Overview

Today’s medical device manufacturing landscape is a complex global ecosystem consisting of original equipment manufacturers, strategic partners, and multiple tiers of small and medium sized enterprises. The “good” here is that method allows manufacturers to work with the cream of the supplier crop, no matter their location. However, on-the-go resources and geographically dispersed functions mean quality is less likely to be managed internally by just one organization, which can sometimes turn ugly. With many partners and suppliers providing multiple or inconsistent sources of information, it’s easy for confusion and a lack of unity to creep throughout a supply chain—potentially resulting in severe quality defects that could impact patient safety. What’s worse is that these defects are often only found once a faulty device makes it into the market and has been implanted into patients – this, understandably, can be extremely bad.

The Bad and the Ugly of Supplier Management

While using suppliers around the world may be essential in reducing the cost of a finished medical device, this practice adds new opportunities for risk: Do you know how many suppliers are making the materials that get shipped and turned into various components by other suppliers? Do you know where these suppliers are based? How many people touch some part of the finished device? Do they uphold and promote certain ethical standards?

Within a complex supply chain where contract manufacturers have their own suppliers (who have their own sub-tier suppliers, and so on) there is always the chance that one “trusted partner” may be looking to cut corners in order to provide a component at the lowest cost for the highest profit. This not only poses a threat to patients by increasing the chance of a device defect, but also the reputation of the original equipment manufacturer (OEM) and its additional partners.

Another way manufacturers and suppliers often look to reduce costs is by rationalizing Information Technology spending. This practice often leads to users struggling with ineffective processes, disparate systems and increased regulatory compliance risks. Rather than settle for a subpar system, organizations should learn how investing in an enterprise quality management software (EQMS) system can save money overall while increasing compliance and ensuring quality is upheld throughout a medical device’s entire lifecycle.

Leveraging EQMS to Ensure Quality

In a rapidly growing and highly competitive landscape, medical device manufacturers face countless unique industry challenges, including shorter product lifecycles, increased legal and regulatory scrutiny, and the need to manage strategic partnerships across the supply chain. The ever-evolving global regulatory landscape is driven by a greater focus on safety and traceability. As regulatory scrutiny increases, a well-implemented supplier evaluation process helps manufacturers produce, manage, and track goods effectively in order to deliver safe, reliable, and high-quality medical devices to the end user. A holistic EQMS system enables companies to obtain a global view of all quality issues and supplier information.

An EQMS offers insight into quality processes and work flows, streamlines supplier audits, helps manage design changes and can even trigger warnings early on in the manufacturing process should something seem wrong. By leveraging an EQMS to tie various internal departments and suppliers together, OEMs can achieve greater traceability and accountability. An EQMS can also help log and analyze data through predictive analytics and leading indicators, turning issues or mistakes into valuable lessons learned.

Supplier Quality Warning Signs

Having structured, automated workflows and quality processes throughout your supply chain can help ensure that medical devices meet not only written, but internal, quality standards. This is especially important in today’s increasingly regulated global business landscape. With new regulations being imposed by government bodies frequently, medical device manufacturers are under extreme pressure to ensure quality is maintained.

Mistakes unfortunately do happen. Should it become apparent that quality standards are not being met, either internally or by a supplier, a corrective and preventative action (CAPA) or a supplier correction action request (SCAR) should be established and addressed. Being aware of the common warning signs that may trigger the need for remediation helps ensure issues are addressed quickly. The warning signs include:

  1. Non-conforming materials. For example, should an audit reveal that a supplier is using a conflict mineral (tungsten, tin, tantalum and/or gold mined from war-torn areas such as the Democratic Republic of Congo) to produce a specific device component, that supplier – and, in turn, the OEM – is not in compliance with the Dodd-Frank Act.
  2. Changes that have not been approved. Change control is crucial for all manufacturers, but doubly so for makers of medical devices. Should a supplier decide it’s more cost effective to use latex instead of neoprene, a supplement to the medical devices UDI must be filed.
  3. Changes that have been made without informing pertinent members/departments of a supply chain. A lack of transparency between internal departments and external suppliers means a lack of control over quality, which increases the chance of an uncaught error and potential recall.
  4. Incomplete incoming materials. There are some instances where incomplete materials — such as integrated chips without heat-sink mounting — can pose an issue to the final medical device.
  5. Excessive field failures as a result of a supplier component. Should some suppliers use an outdated assembly process or material, too many of the non-conforming products could make it to market, resulting in greater-than-forecasted field failures and product returns.

An EQMS helps streamline the warning sign/trigger process by developing a repeatable, compliant, and closed-loop CAPA and SCAR process that logs and manages quality issues originating from any source. Having same-system access with all of your suppliers helps for the quicker assignment and completion of CAPAs and SCARs, ensuring quality is maintained without slowing down the manufacturing process.

Prevent – Don’t React – To Quality Issues

From 2007 to 2012, the total number or FDA warning letters increased by 104 percent. Specifically for the medical device industry, FDA-issued warning letters nearly doubled from 2007 to 2012:

Rather than waiting for a warning letter from the FDA – or worse, a device recall – medical device manufacturers should take a proactive approach to preventing, rather than reacting to quality issues. If a medical device company is spending too much time and resources on corrective actions, this is a leading indicator that they are in reactionary mode instead of taking preventative measures to invest in the proper resources, tools and processes necessary to maintain quality.

An EQMS can be used to help prevent said issues; for example—streamlining employee training programs. The automated tracking and management of employee training helps ensure relevant activities are scheduled and tracked through to completion. An EQMS provides a seamless environment to ensure compliance with government and industry regulations while maintaining a standard of excellence in controlling the training initiative. Centralized, comprehensive training records that are managed via an EQMS provide proof of compliance and maintain an accurate reflection of training needs.

While we have seen a slight trend in final assembly re-shoring recently, we shouldn’t expect global supply chains to shut down over night. There are many advantages to working with contracted partners and suppliers around the world, including decreased costs and the ability to join forces with the best and the brightest our planet has to offer. By adopting an EQMS to help streamline and manage various initiatives, medical device manufacturers help ensure quality is backed and managed throughout a medical devices’ entire lifecycle, no matter which site the devices were manufactured – that’s not just good, it’s great.