bmeidea

In 2010 the BMEidea competition continued its tradition of supporting student teams in developing devices that can improve healthcare outcomes in the US and around the world. Included in the 2010 cohort were three devices with the potential to save lives: a portable device to induce hypothermia in cardiac arrest patients, a low-cost ventilator, and a device to improve urogynecological procedures by providing surgeons with better visibility and access to deep target tissues. Twelve months later we caught up with members from each of the three winning teams to see what they were up to, how their projects were going, and how participating in the BMEidea competition has influenced their projects and their careers.

First prize winner: Rapid Hypothermia Induction Device, Johns Hopkins University
The biggest killer in the US isn’t cancer, it isn’t diabetes and it isn’t accidents—it’s heart disease, and a significant percentage of those deaths, a full 335,000 per year, come as a result of cardiac arrest.

The numbers surrounding cardiac arrest are stunning: brain damage starts to occur just four to six minutes after the heart stops pumping blood; a victim's chances of survival are reduced by seven to ten percent with every minute that passes without CPR and defibrillation; few attempts at resuscitation succeed after ten minutes. Worst of all, the total survival rate is 5%--which means that 95% of cardiac arrest patients do not make it to the hospital.

Such dismal numbers express two things: the severity of the disease and the opportunity for vast improvements in emergency treatment.

This team, winner of first prize in the 2010 BMEidea competition, is taking on the challenge with the Rapid Hypothermia Induction Device (RHID). The device is based on the idea of therapeutic hypothermia (TH), a medical treatment gaining in popularity in which a patient's body temperature is purposely lowered in order to lessen the risk of tissue damage following a period of insufficient blood flow. TH can be induced by pumping cooling saline through a catheter inserted into the heart via the femoral vein, but this is highly invasive and can only be done in a hospital setting—not in the field, where cardiac arrest claims most of its victims. TH can be induced in the field with chilled water blankets, torso vests and leg wraps, but this is slow and hard to control, and the refrigerated blankets and wraps are hard to store in ambulances.

The RHID team is trying to fill the need, then, for a simple, portable device that can reliably induce hypothermia in the field, keeping cardiac arrest victims alive long enough to make it to the hospital. Led by then-undergraduate David Huberdeau and faculty sponsor Dr. Harikrishna Tandri, the team’s device can be carried in an emergency technician’s handbag and induces TH by blowing regulated air through the patient’s nose.

It works by using the principle of evaporative cooling: when water evaporates from the body, it carries with it a large amount of heat. Nasal cavities have highly specialized vascular heat exchangers, called turbinates, which humidify and warm the air that passes to the lungs. During periods of low temperature, blood flow increases to the turbinates, allowing for high levels of mucus production. RHID forcibly accelerates the evaporation of water from the nasal cavity by continuously flushing cold, dry air on the surface, carrying heat away and cooling the brain.

The device got its start in Johns Hopkins’ Senior Design Team course, in which groups of students pair with a faculty sponsor to take on a biomedical design challenge. Huberdeau led a team of ten undergrads in search of a project, and found Dr. Tandri, an assistant professor in the School of Medicine and a member of the Johns Hopkins Heart and Vascular Institute. “Dr. Tandri had already had the idea for a scalable, portable, rapid hypothermia induction device, and we were put together through mutual contacts,” said Huberdeau.

Dr. Tandri got the idea for the device directly through his work—he could see the need quite clearly. “My background is in cardiac physiology, and I’m a cardiologist by training. I deal with a lot of patients suffering from cardiac arrest and sudden death. The motivation for the device came from there—to improve survival rates.”

The team decided to go forward with the project in September of 2009, and over the next academic year Huberdeau and his team worked in collaboration with Dr. Tandri on developing the device. Said Huberdeau, “Dr. Tandri already had a provisional patent on the idea, and we tried to make improvements to the concept as the year went on.”

At the end of the course they’d reached a level where they could begin pursuing intellectual property and considering paths to commercialization; they submitted for BMEidea and won the competition.

