Development

Aiming for a “sure thing.”

Highly effective product development requires a balance of skilled engineering and creative design in order to optimize form and function for rapid market acceptance. We offer accelerated development of a rigorously tested, user-validated, cost-optimized product, bringing you as close as possible to a “sure thing” medical innovation.

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.

creating the right process for your product:

  • We adhere to a philosophy of form-follows-function.
  • At all phases of planning, development, regulatory compliance and manufacturing, we scrutinize the efficiency and cost-effectiveness of the product’s design, driving improvement where possible through lean problem solving.
  • We champion the use of accelerated minimum viable product (MVP) development, providing tangible prototypes for demonstration, testing and validation.
  • Pathway offers a complete range of in-house analysis and ISO/ASTM standard testing services as well as custom designed and engineered test fixtures.
  • Pre-validated packaging solutions

deliverables:

  • Hazard Analysis
  • Design FMEA
  • Product requirement specification/traceability matrix
  • Mechanical, electrical, and software engineering
  • User Interface design
  • Ergonomics and human factors design
  • 1st article inspection for design
  • Stability, sterilization, biocompatibility, strength and custom testing
  • Packaging validations/label integrity
  • Patent filing of your new IP