Pathway Medtech Announces Completion and Certification of Fourth ISO Class 7 Cleanroom

Santee, California, March 23, 2026 — Pathway Medtech today announced the completion and certification of its fourth ISO Class 7 cleanroom, bringing its total cleanroom capacity to more than 1,600 square feet. The expansion enhances the company’s ability to support early-stage medical device companies as they transition from prototype into Design Verification, clinical, IRB, and early-stage commercial manufacturing within a controlled and compliant environment.

Unlike many contract manufacturers, Pathway’s cleanroom capabilities were not part of its original business model. They were developed in response to the needs of a single client.

“We didn’t start Pathway to be a contract manufacturer,” said Arthur Deptala, Co-Founder and CEO of Pathway Medtech. “We started as a product development firm. The cleanroom, and everything that came with it, was something we built because a client needed it.”

That client required more than design and engineering support. They needed a partner capable of supporting Design Verification builds, navigating regulatory requirements, and manufacturing product in a compliant environment. In response, Pathway became ISO certified, built its first cleanroom, and registered with the FDA.

As the client’s program scaled to tens of thousands of units per month, Pathway expanded its cleanroom capacity to meet production demand.

“We grew alongside that program. What started as one cleanroom turned into multiple as production increased. Through that process, we built the infrastructure, quality systems, and manufacturing capabilities that we have today.”

When the client ultimately transitioned manufacturing in-house, Pathway was left with something unexpected. The company had developed cleanroom infrastructure, established quality systems, and gained firsthand experience supporting regulated builds across development and early production.

“There’s a very real gap between prototype and full-scale manufacturing. A lot of companies can help you design a product. A lot of companies can manufacture at scale. Very few can support you in between, when you need to build under design controls, in a cleanroom, with full traceability, and with the flexibility to adapt as the product evolves.”

Today, Pathway Medtech operates at that intersection. The company supports early-stage medical device programs through:

• Design Verification builds
• Clinical and IRB builds
• Early-stage commercial production
• Process development, refinement, and transfer readiness
• Tooling, automation, and semi-automated manufacturing approaches

The addition of a fourth ISO Class 7 cleanroom expands Pathway’s ability to support multiple programs simultaneously while maintaining the controlled environments required for sterile and high-sensitivity manufacturing.

“This expansion is not just about adding space. It is about continuing to invest in the stage where most programs run into challenges. That transition from a working prototype to something that can be manufactured, documented, and scaled in a regulated environment is where a lot of teams struggle.”

Pathway’s cleanroom environments are designed to support flexible, low-to-mid volume production while integrating closely with engineering, manufacturing, quality, and regulatory workflows. This allows programs to progress without the typical disconnect between development and production.

“We’ve built this to support that transition. That is where we fit, and where we can provide the most value.”

Pathway Medtech is an ISO 13485-certified medical device development and manufacturing partner based in Santee, California. Founded in 2013, the company integrates product development, quality systems, regulatory strategy, and low-volume GMP manufacturing into a single, accountable partner supporting medical device companies from early feasibility through design verification and early commercialization.

Pathway operates at the critical stage between prototype and scalable manufacturing, helping companies establish the infrastructure required to build under design controls and regulatory scrutiny. Its approach emphasizes the integration of development, manufacturing, and quality systems, ensuring that products are not only designed effectively, but are also manufacturable, compliant, and prepared for long-term growth.

By embedding quality systems, documentation, and traceability into daily execution, Pathway enables its clients to scale with confidence rather than retrofit compliance later in the process. The company supports a wide range of medtech innovators by providing a disciplined, end-to-end framework that bridges the gap between early development and full-scale production.