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."
The 2008 BMEidea winners are looking to make medicine cheaper and more efficient—and save lives in the process—with a new baby monitoring tool, a better pain killer delivery platform and a simple device that makes the closing of surgical incisions easier. So where are the winners now? How far down the road have their projects come a year and half after the competition? We talked with the teams recently to find out.
First prize: Rapid Suture, Stanford University
Laparoscopic surgery is a relatively new technique in which small incisions are made in the abdomen and surgical instruments are passed through, allowing for smaller wounds, quicker recovery times and shorter hospital stays. In a typical laparoscopic procedure, two to five “trocars,” or access ports, are inserted into the abdomen and act as a passageway for surgical instruments. The trocars leave 10-12mm openings through all the tissue layers, and at the end of the procedure the surgeon is faced with the challenge of closing the incision sites.
There are two popular methods of closing the sites: the J needle and the Carter-Thomason closure device. The J needle resembles a fish hook and has to be angled so that it catches only the fascia (soft connective tissue) and none of the skin. Not an easy task, but even if a site is successfully sutured the J needle still has to be removed without puncturing any tissue on the way up and out, a time-consuming process that relies entirely on visualization and tactile feel.
The Carter-Thomason device involves sharp downward-pointing needles that enter the abdomen in order to perform the suture. This method can be dangerous, however, possibly leading to punctured bowels and damage to blood vessels.
The first-prize-winning team in the 2008 BMEidea competition came up with a solution to these problems with Rapid Suture, a small, inexpensive device that allows for quick, safe, and easy suturing during laparoscopic procedures. The unique solution is a small device with housed needles that allows for all critical tissue layers to be sutured except for the skin, which heals naturally. Since the device is simple and easy to use, it has a short learning curve relative to the current approaches, and since it lacks sharp needles pointing toward the bowels, the risk of trauma is minimized. It also makes suturing faster, reducing the amount of time the patient is under anesthesia and thereby cutting operating room costs.
The Rapid Suture project got its start in a class called Medical Device Design at Stanford. Team members Ellis Garai, Sumona Nag and others took the course in the fall of 2007 and, according to Nag, worked through the initial technical aspect of what an improved suturing device would look like. “By the end of the seven-week course we had worked through the first phase of the technical aspect and filed for a provisional patent.”
Sensing commercial promise, the team decided to stay together after the course ended and continue working on Rapid Suture. “We’ve been refining the design and working on the business end of the project, all on our own time,” Garai said.
They’ve made solid progress, having formally incorporated and working now on the third iteration of the device. They’ve also done market research, sending out a questionnaire to a number of different physicians to get as much feedback on the device as they can. They've retained prominent legal counsel to help secure their IP.
They’re now hoping to start FDA trials next year and, depending on how the trials go, apply for FDA approval and move toward a limited product release. Sumona and others will be “looking to do a lot of R&D over the summer—remaining on the project after graduation.”
While the future of Rapid Suture seems bright, the BMEidea competition provided the team with a little stimulus to push the project toward something real. Said Nag: “BMEidea really helped us, especially in the beginning. We didn’t have much experience writing business plans, so applying for BMEidea was a good stepping-stone, a good way to get us thinking about it. And after the competition, we used the material we wrote for BMEidea to finalize a full business plan. It helped push us along the path toward a full venture as opposed to just a technology idea.”
Second prize: KMC ApneAlert, Northwestern University
Premature infants have a number of special needs that make them different from full-term infants: they need warmth (since they lack the body fat necessary to maintain their temperature), special nutrition (their digestive systems are immature), and protection from a slew of potential health problems, from infection to respiratory illness to anemia. To take care of all these needs, preemies often begin their lives in an incubator, which keeps the baby warm with radiant light and guards against trouble with a number of complex monitoring systems.
The problem? Incubators are extremely expensive, making them very hard to come by in the developing world.
What do you do with a preemie when you don’t have access to an incubator? One low-cost alternative gaining in popularity is kangaroo mother care (KMC), a technique in which the infant is kept in a frog-like position on the mother’s chest at all times, keeping the baby warm and allowing the mother to monitor the infant for signs of trouble. KMC has been shown to be an effective alternative to incubator care, but one problem still remains: apnea.
Apnea, a common health problem among premature babies, occurs when a baby stops breathing, the heart rate decreases, and the skin turns pale, purplish, or blue. Apnea is usually caused by immaturity in the area of the brain that controls the drive to breathe, and a long apnea episode can result in neurological problems or even death.
While a mother doing KMC can sense an apnea episode and shift the baby when awake, premature infants remain at risk while the mother herself is sleeping and unable to detect an apnea episode. And although there are plenty of apnea detectors on the market, none are designed to work with the KMC system.
