Partnering with the Leading Diagnostic Companies for Life-Changing Innovations

We bring over six decades of expertise as the trusted partner to leading life sciences and diagnostic companies in the design, development, manufacture of life-changing medical innovations.

Our design and development expertise, reagent handling, materials and process capabilities combined with our global innovation and manufacturing footprint can help you with every phase of the product lifecycle through a single source partnership.

woman checking glucose

Offering design, development and scale manufacturing, we can support you in bringing your in-vitro diagnostic products to market with our specific expertise in:


  • State-of-the-art commercialization support through design and human factors expertise
  • Development support to optimize designs for manufacturability and automation
  • Precision injection molding and manufacturing processes enabling rapid scale manufacturing
  • Global footprint for manufacturing including the United States, Europe, Mexico and China
  • Financial strength to commit resources to meet ambitious customer project timelines
  • Microelectronics capabilities that can integrated with precision plastic injection molding and assembly
  • Reagent handling, final packaging and serialization

Learn About Services

Diabetes Management

• Continuous Glucose Monitoring Devices
• Insulin Pens
• Insulin Pumps

Infectious Disease

• Diagnostic Consumable
• POC In Vitro Diagnostic Tests

Oncology

• Diagnostic Consumable
• POC In Vitro Diagnostic Tests

Capabilities and Offerings


We can work with you to provide expertise in vitro diagnostics design, development and manufacturing that addresses your specific needs. From microelectronics integration, reagent handling and final packaging to scale manufacturing of diagnostic consumables, including microfluidic systems for point of care and at-home testing, we offer the benefits of a single, trusted integrated solution at every phase of the product lifecycle.
 

Capabilities at Every Phase of the Product Lifecycle

  • World-class mold-making partnerships and suppliers
  • Specialized injection molding capabilities (multi-shot, multi-materials, thermoplastic, micro-molding)
  • Reagent handling
  • Deep experience with lateral flow testing
  • Expertise in microelectronic, microfluidics and optic
  • Dedicated design and innovation technical staff
  • Deep expertise in medical product development
  • Apply industry-leading rapid innovation and engineering expertise
  • Diagnostic research insights
  • Diagnostic feasibility analysis
  • Large manufacturing footprint of 30+ fully equipped sites
  • Processes integrated with early design and development
  • Manufacturing strategy expertise
  • Cycle-time reduction strategies
  • Transparent, digital supply chain and network optimization
  • Automation and testing expertise
  • Serialization and final packaging solutions and traceability
  • Cleanroom production facilities, FDA-registered class 7 & 8
  • Dedicated, single-line manufacturing suites at global locations
  • Drug and reagent handling 
  • Robust risk management and quality management systems
  • Global regulatory expertise across all sites
  • Rigorous ISO9001, ISO13485, 21 CFR 820 and TS 16940 controls
  • Integrated medical certifications and regulatory standards compliance
  • National and international medical regulation and certification expertise
Diagnostic Certifications

Extensive quality management processes and regulatory certifications reduce risk and increase peace of mind.