WHO WE ARE
Pathway is a growing leader in medical device development and manufacturing. We serve the industry's leading innovators to deliver an efficient, single-source solution to commercializing products that will improve the healthcare market.
WHAT WE OFFER
Pathway's team represents a single-source product introduction solution. Our firm offers a multi-disciplined development team ranging from ideation/concept design to scalable manufacturing.
Our FDA/ISO 13485: 2016 registered facility is home to an industry leading quality/regulatory team focused on product excellence and efficient market clearance.
Our lean approach to product development leverages a vertically integration solution offering design, engineering, regulatory strategy/execution, quality management per industry standards, and GMP manufacturing.
We provide the right sized development and manufacturing to create pragmatic solutions that exceed industry standards.
Concept Development,
Functional Design, and
Regulatory Focused Design.
No design is complete until the product can
be manufactured efficiently, repeatably,
and to our industry’s quality standards.
Develop the right regulatory approach
with a team that can deliver, is key
to getting to market quickly.
Leverage our experience and
audited cloud-based quality system
to manage growth/expense.
US or low cost (MX) manufacturing,
high-precision short run assembly,
or high-volume manufacturing.
Reduce cost, avoid expensive
validations, we can take care
of all your sterilization needs.
OUR APPROACH
1. Concept Design, Product Requirements Strategy/Definition, Regulatory
Approach, Risk Management
2. Design Input Requirements, Design Development, Prototyping, Proof of Concept Testing, Risk Analysis
3. Device Master Record Creation
4. Verification and Validation Activities
5. Regulatory Submission, Market Release, Process Validation, Sustaining Engineering/Ongoing Cost Reduction Activities
OUR VALUE IS BETTER
ISO 13485:2016
Our registered facility is home to an industry leading quality/regulatory team focused on product excellence and efficient market clearance.
FDA/ISO 13485 Registered Manufacturing
Pathway maintains multiple ISO Class cleanrooms (Class 6/7/8) as well as a highly technical management team capable of efficiently integrating new product assembly lines.
Right-Sized
We specialize in serving small to medium-sized enterprises, providing the right-sized development and manufacturing to create pragmatic solutions.
LEVERAGE OUR EXPERTISE
Not just another design firm or contract manufacturer, we are a trueend-to-end product introduction solution. Leverage our expertise andestablished systems to keep overhead low, and get to market quickly.
11
MARKET CLEARANCE SUBMISSIONS
42
PATHWAY DESIGN PATENTS
26
MEDICAL DEVICES TO MARKET
OUR TEAM
Diverse development team ranging from ideation/concept
design to scalable manufacturing.
RECENT PROJECTS
Pragmatic solutions that exceed industry standards.
