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.


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


Optimize product form and function for rapid market acceptance.


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


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.


  • 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