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

Key takeaways

How we evaluated these firmsWhether the firm holds its own ISO 13485 certification, or borrows a client system.
Suntra MedTech (formerly Sunrise Labs) — best for Class II devices with softwareNashua, New Hampshire. ISO 13485 certified, strong on embedded software, instrumentation and connected diagnostics under full design controls.
Key Tech — best for diagnostics and lab instrumentationBaltimore, Maryland. Fluidics, motion control and instrument engineering for diagnostics companies.
StarFish Medical — best for early-stage medtech that needs a full teamVictoria, British Columbia. Design, human factors, regulatory and low-volume manufacturing under one roof for startups.
Delve — best for human-factors-critical devicesMadison, Wisconsin, with the Philadelphia drug-delivery and consumer-health team formerly known as Bresslergroup.

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

Engineer in gloves measuring a Class I medical device housing with calipers beside design control paperwork and a CAD model — Class I and wellness devices still need dimensional discipline and a documented design history — they just do not need a full ISO 13485 quality system.

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

Comparison of the shortlisted companies: head office, year founded, team size, minimum engagement and who each one fits. Verified August 2026.
Company	HQ	Founded	Team size	Minimum engagement	Best for
Suntra MedTech (formerly Sunrise Labs)suntramedtech.com — Suntra MedTech (formerly Sunrise Labs) official site	Bedford, New Hampshire, US	1992	Not published	Not published	Class II devices where software is part of the system.
Key Techkeytechinc.com — Key Tech official site	Baltimore, Maryland, US	1998	Not published	Not published	Diagnostics and laboratory instrumentation.
StarFish Medicalstarfishmedical.com — StarFish Medical official site	Victoria, British Columbia, Canada	1998	Not published	Not published	Early-stage medtech that needs a full team including regulatory support.
Delvedelve.com — Delve official site	Madison, Wisconsin, US	1968 (as Design Concepts)	Not published	Not published	Devices where human factors decide clearance and adoption.
Nordson Medicalnordson.com — Nordson Medical official site	Loveland, Ohio, US	Not published	Not published	Not published	Component-level design and contract manufacturing at scale.
Regulatory consultantsNot published	Independent specialists, US-wide	Not published	Not published	Not published	Submissions and quality systems when the engineering is already handled.
LA NPDTUslanpdt.com — LA NPDT official site	Ruston, Louisiana, US	2015	In-house team across ten disciplines	Feasibility and concept work from a few thousand dollars	Class I, exempt and wellness hardware that has to be manufacturable at a realistic unit cost.

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.
Source
suntramedtech.com — Suntra MedTech (formerly Sunrise Labs) official site
Key Tech
HQ
Baltimore, Maryland, US
Founded
1998
Team size
Not published
Minimum engagement
Not published
Best for
Diagnostics and laboratory instrumentation.
Source
keytechinc.com — Key Tech official site
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.
Source
starfishmedical.com — StarFish Medical official site
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.
Source
delve.com — Delve official site
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.
Source
nordson.com — Nordson Medical official site
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.
Source
lanpdt.com — LA NPDT official site

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.
Website: Suntra MedTech (formerly Sunrise Labs)

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.
Reviews: 5.0 from 45 reviews on Google
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?

Ready to develop your product?

Get a straight answer

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.

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