Product Design Services
Flambeau Medical is your partner for new product development, starting with design assistance. 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 with your choice in plastic processing method.
Solidworks is our principal design platform, but we can work with virtually any native CAD files. We offer design analysis (DFMEA, PFMEA, Moldflow) to identify potential problems, and work with customers every step of the way to ensure successful product realization.
Flambeau Medical program managers are experienced in a wide range of market and customer-specific applications. All aspects of the project are continuously managed in Project Management software. Application-specific requirements like pull testing, leak testing, and material testing are designed and developed in our automation center, and reviewed during weekly 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 and aluminum tooling for pilot production, and clinical trial production is used to keep costs down.
To ensure your product will meet clinical trial requirements, functional application, components and assemblies, additional technologies are available through our extensive network of specialty providers. Our goal is to provide our customers with ‘real’ parts expediently while providing an effective experience.
DOE & Protocol Writing
The preparation of a Design-of-Experiments (DOE) protocol is the most important stage in a project. It should clearly state the problem to be addressed and lay the plan for the timing, method, and resources required to solve the issue presented. Flambeau Medical’s experienced team of professionals work with customers to develop the appropriate plan for solving problems, while following industry-recognized standards. Through this process, we always keep our customer needs central.
Design Verification and Validation
Flambeau Medical verifies the design of the device or part for process, and ensures it meets specification. We may also assist in facilitating prototype testing to validate it meets the intended use.
Flambeau Medical covers a wide range of medical applications from laparoscopic, endoscopic, and orthopedic devices to dental, fluid, and insulin management systems. Our Class 7 clean room and Class 8 assembly area 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 (SMI), using best-cost manufacturing practices and a world-class ERP system.
Flambeau Medical has a full array of cleanroom options, including a 3,600-square-foot Class 7 area for medical device assembly, packaging, UV curing, sealing, and pouching. A 5,000-square-foot 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 providing 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.