Building a few prototypes for a study and manufacturing thousands of medical products a month are two different things. We are well aware of the challenges that come when transferring a design to manufacturing. All the processes that we develop go through an initial scoping study where we gather data and characterize the process output. We focus our efforts on designing a process that is robust, repeatable, and cost effective.
Fixtures and Automation
A key to develop robust processes is to put in place the right tools and fixtures to control the output of a specific process. We have extensive experience designing and implementing a wide variety of fixtures to support our manufacturing activities. These include holding fixtures and nests, alignment fixtures, cutting fixtures, inspection fixtures, etc… These fixtures bring predictability and repeatability into our manufacturing lines to improve quality and scalability.
One of the challenge of medical device manufacturing is the inherent manual labor involved and we try to automate processes wherever we can. We have built at Corpus Medical a Mechatronics Engineering group who is responsible for developing semi-automated custom machines for specific process applications. These include linear actuator, multi-axis CNC tables, heat controllers, pressure and flow controllers, laser welding automation, etc…
Every manufacturing process has inherent variability coming from the design of the process itself, the inputs of the process and the operating environment. We utilize Design of Experiment methods (DOE) to define and validate the operational window of all the processes that are required to be validated, before transferring to production and in accordance with the Master Validation Plan (MVP). Once the process is transferred and stable we keep monitoring the health of the processes utilizing statistical process control methods (SPC) as part of the Process Control Plan (PCP).
With our 25,000 sqft California facility and its dedicated Controlled Environment Rooms (CERs) Corpus Medical supports product launch, ramp-up activities and full blown volume manufacturing for a wide range of products. Our ability to scale quickly, and our access to the highly talented workforce of the San Francisco Bay Area makes us a partner of choice for the manufacturing of complex medical device assemblies. We provide a full turnkey solution with a complete management of the Supply Chain and a quarterly report of all Quality Metrics. We supply finished packaged devices to major OEMs and have an excellent track record and reputation for the highest level of quality and customer service.
• Process Development
• Fixtures and Automation
• Process Validations
• Operator Certifications
• Volume Manufacturing