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Courtesy: Scanadu

Science


After years of development and a shapeshifting series of prototypes, medical device startup Scanadu began shipping its highly-anticipated Scout product to Indiegogo backers this week. And then it stopped.

The Mountain View, Calif., startup discovered issues with the readings from the device and has temporarily halted distribution as it fixes them. The company is posting a letter to backers this evening from Chief Executive Walter De Brouwer, which states:

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.

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.

He said the company will replace the units that shipped and resume production “as soon as these key issues are resolved,” a period it hopes won’t be more than eight to 12 weeks. De Brouwer added:

The entire Scanadu team is working around the clock — refining algorithms, testing software and hardware, sourcing a new thermometer, and working with our manufacturing and related partners to deliver to you as fast as possible.

Update: The full letter is now available here.

Earlier this week, the company offered Re/code a glimpse of the hockey-puck-shaped gadget, which picks up six readings, including blood pressure, heart rate, heart rate variability, respiratory rate, blood oxygen levels and temperature. A user places the device near his or her temple and in about 10 seconds, the data pops up on an accompanying smart phone app.

Or at least that’s what should happen when everything is working correctly. Upon arrival, we were told we couldn’t actually try it out — perhaps because the issues had already surfaced.

But we did get to see it and talk to De Brouwer about his broader hopes for the product, which he discusses in the video below.

The Scout has inspired comparisons to the fictional medical tricorder of Star Trek fame. The company raised nearly $1.7 million from 8,500 funders last summer in one of the most successful campaigns on the Indiegogo crowdsourcing service. It brought in another $14.5 million in two traditional venture capital rounds.

Ultimately, De Brouwer believes the device — as well as another the company is working on to analyze urine — could begin to change the way medicine is practiced. The products allow people to see for themselves how exercise, diet, drugs and lifestyle choices affect their health on a real-time basis. That, in turn, could motivate them to make better choices — and put them on more equal footing with physicians as they discuss medical options.

“It’s a new kind of healthcare,” he said. “Once we know where we are in that data, we can change it. It’s over with predestination. For me, that’s very important.”

The Scout is a big step beyond the “quantified self” data, such as pulse, steps and calories, offered up by today’s wearables, potentially offering a more direct measurement of a person’s overall state of health. It packs a series of sensors into the device, including an infrared thermometer; a small disc on the bottom that picks up the pulse rate through the thumb; and an ECG, which measures the electrical activity of the heart.

But selling a product that provides medical data, rather than the “wellness” variety, requires the Food and Drug Administration’s approval. The company is pursuing a pair of trials to ascertain its usability, accuracy and safety.

Currently, the Scout is an “investigational device,” and those Indiegogo backers had to fill out informed consent paperwork to receive the device — and will be asked to share additional information if they’d like to opt in to the usability study.

Scanadu has said it hopes to begin selling the device this year or next for $199. But the ultimate timing will depend on when, or if, it gets FDA clearance.




3 comments
cwjuhl
cwjuhl



There was an interesting post today in MobileHealthNews concerning the Scanadu Scout. Walter De Brouwer is certainly singing a much different tune today than he sang in MobileHealthNews back in May of 2013 when he stated 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.” So now he is saying that Scanadu was in fact not ready ???


De Brouwer goes on to assert that he has some sort of "understandings" with the FDA. As for his "understandings" with the FDA, Mr. De Brouwer is at his obtuse best when attempting to explain those "understandings." In fact, it is very, very difficult to conclude that the FDA would allow Scanadu to sell the Scout as an investigational device prior to FDA clearance. The FDA regulations concerning marketing an "investigational" device are actually very definitive:


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.


Mr. De Brouwer himself in this publication has characterized the Indiegogo campaign as selling the scout to buyers on Indiegogo:


“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.


It seems pretty clear that Scanadu by Walter De Brouwer's own tacit admission has violated 21 C.F.R. Sec. 812.7


Perhaps Walter De Brouwer would care to clear up this apparent discrepancy between his current statements concerning his "understandings" with the FDA and the regulatory prohibition against selling or marketing an investigational device prior to FDA approval?


cwjuhl
cwjuhl

Scanadu still has not fulfilled its commitments to its Indiegogo backers and is no longer even indicating that it will. Further, Scanadu is facing significant regulatory obstacles that they were aware of or should have been aware of at the time they marketed the Scout on Indiegogo as a "First Edition" then as an "investigational" device. The FDA prohibits marketing an "investigational device" prior to FDA Pre Market Approval. Further, because all purchasers were enrolled in the "investigational study" and all purchasers are listed on the Indiegogo campaign (many by name), Scanadu may have committed a significant HIPAA breach.

Whatever the merits of the Scanadu Scout may be (which is questionable at this point) crowdfunding platforms like Indiegogo are definitely not appropriate for marketing medical devices which require FDA approval, or conducting medical 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 medical device and a clinical study on Indiegogo.

cwjuhl
cwjuhl

The alleged start and stop of shipping back in March just is not plausible. There was and is no apps on either the Android or Apple app stores, so how and why would they begin shipping when there was no app yet available for the recipients to use the device? Further, one group of backers, the "Qualified Selfers" who paid an extra $70, were supposed to receive access to the app BEFORE the device shipped. Shipping the device with no app and failing to give pre-release access to the app to those qualified selfers seems to contravene the commitments Scanadu made to the Indiegogo backers. Was Scanadu going to refund the "qualified selfers" the extra $70 those backers paid? This is even odder when also considering the fact that Scanadu has maintained all along (and does to this day) that the app was actually ready in early March before that first batch of devices rolled off of the mythical assembly line.

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