Diagnostics & Imaging Week National Editor
Question: How do you get that bigger buzz for your medical device?
Easy – add some high-profile, high-tech enhancements.
Take, for instance, the basic "rescue" inhaler, sometimes called a "puffer," used by those with asthma. It's used every day by millions of people, all around the world, to stave off a sudden tightening of the chest, increased difficulty in breathing, or a fully-fledged attack.
Used to complement everyday therapeutic inhalers, the rescue device is "actuated" to send short bursts of the drug albuterol to keep open the rapidly tightening small air passages of the lungs that signal the first signs of suffocation. It is a common, every-day life-saver.
But it's so common, and commonly used, the puffer has no med-tech pizzazz . . . until you add GPS, global positioning technology.
With that high-tech addition to a relatively low-tech device, and a press statement bannering this addition, this prosaic device turned into a hybrid combination has gotten all kinds of added attention, says its developer, David Van Sickle, PhD.
Added to many puffers, the GPS addition could help to identify their increased use, and thus track and better understand large outbreaks of asthma and their causes, he says.
But Van Sickle, a Robert Wood Johnson Foundation Health and Society Scholar in the Department of Population Health Sciences at the University of Wisconsin (Madison), told D&IW that the GPS is really a sort of added-value technology and, as of now, just the secondary high-tech addition to the device, a triple-tech hybrid.
His first attachment to the puffer is a wireless communication system, used to signal how often the devices are being used. With each actuation, the wireless component sends a message to a data center in Madison, providing a real-time report of their use.
This, in turn, Van Sickle's theory goes, should provide physicians with much more precise information as to how a patient is doing and thus how to manage their medication and overall care.
Van Sickle notes that patients are not really too clear about how often they use their rescue inhalers, written diaries often failing to be equally inaccurate. Thus, the real-time data could provide much greater accuracy, he said, most importantly, whether their asthma is really controlled or not. Better surveillance could provide management to reduce severe attacks and hospitalizations.
Somewhat smaller than a pack of playing cards, the inhaler/wireless/GPS combination is a module that attaches to the front of the inhaler, and Van Sickle says that a key challenge was to add these technologies without compromising device actuation and drug inhalation.
A small pilot trial of the device is currently underway, with Van Sickle saying that about 50 patients have been enrolled so far.
The first phase of the study will compare the data gathered with the enrollees' written diaries, the second phase then to essentially unblind the information gathered – "turn the light on," as Van Sickle puts it by e-mailing to the enrollees graphs and tables of their actuation data as a way of promoting better self-management. Van Sickle has also developed a web site, at Asthmapolis.com, to provide information about asthma and its treatment.
The addition of the GPS system to the device has the goal of creating the ability an "asthmap," the identification of greatly increased frequency of inhaler actuations in a particular geographic area to help track outbreaks and their causes, similar to the way in which Internet hits looking for information about the flu can be used to track flu outbreaks.
Van Sickle has formed a company to commercialize the device, and the GPS system for the inhaler was designed and developed by GPS-integrator SiliconSky GPS (Red Lodge, Montana). The CDC is financing its use of the current trial of the device.
The idea for the "asthmapping" strategy was prompted, Van Sickle says, before moving to Madison in 2006, by his work at the Centers for Disease Control and Prevention (CDC; Atlanta), where he was a disease detective in the Epidemic Intelligence Service, and he investigated a number of outbreaks, including exposure to mold in post-Katrina New Orleans and chlorine gas in South Carolina.
Van Sickle says that the established risk factors for asthma are still somewhat questionable, failing to explain "its global prevalence patterns and time trends. Studies of epidemic asthma have demonstrated that understanding the locations where asthma exacerbations occur can help identify important new exposures."
He provides the example of an epidemic of severe asthma that struck Barcelona in the 1980s. Researchers looked at all the standard possibilities, he said climatology and standard air pollutants and pollens – "but there wasn't anything exceptional" about these. They then found that most initial attacks came while patients were near a waterfront where soybeans were being unloaded from container ships.
"The victims were exposed to massive clouds of soybean dust because the appropriate filters weren't installed in harbor silos,'' he says. It took eight years to discover this, and "it was the first time soybean dust had been shown to be a potent allergen."
Asked his opinion concerning what actually may be the primary causes of asthma, Van Sickle says he avoids accepting the range of causes traditionally and intuitively considered as causations – air pollution and a range of allergens – because he wants to keep an open mind and look at the results of research with the asthmap system.
Parenthetically, he notes that the increase in asthma among children in the U.S. has currently "plateaued" and that this is "just as surprising" as the previous increases that have been seen.
He says the major hurdles in the future development of the hybrid device are to make it smaller and more easily usable and bring down its cost, from about $170 to the $100 range.
He acknowledges also that for asthmapping to be really successful, the device will have to be in the hands of large numbers of people. Candidly, he admits he is not quite sure how this might be accomplished but hopes to establish partnerships with public health organizations, such as the CDC.
Van Sickle says he will be making a presentation concerning his work at the international conference of the American Thoracic Society (New York), May 15-20 in San Diego.
A group of Van Sickle's students also is working to develop a low-cost spirometer for assessing lung problems.
Van Sickle says that commercially available spirometers are too expensive for most clinics in non-industrial countries. The students are working on a design that could lower the cost from about $1,500 to $50. The project is set up as an "open source" endeavor on the Internet, allowing anyone access to the designs.