Originally Published MX May/June 2006

INFORMATION TECHNOLOGIES

Medical device companies are responding to growing market pressures by leveraging new and innovative information technologies.

Tim Gee

The integration of healthcare information technologies (IT) and medical devices continues apace. The market drivers and resulting trends evident in years past have continued their steady progress, and future shifts can be expected as the market pressures for IT adoption grow.

The IT market is growing at both ends. At one end, healthcare IT is expanding beyond its traditional strongholds of hospitals and payers, and is now knitting together the broader fabric of healthcare by integrating physician practices and broad-based community and national healthcare interoperability projects. At the other end, healthcare IT is converging on the point of care by integrating with medical devices to improve patient safety and reduce delivery-of-care costs.

Pressure on medical device manufacturers is increasing as healthcare IT converges on the point of care. In conjunction with the American College of Clinical Engineers, Integrating the Healthcare Enterprise (IHE), a multiyear initiative to create a framework for passing vital health information seamlessly among systems, applications, and settings, has started the patient care device (PCD) work group in an effort to define interoperability for medical devices. Using existing standards, IHE will define the use cases and a technical framework to enable off-the-shelf integration for patient monitors, infusion pumps, and other medical devices. The PCD effort is similar in scope and end result, with its focus on the impact of the digital imaging and communications in medicine (DICOM) standard on interoperability among diagnostic modalities, picture archiving and communications systems (PACS), and radiology information systems (RIS).

In addition to the IHE effort, other organizations, including Massachusetts General Hospital and the Center for the Integration of Medicine and Innovative Technology, are driving plug-and-play interoperability through projects like the Operating Room of the Future and the Medical Device Plug-and-Play (MD PnP) interoperability standardization program. The organizations' goal is to create error-resistant medical device systems to improve patient safety and healthcare efficiency. Led by program director Julian Goldman, MD, the MD PnP initiative seeks the adoption of nonproprietary networking standards and ancillary systems to enable widespread clinical use of medical device data, and to enable network-based medical device control.

Along with these market pressures, IT itself continues to advance. Wireless local-area networks (WLANs) continue to develop, providing improved management tools and mobility with greater coverage and capacity. Commercial products and components are now coming to market that meet all the essential, recently approved WLAN standards for security and quality of service. Moore's law—the idea that the complexity of an integrated circuit will double about every 18 months—is alive and well, as computing power continues to grow while component sizes decrease. Intel's new Pentium M processor and the new multicore central processing units from Advanced Micro Devices Inc. provide vendors with new levels of power conservation and processing power for embedded systems.

In this latest installment of the , MX examines the changes that have occurred in the healthcare IT market over the past year and looks to new trends on the horizon. Many of these observations were evidenced at the most-recent Healthcare Information and Management Systems Society (HIMSS) conference, held in San Diego in February, where vendors unveiled their latest healthcare IT solutions.

Imaging Information and PACS

In the radiology sector, PACS adoption is at the late-majority adoption phase, with most hospitals having already adopted PACS. Now PACS and RIS, historically separate entities, are starting to merge into one market and product category.

The new imaging information market opportunity lies in the cardiology sector, which, next to radiology, is the largest producer and consumer of images and associated patient information. This was the first year that all the major cardiovascular information system (CVIS) players exhibited at the HIMSS conference. Only about 15% of hospitals have adopted any kind of CVIS, with a third of the market expected to adopt a system over the next five years. There has also been a lot of acquisition activity in this segment, with Agfa acquiring Heartlab for $132.5 million, McKesson purchasing Medcon for $105 million, Emageon purchasing Camtronics for $40 million, and, most recently, Philips acquiring Witt Biomedical for $165 million.

The Handheld Interface

Tablet computers appeared to have lost favor at this year's HIMSS exhibition. Rather than being highlighted as a key computing platform, tablets were more often seen as an option for bedside computing cart manufacturers. The size and weight of current tablets have relegated them to more-narrow applications or as a potential substitute for laptops.

PDAs seemed to have shared the fate of tablet computers this year. Small screens, short battery lives, and problems running the same software on multiple vendors' PDAs have limited PDA adoption in the hospital to physician use for reference applications like Epocrates.

One exciting handheld application introduction is GE's AirStrip OB. Deployed on smart phones over wireless carriers' networks, AirStrip OB features a near-real-time display of a fetal monitor. Intended for use by remote obstetricians who wish to consult a live fetal monitor display while out of the hospital, this solution comes with an FDA 510(k) premarket notification clearance.

A new mobile computing product category was created a couple of years ago by start-up computer company OQO. The company's touch screen Windows XP computer is about the size of a paperback book. A few OQO pocketable computers were seen at HIMSS in the hands of members of OQO's new healthcare advisory board, and the computer was also recently used by physicians treating patients during Hurricane Katrina's aftermath. Other similar healthcare pilots are in the works. The OQO system overcomes the pitfalls of tablets and PDAs by providing a standard Windows platform for developers and a larger, easier-to-read display for users—while still fitting in a lab coat pocket.

