Originally Published MPMNApril 2004

SPECIAL SECTION

E-Health and Connectivity

Wired Wards, Wireless Devices

The e-health revolution is well under way. The first medical device equipped with Bluetooth wireless technology was approved by FDA last June. A central control system developed by Stryker Endoscopy, the Sidne establishes wireless connectivity with surgical instruments.

Many more wireless products are in the pipeline, according to Bill Saltzstein of Code Blue Communications. His company collaborated with Stryker and is involved in several other medical projects.

Meanwhile, wired wards are cropping up in hospitals around the globe. Patient records are increasingly called up on wireless laptops and handheld devices. Physicians, usually the last line of defense, are eschewing pen and pad to prescribe medication electronically. By some accounts, error rates have declined by 50% and patients are out of the hospital more quickly as a result.

Wireless products and the Internet are a boon to the home-care market, as well. It is poised to explode as aging baby boomers, who some call the worried well, clamor for remote monitoring devices.

This section profiles a sampling of companies that are behind the technology that is making these advances possible. Some have produced wireless systems for home-care use. Others have partnered with device OEMs to develop wireless hospital equipment. One firm has designed a product that allows plug-and-play data collection from more than 250 models of bedside monitors. In a sign of these globalized times, their headquarters are as likely to be in Noerresundby, Denmark, as Tucson, AZ.

"Making a medical device wireless is not a trivial matter," Pierre Landau, CEO of Polymap Wireless, toldMPMN. It requires a body of technical and targeted regulatory expertise that may not be readily available within a medical device firm. Rather than invest time and money in recruitment efforts, he stressed, it simply makes sense to outsource that activity to a company with 
the required expertise. 

Norbert Sparrow

Cutting the Cord in the OR

Last June, FDA approved the first medical device using Bluetooth wireless technology. A central control system developed by Stryker Endoscopy, Sidne (Stryker Integrated Device Network) establishes wireless connectivity with surgical instruments via a Serial Port Adapter from Code Blue Communications (Woodinville, WA; www.codebluecommunications.com). You should expect to see many more Bluetooth-enabled healthcare products coming on the market this year, says Bill Saltzstein, president and founder of Code Blue Communications. Why now? Because Bluetooth has become boring.

"At a session at the Bluetooth Americas 2003 conference in December, one of the market gurus was trying to put some perspective on why attendance was down," recounts Saltzstein. "And his comment--which I totally agree with--was that Bluetooth has gotten boring. Well, hallelujah! That's exactly where we need to be to begin working on medical applications," he explains. "The device industry doesn't want flashy new things. It wants a solid technology that has all the bugs worked out, and which is gaining marketplace acceptance."

In addition to the Stryker device, Code Blue Communications supplies Bluetooth wireless capabilities to GE Medical's Achilles DexterQUS osteoporosis risk-assessment device. "It's designed for use in a doctor'soffice. The person being screened puts his or her foot in the ultrasonometry device, which sits on the floor. A Bluetooth-enabled PDA serves as the user interface, and it also sends the data to the printer.So you have three Bluetooth devices that are interacting, including the PDA, which is essentially acting as the front panel," says Saltzstein.

Code Blue Communications recently introduced its second-generation Serial Port Adapter, which allows any device with an RS-232, RS-422, or RS-485 port to communicate wirelessly. No software installation nor system changes are required. All of the necessary Bluetooth (at the full product level) and FCC approvals have been obtained.

The next evolution in Bluetooth technology, according to Saltzstein, is the 1.2 specification. "One of the new features is called adaptive frequency hopping (AFH), which allows Bluetooth and 802.11b, more commonly known as Wi-Fi, to coexist with zero interference. Bluetooth picks those frequencies where 802.11b is not." Bluetooth 1.2 is just beginning to ship in chip sets, addsSaltzstein.

