The short answer. Device startups rarely fail on engineering alone. They run out of money because the expensive work happened before the cheap questions were answered. We help founders spend in the right order: discovery and a proof of concept to test the riskiest assumption, then functional prototypes and a golden sample that investors and partners can hold, then verification support and design for manufacturing. Each phase has an agreed budget ceiling and timeline. One post-operative cold therapy device went from concept to clinical trials in 12 months.
Why outsource the engineering early
Outsourcing makes sense when you’re pre-revenue and capital constraint because if you’re a founder if you have like half a million in seed funding you just cannot afford to hire a full in-house engineering team because good medical device engineer in US like 200k fully loaded
A device needs at least a mechanical engineer, an electronics engineer, a firmware engineer and someone who owns quality and documentation. Hiring that team before the product exists commits most of a seed round to salaries. An outside team that has built the same kind of device can also skip mistakes you would otherwise pay for. OVA itself began as a founder story: the team built a health-monitoring sensor that was not integrated into the care pathway, merged with an engineering team in Ukraine and turned to building devices for other founders.
What to build at each funding stage
| Stage | The question to answer | What we deliver | Real example |
|---|---|---|---|
| Pre-seed | Does the principle work, and is the problem worth paying for? | Discovery, a plan with hours, digital prototypes, simulation and a proof-of-concept rig | 10 digital prototypes simulated and the best three built for a blood-handling device |
| Seed | Can it be built and used by real people? | Functional prototypes, then a golden sample that looks and behaves like the production device | Five fully functional cold therapy prototypes before the clinical trial |
| Series A | Will it pass verification, and can it be made at the target cost? | Verification support, clinical builds, design for manufacturing and transfer | A 100-unit batch for bench tests and about 30 clinical devices on a glucose patch |
The golden sample is the pre-certification unit that fully meets the functional requirements and becomes the reference for production. It cannot be sold or used for clinical claims, but founders can show it to investors, take it to trade shows, give it to partners and collect user feedback.
Of course, in the state you cannot sell it as a medical device or make any clinical claims, but it’s enough to understand do you want to invest more on that or not really. But for startups, this is the most useful artifact to open the next round.
How we keep the budget under control
- Phase gates. Each phase has a question and a budget. The next, more expensive phase starts only when the cheaper one has confirmed the assumption.
- A ceiling in the contract. After discovery we commit to a maximum budget and timeline per phase, so an optimistic estimate cannot turn into a year of extra hours.
- Digital before physical. Simulation and digital prototypes cost a fraction of a molded part, so we compare concepts there first.
- One published rate. $125 per hour, with the hours per phase in the proposal.
And the client only enters the expansive phases once the cheap ones have confirmed the assumption. So, you wouldn’t overspend for unnecessary polishing of something that is not working initially. So that is the main tool for controlling the budget risk.
| Project | Engineering hours | At $125 per hour |
|---|---|---|
| Small: clear architecture, proven technology | 2,000 to 3,000 | $250,000 to $375,000 |
| Mid-size: mechanics, electronics and firmware together | 5,000 to 6,000 | $625,000 to $750,000 |
| Design for manufacturing for an average product | 2,500 to 4,000 | $312,500 to $500,000 |
So, for context, median path for a new Class II device from concept to 510(k) is around three million and thirty-one months according to the statistic that I see in the market.
Mistakes we see founders make
Treating the prototype as the product
I’ve heard this mistake from first-time founders, that they’re thinking that once they have a prototype would be the same in the production. It’s absolutely wrong, because you have to build a design for manufacturing.
A prototype proves function. Production needs assembly sequence, tolerances, test points, fixtures, second sources and a cost target, and every one of those can change the design. We plan design for manufacturing from the start and bring the contract manufacturer in before design freeze.
Finding out the device class too late
We’ve seen examples where a product is about to start mass production and they realize they’re receiving a different classification
A different class can mean new tests, new documentation and a redesigned mold. A short regulatory assessment with your consultant, and often an FDA Pre-Submission, costs far less than a late redesign.
Confusing clearance with a market
It doesn’t mean hospitals will buy it. It doesn’t mean that surgeons will adopt it. It doesn’t mean that insurance will reimburse it. It means nothing. It just means it’s safe.
Who pays, who buys and who has to change their workflow are questions for discovery, not for the launch. We ask them in the first weeks because they change the requirements.
Startup projects from our portfolio
Cold therapy device: concept to clinical trials in 12 months
Controlled local hypothermia after surgery: thermal model, temperature-holding algorithm, in-vitro tests, assembly and quality documentation.
