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You might use the alarm on your watch (if you still wear one) or your Treo as a reminder to take your medicine. Now you can go one step further by using a personal digital assistant (PDA) to wirelessly control an internal pump that streams medication directly to its target inside your body.
It's an early but significant advancement in the convergence of consumer gadgets and patient-controlled medical tools. Health-device giant Medtronic (MDT) -- known for its pioneering pacemakers and insulin pumps for diabetics -- recently released a device in the U.S. called the Personal Therapy Manager (PTM), a retooled version of a Palm (PALM) handheld. A first for the market, it's a patient-controlled device with a screen interface that can sync with the company's programmable implanted pumps to deliver medicine, via catheter, to the fluid near the spinal cord -- a process known as intrathecal drug delivery.
"Pain is very subjective, and only the patient is the best judge of chronic pain intensity," says Dr. Stephen N. Oesterle, Medtronic's senior vice-president for medicine and technology, when asked why the Minneapolis company decided to develop such a patient-controlled option for those who continue to suffer extended intense pain after an injury or acute disease.
Synching drug delivery with the PTM
PATIENT INPUT. In developing the PTM, Medtronic's in-house engineers faced challenges that never arose in the creation of its implanted medicine pumps, which patients hadn’t consciously interacted with before. The PTM had to be user-friendly, and it had to look inconspicuous so patients would feel comfortable using it in public. Medtronic also wanted to bring the device to market as quickly as possible to meet increasing physician and patient demand. For these reasons, the engineers decided to base the new tool on an existing platform with well-tested consumer interface.
Patient-controlled medical implants aren't new. Some surgically inserted neurostimulators on the market -- including Medtronic's own Synergy system and Plano (Tex.)-based Advanced Neuromodulation Systems' (ANSI) Eon device -- are activated by small handheld devices with two or three knobs that can control an on/off switch and settings such as the location and intensity of the doctor-prescribed doses of electricity.
These remote controls are often likened by doctors and patients -- most famously by comedian Jerry Lewis, who uses Medtronic's Synergy -- to basic garage-door openers. Patient-controlled implants used to treat other diseases sometimes have even simpler forms of control: Houston-based Cyberonics' (CYBX) VNS Therapy, an internal epilepsy treatment device, uses a handheld or wrist-worn magnet that patients swipe over their bodies to turn the implant on or off.
DOCTORS AGREE. The more sophisticated PTM works with the latest generation of one of Medtronic's most innovative and enduring products, the SynchroMed II drug infusion system, rather than neurostimulation (see BW Online, 3/7/05, "'Pacemakers' for the Rest of You "). A breakthrough when it was released in 1988, SynchroMed delivers a drug such as morphine directly to the spinal cord, where certain types of pain are signaled to the brain.
A painkiller taken in pill form, in contrast, would first have to be digested. Thanks to this highly targeted delivery system, doctors prescribe less medicine, which lowers drug costs. Moreover, patients feel fewer side effects.
Medtronic's PTM works with the SynchroMedII implant
In 1999, during a routine focus-group session Medtronic held to evaluate its second-generation SynchroMed intrathecal drug-delivery device, doctors almost unanimously agreed that the pump needed a patient-controlled mechanism.
"We hadn't thought of a patient controller for the SynchroMed previously," says Tom Valine, a senior product manager at Medtronic who oversaw the PTM's development. "But the physicians overwhelmingly urged us to create one. They argued that intrathecal drug delivery is a very patient-focused therapy, and that patient control was essential. We rarely see such unanimity."
FAMILIAR INTERFACE. At first, the Medtronic design and engineering team created prototypes based on the earlier "garage-door opener" models. But these precedents "didn't allow much feedback or varied interaction. And we wanted a bright and visible screen," says Valine. "So we thought about what user interfaces and human-factor design was effective. We realized that Palm interfaces were friendly and popular."
The neurological division of Medtronic, which oversaw the PTM project, had never used an outside, off-the-shelf product for a patient-controlled device before. "After a lot of introspection, we decided to take advantage of fine design work that was already done by another company that's better at human interfaces," says Valine. Medtronic struck a deal with Handspring, the company bought by Palm in 2003, to modify Handspring PDAs and manufacture, rebrand, and market them as Medtronic PTMs.
The Medtronic team designed a proprietary telemetry "head" and medicine-syncing software to work with the PDAs. The attachment plugs into the top of the PDA and uses radiofrequency to communicate wirelessly with the pump implanted in a patient's abdomen.
COMMUNICATION IS KEY. On screen, the patient is asked what level of pain he or she feels at specific times of day, which is rated on a standard scale of 0 to 10. Patients can also tap on happy and sad-face icons to indicate how they are feeling. If a patient requests an extra dose of medicine, the PTM records the time and dosage.
The device is preset by a physician to allow a limited number of supplemental doses beyond regular intervals of infused medicine, so patients can't overdose. Doctors can also sync a patient's PTM data to their own computers to monitor a patient's self-treatment and, ideally, better tailor future therapy.
Other industrial designers working in the field of patient-controlled medical devices see the PTM as evidence of an emerging trend toward convergence. "Before, serious medical tools had the feel and look of 'Don't touch me, because you don't have the background or education to use this equipment,'" observes Kevin Young, director of industrial design at Boston-based Design Continuum, which designed the OmniPod and the Personal Diabetes Manager (PDM), a two-part, patient-controlled external insulin delivery system. The PDM, released last August by Insulet, a privately held Bedford (Mass.) diabetes-management company, is intended to resemble a mobile phone.
"When you can incorporate a medical device to an existing technology, it's a logical step. Patients will already be very familiar with it because it exists in their lives," says Young.
The PTM looks like an everyday PDA
COST RELIEF NEEDED. Although the PTM can no longer be used as a PDA, even if the telemetry device is removed, Medtronic's Oesterle believes true convergence is coming. "What's next: We'll see medical devices like the PTM combined with what people already carry, like a mobile phone or BlackBerry," he says.
The PTM doesn't come cheap. Implanting a SynchroMed II system averages about $25,000 to $50,000, and an additional PTM handheld costs $2,000. And Valine says "insurance reimbursement is lagging." The expense can exceed the total cost of neurostimulation implant therapy. Medtronic's Synergy system costs about $25,000, for example, and Advanced Neuromodulation Systems' Eon system ranges from $20,000 to $24,000.
But with U.S. companies losing an estimated $62 billion in annual productivity due to pain-related illnesses, according to the most recent study on the economic implications of pain published in the Journal of the American Medical Association, the need is clear.
Jana is a reporter with BusinessWeek Online in New York
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