Masimo Profile
Masimo Corporation operates as a global technology company.
Segments
The company operates through two segments, Healthcare and Non-healthcare.
Healthcare
This segment develops, manufactures, and markets a variety of noninvasive patient monitoring technologies, hospital automation and connectivity solutions, remote monitoring devices and consumer health products. The company’s patient monitoring solutions generally incorporate a monitor or circuit board, proprietary single-patient use or reusable sensors, software, cables, and other services.
The company primarily sells its healthcare products to hospitals, emergency medical service (EMS) providers, home care providers, physician offices, veterinarians, long-term care facilities and consumers through the company’s direct sales force, distributors and original equipment manufacturer (OEM) partners, such as GE Healthcare, Hillrom, Mindray, Philips, Physio-Control, and Zoll, just to name a few.
The company’s core measurement technologies are the company’s breakthrough Measure-through Motion and Low Perfusion pulse oximetry, known as Masimo Signal Extraction Technology (SET) pulse oximetry, and advanced rainbow Pulse CO-Oximetry parameters, such as noninvasive hemoglobin (SpHb), alongside many other modalities, including brain function monitoring, hemodynamic monitoring, regional oximetry, acoustic respiration rate monitoring, capnography and gas monitoring, nasal high-flow respiratory support therapy, patient position and activity tracking and neuromodulation technology solutions.
The company’s measurement technologies are available on many types of devices, from bedside hospital monitors like the Root Patient Monitoring and Connectivity Hub, to various handheld and portable devices, and to the tetherless Radius-PPG, Radius-VSM and Masimo SafetyNet remote patient surveillance solution. The Masimo Hospital Automation Platform facilitates data integration, connectivity and interoperability through solutions like Patient SafetyNet, Iris, iSirona, Replica and UniView to facilitate more efficient clinical workflows and to help clinicians provide the best possible care, both in-person and remotely. Leveraging the company’s expertise in hospital-grade technologies, the company is also expanding its suite of products intended for use both inside and outside the hospital and products for personal home wellness, including Masimo Sleep, a sleep quality solution, the Masimo Radius Tº wireless, a wireless wearable continuous thermometer, the Radius C wireless tetherless capnograph, and the Masimo W1 a wrist worn continuous biosensing health watch.
Non-healthcare
This segment’s consumer audio business develops, manufactures, markets, sells, and licenses premium and luxury audio, and related integration technologies. The company’s consumer audio products are sold direct-to-consumers or through authorized retailers and wholesalers. The company also licenses certain audio technologies to select luxury automotive manufacturers, such as BMW, Maserati, McLaren, Polestar, and Volvo. In addition, the company maintains partnerships with certain airlines for bespoke headphones, allowing for the best in-flight audio experience. The company’s premium and luxury audio business include iconic brands like Bowers & Wilkins, Denon, Marantz, Polk, Definitive Technology, Classe, Boston Acoustics and HEOS, to meet differentiated consumers wants and needs.
Strategy
Some of the company’s key strategic initiatives are to continue to expand the company’s market share across the company’s product categories; continue to innovate and maintain the company’s technology leadership position; expand connectivity and wearables in hospitals and into the home and consumer market; utilize the company’s existing customer base and OEM relationships to market additional product offerings; define and leverage shared Masimo product platforms to scale resources and connected technologies; diversify products to ensure continued operations; expand sales and marketing infrastructure to aid in future grown initiatives; increase efficiency and capacity through internal manufacturing capabilities combined with proven outsourced manufacturing partners; grow the company’s international presence through brand awareness and marketing; expand the company’s direct-to-consumer efforts through existing channel partners and prospective customers; and supplement the company’s internal growth and expand the company’s product portfolio with strategic acquisitions, investments and partnerships.
