Medical Device Link.

Originally Published MX May/June 2005

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

With new IT-based products, medtech companies are meeting customer needs today and anticipating tomorrow's marketplace.

Steve Halasey and Art Kerley

Even among healthcare professionals who are commonly the earliest adopters of new technologies, black boxes filled with zeroes and ones don't have a lot of appeal. So it's easy to understand how some users might be tempted to disregard some of the most complex—and even revolutionary—enhancements currently being made in the world of medical product development.

But little by little, device manufacturers are beginning to incorporate high-end information technologies (IT) into their products. And in doing so, they are gradually creating a world of next-generation healthcare products with features and functionality that users care about very much. Whether the need is for easier transmission and archiving of diagnostic imaging, quicker delivery of patient information to healthcare professionals on the move, or advanced monitoring of patients in alternate-site healthcare settings, device manufacturers are framing new solutions using advanced IT systems.

Unquestionably, one of the forces impelling the development of next-generation IT-based medical products is the gradual convergence of medical technology and information technology. In many hospitals, up until just a few years ago, it was not unusual to find sophisticated, computer-controlled medical devices right alongside stand-alone products that relied on paper-based recording systems for clinical data capture. Moreover, the productivity potential of even the most advanced medical equipment was often severely compromised by its inability to share information beyond the confines of a particular department or medical specialty.

The dream of the all-digital hospital may still be a long way from full implementation, but healthcare facilities continue to plan-and buy-with that goal in mind. Increasingly, they are shunning medical devices and equipment that cannot be networked with their information systems.

While medtech manufacturers have seen device interfaces, communication standards, and networking topologies come and go over the years, most recognize that medical technology is now firmly on the path to convergence with information and communications technology. In response, they are increasingly designing and manufacturing their products to be fully compliant with industry standards.

In this special showcase, MX takes a look at just a handful of products that have embraced the IT model in the design and manufacture of medtech equipment. But judging by the flurry of activity already under way, there's lots more to come.

Imaging Information and PACs

The field of imaging has long been in the vanguard of information technology applications for medical equipment. Digital imaging and communications in medicine (DICOM) is the recognized standard for viewing and distributing high-quality images from x-ray, CT, MRI, ultrasound, and PET scanners. DICOM typically interfaces with picture archiving and communications systems (PACS), which enable detailed images to be saved, stored, and retrieved from any access point on the network.

The Sonoline G40 Ultrasound System by Siemens Medical Solutions (Malvern, PA) features onboard storage for image recording and archiving as well as DICOM capability for transmitting ultrasound images across a hospital network and beyond. (click to enlarge)

Sonoline G40 Ultrasound System by Siemens Medical Solutions (Malvern, PA), a division of Siemens AG (Erlangen, Germany). The Sonoline G40 is an all-digital, compact and mobile ultrasound imaging system featuring high image quality and work flow advancements to meet daily needs in a variety of clinical settings, including general imaging, obstetrics/gynecology, and internal medicine. The unit includes color Doppler and pulse-wave Doppler capabilities, and its phased-array technology expands the unit's clinical capabilities to include cardiac survey and small-footprint abdominal imaging. Other advances include virtual format imaging, which offers a variety of linear, trapezoidal, and steered two-dimensional imaging formats. In addition, parallel B-mode and color signal processing provides higher frame rates and a better color performance.

The system's intuitive user interface enables clinicians to offer comprehensive, diagnostic ultrasound exams to more patients in less time. A compact system design with built-in cable management offers easy transportation and micropositioning in all clinical environments, and the optional integrated workstation includes a built-in CD read/write drive for cost-effective output and archiving of exam data. In addition, embedded connectivity solutions allow integration with DICOM-enabled networks and PC-based workstations.

The open system architecture enables easy integration of advanced capabilities, such as phase inversion tissue harmonic imaging, ultimately helping customers make the most of their equipment investment. Future capabilities are expected to include three-dimensional imaging, tissue gray scale optimization technology, and synthetic aperture technology, which improves penetration and focus.

