Despite the increasing use of new medical technologies, the state of quality and regulatory compliance remains troubling to some.

The Food and Drug Administration (FDA) monitors the safety of marketed devices (not to mention drugs) by receiving spontaneous reports from physicians and patients or through follow-on clinical trials of products that have entered the market. Hospitals track information on medical devices by placing stickers with the product information in paper medical charts. For some devices, hospitals keep an electronic registry and send the information to the manufacturer, wrote Dr. Kevin A. Schulman, a professor of medicine and business administration at Duke University, in a recent Baltimore Sun op-ed (article link no longer available).

FDA regulatory compliance, of course, is a mission-critical requirement for medical device manufacturers. If the administration finds a manufacturer to be noncompliant to, or in violation of, FDA rules, the consequences can be severe with not only warning letters, but also mandatory product recalls, temporary shutdowns, criminal penalties and fines depending on the severity of the violation. These penalties imposed by FDA could seriously dent the manufacturer's brand image and at times could even cripple the manufacturer financially.

Yet in a survey conducted by Compliance-Alliance in July 2006, 21 percent of the 258 responding medical device firms said they would characterize their firm's quality, regulatory and compliance function as mediocre. Another three percent characterized it as weak.

This is a little bit troubling. After all, these companies are making products intended to diagnose, improve quality of life and even save lives of people all around the world. Yet nearly a quarter of the officials participating in the survey described their compliance function as mediocre or weak?

So, then, whose responsibility is it?

Regardless of a firm's size, top management creates the mission, quality policy and quality objectives. From there, management designs the quality system architecture by assigning groups of people to carry out specific activities in support of the firm's strategic quality and compliance objectives.

In the past, the accepted practice was for companies to make quality and regulatory compliance the primary responsibility of a specific department or function. Today it has become increasingly clear that firms must be structured in such a way that management is fully engaged in a transparent and systems-based approach to compliance, Medical Device & Diagnostic Industry recently noted:

Management with executive responsibility needs to legitimize the regulatory affairs (RA), quality assurance (QA), and compliance functions. This means providing the infrastructure, resources and systems necessary to operate successfully. In addition, management must view, use and support these functions as strategic partners in the company's success.

For the systems-based approach to quality to be effective, management at all levels must be accountable for achieving business quality and compliance success. The system must include clearly defined roles, responsibilities, authorities and reporting relationships.

According to J. Glenn George, Kenneth Imler and Nancy Singer at Medical Device & Diagnostic Industry, we can summarize management responsibility by the following basics:

• Being knowledgeable about applicable regulations and requirements;
• Taking responsibility for compliance and holding the entire organization accountable;
• Establishing and monitoring effectiveness metrics;
• Prioritizing projects and issues based upon risk; and
• Allocating or reallocating resources.

Moreover, a successful approach involves the firm's management not only stating its commitment, but also demonstrating it by becoming fully engaged in a process of translating requirements. That includes translating the firm's own policies into practices.

Achieving business, compliance and quality success, however, is complex, and thus compliance and quality should be everyone's responsibility. Many firms fail to realize that quality and regulatory compliance is more than the job of a single individual or department.

Those responsible must be empowered. A majority (90 percent) of the responses to the Compliance-Alliance survey highlighted the need for the top quality and regulatory personnel to be able to stop production and even order a product recall. Top quality and regulatory personnel need the power to act on internal and external events that exhibit a failure to meet specified requirements.

Global compliance and quality management systems and processes are critical for manufacturers competing in the FDA-Regulated industries. Manufacturers face the dual pressures of stringent and increasing regulatory pressure, and the need to streamline internal operations and supply chain interactions to eliminate non-value-added costs.

The bottom line for many medical device firms is that the truth about the state of the quality system can be brutal: serious issues exist and substantial improvements are necessary.

Management must be willing to take a long, hard look at this sometimes-brutal truth, must accept it and take responsibility, and must make the necessary improvements.

People's lives may depend on it.

Additional

Medical Device Regulatory Update: The Asian Market

Consider the Basics when Developing Packaging

Resources

Empowering the Quality and Regulatory Compliance Functions
by J. Glenn George, Kenneth Imler and Nancy Singer
Medical Device & Diagnostic Industry, January 2007

Let's bring drug and medical device safety into the 21st century ...
by Dr. Kevin A. Schulman
The Baltimore Sun, Feb. 19, 2007

Survey Results on The Structure of Medical Device Firms' Quality/Regulatory/Compliance Functions
by Nancy Singer, Compliance-Alliance, USA
MediSourceAsia, July 2006