What changed in this filing

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Item 1. Business

2023-06-22 compared with 2022-06-23 · 100 added, 90 removed, 269 unchanged (41% of the section changed)

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Building on this strong foundation, we are embracing our role as a healthcare technology leader and evolving our business strategy in four key areas:

• Leveraging our pipeline to win market share:

• Leveraging our pipeline to accelerate revenue growth:

The combination of our good end markets, recent product launches and robust pipeline is expected to continue accelerating our growth over both the near-and long-term.

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Financial Statements and Supplementary Data" in this Annual Report on Form 10-K.

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CARDIOVASCULAR PORTFOLIO

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The division develops, manufactures, and markets products for the diagnosis, treatment, and management of heart rhythm disorders and heart failure.

Our products include implantable devices, leads and delivery systems, products for the treatment of atrial fibrillation (AF), products designed to reduce surgical site infections, information systems for the management of patients with Cardiac Rhythm & Heart Failure devices, and an integrated health solutions business.

Our products include implantable devices, leads and delivery systems, products for the treatment of atrial fibrillation (AF), products designed to reduce surgical site infections, and information systems for the management of patients with Cardiac Rhythm & Heart Failure devices.

Principal products and services offered include:

• Implantable cardiac pacemakers including the Azure MRI SureScan, Adapta, Advisa MRI SureScan, and the Micra Transcatheter Pacing System.

The Micra Transcatheter Pacing System, which is leadless and does not have a subcutaneous device pocket like a conventional pacemaker, includes the Micra VR device and the Micra AV device.

Both of these pacemakers treats patients with atrioventricular block.

The Micra Transcatheter Pacing System, which is leadless and does not have a subcutaneous device pocket like a conventional pacemaker, includes the Micra VR and the Micra AV device families.

Both of these pacemakers treat patients with atrioventricular block.

• Implantable cardioverter defibrillators (ICDs), including the Visia AF MRI SureScan, Evera MRI SureScan, Primo MRI, and the Cobalt and Crome portfolio of BlueSync-enabled ICDs, as well as defibrillator leads, including the Sprint Quattro Secure lead.

• Implantable cardiac resynchronization therapy devices (CRT-Ds and CRT-Ps) including the Claria/Amplia/Compia family of MRI Quad CRT-D SureScan systems and the Cobalt and Crome portfolio of BlueSync-enabled CRT-Ds, as well as the Percepta/Serena/Solara family of MRI Quad CRT-P SureScan systems.

• Cardiac ablation products including the Arctic Front Advanced Cardiac cryoablation System, designed for pulmonary vein isolation in the treatment of patients with paroxysmal and persistent AF, as well as the DiamondTemp Ablation system, which is the first U.S.

FDA-approved, temperature controlled, irrigated radiofrequency ablation system.

• Cardiac ablation products include a full suite of electrophysiology solutions to treat patients with arrhythmias, including paroxysmal and persistent AF.

The portfolio includes the Arctic Front Advanced Cardiac Cryoablation System, the DiamondTemp Ablation system, a temperature controlled, irrigated radiofrequency ablation system, Sphere 9 catheter, the first of its kind with high density mapping capabilities combined with radio frequency and pulsed field energies to deliver ablation lesions, and Affera Mapping and Navigation System with Prism-1 software aimed at integrating clinical information to improve patient outcomes.

• Insertable cardiac monitoring systems, including the Reveal LINQ and LINQ II.

These devices are for patients who experience infrequent symptoms such as dizziness, palpitation, syncope (fainting) and chest pain, which may indicate a cardiac arrhythmia that requires long-term monitoring or ongoing management.

The LINQ II device offers improved device longevity, unmatched accuracy and a streamlined workflow with AccuRhythm AI algorithms to reduce clinic workload and data burden.

These devices are for patients who experience transient symptoms such as dizziness, palpitation, syncope (fainting) and chest pain, which may indicate a cardiac arrhythmia that requires long-term monitoring or ongoing management.

The LINQ II device offers improved device longevity, remote programming, unmatched accuracy and a streamlined workflow with AccuRhythm AI algorithms to reduce clinic workload and data burden.

• TYRX products, including the Cardiac and Neuro Absorbable Antibacterial Envelopes, which are designed to stabilize electronic implantable devices and help prevent infection associated with implantable pacemakers and defibrillators.

• Remote monitoring services and patient-centered software to enable efficient care coordination and specialized telehealth nurse support as well as services related to hospital operational efficiency.

• Medtronic stopped the distribution and sale of the HVAD System on June 3, 2021.

• Remote monitoring services and patient-centered software to enable efficient care coordination as well as services related to hospital operational efficiency.

• Medtronic stopped the distribution and sale of the HVAD System in June 2021.

We continue a support program for patients with HVAD devices, and for caregivers and healthcare professionals who participate in their care.

