How Mobile MIM became 1st iPad radiology app FDA approval

One of the exciting early promises of the iPhone for doctors was the ability to view imaging studies, such as CT & MRI, while on the go. Early on, many did not suspect how powerful was the “small touchscreen computer that makes phone calls”, in the words of Mark Cain. So, when MIM Mobile, the first CT/MRI (DICOM) viewer for a smart phone, was released in November 2008, it was an impressive introduction to the potential for mobile medicine.

The radiology software company MIM Software (previously MIM Vista) was started in 2001 when its founder Dennis Nelson, then a biomedical engineer at Cleveland’s Case Western radiology department, noticed how difficult it was for physicians to read combined PET (positron emission tomography) & CT studies. He wrote software to “fuse” the two images into one which eventually became the company’s first and ground breaking product.

In this interview, Mark Cain, CTO of MIM Software, shares with us how they first developed an iPhone viewer for DICOM (CT & MRI) images. The software was so impressive in its early incarnations that Mark Cain was on stage (video)with Steve Jobs at the 2008 WWDC where the iPhone SDK was the main topic and it went on to win one of Apple’s coveted design awards in 2008.

He also tells the story of their submission of the software for FDA clearance in 2008 as a medical device. After four previous submissions to the FDA for various radiology imaging software, he thought he understood the process. But what ensued was an up and down 2 1/2 year journey before their mobile DICOM viewer was finally approved by the FDA in February 2011. This difficult process gives us a window into the short history of the collision between regulatory institutions and the rapidly evolving world of mobile medical software and devices. It also demonstrates how much of what doctors actually get to use is dependent on the regulatory and other non-clincal aspects of the tools.

Be sure to check out our recent review of the iPad app Mobile MIM viewer, the first FDA approved mobile DICOM viewer and their cloud-based DICOM sharing web-application MIM Cloud.
Interview with Mark Cain, CTO, MIM Software
How did you decide to build an iPhone app ?

The company was incorporated in 2003 and originally made its name with software to perform PET CT fusion. Later we expanded to radiation oncology with contouring tools, CT deformation tools, as well as PACS solutions.

When the iPhone SDK came out in 2008, almost on a whim, we thought we would see if we could make an imaging tool. We had good programmers but they had never written in Objective C [the programming language of iOS]. Jerimy Brockway and David Watson worked at home in the evenings for one week, and at the end of that we had a functioning prototype that convinced us that this was real. We spent another month ironing out the kinks. At the end of that, we had an application that, despite the memory limitations of the device, could perform mutiplanar reconstruction on a smartphone.

The app store launched in July 2008, and ours was the first medical app present (before the medical category even existed). We were listed under “Healthcare and Fitness”. It was not long before we realized this was going to be a product that could change the direction of our company.
Tell us about winning the 2008 Apple Design Award [for Best iPhone Healthcare & Fitness Application]

We had already been dealing with an Apple developer relations person who found out about our work on an app and wanted to see it. So, we sent a short video that apparently got passed around and noticed at Apple. A short while later I was invited on to go on stage at WWDC 2008 during Steve Jobs’ keynote address. They had a 11 developers presenting; our app certainly stood out as something very different amongst the games and social apps.
When did you decide to submit it to the FDA ?

After we showed the app to a few radiologists, we knew we would go to FDA with it; it was clear that the use would fall under the definition of “medical device.” We put it out on the app on store for free on day one. We knew that the FDA governs commercial distribution of devices so we specifically made it available for free. But when they found the app in the App Store, they ordered us to take it down. It turns out that, because the FDA also governs the marketing of medical devices, we were, in effect, marketing a product that was still under review.
What did it take to get FDA approval ?

We submitted it in July 2008. Within one week, there were a lot of questions and a lot of confusion. The FDA was confused because it sounded like a hardware device, not software. Also, the fact that we were submitting workstation-type software for a “phone” increased the confusion.

Previous to this, we had four 510(k) applications that went very smooth. A 510(k) application compares a new device to an existing one, and allows for a shorter and simpler review process, given that there are already “substantially equivelant” predicate products on the market. Our predicate was one of our image viewing products.

Our submission fell apart, and was eventually closed as “not substantially equivalent” to a predicate device (NSE) for lack of information.

We gathered some more clinical data and submitted our second 510(k) attempt in the summer of 2009. Typically, an applicant gets a response within 90 days but we heard nothing for months, even despite calls. We were told we were on an “extended track,” though we were unsure if such a thing formally existed. Finally, after 221 days, we got an NSE letter in Jan 2009.

As a new device type with no predicate, the NSE letter bumped our device up to Class III Premarket Approval (PMA), which is the same classification as high risk devices, like implants. We had considered the de novo device clearance process, but it was not clearly defined and had a poor track record of success. During a discussion about our second 510(k) with an FDA director, we were told that the NSE decision was unanimous, and that a de novo or an appeal would be very unlikely to succeed.

We decided to go ahead with the PMA process. We needed to get an investigational device exemption (IDE) to allow us to test in the clinical setting. This would require us to build a complete protocol, specifying users & usage, etc. We hired consultants to help prepare the plan.

At about this time, changes were afoot in the management structure at the FDA. The FDA ombudsman suggested going ahead with an appeal, noting that personnel had changed. So, we got to state our grievance. In the process found out that the “tone” had changed and we were encouraged to resubmit another 510(k) application instead of a PMA, provieded we could address their concerns.

We settled on an intended use that both sides were comfortable with, specifically “diagnostic display of CT/PET/MRI/SPECT modalities when radiologist does not have access to a workstation”. X-rays were excluded due to the many additional questions and concerns which stem from their dramaticaly higher resolution, as compared to the screen resolution of iOS devices. We prepared additional clinical information and resubmitted our third 510(k) in December of 2010.

This time, the process was very different. We had a new reviewer, and we received effective feedback through the process. We provided measurements of the devices’ display characteristic, such as brightness and contrast response. These measurements are typical for other viewing hardware devices, e.g. mammography equipment. The primary focus, however, was on the viewing experience itself, and thus on ensuring safe and effective use. While several factors can impact the reading experience, like the variability of network transfer times, the emphasis was mostly on the lighting and the environment.

Finally, we received FDA clearance on Feb. 4, 2011.
Will graphics improvements in iPad2 make any difference ?

Yes. The speed and additional memory will make Mobile MIM extremely pleasant to use. More memory means even larger data sets can be displayed as multi-planar reconstructions.
Do you have plans for Android versions ?

For over two years we didn’t even know if we would have a product to sell, given regualtory issues. So, we weren’t exactly rushing into additional development. The regulatory process was difficult. What was very good, however, was that the iOS environment and the Apple devices were very stable homogenous. The fact that Mobile MIM today is, at its core, the same app we developed three years ago is a testament to consistency of the platform.

The Android market has significantly more variety and changes at a more dramatic pace. It remains to be seen what the FDA would require for clearance on a platform with hundreds of different devices.