Quality

Quality is a key driver of success for Medtronic and the patients who benefit from our therapies. Impacting everything from patient safety to customer satisfaction, quality was the catalyst for organizational action over the past two years, including the appointment of a Senior Vice President of Quality and Operations and global Quality Fundamentals training and certification for all employees.

Medtronic has a broad range of programs to ensure product quality and safety from design to end of life, with management systems that address regulatory compliance, global complaint handling, supplier quality, product performance, corrective and preventive action (CAPA), and customer satisfaction.

Regulatory Compliance

Medtronic products are heavily regulated by governmental agencies, health ministries, and other regulatory authorities worldwide. Our Regulatory Affairs, Clinical, R&D, Operations, and Quality councils oversee company-wide compliance with worldwide regulations, including design controls, clinical studies, marketing approvals, quality systems requirements standards, labeling and advertising, and product promotions.

All Medtronic manufacturing facilities worldwide comply with U.S. Food and Drug Administration quality system regulations and are certified to ISO 13485, a standard that provides a basis for quality management systems that satisfy international medical device regulations.

Medtronic’s Regulatory Council initiatives for fiscal year 2010 included implementing enterprise-wide compliance to the revised European Union Medical Device Directives; identifying opportunities for operating leverage across Medtronic businesses; analyzing regulatory metrics; and championing quality initiatives, such as Design for Reliability and Manufacturability (DRM), Supplier Management and CAPA, within Medtronic’s Regulatory function.

Global Complaint Handling

Ensuring patient safety is critical to achieving our Mission of alleviating pain, restoring health and extending life. In fiscal year 2010, Medtronic continued deployment of a Global Complaint Handling system designed to improve product complaint processing and associated regulatory reporting. The single support system provides a global data repository for the capture, reporting, and trending of product-related information. This will significantly improve complaint handling and communication between businesses and geographies.

Supplier Quality Management

To deliver competitive advantage through supplier management, Medtronic introduced a Supplier Controls Policy in fiscal year 2009 with full implementation to be completed by January 2011. All Medtronic businesses are required to adhere to the policy, which addresses risk management, evaluation and selection, performance and monitoring, development, certification, and CAPA.

Key fiscal year 2010 supplier management initiatives included:

• establishing process controls with critical-to-quality suppliers;
• consolidating the supplier base, focusing Medtronic’s supplier management and development resources on a smaller number of suppliers thus reducing risk in the supply chain;
• addressing supplier continuity through risk assessments of critical suppliers;
• increasing the number of suppliers with development programs that incorporate quality, lead time, and cost improvement;
• increasing the number of suppliers engaged in Design for Reliability and Manufacturability; and
• achieving materials cost improvement in support of Medtronic’s corporate-wide cost-of-goods-sold initiative.

Product Performance

For nearly three decades, Medtronic has issued Product Performance Reports on our Cardiac Rhythm Disease Management (CRDM) products. These provide important patient management information to physicians, such as device survival estimates, physician advisory summaries, performance notes, and malfunction listings.

In 2003, our Neuromodulation business voluntarily created an Implantable Systems Performance Registry (ISPR) to monitor the performance of infusion and spinal cord stimulation systems. The ISPR allows for active surveillance of products through online data collection. The information is used to guide future product development aimed at improving product reliability and quality.

Because post-market surveillance is key to meeting the growing need among physicians, regulators and payors for critical product data, Medtronic is developing and implementing a global post-market surveillance strategy that will expand post-market studies and the tracking and reporting of product performance and clinical outcomes across all Medtronic products and therapies.

Corrective and Preventive Action (CAPA)

Medtronic takes corrective and preventive action (CAPA) whenever potential product or therapy quality issues are identified. A concept promoted by the U.S. Food and Drug Administration’s Good Manufacturing Practice regulations, CAPA focuses on the systematic investigation of adverse events in an attempt to prevent their recurrence.

In fiscal year 2010, we completed installation of a global CAPA IT tool to drive consistency and standards across Medtronic and established CAPA metrics, cycle times, escalation procedures and governance processes.

Customer Satisfaction

Customer satisfaction measurement was a key objective during fiscal year 2010, as Medtronic began developing corporate level tracking in addition to the customer satisfaction tracking already conducted at the business unit level.

Medtronic has many customers, including physicians, payors, hospitals and patients. We are currently creating an enterprise-wide standard for measuring customer satisfaction. In addition, we are conducting performance surveys with each of these audiences to establish a benchmark for tracking our year-over-year performance moving forward.