About this project
The problem we solve: Accurate and frequent monitoring of blood flow is crucial post-operatively after vascular or flap surgery for early detection of flap compromise. This most often involves the physician interpreting the sound of blood flow from an external hand-held Doppler ultrasound. Depending on the practice setting, in the immediate post-operative period, this auditory verification may be done by nursing staff or residents. Waveform analysis of Doppler sonography has the potential for providing more complete and objective hemodynamic measures, including subtle changes in flow velocity and vascular occlusion, as in the situation of a blood clot. However, most hand-held Doppler ultrasound devices do not have this functionality today, and devices that do are too bulky to encourage regular use. Auditory verification of blood flow requires a trained ear, making it impossible for patients to monitor vascular perfusion at home on their own, and limits monitoring to in-person physician office visits.
About our solution: The Pocket Doppler is a pen-like device that locates arterial pulses by emitting ultrasound waves via a piezoelectric disk located at the tip of the device. It collects and transmits the resulting data via Bluetooth to a user interface application that outputs the waveform and certain hemodynamic measures. The application includes interpretation of the waveform through a proprietary algorithm that identifies triphasic sounds (desirable) from biphasic or monophasic sounds (undesirable). The interface is designed to offer a visual representation of the soundwave and alert the user if the sound is the desired waveform. The Pocket Doppler also contains a built-in gyroscope. In conjunction with the application, this creates a placement map to aid the untrained user to accurately position the Pocket Doppler. Finally, the application has the capability of sharing relevant information amongst members of a treatment team as well as from patient to physician. Progress to date: Our team consists of a medical student, three MBA students, and three engineers. We have put together a schematic of our device and applied for a provisional patent. Our engineers are reviewing existing technologies for vascular Doppler probes. We have identified major components required for the device and have started designing the prototype. The MBA students on our team have pitched our idea to angel investors and we have begun setting up meetings with physicians to get feedback on our design.
About Our Team
Ms. Shruti Mishra, BS (Medical Student) Medical Student, Medical Student Medical school: Washington University in St. Louis School of Bio: Shruti is a rising 4th year medical student at Washington University in St. Louis. She received her bachelor’s degree in Bioengineering from the California Institute of Technology in Pasadena, CA. She holds an endovascular device patent from her time working with Cook Medical. She is interested in radiology research, medical education, and medical innovation. She plans on specializing in radiology after graduation.
Title: Chief Medical Officer
About Team Members
Chief Executive Officer, BSN, MSN-FNP, MBA (2017) Biography: Vera is a first-year MBA with a concentration in Marketing at Washington University in St. Louis. She also is a nurse practitioner and has 7 years of experience as a trauma and general surgery operating room nurse. She received her bachelor's degree from The Johns Hopkins University in Baltimore, MD and practiced as a registered nurse for several years before returning to school and earning her master’s degree from Columbia University in NYC. She plans to work in medical device marketing. LinkedIn:https://www.linkedin.com/in/vera-carter-5312a9100 Jonathan Hum
Chief Financial Officer, BA, MBA (2017) Biography: Jonathan is a first-year MBA at Washington University in St. Louis with a concentration in capital markets and asset management. Before coming to Olin, he worked at Franklin Templeton Investments’ Global Macro team where he covered Russia and Ukraine. He previously worked in equity research at Columbia Partners. He is studying for the CFA and passed Level I in December 2015. For undergraduate, he attended Swarthmore College, with a BA in economics and a minor in mathematical statistics. LinkedIn:https://www.linkedin.com/in/jonathandouglashum Srinivasan Raghunathan
Chief Operations Officer, BBA, MBA (2017) Biography: Srini is a 1st-year MBA with a concentration in consulting. Srini obtained his bachelors of business administration (BBA) at The University of Texas at Austin with a concentration in Supply-Chain Management. After obtaining his Bachelors, Srini worked in Citigroup’s Server and Network Monitoring team as an Operations Manager for the North America and the European market. His main job includes spotting and fixing infrastructure errors before causing a major revenue loss.
LinkedIn:https://www.linkedin.com/in/srinivasanraghunathan Steven Huang
Electrical Design Engineer, BS, MS Biography: Steven is a 4th year Ph.D. student in electrical engineering at Washington University in St. Louis. He received his Bachelor’s degree in Engineering Science from University of Toronto and his Master’s degree in Electrical Engineering from Stanford University. Steven’s current research interest is biosensing using optical microresonators.
Mechanical Design Engineer, BS Biography: Matthew graduated from Washington University in St. Louis with a Bachelor of Science in Mechanical Engineering as well as a Minor in Energy Engineering. He currently works at The Boeing Company as a Quality Engineer supporting F/A-18 Installations & Final Assembly and previously supported the F/A-18 Forward Fuselage, Wing, and Trailing Edge Flap Structures assembly areas.
About Our Company
Pocket Doppler, LLC Location: St. Louis, Missouri Product stage: proto Sales: Working on it Employees: 5-10
How We Help Patients
After flap plastic surgery or vascular surgery, frequent monitoring of vascular flow is essential for detecting blood clots that may compromise the graft. Currently vascular monitoring after the patient is discharged from the hospital is limited to 2-3 postoperative doctor visits. This device gives patients the ability to monitor blood flow at home, in between visits. Gyroscope-assisted placement maps in the smartphone application allow for patients to position the device appropriately, and the waveform analyzing algorithm appropriately interprets the blood flow signal. Small-scale studies have shown that faster detection of compromise in blood flow leads to better outcomes for patients. The Pocket Doppler allows patients to take ownership of their health. Virtual physician oversight allows for more timely intervention, instead of waiting for the patient to become symptomatic or present in the office.
How We Help Physicians
Research shows that many hemodynamic parameters can be accurately assessed through waveform analysis of Doppler sonography. However, to date devices that have such capabilities are bulky and are frequently not readily available. Physicians most often rely simply on subjective auditory assessment of flow to assess for vascular patency. The Pocket Doppler, in conjunction with its smartphone application, gives physicians the ability to get objective metrics of vascular flow as easily as using a penlight. The device connects to physicians’ smartphones through bluetooth technology, eliminating the need for locating Doppler receivers in busy emergency rooms and doctor’s offices. We hope that the Pocket Doppler will be of use in a variety of clinical settings, including, post-operatively after vascular or flap surgery and in the emergency room for diagnosis of peripheral vascular disease.
Mission: Our team is a unique example of student-lead innovation that occurs when medical, business, and engineering students team up to take an innovative idea from bench to bedside. Use of funds: We expect to produce a minimum viable prototype for approximately $16,000. This covers the cost of five to ten iterations of prototyping to reach an acceptable version, including electrical and mechanical components bought at retail, custom made machined parts and printed circuit boards, and software development. We would use the remainder of the $25,000 for design and implementation of a preliminary clinical trial. We are interested in comparing assessment of vascular patency by our application with clinical assessment by auditory cues, as is the current standard of care. For this trial, we will need 1-2 working prototypes and a physician mentor who would be willing to test-run this technology in the clinical setting. Results from this trial would inform our design and further beta testing. Intellectual Property Status: Our provisional patent application was filed 04/2016. FDA Status: The Pocket Doppler should qualify for an expedited program called 510(k) clearance because its risks to patients are similar to existing devices and the device is non-invasive. 510(k) clearance takes five months on average and given our anticipated testing requirements, should cost around $80,000. The device will likely be Class II, which is the same as current doppler probes. Personal Message: We are a team of students who are passionate about medical device innovation. The interdisciplinary nature of team makes us well-suited to navigate device design and development as well as the patent application process. Help us bring the Pocket Doppler into the hands of physicians and patients by supporting us!