Technologies
Conventional Pulse Oximetry
Pulse oximetry enables the noninvasive measurement of the oxygen saturation level of arterial blood (SpO2), which delivers oxygen to the body’s organs and tissues. Pulse oximetry also measures pulse rate (PR), which, when measured by electrocardiogram (ECG), is called heart rate. Pulse oximeters use sensors attached to an extremity, typically the fingertip or certain core body sites. These sensors contain two light-emitting diodes that transmit red and infrared light from one side of the extremity through the tissue to a photodetector on the other side of the extremity. The photodetector in the sensor measures the amount of red and infrared light absorbed by the tissue. A microprocessor then analyzes the changes in light absorption to provide a continuous, real-time measurement of the amount of oxygen in the patient’s arterial blood. Pulse oximeters typically give audio and visual alerts, or alarms, when the patient’s arterial blood oxygen saturation level or pulse rate falls outside of a user-designated range. As a result, clinicians have the opportunity to assess patients who may need immediate treatment to prevent the serious clinical consequences of hypoxemia, or low arterial blood oxygen saturation levels, and hyperoxemia, or high arterial blood oxygen levels.
As one of the most common technologies used in and out of hospitals around the world, pulse oximetry has gained widespread clinical acceptance as a standard patient vital sign measurement because it can give clinicians a warning of possible hypoxemia or hyperoxemia. SpO2 monitoring of oxygen saturation is critical because hypoxemia can lead to a lack of oxygen in the body’s tissues, which can be toxic and result in organ damage or death. Pulse oximeters are used in a variety of critical care settings, including surgery, recovery rooms, intensive care units (ICUs), emergency departments and general care floors, as well as alternative care settings, such as long-term care facilities, physician offices and the home monitoring of patients with chronic conditions. Clinicians also use pulse oximeters to monitor oxygen saturation in premature babies to ensure that appropriate oxygen saturation levels are maintained.
Conventional pulse oximetry has limitations that can reduce its effectiveness and the quality of patient care. In particular, when using conventional pulse oximetry, oxygen saturation measurements can be distorted by motion artifact, or patient movement, and low perfusion, or low arterial blood flow at the measurement site. Motion artifact can cause conventional pulse oximeters to inaccurately measure the arterial blood oxygen saturation level, due mainly to the effect of movement-induced pulsations of venous blood, which is at a lower oxygen saturation than arterial blood. Low perfusion can also cause conventional pulse oximeters to report inaccurate measurements or, in some cases, no measurement at all. In addition, conventional pulse oximeters cannot distinguish oxygenated hemoglobin from dyshemoglobin, including the most prevalent forms of dyshemoglobins, carboxyhemoglobin and methemoglobin. As a result, conventional pulse oximeters may report falsely high oxygen levels when these dyshemoglobins are present in the blood. Furthermore, conventional pulse oximetry readings can also be impacted by bright light and electrical interference caused by the presence of electrical surgical equipment.
The Masimo Difference - Masimo SET Pulse Oximetry
Masimo SET was designed to overcome the primary limitations of conventional pulse oximetry by maintaining accuracy in the presence of motion artifact, low perfusion and weak signal-to-noise situations. The company’s Masimo SET platform is the basis of its pulse oximetry products. Masimo SET utilizes five signal processing algorithms, four of which are proprietary, in parallel to deliver high sensitivity and specificity in the measurement of arterial blood oxygen saturation levels. Sensitivity is the ability to detect true alarms and specificity is the ability to avoid false alarms. One of the company’s proprietary processing algorithms, Discrete Saturation Transform, separates the signal from noise in real time through the use of adaptive filtering and an iterative sampling technique that tests each possible saturation value for validity. Masimo SET signal processing can therefore identify the venous blood and other ‘noise’, isolate them and extract the arterial signal.
The performance of Masimo SET pulse oximetry has been evaluated in more than 100 independent studies and thousands of clinical evaluations. Masimo SET is trusted by clinicians to safely monitor in excess of approximately 200 million patients each year. Compared to conventional pulse oximeters, during patient motion and low perfusion, Masimo SET provides measurements when other pulse oximeters cannot, significantly reduces false alarms (improved specificity), and accurately detects true alarms (improved sensitivity). Masimo SET has been shown to help clinicians reduce severe retinopathy of prematurity neonates, improve CCHD screening in newborns, and, when used for continuous monitoring with Masimo Patient SafetyNet in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.
