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.

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)

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.

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 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)

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.

While other sectors of the device industry are at square one in figuring out how to develop technical standards that will enable them to take advantage of IT-related opportunities, imaging companies already have more than a decade of experience at implementing such standards.

Taking advantage of this experience, a number of imaging companies have begun to turn the corner into the field of health information management, building new business units that may expand their presence in a variety of clinical environments. Companies in other sectors will have to move quickly to catch up with the imaging sector, but they can also learn a lot from the experience that imaging companies have already gained.

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)

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)

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

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)

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 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)

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. Clinical data can be readily uploaded and downloaded from a PC using industry standard wired or wireless interfaces.

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)

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.

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)

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.

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)

Next Up?

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

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.

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