Homemade medical devices present both challenges and opportunities

The unregulated initiative typifies the challenges and opportunities posed by the intersection of technology and healthcare. Using the DexCom G4 Continuous Glucose Monitor, an Android phone and a cheap cable, others can monitor a patient’s blood glucose level’s from afar, as the wait for FDA-approved devices to do so continues.  Nightscout was popularized by a tweet of a photo depicting how to upload the glucose monitor’s information onto the Internet, and the software required can be set up in 20 minutes, The Wall Street Journal reports.  The article tells the story of a little girl who was allowed to go on her first sleepover because her patients could remotely monitor her blood glucose levels.

Still, the program isn’t perfect and occasionally goes down.  So far, the FDA hasn’t cracked down on the unapproved product, and DexCom hopes to offer FDA-approved software by the end of the year, according to The Wall Street Journal.  While remote patient monitoring does not appear to be high on the FDA’s risk-based approach to monitoring and regulating the deluge of new Internet-based products and apps, Nightscout raises broader questions, especially because it was invented and run by tech-savvy individuals, not med tech company employees.  (The infamous tweet came from a software engineer for the grocery store Wegmans, according to the article).

Unapproved software that makes recommendations about therapy or controls insulin delivery would draw the ire of the FDA.  However, as evidenced by the slogan and Twitter hashtag #WeAreNotWaiting, patients are getting impatient, and many are frustrated that the latest insulin pumps are approved in Europe years before the U.S.

The constant updates and tinkering that are trademark of Silicon Valley products (Apple’s new iPhone operating system has already gone through at least two updates) are not consistent with FDA’s cautious approach, or the necessarily deliberate pace of evidence-based medicine. But the two worlds are colliding, and a more integrated approach is needed.

REFERENCE:  Fierce Medical Devices; 29 SEP 2014; Varun Saxena

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