The company’s pulse oximetry technology is contained on a circuit board which can be placed inside a standalone pulse oximetry monitor, placed inside OEM multiparameter monitors, or included as part of an external ‘Board-in-Cable’ solution that is plugged into a port on an OEM or other device. All of these solutions, as well as most of the company’s patient cables, use its proprietary single-patient-use or reusable sensors. The company sells its products to end-users through the company’s direct sales force and through certain distributors, as well as to the company’s OEM partners, for incorporation into their products. In 2013, with the launch of iSpO2, the company began selling its pulse oximetry products in the consumer home wellness market.
To complement the company’s Masimo SET platform, the company has developed a wide range of proprietary single-patient-use (disposable) sensors, including untethered Radius-PPG, and multi-patient-use (reusable) sensors, cables and other accessories designed specifically to work with Masimo SET software and hardware. The company’s single-patient-use sensors offer several advantages over reusable sensors, including improved performance, cleanliness, increased comfort and greater reliability. Although the company’s technology platforms operate solely with the company’s proprietary sensor lines, its sensors have the capability to work with certain competitive pulse oximetry monitors through the use of adapter cables.
Adhesive sensors are single-patient-use items, but the U.S. Food and Drug Administration (FDA) allows third parties to reprocess pulse oximetry sensors. In response to some hospitals’ requests to implement environmentally friendly products, the company offers sensor reprocessing, as well as sensor recycling programs.
Masimo Rainbow SET Platform and Other Technology Solutions
Since introducing Masimo SET, the company has continued to innovate by introducing noninvasive measurements that go beyond arterial blood oxygen saturation and pulse rate. The company’s Masimo rainbow SET platform leverages the company’s Masimo SET technology and incorporates licensed rainbow technology to enable real-time monitoring of additional noninvasive measurements. The company’s rainbow SET platform includes its rainbow SET Pulse CO-Oximetry products, which are the first devices cleared by the FDA to noninvasively and continuously monitor additional hemoglobin species that were previously only measurable using intermittent invasive procedures using multiple wavelengths of light.
In addition to SpO2, PR, perfusion index (Pi), Pleth Variability Index (PVi), Rainbow Pleth Variability Index (RPVi) and respiration rate from the pleth (RRp), rainbow Pulse CO-Oximetry has the unique ability to measure and distinguish oxygenated hemoglobins from the dyshemoglobins that are incapable of transporting oxygen, carboxyhemoglobin (SpCO) and methemoglobin (SpMet). Besides the ability to measure SpCO and SpMet, the Masimo rainbow SET platform also allows for the noninvasive and continuous monitoring of total hemoglobin concentration (SpHb), as well as the monitoring of arterial oxygen saturation, in the presence of carboxyhemoglobin and methemoglobin, known as fractional arterial oxygen saturation (SpfO2). Additionally, the rainbow SET platform allows for the calculation of Oxygen Content (SpOC) and Oxygen Reserve Index (ORi). SpfO2 and ORi have received CE Marking, but are not available for sale in the U.S.
Masimo rainbow Pulse CO-Oximetry products will become widely adopted for the noninvasive monitoring of these measurements in the future. The addition of acoustic respiration rate (RRa), using the company’s rainbow Acoustic Monitoring technology, will strengthen the clinical demand for noninvasive and continuous monitoring using the company’s rainbow platform, especially in the growing general floor market.
Products with the company’s MX circuit board contain its Masimo SET pulse oximetry technology, as well as circuitry to support rainbow measurements. At the time of purchase, or at any time in the future, the company’s customers and its OEMs’ customers have the option of purchasing additional rainbow software measurements, which allow such customers to incrementally expand their patient monitoring systems with a cost-effective solution. To date, over forty companies have released rainbow SET equipped products or announced rainbow integration plans.
Following the introduction of the company’s rainbow SET platform, the company has continued to expand its technology offerings by introducing additional noninvasive measurements, technologies, platforms and other solutions to create new market opportunities in both hospital and non-hospital care settings, including the Masimo Hospital Automation Platform, other connectivity platforms, nasal high-flow ventilation, and neuromodulation therapeutics and telehealth solutions.