The LightSpeed VCT Scanner by GE Healthcare (Chalfont St. Giles, United Kingdom) is fully DICOM compliant with gigabit connectivity for rapid transmission of volume images for faster reading, analysis, and diagnosis. Images can be stored and retrieved via PACS. (click to enlarge)

LightSpeed VCT Scanner by GE Healthcare (Chalfont St. Giles, United Kingdom), a division of the General Electric Co., (Fairfield, CT). The GE LightSpeed volume computed tomography (VCT) scanner is a 64-slice scanner that enables clinicians to noninvasively image any organ in 1 second, scan the whole body in less than 10 seconds, and capture images of the heart and coronary arteries in fewer than five heartbeats. According to the manufacturer, it is 75 times faster than other CT scanners now on the market. The system creates 64 credit card-thin images—totaling 40 mm of anatomical coverage—in a single rotation. The images are combined to form a three-dimensional view of the patient's anatomy for the physician to analyze. The LightSpeed VCT can also be integrated with positron emission tomography (PET) technology, combining the high-speed, high-resolution capabilities of volume CT with the metabolic and physiologic capabilities of PET.

Featuring GE's Xtream technology, the LightSpeed VCT is fully DICOM compliant, providing enhanced work flow and increased productivity. The unit offers gigabit connectivity, making it possible to send images rapidly across a hospital network for speedier reading, results, and diagnosis. Images can be stored and retrieved via PACS.

Designed for single-user operation, the key to Xtream's productivity is its ability to acquire, reconstruct, film, network, archive, transfer, and review images simultaneously. The total process from scanning a patient to reading images for a diagnosis can be shortened to a fraction of the time required for previous processing technologies.

The RadNet Radiology Information System with ProVision PACS by Cerner Corp. (Kansas City, MO) enables clinicians to collect, display, manage, and instantly deliver vital information from radiology workstations to the patient's electronic health record for network access across the hospital's clinical information system. (click to enlarge)

RadNet Radiology Information System with ProVision PACS by Cerner Corp. (Kansas City, MO). ProVision PACS offers the complete range of image-management products, including acquisition, storage, display, and Web distribution devices. When combined with the RadNet radiology information system (RIS), redundant databases and historically separate interfaces can be eliminated, making the environment easier to support, reducing turnaround time, and improving productivity and patient care. Image archiving options are designed for scalability. DICOM archive solutions are available in a number of configurations.

ProVision PACS workstations offer a rich set of image analysis and manipulation tools that can be customized for each user. Protocols automatically display images in the user's preference. The RadNet RIS ProVision PACS provides a seamless connection to the electronic health record (EHR), enabling clinicians to collect, display, manage, and instantly deliver vital patient information.

Cerner is the world's largest manufacturer of EHR systems and has developed medical device interfaces for point-of-care monitoring systems, monitors, ventilators, anesthesia gas monitors, anesthesia systems, dialysis instruments, and other devices.

The Handheld Interface

By its nature, healthcare is a mobile profession. Whether making rounds at a hospital or going from patient to patient in a busy clinic or private practice, physicians cannot be tethered to fixed computer workstations to remain connected. Handheld devices, typically built around a personal digital assistant (PDA) or Tablet PC, are increasingly finding their way into a wide range of point-of-care medical devices. Typically running either the Palm or Microsoft Pocket PC operating system, these off-the-shelf devices can be readily adapted to both medical diagnostic and reference applications at relatively low cost compared with one-off, manufacturer-specific designs. Clinical data can be readily uploaded and downloaded from a PC using industry standard wired or wireless interfaces.

The IQmark Digital PDA by Midmark Diagnostics Group (Versailles, OH) is a portable device which can store hundreds of ECG and diagnostic spirometer test results and wirelessly transmit them to the hospital's information database as well as the patient's electronic health record. (click to enlarge)

IQmark Digital PDA by Midmark Diagnostics Group (MDG; Versailles, OH). MDG hasn't yet performed any time-efficiency studies regarding its products; however, the company believes devices such as the IQmark digital PDA saves healthcare personnel hundreds of hours. Typically displayed via an HP iPAQ or Dell Axim handheld, the device operates on a Microsoft Pocket PC platform. In conjunction with other MDG products, it can store hundreds of ECG and diagnostic spirometer test results. The data can also be transmitted wirelessly into a hospital's patient information database.

"If you use digital diagnostics, there is the savings of supplies, since older, stand-alone ECG and spirometer units used thermal paper which had to be kept on mounting cards to prevent it from curling," says Glen Mizelle, MDG's director of marketing. "If you kept the thermal paper as a record, you typically then had to make a photocopy of it to prevent fading. All this required extra time that personnel should be spending with patients.

