About our project
This project is a finalist in the American Heart Association Challenge. To see the rest of the finalists, please visit MedStartr.com/Heart
What you don’t know can hurt – and far too often actually will kill you.
One in 1000 Americans will die of a heart attack. Getting checked out and taking preventative steps, if warranted, could save your life or the lives of those you love. Ignorance is not bliss. The cost and effort of traditional cardiology exams and a simple test called an electrocardiograph, or ECG, can reduce this statistic.
If tested preemptively almost all heart attack victims would have produced an abnormal ECG 2-3 years before hand, alerting them with enough time to change habits and, thereby, avoid sudden cardiac deaths or myocardial infarction.
As ECG industry leaders, engineers, and cardiologists, we thought that if we could get a low cost, easy to use device into the hands of millions, that the days of cardio health ignorance would end and millions of lives could be saved.
The healthcare device market is wrought with expensive, large, contract driven equipment, and red tape (we know, we designed, sold, and used many of them for decades.) This prevents low cost, easy access for patients and physicians to offer ECG in any office or even a home user with help from a licensed and trained cardiologist.
What is wrong with the currently available technology?
The healthcare device market is wrought with expensive, large, contract-driven equipment and red tape (we know: we designed, sold, and used many of them for decades). The expense is what inhibits access to the preventative ECGs that patients and physicians need in order to save lives.
The other obstacle with current ECG technology is in getting the collected data to where it really matters–i.e., in the hands of certified professionals. The faster people can act regarding cardiac events, the more lives we will save. In a technologically connected world, this can be easily solved, and there is no excuse for people being unaware of potential cardiac events.
Introducing the Spaulding Electrocardiograph System
With the Spaulding ECG we cut through every single barrier by offering a low cost, high quality, connected ECG solution. Our device can link via Bluetooth to almost any device for real-time streaming of ECG waveform data. This includes connection to your cardiologist or our team of experts that can provide an initial reading or a second opinion of your ECG from anywhere in the world, real-time.
How It Works
We have developed a handheld, 2 oz. electrocardiograph that will stream ECG data in real time to virtually any Bluetooth device. You then have the ability to transmit that data anywhere in the world. With our device, anyone can be equipped with the ability to capture a hospital-quality ECG, regardless of professional training. Utilizing our software, you will have the ability to send your ECG record to your physician or have a cardiologist in the Spaulding Clinical network provide you with over-reads.
Our device will empower any user to accurately collect the proper data to allow a team of professionals to help diagnose cardiovascular issues from anywhere. We aim to eradicate sudden cardiac death.
Easy as 1-2-3
1. The Heart of our Solution, the ECG Glove
In this day and age it amazes us that with our advanced technology, people are still dying of undiagnosed cardiac issues.
The complexity of setting up the leads for an ECG is a major stumbling block for even healthcare professionals, so we partnered with the people that made taking an ECG as easy as putting on a glove. Integrated with the Spaulding Electrograph is the EKG Glove from IneedMD. Instead of the traditional tangle of ECG wires and patches, the EKG Glove™ delivers the full range of data quickly and easily (see below). The Spaulding Electrocardiograph works great with traditional leads as well but the EKG Glove™ is easy enough for a patient to use themselves and accurate enough for any medical diagnostic needs
2. Button Pushing and Connecting
It’s as easy as pushing a button: first sync up your Bluetooth-enables device (iPad, iPhone, Laptop, etc.). with the Spaulding ECG device. There are just two buttons to press – that’s it!
Then wait a few moments while the Spaulding ECG App connects…
…and get your data!
3. Get Results
Either review it locally with the patient or send it using our HIPAA-compliant interface to the reviewer of your choice. Hitting send in the application immediately transmits the data to your favorite cardiologist or our trained teams waiting for you. The data integrates directly with your EMR, and you can view it from anywhere at any time.
Progress to Date
Currently we have developed a prototype that is being tested in a clinical research environment. We are in the process of validating the device and performing safety and effectiveness testing. All the images shown are actual pictures or screenshots of the device and data from our system.
FDA Status
We are currently working towards preparing the documentation package, which is needed to apply for FDA clearance and affixing the CE mark. (Please click here for more information). Our team members are experienced in the product commercialization process for medical devices and are able to bring them to market rapidly and compliantly.
Please note that the devices acquired through this program will not be shipped until all necessary testing is completed and health authority clearances are obtained. i.e. 510k clearance, CE mark, etc. Refunds will be issued for all clinical purchases of greater than one unit if FDA clearance is not acquired and requested.
