Clinical Research: Rebuilt, Retooled and Rebooted

September 2nd, 2015

The traditionally conducted clinical trial model requires increasing amounts of time, cost, and resources for both sponsors and sites. In fact, fewer than 10% of clinical trials are completed on time  due to poor patient recruitment, retention and protracted budget negotiations. And since 2008 per-patient, clinical trial costs in the US have risen an average of 70% across all development phases.

In March 2015, however, Bloomberg Business reported “Stanford University researchers were stunned when they awoke Tuesday 10 March to find that 11,000 people had signed up for a cardiovascular study using Apple Inc.’s ResearchKit, less than 24 hours after the iPhone tool was introduced. ‘To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country’ said Alan Yeung, medical director of Stanfoxrd Cardiovascular Health. ‘That’s the power of the phone.’”

Rebuilt

At Scanadu, data collection and clinical studies are key to the development and deployment of our medical devices, and we’re fully aware of the kind of scale and speed and power we’re talking about here. And as a startup developing the next generation of medical devices for consumers, we had to innovate the clinical study process, while bucking the traditional assumptions of how a clinical study should operate.

In May 2013, we launched the most successful crowdfunding campaign for a medical device on Indiegogo –The Scanadu Scout™ for investigational use - because we wanted to leverage this campaign and its platform to put together our FDA study. More than 8,000 people backed the campaign.

More than 8,500 people from 72 countries backed the Indiegogo campaign.

We partnered with Scripps Translational Science Institute (STSI) and, after cautious preparation, officially launched the SCOUT study for the investigational medical device in early 2015.

STSI is now conducting a completely mobile-based trial evaluating the impact of the Scanadu Scout, the first comprehensive, handheld, wireless device designed for personal use, measuring blood pressure, core body temperature, oxygen saturation and heart rate.  The aim of the study is to understand how the device modifies health behaviors in participants and to evaluate the ease of use and acceptance of the technology.

Retooled

All platforms were HIPAA-compliant, all content was Institutional Review Board (IRB) approved and an electronic informed consent form (eICF ) was used. More than 75% of all backers based in the US signed up for the study, and in the latest survey more than 90% of them expressed that they would be willing to participate in such a study again.

Anyone who has enrolled in our study – or is currently using Research Kit in a study such as GlucoSuccess, Asthma Health, Parkinson mPower, or MyHeart Counts – will agree that using an eICF presents many opportunities and advantages for both sponsors and participants. With this new system we now have the ability to enhance a participant's understanding of the trial, to inform about changes to the study’s protocol, to allow for subjects to consent from remote locations with the use of an electronic signature, and make it easier (with appropriate pre-planning) to enroll non-English speaking subjects.

Using a HIPAA-compliant platform for the ICF process has eliminated major problems found on these forms including missing or incorrect signatures and dates or lack of verification that the subject received a copy. However, using this type of platform for eICFs did pose some hurdles. While this particular digital signature platform was user-friendly for the most part, not knowing all of the intricacies of sending the documents led to some confusion for some recipients. This contributed to a pause in enrollment for a few days and resending some ICFs to potential subjects. No system is completely flawless, and during enrollment, we found technical glitches that caused a change in expiration dates on the documents.

While this did not cause any compliance-related issues, the team had to manually close out any eICF document that was not signed by the enrollment end date. Also, because we used a platform that was not specifically designed for eICFs, sending out a revised version proved to be complicated. These challenges led to unanticipated increases to clinical resources/budget in order to manage and rectify the situation.

The online survey tool used in the study was seamlessly integrated into the process. Creation and distribution of surveys has proved effortless. Data is stored on a secure system, which is HIPAA-compliant and only accessible to the clinical team. Data collected from subjects also has audit trails. The data can be downloaded and analyzed in real time. This platform has been very useful in simplifying data collection and subject engagement.

Rebooted

The SCOUT study has an unprecedented enrollment rate for a medical device, and while there were challenges, this success is thanks to the transparency of the process, the incredible engagement from the participants, and the full use of what technology is allowing us to do today.

Access to information, knowledge and rapid development of technologies has an unparalleled impact on the progress of science. We imagine a world in which even more people participate in clinical trials like this one to further our understanding of our health and to improve life for the next generation.

Scanadu team

To learn more about our work , join us later this month at ”Transforming Medicine: Evidence-Driven mHealth” organized by STSI in San Diego on September 30th. Program includes our CEO and  founder Walter De Brouwer speaking about the Empowered Patient.

Scanadu Scout™ App Update 2.3.15

July, 30th 2015

Our record-breaking Indiegogo campaign that gave early access to the investigational Scanadu Scout™ is officially closed. We have shipped thousands of devices to supporters around the globe… and there’s a lot of scanning going on.

Users are scanning an average of about 4 times a day and are generating thousands of data points with each scan, which has already produced billions of data points...

