Scanadu Halts Shipments of Scout Tricorder

11-12-2013 8-14-33 PM

Last summer, medical device startup Scanadu launched an Indiegogo campaign to fund FDA testing and mass production of its tricorder-inspired Scanadu Scout. The Scout was designed to disrupt the in-home digital thermometer market.  By placing the device against the temple for 10 seconds, the Scout will capture heart rate, body temperature, pulse oximetry, respiration rate, blood pressure, emotional stress, and an ECG waveform.

The campaign was incredibly successful, ending in July after netting $1.6 million from 8,000 donors. For $199, entry-level funders were promised an early version of the Scanadu Scout.  At the time, Scanadu reported that it expected to begin shipping units in March of 2014.

Timelines are notoriously shaky when it comes to crowd-funded projects, and so it should have come as no surprise to the Indiegogo backers expecting to receive a Scanadu Scout last month, when they received a notice instead explaining that Scout shipments had been halted due to quality control concerns.

In an open letter on its Indiegogo page, Scanadu explains that after shipping a handful of devices to early backers, problems were discovered that warranted a delay in shipping additional units, and a revisit to the Scanadu Scout design. At the heart of the matter, Scanadu explains, was:

 

  1. 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.

  2. The temperature readings are faulty, but we are in process of identifying the fixes needed to solve this.

  3. Finally, the manufacturing tool used to make the investigational devices broke this week after the first few hundred casings had rolled off the line. 

 

The Scanadu team is quoting an 8-12 week turnaround time to design and implement fixes for the problems, which will include sourcing an entirely new thermometer component. Once the device meets internal quality thresholds, shipping will resume and the Indiegogo funders will subsequently act as early testers, helping Scanadu prepare for it’s FDA pre-market clearance application.

Scanadu raised an additional $10.5 million in VC funding in November 2013. In a statement published at the time, Scanadu CEO Walter De Brouwer suggested that he hoped to clear the FDA approval process and begin shipping units to the general public by late 2014 or during 2015.


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  • cwjuhl

    FDA regulations explicitly prohibit marketing an investigational device prior to FDA approval for commercial distribution:

    21 C.F.R. Sec. 812.7 Prohibition of promotion and other practices.
    A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:

    (a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.

    “It’s sold as a research device for investigational use. Everyone who buys it is essentially a researcher in that project,” De Brouwer told MobiHealthNews in May of 2013 at the beginning of the Indiegogo campaign. Key words there: SOLD, EVERYONE, and BUYS. Walter De Brouwer himself characterized the Indiegogo campaign as selling the Scout as an “investigational device” to Indiegogo buyers, which is explicitly prohibited by the FDA.

    That’s all somewhat academic at this point as Scanadu is more than 6 months past the date it promised to deliver those “investigational” devices to Indiegogo purchasers. The excuses coming from Scanadu for the delays have been pretty lame, and are frankly in direct contradiction to De Brouwer’s claims in May of last year when he stated in MobileHealthNews that “The device has seen 18 iterations, the industrial design is ready, the algorithms are in place, the manufacturer is secured, the FDA audit trails are operational. For Scanadu this is just the end of the beginning. We did Indiegogo when we were over-ready.” That sure seems like one big fat fib right about now.

    The only thing lamer than De Brouwer’s excuses is the failure of media outlets like Histalk to follow up on the hype they helped build for this debacle.

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