How the iPhone Might Disrupt The Medical Device Industry

Doctors wanting to determine a patient's atrial fibrillation burden have a myriad of technologies at their disposal: 24-hour Holter monitors, 30-day event monitors that are triggered by an abnormal heart rhythm or by the patient themselves, a 7-14 day patch monitor that records every heart beat and is later processed offlineto quanitate the arrhythmia, or perhaps an surgically-implanted event recorder that automatically stores extremes of heart rate or the surface ECG when symptoms are felt by the patient. The cost of these devices ranges from the hundreds to thousands of dollars to use.

Today in my clinic, a patient brought me her atrial fibrillation burden history on her iPhone and it cost her less than a $10 co-pay.  For $1.99 US, she downloaded the iPhone app Cardiograph to her iPhone.

Every time she feels a symptom, she places her index finder over the camera on the phone, waits a bit, and records a make-believe rhythm strip representing each heart rhythm. With it, comes the date and time. When the rhythm is in sinus, she learned that her heart rhythm was typically in the 60's at rest:

When the rhythm was in afib, it was considerably higher and sometimes displayed an irregular rhythm:

or sometimes it displayed an error message:

I got a relative picture of how often she was having afib and she got the opportunity to help me with her care.

Was this a medical device?  No, it was an iPhone app.

Was it perfect?  No it wasn't.  I certainly couldn't differentiate frequent PAC's or PVC's from atrial fibrillation reliably.  It was NOT an EKG after all.   But we were past that point in her evaluation.  I just needed to know how often she was having her known paroxysmal atrial fibrillation and she wanted to keep a convenient record of her episodes.

Was it helpful in this case?  Absolutely.

More importantly, she just saved herself and the health care system a ton of money.

Welcome, my friends, to the era of patient-empowered, individualized medicine and a whole new era of patient care.  Now, if we can just keep the FDA from screwing things up.

-Wes

PS: I have no commercial interest in the Cardiograph app and do not endorse it as a standard of care, but merely use this case to demonstrate how innovation can facilitate cheaper, equally-effective health care in some cases.  I'd also like to thank my patient for allowing me to use her screen shots.