medical device

Stanford's 'Endurance Rhythm' team launches startup company

 

Over the past two years, the Endurance Rhythm team, an E-team out of Stanford University, has worked on patenting a micro-generator for electronic implants of the heart.

While in the phases of developing its technology for powering implantable medical devices, the team has launched a new startup company, Endurance Rhythm Inc, for its device.

“Although the grant has ended,” said project primary investigator Paul Wang, “The project is continuing. The grant helped demonstrate proof of principle and ready our project for investment/partnership, which we are continuing to very actively seek. The grant was incredibly helpful and an amazing help for our team.”

Learn more about Endurance Rhythm, Inc. Read about the micro-generator.

E-Team to Develop an Oxygen Flow Indicator for Hospital Transport

University of Pittsburgh, 2001 - $13,085

The Center for Critical Care Medicine at the University of Pittsburgh discovered that some patients experience decompensation during transport while on oxygen support. Decompensation is a life-threatening problem that occurs when a patient's oxygen supply tubing develops a kink or when oxygen depletes within the storage cylinders. No device exists to indicate the flow of oxygen through a patient's tube. In fact, the only current method of determining if a patient is experiencing decompensation is to see if their face turns blue.

In response to this need for an oxygen flow monitor, this E-Team developed the Spindicator, a device made up of a cylindrical tube, an inline impeller, and gas inlet/outlet. Oxygen flowing through the tube forces the impeller to spin. To make impeller monitoring easy, the team painted the impeller two distinct colors that a person can detect from a minimum of six feet away. If the device fails, the inline impeller design facilitates oxygen flow to the patient. The Spindicator attaches to the nasal attachment or face mask just below the patient's face.

At a preliminary survey at the UPMC Presbyterian Hospital, 72% of those surveyed expressed extreme support of the product. Across the US, about 1,500 hospitals need to provide oxygen to approximately sixty-six million patients. If the Spindicator sold for $5 to $10, hospitals would pay only $250,000 to $440,000 each year for the product.

The team originated from a NCIIA-funded class, Product Realization. Three undergraduate students, with skills in mechanical and industrial engineering, worked on the team. They worked with four engineering school advisors and two medical/industry advisors. One of these advisors is a doctor from UPMC Presbyterian and headed the clinical trial for Spindicator.

An E-Team to Develop an Image Quality Analyzer for Endoscopes and Laparoscopes

University of Pittsburgh, 2001 - $13,000

According to the American Hospital Association, there are 6,400 hospitals in the US, and most of them own endoscopic equipment. Endoscopes and laparoscopes are narrow, tube-shaped optical devices that allow surgeons to see inside a patient's body without making incisions. The devices minimize trauma in surgery and therefore shorten patient recovery time. However, scope performance depends on the image quality they deliver, and many factors contribute to image quality deterioration, including collision with alien objects, poor maintenance, and the heat and chemicals used in cleaning and sterilization procedures. Currently, hospitals have no tool to ensure scope performance by evaluating and monitoring image quality.

To fill this need, this E-Team developed an image quality analyzer that facilitates efficient and automatic evaluation of the image quality of scopes. With the analyzer, hospitals can ensure the quality of endoscopic surgery and track the performance of scopes over time. Performance data shows optimal maintenance procedures and when replacement is necessary.

The E-Team consisted of two graduate students in engineering. They worked with an industrial engineering faculty member and the director of minimal invasive surgery at the Magee-Women's Hospital in Pittsburgh.

Building a Design and Innovation Professional Masters Degree Program at the University of Cincinnati

University of Cincinnati, 2009 - $7,500

The Medical Device Innovation & Entrepreneurship Program (MDIEP) at the University of Cincinnati is an interdisciplinary graduate program that focuses on addressing real-life clinical problems. Design teams from the program have been recognized by NCIIA BMEIdea and ASME Innovation competitions. The program currently operates on funding from industry sponsors. This grant will bring forth a new PSM program that will be in partnership with the MDIEP. Team members will survey their respective departments for applicable courses so that each discipline can communicate its strengths and vision. In addition, a lecture series broadening participation in the current MDEIP program will be established.

Global Health by Design

Stanford University, 2006 - $37,500

This grant supports the Global Health by Design (GHbD) project, an innovation fellowship that will address world health challenges through medical device design at Stanford University. The fellowship will be a collaboration between anthropology, engineering, medicine, public health, international economic policy, and business. The fellowship is built on the assumption that, in order to create and disseminate effective medical technologies in developing countries, the process needs to take place within sustainable businesses and industries in those same countries.

