Engineering Impact: Product Quality and Safety

Our business success and growth of our financial capital depend upon our ability to provide safe and effective products and services. By paying close attention to product quality, we build and maintain trust with our key stakeholders and uphold our reputation with patients and healthcare professionals.

The quality, safety, and reliability of our products are essential to the well-being of patients receiving our treatments and vital to delivering on our Mission. We never compromise on quality, and we monitor it throughout every stage of our value chain.

Our approach to patient safety and product quality

Quality throughout the life cycle

From design and manufacturing through product testing and post-market surveillance, we monitor compliance with our quality standards at every point in a product’s life cycle. 

Our risk management process — aligned to ISO 14971 — enables us to identify and escalate potential issues immediately. Our quality management systems are aligned to relevant regulations and international standards, including ISO 13485.

Safety

We take our responsibility to patients and caregivers seriously. Our robust quality management system ensures we maintain high-quality manufacturing practices and all new products adhere to rigorous internal and external regulatory standards for design, testing, and safety.

Our Medical Safety Council oversees and promotes a culture of safety across Medtronic. Internal medical safety clinicians evaluate actual and potential safety issues, harm, and health risks to patients or users of Medtronic products and therapies. Our new quality panels, comprised of independent external physicians and healthcare practitioners, provide expert, unbiased clinical input on patient safety.

Quality culture

Our “Quality Begins with Me” culture requires everyone at Medtronic to share responsibility for quality and uphold four key expectations:

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

Formal oversight of quality ultimately sits with our board and executive leadership. The board's quality committee oversees risks relating to product quality and safety, cybersecurity, and research. Our chief quality officer sits on the executive committee and reports directly to the CEO on all quality matters.

Our companywide assessment model enables a consistent measure of quality culture, helps us identify root causes, and tracks improvement. We reinforce this approach through regular employee communications and training. In FY21, 120,000 employees were assigned training on “Quality Begins with Me.”

Ensuring quality and value

Safeguarding quality is vital, especially as we develop more value-based healthcare (VBHC) models with partners around the world. Our quality team works with our businesses using our Quality Framework to ensure the design of VBHC partnerships minimizes compliance risk and delivers consistent processes, capabilities, and measures of success.

Product design and development

Design, reliability, manufacturability

Our design, reliability, manufacturability (DRM) methodology is a set of best practices that drive product quality, safety, and reliability. We embed DRM in every stage of the product design and development process through:

• Customized DRM training for project development teams
• Project assessments to assure consistent use across our project portfolio
• Annual assessments and improvement plans at product development locations
• Skills and capability development for key functions, such as Research and Development, Operations, Quality, and Marketing
• Progressive training and certification to improve companywide skills

Our DRM methodology includes best practices for all types of Medtronic medical devices, including standalone software products and those that include software. DRM sits at the heart of our predictive engineering process, which our engineers use to simulate product use, forecast performance, and pinpoint potential improvements. At the end of FY21, we assessed more than 64% of all new products in our pipeline using this approach.

In FY21, due to COVID-19, we delivered all DRM training virtually through a mix of prerecorded video lectures and virtual workshops.

Product security

We take the risk of cyberattacks on medical devices seriously and proactively work to identify and address vulnerabilities in our products.

Our Product Security Office manages our product security program and promotes rigorous product development, including vulnerability testing, updates, and remediation, as well as impact assessment for device functionality and patient safety. We engage internally and externally to monitor current practices and emerging risks — including with employees, regulators, peers, healthcare organizations, and security researchers.

Our Global Quality Management System integrates security requirements. Subject matter experts within each business are responsible for integrating security considerations throughout the product life cycle.

Transparent communication is vital to identify and address security measures effectively. In FY21, we publicly disclosed eight security vulnerabilities through our Coordinated Disclosure Process. These vulnerabilities included original bulletins, updates to previous bulletins, and security notices responding to third-party risks that were not applicable to Medtronic, but helped address customer inquiries.

We publicly recognize the work of independent security researchers who have demonstrated ethical behavior and followed coordinated disclosure processes to advance our product security. We encourage anyone with questions or concerns, or who believes they have identified a potential security vulnerability in one of our products or services, to contact us via Medtronic.com/security.

