BBI Contributing Editor

DUSSELDORF, Germany The European medical device market has historically proven to be an attractive arena for the introduction of innovative technologies, due to a less challenging regulatory approval environment and interest among the physician community in evaluating new approaches for the diagnosis and treatment of disease. The MEDICA exhibition, held here in November, often serves as the venue for the introduction of the newest medical devices in the European market, and is the world's largest showcase for medical products. At the November meeting, products for remote patient monitoring were exhibited by a number of companies, as well as products for monitoring of patients in the critical-care setting. Advanced technologies for acquiring and managing patient data are attracting considerable attention as Europe moves closer to adopting a universal patient data card for storage of electronic medical records. The transition to personal electronic medical data cards, scheduled to occur in Germany in mid-2006, is another example of the early adoption of new medical technologies in Europe and will create the foundation for the next generation of patient data systems.

Growth in telemedicine, remote telemonitoring

A wide variety of telemedicine and telemonitoring technologies have been introduced in the European market over the past few years. Remote telemonitoring, being used both for home healthcare as well as disease management, is a rapidly growing segment of the telemedicine market in Europe that, while representing only a small proportion of the total medical device market at present, is expected to be one of the most rapidly growing segments of the market in Europe over the next few years, with a projected compound annual growth rate in excess of 50% through 2009. Table 1 below lists key suppliers of remote telemonitoring products, including those in Europe, their products in the segment, and their market positioning and strategy. The competitors in the market are mainly smaller companies at present that are specializing in dedicated monitoring systems focused on the unique needs of the market for monitoring patients in the home and other alternate site settings. However, as shown in Table 1, certain major players in the medical device market also have entered the segment, such as Philips Medical Systems (Best, the Netherlands) and Bayer Diagnostics (Tarrytown, New York), via a joint venture with Matsushita (Tokyo). Most recently, companies from outside the medical device industry including Motorola (Schaumberg, Illinois), Samsung (Seoul, South Korea) and Honeywell International (Morristown, New Jersey) have announced new ventures to develop products for remote telemonitoring, or, as in the case of Honeywell, entered the market via acquisition. As shown in Table 2, the global market for remote telemonitoring products and services exceeded $60 million in 2003, and is expected to reach about $345 million by 2009. Those estimates exclude the market for cardiac telemonitoring products and services, such as the products marketed worldwide by CardGuard (Schaffhausen, Switzerland), the leading supplier of remote ECG monitoring products, as well as products for Holter monitoring.

Most sales of remote telemonitoring products and services are realized in the U.S. at present. The U.S. accounted for more than 85% of the global market in 2003. While other regions, such as Europe, are expected to account for an increasing share of the global market in the future, the U.S. is forecast to continue to dominate the market throughout the remainder of the decade. Nevertheless, some European suppliers have already entered the market in the U.S., although their revenues were insignificant in 2004. Key companies in Europe include Vitaphone (Mannheim, Germany), which has been selling its cellphone-based ECG monitor for about four years; Telcomed/Medic4all (Dublin, Ireland) and RTX Healthcare (Noerresundby, Denmark). Vitaphone has about 4,500 users in Europe, including physicians and patients, and provides its monitoring device and call center service to users at a monthly rate of between EUR 17 and EUR 46 per month depending on the type of device and the number of ECGs sent. The company's call center in Germany is staffed by 12 physicians and 35 assistants and operates 24/7. The newest version of the monitor, the Vitaphone 1100, includes individual colored buttons that allow the patient to call the monitoring center in an emergency situation or to directly contact support team members. The Vitaphone also includes a built-in GPS device that allows the monitoring center to pinpoint the location of a caller. Vitaphone is planning a major expansion of the capabilities of its monitor in the second half of this year with the addition of sensors for blood pressure, glucose and body mass. The launch of the new multi-parameter Vitaphone is timed to take advantage of the introduction of the national electronic patient record system in Germany. According to analysts from Frost & Sullivan (London) cited by Vitaphone, more than 4 million cardiac patients will own mobile devices that will monitor their cardiac rhythms by 2011 in Europe alone. Telcomed, a unit of Medic4All, is another supplier of remote telemonitoring devices in Europe that is aggressively expanding its product portfolio. Telcomed introduced its new WristClinic monitor at the MEDICA exhibition a wrist-worn, battery-powered device that measures and stores blood pressure, single-lead ECG, heart rate, breathing rate, oxygen saturation and body temperature readings, and transmits the data via a wireless interface to a gateway unit placed in the patient's home. The gateway forwards the data via regular telephone lines or an Internet connection to a monitoring center. Telcomed does not provide monitoring center services. The company also sells the MiniClinic, a wristwatch-type monitor that tracks heart rate, heart rhythm, 1-lead ECG, breathing rate, and body temperature, and also includes an optional distress alarm. The company has sold thousands of the MiniClinic units in Europe. Other Telcomed products include a wireless weight scale and a wireless blood pressure monitor. In mid-2005, Telcomed plans to launch a new version of the WristClinic that will have cellular telephone capability, allowing the wrist unit to communicate directly to a monitoring center.

