Areas of Expertise
Product Strategies
Define the right approach before committing resource
Clinical need validation and product-market fit assessment
Regulatory pathway definition across FDA, MDR, and CE frameworks
Manufacturing strategy development & cost modelling
Market access strategy for UK, EU & US markets
Product Development
Design devices that are built to scale
Full device development from concept through to design freeze
Design for manufacture and assembly (DFM/DFA) & cost-down engineering
Usability and human factors engineering
Custom fixture design with external fabrication management
Root cause analysis & structured problem solving
Product Industrialisation
Bridge development to reliable production
Manufacturing process design and production line setup
IQ, OQ, and PQ validation execution & regulatory documentation
Pilot and pre-production build management
Strategic supplier identification, qualification, and onboarding
Dual sourcing strategies to strengthen supply chain resilience
End-to-end manufacturing transfer management, including knowledge transfer & documentation control
Contract Manufacturing
Deliver controlled, repeatable manufacturing at scale
Complex, high-value device assembly
Cleanroom production environments
Electro-mechanical & system integration
High-value consumables and single-use instrument manufacture
Right-sized manufacturing solutions aligned to volume & programme needs
Quality Governance
A structured quality approach ensuring regulatory compliance
ISO 13485 certified quality management system
Mature, well-defined quality processes ensuring consistent product quality
Proactive compliance management across the full product lifecycle
Regulatory support to enable approvals and market access
Global Procurement
Deliver the right supply solutions from concept to production
Project buying for complex and time-critical programmes
New product introduction (NPI) support to transition designs into reliable supply chains
Strategic sourcing optimising cost, quality & resilience
Procurement management in production to ensure continuity & performance
Long-term supplier partnership development
Product Assessment
Proving your device performs as intended every time
Verification & Validation strategy, planning & protocol development
Design verification testing
Clinical and performance validation
External test management and coordination
Usability file creation, including formative & summative assessments
Sterilisation validation
Failure Resolution
Systematic root cause analysis driving real issue resolution
Root cause investigation to identify failure modes & inform risk analysis
Containment support to manage immediate risks across the field & supply chain
Cross-functional solution design and implementation to protect market position
Lifecycle Optimisation
Protect performance, compliance, and long-term value
Field data analysis driving continuous improvement
Value analysis and value engineering to optimise cost
State-of-the-art compliance monitoring and maintenance
Operational Transformation
Evolving production to achieve new business needs
Factory throughput improvement & OEE optimisation
Lean manufacturing deployment and continuous improvement programmes
Industrial scale-up support; site selection, capacity planning & automation strategy
Operational turnaround and performance recovery for underperforming sites
Commercial model & cost structure optimisation, including cost-to-serve analysis