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Structural Heart & Aortic

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Principal products offered include:

• CoreValve family of aortic valves, including the Evolut R, Evolut PRO, and Evolut PRO+ systems for transcatheter aortic valve replacement.

• CoreValve family of aortic valves, including the Evolut PRO, Evolut PRO+, Evolut FX TAVR systems for transcatheter aortic valve replacement.

• Surgical valve replacement and repair products for damaged or diseased heart valves, including both tissue and mechanical valves;

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• Endovascular stent grafts and accessories, including the Endurant II Stent Graft System for the treatment of abdominal aortic aneurysms, the Valiant Captivia Thoracic Stent Graft System for thoracic endovascular aortic repair procedures, and the Heli-FX EndoAnchor System.

• Transcatheter Pulmonary Valves, including Harmony TPV and Delivery Catheter System and Melody TPV/Ensemble II Delivery System.

• Transcatheter Pulmonary Valves, including Harmony Transcatheter Pulmonary Valve (TPV) and Delivery Catheter System and Melody TPV/Ensemble II Delivery System.

Coronary & Peripheral Vascular

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Principal products offered include:

• Percutaneous Coronary Intervention products including our Resolute Onyx drug-eluting stent, Euphora balloons, and Launcher guide catheters.

• Percutaneous Coronary Intervention products including our Onyx Frontier and Resolute Onyx drug-eluting stents, Euphora balloons, and Launcher guide catheters.

• Percutaneous angioplasty balloons including the IN.PACT family of drug-coated balloons, vascular stents including the Abre venous stent, directional atherectomy products including the HawkOne directional atherectomy system, and other procedure support tools.

• Products to treat superficial venous diseases in the lower extremities including the ClosureFast radiofrequency ablation system and the VenaSeal Closure System.

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MEDICAL SURGICAL PORTFOLIO

The Medical Surgical Portfolio is made up of the Surgical Innovations and Respiratory, Gastrointestinal, & Renal divisions.

The Medical Surgical Portfolio includes the Surgical and Respiratory, Gastrointestinal, & Renal divisions.

Products and therapies of this group are used primarily by healthcare systems, physicians' offices, ambulatory care centers, and other alternate site healthcare providers.

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Surgical Innovations and Surgical Robotics.

The division develops, manufactures, and markets advanced and general surgical products, including surgical stapling devices, vessel sealing instruments, wound closure, electrosurgery products, surgical artificial intelligence (AI) and robotic-assisted surgery products, hernia mechanical devices, mesh implants, gynecology products, lung health and visualization, and therapies to treat diseases and conditions that are typically, but not exclusively, addressed by surgeons.

The division develops, manufactures, and markets advanced and general surgical products, including advanced stapling devices, vessel sealing instruments, wound closure products, electrosurgery products, AI-powered surgical video and analytics platform, and robotic-assisted surgery products, hernia mechanical devices, mesh implants, gynecology products, lung health and visualization, and therapies to treat diseases and conditions that are typically, but not exclusively, addressed by surgeons.

Principal products and services offered include:

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and the Sonicision 7 curved jaw cordless ultrasonic dissection system.

• Electrosurgical hardware and instruments, including the Valleylab FT10 energy platform, and the Force TriVerse electrosurgical pencils.

• Robotic and digital surgery technologies including, the Hugo robotic-assisted surgery (RAS) system designed for a broad range of soft-tissue procedures and Touch Surgery Enterprise, the first AI-powered surgical video management solution for the operating room.

• Products designed for the treatment of hernias, including the AbsorbaTack absorbable mesh fixation device for hernia repair, the Symbotex composite mesh for surgical laparoscopic and open ventral hernia repair, and Parietex ProGrip, a self-gripping, biocompatible solution for inguinal hernias.

• Electrosurgical hardware and instruments, including the Valleylab FT10 energy platform, the Valleylab LS10 generator, and the Force TriVerse electrosurgical pencils.

• Robotic and digital surgery technologies including, the Hugo robotic-assisted surgery (RAS) system designed for a broad range of soft-tissue procedures, and Touch Surgery Enterprise, the first-of-its-kind AI-powered surgical video management solution for the operating room.

• Products designed for the treatment of hernias, including the AbsorbaTack absorbable mesh fixation device for hernia repair, the Symbotex composite mesh for surgical laparoscopic and open ventral hernia repair, and ProGrip Laparoscopic Self-Fixating Mesh, a self-gripping, biocompatible solution for inguinal hernias.

• Suture and wound closure products, including the V-Loc barbed sutures, the Polysorb braided absorbable sutures, and the Monosof absorbable monofilament nylon sutures.

Respiratory, Gastrointestinal, & Renal

Our Respiratory, Gastrointestinal, & Renal division includes the following Operating Units:

Respiratory Interventions, Patient Monitoring, Gastrointestinal, and Renal Care Solutions.

