Medical Device Design Consultancy
Design, engineering and design-control support for Class I and Class II devices, from concept through verification and manufacturing transfer.
Written by Konstantin Dolgan, Ph.D., NPDP
Founder & CEO, Product Development Engineer
Published August 20, 2026
Medical device design consultancy for Class I and II devices: concept, engineering, human factors, design controls and manufacturing transfer. A medical device design consultancy takes a clinical need and turns it into a manufacturable device with the documentation a regulator expects.
A medical device design consultancy takes a clinical need and turns it into a manufacturable device with the documentation a regulator expects. For Class I and Class II devices that means design inputs, risk management, human factors, verification testing and a design history file assembled as the work happens - not reconstructed the month before submission.
Where a consultancy fits
Three situations bring companies here. A startup with clinical validation and no engineering team. An established manufacturer whose internal team is fully loaded and needs a program run in parallel. And a company whose device works but cannot be built at a viable cost, which is a design-for-manufacturing problem wearing a regulatory costume.
In all three cases the work is the same shape: define the inputs precisely, retire the technical risk with the cheapest possible build, then spend real money only on a design you have already proven.
Scope by phase
| Phase | Deliverables | Typical duration | Our range (labor only) |
| Feasibility | User needs, device classification view, technical risk list, plan | 10 business days | $800 fixed (Stage 1, Review/Analysis + Plan) |
| Concept and industrial design | Concept directions, ergonomics, use-scenario studies | 4 to 8 weeks | $9,500 to $25,000 (stage 2, Class C to D) |
| Detailed engineering | Mechanical and electrical design, materials, tolerance analysis | 10 to 20 weeks | $12,000 to $35,000 (stage 5, Class C to D) |
| Verification | Test protocols, verification builds, reports, DHF assembly | 8 to 16 weeks | $14,000 to $60,000 (stages 6 and 7, Class C to D) |
| Transfer | Manufacturing package, supplier qualification, process validation support | 6 to 12 weeks | $8,000 to $20,000 (stage 9, Class C to D) |
What we handle, and what we do not
| We do | We coordinate | We do not |
| Concept, mechanical and electrical design | Test lab scheduling and biocompatibility | Clinical trials |
| Human factors and use-related risk | Sterilization validation with the contract sterilizer | Regulatory submission as the sponsor |
| Risk management inputs per ISO 14971 | Contract manufacturer selection and quoting | Legal or reimbursement advice |
| Design controls documentation per 21 CFR 820.30 | Notified body and consultant coordination | Quality system ownership |
Standards the work is built around
- 21 CFR 820.30 design controls - design inputs, outputs, reviews, verification, validation and transfer.
- ISO 13485 quality management for design and development activities.
- ISO 14971 risk management, applied from the first requirement rather than at the end.
- IEC 60601-1 for electrically powered devices, including applied-part and leakage requirements.
- IEC 62366 usability engineering, and FDA human factors guidance for use-related risk.
- ISO 10993 biocompatibility for anything with patient contact.
Primary sources: FDA quality and compliance for medical devices and ISO 14971. Nothing here is regulatory or legal advice; confirm your regulatory strategy with your own consultant or counsel.
Start with Stage 1: feasibility and a plan in 10 business days
Stage 1, Review/Analysis + Plan, is a fixed $800, paid up front and not credited toward later stages. Our team reviews your device concept and delivers a technical feasibility analysis, the key risks and a staged plan within 10 business days of receiving your files and intake form.
Medical device design consultancy: common questions
What does a medical device design consultancy do?
A medical device design consultancy takes a clinical need through concept, engineering, human factors, verification testing and manufacturing transfer, producing the design controls documentation and design history file that a regulator expects along the way.
How much does medical device design consulting cost?
Feasibility and planning are Stage 1, Review/Analysis + Plan: a fixed $800, with results within 10 business days.
Later stages follow the stage ranges, labor only: Concept Design (stage 2) $2,000 to $25,000, Technical Design & Engineering (stage 5) $2,000 to $35,000, Alpha Prototyping & Testing plus Beta Prototype (stages 6 and 7) $3,000 to $60,000, and Manufacturing Planning & DFM (stage 9) $2,500 to $20,000.
