Regulatory Scrutiny

At a Medical Device Supply Chain Council meeting earlier this year, it became obvious from the speaker presentations that regulatory efforts for quality are increasing, and quite rapidly. The panel of presentations covered a range of issues, but each one touched on quality and the FDA.

Important to note was data from a presentation by Bernie Student and Linda Meloro, both consulting directors with PwC:

• FDA inspections related to devices increased 18% between 2009 and 2011
• Warning letters related to devices increased 86% between 2009 and 2011
• Regulatory scrutiny is expanding as the FDA pursues more robust inspection programs regarding globalized supply chains
• Other countries and regional regulatory bodies are also stepping up oversight of global supply chains.

Further addressed were recent FDA data showing the increased emphasis on supplier quality. Since 2012, 12% of the Center for Devices and Radiological Health (CDRH) warning letters issued to medical device companies have cited purchasing control issues.

Significant trends noted by participants in the PwC research showed that:

• Supply chains are becoming more complex with more globalization of the supply base and a greater willingness to outsource to contract manufacturers;
• Companies are investing in supplier management and supplier quality programs;
• Suppliers often lack the capabilities and systems required to meet the quality and regulatory requirements of the device industry;
• Prior to regulatory actions, supplier quality activities are often understaffed and lack clear reporting lines to quality; and
• While quality and compliance metrics are generally included in supplier scorecards, they often take a back seat to delivery performance and cost metrics.

Overall, medical device manufacturers need to be aware of the continual changes that are happening in the industry – and the regulatory changes that will affect them.

When approaching work in mature versus emerging markets, there may be a need to have a different quality approach for each. Although both markets may be underserved from a quality standpoint, it may be unrealistic to apply mature market oversight on emerging markets from a cost perspective.

Sometimes, achieving robust supplier and distribution quality can be a 3 to 5 year journey, so patience may be required.

Elizabeth Engler Modic can be reached at emodic@gie.net.

Source: www.FDA.gov