In FY21, we finalized our new product security strategy and roadmap, which includes a focus on pre- and post-market product security rigor and engagement in industry activities to help shape regulations, standards, technology, and practices. We participate in several industry bodies, including the Health Information Sharing and Analysis Center and the Medical Device Innovation Consortium. Many of our team members lead initiatives in these groups to help advance product security for the entire industry.

Also, in FY21, we:

• Conducted our seventh Product Security Symposium, online this year, with a focus on regulatory, clinical, and patient security matters
• Helped sponsor the Biohacking Village at the virtual DEFCON event, volunteering products, technology, and hours to ensure active engagement from attendees
• Developed product security overview training, which was viewed by over 22,000 employees in functions related to product security
• Collaborated with academia on several medical device security projects, helping to develop an industry pipeline of security professionals

Manufacturing quality

Our standardized manufacturing quality programs ensure a consistent approach across product manufacturing processes.

Our FTQ methodology achieves a 90% reduction of targeted high-business-impact risks and quality instabilities. Our FTQ strategy focuses on building engagement across the workforce, developing targeted skills, and increasing deployment of FTQ across the product life cycle. We use our SOAR process to prioritize work with higher-risk suppliers, where our investment can have the greatest impact. In FY21, we expanded the number of SOAR partnerships to more than 70 strategic suppliers, compared to 42 in FY20.

Facility quality and compliance

We assess quality management systems at our manufacturing, design, and distribution centers through Medtronic Corporate-wide Assessment for Regulatory Excellence (MCARE). Our MCARE assessments — undertaken remotely in FY21 — focus on maintaining consistently high-quality management levels and complying with evolving regulatory requirements.

External regulatory audits help keep us accountable, aware of regulatory priorities and focused on making necessary changes to policies and practices. We share learnings and actions from these assessments via our Knowledge Management process. In FY21, external audits were primarily conducted remotely.

In FY21, we received an average of 0.02 findings per regulatory inspection and 0.02 findings per U.S. Food and Drug Administration (FDA) inspection — continuing to demonstrate year-on-year improvements.

These figures were impacted by a reduction in FDA inspections during the COVID-19 pandemic and we expect them to increase in FY22. However, the overall number of inspections in FY21 remained consistent with previous years, as we still conducted notified body audits remotely and saw an increase in E.U. Medical Device Regulation audits.

Preclinical research

Preclinical research lets us examine how potential new treatments will function in practice, prior to evaluating them in clinical trials. Our biomedical research sometimes involves human cadaver and modeling work, animal-related research, and the use of animal-derived stem cells, but does not involve use of human embryonic stem cell lines.

Animal-related research

Animal research and testing is sometimes a regulatory requirement for the development of new medical products. We use animals in research activities only when no acceptable alternatives exist, as described in our Policy Regarding the Use of Animals. The policy applies to:

• Research that contributes significantly to patient welfare
• Work specifically mandated by regulatory agencies to ensure patient safety or effectiveness

Any animal-related research or testing is first externally approved by the Institutional Animal Care and Use Committee. We comply with the U.S. Animal Welfare Act and other relevant standards and requirements set by the National Academy of Sciences Guide for the Care and Use of Laboratory Animals.

We are committed to a respectful, humane approach and take the welfare of animals used in research seriously. Our work with scientists, veterinary surgeons, and other experts helps refine our methods, always aiming to alleviate or minimize harm and distress.

Alternatives to animal-related research

Where possible, we reduce the use of animals and replace animal-related research with other methods, including:

• Submitting research findings to inform the work of the International Organization for Standardization (ISO) on a standard for the testing of human skin cell-based irritation without the use of animals
• Investing in our Corporate Research Group’s fundamental modeling work to reduce the number of animals used in future research

Clinical trials

Following preclinical research, we advance the most promising innovations to clinical trials. Our Clinical Research and Medical Science functions collaborate on trials that are a vital step in establishing the safety and effectiveness of our products. More than 2,000 clinical research and medical science employees work to ensure robust, ethical practices in our studies. With a focus on both gender and racial and ethnic diversity, we are increasing the representation in our clinical trials around the world to ensure our products benefit everyone who needs them.