Since then the team has dispersed: Huberdeau entered the biomedical engineering PhD program at Johns Hopkins; four team members went to work in industry; one is working in a hospital; and some were freshmen when the project began and are still undergraduates. That hasn’t stopped the project from moving forward, however, as Dr. Tandri is continuing testing and has applied for an SBIR grant.

“We’re moving along, slowly but surely, but in the right direction,” he said.

Meanwhile, simply submitting for BMEidea was worthwhile, according to Huberdeau. “Submitting the application forced us to get our thoughts in order. It really helped us organize our project.”

For Dr. Tandri, the most important thing about winning the BMEidea competition is credibility. “Now when we talk to people—investors, venture capitalists, etc.—it helps us move the business end forward. Knowing that this device was recognized by the NCIIA in a national competition absolutely gives us credibility.”

Winning the competition has given Huberdeau much more confidence to pursue a career in translational medicine, including entrepreneurship, in the future. “The basic and clinical science research coming out of academic medical institutes such as Johns Hopkins is breaking new ground in our understanding of disease, biology, and medicine,” he said.  “Biomedical engineers like myself, in close partnership with researchers and clinicians, are uniquely positioned to facilitate the widespread adoption of these discoveries to medical practices the world over.”

Second prize winner: OneBreath, Stanford University
One aspect of entrepreneurship that’s about as close to a universal law as you can get is this: making something cost less is a good thing. Making it cheaper by an order of magnitude? Even better. Saving lives in the process? Perfect.

The second prize-winner of the 2010 BMEidea competition is shooting for all three of those targets with OneBreath, a low-cost ventilator that keeps critically ill patients breathing when their respiratory systems are unable to function.

OneBreath is designed to address two distinct problems: emergency readiness in developed countries and the shortage of ventilators in developing countries. The buzz about emergency readiness in the US started during the flu pandemic scare several years ago; people realized that, in a worst-case scenario, hospitals would not have enough ventilators to meet the anticipated demand. More than 740,000 would be needed, but the US has only 205,000—meaning that in a crisis, hospital staff would have to decide who gets a ventilator (and lives), and who doesn’t get a ventilator (and dies). Meanwhile, in developing countries, millions die each year from lack of access to a common ventilator—India has 35,000 ventilators for a population exceeding 1.1 billion.

The biggest reason for the shortages in both cases is the current cost of ventilators. Ventilators cost hospitals from $3,000 up to $40,000 for state-of-the-art models, making it impractical for most hospitals to stockpile them for emergencies and completely pricing them out of the vast majority of clinics in the developing world.

The OneBreath team, led by Stanford post-doc and device designer Matthew Callaghan, is well aware of this dilemma and is going low cost in response. A OneBreath ventilator costs a mere $300, a massive price reduction, and the device is rechargeable, portable, and disposable—perfect for one-off emergency situations no matter what country you’re in.

Callaghan achieved the cost reduction with slick engineering. The no-frills device, smaller than a toolbox, runs on a twelve-volt battery for six to twelve hours at a time. Whereas most ventilators use expensive flow sensors, servo motors and other specialized components to push air in and out of the lungs, Callaghan started from scratch with a basic pressure sensor, typically used in devices like blood-pressure meters, that costs about $10. Callaghan also replaced the single permanent air valve on expensive respirators, which requires time-consuming cleaning between patients, with two—one that is exposed to patient air and one that never comes into contact with it. When the inner valve opens as the patient inhales, air forces the outer valve closed, keeping air that the patient expels from contacting the pristine inner valve. The contaminated outer valve can be thrown out and replaced with a new one.

The team has made impressive strides since the BMEidea competition in 2010. While Callaghan is still a physician at Stanford, the rest of the time he’s working on OneBreath. The team is now officially incorporated, with a CEO, VP of business development, Chief Medical Officer (Callaghan) and several engineers. They’ve continued development of the device, are seeking regulatory approval after successful animal tests, and have partnered with GE Healthcare to stockpile ventilators for the US government to use in pandemic situations.

