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008 IT Showcase

Shifting standards and market pressures are driving connectivity among medical devices and healthcare information technologies.

INFORMATION TECHNOLOGIES

The convergence of healthcare information tech­nologies (IT) and medical devices is continuing with advances on a number of fronts. In this installment of its annual IT showcase, MX looks at changes in the healthcare IT environment over the past year and into the future. Observations from the 2008 annual meeting of the Health Information and Management Systems Society (HIMSS) provide a frame of reference against years past and serve as a harbinger of things to come.

Driving Forces

According to Gregg Malkary, managing director of Spyglass Consulting (Menlo Park, CA), 36% of hospitals are now collecting vital-signs data electronically in high-acuity areas. In low-acuity areas, only 5% of hospitals are using any form of automated vital-signs collection.1 "There is a definite trend in hospitals investing in electronic medical record (EMR) connectivity for high-acuity areas," said Malkary. "High-acuity units provide a manageable first place to adopt connectivity, and there is definite interest in automating vital-signs collection in lower-acuity areas, in subsequent phases."

The business models of established connectivity vendors are evolving, and new market entrants are launching innovative systems. In fact, for the first time, a major healthcare IT vendor, Cerner Corp. (Kansas City, MO), has aggressively entered the space with its own medical device data system.

Meanwhile, the regulatory environment and industry standards for healthcare IT are also changing rapidly. Earlier this year, FDA published a proposed rule governing medical device data systems that, if implemented, would affect many solution providers that enable device connectivity and alarm notification.2

Meanwhile, the International Electrotechnical Commission (IEC; Geneva) has developed a draft standard (IEC 80001) covering risk management for medical devices incorporated into IT networks.3 In addition, the initiative known as Integrating the Healthcare Enterprise (IHE) is gathering mo­mentum in formalizing standards-based medical device interoperability. These developments and others are increasing pressure on medical device vendors to improve the connectivity of their devices and provide new work flow automation solutions.

Venture Connections

For the second year, legal firm Blank Rome and HIMSS cosponsored the Health IT Venture Fair, held a day prior to the 2008 HIMSS conference and exhibition in Orlando, FL, this past February. Venture fair founder Howard Burde, a partner at Blank Rome, says the event is designed to facilitate interaction among healthcare IT entrepreneurs and venture capitalists. Leading up to the event, Burde and a group of volunteers evaluate healthcare IT start-ups and help selected companies prepare their presentations for the fair.

The growing importance of wireless communications in healthcare was underscored by a presentation by Ed Cantwell, president and CEO of InnerWireless Inc. (Richardson, TX). InnerWireless is focused on transforming often-criticized wireless communications into a trusted infrastructure. Hospitals are increasingly looking at ways to improve the in-building wireless coverage in their facilities, for both local-area networks and cellular carriers. As work flow automation continues to expand beyond the physical enterprise, wide-area-network providers are playing a more critical role in communications.

During his presentation, Cantwell discussed the convergence of multiple technologies and applications at the point of care, all being facilitated by wireless communications. After the conference, Cantwell noted that the venture fair was a success for his company; his presentation resulted in 15 follow-up meetings with venture capitalists.

The sole medical device vendor to present at the Health IT Venture Fair was Zin Medical (Cleveland). Described as a medical data router, the company's vMetrics system is a modular platform with major software and embedded-system components. A configurable clinical data management system constitutes the software platform. The embedded system is also configurable, supporting five different physiological parameters and various wireless technologies for use in ambulatory and acute-care settings.

A Cleveland Clinic spin-off, Zin Medical's device has the potential to disrupt the established patient-monitoring market. The company also highlights a growing necessity for many medical device start-ups: to provide a comprehensive suite of software to facilitate work flow automation and systems integration with other healthcare IT systems.

