Item 1. BUSINESS.
18K characters. Original on sec.gov ·
Item 1. BUSINESS.
Stryker Corporation (Stryker or the Company) is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The Company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
Our core values guide our behaviors and actions and are fundamental to how we execute our mission.

Stryker was incorporated in Michigan in 1946 as the successor company to a business founded in 1941 by Dr. Homer H. Stryker, a prominent orthopaedic surgeon and the inventor of several medical products. Our products are sold in over 85 countries through company-owned subsidiaries and branches, as well as third-party dealers and distributors, and include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling, emergency medical equipment and intensive care disposable products; neurosurgical, neurovascular and spinal devices; as well as other products used in a variety of medical specialties. In the United States most of our products are marketed directly to doctors, hospitals and other healthcare facilities.
As used herein, and except where the context otherwise requires, "Stryker," "we," "us," and "our" refer to Stryker Corporation and its consolidated subsidiaries.
Business Segments and Geographic Information
We segregate our operations into three reportable business segments: Orthopaedics, MedSurg and Neurotechnology and Spine. Financial information regarding our reportable business segments and certain geographic information is included under "Results of Operations" in Item 7 of this report and Note 13 to our Consolidated Financial Statements.
| Net Sales by Reportable Segment | |||||||||||||||||
| 2017 | 2016 | 2015 | |||||||||||||||
| Orthopaedics | $ | 4,713 | 38 | % | $ | 4,422 | 39 | % | $ | 4,223 | 43 | % | |||||
| MedSurg | 5,557 | 45 | 4,894 | 43 | 3,895 | 39 | |||||||||||
| Neurotechnology and Spine | 2,174 | 17 | 2,009 | 18 | 1,828 | 18 | |||||||||||
| Total | $ | 12,444 | 100 | % | $ | 11,325 | 100 | % | $ | 9,946 | 100 | % |
Orthopaedics
Orthopaedics products consist primarily of implants used in hip and knee joint replacements and trauma and extremities surgeries. We bring patients and physicians advanced implant designs and
specialized instrumentation that make orthopaedic surgery and recovery simpler, faster and more effective. We support surgeons with the technology and services they need as they develop new surgical techniques. In 2015 we received clearance by the United States Food and Drug Administration (FDA) for our Mako total knee application and completed the full commercial launch in 2017. This expands our Mako product offerings of partial knee and total hip applications to provide a comprehensive solution in the robotic arm-assisted reconstructive surgery line.
Stryker is one of four leading global competitors for joint replacement and trauma and extremities products; the other three being Zimmer Biomet Holdings, Inc. (Zimmer), DePuy Synthes (a Johnson & Johnson company) and Smith & Nephew plc (Smith & Nephew).
| Composition of Orthopaedics Net Sales | |||||||||||||||||
| 2017 | 2016 | 2015 | |||||||||||||||
| Knees | $ | 1,595 | 34 | % | $ | 1,490 | 34 | % | $ | 1,403 | 33 | % | |||||
| Hips | 1,303 | 28 | 1,283 | 29 | 1,263 | 30 | |||||||||||
| Trauma and Extremities | 1,478 | 31 | 1,364 | 31 | 1,291 | 31 | |||||||||||
| Other | 337 | 7 | 285 | 6 | 266 | 6 | |||||||||||
| Total | $ | 4,713 | 100 | % | $ | 4,422 | 100 | % | $ | 4,223 | 100 | % |
MedSurg
MedSurg products include surgical equipment and navigation systems (Instruments), endoscopic and communications systems (Endoscopy), patient handling, emergency medical equipment and intensive care disposable products (Medical), reprocessed and remanufactured medical devices (Sustainability) and other medical device products used in a variety of medical specialties.
Stryker is one of five leading global competitors in Instruments; the other four being Zimmer, Medtronic plc., Johnson & Johnson and ConMed Linvatec, Inc. (a subsidiary of CONMED Corporation). In Endoscopy we compete with Smith & Nephew, ConMed Linvatec, Arthrex, Inc., Karl Storz GmbH & Co., Olympus Optical Co. Ltd. and STERIS plc. In Medical our primary competitors are Hill-Rom Holdings, Inc., Zoll Medical Corporation, Medline Industries and Koninklijke Philips N.V.
| Composition of MedSurg Net Sales | |||||||||||||||||
| 2017 | 2016 | 2015 | |||||||||||||||
| Instruments | $ | 1,678 | 30 | % | $ | 1,553 | 32 | % | $ | 1,466 | 38 | % | |||||
| Endoscopy | 1,652 | 30 | 1,470 | 30 | 1,390 | 36 | |||||||||||
| Medical | 1,969 | 35 | 1,633 | 33 | 823 | 21 | |||||||||||
| Sustainability | 258 | 5 | 238 | 5 | 216 | 5 | |||||||||||
| Total | $ | 5,557 | 100 | % | $ | 4,894 | 100 | % | $ | 3,895 | 100 | % |
In 2017 Instruments launched System 8, the next generation of power tools comprised of a sagittal saw, reciprocating saw, rotary drill and sternum saw. The new power tools offer improved ergonomics, a quick and efficient keyless chuck system preventing loosening through a secondary locking mechanism and advanced material and coating to prevent sticking and slipping. In addition, the handpieces are built to be actively washed and temporarily submerged prior to sterilization.
