International drug and device supply chain monitoring is top of mind for Supplier Quality Personnel around the globe, with the FDA’s recent announcement to tighten the international drug and device supply chain. To gain insight, executives from FDA-regulated enterprises around the globe gathered in Bethesda, Maryland from July 31 to August 2 at the fourth annual Supplier Quality Management Congress.
Top regulators, policymakers, industry experts, lawyers and consultants presented at this intensive learning conference in supply chain management and monitoring. To kick-off the conference, Dan O’Leary, President of Ombu Enterprises, and John Avellanet, Consultant at Cerulean Associates, conducted a compelling workshop on cost effective implementation in extended supply chains and major issues in risk management. To reduce risk from components and services as well as risk in the supply chain, they demonstrated how to organize and execute a three step Supplier Control Plan, which included implementing a supplier questionnaire, and regular on site and remote audits.
With the new FDA focus on supply chains, maintaining strong supplier oversight and purchasing controls is not only important for regulatory compliance but also for liability risk management. Sarah Dyson, Assistant Vice President at Medmarc Insurance group, presented eye-opening case studies, legal claims and monetary awards, and explained the “Supply Chain Gang,” demonstrating that all members in the supply chain have legal responsibility when a product causes injury.
Other keynote speakers included Camstar’s Jason Spiegler, who spoke on the importance of “real-time” monitoring using state-of-the-art technology to monitor and collaborate with globally dispersed sites, suppliers, and contract manufacturers to improve product quality and reliability. The presentation provided a unique opportunity to benchmark the electronics industry with Fred Malcom of Siemens Enterasys, a Camstar customer whose company has realized the significant impact of leveraging technology for supply chain management and monitoring. For example, Siemens Enterasys saw a 41% reduction in 1st year return rate in their highest volume product line. As the FDA looks ahead to expand its efforts for global product safety and quality, it will be important to embrace technology to reduce risk and drive profitability with timely issue detection.
At the conference end, FDA-regulated enterprises left with a sense of urgency and helpful “next steps” to reduce regulatory and liability risk, align with the new compliances, and embrace technology designed to support overall processes. With the new FDA effort to tighten the international supply chain, it is time to get serious about supply chain and quality monitoring processes. Now that’s not a risky endeavor!
Websites to link to:
The Gartner Top 25 Supply Chain for
FDA Pathway to Global Product Safety and Quality
Statistics related to the FDA and international supply chain (from the FDA Global Product Safety & Quality article):
- “We live in a nation that increasingly relies on other countries to produce food, drugs, cosmetics, and devices we use in our daily lives… Half (50%) of all medical devices used in this country are imported”
- These days, a typical manufacturing company relies on more than 35 different contract manufacturers around the world. Auto and airplane manufacturers rely on tens of thousands
- Today, nearly 25 cents of every dollar spent by Americans are on products regulated by the FDA
- FDA-regulated products account for about 10% of all important into the US, arriving from more than 300,000 facilities in 150 different countries.
- For medical devices, complex products, which were once primarily manufactured domestically, are increasingly being manufactured overseas and imported. As a consequence, it will become more difficult to distinguish the risk and complexity of a product based on where it is produced.
- it is estimated that imports of FDA-regulated products will triple, corresponding to a 15% growth rate.