Since deployment we have released several app updates on both the iOS App Store and Google Play to improve system performance and fix some minor bugs. The latest app update 2.3.15 includes two additional features embedded into the app. We have introduced the ability to see a pulse wave (PPG) while scanning, and are making sharing Scanadu Scout™ results fast and easy.

What is a PPG? (Photoplethysmogram) 

  ppg

A PPG signal, also known as a ‘pulse wave’, uses optical sensors to measure oxygen saturation and blood flow in your body. PPG (Photoplethysmogram) works by shining light waves through your skin and analyzing  the changes in the light reflected from your blood vessels with each beat of your heart.

In the Scanadu Scout™ system, we combine PPG signals with signals from our other sensors, clean this raw data of noise, and apply our algorithms to then calculate your vital sign measurements in real time.

The PPG signal is a concept you may not come across every day, not even during doctor visits, but in the context of understanding the hidden working of your body using the Scanadu Scout™ - it’s an important signal to tap into.

Above, the PPG signal in orange and the ECG signal in yellow displayed while scanning.

Sharing

We have also added a share button  for the ‘results’ and ‘trends’ screens. Now users can send Scanadu Scout™ vital sign readings via text message, email, Facebook, Twitter or any sharing app already installed on their phone. Of course it’s up to the users if they want to share their results; they own the data and should always decide what they want to do with it.

#Innovating while #complying

We’ve been sharing along this journey how #innovating while #complying may not be easy, but is both very exciting and important. In the coming weeks we will share more about this journey and how, with the robust remote technologies available today, including mobile health delivery systems, and remote sensor devices, powerful web-based clinical trials are becoming increasingly feasible.

We’d love to be able to distribute more Scanadu Scouts™ to those who are requesting devices, but as you know, we are still seeking FDA clearance for the Scanadu Scout™ and we must comply with the regulations. This includes IRB approvals for everything from our software updates to our emails to our backers who are participating in our study with Scripps Translational Science Institute.

Teamwork

In other news…We were at the Quantified Self Conference Expo day in Fort Mason San Francisco on June 20th. It was great to be there and meet with young and old, all with the same hunger for understanding and sharing each other’s health experiences.

QS1QS

Joining Forces

April 15th, 2015
We are very excited to share that we at Scanadu have Joined Forces with Zensor to form Team Scanadu/Intelesens in the quest for the $10 Million Qualcomm Tricorder XPRIZE, read more here.

Entering a new era of Citizen Health

April 6, 2015

 

Our CMO, Dr.Alan Greene, was at the Stanford Child X Conference last Friday and explains how we're living in the most exciting time in medicine. Changes are happening fast, and this brings people together to approach health in a new way - we're entering the era of Citizen Health.

Shipping Full Steam Ahead

February 20th, 2015

 

We're moving full steam ahead in shipping the Scanadu Scout™ investigational devices and expect the complete process will take several more weeks. A few thousands devices have been assembled, packaged and shipped already, and the cadence quickens each day. We have taken care of all costs for duties & taxes on our side, and as soon as you get the email from UPS (in USA) or DHL (outside USA) this indicates your device is en route to you!

We are already receiving a lot of feedback, as well as many ideas about how you see the future of the device and how you would like to manage your health. We can’t wait to have you all using the Scanadu Scout™ and sharing your experiences.

We're listening and have found a few notes to highlight:

- We currently support the following phones: iPhone 4s, 5, 5s running iOS 8 or newer, Samsung Galaxy S4, S5, and Nexus 4, 5. Many of you are already using the iPhone 6 and 6 Plus, but please be aware we are still in the process of validating those two models.

- Some Android phones are showing issues with the BLE connection and we have decided to extend the list of phones we will support. We can’t possibly support every Android phone model out there, but we can already confirm that we are expanding this list, please give a couple of weeks to get into it.

- Request for multiple profiles has been high, and indeed it is not implemented in the current app. Though it is technically possible, we can’t make it available at this point because the study linked to the investigational device is part of our regulatory framework. We will be making software updates as we are developing with full consideration of our backers requests and of the regulatory aspects for every feature we are adding.

- We have a large group of people who want to connect about how they see the future of their health monitoring using mobile technologies, and the concept of a Scanadu Forum has also been suggested, this is something we are currently looking into. Please stay tuned as we explore this idea.

There is a lot of scanning going on!  We continue to expand our database with every device that is used in the investigational study; all of this data is an essential component in improving the measurement accuracies for vital signs and will be the basis for improving our system performance.

For more information on how to use the device, please reference the Video Tutorial and User Guide. Here you will find instructions for setup, tips for scanning, basic troubleshooting, and device maintenance.

And, of course, our team can be always be reached by emailing support@scanadu.com

Thanks,
Scanadu Team

 

Shipping has begun

January 30th, 2015

Dear backers,

We have started shipping.

Untitled drawing (12)

We are excited to share this moment with you all, as we’ve been incredibly motivated by your fantastic support and patience.