The Masimo Hospital Automation Platform
Patient SafetyNet, the company’s patient surveillance, remote monitoring and clinician notification solution, works in concert with the company’s bedside and ambulatory monitoring devices to facilitate the supplemental monitoring of the oxygen saturation, pulse rate, perfusion index, hemoglobin, methemoglobin and respiration rate of up to 200 patients simultaneously from a single server. Patient SafetyNet offers an intuitive and powerful user interface with trending, real-time waveform capability at a central station, as well as remote clinician notification via pager, voice-over-IP phone or smart-phones. Patient SafetyNet also features an Adaptive Connectivity Engine (ACE) that enables two-way, HL-7 based connectivity to clinical/hospital information systems. The ACE significantly reduces the time and complexity to integrate and validate custom HL-7 implementations, and demonstrates the company’s commitment to innovation that automates patient care with open, scalable and standards-based connectivity architecture.
Patient SafetyNet Series 5000, along with Hospital Automation Connectivity, Iris Gateway, Kite, iSirona, UniView, UniView: 60 and MyView through the Root patient monitoring and connectivity platform, offers a new level of interoperability designed to enhance clinician workflows and reduce the cost of care in a variety of hospital settings, including operating rooms and the general care floors. Patient SafetyNet Series 5000 with Iris ports enables Root to assimilate data from all devices connected to the patient, thereby acting as a comprehensive in-room patient monitor and connectivity hub. Alarms and alerts for all devices are seamlessly forwarded to the patient’s clinician and device data can be transferred to the patient’s electronic medical record (EMR). In an operating room setting, the patient-centric user interface of the Patient SafetyNet Series 5000 displays near real-time data from all devices with Kite, providing a single unified dashboard of patient information.
Connectivity Platforms
Despite medical technology advances, the lack of device communication and integration creates risks to patient safety in hospitals around the world. Without device interoperability, critical patient information can go unnoticed, leaving clinicians unaware and patients at risk. Existing approaches for device interoperability require separate hardware, software and/or network infrastructure, which can clutter the patient room, increase complexity, burden IT management and increase costs. To address these challenges, the company introduced Iris connectivity in its Root patient monitoring and connectivity platform. iSirona and Iris connectivity enables multiple standalone third-party devices, such as intravenous pumps (IV), ventilators, hospital beds and other patient monitors to connect through Root, enabling display, notification and documentation to the EMR through Masimo Patient SafetyNet.
The addition of Iris connectivity to Root and Patient SafetyNet provides multiple advantages to hospitals, such as allowing standalone device information to be remotely viewed at a Patient SafetyNet view station, transmitted through notification systems to clinicians regardless of location or sent to electronic health record systems. This may enhance patient assessment, clinical workflows and decision support. In addition, bringing data from disparate devices together facilitates more integrated patient care and provides a flexible and cost-effective platform, while avoiding installation of separate costly systems and potentially reducing costs by leveraging existing network infrastructure.
Nasal High-Flow Ventilation
The Masimo softFlow technology provides respiratory support by generating a precisely regulated, stable and high flow of room air or a mix of room air and oxygen through the nose of the patient by means of thin nasal prongs. Controlled oxygen supply ensures oxygenation while, at the same time, the respiratory airways are humidified. A stable air flow is essential for treating hypoxemic and hypercapnic respiratory failure. Together with the Masimo softflow nasal applicator, the Masimo softflow generator provides a constant air flow and in doing so, it is completely independent of external pneumatic systems. Due to this, the Masimo softFlow technology is able to treat respiratory insufficiency and allows therapy at home in a manner that is as reliable and efficient as in the hospital.
Neuromodulation Therapeutic
Bridge is the first FDA-cleared, drug-free, non-surgical device to use neuromodulation to aid in the reduction of symptoms associated with opioid withdrawal. Bridge can be used for patients experiencing opioid withdrawal symptoms, while undergoing treatment for opioid use disorder when initiating treatment, transitioning to naltrexone or tapering off medication-assisted treatment. In addition, Bridge may reduce pain and addiction-related side-effects. Bridge is a small electrical nerve stimulator device that contains a battery-powered chip and wires that are applied percutaneously around a patient’s ear. It requires a prescription and is offered to qualified healthcare professionals with training. Bridge has been granted a FDA 510(k) de novo classification.