That takes care of the first half of OneBreath’s mission. In the meantime, the other half of the project was emerging markets and developing nations. “To that end,” said Callaghan, “we’re finishing up our grant funding and looking to raise funds from private, local venture firms, and hopefully be able to close on that round of funding by the end the summer. After that we’ll start on the CE mark process, which is the outside-the-US, non-FDA approval for selling in India, China, and the Middle East.”

Along the way Callaghan is taking a typical entrepreneur’s path, working hard and performing whatever tasks are required. “Between me and the CEO and the VP, we kind of wear all the hats. It’s a startup, so you do what you have to do—I made business cards the other day. You end up doing things that you never imagined would make up your job, but they do.”

While Callaghan and his team have participated in a number of business plan competitions and written many grants, the BMEidea competition sticks out for him as being “very engineering-focused. It forced us to put our thinking caps on on the engineering side. There’s really no other competition that I’ve seen that focuses on the engineering like that—on making something real.” According to Callaghan, most competitions tend to be focused more on the research hypotheses, “So BMEidea was nice. It gave us a chance to do something real.”

Look for OneBreath to make a real impact on the world in the near future.

Third prize winner: Natural Orifice Volume Enlargement (NOVEL) Device, University of Cincinnati
When the muscles and ligaments supporting a woman's pelvic organs weaken, the organs can slip out of place, known as prolapse. Pelvic organ prolapse can worsen over time and eventually some patients need surgery to fix it.

It’s the surgery for this condition that the third prize winner of the 2010 BMEidea competition is looking to improve.

Currently, surgeons looking to fix pelvic organ prolapse have at their disposal two options: sacral colpopexy, the most commonly used procedure, which requires opening up the patient fully, introducing complications and increasing pain and recovery time; and a newer, less invasive natural orifice (transvaginal) approach.

The problem with the transvaginal approach? No device currently on the market can provide enough tissue retraction and visibility to perform it well—surgeons are stuck with old style retractors to move tissue out of the way. The retractors, essentially simple levers, are hard to use and don’t do their job particularly well. Even with the simultaneous use of multiple retractors and packed towels, the surgical workspace provided to the surgeon is still small, dark, and shallow; target structures are obstructed, and the lack of visibility and access impedes progress and affects success.

This team, developers of the Natural Orifice Volume Enlargement (NOVEL) device, is filling the need for a better transvaginal surgery tool. The design is based on two components: a reusable handle and blade system made of stainless steel and a disposable membrane placed over the blade system comprised of biocompatible elastomer. When deployed, the device, which looks like a large pair of scissors connected by a smooth steel tube, locks into place and provides constant support to soft tissues while being self-retained in the patient. Surgical workspace is greatly increased, making a newer, better procedure more feasible than before.

Mary Beth Privitera, a faculty member in the Medical Device Innovation and Entrepreneurship Program at the University of Cincinnati where the device got its start, said that the novelty of the device “is that it’s a one-person device. Most of the devices available today need an assistant to hold it and provide the actual retraction. This does it all in one. It enables the physician to have complete control over it.”

One unique aspect of the project, according to Privitera, is that UC faculty requested at least a few female team members on it from the very beginning. Said Privitera: “Normally we don’t specify whether we want men or women to work on these projects, but in this case we did. We made a big push to get women on the design team, and ended up with a female engineer and a female designer.”

The focus on female participation had a positive net influence on the project, according to Privitera. “It absolutely helped,” she said. “It gave the team balance. The product’s form and function are inherently tied together, so understanding the problem, understanding what it’s like to be a gynecology patient, was paramount to creating an appropriate solution.”

Since winning BMEidea funding, the device has been pulled back in-house by the company it was sourced from, Cincinnati-based medical device development company Device & Implant Innovations. Immediately after winning the competition, Privitera said the company “reigned it in and said, ‘This is great, now we need to make it real.’” They are moving the device forward with the idea that it could form the foundation of a completely new procedure.

