path, from an idea to a design your manufacturer can build, takes 4,340 to 6,040 engineering hours for a device like this. Large programs such as ventilators or glucose monitors take 10,000 to 30,000 hours, that is $1.25 million and more.
How the number is built
Every OVA estimate is split into phases, and so is the calculator: discovery and requirements, concept and feasibility, the first working prototype, testing and the next prototype, design documentation, units for verification and clinical testing, and design for manufacturing. Your answers decide which phases you need and how big each one is.
- Starting point. A proof of concept removes most of the concept work, and a working prototype also shortens the first build. A device already on the market needs the least new design.
- Goal. A demo needs one short build. Units for clinical testing add documentation and a pre-production batch. A production-ready design adds design for manufacturing, the largest single phase.
- Medical class. Wellness products skip most of the design documentation. Class III adds documentation, verification and more prototype rounds.
- What is inside. Body signals, radios, batteries and moving parts each add engineering. A device with none of them can cost about a quarter less than our base case.
- Project management. Coordination adds 12% on top of the engineering hours; in our own estimates it runs from 9% to 17%.
Discovery usually comes first, as a separate step of 3 to 8 weeks. Until it is done, our own estimates carry a tolerance of plus or minus 15%, which is why the calculator shows a range.
Working to a fixed budget
Lisa Voronkova, CEO of OVA Solutions, puts it simply: tell us what you have budgeted, and we will show you how to phase the program so that every phase ends with something you can use. Must-haves come first; nice-to-haves wait for the next phase.
Almost every program starts with discovery: requirements, the architecture, a list of risks and an estimate in hours for everything after. From there each phase has its own budget and its own deliverable, so you can raise the next round or decide on the next phase with a result in hand.
When the budget is set before the scope, these are the levers we use most often:
- One board spin instead of two.
- Off-the-shelf modules where they are good enough, custom electronics later.
- A 3D-printed enclosure before industrial design.
- A slower monthly pace instead of a smaller scope.
Three projects for scale
| Project | Engineering hours | Time | Result |
|---|---|---|---|
| Single-use glucose monitoring patch | 11,600 | about 1.5 years | Eight phases to a clinical-ready prototype, now in clinical trials |
| Load-sensing rehabilitation crutch | about 1,660 | 8 months | 100 pairs produced |
| Post-operative cold therapy device | about 3,380 | 12 months | Five functional prototypes and clinical trials |
What is not in the number
- Prototype materials: components, boards, 3D printing and machining. We bill them at cost without markup; the calculator shows a range per prototype unit.
- Test labs: electrical safety and EMC under IEC 60601, radio certification, biocompatibility. The lab quotes them, and you pay the lab.
- FDA fees: for fiscal year 2027 a 510(k) costs $28,653, or $7,163 for a qualified small business. See FDA user fees for fiscal year 2027.
- Clinical studies and human factors studies.
- Tooling and production: your manufacturer quotes them.
What our rate covers, and what you pay to others: how much medical device development costs.
Questions
How much should we raise for development?
Take the engineering range for the phases you plan to fund, then add prototype materials (the calculator shows a range per unit), test labs and FDA fees. Plan the round to reach a result you can show: a working prototype, units for a clinical study or a design ready for production.
Do you manufacture the device?
Not in volume. We build prototypes and small pilot or clinical batches, design the device for manufacturing, prepare the transfer package and support your contract manufacturer through the first builds. Volume production stays with the manufacturer.
How accurate is the calculator?
It gives the range our engineers would give on a first call for a typical device of that kind. The hours per phase come from 35 OVA estimates sent in 2024 to 2026 and from finished projects. A firm number needs discovery; until it is done, our estimates carry a tolerance of plus or minus 15%.
Why do you show hours and not a fixed price?
Because hours are what you can check. Our estimates are built from hours by phase, each with its deliverable, and you approve a phase before it starts. At $125 per hour, 1,000 hours cost $125,000.
What if our budget is already fixed?
Tell us the number. We will split the program into phases that fit it, must-haves first, and show what each phase delivers. Discovery comes first and ends with an estimate in hours for everything after.
Does the estimate include FDA clearance?
No. We prepare the engineering evidence and the design documentation for the submission. The regulatory strategy, the submission and the FDA fees stay with you or your regulatory consultant.
How long does development take?
With a dedicated team of 3 to 5 engineers, the full path from an idea to a production-ready design takes about 6 to 12 months for the device in the table above; Class III devices and devices with more inside take longer.
Is the rate the same for every engineer?
Yes: $125 per hour for electronics, firmware, mechanical engineering, testing and documentation.
Related pages
Want a real estimate?
Send us what you have: a sketch, a proof of concept or a prototype. An engineer will go through it with you and give you an estimate in hours by phase.
Sources
- OVA Solutions estimates sent to clients, 2024 to 2026 (35 estimates, internal data, no client names)
- Single-use glucose monitoring patch
- Load-sensing rehabilitation crutch
- Post-operative cold therapy device
- FDA user fees FY2027
Updated on October 10, 2026.