Medical Device Design Companies: Who Fits Which Device Class
Which medical device design companies fit Class I, Class II and Class III programs, what design controls and ISO 13485 actually cost, and when a general product firm is the wrong call.
August 30, 20263 min read
Written by Konstantin Dolgan, Ph.D., NPDP
Founder & CEO, Product Development Engineer
Published August 30, 2026
Short answer: if your device is Class III or a Class II with a 510(k) and software, hire a firm that runs a certified ISO 13485 quality system in-house — Suntra MedTech, Key Tech, StarFish Medical, Delve or Nordson MEDICAL.
If you are building a Class I or an exempt wellness product and need form, engineering and manufacturable parts, a general product development firm like LA NPDT is cheaper and faster. Choosing by device class, not by brochure, is the whole decision.
Match the firm to the device class
What you are building | Right kind of firm | Typical program |
|---|---|---|
Class III implant or life-sustaining device | Regulated design house with ISO 13485 and clinical experience | Six to seven figures, multi-year |
Class II with 510(k), electronics and software | Medical-specialist firm with in-house QMS and IEC 60601 testing support | 250,000 dollars and up |
Class II, mechanical only, predicate exists | Medical-capable engineering firm plus a regulatory consultant | 75,000 to 250,000 dollars |
Class I or 510(k)-exempt device | General product development firm with documentation discipline | 15,000 to 80,000 dollars |
General wellness or fitness product, no claims | General product design and engineering firm | 10,000 to 60,000 dollars |
What design controls actually add to a project
How we evaluated these firms
- Whether the firm holds its own ISO 13485 certification, or borrows a client system.
- Cleared devices on the market, not renderings of concepts.
- In-house software and electronics, since most Class II devices now carry both.
- Whether the same firm can support manufacturing transfer and process validation.
- Honest minimum engagement — a firm that takes a 20,000 dollar Class II project is telling you something.
The shortlist
Shortlist at a glance · Last verified August 2026
Suntra MedTech (formerly Sunrise Labs)
- HQ
- Bedford, New Hampshire, US
- Founded
- 1992
- Team size
- Not published
- Minimum engagement
- Not published
- Best for
- Class II devices where software is part of the system.
Key Tech
- HQ
- Baltimore, Maryland, US
- Founded
- 1998
- Team size
- Not published
- Minimum engagement
- Not published
- Best for
- Diagnostics and laboratory instrumentation.
StarFish Medical
- HQ
- Victoria, British Columbia, Canada
- Founded
- 1998
- Team size
- Not published
- Minimum engagement
- Not published
- Best for
- Early-stage medtech that needs a full team including regulatory support.
Delve
- HQ
- Madison, Wisconsin, US
- Founded
- 1968 (as Design Concepts)
- Team size
- Not published
- Minimum engagement
- Not published
- Best for
- Devices where human factors decide clearance and adoption.
Nordson Medical
- HQ
- Loveland, Ohio, US
- Founded
- Not published
- Team size
- Not published
- Minimum engagement
- Not published
- Best for
- Component-level design and contract manufacturing at scale.
Regulatory consultants
- HQ
- Independent specialists, US-wide
- Founded
- Not published
- Team size
- Not published
- Minimum engagement
- Not published
- Best for
- Submissions and quality systems when the engineering is already handled.
- Source
- Not published
LA NPDTUs
- HQ
- Ruston, Louisiana, US
- Founded
- 2015
- Team size
- In-house team across ten disciplines
- Minimum engagement
- Feasibility and concept work from a few thousand dollars
- Best for
- Class I, exempt and wellness hardware that has to be manufacturable at a realistic unit cost.
Facts come from each company’s own public website on the date above. “Not published” means the company does not state that figure publicly — we do not substitute an estimate.
1. Suntra MedTech (formerly Sunrise Labs) — best for Class II devices with software
- HQ
- Bedford, New Hampshire, US
- Founded
- 1992
- Team size
- Not published
- Minimum engagement
- Not published
- Services
- Class II medical device engineering, embedded software, systems engineering
- Best for
- Class II devices where software is part of the system.
- Not for you if
- You are a solo inventor with a wellness accessory.
Nashua, New Hampshire. ISO 13485 certified, strong on embedded software, instrumentation and connected diagnostics under full design controls. Not for you if: you are pre-funding and hoping to spend under six figures.
Website: Suntra MedTech
2. Key Tech — best for diagnostics and lab instrumentation
- HQ
- Baltimore, Maryland, US
- Founded
- 1998
- Team size
- Not published
- Minimum engagement
- Not published
- Services
- Diagnostics, lab instrumentation, medical device development
- Best for
- Diagnostics and laboratory instrumentation.
- Not for you if
- Your product is a simple molded consumer good.
- Website
- Key Tech
Baltimore, Maryland. Fluidics, motion control and instrument engineering for diagnostics companies. Not for you if: your product is a simple mechanical Class I device — you will overpay for capability you do not need.