This will be the last post we'll do on the Indiegogo platform. We’ll continue to share on our blog and we’ll also release updates via the apps. As we will no longer monitor on Indiegogo, please address your questions and comments to support@scanadu.com. Please email your feedback too, as this is very valuable to us.  Also note that for privacy reasons, questions and comments related to the Consumer Health Study should be addressed privately via email to scanadutrial@scrippshealth.org and to our team support@scanadu.com only and not on public platforms.

Here is a short but great tutorial video to help you get started with your Scanadu Scout.

Thank you for helping to make this the last generation to know so little about our health

Scanadu Team

 

The Final Stretch

January 16, 2015

After all the preparation for manufacturing and several successful qualification builds over the past few months, yesterday we released the manufacturing line and will start the production builds of your investigational Scanadu Scout™s early next week at our manufacturer in Fremont, California!

manufacturing (1)

We will start shipping in the last week of January, domestically and internationally. The shipping process will take a few weeks, and you’ll automatically receive a tracking number via email from UPS (domestic) or DHL (international) when your device is in route to you. We‘ve emailed everyone to confirm shipping addresses and thank you for your speedy responses :)

Next week, you’ll receive an email invitation with details on how to enroll into the Consumer Health Outcomes Study managed by Scripps Health in San Diego, California. As we noted in previous updates, this study is a part of our FDA roadmap and will be one of the largest consumer health studies of its kind in the world.

Scan screenshot jan 2015 blog (1)

The iOS app has been validated and submitted to the App Store. The Android version is in its final stage of validation, and we expect it to be finalized by next week. Both apps will be available in the AppStore and GooglePlay, respectively, by the time we start shipping the Scanadu Scout™ investigational devices.

Data collection has been and is still an essential part of our journey. We have collected huge amounts of data to feed our algorithms, and this will be an ongoing effort for our company. The last two months have been dedicated to the final verification and validation of the Scanadu Scout™ system for Indiegogo backers.

We have successfully completed the verification and validation on the vital signs that the Scanadu Scout™ measures in this investigational device, and are within the ranges and confidence limits we shared with the FDA, for:

Cuffless Blood Pressure / Systolic
Cuffless Blood Pressure / Diastolic
Clipless SpO2
Heart Rate
Temperature

Throughout all our work, we have realized the importance of data collection. Knowledge starts with data.  Only then comes the observation of data, which leads to protocol, which leads us back to knowledge again.

We are both excited by our progress and humbled by the difficulties we have encountered in the process of bringing the Scanadu Scout™ to you. We faced challenges that have never been solved before - and are only possible today thanks to the intersection of science, technology and mathematics. Our team has a breadth and depth of capabilities in these domains, and overall your continuous support has been a great reminder that designing and building the new generation of medical devices is not happening in silos anymore, but as a unified effort.

Thank you.

 

The Scanadu Team

“We shall not cease from exploration, and the end of all our exploring will be to arrive where we started and know the place for the first time.” - TS Elliot

P.S. At this time, changing the color of your Scanadu Scout™ is no longer possible. For all other questions, contact us at support@scanadu.com

THUMBS-UP

 December 12, 2014

January is looking good! 8,000+ Scanadu Scout™ investigational devices are well on their way towards shipping.  The apps are in the process of being submitted, data collection continues, hardware is ready, and firmware & algorithms are reaching the finishing line. Expect a few emails from us over the next few weeks to verify your shipping information.

APPS

As we are finishing the stress testing and app validation, we have already started the process of getting approval from Apple, which we expect to be complete in a few weeks.  We have submitted a hardware prototype to the Cupertino HQ and our app to the App store. As a note, it will not be publicly available right away, nor downloadable until we are closer to shipping.  We're doing this now because, as some of you may know, this process can take some time given the holidays.  The submission of the Android App to Google Play on the other hand takes very little time and will happen a few hours before we start shipping

DATA

We continue to collect data to refine our solutions. Our biggest challenge has become our biggest opportunity: we have collected over 40,000 vital sign measurements!   This week we continue to collect hypoxia data in Colorado and fever data in Europe, but capturing fever data has been challenging.  Modern medicine is getting so efficient that by the time we arrive on the scene for a scan, the patient is fever-free.  However, we do have our first dataset of febrile information, and will collect more while we are shipping.

ALGORITHMS

With this, we are now validating the algorithms responsible for the measurements for the Scanadu Scout™ investigational devices. Cuffless Blood Pressure (non-oscillometric method of non-invasive BP which we refer to as ni-BP) and Heart Rate are finalized. We are very close to finishing validation of SPo2 (PPG, photoplethysmogram for pulse oximetry) and core body temperature.

IMG_1633

Screenshot of scan results.

MANUFACTURING & SHIPPING PREPARATION

Our manufacturing team has taken their battle stations and are ready to start building since the new hardware is done! Right now, we’re focused on software completion (final integration, testing, validation etc...).

FullSizeRender (2)

The new finalized hardware.