How We Help Patients:
The Spaulding Electrocardiograph helps cardiac patients by not only tracking known cardiac risk patients, but allowing everyone to catch problems with cardiac health before those issues become life threatening. Screening and diagnosing before a problem happens IS the number one way to help the patient. Please show your support for our mission and we will send you out a tweet, a t-shirt, or even a unit (for informational purposes only, non-diagnostic) to borrow and return AND a professional review of your results. See the options at the right. You can even be the first to receive a unit when they are available if you know you have an issue and want to stay on top of it. As famous ePatient Dave DeBronkhart says, now you don’t have to ask anyone to #GimmieMyDamnData, you can get it yourself and share it with whom you see fit.
How We Help Cardiologists
Utilizing the industry-leading Glasgow algorithm, the Spaulding Electrocardiograph will provide high quality 12-Lead ECG data to your Bluetooth-enabled device instantly. This will allow the physician to manage his or her patient’s health right in the room, minimizing the need to send the patient to another location to have a simple ECG taken. It allows the physician to have a more integrated approach to his or her patient’s health data and record, while also reducing the cost and complexity of care. Just imagine sending your patient home with one of our systems and reading as needed. Think of how much better care would be possible for the patients about whom you are most concerned. The Spaulding ECG can transform your practice. Please show your support and be one of our leading Early Adopter Physicians!
How We Help Non-Cardiologist Medical Providers
Do you ever wish you had your own ECG and cardiology consult right in the office? With our device, you can easily do that and get better diagnostic information faster so you can sort the heartburns from the true cardiac issues before they leave your office. We think every medical office should have a Spaulding ECG, don’t you?
How We Help Hospitals, Institutions, and/ or Medical Facilities:
Utilizing the cloud-based WebECG service, the data from the Spaulding Electrocardiograph can easily integrate with existing EMR systems—without bulky contracts and a simple turnkey system. Our solution saves a significant amount of money and can allow you to push ECG study capabilities into more departments in a distributed delivery model with centralized reads, allowing greater revenue at reduced capital expenditure and improving care.
For Urgent Care and Ambulance companies, we also offer a low-cost way to quickly assess potential cardiac patients in any care setting.
For Urgent Care and Ambulance companies, we also offer a low cost way to quickly assess potential cardiac patients in any care setting.
How We Help Our Partners:
We know our product is highly disruptive, but we also know our approach and philosophy will change how ECGs are performed in the coming decades. If you want to be part of this future, please do not hesitate to take the PARTNER MEETING reward at the right. We are open to mutually-beneficial discussions anytime. If you can imagine it, we can work with you to make it happen.
How We Further the AHA2020 Mission
Our solution directly aligns with the AHA’s mission by making the pre-screening of individuals a reality. The best way to reduce and stop sudden cardiac events are to discover the potential of cardiac issues before the time bomb goes off. We offer a unique solution that allows a lay person to easily obtain ECG’s by themselves or a healthcare professional. Imagine a screening at your high school of every parent in town, and the people administering the tests make up an army of volunteers with only 30 minutes of training. This could change the frequency of heart attack and sudden cardiac death drastically.
How We Will Use The Proceeds of Funding
If our goal is met, we will use the money to bring the device into testing in order to meet FDA requirements for distribution in the US and CE requirements for distribution in Europe. Additionally, we will set up our supply chain to ensure we can source the parts to adequately meet demand. Once we are in full production of the device, we plan to work with non-profits and various humanitarian organizations to truly follow our main goal: ERADICATING SUDDEN CARDIAC DEATH!
Who We Are:
Founders:
Randol Spaulding – CEO – @)+ years as lead engineer at Marquette Medical and GE responsible for developing some of the first ECG devices that are still used on the market today. See more here.
Jay Mason, MD – Chief Medical Officer – Cardiologist and former Chairman of the Department of Medicine at the University of Kentucky. See more here.
Joe Erato – Product Director – Retired Firefighter/EMS professional with several years of experience in Clinical Research. His experience has been integral in the design and function of the ECG device. See more here.
How to Find Us:
Twitter: @SpauldingCRS
Facebook: Spaulding Clinical
Thank You
Thank you very much for your consideration and we truly hope you are passionate about saving and changing lives for the better as we are.
Sincerely Yours,
Randy Spaulding, Jay Mason, MD, & Joe Erato
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Have a question?
If the info above does not help, you can ask the project creator directly.
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