And while the team has since dispersed, Privitera said that the project “was successful from the academic standpoint of meeting curricular goals and the experience the students had. Our clinical partner was extremely happy with the students’ work, and all in all it was one of the best possible experiences for the team and it provided value going forward.”

The BMEidea competition itself continues to up the ante on UC campus, according to Privitera. “BMEidea puts things in a different perspective. It elevates the student’s perspective—a lot the time you think you’re doing a good job and you hear from your faculty that you’re doing a good job, but to hear it nationally is tremendous from the students’ perspective.”

Lastly, much like many BMEidea winners in the past, Privitera has found that the competition lends credibility. In Privitera’s case, it helps her form connections at UC and beyond. “The competition has really assisted me in forming a new host of relationships for the entire program here,” she said. ”When we go to talk to new partners, they know that the students can actually do what we say they can do. And that’s invaluable.”
 

The 2005 BMEidea Winners: 1.5 years later

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.”

The 2007 BMEidea Winners: 1.5 years later

The third round of BMEidea competition winners featured technologies with the potential to revolutionize how we deliver vaccines, how we treat Parkinson's disease and how we repair peripheral nerve injuries. We caught up with the teams a year and a half after the competition to see what they were up to, how their projects were going, and how participating in the BMEidea competition influenced their careers.
 

First prize: Rotavirus Vaccination via Oral Thin Film Delivery, Johns Hopkins University 

A big part of innovation is thinking about problems in a different way. Changing your point of reference can lead to creativity, and creativity can lead to originality.

An example is the Rotavirus Vaccination team from Johns Hopkins University, winner of the 2007 BMEidea competition. Rotavirus, a disease that causes severe diarrhea and vomiting in children, kills 600,000 people in the developing world each year. While there is a vaccine for the disease, few children in the developing world end up getting it due to problems with cold chain storage: the vaccine has to be kept refrigerated, often an impossibility in rural areas where refrigeration is scarce. 

The innovative solution? Change the vaccine itself. While the liquid form of rotavirus vaccine requires refrigeration, the Johns Hopkins team is developing a dry form derived from thin film technology, similar to Listerine's quick-dissolving breath strips. The team's dissolvable strip is seeded with the vaccine, then coated with a special material to protect it in the child's stomach. That same coating disintegrates in the small intestine, releasing the vaccine, triggering an immune response and preventing future infection. All on a little strip that requires no refrigeration and is light and easy to ship.

The Rotavirus project began at Aridis Pharmaceuticals, a San Jose firm that invented a rotavirus vaccine stable at room temperatures. Aridis approached Johns Hopkins professor Hai-Quan Mao about coming up with a drug delivery vehicle for its novel vaccine. Mao brought the challenge to one of his undergraduate lab assistants, Chris Yu, who became co-leader of the team that tackled the project.

They faced several obstacles right out of the chute. For one, they couldn't copy the manufacturing process that Listerine uses to make breath strips, since the harsh solvents and high temperatures it requires ended up destroying the live vaccine. They also had to devise a protective coating that would remain intact when exposed to stomach acid but dissolve in the small intestine. Said Yu, "Our technology is geared toward delivering a live attenuated virus for a vaccine, not just freshening breath. We quickly found out that in order to get it to work, we'd need to take a different approach--use more advanced technology.

They got through the challenges with hard work and research. They developed a room-temperature production and drying process to fabricate the strips and identified an FDA-approved biocompatible polymer coating that would protect the vaccine in the stomach and release it in the small intestine.

Much more work remains before the vaccine is a finished product, however. Since winning BMEidea funding the team has continued research. And while most of the team has graduated and moved on, Yu is remaining on the project while pursuing his masters at Johns Hopkins. "Aridis is still very interested in the product, of course," said Yu. "They're very happy with our progress, and have hired a post-doc to work with me in the lab."

"The foundation of the system has already been laid: how we're going to deliver the vaccine to the small intestine, what kind of release profile it will have. Now we need to optimize the system. We need to optimize the film formulation, and ultimately add as many components as possible to make it easy to ship and make sure it's easy to use for inexperienced healthcare providers."

