Mobile Medical Applications - More Apples, More Hassles

Could it get much worse for mobile medical applications and their developers trying to utilize phones and tablets as point-of-care medical devices? OK, surely it could, but this story can't make it any easier.

As this Bloomberg article reports, a 14-year-old completed a study that found that the Apple iPad2 smart-cover can, in some cases, interfere with life-saving cardiovascular devices because of the magnets used in its design. It is important to note, however, that most defibrillators will turn back on once the magnet no longer impacts the device.

This story, if interpreted incorrectly and sensationalized, could greatly impact two areas:

- Mobile Medical Applications: I don't think this group of devices is going to carry a good connotation with the FDA until industry thought-leaders and FDA leaders meet for a week to hash out exactly how to control them to protect the public from harm while still expediting the development and use for the betterment of healthcare. No, this exact story doesn't impact the apps themselves, but it is another potentially negative data point for an industry struggling to understand how to play with the FDA.

- Risk Management for Medical Device Companies: The risk management concern that arises is that companies are supposed to factor in foreseeable risks to ensure the devices are safe to use. If this story has a big impact on FDA interpretation of safety risk - it is Apple after all, meaning this could be a big deal - the risk management processes of all device-makers could be negatively affected. The expectation of foreseeable risk and the expected depth of development of theoretical and hypothetical hazards could become overly burdensome, catering to the impression that the FDA is stifling innovation.

Both outcomes are unfair, mind you. But, it is not out of the question for an event like this to mar the progress of mobile medical applications and risk management processes for medical device manufacturers if it is sensationalized.

-RTK

Image Credit - Nick Perla on Flikr