First ‘tricorder’ as a crowdsourcing project for FDA approval

Scanadu asks Indiegogo users to test its “tricorder,” but don’t call it a pre-order
[Via PandoDaily]

Scanadu SCOUT_back

Scanadu, the healthcare company trying to build a real-world version of “Star Trek’s” tricorder, is looking to raise $100,000 on Indiegogo, but it would prefer that you don’t refer to its campaign as crowd-funding or pre-ordering its Scout device. It’s using Indiegogo to crowd-source the hunt for willing participants in a usability trial required by FDA — the money is secondary, or at least that’s how Scanadu views the initiative.

“We’ll learn a lot about how end users are going to treat the medical readings,” says Scanadu CEO Walter de Broweur. “If they want to, and are going to, change based on these readings.” He says that interest in the company’s product has far exceeded expectations — unsurprising, given the constant “Star Trek” references — and the campaign will allow Scanadu to learn from a few of its more fervent fans.

Scout has changed since last November, when de Brouwer showed me the device’s capabilities in a crowded Starbucks. It’s more circular and more powerful — de Brouwer says that it’s the same size but weighs a bit more — and, due to popular demand, is no longer restricted to one user per device. The new Scout will allow you to collect your children’s and parents’ heart rate, blood oxygenation, and, yes, temperature, among a slew of other stats.

[More]

An innovative way to garner FDA approval! This is how they descirbe this effort:

We are creating a medical-grade device, which is not yet fully accurate and not FDA-approved. Hence this is not a medical device. Via this campaign, you may contribute and your input may affect the final design and characteristics of this revolutionary tool.

The exploratory version of the Scanadu Scout™ is not a medical device and makes no medical claims. As a research tool, it can be used to collect data that will be submitted in a marketing application to the regulatory authorities.

Before Scanadu Scout™ can become a medical device it will have to go through the FDA (Food and Drug Administration) approval process and this is where your help comes in. With the Scanadu Scout™ you will help us by Scouting yourself and giving us feedback to refine the Scanadu Scout™.

This will happen in the framework of official clinical studies in which you will be invited to partake, ONLY IF YOU OPT-IN. For each study, some of you will be contacted and will have to sign an Informed Consent form. With your help we can put Scanadu Scout™ through FDA to become an over-the-counter consumer-grade diagnostic tool.

When do I get to sign the Informed Consent document? At several moments. When you receive your Scanadu Scout™, you will also be receive the Informed Consent document which will enable you to take part in the community, participate in our usability study, and help us define the final properties of the device.

Damn. I’m too late to get the special deal. And their project is already well overfunded. 

The Scout will be able to determine a lot of useful information. 

But what is kind of cool here is that the FDA requires all sorts of validation data for medical devices. Usually the company has to pay a lot of people to accomplish this. Validation costs  money.

Here, they are recruiting 1000 people – who all paid to be part of the trial – to help gather the data the FDA requires. A great idea.

And they will be validating their ScanaFlo – a urine testing device – in a similar fashion. Stay tuned.

4 thoughts on “First ‘tricorder’ as a crowdsourcing project for FDA approval

  1. And who is going to have access to this data? RE: your previous blog, adults like privacy also.

    1. I currently use the cloud to hold my data regarding weight, body fat and calories. I control access. The positive benefit I get from being able to track all this far outweighs the pretty infinitesimal chance that not only will someone see this but that it will somehow harm me.

Comments are closed.