"This technology can integrate the data directly into the patient's electronic medical record without the need of any additional scanning or manpower," Mizelle adds.

MDG is implementing the technology of its PDA system throughout its IQmark product line by incorporating Microsoft ActiveX Controls for healthcare software into the products. The software permits direct acquisition of data from IQmark products by electronic health record systems. Test results can be stored in a local stand-alone computer, a central network, or an advanced SQL server database for recordkeeping, future viewing, or editing.

The i-Suite by Stryker Endoscopy (Kalamazoo, MI) combines state-of-the-art surgical tools, instruments, and support systems with fully integrated access to information networks within and beyond the hospital. Offering a wide range of live video, real-time, and asynchronous image and information output which can be saved, archived, and retrieved, the i-Suite is also compatible with electronic health record systems. (click to enlarge)

Integration and Interoperable Systems

As hospitals prepare to implement end-to-end, enterprisewide information systems, integration and interoperability are the guiding watchwords. The electronic health record (EHR) will become the key focal point of clinical information systems. All electronic medical devices and equipment will be required to share and exchange information with EHRs, which are expected to become ubiquitous over the next 10 years as part of a federal government initiative to streamline the delivery of healthcare services.

The i-Suite by Stryker Corp. (Kalamazoo, MI). The i-Suite is a family of operating rooms designed to create the optimal environment for the surgeon, staff, and patient. In addition to state-of-the art surgical tools, instruments, and support systems, the i-Suite is fully integrated with information networks within and beyond the hospital. Surgical staff can pull in information from other hospital departments and send real-time or batched clinical information and images back to those units as well as to external physicians and facilities. The system can stream live video to remote locations for training and telemedicine applications.

Fully PACS compliant, i-Suite can store and retrieve images and information from a variety of mediums, including servers, CDs, DVDs, and removable hard drives. It can also be interfaced with EHR systems. According to the manufacturer, the i-Suite's ergonomic design and built-in connectivity and communications capabilities result in better use of medical staff and facility resources, improved patient care, and overall cost savings when compared with traditional operating rooms.

The Propaq LT Patient Monitor by Welch Allyn Inc. (Skaneateles Falls, NY) is a rugged, lightweight patient monitoring system that can be used in a number of bedside, transport, and ambulatory applications. Clinical data are networked via a wireless connection to a central monitoring station. (click to enlarge)

Propaq LT Patient Monitor by Welch Allyn Inc. (Skaneateles Falls, NY). The Propaq LT is a rugged, lightweight patient monitoring system that can be used in a number of bedside, transport, and ambulatory applications, as well as during procedures and at out-of-hospital locations. Weighing less than 2 lb, the unit can monitor heart rate, ECG, pulse oximetry, noninvasive blood pressure, and respiration via an easy-to-use interface. Featuring a full-color LCD screen, the Propaq LT can be configured for use on neonatal, pediatric, and adult patients. It can be used in stand-alone mode, or networked via wireless connection to a central monitoring station.

Apollo 3-D Anesthesia Platform by Dräger Medical AG & Co. (Lübeck, Germany). The Apollo 3-D anesthesia platform has the ventilation technology to care for patients with a wide range of ages and acuities. The unit's advanced capability provides ICU-quality ventilation in the operating room. The portable unit features enhanced monitoring to facilitate clinical decision making. The large, high-resolution color screen with its intuitive operation optimizes work flow.

The Apollo 3-D Anesthesia Platform by Dräger Medical AG & Co. (Lübeck, Germany) is a portable workstation that provides full documentation of the anesthesia process. The unit collects and exports ventilation and gas-flow data to an information management system using the industry standard HL7 messaging protocol. (click to enlarge)

All ventilation and gas-flow data are collected and exported to an information management system for ongoing documentation of the anesthesia process. Using the industry standard HL7 messaging protocol, the data link provides continuous patient information from the ER or ICU prior to surgery and a continuous record for postsurgery follow-up. The manufacturer describes the system as providing 3-D anesthesia care: digital delivery, documentation, and data mining.

