Planning

Despite the cliché, the best laid plans do yield the desired results.

Our experts in mechanical, electrical, software, and biomedical engineering, industrial design, FDA guidelines, and medical engineering physics collaborate with your team to define an end-to-end plan for success that will minimize surprises and speed time-to-market.

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.

get off to a good start:

  • Pathway begins each engagement by studying your technology to identify any technical challenges and opportunities to manage risk.
  • We collaborate with your team and potential users to assess and propose design improvements.
  • Pathway forms a regulatory strategy to align your product with ISO 13485 design control and documentation standards and FDA  specifications.
  • We plan a customized manufacturing process optimized for quality, cost, and the efficient use of time and materials.

deliverables:

  • Proof of concept
  • Intellectual property review
  • Renderings of concept
  • High quality working prototypes for hands-on evaluations
  • Product Specifications/ Traceability Matrix
  • Manufacturing strategy with volume projections that match go-to-market objectives