Docinfo Ltd. (Szentendre, Hungary) exhibited the CARDY personal ECG monitor, a compact, handheld device that measures either a 6-lead (home version) or 12-lead (lab version) ECG and provides automatic interpretation of cardiac rhythm disorders. The EUR 250 device, which has been on the market in Hungary for about two years, can compare an ECG measured by a patient in the home with a reference ECG taken by a physician and stored in the device's memory. An algorithm in the CARDY's software assesses differences in the ECG pattern vs. the stored reference, and provides a simple interpretative output to the patient. If the result indicates significant abnormalities, the patient can visit a cardiologist who can download the data to assess the ECG in the office. In addition to monitoring of patients with cardiac rhythm disorders, the CARDY can be used to monitor patients undergoing total parenteral nutrition therapy in the home, since cardiac arrhythmias are a common side effect of such treatment.

Alive Technologies (Queensland, Australia) is another medical device company that is targeting the mobile cardiac monitoring market, with a new patient-attached ECG monitor that transmits data wirelessly to Bluetooth-enabled devices within a range of 100 meters including mobile phones, PDAs or personal computers. Applications include the management of atrial fibrillation and heart failure, cardiac rehabilitation and fitness monitoring. The device is capable of two-way communication with a central monitoring center. Alive also is developing a mobile diabetes management system that will provide automatic real-time records of blood glucose readings via a wireless Bluetooth interface module that mates to a glucometer.

Micrel Medical Devices (Athens, Greece) introduced a new version of its Rhythmic ambulatory infusion pump family that brings telemonitoring capability to home drug delivery. A mobile phone module has been developed by Micrel Medical that can interface to the company's Rhythmic pump to provide remote monitoring of pump settings, detect depletion of the drug reservoir bag and provide remote start/ stop of infusion. The data module transmits via the TCP/IP protocol to a server in Greece. The company is establishing a monitoring service center to manage patients who are receiving home infusion therapy, and planned to have the center operational early this year. A new device is in development that will have the capability to monitor ECG and oxygen saturation (via an earlobe sensor) and link to the mobile phone data transmitter via a short-range wireless area network. The device will automatically analyze the vital signs data along with infusion data, and transmit to the monitoring center when abnormal readings are detected.

Geratherm Medical (Geschwenda, Germany), one of the leading suppliers of body temperature measurement devices worldwide, is another European company that is targeting expansion into the remote telemonitoring market. Geratherm is developing a new family of mobile, Internet-compatible temperature monitors which will store body temperature data over time, and transmit the data to a physician via a telecommunication interface. The new monitors will be targeted at applications in home healthcare and clinics, with particular emphasis on prenatal and ovulation monitoring.

