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.
This article originally appeared on Recode.net.