Wi-Fi Module Connects with Device OEMs

When DPAC Technologies (Garden Grove, CA; www.dpactech.com)introduced its drop-in Internet-enabled 802.11b module in September 2003, med-tech applications were at the front of the company's mind. "Our system design services group had several existing relationships with device firms," says Mike Grobler, director of wireless applications. When the product was under development, some of them signed on as beta testers. 

"The self-contained design of the Airborne Wireless LAN node module makes it very easy to integrate into a product," says Grobler. "It's based on a widely accepted standard, and there is a plethora of equipment to support it from an infrastructure point of view," he adds. A typical application might involve adding the module to an infusion pump. Prescription data are downloaded to the device from a PDA; the module also allows the device's operation to be monitored from a central nursing station.

"From that base wireless LAN module we have made derivative encapsulated products suited for use with legacy devices," says Grobler. The AirborneDirect family of products are designed to provide wireless local area network and Internet connectivity to installed-base OEM devices. Several makers of medical equipment are interested in the technology, according to Grobler.

AirborneDirect Serial, which the company introduced in January, is under review for use with a bedside monitor. To create a wireless connection between the monitor and a nursing station, "the product is simply plugged into the device's existing serial port." As with the module, much of its appeal lies in its simplicity. OEMs do not need RF or communications expertise, and there is no need to develop software.

AirborneDirect Serial also allows alerts to be sent from the system via the Internet to cell phones, pagers, and PDAs. 

The company is currently looking into enabling SpO2 devices. "The existing products have no local area network connectivity. The manufacturer wants to multiplex them so the data can be observed on a network. And he wants portability," adds Grobler.

At this year's MD&M West show in Anaheim, CA, DPAC showcased the use of its 802.11b module in a prototype intelligent hygiene management system. The i-Hygiene device wirelessly monitors compliance to corporate hand washing and other policies. An RFID badge worn by the user communicates with the system, which has an embedded wireless LAN node module from DPAC. Transmitted over the Internet, the data can be monitored in real time. Food preparation is one of the obvious target industries for the product, but hospitals and even industrial cleanroom environments can derive a significant benefit, saysGrobler. 

Supplier of Wireless Systems Has a Unique Relationship with Medical Technology

A recently introduced drop-in Bluetooth system partly owes its existence to a medical device manufacturer. "We were initially approached by a device OEM who was looking for an off-the-shelf product that would provide connectivity," says Pierre Landau, CEO of Polymap Wireless (Tucson, AZ; www.polymapwireless.com)."Many, many years ago, I worked in the medical device industry," he adds. (In the early 1980s, Landau was involved in the development of the evoked potential monitor, which monitors neural activity during neurosurgical procedures.) "So, there was this natural interest on my part in fulfilling that need." That project led to the launch of the more broad-based Polytel product at the beginning of this year.

The Polytel system wirelessly transmits encrypted data from a device to the Internet. It can be integrated into any medical device with a serial port.

The system comprises a remote circuit board placed inside the device, an access point that plugs into a regular telephoneline, an Internet service provider (ISP), and a wireless data center. The remote unit records, time-stamps, and saves data untilit is within range of the modem. Bluetooth technology is used to transmit the datawirelessly to the modem, which dials up the ISP and sends the data to the center via the Internet. The unit was designed for the home-care market, but it can be used in other settings just as easily.

"What we call the access point, which is sort of a home hub, works with a regular telephone line. So you could say that the hardware is more suited to home use," says Landau. "But there'sno reason to limit the device to that end. In fact, we are working with clients who want to connect different devices with a remote unit in hospital networks."

Polymap also offers custom Bluetooth-based products. It recently entered into an agreement with Zeevo, a supplier of system-on-chip components based in Santa Clara, CA, to expand these capabilities. "Some device manufacturers are interested simply in our built-in components," explains Landau. "They have another way of bridging the rest of the wireless link. Others already have the back-end system components, and we dovetail our [technology] with theirs."