COVID-19 impact

In FY21, the COVID-19 pandemic continued to impact our clinical trials. We shifted to remote study monitoring in many cases, with nearly 95% of visits in the United States and approximately 40% in Europe, the Middle East, and Asia completed remotely. We also utilized direct-to-patient follow-up via telehealth solutions. This shift has been positively received by clinical sites and has improved efficiency by 20%, mainly because travel was avoided. There has been no difference in the level of monitoring report action items or internal audit observations compared to in-person monitoring. We expect to maintain a significant level of remote monitoring activities post-COVID-19.

Standards and regulations

Our internal Code of Conduct and Global Business Conduct Standards Policy guide our approach to clinical trials. We adhere to all relevant laws and regulations, including the E.U. Medical Device Regulation and the revised ISO 14155:2020 standard for clinical research.

Collaboration, engagement, and data sharing

Effective medical research depends upon transparent data sharing and collaboration. We share knowledge in several ways:

• Along with other companies operating in the United States, we disclose information on applicable trials to the U.S. Clinical Trials Registry — a database of more than 380,000 studies.
• We publish trial findings in peer-reviewed journals.
• We collaborate with research scientists, institutions, and physicians to advance our clinical trials practice.
• We contribute to the advancement of clinical standards by working with the Association for the Advancement of Medical Instrumentation, the Clinical Trials Transformation Initiative, and the Medical Device Innovation Consortium.

Product use and performance

Post-market surveillance

Once we launch a product, we monitor its use and performance to measure and improve safety and inform future designs. Through our post-approval clinical surveillance process, we collect patient outcome data in partnership with hospitals, physicians, clinics, governments, and third parties. We also gather data from:

• Post-market clinical studies on specific products and therapies
• Customer feedback analyzed via our global complaint handling system — now consolidated into a single companywide organization to improve our ability to detect product performance issues and resolve them quickly We develop standardized models to measure and improve patient safety and clinical outcomes. We regularly engage the U.S. FDA and other regulators to make sure we meet their post-market surveillance expectations.

Caring for patients

We work to improve the patient experience through many avenues, including how patients interact with our products and the outcomes they experience. For example:

• The PillCam™ is the only noninvasive diagnostic test that directly visualizes the colon for the evaluation of polyps in patients who are at major risks for colonoscopy or moderate sedation. This vitamin sized capsule endoscope is taken orally and does not require sedation, anesthesia or radiation, making it more convenient than other invasive colon exams.
• The TYRXTM Absorbable Antibacterial Envelope reduces the rate of significant infection by 40% and pocket infection by 61% in patients with cardiac implantable electronic devices, compared to standard-of-care preoperative antibiotics.

An important indicator of patient experience and product quality are complaint rates. We continuously strive to reduce complaints. For example, we achieved a greater than 40% reduction in customer reported complaint rate for our pacemaker/defibrillator devices and lead systems during a previous multi-year period. As we seek to enhance product quality and patient experience, we set a new performance target to achieve a 10% reduction in aggregate product complaint rate by FY25, compared to a FY20 baseline, for key product families.

Product-related regulatory actions

We take prompt action whenever we are alerted to regulatory or field-safety issues with a Medtronic product. Following immediate assessment, we take corrective action, including voluntary product recalls, when needed. We examine underlying issues and root causes and work to resolve these to avoid recurrence.

Our new Design Quality Center of Expertise works to implement quality and reliability improvements via our product-development process, including incorporating lessons learned from post-market surveillance. Our Risk Management Center of Expertise provides oversight of the post-market safety process, ensuring consistency of decision-making across Medtronic.

In FY21, 10 Medtronic products were subject to voluntary Class I recalls. This represents 0.005% of product models offered by Medtronic in FY21.

There is nothing more important than the safety and well-being of patients. Anytime a signal is identified that calls product performance into question, Medtronic acts swiftly to engage in transparent communications, reduce risk, and ensure optimal patient management. A recent example of this can be found in the Valiant Navion recall. In this case, Medtronic investigated and assessed the risk of the issue, resulting in removal of the product from the market and communication to existing users within just weeks of receipt of the first signal.

With each recall, we not only focus on correcting safety issues, we conduct rigorous root-cause investigations focused on the product and our processes. Through these root-cause investigations, we have not identified common root causes that reflect a systemic issue. There is no goal more important to us than continuing to strive for perfection in quality and continuous improvement in patient safety.

Read report.