Neurotechnology and Spine
Neurotechnology and Spine products include neurosurgical, neurovascular, and spinal implant devices. Our neurotechnology offering includes products used for minimally invasive endovascular techniques; a comprehensive line of products for traditional brain and open skull based surgical procedures; orthobiologic and biosurgery products, including synthetic bone grafts and vertebral augmentation products; and minimally invasive products for the treatment of acute ischemic and hemorrhagic stroke. Our spinal
| Dollar amounts in millions except per share amounts or as otherwise specified. | 1 |
STRYKER CORPORATION 2017 FORM 10-K
implant offering includes cervical, thoracolumbar and interbody systems used in spinal injury, deformity and degenerative therapies.
Stryker is one of five leading global competitors in Neurotechnology; the other four being Medtronic, Johnson & Johnson, Terumo Corporation and Penumbra, Inc. Stryker is one of five leading global competitors in Spine; the other four being Medtronic Sofamor Danek, Inc. (a subsidiary of Medtronic), DePuy Synthes, Nuvasive, Inc. and Globus Medical, Inc.
| Composition of Neurotechnology and Spine Net Sales | |||||||||||||||||
| 2017 | 2016 | 2015 | |||||||||||||||
| Neurotechnology | $ | 1,423 | 65 | % | $ | 1,255 | 62 | % | $ | 1,088 | 60 | % | |||||
| Spine | 751 | 35 | 754 | 38 | 740 | 40 | |||||||||||
| Total | $ | 2,174 | 100 | % | $ | 2,009 | 100 | % | $ | 1,828 | 100 | % |
In 2017 the New England Journal of Medicine published the results of the DAWN Trial, the first to provide compelling evidence in treating late window and wake-up stroke patients with mechanical thrombectomy. The purpose of the study is to demonstrate superior clinical outcomes at 90 days with Trevo™ Retriever plus medical management compared to medical management alone in appropriately selected stroke patients treated six to 24 hours after last seen well (for cases of unknown time of onset). The Trevo™ Retriever’s indication within the DAWN Trial, for use in patients treated six to 24 hours after last seen well, is currently under an Investigational Device Exemption (IDE), and the submission for expanding the indication for the later time window is pending.
Raw Materials and Inventory
Raw materials essential to our business are generally readily available from multiple sources; however, certain of our raw materials are currently sourced from single suppliers. Substantially all products we manufacture are stocked in inventory, while certain MedSurg products are assembled to order.
Patents and Trademarks
Patents and trademarks are significant to our business to the extent that a product or an attribute of a product represents a unique design or process. Patent protection of such products restricts competitors from duplicating these unique designs and features. We seek to obtain patent protection on our products whenever appropriate for protecting our competitive advantage. On December 31, 2017 we owned approximately 2,674 United States patents and approximately 3,886 international patents.
Seasonality
Our business is generally not seasonal in nature; however, the number of orthopaedic implant surgeries is typically lower in the summer months, and sales of capital equipment are generally higher in the fourth quarter.
Competition
In each of our product lines we compete with local and global companies. The development of new and innovative products is important to our success in all areas of our business. Competition in research involving the development and improvement of new and existing products and processes is particularly significant. The competitive environment requires substantial investments in continuing research and maintaining sales forces.
We believe our commitment to innovation, quality and service and our reputation differentiates us in the highly competitive product categories in which we operate and enables us to compete effectively. We believe that our competitive position in the future will depend to a large degree on our ability to develop new products and make improvements to existing products.
Research and Development
Continued investment in research and development activities is critical to drive future growth and supports our strategy to make healthcare better through development of products and services that improve patient outcomes. Most of our products and product improvements were developed internally at research facilities in the United States, China, France, Germany, India, Ireland, Puerto Rico, Sweden, Switzerland and United Kingdom. We also invest through acquisitions in technologies developed by third parties that have the potential to expand the markets in which we operate. We maintain close working relationships with physicians and medical personnel in hospitals and universities who assist us in product development efforts. The total cost of research, development and engineering activities were $787, $715 and $625 in 2017, 2016 and 2015.