NCIIA funding is going toward cross-institution planning, which will take place for one year and include: choosing a host country, making connections with key colleagues in that country to facilitate the clinical immersion of the fellows, and finding partners in the host country to actualize the business plan and fund raising. GHbD will recruit four fellows, one of whom might be from the host country, and will train the fellows through a six-week boot camp that will include classroom lectures on health care, background on needs identification, information on basic biomedical technologies, an introduction to intellectual property, health care regulation, and basic health care technology economics. Fellows will travel to the host country in September for a three-month immersion, during which they will participate in the local health care delivery system and identify at least 250 clinical needs. On returning to Stanford, the fellows will process the clinical needs, conduct extensive research on forty of them, develop a detailed written profile of the clinical background, and present the profile to a faculty from the host country. Following this, fellows will invent several solutions to each problem. The solutions will be evaluated for technical feasibility, practicality, cost and manufacturability. Students from the Biodesign Innovation Class will further develop these concepts and GHbD fellows will serve as TAs for the course.

UR-PUCP: Collaborations for Healthcare in Developing Countries

University of Rochester, 2008 - $25,200

The University of Rochester team will form international E-teams to tackle health issues in Peru. They seek to target the urgent health needs outlined by the Peruvian government, supplement the number of global-health design teams in the UR Biomedical Engineering design sequence, provide a more realistic and innovative design experience for Pontificia Universidad Catolica del Peru engineering students and build an infrastructure for collaborative experiences between international engineering students and healthcare providers. They will employ an unique strategy – interactions between engineering students, healthcare providers, and business consultants for a truly multidisciplinary team approach. UR’s Senior Design sequence will be extended as a way to generate E-teams in cohort with PUCP students. These teams will work to design affordable medical devices for the healthcare needs identified in Peru.

Restoration of Fecal Continence in Women

Stanford University, 2008 - $19,166

Most treatment options for fecal incompetence (a condition impacting six million Americans, mostly women) often result in infection or the need for reoperation. This E-Team is developing a new device designed to treat the condition safely. The device consists of a disposable plug kept in place by an anchor stapled into the rectum. Three characteristics separate this design from current treatment options: it prevents stool from exiting regardless of etiology, it poses little risk of infection since it does not invade any internal tissue, and the procedure can be done on an outpatient basis.

Development of a Novel, Low-Cost Point of Care HIV Viral Load Diagnostic for Resource-Limited Communities

Arizona State University at the Tempe Campus, 2008 - $20,000

HIV viral load testing, which measures the number of HIV copies in a milliliter of blood, provides important information in monitoring the status of HIV disease by guiding recommendations for therapy and predicting the future course of the disease. However, the current viral load test is expensive ($50k initial capital outlay, $40 per test), requires skilled technicians and significant training, and is available only in well-equipped medical facilities.

This E-Team is developing a new viral load test that is far cheaper ($200 capital outlay, $6 per test), does not required skilled technicians, and can be implemented in rural clinics in the developing world. The team’s simple approach is to use the naked eye to confirm the presence and quantity of HIV in the blood. The product will be a kit consisting of two pieces of equipment (a blue-light box and a water bath) and a package of inexpensive reagents that do not require cold-chain storage. Blood samples drawn from the patient are processed in 2.5 hours and read in a dark room using the blue-light: blood containing HIV above threshold levels fluoresce, indicating a high viral load.

SMART Kit

Lehigh University, 2008 - $19,600

LifeServe Innovations is an entrepreneurial venture formed at Lehigh University by aimed at developing and commercializing an emergency tracheostomy device. Currently the standard surgical airway procedure for the emergency field is a cricothyroidotomy, but this procedure is problematic as the airway it creates is temporary and needs to be replaced at the hospital. LifeServe intends to improve the practice by bringing an in-hospital procedure, the percutaneous tracheostomy, to the field of emergency medicine.

The team is developing the SMART Kit, which will contain all the tools necessary to perform a percutaneous tracheostomy in the field. The vital component of the kit is LifeServe's patentable SnakeBite Dilator (pictured). This device transforms a percutaneous trachestomy from a timely and involved surgery to a fast and user-friendly procedure.

LifeServe has already prototyped an initial version of the dilator, performed market research, and gained insight and feedback from medical professionals.

Development of a Total Cancer Marker through Single Molecule Assessment of DNA Integrity

Johns Hopkins University, 2008 - $20,000

Despite a number of advances in cancer detection technologies, the development of clinically validated, blood-based cancer biomarkers remains an unmet challenge for many common cancers. Better markers would lead to earlier detection, saving lives and cutting down on hospital costs. A new method, the DNA Integrity Assay (DIA) has the potential to accurately discriminate cancerous cells from normal cells for a wide range of cancers, but its clinical acceptance has been limited due to the complexity of the test, sampling errors, and the high cost of the materials, instruments and highly trained personnel needed to run it.

This E-Team is developing a new DIA testing method called smDIA (single molecule assessment of DNA integrity), which has the potential to eliminate errors and reduce the costs associated with the traditional DIA approach. In this method, a patient’s DNA sample (blood, stool, etc.) is transported by a microfluidic device through a sheet of laser beams (Cylindrical Illumination Confocal Spectroscopy), enabling direct analysis of the patient's DNA integrity in a rapid, uniform manner.

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