We’re also working on shipping plans and preparing the special experiences for different perk levels. As part of this, during this holiday period we need to verify the shipping address information of backers and re-launch the signing of the Informed Consent for the study at Scripps Research Institute in La Jolla. So stay tuned backers, you’ll be receiving some emails from us soon.

Happy Holidays!  Here’s to a healthy New Year from our team to you.

Scanadu Team

Good News

November 14th, 2014

Our gap of temporal specificity is closing rapidly and the shipping ecosystem is preparing to reboot. We are on track to initiate shipping by the end of January :)

Starting in December, we will contact backers to verify shipping addresses and make sure that all informed consent forms are signed (as this is an investigational device prior to FDA clearance). Please note that it is no longer possible at this point to change your choice of color.

Thanks to the huge collection of data and time spent in testing, our Machine Learning group has made our algorithms fitter and faster everyday. We are getting our SDs  (standard deviations), MAE’s (Mean Absolute Error) and RMSE (Root Mean Squared Error) in the application in closer and closer agreement with the algorithm. With our decision to submit for FDA clearance, we knew that giving life to the Scanadu Scout™ investigational device would be a complex and challenging path. We are increasingly confident as the readings are reaching the level of accuracy that we had informed the Food and Drug Administration Agency will apply to our investigational device.

Both our Android and iOS apps are undergoing internal pre-validation testing and evaluation. We will soon be entering more formal validation and stress testing.  While we were solving hardware and software issues, we took advantage of the opportunity to fully prepare the Scanadu Scout app for iOS 8. Of course new features will be pushed via updates in the future.

apps1
iPhone and Android versions of the app.

Our biggest challenge has been ‘data’.  We needed a lot of patient data for each of the vital signs. The fact that we're doing multiple measurements in parallel has made data collection complex.   To help, we have extended our protocols for partnerships for clinical testing and data collection with medical facilities outside the Bay Area. Our clinical teams went onsite to train partner teams in several locations, even one outside the US.  Since then thousands of data points are regularly flowing into our systems.  There are about 540,000 raw data points per scan totaling  about 1 megabyte, which is much more than many commonly used electronic devices.  The good news about this huge amount of data collected with our new partners is that it’s helping us go faster in validating all of our vital sign results.

partners1

Our clinical research team training our new partners.

Once the Scanadu Scout™ is in your hands we will all work together to test and evaluate it, increase the accuracy of the medical investigational prototype towards a clinical prototype, and add or delete new features, which we can push through firmware updates.

In addition to the Scanadu Scout™ we have other products in our pipeline at Scanadu, as you may know.  We are preparing a suite of products that work with vital fluids.  These are disposable, and will interact with your vital sign readings.  The first of these is the urinalysis called Scanaflo which is due to go through clinical trials and FDA in early 2015.

Thanks for having been on our side, sharing our enthusiasm, for the grace with which you received the news of our delays, and helping us collect vital sign data by participating in the Scanathons.

 

Scanadu Team

Scanadu Takes the Stage at WSJ.D Live

October 31, 2014

Reducing barriers to access for consumer health information will certainly have far-reaching impacts on the medical system, empowering individuals with tools to monitor and manage pre-symptomatic disease. The individual will be the core of the medical experience, pulling together once-disparate silos of clinical, environmental, emotional, and wellness data (among many more). This is a critical step in the path to building a true healthcare system out of the multitude of isolated pieces of our current "sick-care" system, which only registers you as soon as something is going very wrong.

The Scanadu Scout™ is a bold step forward in this movement: for the first time giving consumers a simple and elegant means of extracting and understanding their vital signs - literally what makes you tick! But external sensors can only take you so far. If you truly want to know yourself, you have to take a dip into the fluids. That's why we're excited to give you a glimpse of ScanaFlo™.

ScanaFlo™ is a urinalysis system that is designed to enable consumers to collect valuable information about their liver, kidneys, urinary tract, and metabolism.  Urinalysis has been performed for centuries, however technology has advanced tremendously since our first recognition of the diagnostic value of urine, and ScanaFlo™ now brings urinalysis into the 21st century. We have developed a smartphone application to guide users through the full process from sample collection to results - with additional tools to help them understand what the data means, and to share results with their doctor to enable richer conversations.

We were honored to be invited to demo both the Scanadu Scout™ and ScanaFlo™ at the inaugural WSJ.D Live conference earlier this week. Check out the video here.

We’re excited to soon bring the Scanadu Scout™ and ScanaFlo™ through the regulatory process and ultimately into consumer's hands. So, every individual will be able to take one more step towards truly knowing themselves.  Stay tuned!

http://www.wsj.com/video/medical-devices-allow-you-to-check-vitals-at-home/85CFDCEC-8127-4C00-AE65-468B02713F57.html

 

Scanadu Team

Build-a-thons

October 10th, 2014

Vital sign collection, testing of our hardware solution, and finalization of the UI for the app are going well. We are still collecting great amounts of data and are continuously improving the training of our algorithms.

We are working towards resuming shipping early this winter, and are currently in preparation for manufacturing.