Shifting Architecture

Intelligent InSites (Fargo, ND) also stood out among the venture fair presentations as an example of the use of a software architecture that is gaining rapid adoption. Intelligent InSites provides an enterprise visibility platform. Using positioning data from almost any real-time location system vendor, the InSites system can automate, coordinate, and monitor complex processes throughout a hospital. Applications include asset management, device sterilization, and other infection-control applications, as well as hospitalwide patient flow and work flow processes at the departmental level, including emergency and surgery departments.

The key to the InSites platform—and a surprising number of similar and dissimilar systems—is a collection of generalized software engines that are configured by application specialists to perform specific tasks. This approach contrasts with applications that are designed to implement specific tasks in the software rather than through configuration. The current more-conventional ap­proach relies on engineers to implement detailed features in the software, while application specialists only provide limited configuration upon installation.

Systems from new market en­trants in a number of segments are using this new style of product architecture. Examples include InSites competitor Agility Healthcare (Glen Allen, VA), as well as hospitalwide patient flow solution providers like StatCom (Alpharetta, GA). Communications middleware vendor Emergin Inc. (Boca Raton, FL) and lesser-known Aionix (San Diego) also incorporate engine architectures. Innovators in server-based medical device software systems are also looking to adopt this type of software architecture.

Device Integration

A clinical engineering symposium, hosted by HIMSS and the American College of Clinical Engineering (ACCE), also preceded the main HIMSS conference this year. ACCE has cosponsored the symposium since 2004. This year's symposium focused mainly on the integration of medical devices and IT. Topics included how such integration can improve outcomes, as well as issues surrounding implementation.

A presentation by Rick Hampton, wireless communications manager for Partners Healthcare System (Boston), and Michael Fraai, director of biomedical engineering for Brigham and Women's Hospital (Boston), focused on connecting medical devices to wireless local-area networks (LANs). Connecting medical devices to wireless LANs for spot or intermittent data capture is usually a straightforward process, but the issue is greatly complicated by the need to support continuous data that are streamed constantly from a device. Life-critical applications such as wireless patient monitors and alarm notification (from a variety of devices) are frequently mobile with patients, moving across many areas of a hospital. These types of applications are increasingly challenging for hospitals and vendors alike.

The presentation by Hampton and Fraai highlighted the growing importance of the medical device manufacturer's role in deploying wireless medical devices. Most wireless LAN infrastructure vendors and their resellers know little about designing networks for medical devices. Hospital IT staff and biomedical engineers are increasingly looking to medical device manufacturers to define wireless LAN requirements and help them certify their currently deployed networks. The level of expertise required to develop, sell, and service wireless medical devices continues to increase over time, and many in the market—hospitals, device manufacturers, network vendors, and resellers—are behind the curve regarding market requirements, knowledge, and expertise.

At the HIMSS clinical engineering special interest group breakfast, attendees discussed the need for and desirability of creating a voluntary standard for network design and management as a way to reduce complexity and improve the safety of networked medical devices. Such an effort would affect wireless LAN vendors, as well as their resellers, hospitals, and device manufacturers. The standard under consideration is not too different from IEC 80001, a voluntary standard of risk management for medical devices in networks. Currently in draft form and due to be adopted by 2010, the standard was discussed widely by network-savvy vendors and clinical engineers attending the 2008 HIMSS conference.

Making Connections

In recent years, HIMSS has steadily shifted from what was once a show targeting hospital buyers to one that is increasingly a business development event between device and healthcare IT vendors. "Over the past three years, the growing number of medical device vendors incorporating connectivity has fueled this transition," says Tim Bosch, chief architect of the medical division at Foliage Software (Burlington, MA). Bosch points out that business development activities are frequently required to realize working connectivity and to provide a whole-product solution for hospital customers.

The most tangible example of such business development efforts is IHE's Interoperability Showcase. This year at HIMSS, 51 vendors with more than 74 clinical information systems hosted 2800 attendees visiting the showcase. And, for the second year in a row, medical devices—referred to by IHE as patient care devices, or PCDs—made a big splash.

