Successful medical product design transition to manufacturing requires attention to detail to avoid unnecessary costs and schedule delays. Here are several tips and techniques to smooth medical product design transition to manufacturing and ensure products are delivered to market on time and on budget.
1) Start the transition process early
The first and perhaps most important tip to smooth the transition from design to manufacturing is to start early. Making changes to the product design once the hand off to manufacturing has occurred will only create additional costs and time delays.
2) Assemble cross functional teams
Members of these teams must bring to bear a broad knowledge base. Combining their diverse skill sets and areas of expertise enables a holistic approach to device manufacturing and the regulatory approval process. Together, they devise well-defined goals and objectives for each phase of development that minimize manufacturing obstacles and ensure devices and instrumentation adhere to U.S. Food and Drug Administration (FDA) and European Union (EU) regulations.
Cross-functional team members working closely together to review product requirements, address technical risks and manage instrument costs reduce development cycles to shorten time to market. By assembling the cross functional experts early ensures that manufacturability, serviceability, reliability, and supply chain issues are dealt with before the product is in production.
3) Rely on proven processes
For a smooth handoff to manufacturing, planning for transition must begin in the product development stage well before the software and system verification and validation efforts have been completed.
A manufacturing test plan and detailed test specifications defining acceptance criteria for system level testing, sub-assembly testing, and spare part testing is essential for a successful transition to manufacturing.
4) Implement staged reviews
Continual checkpoints/reviews should be held throughout the product design and development process. Specification/concept, prototype design, critical design, pilot production readiness and manufacturing readiness reviews should be conducted at a minimum.
The readiness of a product design to begin transition to manufacturing can be determined with a pilot production readiness review . This review records that all appropriate design and program activities at this point in the development process have been completed satisfactorily. The review will provide the confirmation that the manufacturing team has all the necessary tools, processes, and documentation in place for the pilot production build.
5) Train the manufacturing team
For a seamless and speedy manufacturing ramp-up, begin the training and knowledge transfer to the production team during product development phase. Engage the manufacturing team to create detailed assembly instructions when the design matures state. This activity provides an environment for knowledge transfer. It also allows early intervention for the manufacturing team to identify opportnities for improved assembly and test efficiencies.