Blood-handling device from a founder’s vision
10 digital prototypes and simulations, the best three built physically and tested with pig’s blood to choose one.
Colonoscopy device component, proof of concept
Proof-of-concept units in molded silicone and 3D-printed parts, tested in a simulated wet colon environment before full design.
Glucose patch: a startup inside a pharma company
The same phase-gated path, from discovery to a golden sample and a clinical-ready prototype now in clinical trials.
It was just a founder’s vision. We created 10 different digital prototypes, ran simulations, selected the top three, built them as physical prototypes, and are now doing tests with pig’s blood to select the best one.
FDA fees, programs and grants for startups
| Item | FY2027 standard fee | Small business fee |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| De Novo | $191,020 | $47,755 |
| PMA | $636,732 | $159,183 (first PMA fee waived for receipts of $30 million or less) |
| 513(g) classification request | $8,596 | $4,298 |
| Program | What it gives a startup | 2026 numbers |
|---|---|---|
| Pre-Submission (Q-Sub) | Written FDA feedback on your plan before you test or submit | Feedback within 70 days; 4,431 Pre-Subs received in FY2025, about 97.5% answered on time, about 62 FDA days on average |
| 513(g) request | FDA’s view on class and pathway when you are not sure | Answer within 60 days |
| Breakthrough Devices Program | Priority interaction with FDA for designated devices | 1,320 designations granted and 210 designated devices authorized as of June 30, 2026; decision within 60 days |
| TAP | Early, frequent FDA advice for Breakthrough and STeP devices | 159 devices enrolled as of October 7, 2026; open to all review offices since July 1, 2026 |
| NIH SBIR | Non-dilutive grants, reauthorized through 2031 | Phase I up to $323,090, Phase II up to $2,153,927; next standard due date January 5, 2027 |
| NSF SBIR | Non-dilutive grants after an invited project pitch | Phase I up to $305,000; next deadline November 4, 2026 |
If you plan to pay an engineering firm from an SBIR grant, check the subcontracting limits first: under SBIR Phase I the small business must do at least two thirds of the research effort, under Phase II at least half. Our SBIR and STTR page has the details.
Questions
How much money do I need for a first working prototype?
It depends on how much of the device is new. On our rehabilitation chair program discovery took about 280 hours and the first prototype about 720, roughly $125,000 at $125 per hour. A whole small project on proven technology takes 2,000 to 3,000 engineering hours ($250,000 to $375,000); projects that combine new mechanics, electronics and firmware take 5,000 to 6,000. A discovery phase of a few hundred hours gives you a firm estimate before you commit.
What is a golden sample?
The pre-certification device that fully meets the functional requirements and serves as the reference for production. It cannot be sold or used for clinical claims, but it is what investors, partners and early users can hold.
Can a startup pay a lower FDA fee?
Yes, if your company qualifies as a small business (gross receipts of $100 million or less, including affiliates). In FY2027 that cuts a 510(k) fee from $28,653 to $7,163 and a De Novo fee from $191,020 to $47,755. You need the small business determination before you submit.
Should we talk to the FDA before building?
Often yes. A Pre-Submission gives written FDA feedback within 70 days on your testing plan or pathway; FDA received 4,431 of them in FY2025. If you are unsure of the class, a 513(g) request answers within 60 days for $4,298 with the small business rate.
How fast can we get to clinical trials?
One documented path was a post-operative cold therapy device: concept to clinical trials in 12 months and 3,380 engineering hours, with five fully functional prototypes. Complex devices with their own sensor chemistry take longer: a glucose patch took 1.5 years and 11,600 hours to a clinical-ready prototype now in clinical trials.
Do you sell only engineering hours?
We sell engineering by phase: a plan with hours, a budget ceiling and a deliverable for each phase. The rate is $125 per hour.
Related pages
Founder with a device idea?
Bring the problem, the user and what you have so far. On a short call an engineer will tell you what to prove first and roughly how many hours it takes.
Sources
- Lisa Voronkova on the Global Medical Device Podcast, September 2026
- Lisa Voronkova on Industry Ignited, February 2026
- Lisa Voronkova at the Grant Engine roundtable, July 2025
- Lisa Voronkova on MedTech Sustainability by Design, March 2026
- Lisa Voronkova on Digital Health Interviews, June 2024
- Federal Register, FDA device user fee rates for FY2027
- FDA, The Q-Submission Program guidance, May 2025
- FDA MDUFA quarterly report, Q3 FY2026
- FDA, Breakthrough Devices Program
- FDA, TAP program
- OVA Solutions: SBIR and STTR grants in 2026
Updated on October 9, 2026.