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Monitoring and managing early signs of dementia using MouthLab, a rapid medical assessment device for both patients and caregivers.

MouthLab, a non-invasive remote monitoring device that measures > 10 vital health parameters in 30secs essential for managing dementia pt's.

Photo of Sathya Elumalai

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Who is your idea designed for and how does it better support family caregivers as they care for a loved one with dementia?

Vitals monitoring are essential for managing someone with dementia. Specifically, parameters like BP, ECG, respiratory rate, temperature, pulse rate and dehydration, are very critical in managing older patients with dementia or its co-morbidities. Specifically, infection is a common cause of increased confusion and pain in someone with dementia, which could be measured with temperature. Hospitalization due to dehydration is also very common with dementia patients. We helps caregivers to monitor.

Multisensor Diagnostics (MDx) is a diversified health and wellness management company enabled by an innovative device and supported by proprietary software.

Vital signs are an important component of monitoring dementia patients. They help determine the effectiveness of treatment protocols, provide critical information needed to make life-saving decisions, and confirm feedback on treatments performed. Accurate, documented vital signs are a very important part of assisting caregivers in better understanding the patient health status.

But, today, dementia patients don’t get access to all the vital signs associated with their disease and co-morbidities. Even if devices are provided, they are expensive, bulky, requires training and assistance, and definitely need technology assistance of connectivity to a smart device (phone or tablet).

The only three options that are currently available to them are.

Going to the hospital to get your vitals checked, but you cannot take all those bulky devices home.

Alternatively, you could use single home monitoring devices, like BP cuff, pulse ox, thermometer, but you are not monitoring everything that is associated with the disease.

The third and most effective approach is to use devices that can measure everything associated with a dementia patient but it significantly lacks patient adherence.

Ultimately, patients get re-hospitalized or visit ED frequently.

That is exactly why we created MouthLab, a non-invasive, RAPID MEDICAL ASSESSMENT device that measure multiple vital health parameters in 30 seconds and send data to the provider in real-time. We put together a cadre of tools essential for monitoring and managing dementia patients at the comfort of their home.

Patient use our single, rapid medical assessment device, MouthLab, rapidly and non-invasively measures respiratory-rate and pattern, pulse-rate, electrocardiogram, SpO2, temperature, blood pressure, dehydration, and spirometric lung functions in less than a minute. Our software supports seamless connectivity with providers, patients and caregivers, and unifies all aspects of patients’ health in a single place.

A tool like this even if its use irregularly gives more meaningful data points to the provider then the current tools. Our AI-powered triaging system helps guide through the care management process and enable early identification of clinical deterioration, early enough to intervene and provide appropriate care at home. 

And we have shown the accuracy through a randomized clinical trial with 52 patients at Johns Hopkins. We found sensitivity and specificity of our device close to the Gold Standard. We also published the study at the reputed Annals of Biomedical Engineering Journal.

The market for MouthLab is Tremendous, once we achieve success in the dementia market we aim to target several other chronic conditions.

The current options are focus on providing multiple peripheral devices that are complicated, expensive, and often requires special training and assistance. Instead, we are providing patients with a single device that is easy to use. In addition to providing significant cost and time reduction, we provide value to the stakeholders by improving patient adherence. We also inbuilt an IoT technology that is integrated into our device, so we are using the cellular network or LTE-M technology to send data in real-time to the providers without the need for a smart device (cellphone or tablet).

We have gotten great traction so far and featured in more than 80 prominent media outlets. And have participated in more than 26 global competitions and won more than 11 prestigious awards, including an opportunity to meet Joe Biden to be a part of his moonshot initiatives.

We partner with industry leaders and health transformers. And, being part of Johns Hopkins and TMCx helped us to garner more traction in obtain pilot partnerships with health systems and commercial partners.

We have a team that was founded by a technologist; and medical device industry veterans who helped develop and commercialize a number of medical devices. We also surrounded ourselves with relevant experts in a number of fields that are incredibly germane to what we’re doing.

We developed a tool to not only help identify and manage dementia patients or susceptible to dementia but also managing caregivers. Because, caregivers are highly subjected to stress and physiological changes due to caring for patients with dementia. Therefore, we developed a tool for better management of both the patients and their caregivers. Ultimately, we believe if we don't take care of a caregiver we would be developing another patient.

We want MouthLab to be used daily to have a significant impact on monitoring the overall health of both the patients and caregivers, similar to what brushing as done to our dental health and hygiene.

The current ability of MouthLab to measure all vitals signs are only the beginning. Because, our device is positioned in the mouth, we have access to blood vessels, breath & saliva, which in turn provides access to many biological indicators of health.

Imagine if a dementia patient regularly monitors their health with MouthLab, they could reduce the number of hospitalization by half or even to zero, and ultimately, help their caregivers to better manage the condition. Our mission as a company is to change the culture of healthcare monitoring. I would like to invite each and everyone of you who believe in us and passionate about caring for your loved ones to join us to make this a reality.