IHE tackles device and system interoperability by identifying specific clinical work flows and use cases. To automate the work flow in the chosen use cases, the IHE committees select existing standards and develop configuration profiles. Every fall, IHE holds its Connectathon, during which participants test the compatibility of their profiles against a variety of other vendors. This year's use cases focused on establishing and managing patient context and passing device data to electronic medical records. Devices included vital-signs monitors, patient monitors, infusion pumps, ventilators, an emergency department information system, and an anesthesia information system.

Individual work flows and initial-use cases for medical devices have not been sufficiently broad to capture providers' attention. But the IHE PCD effort is rapidly approaching the point at which hospitals will include specific IHE profiles in requests for proposals, as is common in cardiology and diagnostic imaging. Catching up with IHE PCD profiles is a relatively simple process now; however, starting in 2009, adopting PCD profiles will take considerably more time and resources as the number and complexity of profiles and use cases increases.

Connectivity Product Highlights

The evolution of the healthcare IT products being showcased at HIMSS also has significant implications for medical device manufacturers. In particular, Cerner's CareAware represents one of the most dramatic product introductions by a healthcare IT vendor at this year's conference. Positioning the electronic medical record at the center of all generated and stored patient information, the CareAware system is a medical device connectivity system that establishes and maintains patient context with medical devices, integrates devices into clinical work flow, and guides work flows to improve patient outcomes.

A work in progress for Cerner for several years, CareAware is a feature-rich system, especially for a first release. Under the CareAware system, medical devices are divided into three classes: certified devices whose manufacturers are actively participating in CareAware, supported devices that Cerner has tested and supports, and unsupported devices. Participating manufacturers must pay an annual fee of $100,000 and provide considerable engineering resources to support the effort. The resulting connectivity and systems integration are proprietary to Cerner's CareAware system.

Communications systems also continue to have strong ties with medical devices. The recently proposed FDA rule on medical device data systems (MDDS) was a topic of much discussion among dedicated connectivity vendors like Capsule Technologie (Andover, MA), iSirona (Panama City, FL), LiveData (Cambridge, MA), and others. The regulatory status of medical device data systems and alarm notification systems is currently open to interpretation. Consequently, some vendors have submitted to regulatory oversight, while most have not. The proposed MDDS rule is an effort to clarify the regulations and catch up with the market. Vendors such as Capsule and Cardiopulmonary Corp. (Milford, CT) are already regulated, but many others are not.

Connectivity vendor iSirona has also made considerable progress over the past year. Moving beyond its wireless terminal server, this year the company demonstrated an intelligent module for legacy medical devices that maintains patient context at the point of care rather than at a server.

Meanwhile, device networking provider Lantronix Inc. (Irvine, CA) demonstrated a new product called MatchPort b/g Pro. The module can be plugged into a circuit board to provide a self-contained connectivity module for portable or mobile medical devices.

Conclusion

As the market continues to demand greater levels of work flow automation at the point of care to improve patient safety and productivity, medical device connectivity is becoming increasingly important. Medical device manufacturers are fielding a greater number of software-based medical devices, and healthcare IT vendors are crossing into the realm of medical device software like never before. Cerner's move to develop and launch an MDDS—the principal focus of the company's booth at HIMSS this year—portends increasing competition and collaboration among IT vendors and device manufacturers. The evolving regulations and standards, blurring market segments, and new product architectures will affect the industry for years to come.

References

1. Point of Care Computing for Nursing (Menlo Park, CA: Spyglass Consulting, 2007).
2. "Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data
    System," Federal Register, 73 FR:7498-7503, February 8, 2008; available from Internet:
    www.fda.gov/OHRMS/DOCKETS/98fr/E8-2325.pdf.
3. Application of Risk Management to Information Technology (IT) Networks Incorporating Medical Devices, IEC
    80001 [draft standard, cited 17 April, 2008] (Geneva: International Electrotechnical Commission,
    2008).

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

Copyright ©2008 MX
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