The division develops, manufactures, and markets products in the emerging fields of minimally invasive gastrointestinal and hepatologic diagnostics and therapies, patient monitoring, respiratory interventions including airway management and ventilation therapies, and for the treatment of renal disease.

Respiratory Interventions;

Patient Monitoring;

and Gastrointestinal.

The division develops, manufactures, and markets products in the emerging fields of minimally invasive gastrointestinal and hepatologic diagnostics and therapies, patient monitoring, and respiratory interventions including airway management and ventilation therapies.

Effective April 1, 2023, we have contributed our Renal Care Solutions (RCS) business as part of an agreement with DaVita to form a new, independent kidney care-focused medical device company (“Mozarc Medical”).

Principal products and services offered include:

• Gastrointestinal and endoscopy products, including the PillCam capsule endoscopy systems, the Bravo calibration-free reflux testing systems, the EndoFLIP imaging systems, the Emprint ablation system with Thermosphere Technology, the ManoScan Bravo system, the Barrx platform through ablation with the Barrx 360 Express catheter, the GI Genius intelligent endoscopy module, the Cool-tip radiofrequency ablation system, and the HET Bipolar System.

• Gastrointestinal and endoscopy products, including the GI Genius intelligent endoscopy module, the PillCam capsule endoscopy systems, the Bravo calibration-free reflux testing systems, the Endoflip Impedance Planimetry System, the Emprint ablation system with Thermosphere Technology, the ManoScan Bravo system, the Barrx platform through ablation with the Barrx 360 Express catheter, the Cool-tip radiofrequency ablation system, the HET Bipolar System, the Beacon delivery system, and the Nexpowder endoscopic hemostasis system.

• Airway, ventilation, and inhalation therapies products, including the Puritan Bennett 980 and 840 ventilators, the Newport e360 and HT70 ventilators, the TaperGuard Evac tube, Shiley Endotracheal Tubes, Shiley Tracheostomy Tubes, McGRATH MAC video laryngoscopes, and DAR Filters.

• Products focused on patient monitoring, including Nellcor pulse oximetry monitors and sensors, Microstream capnography monitors, Bispectral Index (BIS) brain monitoring technology, INVOS cerebral/somatic oximetry systems, Vital Sync remote monitoring, and WarmTouch convective warming.

• Products providing solutions for the treatment of renal disease, including Palindrome, Mahurkar and Mahurkar Elite Dialysis Access Catheters for renal therapy, Argyle peritoneal dialysis catheters, Carpediem dialysis machines for pediatric patients,

Amplya dialysis machines for acute patients, and other products designed for use in treatment of both acute and chronic renal failure conditions.

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NEUROSCIENCE PORTFOLIO

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Our Cranial & Spinal Technologies division and Operating Unit develops, manufactures, and markets an integrated portfolio of devices and therapies for surgical technologies designed to improve the precision and workflow of neuro procedures, and a comprehensive line of medical devices and implants used in the treatment of the spine and musculoskeletal system.

The division also provides biologic solutions for the orthopedic and dental markets and offers unique and highly differentiated imaging, navigation, power instruments, nerve monitoring, and robotic guidance systems used in spine and cranial procedures.

The division also provides biologic solutions for the orthopedic markets and offers unique and highly differentiated imaging, navigation, power instruments, and robotic guidance systems used in spine and cranial procedures.

Principal products and services offered include:

• Neurosurgery products, including platform technologies, implant therapies, and advanced energy products.

This includes our StealthStation S8 Navigation System, Stealth Autoguide cranial robotic guidance platform, O-arm Imaging System, Mazor X robotic guidance systems used in robot-assisted spine procedures, and our Midas Rex Surgical Drills, including our MR8 high-speed drill system.

This group of products also includes our cerebrospinal fluid (CSF) Management Portfolio, Visualase MRI-guided laser ablation, Aquamantys Sealers, and our PEAK Surgery System used in tissue dissection that consists of the PEAK PlasmaBlade and PULSAR Generator.

• Neurosurgery products, including platform technologies, implant therapies, and advanced energy products through the Aible spine technology ecosystem.

This includes our StealthStation S8 Navigation System, Stealth Autoguide cranial robotic guidance platform, O-arm Imaging System, Mazor X robotic guidance systems used in robot-assisted spine procedures, UNiD Adaptive Spine Intelligence AI-driven technology, and our Midas Rex surgical drills, including our MR8 high-speed drill system.

• Products to treat a variety of conditions affecting the spine, including degenerative disc disease, spinal deformity, spinal tumors, fractures of the spine, and stenosis.

These products include our CD HORIZON SOLERA system, T2 STRATOSPHERE, and CLYDESDALE interbody spacers.