Integration and Interoperable Systems

While healthcare waits for industry to adopt standards, some vendors are already fielding systems that integrate medical devices, nurse-call systems, and wireless phones. For years this point-of-care work flow automation has been facilitated by integration solution provider Emergin. The company was present in more than a dozen vendors' booths at this year's HIMSS conference. Its vendor partners range from some of medtech's biggest players, such as GE and Philips, to smart-pump providers such as Cardinal Alaris. Other vendors partnered with Emergin included wireless phone providers Vocera and SpectraLink, nurse-call systems suppliers Rauland Borg and GE Dukane, and healthcare IT vendor Cerner. Emergin has stepped beyond point-integration products to offer enterprise integration middleware that includes work flow support for nurse-to-patient assignments and retrospective event review.

As more hospitals advance their plans to implement electronic health records (EHRs), questions about medical device data integration are arising. Most vendors with networked medical devices already offer Health Level 7 (HL7) gateways. However, there are many device categories, such as vital signs monitors and ventilators, with little or no connectivity, and there exists a large installed base of legacy devices with no practical connectivity features. No hospital can buy all new or upgraded devices in order to integrate data into its EHR; therefore, solutions to integrate legacy devices must be used. The most established company in this area is Capsule Technologie. However, competitors with connectivity and work flow automation solutions have been emerging over the past few years. Both Sensitron and Care Fusion were present at this year's HIMSS exhibition, where they showcased data acquisition solutions based on personal digital assistants (PDAs) as well as work flow automation systems.

Recently, Stinger Medical has found market traction with its computer-on-wheels (COW) carts and integrated vital signs monitor. This monitor, acquired by Stinger when it purchased Integriti Systems, provides wireless connectivity and a centralized HL7 interface for EHR integration.

This year, Welch Allyn introduced the Spot LXi, the first major spot vital signs monitor with integrated connectivity. Networked medical devices talk to a server, which is then interfaced with hospital IT systems via HL7. These connectivity servers are not technically complex but are very comprehensive; however, medical device vendors' implementations to date have been limited. Welch Allyn has partnered with Wellogic to field a fully capable clinical server for the Spot LXi.

This past year also saw the introduction of two new wireless continuous patient monitors, the GE Dash and the Spacelabs Ultraview SL 2600. Both monitors use 802.11b radios rather than wireless medical telemetry service.

Wearable and Implantable IT

Over the past year, wearable IT seems to have evolved into implantable IT. Medtronic, Guidant, and Biotronik have all released implantable medical devices with wireless radio-frequency connectivity. These implants connect to a patient-carried or home-based gateway that connects to a central information system over the Internet. These information systems can provide immediate feedback to patients for improved self-management of chronic conditions. They can also alert physicians to changes in a patient's condition, thereby limiting unnecessary hospital admissions.

On the diabetes-management front, DexCom has a new implantable continuous glucose monitoring system that provides data every five minutes. Studies have shown that more- frequent patient feedback, enabled by such implantable devices, results in better self-management and better patient outcomes.

Alternate-Site and Home-Use IT

Earlier this year, Philips entered the home-healthcare market with the $750 million acquisition of personal emergency response company Lifeline. Lifeline's call center will serve as key infrastructure for Philips' own Motiva disease-management products.

This past year also saw several companies outside the healthcare arena make entrances into the realm of alternate-site and home-use healthcare IT. Burglar-alarm company ADT Security Services entered the remote monitoring market with WellHealth, a bundle of services for monitoring medication compliance, vital signs, and health behaviors. Additionally, Intel has been investing heavily in technologies for home health in the past few years. Time will tell whether these nonhealthcare industry entrants will be able to field products that generate real adoption.

Conclusion

The traditional medical device market faces competitive challenges from nonhealthcare companies, new niche-market vendors, and healthcare IT vendors. Technology evolution continues its rapid pace, challenging device manufacturers' traditionally long product cycles with rapid change and creating opportunities for new products using the latest technology. And the healthcare market, with significant changes in both the clinical and IT domains, isn't standing still either.

EHR adoption is increasingly driving medical device connectivity. This integration will create opportunities for third-party vendors to provide solutions for the huge installed base of medical devices that have only a serial port for data output. How these new entrants will leverage their footholds in the market—especially in the face of new devices with built-in connectivity—remains to be seen.

Reacting to the nursing shortage and continued reimbursement pressures in the United States will require significant productivity gains at the point of care. At the same time, patient safety and patient-flow bottlenecks are driving point-of-care connectivity and work flow automation. Increased patient acuity outside of critical-care areas is driving demand for more pervasive and distributed surveillance. In response to these pressures, basic clinical market requirements are evolving.

Increased IT involvement will continue to influence the purchase of new medical devices. Besides technology, perhaps the biggest challenge facing medical device vendors will be related to sales. Connectivity changes the selling process, creates new decision makers, and even affects sales administration. The days of simply "selling the box" are fading.

Tim Gee is the principal of Medical Connectivity Consulting (Beaverton, OR). For more information, visit www.medicalconnectivity.com.

Copyright ©2006 MX