What are the steps required to create a medical device that can be paired with a medical app on an iPhone or iPad? Technology review tackles this scenario in a recent article, publishing a rough outline of the various items that are required for this to work. They compiled this list by interviewing various developers and companies who have medical devices and medical apps in the App Store.
By no means is this an in-depth analysis — but it’s a great starting point for those who want to know the various types of steps required. Note, their first step is talking with the FDA. Interestingly, they state that Apple won’t even talk to you unless you are at least in the process of getting your medical device FDA approved.
This week we’ve been covering the FDA draft guidance workshop for medical apps, so make sure to reference our articles for the beginning steps of this protocol:
First stop, FDA: A medical device is a medical device. If you aren’t cleared by the FDA, or working on it, Apple won’t talk to you.
Apply: To sell an app in the iTunes store, submit it to Apple’s website.
Developing devices, as the steps below show, is more involved.
First step: Apply to Apple’s MFi program (Made for iPhone) for hardware developers.
Prepare for feedback: Apple’s health-care developer team is led by Liang Hoe, who has an MBA and a biology background. He didn’t return our calls, but we hear he loves wild ideas and helping developers refine them.
Integrate: The tighter the connection with the iPhone, the better. Slip-on cases or cordless plug-ins are a plus.
Stay small: Space in Apple stores is at a premium. Small devices have a better chance of getting on shelves.
Design at will: Surprise. Design-centric Apple doesn’t dictate what medical devices should look like.
Submit your device: You’ll have to send Apple plenty of information about your product, including prototypes.
Keep mum: Apple makes device makers sign strict nondisclosure agreements. Apple’s tough legal language “gets personal,” developers say.
Secret sauce: Now you’re ready for the secret stuff. Developers who get this far will obtain the “iPod Accessory protocol,” the secret technical specs needed to communicate with the iPod, iPhone, and iPad.
Connect! The iPhone is famously locked down. Apple provides special hardware and other components needed to connect through Apple’s 30-pin dock connector.
Get approved: All that’s left is final approval by Apple. Developers say that’s harder than getting a green light from the FDA. Unlike the government, Apple can reject you without telling you why.