Manufacturing Biomedical Device Parts: The Nuts and Bolts of Quality Control

Biomedical asset buyers understand that high-quality equipment is essential for effective care delivery, risk management, and ROI. Traditionally, we trust brands with a proven reputation for quality because they deliver, and they last.

Quality also matters when choosing replacement parts for infusion pumps, telemetry systems, and other mission-critical devices. Third-party replacement parts have many benefits, including greater availability and affordability.

But the truth is that not all 3rd-party parts meet OEM quality levels. Using these parts can increase risk for hospitals because they often compromise device performance, which affects patient care and safety.

It’s critical for decision-makers to evaluate the quality practices of potential 3rd-party manufacturing partners. Understanding the basics of quality management helps buyers identify a partner who can deliver replacement parts that keep devices on the floor, facilities in compliance, and patients safe during hospital stays and medical procedures.

If you are looking to vet and evaluate the quality management of potential 3rd party manufacturers, then here’s what you need to know:

What is a Quality Management System?

According to the American Society of Quality (ASQ), "A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives."

A QMS requires a manufacturer to define its operations in detail, create standard operating procedures, and designate quality checkpoints. A QMS provides operational consistency; this minimizes errors and maximizes the ability to identify design and production flaws that could cause dangerous product failures. In biomedical manufacturing, the primary focus of a QMS is on safety and risk mitigation.

FDA Quality Standards

To market a new medical device, an original equipment manufacturer (OEM) must comply with the FDA Quality System Regulation (QSR; 21 CFR Part 820). 21CFR 820 includes guidelines for a QMS that thoroughly documents the safety and efficacy of the new device. 21CFR 820 does an exceptional job at protecting patients who require biomedical equipment for healthcare, and at preventing medical facilities from taking on additional risk when purchasing new devices.

How do 3rd Party Manufacturers Ensure Quality?

Because 3rd-party manufacturers replicate the design of OEM parts for use in after-market equipment, they aren't required to adhere to 21CFR 820. In fact, the quality management practices of some 3rd-party manufacturers fall well below the FDA standard.

It’s key to understand that a quality-driven 3rd-party manufacturer will always prioritize safety and reliability over profit. These businesses will voluntarily integrate 21CFR 820 standards and robust quality management into their business model, including:

ISO 13485:2016 The global standard for medical devices

The FDA doesn't verify 3rd-party businesses that choose to follow 21CFR 820 guidelines.

However, companies can become certified to International Organization for Standardization (ISO) standards. This international entity creates technical, industrial, and commercial standards that meet or exceed regulatory requirements in many countries. ISO 13485:2016 is the standard designed specifically for the medical field.

An independent, accredited ISO registrar performs ISO certification audits. To remain certified, the manufacturer must be ready to demonstrate an ISO 13485:2016 compliant QMS at any time. For this reason, certification guarantees that a 3rd-party manufacturer is following the processes and procedures put in place.

FDA Registration: What many 3rd party manufacturers don’t do

FDA registration is required for OEMs and voluntary for 3rd-party manufacturers. Registration means the company agrees to follow the FDA's current Good Manufacturing Practices (cGMP) and to allow FDA facility inspections that confirm cGMP compliance.

Reverse Engineering vs. Copying

Third-party manufacturers can choose to replicate OEM parts either by copying or reverse-engineering the product design.

Copying involves measuring all the part's components and then duplicating them. It's quick and cost-effective. Unfortunately, copied parts fail much more frequently than reverse engineered products, increasing device downtime, and the risk of adverse patient events.

Reverse engineering is a more extended process in which skilled specialists use advanced technology to inspect and analyze every aspect of the OEM part. Reverse engineering takes a little longer and costs a bit more than copying. But ultimately, reverse engineering offers a significant payoff where it counts—enhanced ROI and greater patient safety.

What does a robust medical device QMS look like?

The QMS at Elite Biomedical Systems is an example of one of the most robust systems in the 3rd-party biomedical manufacturing industry.

Elite’s parts are reverse engineered and manufactured entirely in the United States, with materials sourced through a well-vetted US supply chain. Elite is ISO 13485:2016certified, and FDA registered.

Some highlights of Elite's process and QMS:

Research phase

Quality and product development teams investigate initial risk before the product is approved for development.

Development phase

Quality planning takes place during reverse engineering and initial testing, a meticulous process that can take up to 18 months or longer. Quality planning defines product performance parameters, the manufacturing qualification process, and testing and documentation procedures.

Validation phase

Validation is an intensive, multi-department phase. It includes validation of the molding and assembly processes, product sample runs, and ingress testing to confirm the product meets the same IPX rating as the OEM part. Finally, biomedical engineers install sample parts in OEM devices and perform extensive functional testing in field scenarios. At the end of validation testing, all quality documentation is reviewed before the part is approved to launch.

Market production

The work instructions for each production run include the requirements for product acceptance and inspection. During production and assembly, workers document the outputs of the process at each step on a job traveler.

Quality isn't just a system, it's a culture

"The most important feature of our QMS is that, from the top down, everyone has ownership in the quality management system," says Brenda Compliment, Director of Quality at Elite Biomedical Solutions.

From research and design through production, any Elite employee, regardless of their position, can stop the process at any time if they suspect quality has been compromised.

How to vet a 3rd-Party QMS

These steps can help hospital purchasing agents ensure that a 3rd-party manufacturer has a robust QMS:

• Confirm the QMS aligns with FDA CFR 820
• Verify ISO 13485:2016 Certification can be traced back to the IAF accreditation body.
• Consider whether the product is made in the USA or overseas
• Discuss how suppliers are qualified and evaluated
• Request an audit or documentation of the QMS
• Ask to observe a live production run

A quality-driven partner like Elite Biomedical Solutions will have no problem sharing details about any part of the production cycle or demonstrating how they control and document quality in each phase.

Our industry-leading QMS, cutting-edge reverse engineering process, and commitment to the highest quality standards produce OEM-level replacement parts that can extend the lifespan of infusion and telemetry assets.

To connect with a team member, contact us today.