Chance-takers are accident-makers

March 11, 2010 by Tim Mohn

Improving medical device safety from pre-review to post-market.

It pays to remember an old adage: "Better to be safe than sorry." Indeed, many medical device manufacturers are re-evaluating their quality systems as a result of the Food & Drug Administration's recent review of pre-market notifications and a FY 2011 budget request for additional funds to address product safety. Device makers should heed this advice and take the necessary steps to pro-actively — rather than reactively — address compliance issues.

Long before a product recall has an impact on a brand and its profitability, manufacturers need to closely evaluate their compliance processes and systems. This can have a significant impact on a firm's ability to get products to the market more quickly — and in accordance with current and future regulations. For example, few medical device manufacturers have automated the process of adverse event report submission to the FDA in response to the eMDR mandate, a requirement that will likely become law later in 2010. By anticipating upcoming regulations such as this and creating effective monitoring during every step of the manufacturing process, device manufacturers can create a real competitive advantage.

Striving to maintain an effective quality management system is a constant challenge in this evolving industry and one that I've seen repeatedly for medical device companies — both in my current post as industry principal at Sparta Systems and during my time as manager of worldwide quality systems at a major device manufacturer. Implementing enterprise-wide quality and compliance can seem like a daunting task for businesses, but the rewards justify the effort. Companies should leverage these top five best practices when preparing to improve business and meet compliance requirements:

Supplier quality management: Track and manage global suppliers, monitoring which suppliers consistently offer the highest quality materials, and prioritizing relationships accordingly.

Electronic medical device reporting (eMDR): Automate and streamline report submission processes, ensuring efficiency and accuracy of submitted reports and creating a single system-wide standard to achieve compliance with reporting regulations. (Companies with multiple divisions should strive to aggregate data into one system in order to systemically review adverse events across the enterprise — even if the divisions operate under separate quality systems.)

Change management: Enforce rigorous change control procedures across the enterprise that can track requests, approvals, preauthorization and implementation, then accurately assess quality-related impacts across the organization – including design changes.

Complaint handling: Integrate a global point of record for tracking and trending of adverse events and notifying authorities of customer complaints that is seamlessly integrated to the CAPA process.

Corrective and preventative action (CAPA) management: Establish processes that can trace non-conformities to their root cause, address deviations quickly, and enforce measures to prevent future product safety issues

If recent headlines are any indication, the medical device industry will see increasing scrutiny in 2010 and beyond. How companies prepare for the coming changes will have considerable impact on ensuring that their businesses can continue to succeed and innovate regardless of current and future regulatory pressures.

Tim Mohn