Product Design Services
Flambeau is your partner for new product development starting with design. Our team of experts can model, prototype and fabricate plastic components for injection molding and blow molding processes.
Capitalizing on our years of experience we provide design guidance, including recommendations on material. Our collaborative approach to DFM (Design for Manufacturability) enables us to optimize product performance and appearance while reducing cost and improving quality.
Solidworks is our principal design platform, but we can work with virtually any native CAD files. We offer free design analysis (DFMEA, PFMEA, Moldflow) to identify potential problems and work with customers every step of the way to ensure successful product realization.
Flambeau program managers are experienced in a wide range of market and customer specific applications. All aspects of the project are managed continuously using our proprietary Charts module with full integration into our Enterprise Resource Planning (ERP) manufacturing system. Application specific requirements like pull testing, leak testing, material testing are designed and developed in our automation center and reviewed during project update meetings with customers and the entire project team at Flambeau.
Flambeau Medical has extensive capabilities internally for model creation using FDM and advanced machining technologies directly from CAD files.
Our expertise in engineered resins includes Ultem, PEEK, Polysufone, LCP and Polycarbonate as well as other USP Class VI materials.
We use MUD Base tooling technology to maintain consistency with full scale up production demands and aluminum tooling for pilot production and Clinical Trial production keeps costs down.
Functional components and assemblies using other technologies are available through our extensive network of specialty providers to ensure that your product will meet clinical trial requirements. Our goal is to provide customers with ‘real’ parts expediently.
DOE & Protocol Writing
The preparation of a Design of Experiments (DOE) protocol is the most important stage in a project. It needs to clearly state the problem to be addressed and lay the plan for the timing, method and resources required to solve the problem. Flambeau’s experienced team of professionals work with customers to develop the appropriate plan for solving problems following industry recognized standards. We always keep our customer needs central through this process.
Design Verification & Validation
Flambeau Medical verifies the design of the device and ensures that it meets specification. We also test the prototype to validate that it meets the intended use.
We cover a wide range of medical applications from laparoscopic, endoscopic and orthopedic devices to dental, fluid and insulin management systems. Our Class 7 and Class 8 Clean Rooms are capable of producing small qualification lots of individual components to high volume complex assemblies. We also provide medical packaging services including tray sealing, pouching and sustainable packaging. Flambeau excels at Just-In-Time (JIT) production and Supplier Managed Inventory using best cost manufacturing practices and a world class ERP system.
Clean Room Services
Flambeau Medical has a full array of cleanroom options including a 3,600 sq. ft. Class 7 area for medical device assembly, packaging, UV curing, sealing and pouching. A 5,000 sq. ft. clean molding environment includes state of the art molding machines for producing complex and high cavitation components in a variety of engineered and commodity resins. Flambeau is committed to quality with emphasis on zero defect manufacturing. Flambeau also has multiple Class 8 portable cleanrooms for specialty applications including ultrasonic welding and assembly, UV bonding, decorating, cleaning and packaging.
For products requiring sterilization, Flambeau Medical will manage the process through a network of qualified partners that provide a variety of sterilization options including Gamma, E-Beam and EtO. Our materials experts can guide you through the selection process to use the best method based on your product material and packaging requirements. We manage the entire process and can serve as your distribution hub.