Enter the team from Northwestern. Winners of second place in the 2008 BMEidea competition, the team is looking to fill the void in the market by developing the KMC ApneAlert, a low-cost, KMC-compatible apnea detection system. The device, essentially a flexible patch, detects apnea by monitoring the typical abdominal movements of a premature infant while breathing. If there is no breathing for a stretch of time, the device sets off an alarm, waking the mother. The patch is attached to the baby’s abdomen using a gentle, double-sided adhesive pad.
The KMC project got its start in Northwestern’s senior design project course. NU’s biomedical engineering department has strong relationships with South African universities and hospitals, and according to team member Lauren Hart Smith, South African nurses and engineers came to NU and explained the need for a KMC-compatible apnea monitor. Said Smith: “They came to us and asked to have Northwestern students work on a device, so from the beginning we’ve had a general definition of the problem.”
Several teams worked on iterations of the device over the course of several classes. Smith’s team then “took their work and went into greater depth—took it in a different direction.”
Recognition followed. They won 2nd prize in the BMEidea competition, 2nd prize in the senior design project competition at Northwestern, won NCIIA E-Team grant funding, and were finalists in the CIMIT competition.
Although the team was comprised mostly seniors who have gone on to graduate, the project is moving forward under the direction of Smith and current team leader Kurt Qing. “We’ve been working on two fronts,” said Smith. “We have a team in Chicago working on prototyping and team working in the field in South Africa, our initial target market. We’ve modified the device, updated the circuitry, and reassessed some of the requirements for the design.”
They’re also taking steps toward commercialization, working with a businessman in South Africa who developed a SIDS-related commercial device. He’s helping the team develop a business model that makes sense for the developing world.
As far as the impact of the BMEidea competition is concerned, Smith says it broadened the team’s perspective and made them take into account all aspects of the project. “First of all, just thinking about submitting the BMEidea application itself made us think about all the different components of the project: how to build and market a medical device from start to finish. We engineers can have lofty ideas, and say, ‘This can work—how cool would that be?’ but we don’t always think about the logistics: how am I going to market this? Is it feasible? What are the regulations? Those are the things that the BMEidea competition stresses. It’s very helpful to think about the project in its entirety, from prototype to commercial product.”
Third prize: REGEN: Local Delivery of Post-Operative Analgesia, Johns Hopkins University
Minimally invasive surgery is a rapidly growing alternative approach to traditional surgery, and it’s not hard to understand why: the smaller the cuts, the better. Patients recover faster, have smaller surgical scars, and experience less post-operative pain.
There is still some post-operative pain, of course, the bulk of it located right at the multiple incision sites that surgeons make during laparoscopic (minimally invasive) procedures. As a result, 80% of laparoscopy patients require painkillers to mitigate the effects. These systemic narcotics (Vicodin, OxyContin and the like) have a number of side effects, none of them good: cognitive impairment, nausea, dizziness, itching, constipation and more.
The REGEN team from Johns Hopkins is looking to take the painkillers out of the equation and make laparoscopic surgery that much more efficient in the process. They have designed, developed, and tested an implantable receptacle that allows analgesic to diffuse out at a controlled and sustained rate directly at the site of the incision. By delivering pain medicine right to the site, the device relieves pain without the need for narcotics. No oral pills, no nasty side effects.
The REGEN project got its start in Johns Hopkins’ design program. As seniors in 2007, Dhanya Rangaraj and Henry Chang started looking around for a design project and found a solid sponsor—Malcolm Lloyd, an alumni of the Johns Hopkins Biomedical Engineering program, doctor, and serial entrepreneur with his hands in a number of startups. Lloyd had already identified the clinical need for a device like REGEN, and the team worked with him to help refine the idea and narrow it down. They then built their team from a list of students interested in the program, and made sure to involve people with a variety of skill sets. “Part of the process of design is designing your team to make sure you get maximum efficiency,” said Chang. “You pick people with different backgrounds and different skills and combine them together to create a unit that works together well.”
And the team did perform well, although they encountered some resistance along the way both in terms of device development and external issues. “The design program at Johns Hopkins isn’t designed to encourage materials science projects,” said Rangaraj. “The program is formed more around assessing a mechanical design, so we were somewhat of an outlier in the group. It was hard to get resources and we weren’t working directly out of a lab.”
Then there were design challenges. “We looked at the problem from a number of different angles,” said Chang, “and came up with different solutions. Our initial solution ended up not working, and the final design turned out to be significantly different. But that’s one of the normal challenges of any design process.”
And of course the other challenge was handling a team of nine students. “That’s a skill you have to develop and learn,” said Chang. “About half the problems we faced were related to dealing with people, whether part of the team or outside it—students, doctors, surgeons, businessmen.”