These products also include titanium interbody implants and surface technologies, such as our Adaptix interbody system and the Titan Interbody Fusion Device with NanoLOCK technology.

• Products that facilitate less invasive thoracolumbar surgeries, including the CD HORIZON SOLERA VOYAGER Percutaneous Fixation System.

These products include our CATALYFT PL expandable interbody spacers, CD Horizon ModuLeX spinal system, and T2 STRATOSPHERE Expandable Corpectomy System.

These products can also include titanium interbody implants and surface technologies, such as our Adaptix interbody system and incorporated Titan Interbody Fusion Device with nanoLOCK technology.

• Products that facilitate less invasive thoracolumbar surgeries, including the CD HORIZON SOLERA VOYAGER Percutaneous Fixation System and various retractor systems to access the spine through smaller incisions.

• Products to treat conditions in the cervical region of the spine, including the ZEVO Anterior Cervical Plate System, the INFINITY OCT System, and PRESTIGE LP Cervical Artificial Discs.

• Biologic solutions products, including our INFUSE Bone Graft (InductOs in the European Union (E.U.)), which contains a recombinant human bone morphogenetic protein-2, rhBMP-2, for certain spinal, trauma, and oral maxillofacial applications.

• Demineralized Bone Matrix products, including MAGNIFUSE, GRAFTON/GRAFTON PLUS, and the MASTERGRAFT family of synthetic bone graft products – Matrix, Putty, and Granules.

• Demineralized bone matrix products, including MAGNIFUSE, GRAFTON/GRAFTON PLUS, and the MASTERGRAFT family of synthetic bone graft products – Matrix, Putty, Strip, and Granules.

Specialty Therapies

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and Pelvic Health.

The division develops, manufactures, and markets products and therapies to treat diseases of ENT, patients afflicted with acute ischemic and hemorrhagic stroke, and help control the systems of overactive bladder, (non-obstructive) urinary retention, and chronic fecal incontinence.

The division develops, manufactures, and markets products and therapies to treat patients afflicted with acute ischemic and hemorrhagic stroke, diseases of ENT, and patients suffering from overactive bladder, (non-obstructive) urinary retention, and chronic fecal incontinence.

Principal products and services offered include:

• Pelvic health products, including our InterStim X, InterStim Micro, and InterStim II neurostimulators, and InterStim SureScan MRI leads, to help control the systems of overactive bladder, (non-obstructive) urinary retention, and chronic fecal incontinence.

Our NURO System delivers Percutaneous Tibial Neuromodulation therapy to treat overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

• ENT products, including the Straightshot M5 Microdebrider Handpiece, the IPC system, NIM Nerve Monitoring Systems, FUSION Compact and StealthStation ENT Navigation System, as well as products for hearing restoration and obstructive sleep apnea.

• Neurovascular products to treat diseases of the vasculature in and around the brain.

This includes coils, neurovascular stent retrievers, and flow diversion products, as well as access and delivery products to support procedures.

Products also include the Pipeline Flex Embolization Devices, endovascular treatments for large or giant wide-necked brain aneurysms, the portfolio of Solitaire revascularization devices for treatment of acute ischemic stroke, the Riptide Aspiration System, the Onyx Liquid Embolic System, and a portfolio of associated access catheters including our React aspiration catheters also for the treatment of acute ischemic stroke.

Products also include the Pipeline Flex Embolization Device with Shield Technology, endovascular treatments for large or giant wide-necked brain aneurysms, the portfolio of Solitaire revascularization devices for treatment of acute ischemic stroke, the Riptide Aspiration

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System, the Onyx Liquid Embolic System, and a portfolio of associated access catheters including our React aspiration catheters also for the treatment of acute ischemic stroke.

• ENT products, including the Straightshot M5 Microdebrider Handpiece, the Integrated Power Console (IPC) system, NIM Vital Nerve Monitoring Systems, Propel and Sinuva Sinus Implants from the acquisition of Intersect ENT, StealthStation ENT and StealthStation FlexENT Navigation Systems, as well as products for hearing restoration.

• Pelvic health products, including our InterStim X and InterStim II recharge-free neurostimulators, InterStim Micro rechargeable neurostimulators, and SureScan MRI leads.

Our NURO System delivers Percutaneous Tibial Neuromodulation therapy to treat overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

Neuromodulation

Our Neuromodulation division and Operating Unit develops, manufactures, and markets spinal cord stimulation systems, implantable drug infusion systems for chronic pain, as well as interventional products.

Our Neuromodulation division and Operating Unit develops, manufactures, and markets spinal cord stimulation and brain modulation systems, implantable drug infusion systems for chronic pain, as well as interventional products.

Principal products and services offered include:

• Spinal cord stimulation products, including rechargeable and non-rechargeable devices and a large selection of leads used to treat chronic back and/or limb pain and chronic pain resulting from diabetic peripheral neuropathy.

