United States medical device QA/RA blog

News and commentary on regulatory changes.

A Blueprint for Optimizing Supply Chain Control within the Medical Device Industry

One of the most significant growth challenges facing medical device manufacturers is improving supply chain control.

This struggle spans across QA/RA, production and product development teams. For operations, today’s volatile demand chain is forcing medical device and other life science companies to gain additional visibility into supplier qualification, selection and communication. This visibility would enable companies to quickly react to any number of unanticipated activities that could disrupt the demand chain.

For the supplier quality team, the US Food and Drug Administration has increased its inspection focus on purchasing controls. And worldwide, many global regulators require companies to control supply chain procurement, surveillance, manufacturing and product distribution. Beyond the regulatory challenges are other factors that are making the supply chain more complex, such as supplier diversity.

Increased global regulatory vigilance

The impetus pressing the life science industry can be viewed particularly through the medical device segment. The US FDA and global regulators are focused on device manufacturers’ control of their supply chains. From 2010 to 2014, the FDA has increased the number of Form 483 warning letters issued to medical device registrants for deficiencies against CFR 820.50.

The 820.50 regulation states that “each manufacture shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.”

The intent of Sec. 820.50 is to ensure that device manufacturers select only those suppliers, contractors, and consultants who have the capability to provide quality product and services. FDA’s ongoing mantra with finished devices has always been that quality cannot be inspected or tested into products or services.

In the past five years, the number of Form 483s citing 820.50 has increased 25%.  With this increase, the number of 483s issued relative to the overall supply chain represents approximately 13% of the total 483s issued in this five-year period.

FDA officials have in recent years identified key supplier issues and emphasized the need for companies to identify those processes necessary to manufacture supplied parts, such as:

  • Ensuring suppliers have performed  adequate and appropriate validation studies;
  • Inspecting Critical to Quality (CTQ) attributes—manufacturers shouldn’t assume that all specifications are tested or inspected by their suppliers.
  • Implementing methods for documenting oversight, such as balanced scorecards.

This third point requires a significant amount of vigilance from the manufacturer, as a balanced supplier scorecard demands a commitment to collect consistent and reliable data on all critical suppliers. With the proliferation of regulatory requirements specifically relating to supply chains and the increasing globalization of supply chains, medical device companies need reliable real-time data, not results from self-assessments conducted months earlier.

Increased supply chain complexity

Beyond the regulatory aspects, the medical device manufacturing supply chain has another layer of complexity from just the sheer volume of product SKUs, various long and short lifecycles, security issues, sustainability issues, and related challenges.

A blueprint to optimize supplier controls

Addressing regulatory and production-related complexities has become increasingly difficult.  Medical device companies must seek proven processes to control their supply chains, while also focusing on the costs, speed and quality of their operations. A focused effort is required to transform traditional supplier relationships into a more unified supplier network, in which evaluations, qualifications, communications, and continuous improvement are managed within a single platform.

Joseph Madden is Director of Innovation and Strategic Accounts at UL.

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