Online editor Jonathan Vanian interviews Jonathan Kohl on what it's like to work on software development and testing for mobile medical devices in light of the recent news that the Food and Drug Administration is developing a set of guidelines to regulate the mobile medical device app market.
With the Food and Drug Administration gearing up to create an agreed upon set of guidelines to regulate the mobile medical device app market, software developers who take on such projects need to be aware of what it’s like to work with a government agency right by your side. For an in-depth discussion on what exactly it’s like to work on software development and testing for mobile medical devices, I contacted Jonathan Kohl, a contributor to StickyMinds, who has recently written about exploratory testing in an FDA-regulated environment. Part one of our conversation focuses on the software project he worked on in addition to what it’s like to work under FDA regulations.
Here’s an edited version of our interview conducted through email.
Jonathan Vanian: Can you tell us a bit about the device you once worked on and its related software?
Jonathan Kohl: I worked on medical visualization software for popular smartphones and tablets.
In the old days, we used to get scans printed on film. The classic example is an X-ray. If you injured yourself as a child, you probably went to see the doctor and they took an X-Ray, then put the film up on a lighted board and showed you where you broke it. Well, those days are gone; all the scans are now stored as image files on servers and sometimes the only way you can show a patient what his pathology looks like and why doctors are recommending a certain course of treatment is to book time on the actual scanning machine itself. If you're lucky, the specialist you see has a machine in their office and they can show you in a consultation just after the scan. If your medical scans are sent to an expert, you won't see them. By the time this information gets down to your family doctor or the specialist who ordered the scan, they may not have any images to show you. So this application and system that I worked on provided access and visualization so that a medical practitioner could pull out a smartphone or tablet and show you exactly what was going on during the consultation. This is a huge improvement for patient care because digital technology has caused us to lose something now that the medium has changed.
Another use of the software was for remote diagnosis assistance. With certain pathologies or events, getting a course of action for treatment in place needs to be done as soon as possible. So if a patient has a medical emergency, gets rushed to the hospital, and a specialist or radiologist is on call, the specialist can quickly look at the scans and recommend an immediate course of treatment to start with while he or other experts rush in to help. In smaller centers, the hardware they use might be located in a larger city, so getting access to studies might require file transfer or sending images in an email. That isn't always secure and some file sizes can be quite large, so having secure, remote access to a larger system can be important.
The software does more than just show images. For example, it creates 2D or 3D rendering and allows people to zoom in and rotate images to look at them from different angles and cut sections out to get different views, among other things. It’s almost like a game—you load a medical study and start gesturing to view it in different ways.