This includes the Intellis Spinal Cord Stimulation System, with AdaptiveStim and SureScan MRI Technology, DTM (differential target multiplexed) proprietary waveform, the Evolve workflow algorithm, and Snapshot reporting.

Products also include our RestoreSensor (rechargeable) SureScan MRI neurostimulation system with its proprietary AdaptiveStim technology.

• Spinal cord stimulation products, including rechargeable and recharge-free devices and a large selection of leads used to treat chronic back and/or limb pain and chronic pain resulting from diabetic peripheral neuropathy.

This includes the Intellis (rechargeable) and Vanta (recharge-free) Spinal Cord Stimulation Systems, with AdaptiveStim and SureScan MRI Technology, DTM (differential target multiplexed) proprietary waveform, the Evolve workflow algorithm, and Snapshot reporting.

• Brain modulation products, including those for the treatment of the disabling symptoms of Parkinson's disease, essential tremor, refractory epilepsy, severe, treatment-resistant obsessive-compulsive disorder (approved under a Humanitarian Device Exemption (HDE) in the U.S.), and chronic, intractable primary dystonia (approved under a HDE in the U.S.).

Specifically, this includes our family of Activa Neurostimulators, including Activa SC (single-channel primary cell battery), Activa PC (dual channel primary cell battery), and Activa RC (dual channel rechargeable battery).

This also includes our Percept PC Neurostimulator DBS system with BrainSense technology.

Specifically, this includes our family of Activa neurostimulators, including Activa SC (single-channel primary cell battery), Activa PC (dual channel primary cell battery), and Activa RC (dual channel rechargeable battery), as well as Percept PC neurostimulator and SenSight directional lead system with the proprietary BrainSense technology.

• Implantable drug infusion systems, including our SynchroMed II Implantable Infusion System, that deliver small quantities of drug directly into the intrathecal space surrounding the spinal cord.

• Interventional products, including the Kyphon Balloon, the Kyphon V, and Kyphon Assist systems and the OsteoCool RF Tumor ablation system.

• Interventional products, including the Kyphon Balloon, the Kyphon V Premium, and Kyphon Assist systems and the OsteoCool RF Tumor ablation system.

• The Accurian nerve ablation system, which conducts radio frequency ablation of nerve tissues.

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• Insulin pumps and consumables, including the MiniMed 770G system and MiniMed 780G system, which are all powered by SmartGuard technology.

The MiniMed 770G system provides smartphone and Bluetooth connectivity, continuously delivers background insulin, monitors sugar levels, and an expanded age indication to ages two and up.

The MiniMed 780G enhances the insulin pump systems by including automatic correction boluses and an adjustable glucose target down to 100 mg/dl.

The MiniMed 770G and 780G system provides smartphone and Bluetooth connectivity, continuously delivers background insulin, monitors sugar levels, and an expanded age indication to ages two and up.

The MiniMed 780G further reduces patient burden by including automatic correction boluses, meal-time detection system, and an adjustable glucose target down to 100 mg/dl.

• Continuous glucose monitoring (CGM) systems and sensors, including the Guardian Connect smart CGM system, the Guardian Sensor 3, and the Guardian Sensor 4, are products worn by patients capturing glucose data to reveal patterns and potential problems, such as hyperglycemic and hypoglycemic episodes.

• The InPen smart insulin pen system that combines a reusable Bluetooth-enabled insulin pen with an intuitive mobile app that helps users administer the appropriate insulin dose.

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• The InPen smart insulin pen system combines a reusable Bluetooth-enabled insulin pen with an intuitive mobile app that helps users administer the appropriate insulin dose.

The InPen application integrates with our CGM data to provide real-time CGM readings alongside insulin dose information.

• Consumables and supplies, including infusion sets.

HUMAN CAPITAL

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We aspire to create a truly inclusive, diverse, and equitable workplace that fosters innovation and creativity, and where every employee feels a sense of belonging and well-being.

Medtronic has 95,000+ full-time employees, of which forty-four percent are based in the U.S.

Medtronic has 95,000+ full-time employees, of which forty-three percent are based in the U.S.

or Puerto Rico.

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By breaking down barriers to Inclusion, Diversity and Equity (ID&E), we open doors for everyone, driving progress and prosperity around the world.

We integrate ID&E principles throughout our Company to ensure every operating unit, team, and leader recognizes and celebrates the value of diverse experiences and backgrounds.

As of the end of fiscal year 2023, 40 percent of our U.S.

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women comprise 51 percent of our global workforce;

and 42 percent of our manager and above employees are women.

43 percent of our manager and above employees are women;

and 28 percent of our U.S.

managers are ethnically diverse.

Additionally, Medtronic employee resource groups (ERGs) are employee-led affinity groups that provide career development and networking opportunities for members and strengthen ties between employees of many different backgrounds, cultures, and interests.

