Bringing a medical device to market is a complex journey filled with regulatory challenges, engineering hurdles, and manufacturing constraints. Many MedTech companies struggle with inefficiencies, delays, and unnecessary costs along the way.

Pathway Medtech was founded to eliminate these barriers. With a mission to provide a seamless, efficient, and high-quality pathway for medical device development and manufacturing, the company has become a trusted partner for startups and established firms alike. Their expertise ensures that life-saving medical devices reach the people who need them—quickly, safely, and with uncompromising quality.

A Legacy of Engineering Excellence

Founded in 2013 by two visionary mechanical engineers, Pathway Medtech was built on a foundation of efficiency, adaptability, and a deep understanding of the entrepreneurial challenges in the MedTech industry. Unlike rigid, impersonal contract manufacturers, Pathway Medtech thrives on collaboration and a genuine commitment to its clients' success.

By integrating design, engineering, regulatory compliance, and contract manufacturing under one roof, the company offers a holistic engagement model, allowing clients to enter the process at any stage—from early-stage development to FDA market clearance.

Expertise in Medical Device Manufacturing

Precision-Driven Contract Manufacturing

Pathway Medtech specializes in low-cost, U.S.-based manufacturing, offering high-precision short-run assembly and large-scale production. Their state-of-the-art facilities ensure efficiency, scalability, and adherence to the highest industry standards.

FDA & ISO 13485 Certification: Compliance You Can Trust

Pathway Medtech’s FDA-registered and ISO 13485-certified facility guarantees compliance with stringent regulatory requirements. Their dedicated quality assurance and regulatory teams streamline the approval process, eliminating unnecessary delays.

Optimized Product Development

A great idea is only as good as its execution. Pathway Medtech ensures that every design is optimized for efficient, repeatable, and cost-effective manufacturing. Their expertise spans concept development, functional design, and regulatory-focused engineering, ensuring smooth production at scale.

Regulatory Expertise: A Clear Path to Market

Navigating regulatory complexities can be daunting. Pathway Medtech provides strategic regulatory guidance, expediting approvals and ensuring full compliance with FDA 21 CFR 820 quality system regulations.

Cutting-Edge Manufacturing Capabilities

ISO-Classified Clean Rooms for Controlled Production

Pathway Medtech operates ISO Class 6, 7, and 8 clean rooms, maintaining the highest contamination control standards crucial for medical device manufacturing.

Advanced CNC Machining & Laser Cutting

Using multi-axis CNC machining and advanced laser-cutting technology, the company delivers unparalleled precision for surgical instruments, implantable devices, and other critical components.

ESD Packaging & Sterilization Validation

To protect electronic components, Pathway Medtech offers Electrostatic Discharge (ESD) packaging. They also facilitate ethylene oxide (EO), gamma, and e-beam sterilization validation to ensure devices remain sterile and effective upon use.

3D Printing & Thermoforming for Innovation

Pathway Medtech leverages additive manufacturing for custom prosthetics, implants, and surgical tools. Their thermoforming and die-cutting services provide cost-effective solutions for custom components and packaging.

The Pathway Advantage: A Commitment to Excellence

At Pathway Medtech, the focus is not just on manufacturing but on delivering a comprehensive solution that helps clients bring innovative medical devices to market faster and more efficiently. Their commitment to excellence is reflected in their:

• Rapid Prototyping and Development: Enabling faster iterations and reduced time-to-market.
• Scalable Manufacturing Solutions: Supporting both short-run and high-volume production with seamless transition.
• Regulatory Expertise and Support: Navigating complex compliance requirements with ease.
• Client-Centric Approach: Building lasting partnerships based on trust, collaboration, and shared success.

Partnering for a Healthier Future

Pathway Medtech understands that every medical device has the potential to save or enhance lives. That’s why they go beyond traditional contract manufacturing, acting as a strategic partner invested in the success of their clients. Their ability to integrate innovation, engineering, and regulatory expertise makes them an invaluable asset in the MedTech space.

Pathway Medtech continues to redefine the industry, ensuring that the next generation of medical devices reaches the market with speed, precision, and confidence. For those looking to bring their medical devices to market with efficiency and regulatory assurance, Pathway Medtech remains the premier partner in turning vision into reality.

Arthur Deptala | Co-Founder & Managing Partner

Arthur has 20+ years of expertise in medical device development and manufacturing. A self-described “true-blue engineer,” his experience covers a diverse array of product types, including surgical instrumentation and robotics, patient-worn body sensors, and high-volume disposables.

Arthur oversees and directs a variety of projects at Pathway Medtech, with a concerted focus on design for manufacturing (DFM) and manufacturing integration. Clients benefit from Arthur’s extensive experience in DFM to help transition proof-of-concept technologies into manufacturable, commercially viable product.

“Pathway Medtech is a contract manufacturer and developer specializing in medical devices. We serve the medtech industry's leading innovators to deliver an efficient, single-source solution for commercializing products.”