Saving Lives: Strict Regulations Ensure Medical Device Reliability

The U.S. Food and Drug Administration oversees the medical device industry in the U.S., setting forth a series of standard regulations that device manufacturers and other vendors throughout the supply chain must adhere to – including every entity from the actual manufacturer to vendors supplying individual components that will be used in medical devices, and even vendors that affix identification labels to devices before they’re distributed in the market. It’s a lot of red tape for any company involved at any stage, but the result is a much safer, more secure supply of medical devices that ensure patient safety.

Quality and Compliance Regulations

One of the most important components of the FDA’s regulations related to medical devices is the quality and compliance component. This section addresses the quality assurance steps vendors are required to follow. Part of this effort is the collection and analysis of data reflecting safety, adverse events and other details.

While the FDA has always set forth minimum compliance standards related to the design and manufacturing of medical devices, the agency has also implemented a critical-to-quality approach that will delve deeper to identify the practices associated with positive outcomes, using this data to drive future regulations.

This initiative brings together the multiple disciplines involved with medical device manufacturing, use, or distribution, including healthcare providers, the industry at large, payors, patients, and investors in an atmosphere of data transparency.

Quality Design and Manufacturing Cuts Costs

There’s a clear benefit to manufacturers, as well. The FDA finds that device manufacturers using quality-based design and production methods realize a 20 to 30 percent reduction in quality-related expenses and a three to four percent increase in profits. That means that manufacturers that outsource components of design and manufacturing, such as membrane switch (user interface) design, can reduce costs and boost the bottom line by working with quality-focused providers such as Pannam.com.

The ultimate goal is to be able to identify manufacturers with clear quality standards and established and proven quality processes, allowing the FDA to reallocate its already-limited compliance resources to other manufacturers that require a bit more oversight.

Design and Manufacturing Comprise a Big Portion of Recalls

Related research finds that more than half of all medical device recalls are attributed to design and manufacturing flaws. This report names design and reliability engineering as one of the key opportunities for reducing these device defects, which would potentially correlate with better patient outcomes.

Likewise, going above and beyond current compliance regulations to implement more comprehensive postproduction quality assurance testing, quality metrics and measurement systems, and performance management programs that incentivize design engineers and similar roles for superior quality performance are all essential areas of opportunity.

Of course, one major deterrent of implementing these strategies is the cost factor, along with time to market and other competitive pressures. But as the costs of non-compliance and quality issues increase and more studies show that the added upfront costs of enhancing quality actually boost eventual profits, more device manufacturers will start taking quality control into their own hands and making wise investments into quality design and engineering.

Another influencing factor is the fact that the medical device industry itself is becoming increasingly complex, and devices are becoming more technologically advanced. That naturally lends itself to more potential concerns, only solidifying the notion that device manufacturers must opt for the most skilled design and engineering firms – and those that have experience designing customized, highly complex user interfaces for the medical field.

Eventually, continued efforts by the FDA to improve transparency and collaborate with the device industry to improve quality, combined with advancements in medical device technology and capabilities, will lead to a reduction in device recalls and an increase in lives saved.