Medical device development
Medical device development from concept to manufacture
Structured stages from feasibility through design for manufacture. You know what you're getting at every step.
Technical capabilities
What we do
Technical Feasibility
Find out what will fail before you commit time and capital.
Medical Device Design Development
Design decisions that hold under real constraints, not just in CAD.
Prototype & Bench Testing
Working prototypes that answer technical questions with data.
Design for Manufacture
Make sure the design can actually be produced. No late redesigns.
Supplier & Process Development
Production routes defined and validated before you commit to scale.
Technical Documentation & Validation
The technical record regulators and manufacturers expect to see.
Development process
Five stages to manufacturing readiness.
Technical Review
Define scope, risks, and development path.
Deliverable: Scope + risk register + development plan
Feasibility Definition
Confirm architecture and constraints before build begins.
Deliverable: Architecture + constraints + go/no-go decision
Prototype Development
Working builds that prove function and performance.
Deliverable: Working prototype + bench test results
Manufacturing Preparation
Align design with real production and suppliers.
Deliverable: DFM package + supplier plan
Documentation & Progression
Prepare technical evidence for regulatory and commercial next steps.
Deliverable: Technical file + regulatory evidence pack
Technical leadership
Built cleanrooms. Prototyped pacemakers. Running a national device manufacturing facility.
One technical lead throughout. No handoffs.
Michael leads engineering at MAISI, King's College London. A decade in medical device development, including Smith & Nephew manufacturing operations. Built a cleanroom from an empty room and took devices in cardiac, dental oncology, and infection control from concept to functional prototype.
Michael Capes | Engineering Director of Medical Technology Laboratory | Process Engineer
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