 Untitled-5-02

Bob, Scanadu’s  Manufacturing Director, and Sam, our co-founder, at our manufacturing  partner  in Fremont, California.

More than 8,000 Scouts will go out this winter to Indiegogo backers around the world, and we are committed to meet robust quality, reliability and performance standards.  To ensure the delivery timing and Scout robustness, below are a few examples of the actions currently underway as we approach our volume production build:

Rolling Builds

Across the extended operations organization, we have “rolling builds” which means making small to medium-sized batches of the complete Scanadu Scout™; our very own “Build-a-thons”.   Every two weeks we are planning, building, and carefully examining the results in our engineering labs and at our manufacturing partners in Fremont, California.  The quantity increases with every new build and will transition later this Autumn to the full 8,000 plus unit build.

Untitled-5-01

Board assembly tester which includes all the sensors, firmware and software.

Linkage Analysis

In our process quality plan, we are refining and reinforcing our focus on the product specification's features. Each assembly step contributes to the final device performance which is critical to our backers.  Behind this quality control plan is an in-depth analysis – or “linkage analysis”- linking the features to the specific aspects of incoming materials, the assembly steps, and the final investigational devices coming off the production line. We’re ensuring rigorous testing of the device’s electronics and optical sub-systems before final assembly in the Scanadu Scout™ enclosure.

Environmental Testing

Finally, samples of both critical sub-assemblies (system electronics) and completed Scanadu Scouts™ have been tested under extreme environmental conditions resulting in accelerated aging in order to reveal any areas needing attention or improvement.  Environmental testing was continued for a week, tests are a) damp heat – 85°C and 85% relative humidity – and b) temperature cycling, repeatedly alternating between -40°C and +90°C for 100 cycles. Measurements before and after have shown no failures or change in the values of the vital sign readings!

These are just a few of the many activities underway to ready the Scanadu Scout™ investigational devices to come off the assembly line.   Things are moving forward in an exciting way, and we expect our delivery timelines by the next update.

On another note, next weekend NASA Ames - where our company is based - is opening its doors to the public for the first time in over 17 years for their 75th Anniversary Open House. We have accepted NASA’s invitation to be part of this exceptional day, and our teams will be present to showcase our work to the public as they pass through the campus.

Untitled-5-03

NASA Ames Research Park

The event is sold out with more than 120,000 visitors but we’ve been able to snag 10 extra invitations for our backers only! Let us know via support@scanadu.com if you’d like to come!

Of course, if waiting is not an option you can email us at support@scanadu.com.

Thank you!

Scanadu Team

The Beat Goes On

 September 12th, 2014

Our Scanadu team continues to be hard at work. Hardware modifications and an aggressive schedule of data collection is helping us improve the quality of our readings, and we’re on track with our internal planning for testing and validation. We are continuing to gather more data to train our algorithms and validate our latest results. We’re also working on the manufacturability of our new prototype, a key requirement for us to resume shipping.

SCANATHON

The last Scanathon with our Indiegogo backers was oversubscribed and took place on August 11th, 12th and 13th. A number of participants brought partners and family members to see what we are working on - check out the photo album on our Facebook page. After testing the new prototype, participants were brought to another testing area to evaluate our mobile app with our UI team. The feedback we received on the app interface was tremendously valuable and highly consistent, and our design team has already  incorporated much of this in an updated version of our app.

We’re holding another Scanathon for our backers on September 19th. If you’re interested fill out this form to receive a formal invitation. Many of our backers who came to the previous events have registered again so we only have a few slots left! Your vital sign data will be used to further validate our tests and you’ll have a chance to review the updated app for iPhone and Android.

If you can’t make this Scanathon event, NASA Ames is opening its doors to the public (for the first time in over 17 years) for its 75th Anniversary Open House on October 18th. The Scanadu team will be present to meet and greet you all, join us then!

One more thing.. the XPRIZE!

As you may have heard, we have been selected as one as the final 10 teams for the Qualcomm Tricorder XPRIZE. This is a big achievement for our team. You can read all about it here in our blog post. We’d like to take a minute to explain the difference between our work on the XPRIZE, and our work for the investigational device for Indiegogo. Work on both initiatives, and everything coming out of the Scanadu labs, is in service of our mission of making this the last generation to know so little about our health.  And while both the investigational device for Indiegogo and the XPRIZE carry the spirit of the Tricorder and the advancement of digital health, the product features and physical forms are intended for very different use cases. The XPRIZE aims to diagnose more than 15 conditions through vital signs, blood, saliva, fluidics analysis and more, while the Scanadu Scout™ is built specifically for capturing vital signs digitally. We have dedicated teams working on both efforts, but rest assured, the Scanadu Scout™ remains our top priority.

Thank you for your ongoing patience and support!  If waiting is not an option please reach out to our team at support@scanadu.com.

