Comprehensive Solutions for Medical Device Development.
From early-stage commercialization to scalable manufacturing — expert support at every step of your product journey.
Strategic, Tactical and Implementation services
Product Realisation for Start-ups:
- Commercialization strategies and product roadmaps
- Technology readiness assessments, gap analyses, and risk evaluations
- Partner selection and management for product development and manufacturing
- Oversight of contract manufacturing organizations (CMOs)
- Identification of technology partners to address critical innovation gaps
- Design input reviews and design-for-manufacturability (DFM) guidance
- Cost modelling and early-stage financial planning
Product, Process and Supplier Development:
- Technology assessment, solution development
- Selection of partners of development, prototyping, manufacturing
- Requirements management, design reviews, verification, and validation,
- Risk mitigation assessment, technical mitigations
- Supplier selection, control systems assessment, and continuity planning
- Quality, supply and service agreements
- Setup of pilot production lines, cleanroom facilities, and manufacturing equipment
- Process development, characterization, and validation for devices and combination products
- Specialized expertise in moulding, micro-manufacturing, joining, silicone processing, and laser-based manufacturing
- Development of automation systems for high-volume production
- Manufacturing cost analysis (COGS), cost reduction strategies and LEAN deployment
- ERP systems selection and deployment
Quality and Regulatory Systems (ISO 13485 & 21 CFR Part 820):
- QMS development for Class III and Class II devices
- Product realization procedures, supplier selection frameworks
- Design control systems, risk management, design transfer protocols
- Management of non-conformances and CAPAs
- DMR review for CE and FDA submissions
Class III Medical Device Expertise:
- Fifteen years of product realisation, innovation experience at Cochlear, recent consultancy for a neuromodulation start-up
- Supply chain development, internal vs external sourcing, finding reliable partners
- Manufacturing process controls to ensure the reliability of long-term implantable Class III devices
- Materials and process selection tailored for long-term implantation and biocompatibility
- Guidance on product realization, process validation, risk assessments and developing DMR documentation
-Troubleshooting process issues