The short answer. If you are a startup or a mid-size medtech company, a large design firm is not the only way to get a device built. The realistic alternatives are a specialist engineering group of 30 to 150 engineers, your own in-house team, freelancers, or the design services of a contract manufacturer. They differ in cost, speed, who does the work and who owns the files. Large firms are the right choice when you need clinical, regulatory and volume manufacturing under one contract.
| Option | When it fits | What to watch |
|---|---|---|
| Large design and development firm (200 to 800+ people) | Big budgets, many parallel workstreams, clinical and manufacturing services under one roof | Senior people sell the project and others may deliver it; higher overhead in the rate; minimum project sizes |
| Specialist engineering group (30 to 150 engineers) | Class I to III devices where one team should carry electronics, firmware and mechanics from concept to DFM | Check that they have built devices like yours and how they hand over to manufacturing |
| In-house team | You have the funding to hire for years and the product line to keep the team busy | Hiring takes months; you need people for every discipline and a quality system |
| Freelancers or marketplaces | Narrow tasks: an enclosure, a board review, a test fixture | No single owner of the design, documentation gaps, IP assignment |
| Contract manufacturer’s design services | The design is nearly done and you already chose the manufacturer | Design choices may tie you to that manufacturer and its parts |
Published price signals are thin. Design 1st writes that North American development teams charge $125 to $400 per hour. On Clutch the few medical device firms that show a rate sit between $100 and $199 per hour. OVA publishes $125 per hour. See medical device engineering firms compared for the sources.
When a large firm is the better choice
- You need clinical studies, regulatory submission and production from one supplier.
- The program is large enough to keep several teams busy for years.
- Your investors or partners require a specific firm or a certified manufacturing site.
Why teams choose a specialist group like OVA Solutions
- The people you meet do the work. 62 engineers in electronics, firmware and mechanics, working as one team on your device.
- Experience you can check. 220 devices developed, across wearables, neurotechnology, orthopedic and rehabilitation devices, hospital equipment and connected electronics.
- A price you can see before the first call. $125 per hour, published on our cost page, with a fixed budget and timeline per phase.
- Speed. From idea to design for manufacturing typically in 6 to 12 months.
- Quality system and accountability. ISO 13485:2016 certified QMS; if something we designed doesn’t work, we fix it at our cost.
On Industry Ignited, Lisa Voronkova explained that outsourcing makes sense when a company is pre-revenue and capital constrained: with about half a million dollars in seed funding, a founder cannot afford a full in-house engineering team. More of her answers on outsourcing: working with an engineering partner.
Questions to ask any alternative
- Which devices like ours have you taken past the prototype stage, and can we speak to that client?
- Who exactly will work on our project, and will they stay until design transfer?
- What is the estimate in hours and dollars per phase, and what happens if it runs over?
- Which files do we own at the end, and in what format?
- Who holds your ISO 13485 certificate, for which scope and sites, and until when?
Sources
- Design 1st: product development process (rates)
- Clutch: CLEIO
- Clutch: Design 1st
- Clutch: HS Design
- StarFish Medical: About (team size)
- Veranex (team size)
What OVA does here, and where our responsibility ends
OVA Solutions is a medical device engineering group working under an ISO 13485:2016 certified quality system: 62 engineers, 220 devices developed, $125 per hour, offices in New York, Florida, the United Kingdom, Estonia and Ukraine. We design electronics, firmware and mechanics and take a device from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
More from OVA: what medical device development costs, how to choose a development firm, answers from Lisa Voronkova, our quality system.
Updated on October 8, 2026.