With robust and repeatable validated processes and ISO 9001:2008/ISO 13485:2003 registered quality systems, the Group ably supports all documentation and traceability requirements.
Outsourced Medical Device Components & Sub-Assemblies
- Press sizes from 12.5 to 600 ton
- Single to multiple cavity molds
- Tight tolerance molded parts
- Multi shot molding, insert-, over-, and micro-molding
- Mid-to-high volume medical components and sub-assemblies
- Dispensing devices, enclosures, covers, etc.
Implantable Surgical Components & Systems
Spectrum's molded solutions pioneered thermoplastic implantable and bioresorbable components. We have developed an expertise with implantable PEEK, the full range of bioresorbable materials and other engineered materials approved for implant as metal replacements for screws, suture anchors, and various types of fasteners.
- PEEK-OPTIMA®, polyurethane, ABS/PC, polysulfone, and Solviva® Biomaterials (Invibio™, Zeniva® PEEK, Evonik, Veriva™ PPSU, and Eviva® PSU)
- Miniaturized screws and fasteners; metal replacement
- Products and components hold bone, tissue, ligaments, etc.
- Devices for ligament reattachment, anastomosis of small vessels, nerve reconstruction, and cranial maxillofacial surgeries
Bioabsorbables / Bioresorbables
Bioabsorbable products and components return to carbon dioxide in the body. Spectrum's Minnesota operation is one of a select list of operating sites with the ability to manufacture and process these lactic acid-based materials. They can remain in the body from 1-2 months to 4 years, depending on the application and the material chemistry. They pose unique preparation, processing, and handling challenges due to their chemical makeup.
- PLA, PLLA, PDL, PLC, and PDLG
- Suture anchors and screws
- Bone & tissue scaffolding
For low-volume hand-loaded programs, Spectrum offers horizontal and vertical presses, some with shuttles. For mid-volume applications, we offer operator-assisted, semi-automated loading of inserts using offline loading fixtures. We also provide fully automated, robotic insert placement in dedicated injection molding cells. Insert molding provides customers with a lower cost alternative to other manufacturing methods by reducing assembly and labor and increases product reliability as parts are secured tightly into thermoplastic to provide added strength by consolidating parts. Our micro insert molding capabilities extend those benefits even further, from electronic sub assemblies, to complex components, even implantable assemblies for medical applications.
Multi-shot refers to the ability to shoot two or more different materials into the same mold, into different locations, resulting in parts with increased functionality, improved cosmetics, and multiple mechanical properties. Our process experts will help determine the best way to combine one or more materials into the same molded component, to help you determine if multi-shot molding is the best solution for your next program.
- Reduced cycle time: Compared to multiple molding cycles of separate components, molding multiple materials in the same cycle has obvious time and labor benefits.
- Reduced part cost: Combine reduced cycle times, reduced labor times, and eliminated assembly operations, and the total cost of multi-shot molded parts becomes less, compared to alternative single-shot methods.
- Improved Adhesion: With multi-shot molding we get a true physical bond, resulting in a much stronger, longer lasting bond, compared to more traditional “skin on skin” insert molding or post-molding assembly.