The Basics of Medical Device Risk ManagementThe Basics of Medical Device Risk Management

The bar for risk management has suddenly moved higher for medical device companies. After numerous product-safety-related recalls and field actions over the past few years, FDA has dramatically increased its scrutiny of the product risk management practices, demanding adherence to the current standard, ISO 14971:2007. With the agency now examining risks in terms of the worst possible outcome, practices that had been presumed acceptable are subject to heightened scrutiny. The rate at which FDA issues warning letters citing risk management deficiencies has more than doubled since 2007. Recent warning letters have highlighted inadequate links between risk management practices and corrective and preventive actions (CAPA) that have always been the focus of FDA inspections. This shift in risk management regulatory expectations makes it imperative for medical device companies to revamp their risk management practices.

The change on the regulatory front is only one reason for companies to reassess their practices. The use of risk management as a development tool to drive product quality often falls short of its potential. Much of the time, it is seen by development teams as a paper exercise to be completed right before launch. Poorly implemented risk management programs further fuel this misguided notion that the practice adds little value. To the contrary, a well-executed risk management program that includes product development and safety, process development, strategic planning, and project execution can serve as a powerful tool for a firm to innovate and grow.

When initiated early and employed frequently throughout the product life cycle, risk management can promote innovation, leading to a reduction in the number of customer complaints, lowered service and support costs, fewer disruptions from field actions, and improved execution against program expectations. Resources once spent on such non-value-added activities can instead be used to fuel growth and shareholder value.

To reap these benefits, the organization needs to apply risk management practices across the product life cycle. This means eliminating silos and aligning incentives between development and post-commercial organizations. For maximum impact, risk management practices must be data driven, with logical, consistent risk characterization that is well communicated across the organization.

Companies should ensure robustness in the following fundamental areas:

Given the current regulatory climate, there is no better time for companies to revamp their risk management programs—and to realize the potential business benefits.

Sharad Narayan is a PRTM manager in the healthcare business group. Jim Prutow is a PRTM director in the healthcare business group.