Yu is honest about the biggest benefit of winning the BMEidea competition: the money helps. "NCIIA has given us a lot of the financial backing for what we're doing. A lot of the components that are needed to formulate and test our design are actually quite expensive. We wouldn't be as far along as we are without the funding."

Beyond that, Yu says that participating in BMEidea gave him a better grasp of the business issues surrounding rotavirus. "Even though the rotavirus vaccine is abundant in the US, virtually none of it is making it to developing countries that need it," he said. "Science aside, the business end of this project--getting the vaccine into the hands of people who need it--is extremely important and will need to be addressed as soon as our prototype is ready to go."
 

Second prize: enLight: Enabling Life with Light, Stanford University

Parkinson's disease is a degenerative central nervous system disorder that causes a breakdown in muscle function and speech. The disease affects 1.5 million patients in the US alone--a number that will likely rise as the population ages--yet there remains no definitive treatment for PD. Current therapies run the gamut from drugs to surgery all the way to qigong, a traditional Chinese breathing exercise.

One of the most promising new approaches to treating PD is deep brain stimulation (DBS). Since a main factor involved in causing Parkinson's is the insufficient formation and action of dopamine, DBS involves placing an electrode deep within the brain to stimulate the parts of the brain responsible for dopamine production. DBS has been shown to alleviate some of the motor tremors in Parkinson's patients and can lead to an improvement in quality of life. 

The drawback? DBS is only effective in a very small percentage of PD patients (~5%) because electrode-based stimulation is highly nonspecific. During DBS, many more brain cells other than those responsible for PD pathology are stimulated, which can lead to a number of severe side effects including apathy, hallucinations, compulsive gambling, hypersexuality, cognitive dysfunction and depression. Clearly there is a need for a better device--one that can specifically target only the neurons involved in PD, lessening the side effects.

This Stanford University team, winner of second place in the 2007 BMEidea competition, believes it's found the solution. The team is developing enLight, a remarkably forward-thinking, novel treatment for PD that enables the effective and reliable control of neural activity using light.

Here's how it works: instead of implanting an electrode, the team implants a thin optic fiber in the brain. Then, using gene therapy techniques, they introduce a genetically coded protein that makes the neurons specifically involved in Parkinson's sensitive to light. The optic fiber shines light into the right region of the brain, and voila, only the neurons associated with Parkinson's are activated. The ability to directly and specifically control neurons represents a major step forward and has the potential to revolutionize the field.

It all started with algae--or, more specifically, the algae-related lab work of Feng Zhang, a graduate student at Stanford. "When I first joined the lab in January 2005," says Zhang, "I started working on technology that would allow you to take protein from green algae and transfer it to neurons to make them light sensitive. Algae have light-sensitive neurons that they use to find sunlight for photosynthesis; by transferring this algal protein into animal neurons we figured we would be able to very precisely control neural firing."

Zhang was right. After establishing the validity of the technology, his team started developing genetic techniques that would allow them introduce the protein into specific neurons. They do this through lentiviruses, a genus of viruses that can deliver a significant amount of genetic information into the DNA of a host cell. Thus the biological basis of the technology was formed.

Soon enough they began to think about ways to use the technology for therapeutic purposes, and hit upon Parkinson's as the most likely first target. "We looked into diseases that could be treated using our approach, and, largely because of the body of research that has already been formed on Parkinson's and deep brain stimulation, we chose Parkinson's."

The team has made solid progress since winning BMEidea funding, filing several patents and moving toward pre-clinical animal testing. According to Zhang, the next steps are getting the biological reagent produced and ramping up to clinical trials. On the device side, refinements need to be made to the optical fiber "to make sure we're bringing in enough light, but not too much light. It's a tough technical challenge."

Other challenges involve finding the right animal model to use for testing, and making sure their virus doesn't cause damage to the brain--that it infects the right neurons. But despite all the obstacles to overcome, Zhang sees this product hitting the market in five to eight years, and making a big impact.

