April 2005 saw the announcement of the first three winners of the BMEidea competition: Embolune from Stanford University, Cervical Bioimpedance from Johns Hopkins University, and Halo-Pack from Washington University in St. Louis. Eighteen months later we caught up with members from each of the ’05 teams to see what they were up to, how their project was going, and how participating in the BMEidea competition influenced their careers.
First prize: Embolune, Stanford University
The Embolune team developed a novel way to treat a cerebral aneurysm—a bulging weak spot in an artery of the brain that, if ruptured, can cause seizures and even death. Current procedures for treating aneurysms are highly invasive, with risks and potential side effects significant enough that some patients choose to live with the possibility of rupture rather than have their aneurysms treated.
Recognizing the need for a lower-risk treatment, the team designed Embolune, a porous balloon mechanism that treats cerebral aneurysm less invasively. To use the invention, a surgeon navigates the balloon to the site of the aneurysm, then detaches it. A hardening polymer substance seeps through the balloon into the aneurysm space, creating a permanent clot that diverts blood flow away from the aneurysm.
A year and a half after winning BMEidea, the team members (Amy Lee, Neema Hekmat, and Pete Johnson) are still pursuing commercialization. They have continued developing the technology, creating a second prototype and conducting animal tests. Stanford, which owns the technology, has secured a non-provisional patent. And while they’ve made progress on the technology and IP front, according to team member Amy Lee raising market interest in the device up to this point has been a challenge. "We’ve been in licensing discussions with several companies," said Lee, "particularly Boston Scientific and one other company on the East coast with experience in microporous balloons. Our technology is still very early stage, however; we’ll have to develop it further before a licensing partner will fully commit."
Another impediment to the project’s success has been the fact that, alongside their work on Embolune, Lee, Hekmat and Johnson all work for other small medical start-ups in the San Francisco Bay Area. "There are only so many hours in the day," said Lee. "It would be very hard to put a lot of work into Embolune and do our jobs at the same time."
All is not lost for Embolune, however. The team remains dedicated to the project and, at the same time, the fact that each of the team members work for a small start-up speaks in part to the influence of the competition on their choice of career. When asked how BMEidea influenced her, Lee said, “In my case, I can say for sure that having participated in the BMEidea competition has helped me in my job. I feel like I’ve got a better handle on the entrepreneurial process: how to go about getting funding, how to explain and round out our proven concepts to investors and other interested parties. Without BMEidea, we would probably be just a bunch of engineers saying, ‘Let’s make this, or this,’ without considering the business end as much. There’s definitely a whole other side to starting a company other than just the technology, and participating in BMEidea and writing a business plan helped me understand how that other side works.”
“Having a wider viewpoint is liberating, and has made the entire process much more interesting.”
Second prize: Measuring Bioimpedance in the Human Uterine Cervix: Toward Early Detection of Preterm Labor, Johns Hopkins University
Premature births, over 400,000 of which occur annually in the US, are associated with a higher risk of maternal and infant death as well as higher incidence of debilitating infant illnesses such as cerebral palsy, autism, mental retardation, and vision and hearing impairments. Although several tools currently on the market can predict when a pre-term delivery is about to occur, they don’t work early enough to safely and consistently administer labor-suppressing drugs.
Enter the Johns Hopkins team. Working on an idea developed by a JHU clinician, they designed a probe that allows physicians to accurately predict when preterm labor is about to occur by measuring subtle changes in cervical hydration. Using the data, physicians can predict the onset of labor early enough to safely administer labor-suppressing drugs and avoid premature birth.
This project has seen a lot of success already, both in terms of commercial success and student outcomes. First, the device has been patented by Johns Hopkins University and licensed to a serial entrepreneur, who is continuing prototype development and aggressively pursuing commercialization. $1.6 million in venture capital has been invested in the device to date, and clinical trials are expected to begin in England next year.
Though none of the original students are still working on the project, many have moved on to pursue their education in similar fields. One is enrolled as an MD/PhD student at the University of Pittsburgh, one as a PhD student at JHU (also interested in continuing on the probe project), another as a PhD student at MIT, another is in medical school, another works at the National Institutes of Health, and the last is in industry. And they’ve taken their BMEidea experience with them. Melanie Ruffner, enrolled in the MD/PhD program at the University of Pittsburgh, said, “Although I plan to remain in academics, the E-Team experience was very valuable because it gave me exposure to how the biomedical device industry works. That experience will help me organize collaborations between academics and industry in my future career. Thank you for the opportunity to participate in this program!”