 

Scanadu Team

 

 

To boldly go where no one has gone before… @XPRIZE

$10M Qualcomm Tricorder XPRIZE Competition

August 27, 2014

Scanadu is proud to share that it has been selected as one of the Final 10 teams for the Qualcomm Tricorder XPRIZE, a 3.5-year global competition for teams to develop a consumer-focused, mobile device capable of diagnosing and interpreting a set of 15 medical conditions and the absence of disease,  plus capturing five vital health metrics. The field has narrowed over the course of the competition from 255 in 2012 to 34 in 2013 to the 10 finalist teams announced today.  As part of the final round, teams will compete in both diagnostic experience evaluations and consumer testing, slated for mid-to-late 2015. The final judging and awards ceremony is scheduled to take place in early 2016.

Here’s an inside look at what it takes to get to the top:

16 Health Conditions:  The devices are expected to accurately diagnose 16 health conditions – 12 required core conditions plus the absence of disease and a choice of three elective conditions – in addition to capturing five real-time health vital signs, independent of a healthcare worker or facility, and in a way that provides a compelling consumer experience.

13 Required Core Health Conditions: Anemia, Atrial Fibrillation (AFib), Chronic Obstructive Pulmonary Disease (COPD), Diabetes, Hepatitis A, Leukocytosis, Pneumonia, Otitis Media, Sleep Apnea, Stroke, Tuberculosis, Urinary Tract Infection, and absence of condition.

3 Elective Health Conditions (Choice of 3): Allergens (airborne), Cholesterol Screen, Food-borne Illness, HIV Screen, Hypertension, Hypothyroidism/Hyperthyroidism, Melanoma, Mononucleosis, Osteoporosis, Pertussis (Whooping Cough), Shingles, Strep Throat.

5 Required Health Vital Signs: Blood Pressure, Heart Rate, Oxygen Saturation, Respiratory Rate, Temperature.

Consumers Only:  This diagnosis must be performed in the hands of a consumer, independently of a healthcare worker or facility.

Scanadu’s journey to build a medical tricorder started in 2011 in San Francisco, CA.  Just a few months later at the 2012 Consumer Electronics Show (CES) the $10M Qualcomm Tricorder XPRIZE was launched. The Scanadu team was elated - our vision had earned new recognition in the industry.

This announcement was vital for Scanadu for several reasons:

* It indicated that time had come to build what was once considered a mythical device

* XPRIZE had licensed the name Tricorder™ from CBS, so the members of the race could use it

* XPRIZE had sought the advice and support of the FDA so that the agency was involved in the proof of concept of the investigational prototype from the start

* XPRIZE was going to source the best minds in the world to build this together.  A sort of modern-day, distributed, Manhattan project for mobile medicine.

XPRIZE expects participants to push the envelope beyond where any institution has ever gone before.  Nearly every condition requires revolutionary technology to be developed, from the fluidic handling to the sensors to the user interaction.

This is a groundbreaking competition that cannot be won by one team alone.  XPRIZE has created a marketplace that has now been pruned to the last 10 teams, three of which will win a prize: First Place $7M, Second Place $2M and Third Place $1M.  Together, some of the brightest minds in the industry are working to develop a scientific breakthrough that has the potential to change healthcare as we know it. Winning cannot be done alone, and we are honored to be part of the journey thus far.

Thanks to all of our supporters along the way. To be continued...

Scanadu Team

 

Note: The Tricorder being developed for XPRIZE is technically different and therefore separate from the investigational device being developed for Indiegogo backers.

Making Headway with the Scanadu Scout™

August 8, 2014

Dear Indiegogo Backers,

Since our last update, we’ve been focused on working through the technical issues with the Scanadu Scout™ investigational devices. We know many of you are hungry for an update on what’s been happening at Scanadu HQ. We’d like to share with you some color on our quest to bring the Scanadu Scout™ to life and put it in your hands.

RECAP: Diagnosing the Issues

The Scanadu Scout™ was originally set to ship in March, however in April, we had to pause shipment because the units that rolled out of manufacturing did not meet our standards of accuracy. To diagnose the situation, we pulled out all of the guts of the device – the sensors, the interconnects, the components – to identify the exact sources of the problems. We had some assumptions, but needed to test each detail to be sure.

We invited you to our headquarters to donate data in May and reported our initial results from the Scanathons in June. We were excited to meet with so many of you! As we mentioned in our latest blog post in July, finding the ultimate solution would require a significant amount of work and testing. Thanks to the participation and the data from many of you, we were able to confirm most of our suspicions about what was wrong.

It turned out that some last minute design decisions earlier this year about the placement of the sensors resulted in them being moved by a few millimeters (particularly the temperature and SPO2 sensors). That very small decision had significant impact in corrupting a lot of the raw sensor data. Because the raw sensor data is the essence – the life blood – of the device, it polluted the entire system.

Here’s more detail:

TECHNICAL UPDATE: Straight from the Workbench 

Temperature

In the original version, accuracy of temperature measurements was affected by heat transfer between the electrocardiogram (ECG) electrode and the skin in cases when, just before the scan, the ECG electrode had been exposed to temperature levels significantly deviating from room temperature.