Alternate Site and Home-Use IT

The rising costs of hospital-based healthcare have brought about a move to provide medical services at alternate sites, including the patient's home. Reflecting this trend, homecare is now one of the fastest-growing sectors of the medical industry. Much of this growth has been attributed to the use of remote diagnostic, monitoring, and therapeutic devices that can readily tap into the resources of full-featured medical facilities regardless of their location. Using wired or wireless communications capability, devices designed for a broad range of applications can provide patients with expert, timely, more-convenient, and lower-cost healthcare.

Motiva Interactive Healthcare Platform by Philips Medical Systems (Bothell, WA). Motiva is an interactive healthcare platform that delivers remote patient management and personalized education through the home television. The system uses broadband technology, combined with vital-sign telemonitoring devices, to connect patients to their healthcare providers. It is designed to improve quality of life, while reducing medical costs, for the chronically ill.

The Motiva Interactive Healthcare Platform by Philips Medical Systems (Bothell, WA) provides remote patient-management and education services delivered through a broadband TV connection. The Motiva system has been named a winning product in the 2005 Medical Design Excellence Awards competition. (click to enlarge)

The Motiva platform provides patients with relevant, multimedia healthcare information—educational videos, medication reminders, and personalized messages—plus vital-sign trend charts so both patient and care manager can track their progress. The content is accessed via an easy-to-use interactive television interface, delivered via a broadband TV connection.

Wireless Wellness System by Carematix Inc. (Chicago). The Carematix Wellness System (CWS) provides a communications link between patients with chronic disease and their caregivers. The system provides easy monitoring of basic wellness parameters such as blood pressure, pulse, weight, and sugar level via the Web, enabling healthcare professionals to make better-informed and more-timely patient-management decisions that contribute to reduced ER visits, fewer hospital readmissions, and improved quality of life.

CWS is a low cost, user-friendly, modular, wireless, Web-enabled, wellness monitoring system. System components include a wireless-enabled monitoring device for vitals such as blood pressure, pulse, and weight; a hub that collects the data from the monitoring device; and an Internet server that receives and stores the data from the hub. The monitoring device stores the vital signs readings with a time stamp and transmits the data to the hub. The communication between the monitoring device and the hub occurs over a wireless network, and can work through multiple walls up to 100 ft away. Once the hub receives the reading, it is transmitted via a phone or personal computer to the Carematix Internet server, where it is added to the patient's chart. The patient or caregiver can then track the relevant data, graph it, monitor trends, annotate variances, set alert criteria, and receive alerts via e-mail or pager.

The Wireless Wellness System by Carematix Inc. (Chicago) wirelessly links chronic disease patients with their caregivers. (click to enlarge)

The company has deployed its equipment in healthcare programs that remotely monitor patients suffering from congestive heart failure, coronary artery disease, diabetes, hypertension, chronic obstructive pulmonary disease, and asthma. The following devices are currently available from Carematix: blood pressure unit (arm cuff and wrist cuff), weight scale, and glucose meter.

Carematix has recently entered into an agreement with Medtronic Inc. (Minneapolis) in which its wireless wellness system will be used in conjunction with Medtronic's CareLink network. The company's system will be used to assess the efficacy and convenience of remotely monitoring physiological heart data, weight, and blood pressure in the management of heart failure.

Vigil Dementia System by Vigil Health Solutions Inc. (Victoria, BC, Canada). The Vigil Dementia System is a proprietary software and hardware system that monitors residents in long-term-care facilities. The system is a sophisticated automated nurse-call system that provides long-term-care residents suffering from Alzheimer's disease or other dementias with a means of summoning help that does not require them to be cognitively alert. The system is unobtrusive and allows the facility in which it is installed to replicate the privacy and comfort of home, within a secure living environment.

The Vigil Dementia System's intelligent software and infrared motion sensors unobtrusively monitor residents' rooms, identifying and recording behavioral patterns. When a resident departs from his or her typical behavior, a silent page alerts a caregiver to respond. Irregular behavior may include extended time out of bed or in the restroom, which may indicate that the resident has fallen or requires assistance.

The Vigil Dementia System by Vigil Health Solutions Inc. (Victoria, BC, Canada) enables long-term care facilities to unobtrusively monitor patients suffering from Alzheimer’s disease and other forms of dementia. The system improves safety and quality of care while maintaining a homelike environment. (click to enlarge)

Also, the Vigil Dementia System helps to regulate wandering—a common but potentially dangerous occurrence among dementia sufferers. Motion sensors placed in the door threshold detect a resident leaving his or her room or entering another resident's room, and immediately notifies caregivers. The software can be programmed to meet each resident's individual needs. The settings for a resident at risk for falls, for example, may be set to notify a caregiver immediately when that resident exits his or her bed. Another resident may be permitted to visit the washroom, with settings that will alert a caregiver to check on that person only if they do not return to bed within a predetermined safe period.