Telehealth Solutions
In an effort to help clinicians and public health officials combat the COVID-19 pandemic, the company developed the Masimo SafetyNet solution. The Masimo SafetyNet solution provides continuous tetherless pulse oximetry and respiration rate monitoring coupled with a patient surveillance platform. Masimo SafetyNet solution is available worldwide. In partnership with Samsung Electronics America, Inc., the Masimo SafetyNet Patient App is available on select Samsung smartphones, pre-installed and pre-configured.
Hearables and Wearables
The company’s hearable and wearable products are engineered for a wide range of consumers, including professional athletes, medical clinicians, active lifestyle practitioners, the health conscious, online gamers, and even the most demanding of sound enthusiasts; all with differentiated technologies that leverage its legacy of trusted brands. The company’s hearable and wearable products include best-in-class health sensors and high-fidelity wireless headphones and earbuds.
Premium and Luxury Home Audio
The company’s premium and luxury home audio product range includes wireless sound bars and speakers, home theater speakers and surround sound technology, high fidelity amplifiers and processors, audio visual receivers (AVR) and components, and other accessories to address the company’s customers’ evolving audio needs and desires. In addition, the company has partnered with certain organizations that allow the company to provide the highest quality audio technologies into sound studios, home theaters, automotive and airline environments.
Products and Markets
Patient Monitoring Solutions
Circuit Boards and Modules (e.g., MX-7, MX-5, and MSX)
The company’s Masimo circuit boards perform all signal processing and other pulse oximetry functions incorporating the Masimo SET, Masimo rainbow Pulse CO-Oximetry or rainbow Acoustic Monitoring technology with specific functionality or measurements. The company’s MX-7 OEM circuit board is its latest and most advanced rainbow SET board, offering more efficient power utilization, and designed for integration into the more than 200 multi-parameter monitors available from the company’s more than 90 OEM partners. The MX-7 has the ability to support all 13 of Masimo’s SET pulse oximetry and rainbow Pulse CO-Oximetry measurements.
Monitors and Devices (e.g., Radical-7 and Rad-97 with Nomoline Capnography)
The company offers a variety of continuous bedside monitoring and transport devices suitable for all patient populations. Fueled by clinically proven Masimo SET pulse oximetry and advanced rainbow Pulse Co-Oximetry and additional noninvasive monitoring technologies, these highly versatile and configurable monitors are designed to accommodate patient scenarios across the continuum of care, from high-acuity ICUs and surgical suites, to low-acuity general floors and recovery units, to long-term care facilities and beyond.
Patient Monitoring and Connectivity Platform (e.g., Root with Radius-7, Root with NIBP and Root with Next Generation Sedline)
The company’s patient monitoring and connectivity platforms are expandable, customizable patient monitoring and connectivity hubs that integrate an array of technologies, devices and systems to provide multimodal monitoring and connectivity solutions in a single, clinician-centric platform. With plug-and-play expansion capabilities, clinicians can centralize patient monitoring by bringing together advanced rainbow SET Pulse CO-Oximetry, brain function monitoring, regional oximetry and capnography measurements on an easy-to-interpret, customizable display, empowering them with more information for making patient assessments. Further, acting as a central connectivity hub, with automated electronic charting of Masimo and third-party device data to patient data management systems (PDMS), the hub can help with manual data documentation.
Sensors (e.g. RD SedLine, TFA-1, RD SET, RD rainbow SET, O3 Pediatric, RD rainbow Lite SET, rainbow DCI-Mini, Centroid and Radius PPG)
The company’s noninvasive monitoring devices depend on reliable, high-quality sensors, cannulas, and accessories to capture the accurate, high-fidelity patient data trusted by clinicians all over the world. The company offers a wide variety of these components, all manufactured to the highest standards, many in both single-patient-use and reusable configurations, to meet a broad spectrum of monitoring needs across all patient populations and care scenarios.
Capnography and Gas Monitoring (e.g., NomoLine Cannula with Radius PCG Capnograph with disposable adapter, IRMA CO2, IRMA AX+ and EMMA)
The company offers a complete portfolio of capnography and gas monitoring solutions, both sidestream and mainstream, to meet the challenges of ventilation and gas monitoring across care areas, from pre-hospital and in-hospital to transport, long-term care, home care and more. Solutions range from external ‘plug in and measure’ gas analyzers, to bedside and handheld devices, to flexible, integrated OEM offerings.
