Medical Device
Outsourcing

Fully-Integrated Contract Manufacturing
for Complex Medical Devices and Components

Case Study

Medical Device Outsourcing

Fully-Integrated Contract Manufacturing
for Complex Medical Devices and Components

Case Study
SDNA Saliva Collection Device Molecular Diagnostic

Innovative and Scalable
Expert Solutions

Medical device outsourcing is a vital component of the life science industry. Typical to the industry are cyclical fluctuations in demand. Contract outsourcing offers the solution to managing these highs and lows that consume internal resources and jeopardize new product development.

Spectrum offers dedicated internal resources at each stage of its fully integrated custom product manufacturing process. From concept to device manufacturing, all the way through to an order and direct-to-user product fulfillment. Our complete, turn-key operation includes engineering and design to microfluidics chemical formulation, custom packaging, and specialized kitting. Combined with our global footprint, we help lower your fixed overhead costs and provide access to foreign markets.

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. Advancing your medical device product program means choosing the right outsourcing partner. This decision should include one with the proven ability and skill to handle the complexities of mass-scale medical manufacturing.

There is no substitute for medical industry experience or certifications. We focus our expertise on every detail so you don’t have to.

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SDNA Saliva Collection Device Molecular Diagnostic

Innovative and Scalable
Expert Solutions

Medical device outsourcing is a vital component of the life science industry. Typical to the industry are cyclical fluctuations in demand. Contract outsourcing offers the solution to managing these highs and lows that consume internal resources and jeopardize new product development.

Spectrum offers dedicated internal resources at each stage of its fully integrated custom product manufacturing process. From concept to device manufacturing, all the way through to an order and direct-to-user product fulfillment. Our complete, turn-key operation includes engineering and design to microfluidics chemical formulation, custom packaging, and specialized kitting. Combined with our global footprint, we help lower your fixed overhead costs and provide access to foreign markets.

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. Advancing your medical device product program means choosing the right outsourcing partner. This decision should include one with the proven ability and skill to handle the complexities of mass-scale medical manufacturing.

There is no substitute for medical industry experience or certifications. We focus our expertise on every detail so you don’t have to.

  • 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

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Dedicated account managers with technical and commercial capability

FDA Registered Medical Device Organization, ISO 13485 Certified

Current Good Manufacturing Practices (CGMP) Compliance

End-to-End Medical
Device Outsourcing

What you need. When you need it. Where you need it to be.

Customize my Solution

MEDTech Contract Manufacturing Solutions

  • 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

Unlock Your Competitive Advantage

Medical device outsourcing is a vital component of the life science industry.
Typical to the industry are cyclical fluctuations in demand. Only outsourcing offers an easy solution to managing these highs and lows that consume internal resources and jeopardize new development.
Advancing your medical device product program can hinge on choosing the right outsourcing partner with a proven mastery of the complexities in end-to-end mass-scale manufacturing.

Complex IVD and MEDTech Devices

Exclusive focus on the highly specialized life science MedTech industry.

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 individual medical device contract manufacturing roadmap begins.

Complex IVD and MEDTech Devices

Exclusive focus on the highly specialized life science MedTech industry.

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 individual medical device contract manufacturing roadmap begins.

Version 3 blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank blank LEVERAGE
EXPERIENCE
Gain critical regulatory
understanding with our pure medical expertise
DRIVE PREDICTABILITY SPEED TO MARKET Competitive lead times, supported by fully integrated capabilities, offer a faster and more efficient time to market strategy ROBUST QUALIT & DEDICATED
CLEAN ROOMS
Essential in providing stability,
reliability, & control with batched
quality product releases & lot-based testing
NEXT-GEN
DIAGNOSTICS
Onsite formulation labs REAL-TIME OVERSEE VISIBILTY
Web-based portals provide instant custom order
and inventory visibility as well as resource management
with SOX compliant control and accuracy. In addition,
API interface offers same day and 99+% on-time ship
with quality control at both pick and pack.
blank Achieve absolute quality, cost effectiveness & increased efficiency through Six Sigma, Lean Manufacturing, Theory of Constraints, & FEMA CONTRACT MFG-INFO GRAPHIC PHOTOS-05 CONTRACT MFG-INFO GRAPHIC PHOTOS-06 CONTRACT MFG-INFO GRAPHIC PHOTOS-07 CONTRACT MFG-INFO GRAPHIC PHOTOS-08 CONTRACT MFG-INFO GRAPHIC PHOTOS-09 CONTRACT MFG-INFO GRAPHIC PHOTOS-10 blank blank blank blank blank blank blank blank blank blank blank
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Considering a Product
Development Partner?

Fully integrated industry expertise creates forward-looking end-to-end solutions. From concept design and engineering to high-quality product manufacturing, let us help reduce costs, quickly scale up production, or handle overflow. Easily simplify order fulfillment, supply chain management, bolster quality control, & manage regulatory compliance with real-time, web-based visibility.

Spectrum Solutions Commercial Product Innovation

Considering a Product
Development Partner?

Fully integrated industry expertise creates forward-looking end-to-end solutions. From concept design and engineering to high-quality product manufacturing, let us help reduce costs, quickly scale up production, or handle overflow. Easily simplify order fulfillment, supply chain management, bolster quality control, & manage regulatory compliance with real-time, web-based visibility.