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Automating urine output measurements

by Jay Joshi, MD, MBA

ICU patients at a high risk of fluid imbalance risk delays in diagnosis and management of acute kidney injury due to manual, time-intensive methods of urine output measurements.

Chicago, IL Clinical Interventions

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About this project

The problem we solve:
Our product addresses the limitations that exist in current medical technology using urine output specifically to diagnose Acute Kidney Injury (a complication that affects nearly 20% of all ICU patients). Urine output is the most important vital sign used in treating patients with Acute Kidney Injury (AKI). In-hospital acquired AKI is a major cause of increased morbidity and mortality among critical care patients. Several clinical studies suggest a direct correlation between the mortality of AKI and the number and duration of low urine output episodes. These studies show that patients who develop in-hospital AKI are at more than 3x higher risk of death.

About our solution:
This medical device uses a bivalve add-on adapter that fits between the Foley catheter and the distal tubing to measure urine output in 20 minute intervals as the urine passes through, the optimal time interval of data read-outs as per our physician interviews. We integrate the output data into ICU tele-monitor screens and hospital EMR’s. As a result, we improve clinical quality, create hospital cost savings, and improve nursing productivity.
Progress to date: We are in the last phases of prototyping development: concept refinement. We are currently working on (1) the FDA application, in which we will be a Class II 510k exempt medical device; (2) the clinical study design which is to take place at the University of Chicago Medical Center; (3) and selecting the appropriate manufacturer to mass produce the completed prototype. Additionally, we are continuously networking with Physician thought leaders in the AKI field to identify additional sites for clinical studies and build sales channels.

About Our Team


Dr. Jay Joshi, MD, MBA
Gastroenterology, Practicing Physician
Medical school: University of Illinois Medical Center
Bio: Dr. Jay Joshi is a Physician Entrepreneur with a known history of identifying improvement opportunities within the health care sphere to optimize care practice and clinical guidelines.
Title: CEO & Founder
Twitter: https://twitter.com/outputmed
LinkedIn: jay-k-joshi-8456221a

About Team Members

Alex Holterman
Product Development Director, BME
Biography: Alex Holterman is a Biomedical Engineering graduate who serves as Product Development Director of Output Medical. He has experience with product design and verification testing.

About Our Company


Output Medical
Location: Chicago, Illinois
Website: www.outputmed.com
Twitter: https://twitter.com/outputmed
Facebook: https://www.facebook.com/outputmedical/
Product stage: proto
Sales: Working on it
Employees: 3-5

How We Help Patients

Urine output is the only key vital or measurement still measured manually in the ICU. That is hard to imagine in today's health care, where there is a sensor, gadget, or app to solve everything. But sadly it is true. And the manual methods to measure urine output are impacting patient lives and limiting physicians' and nurses' ability to manage high risk patients.

How We Help Education

The current manual methods of urine output measurements violate optimal standards of care. For example, excessively providing fluid diuretics or maintaining patients on dialysis for longer than is necessary adversely affects acute kidney injury management. By automating urine output measurements, physicians and nurses have an automated platform to measure and detect changes in urine output. Through this platform, we can then establish protocols for treatment, preventing excess diuretic use or other harmful practices. Once we establish protocols for care management through the automated measurements, patients will receive more standardized care.

How We Help Physicians

Physicians often have to guess whether the kidneys are responding to certain fluid interventions or whether the patient is really in a state of kidney injury or not. As a result, they may erroneously provide additional fluid bolus treatments or diuretic treatments when it is not necessary because the urine output measurements were not measured properly and taken in a timely manner to assist with decision making. With more easily available access to standardized measurements, physicians can more confidently determine the urine response to various treatment interventions.

Challenge Mission

Mission: Output Medical was started by a resident physician who saw first-hand the problem with urine output measurements. Output Medical can inspire residents to identify solutions to problems they see.
Use of funds: We would use the funding to finance a clinical study at the University of Chicago. The outcomes of the clinical study would focus on improved nursing efficiency and improved physician decision making.
Intellectual Property Status: Output Medical has developed all intellectual property internally, and all patent rights have been assigned to the company.
FDA Status: Output Medical has initiated the FDA application and we plan to submit the full FDA application in July, 2016. Application details include: Device Class 2, Product Code EXS, and Review Panel: Gastroenterology/Urology.
Personal Message: Please support Output Medical and support physicians that create solutions to problems we see everyday in patient care.

Supporters

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    12/09/2016 Eduardo Fidalgo - Medical Device Industry

    Interested in partnership.

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    12/09/2016 Eduardo Fidalgo - Medical Device Industry

    Liked the project.

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    12/09/2016 Eduardo Fidalgo - Medical Device Industry

    Followed the project.

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    05/17/2016 Dr. Carrie Mendoza - Physician

    Liked the project.

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    05/14/2016 Oleksii Vynogradov - Private

    Followed the project.

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    05/14/2016 Dr. Udai Jayakumar - Physician

    Liked the project.

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    05/05/2016 Nadia Silva - Medical Student

    Liked the project.

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    04/26/2016 Jacob Petrosky - Resident

    Liked the project.

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    04/26/2016 Dr. Jay Joshi - Private

    Liked the project.

  • image
    04/26/2016 Dr. Jay Joshi - Private

    Followed the project.

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Jay Joshi, MD, MBA
Private
CEO & Founder
University of Illinois Medical Center

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