The team’s faculty advisor at JHU, Dr. Robert Allen, agreed that all the students benefited by taking part. “I think that, while they were here, it definitely motivated them—they worked hard on this project, beyond the normal semester. And even just submitting and being considered for the award was a rewarding experience, let alone winning and receiving recognition.”
Third prize: Halo-Pack, a Low-profile Cervical Spine Orthosis, Washington University in St. Louis
The “Halo” is a time-tested, familiar medical device that immobilizes a patient’s head, allowing the cervical spine to heal after a fracture or a surgery. The Halo design, however, has gone more or less unchanged for the last 45 years: it features a metal ring encircling the head which is then attached to a bulky clamshell vest by 2-4 posts. Although it excels at cervical immobilization, the Halo isn’t comfortable, and can pose a health threat if doctors need quick access to the patient’s head and neck in an emergency situation.
Looking to shore up the shortcomings of the current design, this team designed the Halo-Pack, a novel device that utilizes a single arm for cervical support positioned behind the head and attached to a remodeled harness, similar to a modern backpack. The pins attaching to the user’s skull are less protuberant, and the front of the ring is left open to keep the face exposed. The cumulative effect is a device that immobilizes the cervical spine while significantly reducing the profile of the apparatus and allowing for easier access to the head and neck.
A year and a half later, the Halo-Pack project continues to move toward commercialization. The design is complete, and the team is working on a sixth prototype. Washington University has a patent issued on it, and representatives are from WU are talking with several financial groups interested in investing in the technology. Eric Leuthardt, a WU neurosurgeon and advisor to the Halo-Pack team, said that “one of these groups is particularly interested in doing a startup/spinoff of the idea. We’re currently in negotiations with them to make that happen.”
Potential commercial success aside, Leuthardt believes the Halo-Pack project has had an effect on both the student team members and the institution itself. On the institutional side, a new neuroscience entrepreneurship center has been founded on campus, due partly to the Halo-Pack project experience. Said Leuthardt: “The relationships around the university that developed as a result of Halo-Pack and other projects like it helped spawn the center. These projects created novel relationships between physicians in the department of neurosurgery and engineers, and it’s that kind of cross-hybridization—that exchange of ideas across disciplines—that leads to new innovations. The experience of Halo-Pack was one of the grassroots projects that led to the larger effort.”
And while none of the original students remain on the team, having all started their careers or entered graduate school, the BMEidea experience was again found to be engaging and worthwhile. Team member Elizabeth Tran said that “working with such a diverse team of professors, doctors, and students was a great experience that I’ve carried with me into the work force. The opportunity helped us realize our love for biomedical and engineering design.”
For his part, Leuthardt believes that E-Team projects like Halo-Pack are beneficial to both students and faculty. “For the students,” he said, “it’s a unique chance to work alongside engineering professors, neurosurgeons, and others, all in a collegial, non-hierarchical environment where we’re all capitalizing on each other’s strengths. Students have young, enthusiastic minds, and participating in a cross-disciplinary environment gives them broad exposure to different people doing different things. On the faculty side, we get charged up just being around enthusiastic people. It gets us excited about things that we sometimes view as mundane or tiring. It really recharges our batteries.”
University of Massachusetts, Lowell, 2005 - $20,000
This E-Team developed an infrared imaging system for medical diagnosis. The team envisions the imaging system as a low-cost alternative to X-rays, possibly helping make medical diagnostic equipment more readily available in developing countries.
This E-Team developed a novel, contactless, magnet-based buoy to capture the ocean's wave energy and convert it into electrical energy. By "contactless" the team means that previous buoy designs have used hydraulic or pneumatic approaches, which create physical contact between the piston and cylinder, leading to system damage during rough storms as well as decreased efficiency, while their design employs magnets for contactless mechanical energy transmission. The magnets are configured in a piston, producing radial magnetic flux that transmits a generator load to the cylinder; the motion of the piston is transformed to rotation using a ball screw to drive the permanent magnet rotary generator. Thick cables attached to the bottom of the buoy connect it to an electrical grid on the mainland.
The team created a proof-of-concept prototype that showed an overall system efficiency of 70-80%. The goal of this grant was not so much to commercialize a product immediately, but to further prototype and test their design to enable commercial-scale devices in the future.
This E-Team undertook two separate activities: prototyping its micro-fuel cell technology, and creating a long-term marketing plan. The technology is PM2, a novel planar, micro-fluidic, membraneless micro-fuel cell that relies on laminar flow of fuel and oxidant solutions. Initial lab tests demonstrated that the design has the potential to deliver superior power density to portable electronic devices when compared with competing membrane and membraneless fuel cell designs.