As far as the impact of winning BMEidea is concerned, Zhang strikes a familiar chord: winning gave his project credibility. "First of all it gave us validation--maybe our idea isn't so crazy after all!" he said. "Plus the events that we've attended as a result of winning BMEidea have been very helpful. I've been able to network with people who work in the medical device industry and gotten insight on basic things, like how to think about medical devices, how to manufacture a device, etc. They were very helpful."
 

Third prize: Bioactive Nanopatterned Grafts for Nerve Regeneration, University of California, Berkeley

Peripheral nerves are the extensive network of nerves outside the brain and spinal cord. Like static on a telephone line, peripheral nerve injuries distort or interrupt the messages between the brain and the rest of the body, affecting a person's ability to move or feel normal sensations. This is a common problem affecting about 800,000 Americans each year.

The gold standard approach to fixing it is the nerve autograft--removing a segment of nerve from one part of the body and suturing it in place at the site of injury. While this is effective in some cases, the approach comes with a number of risks and drawbacks: the donor nerves tend to be small, usually requiring the doctor to stack a bunch of them together to make an implantable graft; two invasive surgeries are required, one for harvesting the donor nerves and one for implanting them; sometimes the graft simply doesn't work; some patients don't have any nerves suitable for donation; and the donor site can react badly, causing more pain than the nerve injury itself.

A different approach to the problem gaining in popularity is the world of synthetic grafts. Made of various polymers wrapped into a sturdy tube shape, a handful of grafts are currently on the market. But the current designs come with limitations as well: none can outperform the nerve autograft in clinical trials, they don't provide cues for regeneration the way a normal nerve would, and they can't bridge gaps longer than four centimeters. There is a clinical need for a synthetic graft that better mimics the nerve autograft and has the ability to regenerate damaged nerves of all sizes, and this UC Berkeley team is looking to provide it.

The team, winner of third place in the 2007 BMEidea competition and now incorporated as NanoNerve, is developing a novel synthetic graft that enhances and guides nerve regeneration across a range of peripheral nerve injuries. The tubular graft is composed entirely of nanoscale polymer fibers loaded with bioactive molecules that provide growth cues for regenerating. The technology is also capable of spanning large gaps.

Altogether, this makes a product that is "simply better than what's out there," according to team leader Shyam Patel. "We can heal longer nerve injuries, we can provide growth cues, and we'll be proving that through human trials taking place next year."

The key to the technology has to do with how the grafts are fabricated. The most common method of fabricating polymer nanofibers is to use an electrical field to "spin" very thin fibers. This technique, called electrospinning, can be used to make nanofiber scaffolds in various shapes. The key innovation allows the team to fabricate grafts composed entirely of nanofibers aligned along the length of the tubes, allowing for customization of the length, diameter and thickness of the grafts. Combine that innovation with a way to make the nanofibers bioactive by attaching chemicals directly to the surface, and you've got a technology that mimics the nerve autograft by providing both physical and biochemical cues to direct nerve growth.

Armed with a potential breakthrough technology, things are moving quickly for NanoNerve. After graduating from Berkeley, Patel and a handful of others licensed the technology from the university and formed the company around it. They're currently in the development phase of the product, but according to Patel they're "actually very far along in the process. We hope to file for FDA 510k clearance by the end of the year, which will allow us to start marketing the product in 2009."

Assuming all goes well in human clinical trials, Patel sees NanoNerve taking off. "We'll be able to sell the product as something that is functionally better than what's currently available, something that will serve as an effective alternative to the autograft. Our technology takes full advantage of the fact that the shortest distance between damaged nerve endings is a straight line. It directs straightforward nerve growth and never lets them stray from the fast lane."

NanoNerve may very well be in the fast lane itself. And according to Patel, participating in the BMEidea competition has helped put it there. "The press and publicity as a result of winning third in BMEidea was very helpful in terms of getting the word out about what we're doing," he said. "It's helped the company since it shows that the project has scientific merit, shows that is has value to the medical community. It's helped us impress the people we've been talking to about it and has definitely validated what we're trying to do."