Spectrum Solutions

Company Headquarters

12248 Lone Peak Parkway
Suite 108
Draper, UT 84020
United States

View Phone No.

Company Description

Spectrum Solutions, a life science company, is a single-source provider for innovative medical device engineering & product manufacturing. Our full turn-key operation includes molding, microfluidics chemical formulation, packaging design, customized kitting, & direct-to-user fulfillment. We focus our expertise on every detail so you don't have to

Life Science Innovation & Medical Device Development

Your market success hinges not only on the innovative medical device design, development, and manufacturing of your outsourcing partner, but additionally requires a vast range of academic influence, expert experience, and critical patient understanding. It's from this mix of Spectrum's scientific-based medical expertise that your medical device contract manufacturing roadmap begins.

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.

Our Expertise,
Your Competitive
Advantage

It's not the buildings, equipment, or automation from one contract manufacturer to another. They all fundamentally work the same at producing a quality part.
The difference between designing and delivering a good or industry-transforming medical device that advances your product program, even in the throes of a global pandemic, actually hinges more on the talented experts behind the curtain.
It's identifying, recruiting, and building the industry's most talented medical device manufacturing dream team to successfully deliver a new saliva diagnostic solution, so innovative, it changed the industry testing protocols worldwide.
That's Spectrum.
Advancing your medical device product program means choosing the right outsourcing partner with the superhuman ability to handle the complexities of mass-scale medical manufacturing and global fulfillment.
Can our strategic industry knowledge, specialized skill, and proven business acumen transform, inspire, or advance your medical device program?
Yes. Yes, it can.

Injection Molding

Precision Medical Device Molding & Manufacturing

Rapid & On-Demand Concept Prototyping
Quick Mold Validation & Qualification Turnarounds
R&D Scientists and Engineers
Fully Automated Error-Free Machine Processes
Expert Tool Maintenance
Scalability Program Designed to Match Your Needs
Multi-Component Molding
Overflow Molding & Manufacturing Support According to GMP Standards
Tight Precision & Repeatability with Lower Scrap Rates
Shorter Start-up Times & 70% Energy Savings
Documented Preventative Maintenance Program With Regular Visual and Dimensional Part Inspections

Contract Manufacturing & Outsourcing

Fully Integrated Contract Manufacturing for
Complex Medical Devices and Components

Medical Product Design, Development, CAD and Concept Prototyping
R&D Scientists and Engineers Including Quality, Design Controls, and Process Validation
Injection Molding & Expert Tooling with Rapid Prototyping Capabilities
Microfluidics Chemical Formulation Development
Custom Packaging, Unique Barcode Serialization, and Specialized Kitting
Direct-to-User Global Fulfillment with SaaS biosample chain-of-custody & customizable track-and-trace notifications