The device industry has been cautious in its adoption of wireless technology, and rightfully so, notes Landau. "Making a medical device wireless from scratch is not a trivial matter. You have to understand RF propagation. You have to interact with regulatory bodies you might not normally deal with. And it can require a substantial up-front investment," says Landau. "With our solution, you drop the little unit into your device, and you're done. We offer medical device manufacturers, who may be reluctant to jump in and spend the kind of money that is required, an opportunity to avail themselves of this technology." 

Danish Company Embarks on Global Mission to Make Medical Devices Wireless

Improving a patient's quality of life while reducing overall treatment costs could be considered the Holy Grail of medical device manufacturing. RTX Healthcare (Noerresundby, Denmark; www.rtx.dk)believes that integrating wireless communications capabilities with medical diagnostic equipment is a meaningful step in that direction.

RTX Healthcare is a subsidiary of RTX Telecom, which has completed more than 300 projects, developing everything from chip sets to finished products for global OEMs. RTX Healthcare (formerly Penell a/s) is dedicated to using its considerable resources in wireless connectivity to benefit medical products. "We feel that the healthcare market is immature in this regard," says marketing manager Jens Kofoed, "and our mission is to make medical devices wireless worldwide." The introduction of a family of OEM homecare products that incorporate Bluetooth technology represents the most recent milestone in this campaign.

The system's core components are devices that measure blood pressure and weight, and a Telehealth Gateway unit that collects and transmits the data to a remote server via the Internet. All of this is donewirelessly. The product line represents a "step up in the value chain for the company," notesKofoed.

In the past, the company has followed a traditional outsourcing model by supplying electronics and subassembly design services to device manufacturers. This new line of products takes that business model in a new direction. The company now purchases technology in the form of basic devices, integrates wireless e-health capabilities, obtains the necessary product approvals, and markets the resulting products to device firms and system integrators. The underlying communications platform, which supports Bluetooth, GSM/GPRS, and LAN protocols, will also be offered for integration with other devices.

"One of the key features of the system is its simplicity," says engineering manager Niels Ole Andersen. "The user makes no adjustments.
The devices and the Gateway are configured prior to shipment. All the patient needs to do is plug itinto a power source and a phone line," he explains.

Data are encrypted using the Secure Socket Layer protocol. It is implemented in the company's proprietary Callisto software platform that is part of the Gateway unit. Callisto also supports authentication on the client and server ends, and configuration options can be hidden behind two levels of user names and passwords. None of this will be visible to the patient. He or she sees only a sleek box adorned with a light-emitting diode to indicate that the device is working. "The data are delivered in XML," adds Andersen. "This gives the manufacturer maximum flexibility in displaying the information."

The price point is substantially lower than existing products that perform a similar function, he adds.

"When OEMs see this technology, they immediately begin thinking about a whole range of other applications," says Kofoed. (Indeed, several other medical devices that apply this technology are in RTX Healthcare's pipeline.) For instance, "there are a lot of potential wireless applications that simply involve capturing information," notes Andersen. He sees home care and its enabling technologies as a market that is on the verge of exploding. It's a wave thatRTX Healthcare is well-positioned to ride, he adds. "We have the experience, knowledge base, and capabilities to meet the anticipated demand for high-volume products that comply with global regulatory standards."

Wide-Area-Network Services Provider Goes Vertical

"In the telemetry world, SkyTel Corp. [Jackson, MS; www.skytel.com]has always been a wireless services provider," says Donald Solar, director of telemetry services for SkyTel. This year marks something of a shift for the company, as it expands its scope in a vertical direction. "In the second quarter, SkyTel plans to offer an end-to-end service for machine-to-machine and people-to-machine applications." The objective, explains Solar, is to accelerate the development cycle for OEMs. "We are matching up a transceiver; microprocessor; and serial, digital, and analog ports. The Remote Access Device will make it very easy for OEMs to integrate our product with their equipment and begin transmitting information quickly and effectively."

