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Scanadu production problems mar rollout of mobile health device to Indiegogo backers

After raising a recordbreaking $1.6 million on crowdfunding website Indiegogo, Scanadu backers were looking forward to receiving its device Scanadu Scout. Users can track pulse rate, temperature and other vital signs in less than 10 seconds when it’s applied to the head. But the digital health company has halted a rollout amidst production problems, re/code […]

After raising a recordbreaking $1.6 million on crowdfunding website Indiegogo, Scanadu backers were looking forward to receiving its device Scanadu Scout. Users can track pulse rate, temperature and other vital signs in less than 10 seconds when it’s applied to the head. But the digital health company has halted a rollout amidst production problems, re/code reported.

The mobile health technology is viewed as part of a broader trend in the future of healthcare because it allows users to collect so much information about themselves.

In a message to Indiegogo backers published on the company’s blog, Scanadu CEO Walter De Brouwer said some of the readings on the device weren’t working as well as expected:

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“Since that moment the Scanadu team has been working non-stop to determine why the initial batch did not meet our internal design control standards.

Based on our assessment these last few days, we’ve made the decision to delay shipment of the Scanadu Scout™ investigational devices until we feel it meets our internal standards. There are three fundamental issues that led to this decision:

  • The algorithm that connects the investigational devices with the app is inconsistent in reading scans made with the newly manufactured investigational devices. We have identified the issues in the algorithm and are working feverishly to address them.
  •  The temperature readings are faulty, but we are in process of identifying the fixes needed to solve this.
  •  Finally, the manufacturing tool used to make the investigational devices broke this week, after the first few hundred casings had rolled off the line.

DeBrouwer added that Scanadu would replace the faulty units and resume production when it has resolved the problems, hopefully in eight to 12 weeks.

What makes this rollout hiccup particularly embarrassing is that it’s supposed to be part of a usability study. Donors who backed the campaign with $199 or more, and received a prototype of the device in exchange, could opt to share their data and feedback with Scanadu. Last year DeBrouwer said:

“Indiegogo was an important step in the FDA process. For the file we will submit [in 2014] we must have a usability study in addition to clinical trials that shows how consumers will use the device…It was never about the money, but gathering people from all over the world who believe in Scanadu’s mission and wanted to be part of making the medical tricorder a reality. We are embracing the crowd as researchers as well as our customers.”

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