New Product Development

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.
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FDA Guidance

Leverage Our Expertise

20+

FDA Clearance Submissions

50+

Devices Commercialized

60+

Patented Designs Developed

What We Offer

Product Design

Product Design

Concept Development, Functional Design, and Regulatory Focused Design.

New Product Development

New Product Development

No design is complete until the product can be manufactured efficiently, repeatably, and to our industry’s quality standards.

FDA Guidance

FDA Guidance

Develop the right regulatory approach with a team that can deliver, is key to getting to market quickly.

Quality Management

Quality Management

Leverage our experience and audited cloud-based quality system to manage growth/expense.

American Manufacturing

Medical Device Contract Manufacturing

US or low cost (MX) manufacturing, high-precision short run assembly, or high-volume manufacturing.

Sterilization

Sterilization

Reduce cost, avoid expensive validations, we can take care of all your sterilization needs.

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Our Process
Ideation / Planning
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Our Process
Design / Requirements Development, Proof of Concept
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Our Process
Requirements Development, Proof of Concept

Verification and Validation

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Our Process
Requirements Development, Proof of Concept

Market Clearance, Manufacturing