Medical device manufacturers frequently face unique industry challenges, including the need to manage quality processes across disparate sites or business units and increased legal and regulatory scrutiny. The FDA requires that each medical device comply with a standard set of guidelines to ensure quality is upheld. In order to validate that this criteria is being met, the FDA states that all medical device manufacturers have some form of quality management system (QMS) in place to define, communicate, measure, and improve key company processes. QMS is intended as the tool to manage the quality system regulations imposed by the FDA. Though implementing a QMS is required by law, this article examines additional business benefits associated with using a QMS.

Quality Is More than Keeping Up with the Joneses

Fig. 1 – When it comes to complying with FDA regulations, your “good enough” might not be enough.
Medical devices like pacemakers, artificial joints, replacement heart valves, scanners, diabetes insulin pumps, and radiotherapy machines represent breakthrough innovations that make it possible to diagnose diseases earlier, manage health maladies effectively, and provide better quality of life. A major component in the design and development of safe, effective medical devices are the manufacturing processes that can identify, analyze, and control the risks associated with manufacturing medical device hardware, software, and electronics. Concurrent to managing these risks effectively, medical device manufacturers also need to meet rising demand for their products, effectively manage increased costs to meet those demands, and maintain quality benchmarks while complying with various regulatory requirements.

One set of regulatory requirements that all medical device manufacturers must comply with are the Good Manufacturing Practice (GMP) regulations set by the FDA under the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers of medical devices take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.

Medical device executives no longer have the luxury to just believe their quality procedures are working well, but rather must ensure they have the best-in-class quality practices in place. Otherwise, they face regulatory consequences, such as Form 483s or warning letters, and/or financial consequences that can severely damage their reputations and bottom line, or worse, the complete demise of business. (See Figure 1)

Even though quality processes exist, they are usually unique to departments, business units, regions, and individual sites or functions. Quality events are frequently handled differently across an organization and seldom is the information shared about the lessons learned between disparate sites or business units. To help globally manage all quality-related processes for true quality harmonization and visibility, industry-leading medical device companies are implementing Enterprise Quality Management Systems (EQMS).

An EQMS allows companies to have transparency of quality from the shop floor to the executive suite and into the supply chain in near real time. The unique characteristic of an effective EQMS is that it provides repeatable, consistent, and harmonized processes to manage quality events in an efficient and effective manner. When an issue is discovered at one site, root cause is determined and the corrective actions happen there, but preventive actions are assigned to any department or site around the world that may have the same conditions present. An automated corrective and preventative action (CAPA) system supports continuous product and business improvement, provides a systemic approach to managing challenges, and drives cost containment throughout the organization. This, in turn, also manages the risk associated with such events. (See Figure 2)

Collaborative, Methodical, and Evidentiary Aspects of a CAPA System

Fig. 2 – Reduce the risk of lost or incomplete data with closed-loop CAPA management systems.
The FDA mandates that medical device manufacturers have a CAPA system in place that includes written procedures delegating responsibility for linking the CAPA system to the device manufacturer’s production and process controls, as stipulated under 21CFR820. Under the auspices of good manufacturing practices requirements, the FDA performs a detailed audit to be sure a medical device manufacturer’s system is a sound structure for managing current and future product production safely and within the bounds of GMP. That means that there must be staff with required training/certifications, knowledge, and experience in managing CAPA, and the CAPA system must be specific to the manufacturer’s products and processes. Additionally, the CAPA system must be able to capture and analyze quality data, including process, work operations, concessions, quality audit reports, quality records, service records, complaints, and product returns. An effective CAPA system unites all aspects of a global medical device manufacturer’s supply chain, making sure all stakeholders are on the same page with regard to quality.

During an inspection, the FDA expects to see examples of the CAPA system at work, ensuring the system is capable of forward and backward traceability, called an “audit trail.” The FDA will review how the system worked with a specific product or products for which corrective or preventative actions were performed. For that to happen, there must be a statistical methodology in place to analyze quality data and identify quality problems. In selecting quality data to analyze, it is critical to include data sources and elements that are both internal and external to the company. An FDA audit will investigate how a medical device manufacturer’s CAPA system identifies root cause and triages based on risk.

Finally, the FDA requires that a CAPA system be able to record that adequate corrections and corrective actions have been implemented to fix identified quality problems. That means evidence must be available that explains how the manufacturer complied with the requirements to correct a nonconformity and how it employed reasonable measures to limit the risk of exposing it to unsafe or ineffective products. Evidence also must exist that shows how the medical device manufacturer has identified a root cause and then validated corrective actions to ensure those actions were effective and did not introduce new problems. In addition, an FDA audit will look for evidence that proves changes were recorded and reviewed by management in order to show that management is involved in the implementation and validation of corrective procedures. FDA also looks for rationale under which the manufacturer deemed a CAPA completed and closed, meaning there must be a sound methodology of gathering, considering, and rationalizing effectiveness before the CAPA closure.

Choosing the Right Quality Management System

Quality and IT departments typically have different and opposing approaches to evaluating new software purchases. Often, the quality department’s primary concern is finding a solution that will meet its needs, i.e., help it manage quality and safety of its products and maintain regulatory compliance, now and in the future, as the organization and regulations evolve. IT, on the other hand, has a different perspective and works to identify vendors that fulfill the identified requirements at the lowest total cost of ownership (TCO). Frequently, low TCO is associated with leveraging existing systems rather than buying new, with the incremental support and infrastructure costs, so IT is always on the lookout for ways to extend existing systems.

For the FDA, however, it is not enough to rip and replace or clamp on additional quality management systems. As such, the FDA has implemented CFR21 Part 820 and 21CFR Part 11, in addition to adopting ISO 9001 and ISO 13485—various regulations that help ensure the adequacy of quality systems involved in the manufacturing of medical devices. As previously mentioned, the FDA often conducts audits to ensure a medical device manufacturer’s QMS is able to manage future product production safely and within the bounds of GMP. This statement is more meaningful than ever as many manufacturers are entering into the gray area of wearable device fabrication. Companies that have never dealt with FDA regulations must now achieve validation for the connected watches, smart lenses, remote patient monitoring sensors, etc., that they are producing and selling. Not only does the proper implementation of an EQMS ensure manufacturers are being proactive, it is also a competitive advantage that helps ensure patient/user safety.

The Impact of Not Complying with FDA Validation

Some of the most obvious risks for medical device manufacturers that can’t prove compliance with the FDA’s various regulations, including validating that the quality management system used is itself adequate and up to standards, are production delays, FDA-issued warning letters or 483s, device recalls, or even a full facility shutdown. There are many other risks associated with noncompliance, however, including a negative impact on top-line growth, brand erosion, diminished shareholder value, increased TCO, increased time-to-market, hidden costs, and failed projects. In addition, more serious issues can lead to criminal prosecution of the executives and even jail terms. Don’t risk the demise of your manufacturing business— adopt an EQMS you can count on to help ensure all of your (highly regulated) boxes are checked.

This article was written by Mohan Ponnudurai, Industry Solution Director at Sparta Systems, Inc., Hamilton, NJ. For more information, Click Here .


Medical Design Briefs Magazine

This article first appeared in the February, 2015 issue of Medical Design Briefs Magazine.

Read more articles from this issue here.

Read more articles from the archives here.