But the team worked through the challenges, eventually creating a working prototype with positive clinical results and taking third prize in the BMEidea competition. They went on to license the technology to Dr. Lloyd; it’s currently under development in Dr. Lloyd’s company, Device Evolutions.
Neither of the team leaders is still on the project, with Rangaraj entering the biomedical device industry after graduation and Chang pursuing an MD PhD. Nevertheless, they both believe that participating in BMEidea was worthwhile and changed their professional outlooks. “Our project was much more of a clinical design challenge than anything else,” said Chang. “We were doing presentations and talking to doctors and engineers about the technical problem alone—there was no real focus on the business side of the equation. So one of the great things about being a part of BMEidea was that we had to shift our focus away from explaining the science behind our product and moving toward a business orientation—‘Why is this important? Why would people be interested in this?’ It gave us a different perspective on the project than we would’ve had otherwise.”
Said Rangaraj: “As an undergraduate majoring in engineering, the business side of my education was completely neglected. I really didn’t know much about the larger business picture. Submitting to BMEidea made me think about that side, which was very valuable. I found the experience incredibly educational.”
The 2009 cohort of BMEidea winners included two new diagnostic technologies and a surgical device, each designed to make healthcare more efficient, more effective, and less costly. We caught up with the winners a year after the competition to see where they're at, what progress they've made, and how winning the BMEidea competition has affected their projects.
First prize: Lab-on-a-Stick, Stanford University
It’s a situation most of us take for granted: if you go to the doctor for, say, a blood test, it’s going to take some time to get the results back. The sample is drawn, the doctor sends the sample to a lab, the lab runs the test and sends back the results. The entire process takes several days, if not more, and in the developing world (where labs can be distant or non-existent) it may not be an option at all.
Two Stanford doctoral students are looking to change all that. Richard Gaster and Drew Hall, winners of the 2009 BMEidea competition, are the creators of a technology that has the potential to test for disease any time and any place, without doctors, technicians or special lab equipment. The device, dubbed NanoLab (formerly Lab-on-a-Stick), is the size of a small paperback book and consists of an electronic circuit board, LEDs and a tiny well, just big enough to hold a few drops of blood from a pipette.
It works like this: the user adds a droplet of a sample (blood, saliva, urine, etc.) into the well, adds magnetic tags to label the viral proteins (making them detectable by the device’s nanosensors), and finally adds a protein solution containing disease antibodies. The tester hits start and, ten to fifteen minutes later, small green, orange and red lights illuminate, indicating which disease proteins were detected, and at what level. This is essentially miniaturizing a 250-pound electromagnet and desktop computer from a normal-sized lab into tiny wires that fit in the palm of your hand, and has the potential to become a disruptive technology in both developed and developing countries.1
The idea for the project came out of Gaster and Hall’s research. Gaster, a fourth-year MD and PhD candidate in bioengineering, and Hall, a fifth-year PhD student in electrical engineering, have been collaborating together for years on their research projects involving ultra-sensitive diagnostic lab equipment. But they hadn’t thought of bringing their research to a larger world until the BMEidea competition. According to Gaster, “When we heard about the BMEidea competition, it was a great gateway for us to say, ‘Let’s do something—let’s make a difference.’ We brainstormed potential projects that we could pursue with our expertise, and we realized that we could make an affordable device that could be useful to a lot more people than just those working in labs and research facilities like our own.”
Hall added, “We wanted to do something that could benefit humanity and be helpful on a large scale, not just to a small subset of people.”
Just submitting for BMEidea itself turned out to be something of a challenge, however, since Gaster and Hall started late in the application process and only had enough time for two phases of design. “That meant one opportunity for failure,” said Gaster. The first design they created was indeed a failure, but in the second round of design they fixed the problems, and the device worked. “It was fortunate that we’ve been working in this area in general,” said Hall. “We knew what the technical challenges would be, and it all worked out in the end.”
The team has had a series of successes since winning BMEidea, finalizing a utility patent on the device, winning a Gates Foundation grant to support development of the technology for point-of-care HIV/AIDS diagnosis in sub-Saharan Africa, winning first prize in the IEEE Presidents’ Change the World Competition, and making several technical advances to automate the device more than before—streamlining the process.
The team is just now getting into the thicket of commercializing the device, figuring out the business model they want to use to bring it to market. They’ve spoken with several companies regarding licensing, but they haven’t decided if licensing or creating a startup is the right path for them.
“We’re looking into all the different opportunities right now, as we speak,” said Hall. “We’re working on a business plan to figure out whether it’s financially feasible for us to turn this into a startup company or whether it’s better for us to license it to a bigger company with more resources. We haven’t decided yet what the best path is.”