What early, lightweight experiment might you try out in your own community to find out if the idea will meet your expectations?

We would like to perform a pilot study with 20 dementia patients & 20 caregivers, and provide MouthLab to collect daily biometric data. We will develop a prediction model and algorithm for dementia and behavioral analysis of both patients and caregivers based on MouthLab vitals data. This algorithm will be used to identify early signs of disease progression and with the assistance of providers we aim to provide right interventions and treatment strategies in real-time to avoid ED visits.

What skills, input, or guidance from the OpenIDEO community would be most helpful in building out or refining your idea?

We are seeking assistance from the OpenIDEO community to help us put together a focus group to understand patient and caregiver needs as we design the final device/solution. We also would need inputs and guidance from OpenIDEO with respect to building an efficient real-time secure user communication system between the patients, caregivers and care providers. We also need funding and mentorship to help complete our pilot studies in partnership with the Memory Disorders Center at Johns Hopkins.

How long has your idea existed?

  • 4 months - 1 year

This idea emerged from

  • A group brainstorm
  • An Individual

Tell us about your work experience:

Mr. Elumalai, CEO, has >14 years experience in healthcare, worked at Johns Hopkins Medicine, patient advocate and policy lead at PCORI. Worked with 8 startups before MDx. Prof.Gene Fridman, CTO,has >30 years experience in BioMedical Industry, authored >18 patents; working on brain research @ Hopkins

How would you describe this idea while in an elevator with someone?

For patients & caregivers who are managing the dementia patients or chronic patients with dementia, MDx offers an end-to-end solution that amplifies existing dementia management models by enabling pro-active monitoring & management of patients to avoid costs, improve adherence, detect early signs of functional decline &thus, enable providers to significantly improve care delivery & health outcomes

How does your idea demonstrate our Criteria of Accessibility?

We developed MouthLab to not only help early identification and monitoring of symptoms and effects of dementia on patients at home but also provide a solution to manage caregiver’s health. MouthLab enables easy daily monitoring of vitals and alerts the changes in patients condition early enough to intervene and provide appropriate care. Through our real-time triaging software, caregivers are informed about the changes in patients conditions and help select appropriate interventions. CMS pays!

How does your idea demonstrate or plan to demonstrate scalability?

We would like to perform the initial pilot at Johns Hopkins, but using our close network with providers and health institutes at the Texas Medical Center, we aim to expand to more patient population. We also aim to work with CareMore team to target more patients within their member population. As a part of PULSE@Mass Challenge 2018 cohort, we are also working with Mass. eHealth Institute and would leverage their health network in Massachusetts to scale our solution to large number of people.

How do you plan to measure the impact of your idea?

Using the pilot studies, our primary objective is to measure the impact of daily vital measurement using MouthLab by demonstrating the the reduction in the number of hospitalization & ED visits. We aim to improve the patient and caregiver satisfaction using the device. From a patient’s perspective, we want to show the ease of use and adherence. Regarding the caregivers, we want to show the changes in their health over a period of time and how it impacts the way they are managing their loved ones

What are your immediate next steps after the Challenge?

1) Our immediate next steps after the challenge is to publish a whitepaper on the impact of MouthLab on dementia. 2) Use data & whitepaper to target other providers & health institutes to perform larger studies. 3) Apply for NIH grants in partnership with dementia experts to help expand on our disease focus.4) Partner with patient advocacy groups associated with PCORI for pilot partnerships. Ultimately, we aim to raise more funds to expand our device capabilities & team to commercialize MouthLab

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Photo of Sameer Khan
Team

Hi Sathya Elumalai 

I'm very interested to know more about the molecules your device can detect. Please do tell me more if you are able to share without disclosing your IP.

Two local companies in Waterloo, Canada are trying to work in the same way to detect early signs of Alzheimer's and multiple sclerosis through particular proteins and organic molecules detectable in saliva. The two project aren't commercially ready yet. Both use infrared spectrometry.

Could you please let me know what stage of CE certification, and ISO certification you have completed or planning to complete and by when. In Canada such a device would be regulated under PHIPA and in US under HIPAA. I can put you in touch with companies here who can help you with regulatory compliances if you are planning to market and sell in Canada.

Our sales partner - Bosse Medica is interested to test a working model like your device. Please get in touch if you'd like any help and if you can send a test sample for our sales partner.


Best,
Sam

email: sam at brightguide dot ca

Photo of Sathya Elumalai
Team

Hi Sam,
Many thanks for your kind message. I will send you an email with more information about the molecules that we could detect. Regarding the ISO and CE Mark, we are currently working on it. We have an in-house HIPAA and PHIPA consultants at this point, but would definitely reach out if we need more information. We don't have many devices to provide samples but would be more than happy to reconnect once we have enough devices for testing. Thank you again for your support. Look forward to staying connected.
Best regards,
Sathya

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