Why Choose Pathway NPI?
Engage Pathway NPI for assistance with medical product design, development, market clearance, and/or manufacturing. Our holistic engagement approach allows us to engage at any stage (Design and Engineering, Regulatory, or Manufacturing) and assist with your most critical needs first.
Pathway NPI was launched in 2013 by two experienced mechanical engineers eager to leave the corporate red tape behind and create a path of least resistance for medical device contract manufacturing. We can relate to small businesses and startups navigating the entrepreneurial journey and funding/registration processes. Read our story here. When you work with Pathway NPI, you’re partnering with real people who understand the investment at hand.
What Pathway NPI Offers
FDA/ISO Certification
Our FDA/ISO 13485-registered facility is home to an industry-leading quality/regulatory team focused on product excellence and efficient market clearance.
Quality Management
Leverage our audited, cloud-based quality assurance/quality control system to manage growth and expenses.
New Product Development
No design is complete until your product can be manufactured efficiently and repeatedly, and meets all relevant quality standards.
Design & Engineering
Concept development expertise for both functional design and regulatory-focused design.
Regulatory
Develop the right regulatory approach for your exact product to get to market quickly.
Manufacturing
Low-cost, U.S.-based manufacturing options, high-precision short-run assembly, and high-volume manufacturing capacity.
Leverage Our Expertise
20+
FDA Clearance Submissions
50+
Devices Commercialized
60+
Patented Designs Developed
Start Today
Whether you’re ready to start today, or just exploring your options, we are ready to meet. Click on the button below to get started.