The leading supplier in the worldwide remote telemonitoring products market, HomMed (Brookfield, Wisconson), also is continuing to expand its product portfolio. HomMed, which is in the process of being acquired by Honeywell International (Morristown, New Jersey), claims an 80% share of the home telemonitoring products market in the U.S., with more than 250 clinical sites including home care agencies and hospitals using its Sentry and Genesis monitors, and a base in excess of 250,000 patients who have used its monitoring devices. At present, more than 20,000 patients transmit vital signs and other medical data from HomMed monitors to monitoring centers daily. HomMed is planning to expand into the European market via a distributor partnership. In addition, the company is expanding the range of parameters that can be monitored from blood pressure, heart rate, temperature, body weight, glucose, PT/INR, ECG and spirometry data to include medication monitoring.

At MEDICA, HomMed exhibited a prototype device for medication management called MedPartner that communicates with the Genesis home telemonitoring system via a wireless interface, and allows a telenurse in a remote monitoring center to set up a drug dosage schedule for a particular patient and to then monitor compliance on a real-time basis. The company has data showing that, in the U.S., 10% of hospital admissions are caused by taking the wrong drug or by not taking a drug when scheduled. The MedPartner will allow patients to track their own medication dose based on the positions of pill containers loaded onto a tray, while simultaneously sending data on patient access to the tray via the telemonitoring interface. The acquisition of HomMed by Honeywell provides the company with considerable financial resources and gives Honeywell a leading position in one of the most rapidly growing segments of the medical device market.

Medication compliance monitoring is a new application that is beginning to attract the interest of a number of existing suppliers of telemonitoring equipment as well as some new market entrants. Informedix (Rockville, Maryland) is an early stage company that is developing the Med-eMonitor, a dedicated telemonitoring device for monitoring medication compliance. The Med-eMonitor includes an integrated pill tray and a large screen and pushbuttons to allow the patient to respond to questions about medication usage, and also electronically tracks access to drugs via the pill tray. The system includes 50 virtual compartments, in addition to physical compartments used for drug storage and dispensing. The virtual compartments can be used to track other facets of the treatment program such as performing blood pressure readings or body weight measurements. The primary application being targeted by Informedix initially is monitoring of medication compliance of patients in pharmaceutical clinical trials. Informedix has reported a partnership with McKesson Biosciences, a subsidiary of McKesson (San Francisco), for joint development of a medication compliance system for use in clinical trials and last fall said that Enhanced Care Initiatives (Trumbull, Connecticut) will purchase a number of customized Med-eMonitors for use in its disease management programs, focusing on the management of complex psychiatric patients and frail, elderly patients.

To date, the major global suppliers of patient monitoring equipment have not established a significant presence in the remote telemonitoring market, at least for monitoring of patients outside the hospital. Philips Medical is a notable exception, having participated in the market for a few years, with a product line that includes a number of vital signs monitoring devices including sensors for body weight, blood pressure, pulse and heart rhythm, which interface wirelessly to the Philips TeleStation. The TeleStation communicates via regular telephone lines to a monitoring center operated by the healthcare provider. So far, Philips has had some successes in the market in the U.S., although its market position is well behind that of leaders such as HomMed and Alere Medical (Reno, Nevada). However, Philips, in partnership with Comcast (Philadelphia), is developing a next-generation system that may provide a vehicle for achieving greater penetration of the market. The new system, Motiva, will employ an always-on, broadband communications link between the patient and a monitoring center, and will provide wireless interfaces to various vital signs sensors, plus a video interface to a nurse or physician at a monitoring center for patient exams as well as educational sessions to help patients improve the management of chronic diseases. Comcast is providing broadband access for users, and a pilot study of the Motiva platform is under way at Cardiovascular Associates of the Delaware Valley (Haddon Heights, New Jersey), a U.S.-based physicians' group. The company also planned to report the initial results of a study performed with the Motiva system in Europe early this year.

Alere Medical, No. 2 player in the remote telemonitoring market, offers home patient monitoring services, using its DayLink Monitor that is placed in a patient's home to track body weight and responses to scripted questions that provide information on symptoms. Alere does not sell equipment, but provides the monitors as part of a contract that also includes telenurse monitoring services through the company's own call center. Alere reported sales of $17.6 million in 2003 and a 411% compound annual growth rate in sales over the prior four years. The company focuses on management of patients with congestive heart failure, using changes in body weight and other symptoms to provide an early indication of deterioration in the patient's condition. Alere has initiated a program to develop monitoring services for patients with coronary artery disease, and it also is engaged in a pilot study with Roche Diagnostics (Indianapolis) for monitoring of patients with diabetes.