Website: Key Tech
3. StarFish Medical — best for early-stage medtech that needs a full team
- HQ
- Victoria, British Columbia, Canada
- Founded
- 1998
- Team size
- Not published
- Minimum engagement
- Not published
- Services
- Medical device design, human factors, regulatory support, manufacturing
- Best for
- Early-stage medtech that needs a full team including regulatory support.
- Not for you if
- You need the lowest-cost route to a first prototype.
- Website
- StarFish Medical
Victoria, British Columbia. Design, human factors, regulatory and low-volume manufacturing under one roof for startups. Not for you if: you require a US-domiciled supply chain from day one.
Website: StarFish Medical
4. Delve — best for human-factors-critical devices
- HQ
- Madison, Wisconsin, US
- Founded
- 1968 (as Design Concepts)
- Team size
- Not published
- Minimum engagement
- Not published
- Services
- User research, industrial design, engineering, medical and scientific products
- Best for
- Devices where human factors decide clearance and adoption.
- Not for you if
- You only need a mechanical part designed.
- Website
- Delve
Madison, Wisconsin, with the Philadelphia drug-delivery and consumer-health team formerly known as Bresslergroup. Usability research and validation feeding design — valuable where use error is the dominant hazard. Not for you if: budget pressure means you plan to skip formative usability studies.
Website: Delve
5. Nordson Medical — best for components and contract manufacturing scale
- HQ
- Loveland, Ohio, US
- Founded
- Not published
- Team size
- Not published
- Minimum engagement
- Not published
- Services
- Medical components, catheters, contract design and manufacturing
- Best for
- Component-level design and contract manufacturing at scale.
- Not for you if
- You need a full device program from concept.
- Website
- Nordson Medical
Multiple US sites. Design paired with validated high-volume manufacturing for catheters, fluid components and single-use devices. Not for you if: you are one product away from a first prototype.
Website: Nordson MEDICAL
6. Regulatory consultants (not design firms) — best for the paperwork alone
- HQ
- Independent specialists, US-wide
- Founded
- Not published
- Team size
- Not published
- Minimum engagement
- Not published
- Services
- 510(k) submissions, quality systems, regulatory strategy
- Best for
- Submissions and quality systems when the engineering is already handled.
- Not for you if
- You still need the device designed and prototyped.
Nationwide. If you already have a working device and a manufacturer, an independent regulatory consultant will assemble your 510(k) for a fraction of a full design program. Not for you if: the device itself is not finished — consultants do not engineer hardware.
7. LA NPDT — best for Class I, exempt and wellness hardware that must be manufacturable
- HQ
- Ruston, Louisiana, US
- Founded
- 2015
- Team size
- In-house team across ten disciplines
- Minimum engagement
- Feasibility and concept work from a few thousand dollars
- Services
- Concept design, industrial design, CAD, prototyping, testing, design for manufacturing, manufacturing transfer
- Best for
- Class I, exempt and wellness hardware that has to be manufacturable at a realistic unit cost.
- Not for you if
- You need a Class III device or a full 510(k) program run in-house.
- Website
- LA NPDT
Ruston, Louisiana. Industrial design, mechanical engineering, prototyping and design for manufacturing for Class I devices, 510(k)-exempt products, wellness hardware and clinic accessories — plus documentation your regulatory consultant can build on. Not for you if: your device is Class II or Class III, needs a certified ISO 13485 partner, or requires IEC 60601 testing management. We will point you to the firms above. See our medical device work.
Questions to ask a medical device design firm
- Are you ISO 13485 certified yourself, and can I see the certificate and its scope?
- Name two devices you designed that received clearance, and what your role was in the submission.
- Who writes the design history file — you, me, or a consultant I have to hire separately?
- Do you run verification testing in-house, or manage outside labs, and who pays for reruns?
- What happens at manufacturing transfer, and have you supported IQ/OQ/PQ before?
- Would you decline my project, and under what conditions?
Related: best product development companies, best industrial design firms and product development consultants.
Not sure which class you are in?
Send us a description of the device and the claims you intend to make. We will tell you the likely classification path and whether you need a regulated firm instead of us.
Frequently asked questions
How much does medical device design cost?
Class I and exempt devices commonly run 15,000 to 80,000 dollars for design through manufacturable CAD. A Class II device with a 510(k), electronics and software typically runs 250,000 to 1,000,000 dollars once design controls, verification testing and regulatory work are included. Class III programs are multi-year and multi-million.
Do I need an ISO 13485 design firm?
You need a supplier operating under a compliant quality system when your device requires design controls — practically, any Class II or Class III device. For Class I and exempt devices, good engineering documentation is usually enough, and paying for a certified system adds cost without adding clearance speed.
Can a general product development firm design a medical device?
For Class I, exempt and general wellness products, yes, and usually for less money. For anything that needs a submission, a general firm should either work under your quality system with a regulatory consultant attached, or decline the work. Ask which they intend to do before you sign.