In fiscal year 2022, there were 12 ERGs and Diversity Networks across 75 countries with more than 34,000 members.

For fiscal year 2022, in the United States we have achieved 100% pay equity for gender for the third consecutive year and 100% pay equity for ethnically diverse employees.

In fiscal year 2023, there were 13 ERGs and Diversity Networks across 300+ Network and ERG chapters in 70 countries with more than 35,000 members.

In our most recent reported period available, in the United States, we have achieved 100% pay equity for gender for the third consecutive year and 100% pay equity for ethnically diverse employees.

Globally we have achieved 99% pay equity for gender.

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Our competitive approach to compensation reflects industry benchmarks and local market standards.

Our programs include annual and long-term incentives that provide the means to share in the Company’s success.

Our programs include annual and long-term equity-based incentives that provide the means to share in the Company’s success, based on business and individual performance.

To attract the best leaders, we offer competitive benefits and cash and equity incentives.

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The skills and dedication of our employees drive our business performance.

Our comprehensive professional development programs empower our people to build rewarding careers and help us attract world-class talent.

Our comprehensive professional development programs empower our people to build rewarding careers and help us attract world-class talent from global and diverse populations.

Our suite of professional development programs ensures that our employees, regardless of level, location, language or learning preferences, have access to opportunities to develop and grow.

Our investment in employee development has contributed to more than 32 percent of our open roles being filled with internal employees.

In fiscal year 2022, we began our shift away from degree requirements to focus on skills-based certification for certain roles within Medtronic.

Additionally, as members of the Multiple Pathways Initiative, we have used a skill – based approach to offering opportunities to expanded pools of external talent that have previously been held back due to lack of access to undergraduate education.

We have shifted away from degree requirements to focus on skills-based certification for certain roles within Medtronic.

Additionally, as members of the Multiple Pathways Initiative, we have used a skills-based approach to offering opportunities to expanded pools of external talent that have previously been held back due to lack of access to undergraduate education.

Internally, employees can now participate through MAPS (Medtronic Advancement Pathways and Skill-building) in undergraduate courses from top-tier universities to enhance or obtain new skills, at no cost to the employee.

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Employee Engagement and Culture

Through our organizational health survey, we gain valuable insight into the Medtronic employee experience and identify areas where we can improve in four key priority areas:

1) Employee Engagement, 2) Inclusion, 3) Innovation, and 4) Ethics.

Through our Organizational Health Survey, we gain valuable insight into the Medtronic employee experience and identify where we can improve in key priority areas:

1) Employee Engagement, 2) Inclusion, 3) Innovation, 4) Ethics and 5) quality culture as part of our commitment to Put Patients First in our everyday decisions and actions.

In our most recent survey ending in the fourth quarter of fiscal year 2023, more than 82 percent of our employees responded.

Medtronic carefully reviews and implements actions based on employee feedback in order to partner and create an inclusive, innovative and supportive environment.

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To enable our transformation to be the global healthcare technology leader, we introduced a reinvigorated and revived culture.

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As a large, global employer, it is our responsibility to maintain a safe workplace and support the well-being of our employees.

Throughout the COVID-19 pandemic, we have placed a high priority on employee health, providing comprehensive benefits, accommodations and resources to support our workforce through this challenging time.

During fiscal year 2022, we offered on-site vaccinations to our employees, enabling a vaccination rate of nearly 90% for our U.S.

and Puerto Rico – based workforce.

To help limit exposure to the virus, we acted to ensure employees in business-critical functions who cannot work from home were protected, including those in research and development, quality, manufacturing, distribution, and sales.

Personal protective equipment, increased sanitation, social distancing guidance, and facility updates (one-way hallways, cafeteria partitions and extra sinks) were provided to protect our employees.

Medtronic has a comprehensive approach to providing robust support for our employees and their families not only during the pandemic, but also in natural disasters, civil unrest and war, bereavement, and other challenging events.

Medtronic has a comprehensive approach to providing robust support for our employees and their families in natural disasters, public health crises, civil unrest and war, bereavement, and other challenging events.

Along with other programs, the Medtronic Employee Assistance Program and the Medtronic Employee Emergency Assistance Fund have historically supported employees and their families when faced with difficult times by providing a variety of services such as mental health, safety, and financial resources and support at no cost.

These programs have proven invaluable in navigating our employees through unique challenge, including in fiscal year 2022.

These programs have proven invaluable in navigating our employees through unique challenges, including in fiscal year 2023.

The Medtronic Employee Emergency Assistance Fund is supported by donations from employees and the Medtronic Foundation, and over the last five years has provided over $6 million in grants to employees experiencing unexpected events creating a financial hardship.

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protecting our planet, accelerating access to healthcare technology, and advancing ID&E.

