Spectrum Solutions Company Profile

Spectrum Solutions, a life science company, focuses its fully integrated industry expertise on creating forward-looking end-to-end solutions for clinical diagnostic projects and commercialized product plans. Spectrum is a single-source provider for innovative medical device engineering & product manufacturing, molding, formulation, packaging design, customized kitting, & direct-to-user fulfillment.

FDA Registered Medical Device Organization, ISO 13485 certified, cGMP Compliant, Spectrum is regularly audited by federal and industry officials to ensure compliance with stringent federal regulations such as 21 CFR Part 820. We manufacture medical products for various regulatory jurisdictions, including the US (FDA), Europe (CE), Health Canada, and APAC region. These include low-risk to higher-risk IVDs and medical devices using the FDA’s cGMP standards.

Spectrum’s all-star team of medical, design, engineering and manufacturing experts leverage the ideal combination of Six Sigma, Lean Manufacturing, Theory of Constraints, and FEMAs to deliver the products and services crucial in supporting a global healthcare system.

The advantages of aligning with the right project partner means the best combination of industry-innovating products, specialized services, and tailored solutions supporting fast project successes. There is no substitute for medical industry experience or certifications. We focus our expertise on every detail, so you don’t have to.

MEDICAL DEVICE OUTSOURCING

Fully integrated Contract Manufacturing for Complex Medical Devices and Components

• Dedicated account managers with technical & commercial capability
• Medical Product Design, Development, CAD & Concept Prototyping
• R&D Scientists & Engineers Including Quality, Design Controls & Process Validation
• Injection Molding & Expert Tooling with Rapid Prototyping Capabilities
• Microfluidics Chemical Formulation Development
• Custom Packaging, Unique Barcode Serialization, & Specialized Kitting
• Direct-to-User Global Fulfillment with SaaS biosample chain-of-custody & customizable track-and-trace notifications
• Exclusive Focus on the Highly Specialized Life Science MedTech Industry
• Speed to Market
• Clean Room (Space) Assembly

PRECISION MEDICAL DEVICE MOLDING & MANUFACTURING

Turnkey, Scalable, High-Performance Thermoplastic Molding & Rapid Tooling Experts

• State-of-the-Art Facilities
• Concept Rapid Tooling & 3D Printing
• Dedicated Clean-Rooms
• Precise Metrology Lab
• Quick Mold Validation & Qualification Turnarounds
• R&D Scientists & Engineers
• Fully Automated Error-Free Machine Processes
• Expert Tool Maintenance
• Scalability Program Designed to Match your Needs
• Overflow Molding & Manufacturing Support According to GMP Standards
• Tight Precision & Repeatability with Lower Costs, Less Waste & Lower Scrap Rates
• Shorter Start-up Times & 70% Energy Savings
• Documented preventative maintenance program with regular visual & dimensional part inspections
• Medical Device Redesigns
• Automated Precision Molding
• Multi-Component Molding
• All-Experienced & Well-Trained Techs
• Fully-Electric Medical Molding