Medical device manufacturing is a complex endeavor requiring a multitude of baseline processes and foundations to be in place. All work must be executed according to strict process traceability and governance standards for a Quality Management System, such as set by ISO or the Quality System Regulations of the FDA of the United States. Participating successfully in this domain requires careful planning and meticulously controlled operations, not only internally, but also externally as regards the supply chain partnerships required to establish a successful medical device manufacturing business. An international client in a developing nation contacted Simera International to assist with setting up a trial medical device manufacturing establishment.
The Simera Innovate core team has extensive experience in medical device manufacturing in developed and developing nations. We were well positioned to develop a turnkey strategy and detailed proposal to establish a trial product development center for medical components and systems. Our team is familiar with the multitude of different machining technologies and bio materials required as well as the best suppliers to achieve this goal. Additionally, by using our internal knowledge of product life-cycle management (PLM) and Industry 4.0 business frameworks, the initial rollout could from inception serve as a showcase for precision production and production data control in an Industry 4.0 business framework.
Simera Innovate developed a detail implementation plan spanning multiple years with clear and concise milestones building on successfully implemented prior steps. The extent of support ranged from identifying and defining required processes and linking these to equipment and facilities to getting equipment quotations from various contending suppliers, ensuring all systems were installed and commissioned correctly, training client operators and linking the new trial product development center with existing international medical device manufacturers to do sample hardware production runs. A detailed set of key performance indicators for the different facility establishment life-cycle stages was defined to give all stakeholders continuous insight into the implementation progress. The PLM implementation plan was tailored to suit medical device manufacturing requirements.