Medical Device Link.

Originally Published MDDI August 2002

NEWS & ANALYSIS

Jason Thibeault

In a move that coincides with the growing popularity of wireless patient monitoring, FDA recently cleared 510(k)s for two glucose meters that can be controlled by personal digital assistants (PDAs). Both devices, one from Therasense (Alameda, CA) and the other from Roche Diagnostics (Indianapolis), combine a test module with a Handspring Visor PDA.

According to Bill Wood of Colorado MEDtech (Boulder, CO), a company developing PDA-based interfaces with existing medical devices using Bluetooth technology, these two devices illustrate a growing trend. "We will see more devices introduced to the market where the PDA is the primary interface to the medical device," says Wood. That opinion is shared by Julie Stasca of Handspring (Mountain View, CA). "Medical developers are the most aggressive and creative in leveraging handheld technology to get devices quickly to market," she says.

There are a number of issues driving this aggressive push by device manufacturers. The first is cost. For example, Stethographics (Westborough, MA) developed a PDA device and stethoscope that allows the visual display and analysis of lung and heart sounds. This PDA device is a replacement of their previous instrument—a $14,000 bedside unit. "We found that we could move a lot of the functionality of the bedside unit (about 80%) into a PDA at a fraction of the cost," says Bill Kania, CEO of Stethographics. He adds that the PDA costs less than $1000. "This PDA unit fits more with the work style of our users—cardiologists, pulmonary doctors, and even EMTs and veterinarians."

The second issue is usability. "PDAs are friendly, stable, and the adoption rate in healthcare is growing steadily," says Wood. According to a 2001 survey from Harris Interactive Inc. (Rochester, NY), 26% of the country's practicing physicians used handhelds for professional and personal activities in 2001, up from 15% in 1999. Of the physicians surveyed, 18% use the devices as an integral part of their office. By 2005, Harris Interactive projects that close to 50% of the country's physicians will recognize the value of PDAs and begin to incorporate them into their work flow.

The third issue is upgrading. Medical devices are expensive pieces of equipment and often need to be physically replaced when new versions are developed—resulting in significant costs. PDA-integrated medical devices, however, don't require near-constant replacement. According to Patrick Lichter of QRS Diagnostics (Plymouth, MN), one of the oldest companies developing this technology, "we can just keep updating our software once a sensor is developed. The cost to the end-user then becomes just an upgrade, rather than replacement."

The fourth issue is analysis. According to Kania, PDA-integrated medical devices provide the practitioner "the ability to capture all information and have it analyzed on the spot. Our software counts the number of wheezes and various types of crackle sounds on both inspiration and expiration." Furthermore, users of the Stethographics product can get a companion software application for their PC that allows them to save patient sensory data [from multiple readings] to see longitudinal results.

In addition to the Therasense and Roche Diagnostics glucose meters, there are a number of other companies creating devices that cover the spectrum of point-of-care diagnostics.

Active Corp. (Castine, MA) produces a PalmOS– based electrocardiograph (ECG) monitor. The actual monitor weighs only 6.7 oz and clips onto the belt or bedside of a patient. The connectors wind up into the ECG device while the PDA is connected by a single cable.

Vivometrics (Ventura, CA) has created a "sensory vest" that monitors more than 30 cardiopulmonary parameters. Data analysis is done through either an integrated Handspring PDA or a desktop software application.

In general, the focus of such companies has largely been on improving point-of-care diagnostics through handheld technology that is directly connected to the medical device. Many of the companies with currently approved FDA products, however, are looking at ways to add further value to their products. One such method is through wireless technologies, such as Bluetooth and 802.11b. "The industry seems to be moving in this direction," says Kania. "Cutting the cord [between the device and the handheld] is an important step in providing even better point-of-care diagnostics. This allows the patient to move around." Stethographics hopes to have a Bluetooth-enabled version of its product available sometime in the next year. Colorado MEDtech and QRS Diagnostics are also actively working on Bluetooth-enabled versions of their products.

There doesn't really seem to be any limitations to what applications might come next because, according to Wood, it's more about the ubiquity of the PDA platform than about any specific application. "Using an off-the-shelf product like a PDA means that manufacturers can get their devices to market more quickly and easily than developing a device [with a proprietary interface] from the ground up," says Wood.

In thinking about future applications, companies like Colorado MEDtech are looking at what manufacturers in other industries are doing with PDAs. For example, Teledyne Technologies (City of Industry, CA) and New Focus (San Jose) are both exploring the physical integration of a handheld unit into their analytical devices. According to Wood, "Watching what others do will provide strong suggestions for the way PDAs will integrate with medical devices."

Whatever the eventual end-unit looks like, there will definitely be enhancements. "Physicians are asking for additional information to carry on their PDAs, along with the medical device software," says Kania. "They want training and diagnosis information so that when data are captured, they don't have to go get a big reference book to confirm their analysis. They can access information resources right on the device."

Nevertheless, there are hurdles involved with developing PDA-integrated medical devices. First and foremost is receiving FDA approval. Despite the special 510(k) review process that brought the Therasense and Roche Diagnostics glucose meters to market, the process still takes time. "If we have a PDA platform change—for example, from PalmOS to Pocket PC—we have to seek revalidation from FDA." Another hurdle is the rapidly evolving PDA market—both hardware and software change very quickly. Although, as Handspring's Julie Stasca states, "changing the hardware any time soon won't stop these medical device developers. Even if we move away from the Springboard and to SmartMedia or Compact Flash, they will still find ways to attach things to the bottom or to the media itself."

Whatever the hurdles, it is clear manufacturers are only beginning to utilize the value of PDA and handheld technology.

Copyright ©2002 Medical Device & Diagnostic Industry