It took nearly three years and three 510(k) applications, but MIM Software finally obtained FDA clearance for its Mobile MIM app, the first-ever radiology mobile app to receive the agency’s seal of approval.
The process was so fraught with confusion and miscommunication — or worse, no communication — that MIM Chief Technology Officer Mark Cain likened the experience to falling into a “black hole.”
If there’s any good news for other radiology app developers, it’s that Beachwood, Ohio-based MIM’s experience might — might — provide a roadmap of sorts for the U.S. Food and Drug Administration to follow when the agency reviews similar mobile apps for devices like the iPhone and iPad in the future. And that’s no small point for a health IT industry that’s suffering from a lack of clarity when it comes to knowing what the FDA wants from developers of medical apps, many of which fall under the FDA’s jurisdiction because they’re considered medical devices.
“Clearance of this technology is a big step toward [the FDA] developing a model to review the next technology that comes down the pike. And there will be a next technology,” said Bradley Merrill Thompson, a regulatory attorney with Epstein Becker & Green in Washington, D.C. (Thompson has written extensively on the intersection of regulation and mobile health technology, and his (pdf) white paper on the topic is highly recommended to anyone who wants to learn more on the subject.)
It’s not as if developing clear requirements for mobile health technology is an easy job for the FDA. The agency has already cleared a handful of apps, including one for heart monitoring and another for obstetrics, but a radiology app, whose success would be completely dependent on its ability to accurately present complex images, presented new challenges. Plus, the agency may be short on the experience and expertise needed to properly evaluate such a new form of technology.
An FDA spokeswoman declined an interview request because the agency is still refining its process for reviewing mobile apps. “Clearance of Mobile MIM’s radiology app does not imply a generalized policy for mobile health devices,” she said.
Still, the health IT industry no doubt hopes that clearance of the app will at least help the FDA formulate some sort of generalized policy for mobile apps. And with 80 percent of physicians expected to be using smart phones by 2012, the sooner that policy becomes clear, the better.
The Mobile MIM story
MIM Software has been developing radiology software since 2001, but as of early 2008, it hadn’t jumped into mobile apps territory. That changed on March 27 of that year, when — on a whim — two developers wrote the first lines of code for what would become the Mobile MIM app.
“It wasn’t part of our business plan. It just happened,” said Cain. “Two of our employees began writing the code just to see if they could do it.”
About two months later, the company had a working app, which shrinks the size of radiology images like CT and PET scans and transfers them securely while still allowing physicians to measure image intensity values.
Knowing the app would be considered a medical device because doctors would use it tomake diagnoses, MIM Software decided to make it available for free in Apple’s AppStore, hoping that the app wouldn’t draw the FDA’s wrath because the company wasn’t trying to profit from it.
That’s not how things worked out. A couple months later, MIM received a notice about the app from the FDA saying, in effect, “Pull it now or our compliance department will be calling you shortly,” according to Cain. The company wasted no time following instructions.
“At that period of time, there were so many unknowns that the level of complexity was beyond our understanding,” Cain said.
MIM then prepared and submitted to the FDA a 510(k) application, which, if cleared, would give the company the right to begin marketing the app. To obtain 510(k) clearance, the applicant must show that its medical device is “substantially equivalent” to an existing device that’s already been cleared by the agency.
From Cain’s perspective, the FDA’s response to 510(k) No. 1 left a lot to be desired. The agency questioned the company extensively about Apple’s iPhone hardware, which the company knew few details about; MIM is a software company.
“We got all these questions that didn’t make any sense,” Cain said. “The communication breakdown was remarkable.”
With both the FDA and MIM apparently unsure of how to proceed, the first Mobile MIM 510(k) essentially fizzled out. MIM went “back to the drawing board,” collected some clinical data and submitted it in another 510(k) in the summer of 2009. Then … silence. Cain said MIM heard nothing from the agency.
“There was no communication, no feedback, no questions,” he said. “We’d call and ask about it and we’d get, ‘No questions. It’s still under review.’”
For 221 days, 510(k) No. 2 languished. Then, in early 2010, the FDA told the company that its application was rejected. Worse yet, the FDA said that the 510(k) process wasn’t the proper route for the app to receive regulatory clearance. With no “substantially equivalent” device, the company would have to go through the Premarket Approval (PMA) Application process, which requires far more data than a 510(k), and thus is much more lengthy and expensive.
MIM pondered what to do next. It appealed the FDA’s decision, and in the summer of 2010, finally began seeing progress. The agency agreed that a PMA would be unnecessary, and that a prior version of MIM’s image-viewing software was, indeed, “substantially equivalent” to the app.
“There was a turnaround that summer,” Cain said. “The communication was fantastic.”
The company submitted 510(k) No. 3 in late 2010, and the FDA announced last week that it had cleared the Mobile MIM app for marketing. The agency stressed that the app is not intended to replace a full workstation, but can be used to make a diagnosis when a physician does not have access to a workstation.
Cain expects the app to be available in the AppStore this week. MIM will make the app available for free, but radiologists will need to use the company’s software, which they’ll have to pay for, to upload images to it.
So what changed? To hear Cain tell it, not much on MIM’s end. Throughout its dealings with the FDA, the company made just one significant design change to the app, an adjustment to its “contrast response” that would compensate for possible hardware changes in subsequent versions of mobile devices, he said.
The majority of the FDA’s concerns all along were related to hardware, which Cain admits represents “a paradigm change” for the field of radiology. How would transferring a large image to a small screen affect a radiologist’s ability to discern subtle details? Was a consumer-oriented hardware device adequate to display complex medical images?
“You’re taking a consumer-grade instrument and you’re trying to show that it’s reliable enough to be used in a medical setting,” said Thompson, the regulatory attorney. “There’s a lot to that.”
Cain attributed the FDA’s decision to clear the app primarily to two things: personnel changes that brought “new opinions and perspectives” and mounting pressure on the agency to provide some sort of clarity to mobile health software developers.
“I’d like to say the experience was purely because they decided to be transparent, but I think the pressure was on to finally accomplish this,” he said. “It had gone on long enough. The medical world needed to understand the FDA’s viewpoint on portable technology in general.”
Thompson said the uncertainty surrounding the FDA’s regulation of mobile health apps is indicative of a “culture clash” between the Rockville, Maryland-based agency and software developers’ Silicon Valley ethos. The regulatory process is moving “very fast in Rockville terms, but very slow in Silicon Valley terms,” he said. “Silicon Valley is just not used to working in the public health environment, so it’s a difficult learning curve.”
At this point, however, there’s more pressure on the FDA than the software industry. The agency must apply its mission — protecting the public from not-ready-for-primetime medical products while not hampering innovation that’s critical for U.S. economic growth — to a new type of technology.
That brings with it a host of questions that don’t present easy answers: What exactly does and doesn’t trigger an FDA review of a mobile app? Should the FDA regulate apps that focus on general wellness, such as one that claims to help a patient manage diabetes or weight loss? If a networked device (for example, an app that’s on a cell phone and is connected to a server, which is connected to a doctor’s PC, which hosts desktop software) presents the wrong data, which vendor in that chain should be held responsible?
Those are questions that will ultimately be decided by the FDA, with industry input, of course. But until that happens, Cain can offer some advice to medical app developers: Make sure you have another source of income.
“For small developers, facing the black hole of the FDA process is tough,” he said. “We were fortunate that we had an existing means to sustain our business during the drought.”
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