Growth of the U.S. market for remote telemonitoring products and services is likely to be stimulated over the next few years by a group of programs recently initiated by the Centers for Medicare & Medicaid Services (Baltimore) the Voluntary Chronic Care Improvement Programs. The programs are being conducted by a number of commercial disease management providers, in some cases in collaboration with remote telemonitoring equipment suppliers, to assess various approaches to improving the management of chronic diseases by helping patients adhere to their physicians' plans of care and ensuring that patients receive the medical care they need to reduce their risk of having adverse events. Although not all of the programs are using telemonitoring as a tool to improve care, a number will employ various types of telemonitoring technology. If the technology assessments performed in the first phase of the program find that telemonitoring has value in improving chronic disease management, the Medicare program will automatically begin to reimburse for use of such technology. That will remove one of the main barriers limiting growth of the remote telemonitoring market at present, and lead to more rapid expansion.

In Europe, the impending implementation of electronic medical records (EMRs), along with "smart cards" that will be used to record individualized patient data, is another factor that could stimulate growth in electronic patient monitoring technologies. By providing patients with access to their medical information, health systems in Europe may succeed in better motivating patients to help manage their own care, in part by increasing their awareness of their condition, improving medication compliance, and increasing their understanding of the factors that are important in determining outcome. As a result, remote telemonitoring suppliers in Europe anticipate that the market will be increasingly receptive to telemonitoring products and services, and to related healthcare information services that facilitate patient understanding of their disease and treatment modalities. One of the leading companies targeting the market for personal EMRs is LifeSensor/InterComponentWare (Walldorf, Germany). LifeSensor has developed an electronic medical record that will be compatible with the requirements of major countries such as Germany.

The basic LifeSensor service is priced at EUR 34.80 per year, and based on a web-based application service provider (ASP) business model. The service provides individuals with an interactive personal health record that is created by the individual patient and which can be accessed by authorized healthcare professionals as needed. The LifeSensor record provides secure storage of results from diagnostic procedures, immunizations, medication use, allergies and other critical health data. Data can be input manually or electronically from monitoring devices or other computerized sources of health information. Data types include radiological images, audio, medical device data, graphics and hypertext documents. In addition to the basic LifeSensor record (LifeSensor START), the company also offers specialized modules priced at EUR 18 to EUR 26 per year including the LifeSensor Diabetes Assistant, LifeSensor Connector (for direct storage of data from medical devices), LifeSensor Fitness Assistant, the LifeSensor Mother and Child package, and the LifeSensor Breast Cancer Assistant. The basic LifeSensor system already is implemented, primarily in Germany, where tens of thousands of patients are using it. It will be fully implemented in 2006 when the German health card system becomes operational. InterComponentWare has established an office in San Mateo, California, and also is in discussions with partners to implement the system in Australia and Eastern Europe.

Advances in patient monitoring

A number of new products for use in the traditional patient monitoring equipment market also were introduced at the MEDICA exhibition. A key trend is the development of less-invasive monitoring devices to replace the need for invasive monitoring techniques associated with a risk of adverse events, particularly in the critical care setting. A new, less invasive hemodynamic monitor the HeartSmart was described at MEDICA by Medics Research (Bradford, UK). The HeartSmart uses physiological parameters, including central venous pressure, heart rate, blood pressure and core body temperature, to provide all of the hemodynamic data associated with the Swan-Ganz pulmonary artery catheter. The Swan-Ganz catheter is an invasive device that has been used for decades to monitor hemodynamic parameters such as cardiac output in critically ill patients. Its use, however, has been associated with an elevated incidence of adverse events, leading clinicians to seek less invasive alternatives. As shown in Table 3, the market for noninvasive hemodynamic monitoring products is expected to grow at a substantially higher rate than that for invasive pulmonary artery catheters.