Further, an unobtrusive sensor is placed beneath a resident's bed linen or mattress to detect incontinence. This eliminates sleep disruption caused when a nurse must physically turn a resident in order to check for moisture. Also, as the sensors immediately notify caregivers when a resident is incontinent, the resident is not left to lie in wet bedding for long periods of time, thereby reducing the aggravation and onset of bedsores.

All calls are sent via a silent paging system, eliminating the need for audible alarms or flashing lights that agitate some residents with Alzheimer's or dementia. All incidents are automatically reported to the appropriate caregiver, and recorded and stored at a central control station from which they can be retrieved for analysis. Together, the elements of the Vigil Dementia System work to deinstitutionalize traditional long-term care facilities while continuing to provide a secure living space.

Wearable IT

Some of the most valid and reliable clinical information can be obtained when the patient is engaged in normal daily activity as opposed to the typically static conditions of the doctor's office or hospital. For this reason, devices that monitor pulse, blood pressure, glucose level, respiration rate, and other vital signs are the focus of many wearable medical IT products. The obtained clinical data are typically transmitted to a central monitoring station or stored onboard for review at the end of the predetermined study period. Wearable technology is also shaping product designs in drug-delivery systems, insulin pumps, filtration systems, and even external artificial organs.

LifeShirt by VivoMetrics Inc. (Ventura, CA). The LifeShirt is a noninvasive, continuous ambulatory monitoring system with embedded sensors that can collect data on pulmonary, cardiac, and other physiologic functions, and correlate them over time. Used in both clinical trials and research applications, the system gathers data during the subject's daily routine, providing pharmaceutical and academic researchers a continuous ‘movie' of the subject's health in real-life situations (work, school, exercise, sleep), rather than the 'snapshot' generated during a typical clinic visit.

The LifeShirt by VivoMetrics Inc. (Ventura, CA) provides clinical researchers with a ‘movie’ of a patient’s health in real-life situations. (click to enlarge)

The LifeShirt System collects, analyzes, and reports on the subject's pulmonary cardiac and posture data. The LifeShirt can also correlate data collected by optional peripheral devices that measure blood pressure, blood oxygen saturation, EEG, EOG, periodic leg movement, core body temperature, skin temperature, end tidal CO2, and cough. The LifeShirt System features an enhanced, ambulatory version of respiratory inductive plethysmography (RIP), the gold standard for respiratory monitoring. RIP is used in more than 1000 hospital intensive care units worldwide. It is ideal for monitoring accurate tidal volume of all subjects, including those who are unable to use spirometers due to age or other factors.

Information collected by the LifeShirt garment is encrypted and recorded in the LifeShirt recorder, an easy-to-use handheld computer, which is analyzed by the clinician or researcher. The LifeShirt System is available in sizes for adults and pediatric patients (ages 5-17). It is available only as a prescription medical device and is not sold directly to consumers.

Next Up?

As manufacturers increasingly commit to integrating network connectivity and enterprisewide interoperability into their electronic medical devices and equipment to meet the competitive demands of the healthcare marketplace, what forces will shape the next generation of medtech equipment? If the electronic health record is to fulfill its promise of capturing clinical data at every point of contact, won't every medical device have to become an electronic device?

Many common medical office devices like temperature probes, stethoscopes, scales, and blood pressure measuring devices already feature digital circuitry, but are typically designed as stand-alone devices. Expect a major shift to wireless connectivity for these and numerous other devices in order to accommodate the networking requirements of electronic health records.

Implants with onboard sensors and radio-frequency capability to track positioning and proper functioning are already being investigated. Nanoscale materials and power supplies are expected to usher in a new wave of microminiature, smart devices that will travel the bloodstream performing both diagnostic and repair functions, all while under electronic surveillance.

For medtech manufacturers, this is a world full of promise. But they're not alone. With such unparalleled opportunities in healthcare markets, IT hardware and software manufacturers are also taking notice. The healthcare divisions already established by those companies could become medtech's next competition.

Copyright ©2005 MX