The 2005 BMEidea Winners: 1.5 years later

BMEidea is a national biomedical competition in which diverse teams of students and faculty develop new health-related technologies that address real clinical needs. Teams are judged on their device’s technical, economic, and regulatory feasibility; its contribution to human health and quality of life; its innovativeness; and its potential for commercialization.

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. This summer we caught up with members from each of the ’05 teams to see what they’re up to now, how their project is going, and how participating in the BMEidea competition has influenced their careers.

First prize ($10,000): 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 ($2,500): 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 ($1,000): 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.”