The team continued prototyping PM2 to go from a 1-mW lab device to a 10-watt commercial prototype with an appropriate price. Alongside prototype development the team identified manufacturing, distribution, sales, and venture capital partners, segmented markets, determined market entry point, and identified partners for commercialization. The primary target markets are the defense and industrial sectors, specifically in the areas of portable power, wireless scanning, and communication devices.
This E-Team developed a clay-based water purification system for household use in developing countries. The system consists of a ceramic filter element, made of kiln-fired clay treated with colloidal silver, set in a plastic receptacle tank with a plastic lid and spigot. These filters have been produced and promoted in Africa, Central America, and Southeast Asia, but have not been widely adopted due to poor financial planning and failures in meeting the expected amount and quality of water produced. The team improved the filtration system and at the same time developed customized training that creates broader awareness, encouraging adoption on a much larger scale, and stimulating local production and support.
Water scarcity is the biggest challenge of the 21st century, and proper wastewater treatment is critical to public and environmental health because it protects and recycles the limited supply of fresh water. Throughout the world, billions of gallons of industrial and domestic sewage are treated in centralized wastewater facilities through the acceleration of natural biodegradation processes, relying on a balance of healthy microbes for optimal performance. This E-Team developed an innovative biotechnology system to monitor and diagnose common microbiological problems that interfere with the reclamation of wastewater in sewage treatment plants worldwide. Problems often result from undesired blooms of microbes, but many microbes do not yield to cultivation, the traditional method of identification. The team's DNA sequence-based technology allows microbes to be detected and identified without cultivation to determine relative quantities in a sample. Once problem microbes are identified, treatment plants can design and apply the appropriate remedy with quantitative information from the team's Biotechnology System.
This E-Team developed SecureGo-Cash, a USB flash drive equipped with encryption capability for secure online transactions. When connected to a USB port, SecureGo-Cash prompts the user for a password. Each SecureGo-Cash has a unique Machine ID, and once the user enters her password, she logs into any SecureGo-enabled website, uses the Machine ID as her identity, and completes a transaction. The website connects to the SecureGo server, verifies the authenticity of the request, and transfers the amount from the user's account to the merchant's account. Additionally, the user can set up a cash recovery account with SecureGo-Cash, and if the device is lost or stolen, can transfer the balance to this recovery account.
Bullex, launched at Rensselaer Polytechnic Institute, received Advanced E-Team grants in 2003, 2004 and 2005 to develop the Intelligent Training System (ITS), an innovative fire extinguisher training device. The majority of today's live-fire extinguisher training is done by taking a bucket and filling it with kerosene or diesel, and water. After an instructor lights the fire, a trainee is given an extinguisher and told to put it out. This method is expensive, can be dangerous, and often requires a HAZMAT cleanup.
ITS makes fire extinguisher training more efficient by simulating the extinguishing of a real fire, removing costly extinguishant from the equation. First, flames are generated in a clean-burning, propane-fed pan equipped with digital sensors. If users aim properly and hit the sensors, they can quell the fire without the mess. The sensors then give out a reading on how well a trainee used the extinguisher. The device is cleaner, safer, and easier to use than the traditional training method.
2003 update: Bullex launched successfully in 2003, and now has 60 employees and estimated annual sales of $7.3 million. The company was featured in Fortune Small Business Magazine after making it to the final round of the magazine's national business plan competition, receiving honorable mention. Their customers include the US Navy, Northrop Grumman, Michelin, International Truck, and Trane.
Arteriotomies (the surgical incision of an artery) are required for all catheter-based procedures. Current medical practice requires a large, open incision, an invasive procedure which increases recovery time, hospital and procedure costs, and patient discomfort. To combat these problems, this E-Team developed a device that closes large arteriotomies percutaneously--that is, closes them through the skin in a minimally invasive procedure. The device consists of two components: a vessel-cutting tool, which creates an incision in the vessel of the specific size and shape of the catheter to be used, and a closure mechanism, made of a pre-placed nitinol structure, that provides complete hemostasis to the arteriotomy when the catheter is removed.
This E-Team is concentrating on the problem of the perishability of food and pharmaceutical items. Currently there are two methods of ensuring food/pharmaceutical safety: human predication of expiration, and chemical tags that change color upon product expiration. The E-Team aims to combat the deficiencies of these methods by developing a Time-Temperature Integrator (TTI) tag which, in a 1x2 inch housing, incorporates a temperature measure, a microprocessor, and an RF transceiver. Instead of using the color-change method, these tags record the temperature and time at thirty-second intervals. A calculation of shelf-life is then made based upon a proprietary algorithm that takes into account the current time/temperature and the optimal shelf-life of perishables under those specific conditions. A report of time, temperature and freshness is then sent to a wireless device.