SAFE AND RESPONSIBLE PRODUCT DEVELOPMENT

KEY POINTS

• At Medtronic, safety is our first and foremost priority. Our business model is based on partnering with physicians, scientists, and patients to develop products that result in better health outcomes and enhance quality of life.
• The process of medical device development, testing, and evaluation for safety and effectiveness is a highly developed scientific field. As a leading company developing new technology that extends patients’ lives, improves their health, and alleviates their pain, Medtronic has deep expertise in the testing and evaluation of new technology.
• Before coming to market, our products are subject to extensive testing, evaluation, and clearance or approval by FDA and other regulatory agencies. As of the end of July 2018, we have 317 active Medtronic-sponsored clinical studies.
• Medtronic supports research and education, and those efforts are intended to ensure that accurate information about our products based on sound science and the information is available to healthcare providers and patients, so that they can make educated, independent treatment decisions.

Overview

1. Safety Is Our First and Foremost Priority
   
   

   Safety is our first and foremost priority. Our business model is based on partnering with physicians, scientists, and patients to develop products that result in better health outcomes and enhance quality of life. In 2017, Medtronic invested $2.25 billion in developing and testing new devices and therapies, and that number is expected to grow in 2018.

   While we want to bring new, potentially life-saving therapies to patients as soon as possible, Medtronic does not bring a device or therapy to market unless and until we have confirmed that the product is safe and effective in treating the medical condition at issue. Before coming to market, our products are subject to extensive testing, evaluation, and clearance or approval by FDA and other regulatory agencies. Medical experts at FDA and other regulators examine the results of these studies, as well as other data, before clearing or approving our products.

2. Deep Expertise, Thorough Research, and Collaboration with Regulators
   
   

   The process of medical device development, testing, and evaluation for safety and effectiveness is a highly developed scientific field. As a leading company developing new technology that extends patients’ lives, improves their health, and alleviates their pain, Medtronic has deep expertise in the testing and evaluation of new technology.

   Our work in this area is overseen by leading regulators such as the FDA and its counterparts in other countries around the world. These agencies also employ thousands of leading scientists, and they draw upon the expertise of independent scientific and medical experts. These officials review our risk analyses, our test plans and study designs, and they evaluate the results of our analyses. They oversee our work to monitor products that have been approved and are in the market, and they audit our facilities and management processes.

   Each new technology, or each update or improvement to an existing technology, requires an evaluation plan based on that specific product, and what is new or changed and what risks may be incurred in its use. Regulatory agencies oversee, guide, and audit our decisions in all of these areas. Getting these processes right and ensuring the safety and effectiveness of our products is the core of our business.

3. Medtronic’s Commitment to Safe and Responsible Product Development
   
   

   Before coming to market, our products are subject to extensive testing, evaluation, and clearance or approval by FDA and other regulatory agencies. As of July 2018, we have 317 active Medtronic-sponsored clinical studies. These include concept, feasibility, verification, and biocompatibility studies, as well as clinical trials. Medical experts at the FDA and other regulators examine the results of these studies, as well as other data, before clearing or approving our products for use by doctors and patients.

4. Medtronic Supports Accurate, Scientifically Sound Research
   
   

   Patients are our focus. Medtronic supports research and education, and those efforts are intended to ensure that accurate information about our products based on sound science and the information is available to healthcare providers and patients, so that they can make educated, independent treatment decisions. We have firm compliance controls managing the payment of grants and donations to ensure clinical independence, fair market value, and integrity in any research the company supports. In accordance with our Global Business Conduct Standards,¹ Medtronic compensates experts and consultant for their time and expenses, not for providing specific opinions or medical recommendations.

See also:

• Continued Safety Monitoring and Adverse Event Reporting
• Responsible Promotion and Compliance
• Medical Device Labeling
• Medical Device Regulations