Pocket-sized, disruptive technologies dominate FDA docket: Tread carefully

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Mobile MIM is a remote diagnostic imaging tool with FDA 510(k) clearance for the iPhone, iPad and iPod touch.
Image source: MIM Software

Pocket-sized powerhouses took center stage last week when the FDA cleared a pair of potentially disruptive technologies: Mobisante’s MobiUS smartphone-based ultrasound and MIM Software’s Mobile MIM, a radiology application that allows physicians to view medical images on the iPhone and iPad. Both promise to extend the reach of medical imaging. However, such diffusion of imaging may be a mixed blessing for radiologists.

Several characteristics distinguish disruptive technology, Jonathan W. Berlin, MD, MBA, clinical associate professor of radiology at the University of Chicago Pritzker School of Medicine, said in an interview. These include: lower cost, greater accessibility, reduced barriers to use and, in some cases, reduced effectiveness.  “These products can eventually unseat more established products,” continued Berlin.

Ever-shrinking world of portable ultrasound
Although the uber portable ultrasound platform promises improved access to ultrasound technology, it might displace full-featured systems used in radiology departments. That’s because some referring physicians may not fully appreciate the diagnostic differences between the platforms.

What’s more, Mobisante suggests that the system’s affordability and portability offer the potential for physicians to generate new revenue streams. Reading between the lines, Berlin suggests indication creep, potentially opening the door to exams that may not be needed. Although Berlin applauds the portable system as a positive development, there are a few potential concerns.

Indeed, the worst case scenario could be increased frequency and decreased effectiveness of ultrasound scanning, stemming both from the system’s basic feature set and scan acquisition and review by novice users. The end result of more diffuse access may be more studies overall but fewer diagnostic studies, or unclear findings that could lead to repeat ultrasound studies or additional testing, which increases costs.

The uncertainties merit a cautious approach. “In this era of trying to determine cost-effectiveness and look at the effect on patient outcomes for any test, we have to be a little circumspect about something that potentially could come with dramatic increase in usage of a particular test without any type of long-term study or analysis to indicate the effectiveness of increased usage of the test,” opined Berlin.

Berlin suggested that radiologists emphasize the ease of access to ultrasound systems based in the radiology department as they discuss the implications of the technology with clinical colleagues.

Expanding iPod apps
The other pint-sized breakthrough--MIM Mobile—further extends image review capabilities, allowing physicians to view images on an iPhone, iPad or iPod. The software could improve communication and accessibility especially as medicine continues its race toward subspecialty image review, Asim F. Choudhri, MD, assistant professor of radiology in the division of neuroradiology at University of Tennessee Health Sciences Center in Memphis, said in an interview.

The goal, he noted, is not to replace conventional image viewing. The technology allows a variety of specialists to evaluate and discuss difficult cases, which might accelerate care.

Consider the surgeon located 30 minutes from the hospital who reviews images via an iPad in anticipation of a case, offered Choudhri. He can request that the OR and patient be prepped as he drives to the hospital and then spend five minutes confirming his findings on PACS, which effectively starts the OR prep clock 25 minutes earlier. Similarly, the model may accelerate decision making for patients who need to be transported to other medical facilities.

“This definitely has the ability to improve the level of care,” said Choudhri, adding that it could strengthen radiology if the profession determines how to leverage the software to improve service to patients and referring physicians.

On the flip side, there’s potential, Berlin suggested, for the software to further remove radiologists from the onsite healthcare process, exacerbating any disconnect between radiologists and clinicians. Plus, the image review process requires consideration. For example, an orthopedic surgeon reviewing trauma images may focus on diagnosis of a fracture but overlook arthritis, a lesion or soft tissue findings.