MEDTRONIC MISSION STATEMENT
It guides our day-to-day work and reminds us that our efforts are transforming the lives of millions of people each year.
OUR MISSION
Our Response To Recent Media Coverage
Medtronic is proud of our long history and tradition of providing high-quality, innovative healthcare products and services. For nearly 70 years, Medtronic has been working to improve the lives of patients around the world. Along the way, we have been consistently recognized as one of the most admired and reputable companies in the world. Our reputation is the result of our commitment to patient safety, transparency, compliance, and ethical business practices.
Safety is our first and foremost priority, and we adhere to the highest medical, scientific, regulatory and legal standards. We regularly hear from patients and their physicians, recounting how our innovative therapies have dramatically improved health and saved lives. In an overwhelming majority of instances, our products perform exactly as intended, and the overwhelming majority of our 86,000 employees serve our customers every day with care, honesty, and integrity. When we communicate about our therapies and offerings, we strive for utmost accuracy, context and safety because we know that people will make life-impacting decisions based on those communications.
As a global healthcare company, we stand behind our products and embrace our responsibility as a leader in innovative, responsible and ethical development of life-saving medical technologies. Every day, we strive to meet and exceed our high standards of excellence in pursuit of our mission to alleviate pain, restore health and extend life.
ICIJ RELATED MEDIA STATEMENTS
Medtronic Statement Dated November 30, 2018
MEDTRONIC STATEMENT ON MEDIA COVERAGE CONCERNING THE COMPANY’S BUSINESS CONDUCT
Medtronic is aware of recent media coverage, advanced principally by the International Consortium of Investigative Journalists (ICIJ) and ICIJ-affiliated journalists, that calls into question the company’s ethics and business practices. The articles point to people and events that are associated with unethical conduct and then attempt to assert the entire company is, in and of itself, unethical.
Medtronic strongly rejects this assertion. Medtronic has more than 86,000 employees worldwide and many thousands of independent distributors, partners, contractors and suppliers that engage with or represent the company in an ethical manner every day. The company has instituted a variety of global compliance and ethics programs to ensure these employees and affiliated partners operate with the utmost integrity – in full compliance with Tenet 3 of the Medtronic Mission which states that we strive to be “recognized as a company of dedication, honesty, integrity and service.”
Statement Briefs
- Ethical Collaboration with Experts
- Quality Assurance Commitment: EU Medical Device Regulation
- Quality Assurance Commitment: Measures to Manage a Range of Recall Types
- Quality Assurance Commitment: Medical Device Regulations
- Responsible Marketing and Promotion
- Improving Delivery of Healthcare for Better Outcomes
- An Ongoing Commitment to Safety: Continued Safety Monitoring and Adverse Event Reporting
- An Ongoing Commitment to Safety: Safe and Responsible Product Development
- An Ongoing Commitment to Safety: Preemption
- Improving the Patient Experience: Integrated Health Solutions (IHS)
- Advancing Health Policy
- Informed Clinical Decisions
- Medical Device Field Personnel in Clinical Settings
- Evolving Products to Advance Patient Safety: CoreValveTM and EvolutTM TAVR Systems
- Evolving Products to Advance Patient Safety: Infuse® Bone Graft
- Evolving Products to Advance Patient Safety: HeartWare™ HVAD™ System
- Evolving Products to Advance Patient Safety: Insulin Pumps
- Evolving Products to Advance Patient Safety: Spinal Cord Stimulators
- Evolving Products to Advance Patient Safety: Sprint Fidelis™
- Evolving Products to Advance Patient Safety: Surgical Mesh Hernia
- Evolving Products to Advance Patient Safety: SynchromedTM II
FAQs REGARDING RECENT MEDIA COVERAGE
Q: It has been alleged that Medtronic’s business model is to develop a product and get it to market as quickly as possible. Do you dispute this characterization?
A: That is not accurate. At Medtronic, safety is our first and foremost priority and we reject any suggestion that Medtronic puts “innovation and profits” over safety. While we want to bring new, potentially life-saving therapies to patients as soon as possible, Medtronic will not offer a device or therapy to patients unless and until we have confirmed that the safety and efficacy profile is favorable in the context of the medical condition at issue and that we meet all of the appropriate regulatory requirements applicable in that market.
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. For this reason, Medtronic employs 86,000 employees, including scientists, clinical research personnel, and regulatory and quality experts, and, during the past ten years, Medtronic has spent more than $10 billion on research and development.
Q: What does Medtronic do to ensure that its products are safe and effective before bringing them to market?
A: Medtronic has a large team of dedicated professionals – including physicians, scientists and engineers – whose first and foremost priority is to ensure that all our medical devices and therapies meet the highest safety, efficacy, and performance standards. During development, our products are rigorously tested to ensure that they are safe. Because our devices and therapies are complex and innovative, before coming to market, we often seek advice from outside experts and regulators, including the FDA.
Our products are also 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. 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. Last year alone, Medtronic invested $2.25 billion developing and testing new devices and therapies, and that number is expected to grow in 2018. In addition to pre-market clinical testing, Medtronic is an industry leader in post-market study and surveillance, during which we monitor, track, report on, and communicate with our regulators regarding safety and efficacy signals that emerge from “real world” experience with many of our products after they have been cleared and are being used by physicians and patients around the globe.