Regulation
Our businesses are subject to varying degrees of governmental regulation in the countries in which we operate, and the general trend is toward increasingly stringent regulation.
In the United States the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act and its subsequent amendments and the regulations issued and proposed thereunder provide for regulation by the FDA of the design, manufacture and marketing of medical devices, including most of our products. Many of our new products fall into FDA classifications that require notification submitted as a 510(k) and review by the FDA before we begin marketing them. Certain of our products require extensive clinical testing, consisting of safety and efficacy studies, followed by pre-market approval (PMA) applications for specific surgical indications.
The FDA's Quality System regulations set forth standards for our product design and manufacturing processes, require the maintenance of certain records and provide for inspections of our facilities by the FDA. There are also certain requirements of state, local and foreign governments that must be complied with in the manufacture and marketing of our products.
The member states of the European Union (EU) adopted the European Medical Device Directives, which form a single set of medical device regulations for all EU member countries. These regulations require companies that wish to manufacture and distribute medical devices in EU member countries to meet certain quality system requirements and obtain CE marking for their products. We have authorization to apply the CE marking to substantially all of our products. In addition, we comply with the unique regulatory requirements of each of the countries in Europe and other countries in which we market our products.
Initiatives to limit the growth of general healthcare expenses and hospital costs are ongoing in the markets in which we do business. These initiatives are sponsored by government agencies, legislative bodies and the private sector and include price regulation and competitive pricing. It is not possible to predict at this time the long-term impact of such cost containment measures on our future business. In addition, business practices in the healthcare industry are scrutinized, particularly in the United States, by federal and state government agencies. The resulting investigations and prosecutions carry the risk of significant civil and criminal penalties.
Environment
We are subject to various rules and regulation in the United States and internationally related to the protection of human health and the environment. Our operations involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. We believe our policies, practices and
| Dollar amounts in millions except per share amounts or as otherwise specified. | 2 |
STRYKER CORPORATION 2017 FORM 10-K
procedures are properly designed to comply, in all material respects, with applicable environmental laws and regulations. We do not expect compliance with these requirements to have a material effect on purchases of property, plant and equipment, cash flows, net earnings or competitive position.
Employees
On December 31, 2017 we had approximately 33,000 employees globally.
Executive Officers
| As of January 31, 2018 | |||
| Name | Age | Title | First Became an Executive Officer |
| Kevin A. Lobo | 52 | Chairman and Chief Executive Officer | 2011 |
| Yin C. Becker | 54 | Vice President of Communication and Public Affairs | 2016 |
| William E. Berry Jr. | 52 | Vice President, Corporate Controller and Principal Accounting Officer | 2014 |
| Glenn S. Boehnlein | 56 | Vice President, Chief Financial Officer | 2016 |
| Lonny J. Carpenter | 56 | Group President, Global Quality and Business Operations | 2008 |
| M. Kathryn Fink | 48 | Vice President, Chief Human Resources Officer | 2016 |
| David K. Floyd | 57 | Group President, Orthopaedics | 2012 |
| Michael D. Hutchinson | 47 | General Counsel | 2014 |
| Graham A. McLean | 53 | President, Asia-Pacific | 2017 |
| Katherine A. Owen | 47 | Vice President, Strategy and Investor Relations | 2007 |
| Bijoy S.N. Sagar | 49 | Vice President, Chief Information Officer | 2014 |
| Timothy J. Scannell | 53 | Group President, MedSurg and Neurotechnology | 2008 |
Each of our executive officers was elected by our Board of Directors to serve in the office indicated until the first meeting of the Board of Directors following the annual meeting of shareholders in 2018 or until a successor is chosen and qualified or until his or her resignation or removal. Each of our executive officers held the position above or served Stryker in various executive or administrative capacities for at least five years, except for Ms. Fink and Mr. Sagar. Prior to joining Stryker in October 2013, Ms. Fink held a variety of senior level human resources roles for the previous six years at Johnson & Johnson, most recently as the Worldwide Vice President, Human Resources of Ethicon. While at Stryker, Ms. Fink held two different senior level Human Resource roles. Prior to joining Stryker in May 2014, Mr. Sagar served as the Chief Information officer for Merck Millipore, and before that as Global Head of Information Systems and a member of the divisional board for the chemicals division of Merck KGaA. Mr. McLean was appointed to the position of President, Asia-Pacific, effective January 1, 2017. Prior to this role, Mr. McLean held a variety of senior level leadership roles at Stryker since 2005.
Available Information
Our main corporate website address is www.stryker.com. Copies of our filings with the United States Securities and Exchange Commission (SEC) are available free of charge on our website within the "Investors Relations" section as soon as reasonably practicable after having been electronically filed or furnished to the SEC. All SEC filings are also available at the SEC's website at www.sec.gov.
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