A whole program typically runs $11,300 to $36,800 for Class A (one part, no moving parts, no electronics), $28,300 to $66,800 for Class B (one mechanism or simple electronics), $49,300 to $111,800 for Class C (several mechanisms, medium electronics and firmware), and $86,800 to $175,800 for Class D (multi-subsystem, firmware, hydraulics, app or custom tech), labor only, with typical timelines of 3 to 6 months (Class A) to 9 to 15+ months (Class D).
Materials and tooling are extra. Regulated medical devices, connected products with app and cloud backends, and large automated or industrial systems often run above Class D, because certification, regulatory documentation and software sit outside these ranges. Our team quotes them stage by stage after Stage 1.
Do you handle the FDA submission?
No. We produce the design and engineering evidence a submission relies on, design inputs and outputs, risk management inputs, verification protocols and reports, and the design history file, and we coordinate with your regulatory consultant. The sponsor and their regulatory advisor own the submission itself. Nothing here is regulatory or legal advice.
How long does Class II device development take?
Twelve to twenty-four months from concept to design freeze is typical for a Class II device. Verification testing, sterilization validation and supplier qualification usually determine the schedule rather than the design work.
Do you work under ISO 13485 design controls?
Yes. Design and development activities follow 21 CFR 820.30 design controls within an ISO 13485-aligned process, with risk management per ISO 14971 applied from the first requirement rather than retrofitted at the end.
Typical cost by product complexity
Our team prices development in fixed stages. These are the typical whole-program ranges for each complexity class.
| Product complexity | Definition | Whole program (labor only) | Typical timeline |
|---|---|---|---|
| A Basic | One part, no moving parts, no electronics | $11,300 to $36,800 | 3 to 6 months |
| B Simple | One mechanism or simple electronics | $28,300 to $66,800 | 5 to 9 months |
| C Moderate | Several mechanisms, medium electronics and firmware | $49,300 to $111,800 | 7 to 12 months |
| D Complex | Multi-subsystem, firmware, hydraulics, app or custom tech | $86,800 to $175,800 | 9 to 15+ months |
Labor only, including equipment and machine time. Materials, tooling, certification, patent fees and app or cloud software are extra. Ranges are typical, not a quote; your price may come in below or above. Large automated systems and regulated medical devices often run above Class D.
Regulated medical devices, connected products with app and cloud backends, and large automated or industrial systems often run above Class D, because certification, regulatory documentation and software sit outside these ranges. Our team quotes them stage by stage after Stage 1.
Every program starts with Stage 1, Review/Analysis + Plan, a fixed $800, and each later stage gets its own fixed quote before it starts.
What founders say after working with us
“This company is awesome. I run a medical device company and we required a number of accessories to be designed and built for our medical device. They delivered a polished design and printed the accessories on time using high-quality materials. I continue to work with them for all of our material needs.”
Matteo ZiffFounder, Virtual Vision“Partnering with LA NPDT to bring LEIA to life was a game-changer. Their blend of market analysis, design expertise, prototyping, and manufacturing streamlined my vision into a tangible solution. For medical professionals with a product idea, there's no team I'd recommend more.”
Dr. Elena DolganFounder, LEIA Cup“Konstantin has been so amazing and his entire team is A+. I researched and interviewed many product development companies across the country and ultimately decided on LA NPDT... and I'm so glad I did. The attention to detail and overall effort has been exactly what I needed and then some. If you are looking for a company to help you bring your product to life, look no further!”
William EvansCEO, BurpleThree reasons founders keep working with us
- 1
One team from sketch to shipped parts. Industrial design, mechanical and electrical engineering, prototyping and manufacturing sit under one roof, so nothing is lost in a handoff.
- 2
You own the work. Native CAD, drawings and source files are yours at the end of every stage, with no lock-in, no re-buying your own design later.
- 3
Fixed scope, fixed price. Every stage is quoted up front with a deliverable list and a date. No hourly meters, no surprise invoices.
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