PRODUCT QUALITY CITIZENSHIP

SHARED ACCOUNTABILITY FOR PRODUCT QUALITY

Patients rely on Medtronic products to be safe and effective. That’s why we expect all employees to monitor product quality at each stage in our value chain — design, manufacturing, pre-clinical and clinical trials, and post-market surveillance. A patient-focused approach and an unwavering commitment to excellence underpin our global quality strategy. We manufacture safe, high-quality products not only to further our Mission, but also to build trust, reduce reputational risk, and improve operational efficiency.

Our “Quality Begins with Me” culture is reinforced by ongoing communications and training. As a result, employees commit to practicing our four fundamental expectations:

• Put the patient first
• Be courageous
• Strive to prevent issues before they arise
• Hold each other accountable

PRODUCT QUALITY HIGHLIGHTS FROM FISCAL YEAR 2018

Every single one of our employees, regardless of role, knows that quality is non-negotiable. In FY18, 95% of global employees completed our Annual Quality Training Certification.

Product quality, safety, and reliability are fundamental to our design and development process. To help ensure that quality is embedded in our manufacturing processes:

• We deployed our First-Time Quality (FTQ) methodology to 88% of our manufacturing sites.
• FTQ has helped individual manufacturing sites realise more than $200,000 in cost savings.

Our new product pipeline relies on clinical trials to test the effectiveness and safety of our innovations. We are rigorous in ensuring that our clinical trials are conducted to the highest standards required by international and national regulations, regardless of where the trial is conducted. This protects patient safety, safeguards patient data, and ensures accurate findings.

• We employ more than 1,700 clinical professionals who develop and standardise models to measure and improve patient safety and clinical outcomes.

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