In early fiscal year 2022, we set new performance targets across the following areas:

In fiscal year 2022, we set new performance targets across the following areas:

Patient Safety & Product Quality;

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OTHER FACTORS IMPACTING OUR OPERATIONS

COVID-19 Pandemic

The global COVID-19 pandemic, together with the preventative and precautionary measures taken by businesses, communities, and governments, has impacted, and may continue to impact significant aspects of our Company and business, including future procedural volumes, supply constraints, healthcare staffing, worker absenteeism with our customers, suppliers, and in our own operations and field teams, and resulting impacts on demand for our products and therapies.

Public Health Crises

The global COVID-19 pandemic, together with the preventative and precautionary measures taken by businesses, communities, and governments, have impacted, and may continue to impact significant aspects of our Company and business, including future procedural volumes, supply constraints, healthcare staffing, and resulting impacts on demand for our products and therapies.

If there are significant outbreaks of other contagious diseases or other global public health crises, we may face similar impacts.

See “Item 1A.

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Research and Development

The markets in which we participate are subject to rapid technological advances.

The markets in which we participate are subject to rapid technological advances and innovations.

Constant improvement of existing products and introduction of new products is necessary to maintain market leadership.

Our research and development (R&D) efforts are directed toward maintaining or achieving technological leadership in each of the markets we serve to help ensure that patients using our devices and therapies receive the most advanced and effective treatment possible.

Our research and development (R&D) efforts are directed toward maintaining or achieving technological leadership in the markets we serve to help ensure that patients using our devices and therapies receive the most advanced and effective treatment possible.

We remain committed to developing technological enhancements and new indications for existing products, and less invasive and new technologies for new and emerging markets to address unmet patient needs.

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We continue to focus on optimizing innovation, improving our R&D productivity, driving growth in emerging markets, generating clinical evidence, and assessing our R&D programs based on their ability to address unmet clinical needs, produce better patient outcomes, and create new standards of care.

Intellectual Property

Intellectual Property and Litigation

We rely on a combination of patents, trademarks, tradenames, copyrights, trade secrets, and agreements (non-disclosure and non-competition agreements) to protect our business and proprietary technology.

In addition, we have entered into exclusive and non-exclusive licenses relating to a wide array of third-party technologies.

In the aggregate, these intellectual property assets and licenses are of material importance to our business;

however, we believe that no single intellectual property asset or license is material in relation to any segment of our business or to our business as a whole.

In the aggregate, these intellectual property assets and licenses are of material

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importance to our business;

however, we believe that no single intellectual property asset or license is material in relation to our business as a whole.

We operate in an industry characterized by extensive patent litigation.

Patent litigation may result in significant damage awards and injunctions that could prevent the manufacture and sale of affected products or result in significant royalty payments in order to continue selling the products.

At any given time, we are involved as both a plaintiff and a defendant in a number of patent infringement actions, the outcomes of which may not be known for prolonged periods of time.

At any given time, we are generally involved as both a plaintiff and a defendant in a number of patent infringement actions, the outcomes of which may not be known for prolonged periods of time.

Sales and Distribution

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We compete in both the therapeutic and diagnostic medical markets in more than 150 countries throughout the world.

These markets are characterized by rapid change resulting from technological advances and scientific discoveries.

These markets are characterized by rapid change resulting from technological advances, innovations and scientific discoveries.

Our product lines face a mix of competitors ranging from large manufacturers with multiple business lines to small manufacturers offering a limited selection of products.

In addition, we face competition from providers of other medical therapies, such as pharmaceutical companies.

Major shifts in industry market share have occurred in connection with product problems, physician advisories, safety alerts, results of clinical trials to support superiority claims, and publications about our products, reflecting the importance of product quality, product efficacy and quality systems in the medical device industry.

Major shifts in industry market share have occurred in connection with product corrective actions, physician advisories, safety alerts, results of clinical trials to support superiority claims, and publications about our products, reflecting the importance of product quality, product efficacy and quality systems in the medical device industry.

In the current environment of managed care, economically motivated customers, consolidation among healthcare providers, increased competition, declining reimbursement rates, and national and provincial tender pricing, competitively priced product offerings are essential to our business.

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Properties” in this Annual Report on Form 10-K.

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Government Regulation

Our operations and products are subject to extensive regulation by numerous government agencies, including the U.S.

FDA, European regulatory authorities such as the Medicines and Healthcare Products Regulatory Agency in the United Kingdom Republic of Ireland and the Federal Institute for Drugs and Medical Devices in Germany, the China National Medical Product Administration (NMPA) , and other government agencies inside and outside the U.S.

FDA, European regulatory authorities such as the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Health Products Regulatory Authority in the Republic of Ireland and the Federal Institute for Drugs and Medical Devices in Germany, the China National Medical Product Administration (NMPA) , and other government agencies inside and outside the U.S.

