Clean Room Workers

Pathway Medtech believes no design is complete until it can be manufactured efficiently, repeatedly, and to meet top quality standards and regulations. We excel at the design and development of medical devices and other new products without ever compromising quality.

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Is your medical device ready for assembly? Pathway Medtech offers scalable, cost-effective contract manufacturing from small to large-volume production (with much less of the hassle interjected by the competition). We can help you meet your production goals without compromising the quality of your product. Change orders, testing, material building, and documentation are all handled and expedited by our experienced professional team with minimal impact on timeline and budget. It’s our goal to support your business’s entrepreneurial spirit and get your project to the finish line seamlessly and without needless hurdles.

Defining the Design Parameters

Pathway Medtech features a highly technical production team capable of efficiently integrating new product assembly lines. Whether you’re looking for high-precision, short-run assembly or for high-volume manufacturing with ongoing cost-reduction support, we know how to help. Our facilities include the following resources and quality management capabilities:

ISO 13485:2016 Certified

ISO 13485 was developed by the International Organization for Standardization (ISO) to create stringent standards for the quality management process—with specifications included for the medical device industry. ISO defines a medical device as “a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.” ISO 13485 certification ensures that medical devices meet rigorous industry requirements for design, production, installation, and servicing.

Testing Manufacturing

FDA 21 CFR 820 Quality System Regulations

Pathway Medtech adheres to FDA regulations that address applicability and good manufacturing practices. This oversight ensures that products brought to market with our help are both safe and effective in accordance with the Federal Food, Drug, and Cosmetic Act. We also make certain that products maintain compliance with 21 CFR Part 820, which is part of Current Good Manufacturing Practice (CGMP) regulations.

ISO Class 6/7/8 Clean Rooms

Our clean rooms are maintained in accordance with both industry and international regulatory standards. This controlled environment earns its classification level according to the cleanliness level of the air, with rankings ranging from ISO 1 to ISO 9. ISO classes 6, 7, and 8 are among the most commonly required clean room classifications for medical device manufacturing processes.

ESD Manufacturing/Packaging

ESD, or electrostatic discharge packaging, is available from Pathway Medtech for the manufacturing, transportation, and storage of medical devices, including electronic components. ESD controls and neutralizes the threat presented by static electricity discharges.

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Ready to begin the manufacturing process, or need advice on how to get started for your medical device currently in development? Contact us for a consultation.

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CNC Machining

Many of the medical devices manufactured in partnership with Pathway Medtech must adhere to rigid precision, repeatability, and consistency benchmarks. Multi-axis CNC machining achieves these standards for surgical instruments and other extremely intricate devices. Let us meet your demands for tolerance and durability in the life-saving health care solutions being brought to market.

Laser Cutting

Stents, heart valves, and other manufactured medical devices require the detail provided by advanced laser-cutting machines. When carried out by Pathway Medtech, laser-cutting processes ensure low cost, fast work, complex shaping and component geometries, and extreme repeatability with no distortion.

Medical Testing

Thermoforming and Die Cutting

Custom medical thermoforming is increasingly popular for medical device and equipment manufacturers. We can help to select the exact thermoplastics and molding that will provide the greatest rate of success for your product. Die cutting is also available for the manufacturing of custom components. Both thermoforming and die cutting can keep fabrication costs down when executed effectively.

EO, Gamma, and E-Beam Cycle Validations

We can also coordinate custom ethylene oxide (EO), gamma, or electronic beam (e-beam) cycle validations as needed for customers. It is critical to validate sterilization processes and ensure they are consistent and will not negatively impact your medical device or its packaging.

Other services offered by Pathway Medtech include label and pouch printing, and sourcing and vendor management. Our integrated approach is built to accommodate medical devices at any stage of design and engineering, regulatory compliance, or manufacturing. We’re here to help you get to the finish line while maintaining good manufacturing practices (GMPs) through proper documentation, and rapid-fire handling of change orders.

Ready to begin the manufacturing process, or need advice on how to get started for your medical device currently in development?

3D Printing

3D printing—or additive manufacturing—is used to create a multitude of advanced, three-dimensional medical devices produced from digital files. Pathway Medtech utilizes 3D printing to manufacture implants, surgical instruments, prosthetics, and numerous other products. The flexibility provided by additive manufacturing lends itself to simple sizing and layering changes to suit various patient anatomies without the need for major adjustments of equipment and tools.

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Contact us for initial consultation on your manufacturing needs or for a free custom analysis.

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