The medical device industry is a highly competitive arena, and earning market recognition depends on the ability to keep innovating. To remain competitive, medical device companies are pushing products out the door to be the first to market while working on the next best thing.

Fig. 1 – Product life cycle. (Credit:

Advancements in technology are disrupting the medical device industry through the introduction of a new breed of devices such as mobile apps that inform, diagnose or treat users by providing a platform to monitor everything from sleep patterns to heart rates, from the comfort of their own home.

The industry’s shorter product lifecycle and advancements in mobility have raised a few eyebrows among regulators. Regulators realize the complexities of life-saving devices being implanted in patients and the rise of consumer- facing applications, and are enforcing stricter guidelines to ensure patient safety. The level of scrutiny applied to the pharmaceutical industry is now relevant to medical device manufacturers.

Once overlooked by regulators, the medical device industry is broken into three classes with Class III being the most complex and most regulated. Based on classification, devices must meet premarket approval to ensure safety and effectiveness. Manufacturers are under more pressure than ever to provide government authorities with the minimum required data needed to remain compliant, while at the same time streamline business operations and face current industry challenges such as the 2.3% Medical Device Excise Tax and Unique Device Identifier initiative.

Medical device products and supply chains tend to have unique challenges in establishing quality practices or systems across multiple cross-functional departments or facilities to minimize risks. This is as a result of discrete manufacturing operations that involve complex operations such as kitting, sterilization, and decontamination or where each process is done by separate facilities located all over the world. Often times, it was far into the manufacturing or distribution supply chain before manufacturers discovered or were notified of discrepancies. (See Figure 1)

Changing Business Models

Internationally, the maturity level or harmonization of regulations is still very much a work in progress. The industry is shifting gears towards risk-based approaches focused more on highrisk devices and forcing global manufacturers to drastically change current business models that will shorten product development times, reduce delays in product approvals by regulators, and foster product innovation.

Current business models that include manual and/or “siloed” processes to monitor medical devices throughout pre- and post-manufacturing stages contribute to increasing the prevalence of recalls and significantly complicate the recovery of recalled products from consumers.

Fig. 2 – An EQMS allows manufacturers and regulators to increase efficiency while reducing cost and effort.

The product lifecycle from prototype to final finished product can be a few weeks to a few years depending if the product is a predicate device. Compared to the pharmaceutical drug lifecycle, which could span upwards of 12 years due to extensive clinical studies, medical devices are rapidly infiltrating the market and need to be tracked for as long as the product remains in commercial distribution.

This obligates suppliers to adhere to post-manufacturing compliance requirements that are several years past a device’s commercial distribution date and highlights the need more for vigilant quality systems that ensure Good Engineering Practices (GEPs) were translated into production of devices that all actual and potential safety risks were mitigated in the device design, and that the device is appropriately designed for use as intended.

To fully comply, produce a quality product, and still maintain a competitive market share, companies need to realign or globally harmonize existing business and quality processes as a result of completely new or ambiguous regulations that were not in place when they started innovating new products and are now imposed on them. While industry struggles with meeting high standards of compliance for highly innovative products, regulators are developing and determining the right level of compliance requirements to regulate them.

With pressure to improve clinical engineering studies and product designs, medical device companies may look for cheaper suppliers that operate with lower quality standards. The globalized supply chain is forcing the FDA to scrutinize quality processes and demand insight into clinical and design engineering data in the early stages of product development.

A Proactive Approach

The FDA’s emphasis on reporting requirements and the complexity of products in use are contributing to the increased recall rate. Medical device manufacturers must have proactive quality assurance and quality management processes in place to prevent recalls from happening at all.

Strong quality assurance processes and quality management oversight allow a company to manage operational issues and enhance product portfolio planning by making sure it has the infrastructure to support the compliant and competitive landscape. Having the proper procedures outlined and a proactive quality culture will foster innovation while reducing any nonconformance components that aren’t being met. Quality assurance systems, when automated, can significantly enhance communication and reporting of data across the organization and to regulators in a more timely and accurate manner.

In addition at the manufacturing “shop-floor” level, quality control processes will help medical device manufacturers create checkpoints to ensure production is managed appropriately. By identifying and controlling the critical control points in these processes, medical device companies can track and manage all the elements and requirements needed for safe and effective products to consumers.

Medical device companies, along with regulators, are relying more and more on technology to meet vigilant industry and compliance requirements while increasing response time to address issues that may occur in all critical supply chain operations.

Now that medical device companies are forced to meet the same level of compliance standards as the pharmaceutical industry for high risk devices (Class II or III), manufacturers will need equivalent solutions to handle nonconformances and product deviations to determine root cause and mitigate any potential risk before the product is out the door. Implementing an enterprise quality management system (EQMS) will give companies the system needed to adhere to regulatory demands and timely oversight to all critical operations throughout the product lifecycle, whether it spans 12 days or 12 years. (See Figure 2)

An EQMS gives medical device companies an automated configurable solution needed to foster open communication and visibility across complex business supply chains that minimize and eliminate gaps to ensure safe and effective products make it to market.

Medical device companies are realizing the greater business value in being compliant and are making efforts to invest in quality across the industry. An EQMS provides a centralized gateway to track and manage all phases of the product lifecycle to give companies streamlined access and transparency of data needed to make safety-related improvements and, ultimately, quality products.

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