The HeartSmart software, which has been evaluated in clinical trials, has been shown to have the capability to provide estimates of pulmonary artery wedge pressure that are accurate to within a few millimeters (as compared to invasive measurements), and to provide accurate cardiac output readings. Other noninvasive techniques for measuring cardiac output, such as impedance cardiography and Doppler ultrasound, have the limitation of not being able to provide pressure data. Medics Research planned to begin shipments of the HeartSmart software product in January and is also developing a completely noninvasive hemodynamic monitor.

Another European supplier of noninvasive hemodynamic monitoring products, Medis GmbH (Ilmenau, Germany), exhibited the Niccomo system. The EUR 12,000 monitor (EUR 17,000 with options) combines impedance cardiography with peripheral pulse wave velocity measurements to provide continuous cardiac output readings. In addition, simultaneous monitoring of central and peripheral blood flow with the device provides data that can be used to provide early recognition of systemic syndromes such as shock. Medis, which also distributes the BioZ impedance cardiography system from CardioDynamics (San Diego), has placed about 20 of its Niccomo systems since the product was introduced a year ago. The system also has applications in optimization of pacemaker settings, cardiac screening, diagnosis of vascular disorders and monitoring of hemodialysis patients to prevent cardiovascular shock.

Other suppliers of less invasive or noninvasive hemodynamic monitoring systems exhibiting at MEDICA included USCOM (Sydney, Australia), Pulsion Medical Systems (Munich, Germany), Cheer Sails Medical (Hong Kong) and CNSystems Medizintechnik (Graz, Austria). The USCOM 1A noninvasive cardiac output monitor uses transcutaneous continuous wave Doppler ultrasound technology to monitor cardiac output on a beat-to-beat basis, and is configured as a compact, portable device that requires no disposable components. The Pulsion PiCCO plus Monitor is a less-invasive hemodynamic monitor that uses pulse contour analysis of the arterial pressure waveform (obtained via the femoral or axillary artery) plus thermodilution measurements from a central venous catheter; a right heart catheter is not required. According to Pulsion, more than 250,000 patients have been monitored with its system.

At the German Congress on Intensive Care and Emergency Medicine, or DIVI Congress, held in early December following the MEDICA exhibition, a number of prominent German intensivists said that the Pulsion PiCCO technology represents a new clinical standard for hemodynamic monitoring in Germany, replacing the right heart catheter which has lost its status as a standard of clinical practice. While, as the data in Table 3 shows, invasive hemodynamic monitoring remains the predominant method in use worldwide, trends, as indicated by the recent pronouncements in Germany, favor the increased use of less-invasive technologies in the future, at the expense of invasive monitoring. Systems such as the CSM-3000 noninvasive cardiac function monitor from Cheer Sails Medical, the BioZ monitor from CardioDynamics and the Task Force Monitor, all of which employ impedance cardiography to measure cardiac output, also are expected to benefit from the trend toward increasing use of noninvasive hemodynamic monitoring.

Additional advances in patient monitoring technology were reported at the MEDICA exhibition by GE Healthcare (Waukesha, Wisconsin) and Viasys Healthcare (Conshohocken, Pennsylvania). GE introduced the IMM Cellular Viewer, a cellphone with a screen that allows physicians to remotely view vital signs data from a bedside monitor in the hospital. The device uses a GPRS data interface and serves to extend the monitoring network to essentially any location with cellular telephone service. Any client who has authorized access to the hospital's electronic data network can use the system. A secure connection to the physician's cellphone is established via an Internet gateway. Importantly, the GE data system represents a low-cost solution for remote monitoring of patients, since it relies on the existing hospital network as well as the ubiquitous cellular telephone network.

Viasys introduced at MEDICA the FlowScreen spirometer, which is manufactured by the company's Jaeger unit. The Flowscreen is not yet available in the U.S. pending 510(k) clearance. It is a full-function spirometer in a compact, tabletop package with an integrated printer suitable for use in either the hospital or a physician's office setting. An important feature of the FlowScreen is its full-color display and ease of use, which allows untrained personnel to perform complex spirometry testing.

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