Manufacturing

Our goal is your goal: Fast, cost-effectively, defect-free new product introduction.

Pathway manufacturing is scalable for high-quality manufacturing of everything from single prototypes to go-to-market production volumes. Custom automation, clean room assembly, testing and packaging – we’ve got you covered.

planning

Despite the cliché, the best laid plans tend to yield quality results.

development

Optimize product form and function for rapid market acceptance.

regulatory

Enter the market with a high quality, audit-ready product.

manufacturing

Scalable, customized and comprehensive manufacturing.

Successful new product introduction often requires innovative new tools.

Learn about Pathway Custom Automation Design.

Simply built better

  • Our facilities offer onsite prototyping capabilities, an ISO Class 7 clean room (Class 10,000 FED STD 209E equivalent), ESD safe manufacturing areas and internal test lab—one source for comprehensive rapid-cycle design improvements throughout product development.
  • We design and build customized fixtures to automate the simulation of product operation for life-cycle and reliability testing.
  • Pathway can design and build unique fixtures for your specific product’s assembly, attestation and packaging including fully automated systems.
  • We specialize in low to medium volume production, yet we are able to manufacture pilot product for short term product introduction at higher volumes.
  • Because your product will reflect the quality of our manufacturing process, we perform diligent FMEA to systematically avoid defect, delays and waste.
  • We will train and support your team’s use of customized manufacturing system in order to pass your ISO 13485 certification audit.
  • Our manufacturing team consists of highly trained operators and, when needed, well-vetted suppliers.
  • Product development is never ending. To ensure your success beyond market launch, Pathway provides a post-market surveillance.

deliverables:

  • Device Master Record
  • 1st Articles Inspection associated to process
  • ISO Class 7 Cleanroom (Class 10,000 FED STD 209E equivalent)
  • ESD safe manufacturing areas
  • Custom Fixturing and Automation
  • Device assembly
  • Establishment of routine biosafety testing
  • Life cycle testing
  • Pre-validated sterile barrier packaging solutions
  • Process Validation (IQ/OP/PQ)
  • Post-market surveillance protocol