Proprietary Measurements
The company’s proprietary measurements include SpHb, SpCO, SpMet, PVi, RRa, RRp, ORi, 3D Alarms and Adaptive Threshold Alarm.
Hospital Automation and Connectivity Suite (e.g., Iris Connectivity, Iris Gateway, iSirona, Patient SafetyNet, UniView, UniView: 60, Replica, Iris Analytics, and Halo ION)
The company’s automation solutions are revolutionizing not only the kind of patient data that can be collected and moved through the continuum of care, but also how that information can empower clinicians to deliver superior, evidence-based care.
The company’s hospital automation integrates patient monitoring, driven by clinically proven SET pulse oximetry and rainbow Pulse CO-Oximetry, with sophisticated connectivity and interoperability solutions to seamlessly provide access to the most accurate, relevant patient data in the most helpful ways at the most important moments, improving workflow efficiencies and helping clinicians deliver the best care possible.
Nasal High Flow Ventilation (e.g., Masimo softFlow 50 and Masimo softFlow junior)
Therapy with Nasal Insufflation (TNI) generates a precisely regulated, stable high flow from room air or a mix of room air and oxygen. A stable air flow is essential for treating hypoxemic and hypercapnic respiratory failure. Together with the TNI applicator (comprising respiratory circuit and patient interface), the TNI flow generator guarantees a constant TNI flow and in doing so, it is completely independent of external pneumatic systems. Due to this, the Masimo softFlow is able to treat respiratory insufficiency and allows therapy at home as reliable and efficient as in the hospital.
Advanced Hemodynamic Monitoring Solutions (e.g., Masimo LiDCO Hemodynamic Monitoring system, Double Channel Pressure Transducer and Stimpod NMS450X Peripheral Nerve Stimulator)
The Masimo LidCO Hemodynamic monitoring system provides beat-to-beat advanced monitoring to support informed decision-making in high-acuity care areas like an operating room. This platform uses an already existing arterial line and blood pressure transducer to monitor hemodynamic parameters through the use of the PulseCO algorithm, which converts beat-to-beat blood pressure into its constituent parts, flow and resistance, which is scaleable to each patient’s age, height, and weight.
Home Wellness and Remote Patent Monitoring Solutions to Extend Care from the Hospital to the Home (e.g., Masimo SafetyNet, Radius T°, Masimo Sleep, MightySat with PVi and RRp, iSpO2, Bridge, and Masimo W1)
Designed to help providers remotely manage patient care, Masimo SafetyNet is a secure, scalable, cloud-based patient management platform featuring clinical-grade spot-checking and continuous measurements, digital care pathways and remote patient surveillance.
Hearables and Wearables
The company’s hearables and wearables are Masimo W1, Bowers & Wilkins Px8 007 Edition and Bowers & WilkinsPi5 earbuds.
Premium and Luxury Home Audio
The company’s premium and luxury home audio include Bowers & Wilkins 600 series anniversary series loudspeakers, Bowers & Wilkins home theater collection, Denon soundbar and speaker set.
Cercacor Laboratories, Inc.
Cercacor Laboratories, Inc. (Cercacor) is an independent entity spun-off from the company to the company’s stockholders in 1998. The company is a party to a cross-licensing agreement with Cercacor, which was amended and restated effective January 1, 2007 (the Cross-Licensing Agreement), which governs each party’s rights to certain intellectual property held by the two companies.
Government Regulation
Product Clearance and Approval Requirements for Medical Devices
Many of the company’s healthcare products are regulated by numerous government agencies, the most significant of which are the FDA, the national authorities in the European Union (EU) and the United Kingdom (U.K.), and the Ministry of Health, Labour and Welfare (MHLW) of Japan.
In the U.S., unless an exemption applies, each medical device that the company wishes to market in the U.S. must, generally, first receive from the FDA either clearance of a 510(k) premarket notification or approval of a premarket application (PMA). The majority of the company’s regulated products have been deemed Class II devices, requiring 510(k) clearance, while some have been deemed Class I devices.
