The short answer. We compared 13 firms that design and develop medical devices, our own company included, on what a buyer can check before a sales call: published rate, team size, ISO 13485 certification and scope. Only five of about 25 firms we checked show any hourly rate on Clutch, and none of the others publishes a rate on its own site. Team sizes run from under 50 people to more than 800. Certification wording varies a lot: some firms certify specific sites, some through a predecessor company, some do not state it.
A note on bias: OVA Solutions is one of the firms in the table. We list only what each firm publishes about itself or what Clutch shows, with the source and date, and we treat our own numbers the same way. If a figure about your firm is out of date, write to us and we will correct it.
| Firm | Locations | Team size | Published rate | ISO 13485 | Scope |
|---|---|---|---|---|---|
| OVA Solutions (us) | New York; Florida, UK, Estonia, Ukraine | 62 engineers (own site) | $125 per hour (own site) | ISO 13485:2016 certified QMS, certificate 044-25 held by group company Canyon Medical Inc. | Electronics, firmware, mechanics from concept to design for manufacturing; no manufacturing |
| CLEIO | Trois-Rivières and Montréal, Canada; Indianapolis | Over 60 experts (own press release) | $150 to $199 (Clutch); minimum project $10,000+ | Certified (own site) | Design and development, quality and regulatory, manufacturing support |
| Delve (merged with Bresslergroup) | Boston, Madison, Philadelphia, San Francisco | 50 to 249 (Clutch) | Not published; Clutch minimum project $50,000+ | Certified since 2021 (own site) | Design and engineering to DFM and manufacturing transfer |
| Design 1st | Ottawa, Canada | 35 professionals (own site) | $100 to $149 (Clutch); site says North American teams charge $125 to $400 and its rates sit at the lower end | Not stated | Design to manufacturing setup, in-house prototype shop; several industries |
| Ensera Design (formerly HS Design) | Morristown NJ; Bristol UK; Longmont CO | Over 100 experts (own site) | $100 to $149 (Clutch, HS Design profile); minimum $5,000+ | Certified QMS (own site) | Design and development; parent group manufactures |
| Kablooe Design | Minneapolis, MN | 10 to 49 (Clutch) | Not published | Certified; TÜV SÜD certificate valid to March 2029 | Design and development only |
| Key Tech | Baltimore, MD | Not published | Not published | Certified (own site) | Diagnostics, drug delivery, life science tools |
| Simplexity Product Development | San Diego; Portland; Seattle | 50 to 249 (Clutch) | Not published | Certified since 2019 (own site) | Wearables, robotics, medical; builds then hands off to a contract manufacturer |
| StarFish Medical | Victoria BC; Toronto; Irvine | 230 full-time staff (own site) | Not published | Certified facilities (own site; sites not named) | Design, development and contract manufacturing |
| Suntra MedTech Solutions (formerly Sunrise Labs) | Bedford, NH | Not published | Not published | Certified; Intertek certificate valid to April 2028 | Design, development and software; no manufacturing |
| Vantage MedTech (Sterling Medical Devices and RBC Medical) | Lyndhurst NJ; Olathe KS | 150+ engineers (own site) | Not published | Certificates held by predecessor companies (own site) | Design through manufacturing |
| Velentium Medical | Richmond (Katy), TX | Not published | Not published | Not stated on own site | Class II wearables to Class III implantables, cybersecurity, contract manufacturing |
| Veranex | Raleigh NC and 15 hubs | 800+ experts (own site) | Not published | Providence and Minneapolis sites certified (own site) | Design, engineering, clinical, regulatory, manufacturing |
What the comparison shows
- Rates are rarely public. Most firms quote only after a call. Design 1st is the only one that explains market rates on its own site: $125 to $400 per hour for North American teams. OVA publishes a single rate, $125 per hour, on its cost page.
- Size is not the same as capacity on your project. A firm of 800 runs many programs at once; what matters is how many engineers work on yours and whether they stay to the end.
- Read the certificate, not the badge. ISO 13485 can cover one site or a predecessor company. Ask for the certificate, the holder, the scope and the expiry date. Ours: certificate 044-25, holder Canyon Medical Inc., scope design and development, production and distribution of medical device prototypes, valid to October 13, 2028 (details).
- Names change. Bresslergroup is now Delve, Sunrise Labs is Suntra, Sterling and RBC are Vantage MedTech, HS Design is Ensera, Ximedica is part of Veranex. Check which legal entity signs your contract.
What each firm claims about its track record
| Firm | Published claim |
|---|---|
| OVA Solutions | 220 devices developed; from idea to design for manufacturing in 6 to 12 months |
| CLEIO | involved in more than 2,500 projects |
| Design 1st | 1000+ ideas turned into working products; 3 to 12+ months from concept to working product |
| StarFish Medical | 1000+ programs; 25+ years |
| Vantage MedTech | 1600+ medical devices developed; 98% on-time delivery |
| Veranex | 1000+ programs accelerated |
| Delve | 1,500 patents and 200 design awards |
How to use this table
- Shortlist by fit: device class, technology (wearable, implant, robotics, diagnostics) and whether you need manufacturing from the same company.
- Ask every shortlisted firm the same questions: who exactly will work on the project, what the estimate is in hours and dollars, which files you own, and the certificate details.
- Compare estimates by hours and deliverables, not by hourly rate alone. Our checklist: how to choose a medical device development firm.
Where OVA Solutions fits
We are smaller than StarFish or Veranex and larger than most boutique studios: 62 engineers who have developed 220 devices, with a published rate of $125 per hour and an ISO 13485:2016 certified quality system. We take a device from concept to design for manufacturing, typically in 6 to 12 months, and hand over to the manufacturer you choose. If something we designed doesn’t work, we fix it at our cost. If you need clinical, regulatory submission or volume manufacturing services under one roof, a larger firm from the table may suit you better. See also alternatives to large medical device design firms.
Sources
- StarFish Medical: About
- Veranex: Certifications
- Delve: About
- Delve: ISO 13485 certification (2021)
- Clutch: Delve
- CLEIO
- Clutch: CLEIO
- Vantage MedTech: About
- Suntra MedTech: Intertek certificate
- Velentium Medical: About
- Key Tech
- Simplexity: Company history
- Clutch: Simplexity
- Kablooe Design: About
- Clutch: Kablooe Design
- Design 1st
- Design 1st: product development process
- Clutch: Design 1st
- Ensera Design: Quality
- Clutch: HS Design
- Clutch: OVA Solutions
- Greenlight Guru: Top 50 medical device product design and development companies (July 2026)
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.