Transferring products to manufacture

Good design and ingenious engineering count for nothing if the final product cannot be made in the required volumes, to the right quality level and at the right cost. From the very outset we think about the end-game. We design products that can be produced reliably and repeatedly, from capable processes, and work closely with manufacturing partners from early on. We understand the increasing importance of the needs of the manufacturer as we move through development, just as we won’t lose focus on the needs of the device – and the user – during the industrialisation process. We strongly believe that these perspectives do not need to conflict, and build our designs around comprehensive knowledge of manufacturing and assembly techniques.

The tools and techniques we use during development help ensure smooth transition through industrialisation and scale-up. We carry out and iterate detailed tolerance analyses, Design for Manufacture and Assembly reviews and Process FMEAs, each based on bespoke in-house systems developed to meet the particular needs of medical device development. We use empirical and analytical methods during the design process to ensure we develop a comprehensive understanding of design functionality and constraints, as this is vital during tooling procurement and sign-off, component reconciliation and design verification.

What you can expect from Team

• Independent experts who have helped many clients launch new products in high and low volumes, working closely with some of the best manufacturing organisations across the globe
• A deep insight into the potential risks and issues around the manufacturing of medical devices, which will help prepare you for the challenges or to bypass them altogether
• A committed partner who is there for you during scale-up and production, and who will work closely and tirelessly with all stakeholders to troubleshoot problems which may arise

Our strengths

• Selection of manufacturing partners and key suppliers
• Design of innovative and robust components and assemblies for medium and high volume manufacture
• Rigorous application of bespoke tools and techniques (DFMA, tolerance analysis, Process FMEA)
• Design Verification and Validation approaches to meet all regulatory requirements
• Definition, development and implementation of bespoke assembly and testing processes
• Supporting the development of small and large-scale manufacturing processes and systems
• Small batch manufacturing for clinical trials
• Production troubleshooting

Next steps

Contact one of our consultants to discuss your requirements in confidence.  If we can help we will be pleased to submit a detailed proposal including clearly defined objectives, activities, deliverables, costs and time scales.