Most of the company’s OEM partners are required to obtain clearance or approval of their devices that incorporate Masimo’s healthcare technologies, like Masimo SET technology, Masimo rainbow SET technology, Masimo Board-in-Cable technology, or are used with Masimo’s sensors. The company generally grants its OEM partners a right to cross-reference the 510(k) submission files from the company’s cleared Masimo SET circuit boards, sensors, cables and notification systems.
The company’s international operations are subject to the Foreign Corrupt Practices Act of 1977 (FCPA), the U.K. Bribery Act 2010 and other foreign anti-corruption laws. As part of the company’s compliance program, the company trains its U.S. and international employees, and the company also trains and monitors foreign third parties with whom the company contracts (e.g., distributors), to comply with the FCPA and other anti-corruption laws.
The company is subject to stringent international, federal, state and local laws relating to the protection of the environment, including those governing the use, handling and disposal of hazardous materials and wastes. Products that the company sells in Europe are subject to regulation in EU markets under the Restriction of Hazardous Substances Directive (RoHS).
Other regulations, which affect the product content, manufacturing, and packaging of the company’s products include, for example, the Registration, Evaluation, Authorization and Restriction of Chemical substances, the Waste Electrical and Electronic Equipment Directive, and the Directive on Packaging and Packaging Waste enacted in the EU which require the registration of and regulate the use of certain hazardous substances and chemicals in certain products the company manufactures, and requires the collection, reuse and recycling of waste product and packaging from, certain products the company manufactures.
Markets
The company sells its healthcare products directly to hospitals and various distributors in the U.S. and around the world, including Europe, the Middle East and the Asia Pacific, through the company’s direct sales force. The company sells its home wellness products through e-commerce internet sites, such as www.masimopersonalhealth.com, www.amazon.com, and www.shopify.com.
The company’s healthcare sales representatives’ primary focus is to facilitate the conversion of competitor accounts to the company’s Masimo SET pulse oximetry and rainbow SET Pulse CO-Oximetry products, to expand the use of Masimo SET and Patient SafetyNet on the general hospital floor and to create and expand the use of rainbow measurements in both critical care and non-critical care areas. In addition to sales representatives, the company employs clinical specialists to work with its sales representatives to educate end-users on the benefits of Masimo SET and assist with the introduction and implementation of the company’s technology and products to their sites.
Additionally, the company sells certain of its healthcare products through the company’s OEM partners who incorporate its technologies into their monitors and sometimes resell the company’s sensors to their installed base. The company’s OEM agreements allow the company to expand the availability of its technologies through the sales and distribution channels of each OEM partner. To facilitate clinician awareness of Masimo technologies, the company’s OEM partners have generally agreed to place the applicable Masimo trademark prominently on their instruments.
The company sells its non-healthcare products primarily through over 20,000 points of global retail distribution and the company’s products are distributed in more than 130 countries. The majority of the company’s non-healthcare sales are transacted through traditional physical retailers, third party distributors, and big box resellers, including on their websites. The company also sells through online retailers and custom installers and directly through the company’s individual brand websites.
Seasonality
The company’s quarterly revenues are influenced by many factors, including new product releases, acquisitions, regulatory approvals, patient holiday schedules, hospital census, the timing of influenza season, and other factors. The company’s healthcare revenues in the third quarter (year ended December 2022) of the company’s fiscal years have generally historically represented a lower percentage of segment revenues due to the seasonality of the U.S., European and Japanese markets, where summer vacation schedules normally result in fewer medical procedures utilizing the company’s healthcare products. The company’s non-healthcare revenues in the fourth quarter of a fiscal year generally produce a higher percentage of the company’s segment revenues than the other quarters of the company’s fiscal year due to the holiday shopping season and the company’s corresponding promotional activities.
Manufacturing
The company’s strategy is to manufacture products in-house when it is efficient and cost-effective for the company to do so.
Research and Development
The company’s research and development expenses were $191.4 million for the year ended December 31, 2022.
Competition
The company’s primary competitor in the healthcare market is Medtronic plc. In the non-healthcare market, the company competes with Sonos, Bang & Olufsen, Sony, Samsung (and its subsidiaries), Apple, Alphabet, Amazon, and others.
History
Masimo Corporation was founded in 1989. The company was incorporated in California in 1989 and reincorporated in Delaware in 1996.
