Indiegogo Alum Scanadu Halts & Delays Shipping For The Scout Tricorder

scanadu scoutThe Scanadu Scout made Indiegogo history after raising over $1.6 million for their medical “tricorder” device. Furthermore, the company was set to buck the prevailing crowdfunding trend by actually delivering a product on time. Unfortunately, that won’t happen.

Shipping of the Scout has been delayed, but not before a handful of units made it out to backers. Scanadu will be replacing those units after catching a few faults in the original design. This was announced recently via the Scanadu blog

From this first set of units, we identified that some of the readings weren’t working as expected. 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.

Screen Shot 2014-04-06 at 7.20.31 PMThe delay is expected to take 8-12 weeks to fix at this point. Backers seem to be taking the news largely in stride, thanks in part to Scanadu’s extremely intensive and transparent approach to backer updates and information sharing both during and after the campaign.

Having said that, that positivity could certainly erode with further delays.

[via Re/code]

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  • cwjuhl

    The FDA requires device manufacturers to create a use-based risk analysis for their products. The FDA recommends formative human factors/usability testing, but does not require it. Further, the recommended the number of participants in human factors/usability testing to around eight, not 8,000, per identified class of users.

    “How many users do you need for the formative testing? The magic number is eight, yes eight—eight from each user group that would have the highest risk/highest frequency tasks using your product. For example, if the device were a ventilator, then there are several different types of users: the technician who calibrates the ventilator, the respiratory therapist, the nurse, the caregiver and the physician. Do you need eight of each for the formative testing? No. You need the users who perform the highest risk/highest frequency tasks. In this case it would be the technician, the respiratory therapist and the caregiver, for a total of 24 test participants. Why the caregiver? The FDA is paying particular attention to caregivers who use medical devices, even if it’s just to monitor the output. The reason the FDA considers caregivers to be the highest risk user group is because they are not professionally trained.

    Your next questions are probably: how long does formative testing take, and how much does it cost? In terms of time, two weeks of preparation, two to four days of testing and two weeks to obtain the report. Yes, that amounts to about five or six weeks. Now, the cost—that depends upon a number of different variables. If your user groups are medical professionals, then it is going to cost more for participant recruiting and incentives than if your user groups are caregivers or patients. There are costs for the facilities used for the testing, creation of the test plan, facilitation of the test and the report writing. I know you would like a number. Formative tests can cost as little as $25,000 up to about $55,000. These are only rough estimates.

  • cwjuhl

    “Scanadu’s extremely intensive and transparent approach to backer updates and information sharing both during and after the campaign.” ????? WHAT are you smoking? By far the BIGGEST complaint on both Scanadu’s Indiegogo campaign site and its FB page is the LACK of transparency, detail, and timely updates. Do you actually do any real reporting or do you just regurgitate PR releases ????????

  • cwjuhl

    Nearly eight months have now past since the scheduled delivery date to Indiegogo purchasers and the Scanadu “Scout” is still vaporware. Walter DeBrouwer was very confidently and unequivocally stating more than 18 months ago that the Scanadu “Scout” performed as described BEFORE the beginning the Indiegogo campaign. In fact he went so far as to state that the “Scout” was ready to go to manufacturing BEFORE the start of the Indiegogo campaign: “We are in a different situation because we started building the tricorder from the bottom up two years ago, we
    did not start after our campaign.” Given Walter’s very confident and unequivocal assurances back in early 2013, the delays in shipping the “Scouts” SHOULD NOT have been expected.

    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.

    And the causes of those delays in manufacturing were portrayed as relatively minor back in April of this year – something that could be fixed in 8-12 weeks. Now, going on eight months after the March deadline that Walter was so confident he would meet, the delays keep piling up and Walter’s 2013 statements that the “Scout” was “more than ready” have morphed into a seemingly endless “winding” and “complex and challenging” path.

    Then there is the Walter’s claim that Scanadu actually shipped some of the Scouts back in March. That frankly is very unlikely and certainly does not jive with the facts or circumstances surrounding the alleged aborted manufacturing startup last March.

    And then there are Walter’s claims about being cleared to ship the “Scout” without FDA pre-market approval as an “investigational” device. I have to call B.S. on that. Heck, I have to SCREAM B.S. on that.

    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. It’s clear that 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.

    In fact, I’m inclined to hypothesize that Walter’s “winding, complex and challenging” path has more to do with the FDA preventing Scanadu from shipping those “investigational” devices sold on Indiegogo than with faulty sensor readings or broken molds.

    That’s not the only potential regulatory issue facing Scanadu. Since every “backer” who pre-purchased a Scout I.D. on Indiegogo is required to enroll in the clinical trials, there may be a significant HIPAA privacy issue. Indiegogo lists all of the “backers” who pre-purchased a Scout I.D. on the project’s page.

    The actual names of many of the backers are prominently displayed there. Participation in a clinical trial is classified as protected health information. To constitute a HIPAA privacy breach requires two elements: a personal identifier (like a patient’s or participant’s name or social media identifier) and a piece of protected health information (like enrollment in a clinical study or trials).

    Whatever the merits of the Scanadu Scout may be (which are questionable at this point) crowdfunding platforms like Indiegogo are definitely not appropriate for marketing Class II medical devices which require FDA approval, or conducting clinical studies which are regulated in large part by HHS and subject to HIPAA compliance.

    I have to wonder what bonehead came up with the idea to market a Class II medical device and a clinical study on Indiegogo.

    I also wonder if Walter didn’t knowingly and cynically come up with the name “Scanadu” as a contraction of “scan” and “Xanadu.” Ted Nelson’s Project Xanadu is infamous for being the longest running vaporware project in the history of information technology, a fact that I am very sure has not been lost on Walter DeBrouwer given Walter’s history.

  • cwjuhl

    So is it REALLY OK with the FDA to sell untested Class II medical devices to consumers under the guise of being “investigational devices?” First there was the Scanadu “Scout” where 8,500 “Scouts” were sold as “investigational devices” on Indiegogo. Now we have Cue selling an “at home” blood testing device without FDA PMA under the guise of it being an “investigational” device:

    “Cue’s technology is not yet FDA cleared. The company explained in May that it plans to use an investigational device exception to sell some advance copies of the device prior to securing clearance, and then use information from those units for the usability testing required by FDA. That’s similar to Scanadu’s plans. The company said back in May that it hopes to ship the pre-sold units by spring 2015. ”

    Is this really OK with the FDA???? If so I have a new as yet untested ionic hand-held home CAT scanner that can detect 27 kinds of cancer. Its the size of a 2 foot long by 1 inch diameter piece of PVC pipe with red, white and blue flashing LED’s on each end. I can’t tell you exactly how it works, but trust me on that. I want to get it on Indiegogo ASAP at the “investigational” price of $199. All I need to raise is $2.5 million to begin production of the Conadu “Special Cancer Activated Measures” device (the Conadu “SCAM” device). Once the necessary funds are raised I expect to begin production by Christmas. But don’t hold me to a firm date. The algorithms may need adjustment, which could take years.