Several possible solutions to this problem were identified and each of these has been built as a “prototype” and is being tested for performance, accuracy, repeatability and manufacturability.

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Above,  Printed Circuit Board (PCB) variations being used for performance, accuracy, repeatability and manufacturability testing and evaluation.

We continue to make significant progress towards collection of a larger volume of data to support the training of our temperature algorithm and detailed validation of the temperature sub-system. The Scanadu clinical team has identified a location for additional data collection, where we will initially focus on gathering data over a wider temperature range.

SpO2

Our March build of Scanadu Scout™ also suffered from parasitic light reflections around the photoplethysmography (PPG) sensor (because of the last minute design change we mentioned above). These reflections were caused by a flaw in the optical design and led to corruption of the PPG signals. These PPG signals also affect three other measurements including: blood pressure, SpO2 level and pulse rate.

In order to ensure that we completely understood the problem and had a definitive solution, we decoupled the hardware development from algorithm development. We made a prototype with PPG sensors exposed outside of the device and exposed the sensors directly to the skin, using this for collection of raw data signals on a large group of individuals. Reference levels of the vital signs were also measured. The data was collected in a number of Scanathon sessions as well as in the Hypoxia lab in San Francisco (to test SpO2). This gave us very clean sensor signals paired with the corresponding reference levels, which allowed development of revised blood pressure and SpO2 algorithms.

Below is the original version of the acrylic window on the left and a potential new solution on the right.

Blood Pressure

Our blood pressure algorithm relies on features found in the electrocardiogram (ECG) and photoplethysmography (PPG) signals. For instance, one such feature - Pulse Wave Transit Time - is a measure of time between contractions of the heart, identified from the R-wave of the ECG and the peaks of the peripheral pulse waves in the PPG.

Those signals are processed to remove noise and artifacts (or filtering). We had to redesign our PPG sensor and retrain the algorithms coming from those features extractions coming from both the ECG and PPG.

We are continuing testing and validating our algorithms and the quality of our readings with help from recent and upcoming Scanathons.

NEXT STEPS: Test, Test and Test Again

We are inviting our backers to come back to our headquarters and help us do more data collection to further verify our solutions (and to help us train our updated algorithms). Our next data collection is planned for Monday and Tuesday of next week. We‘re practically full because many of the backers who participated in previous Scanathons are returning, but there are a few spots still open: please register here to receive the formal invitation.

Our design team was ready with both iOS and Android apps last March but have taken advantage of the delay to further enhance the user experience and implement version 2 of the App. During our upcoming Scanathon we’ll ask our backers to test our new app on iOS as well as on Android devices.

Here’s a sneak peak of the second version of the app:

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We still cannot give a definitive ship date - but we have developed potential solutions for the problems we have encountered and have an aggressive schedule for data collection, testing and validation.  We are determined and hope to resume shipping of the investigational devices before the end of the year. Of course if you prefer not to wait, we are happy to return your donation if you email a request directly to support@scanadu.com.

This has been an incredibly hard journey. We are putting our blood, sweat and tears (not to mention our vitals) into rigorously testing our solutions so we can deliver to you.

Thank you for your continued patience and support. If you have any additional questions, contact us at support@scanadu.com.

Sincerely,

Team Scanadu

The Winding Path

July 7th, 2014

Dear Indiegogo Backers,

We hope you enjoyed your  4th of July weekend with fireworks, friends and family. We’ve been plugging away with our own sparks. Here’s the latest:

SCANATHON

Over the past two weeks, we’ve hosted two Scanadu Scanathon events at our HQ in Mountain View, CA. These events were incredibly helpful in gathering new data points as we move forward with the Scanadu Scout™. Thank you to all who were able to participate!

During the calibration days, each participant completed three Scanadu Scout™ scans and were measured with five other comparison devices - including continuous monitoring, automated and manual methods. A comparison device is a device used in clinical testing that is known to be at a certain level of accuracy according to standards and regulations. These are used to compare and calibrate scans from the Scanadu Scout™.

With over 60 diverse participants throughout two days we captured 200 completed scans, which resulted in over 800 vital sign measurements.

This is just the meta data though - beneath each scan is a combination of thousands of individual raw sensor readings that are captured every two milliseconds from each device. All of the data is ingested by our algorithms - that is then used to improve the model for the measurements for each vital sign and for each individual person. Our team is knee deep in processing all this rich data (code warrior pictured below).

Code Warrior

WORKING ON TIMELINES

During our rigorous testing at the hypoxia lab, we located an opto-mechanical (light sensor) issue in the SPO2 sensors. The aesthetics of the acrylic window causes unwanted light reflection picked up by the photodiode (part of the SPO2 sensor diagramed below) that is interfering with the signals. We have a light blocking solution that will make the signals more stable.