To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution and post-marketing surveillance of our products.

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Product Approval and Monitoring

Many countries where we sell medical devices subject such medical devices and technologies to their own approval and other regulatory requirements regarding performance, safety, and quality of our products.

Many countries where we sell products are subjected to approval and other regulatory requirements regarding performance, safety, and quality of our products.

Authorization to commercially distribute a new medical device in the U.S.

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This process is generally much more time-consuming and expensive than the 510(k) process.

In the E.U., a single regulatory approval process exists, and conformity with the legal requirements is represented by the CE Mark.

In the E.U., conformity with the marketing authorization requirements is represented by the CE Mark.

To obtain a CE Mark, defined products must meet minimum standards of performance, safety, and quality (i.e., the essential requirements), and then, according to their classification, comply with one or more of a selection of conformity assessment routes.

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countries separately regulate the clinical research for medical devices and the market surveillance of products once they are placed on the market.

A new Medical Device Regulation was published by the E.U.

in 2017 which imposes significant additional pre-market and post-market requirements (EU MDR).

The Medical Device Regulation was published by the E.U.

in 2017, and it imposes significant additional pre-market and post-market requirements (EU MDR).

The regulation provided an implementation period and became effective on May 26, 2021.

Medical devices marketed in the E.U.

will require certification according to these new requirements, except that devices with valid CE certificates, issued pursuant to the Medical Device Directives before May 2020, can be placed on the market until May 2024.

The European Commission recently extended the implementation period to the end of 2027 for high-risk devices and to the end of 2028 for medium and low risk devices.

The global regulatory environment is increasingly stringent and unpredictable.

While harmonization of global regulations has been pursued, requirements continue to differ significantly among countries.

While harmonization of global regulations has been pursued, requirements continue to differ among countries.

We expect this global regulatory environment will continue to evolve, which could impact the cost, the time needed to approve, and ultimately, our ability to maintain existing approvals or obtain future approvals for our products.

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impose extensive compliance and monitoring obligations on our business.

These agencies review our design and manufacturing practices, labeling, record keeping, and manufacturers’ required reports of adverse experiences and other information to identify potential problems with marketed medical devices.

These agencies review our design and manufacturing processes, labeling, record keeping, and manufacturers’ required reports of adverse experiences and other information to identify potential problems with marketed products.

We are also subject to periodic inspections for compliance with applicable quality system regulations, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, and servicing of finished medical devices intended for human use.

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and countries outside of the U.S.

If we, or certain third parties through which we sell or provide goods or services, violate anti-boycott laws and regulations, we may be subject to civil or criminal enforcement action and varying degrees of liability.

If we, or certain third

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parties through which we sell or provide goods or services, violate anti-boycott laws and regulations, we may be subject to civil or criminal enforcement action and varying degrees of liability.

Data Privacy and Security Laws and Regulations

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Our global operational footprint comes with the obligation for compliance and adherence to individual data security, confidentiality and breach notification laws at the State Level, Federal Level, and International Level.

Examples of those laws include the Health Insurance and Portability Act of 1996 (HIPAA), as amended, and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) in the U.S., the Global Data Protection Regulation (GDPR) within the European Union, and various other country specific requirements around the world.

Examples of those laws include, in the U.S., the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and various State privacy laws that have become effective recently.

We are also subject to various other country-specific requirements around the world, such as the General Data Protection Regulation (GDPR) in the European Economic Area, the United Kingdom’s version of the same, and China's Personal information Protection Law (PIPL).

Because the laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation, compliance with these laws and regulations may require significant additional cost expenditures or changes in products or business that increase competition or reduce revenue.

Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities, or withdrawal of non-compliant products from a market.

Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities, or withdrawal of noncompliant products from a market.

Regulations Governing Reimbursement

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Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (Exchange Act) are made available under the “Our Company – Investors” caption and “Financials – SEC Filings” subcaption of our website as soon as reasonably practicable after we electronically file them with, or furnish them to, the Securities and Exchange Commission (SEC).

Board of Directors, and information concerning our executive officers, directors and Board committees (including committee charters) is available through our website at www.medtronic.com under the “Our Company – Governance” caption.

Information relating to our corporate governance, including our Principles of Corporate Governance, Code of Conduct (including our Code of Ethics for Senior Financial Officers and any related amendments or waivers), Code of Business Conduct and Ethics for Members of the Board of Directors, and information concerning our executive officers, directors and Board committees (including committee charters) is available through our website at www.medtronic.com under the “Our Company – Governance” caption.

Information relating to transactions in Medtronic securities by directors and officers is available through our website at www.medtronic.com under the “Our Company – Investors” caption and the “Financials – SEC Filings” subcaption.

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Our website and the information contained on or connected to our website are not incorporated by reference into this Form 10-K.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business