Today, OEM-level wireless transceivers manufactured by Belgium-based Advantra International are approved to operate on the SkyTel network. The modules are based on ReFLEX technology, a narrow PCS band used by SkyTel. Advantra's AR200 OEM module, measuring 3.7 ¥ 1.9 ¥ 0.2 in., is designed to be a simple drop-in solution for existing products. The forthcoming Remote Access Device from SkyTel will further facilitate the integration of wireless capabilities.

SkyTel was recently involved in the development of a product that monitors patients with congestive heart failure. "The device sits in the patient's home," says Solar. "Four or five times a day, it wakes up and says it's time to take your blood pressure, step on the scale, take your temperature, and so forth." The built-in transceiver collects and sends the results, via the SkyTel network, to a database, where the data are monitored. "We are seeing steady growth for this application, month over month and year over year," says Solar. Nevertheless, he feels that the device industry's uptake of wireless wide-area network (WAN) technology is not what it could be.

The technology "has not gained significant acceptance in the medical device arena," says Solar. Local wireless technology, such as Bluefoot, is making substantial inroads to hospital equipment, he notes, but device OEMs have not yet fully grasped the "value proposition" of wireless WAN technology. That may be just a matter of time.

The firm is currently working with one of its customers to build an off-the-shelf system that will allow diabetics to take readings and send the results over the network. Mobility is a key factor, says Solar. "Patients can take the readings anytime and anywhere." When that product and the Remote Access Device become available, device OEMs may well decide that wireless WAN technology deserves a closer look.

French Connection Gets Devices Talking

Capsule Technologie (Paris; www.capsuletech.com)has come a long way in a short time. A supplier of universal device connectivity software, the firm began development of its flagship DataCaptor interface in 2000. In early 2002, "interest in our product was beginning to stir among some of the key players in the industry," says CEO Nicolas Choussat. "By the end of that year, we had reached a milestone--ISO 9001 certification and 510(k) clearance--and business took off," adds Choussat. Since then, Siemens, GE Medical, Dräger, and Philips, among others, have integrated Capsule Technologie's product into their medical systems. With the recent launch of DataCaptor 4.4, featuring plug-and-play connectivity, the company is looking forward to even more stellar results.

DataCaptor provides an interface between stand-alone and/or networked medical devices, primarily bedside monitors, ventilators, and infusion pumps. It collects the medical data originating at a device's communication port, translates them into XML or HL7, and distributes them to clinical and hospital information systems. The company claims to have the largest library of medical device interfaces available, with built-in support for more than 250 different products. DataCaptor 4.4 adds unprecedented ease of use to the company's extensive interface capabilities.

The product integrates an Automatic Device Identification module. This allows users to connect and reconnect any of the medical devices supported by DataCaptor without reconfiguring the software. This can be beneficial in hospital settings where bedside monitors are frequently changed. "It was quite tricky fine-tuning the plug-and-play capability," says Choussat, who adds that the firm has succeeded in developing a completely reliable and rapid detection system. A fully functional version of DataCaptor 4.4 can be downloaded from www.capsuletech.com for a free 30-day evaluation.

Healthcare environments are still riddled with so-called islands of information, devices with proprietary data protocols that put up barriers to communication. But manufacturers are increasingly aware, says Choussat, that universal connectivity is the way forward. Third-party connectivity vendors, such as Capsule Technologie, represent the best option to get from here to there, he adds.

"Developing connectivity solutions is a time-consuming task that can be a tremendous drain on resources," says Choussat. This is especially true, he notes, whenit is not a firm's core competency. "Why reinvent the wheel when a best-of-breedproduct is available?" he asks. "Many suppliers of clinical information systems aredevice manufacturers themselves," adds Choussat. "They would have to talk totheir competitors, even ask them for help, to develop the drivers [that allow multiple devices and clinical information systems to communicate]. It's so much 
easier to go through a third party." 

Copyright ©2004 Medical Product Manufacturing News