SPO2 SENSORS (8)

To test our solution for temperature, we need to collect temperature data points from a patient population with fever in a hospital/clinic setting. Our clinical team is setting up the appropriate framework for this. These solutions involve hardware and we’re working with our manufacturer in Fremont, CA to make the right decisions about timelines to be able to resume shipping.

RESILIENT

All in all - why does this take so long? Algorithms. An algorithm is the massive combination and processing all of the data from all our sensors. If one element in our algorithm gives a wrong input, the whole algorithm ecosystem is affected.  Meaning every minute change on hardware or software requires us to redo bench testing (on healthy people) and edge-case testing (on sick people) - which then must be re-calibrated again and again with every change.

There is so much going on in this small unit by putting all these sensors so close to each other that some friendly fire is inescapable. We know you want to have your hands on it - and we want that too and are working towards this every day.  Sorry it takes so much time, if only our team was made of silicon - we could sample and process per millisecond, but we are slow carbon creatures. But resilient.

We value your patience. If you have any additional questions, contact us at support@scanadu.com and we will work with you directly.

Thank you,

The Scanadu Team

Scanathon Part I

June 24, 2014

Last Thursday, we happily hosted a group of our Indiegogo backers for the first Scanadu Scanathon.

Participants came from far and wide; with backgrounds ranging from engineering and medicine, to wine making, teaching and aviation... Some drove for 3 hours or flew from as far away as Chicago for the occasion! We received valuable input and appreciated the conversations about the impact of what we're building. To quote Bill - one of our backers, and one of several named Bill :) - "It is not a sprint - it’s a marathon."

Our medical teams tested backers all day and collected a vast pool of data - over 3 million sample periods that have resulted in over 24 million sensor readouts - that will help us calibrate our investigational devices. We are processing the data now, comparing the measurements made with the Scanadu Scout™ and the comparison devices.

Since our available time slots filled up so quickly last Thursday, we are organizing a second Scanathon this Friday, June 27th.  You can register here and we'll confirm participation later today.

This additional data will allow for more calibration cycles for the device by comparing both sets of Scanathon data to other pools of data we’ve previously gathered.

Thanks for working with us to make this generation the last one to know so little about our health.

 

Thank you,

Scanadu Team

Scanadu Scout™ Progress and Scanathon

May 31, 2014

Dear Indiegogo Supporters,

Since our last update, we’ve been working like mad to fix bugs, tweak software and calibrate results. We’ve basically shut ourselves off from the world to delve deep into the code and system to understand and tackle the technical challenges we reported on April 4th.

We’ve made meaningful progress on a number of fronts and have increased our workforce by 20%, adding a number of code warriors and mathletes to our team.

Here’s a snapshot of our progress so far.

Progress Report

The tool broke.

UPDATE: The manufacturing tool has been repaired. All the casings are ready at our manufacturing facility in California, and once we give the go ahead, our manufacturer will be able to assemble and ship thousands of units.

Temperature readings were faulty.  

UPDATE: The issue with temperature is a combination of hardware and software challenges. We have developed potential solutions and we are in the process of validating them.

Algorithms required too much bandwidth.

UPDATE:  We have streamlined our algorithms so that our scans are much easier to complete. We are putting our test protocols on overdrive across the board. In mid-June, we will have our revised SPO2 algorithm clinically recalibrated in a dedicated research lab at a leading center for the study of the effects of hypoxia on humans.

Become an Early Scanadu Scout™  Test Volunteer    

We need more data - our silicon is in need of your living carbon!

Our next step is to expand our testing at scale. We are hosting a Scanadu Scanathon at our headquarters at NASA Ames Research Park in Mountain View, CA. This is an exclusive invitation to our Indiegogo backers to participate in the next step of the Scanadu journey. More than 10% of you, our Indiegogo backers, already live in Silicon Valley, but wherever you live in the USA - take a hike, walk, fly, drive, ride and come to us.

Our goal is to collect a larger body of test data that will better calibrate our algorithms and get us closer to delivering your Scanadu Scouts.

Join us!

Scanadu Scanathon

When: The week of June 15, 2014 (test date & time will be sent to confirmed participants)
Where: Scanadu HQ at NASA Ames Research Park in Mountain View, CA
Time commitment: Actual testing will take less than an hour per person, but participants are invited to stay on to meet fellow backers and the Scanadu team
Who is eligible to participate: Indiegogo backers over 18 years old
Who will perform the testing: Scanadu’s medical team
What you will get: Test the Scanadu Scout™  investigational device, drinks, food, good company, mathletes, astronauts and the Scanadu team
What to bring: A valid government-issued ID (preferably a driver’s license) is required to enter the NASA campus
What we will be testing: Vital signs
How to apply for the Scanadu Scanathon: Please fill out this form

We are making progress and we’re excited to welcome you to Scanadu HQ to participate in some of the additional testing needed before we can ship.

Gratitude and thanks to all of you... Let’s make it so!

Team Scanadu

For any questions, comments, or feedback, please email us at support@scanadu.com.