Services
From feasibility through to manufacturable design
Technical Feasibility
Find out what will fail before you commit time and capital.
Deliverables
- —Concept viability assessment
- —Risk identification and mitigation strategy
- —Development pathway definition
- —Cost and timeline estimate
- —Written feasibility report
Medical Device Design Development
Design decisions that hold under real constraints, not just in CAD.
Deliverables
- —Mechanical design for manufacture
- —CAD models and technical drawings
- —Material selection and justification
- —Bill of materials
- —Design review documentation
Prototype & Bench Testing
Working prototypes that answer technical questions with data.
Deliverables
- —Functional prototypes
- —Test protocols and results
- —Materials sourcing and procurement
- —Build verification testing
- —Design iteration based on test data
Design for Manufacture
Make sure the design can actually be produced. No late redesigns.
Deliverables
- —Tolerance analysis and optimisation
- —Manufacturing process selection
- —Tooling specification
- —Assembly sequence definition
- —Production-ready CAD package
Supplier & Process Development
Production routes defined and validated before you commit to scale.
Deliverables
- —Manufacturing supplier identification
- —Process FMEA (PFMEA)
- —Supplier technical engagement
- —Process validation planning
- —Supply chain risk assessment
Technical Documentation & Validation
The technical record regulators and manufacturers expect to see.
Deliverables
- —Technical file preparation
- —Design history file support
- —Validation protocol development
- —Risk management documentation (ISO 14971)
- —Regulatory submission evidence packages
Frequently asked questions
We work with projects at any stage from early concept through to existing prototypes that need manufacturing refinement. The most common entry point is a funded concept that needs technical feasibility assessment before committing to full development.
Timelines vary depending on device complexity and scope. A feasibility study typically takes 4-8 weeks. A full concept-to-manufacturable-prototype programme may take 3-9 months. We provide detailed timeline estimates during scoping.
We are not a regulatory consultancy and we do not handle MHRA submissions. What we do is design and develop devices and manufacturing processes that demonstrate the control and compliance regulators need to see. We build devices that are ready to pass scrutiny. If something needs changing to meet requirements, we work with you and your regulatory partners to resolve it.
Every project is scoped individually based on device complexity and development stage. We provide a detailed written proposal with transparent pricing after an initial conversation. There is no cost or commitment for the initial call.
Yes. While we are based in London, we work with clients across the UK, US, and internationally. Development work can be managed remotely with regular video reviews, supplemented by in-person meetings at key milestones.
All intellectual property developed during an engagement belongs to the client. We work under standard NDA and service agreements that clearly define IP ownership from the outset.
Not sure where to start? Begin with a Technical Review.
Most projects span multiple disciplines. We define scope, risks, and the first deliverable.