In the meantime, Gaster and Hall are glad they applied for the BMEidea competition. Said Gaster: “Drew and I have always had an interest in developing our respective research projects for bigger causes, but we never had the motivation to actually do it. We’d always say, ‘Oh, wouldn’t this be cool, wouldn’t that be cool,’ and not pursue it. When we read about the BMEidea competition it motivated us to spend a lot of nights and weekends hammering out this idea, seeing if it was really feasible, and seeing if we had the capability to create a world-changing invention. It really gave us that motivation.”
“And, moving forward, having won the BMEidea competition, it gives us clout in the future when we’re presenting to venture capitalists or even for job applications. It shows that we have the ability to create an interesting idea that has a chance to make an impact on the world.”
Second prize: SurgiSIL, University of Cincinnati
Laparoscopic surgery is a relatively new technique in which small incisions are made in the abdomen and surgical instruments are passed through, allowing for smaller wounds, quicker recovery times and shorter hospital stays. In a typical laparoscopic procedure, two to five “trocars,” or access ports, are inserted into the abdomen and act as passageways for surgical instruments.
This team, winner of second place in the 2009 BMEidea competition, is looking to reduce the number of trocars to exactly one. Calling itself Single Port Solutions, the team is developing the SurgiSIL, a device that allows a surgeon to perform laparoscopy through one access point in the belly button. This single port approach reduces trauma even further, decreases recovery time, and eliminates visible scarring since the single incision is hidden away in the belly button.
Other single port devices are in development by other companies, but the team is achieving competitive differentiation in the SurgiSIL by increasing the range of motion available to the surgeon and by making the exchange of surgical instruments in and out of the SurgiSIL quicker and easier than anyone else.
The SurgiSIL project got its start when a general surgeon contacted Mary Beth Privitera, Assistant Professor of Biomedical Engineering at the University of Cincinnati, with a problem he wanted solved: creating a single-port access device for laparoscopy. The idea was plugged into the Medical Device Innovation and Entrepreneurship program at UC, in which a range of clinical problems in need of solutions is presented to students and they self-select the projects they want to participate in. Four students chose to work on the single-port access device: Michael Wirtz, Fath Kyle, Steve Haverkos and Miao Wang.
The team worked hard on the project, designing a device, forming a company and licensing the IP from the university (and winning second place in the BMEidea competition along the way). They were actively looking into licensing with several industry partners when they hit a roadblock: intellectual property. Said Privitera: “The biggest challenge in commercializing laparoscopy devices is IP. This area has major companies in it—large players that patent everything.”
The hitch was the SurgiSIL’s sealing mechanism. Patents in the area of laparoscopy have been around since the early 90’s, and the sealing mechanisms for the devices have a multitude of patents around them. “So while the SurgiSIL project isn’t shelved,” said Privitera, “it’s in a holding pattern until there’s a solution that’s more readily patentable around the sealing issue.”
IP issues aside, participating in the BMEidea competition was beneficial both to the team members and to the institution, according to Privitera. “The impact of the BMEidea competition was actually quite large,” she said. “Winning BMEidea was probably the biggest motivational factor for the team; it helped them gel, come together, and really hone in on a business plan and get it to a stage where licensing could even be considered.”
From a faculty standpoint, having SurgiSIL take second prize in the BMEidea competition has motivated this year’s teams to “up the ante a bit,” according to Privitera. “They’re looking at SurgiSIL and saying, ‘OK, they did it, they were creative, they worked together, they won this competition, and so can we.’ It’s really set a good example. Even though SurgiSIL isn’t on the market and being sold today, it has paved a path that other students are looking to go down.”
Third prize: A Novel Biosensor to Measure Vitamin D Levels in Serum, Brown University
A curious aspect of modern science is the seeming rise and fall of certain drugs, foods, vitamins, activities—even genes—depending on the latest research. One study will say one thing, a different study will contradict it, and a third will go in a different direction altogether.
A classic example is vitamin D. Nicknamed the “sunshine vitamin” because the skin makes it from ultraviolet rays, vitamin D interacts with over 2,000 genes (about 10% of the genome) in the human body. But for a long time the scientific consensus has been to avoid exposure to sunlight due to the threat of skin cancer.
Now some scientists are questioning that advice.
The reason is that vitamin D increasingly seems important for preventing and even treating many types of cancer. Studies have found it helps protect against lymphoma and cancers of the prostate, lung and, ironically, the skin.2 Research has implicated vitamin D deficiency as a major factor in the pathology of seventeen cancers, heart disease, stroke, hypertension, autoimmune diseases, diabetes, depression and more.
Vitamin D, therefore, is on an uptick. The demand for clinical testing of vitamin D levels is rising as well, and this Brown University team, winners of third prize in the 2009 BMEidea competition, is looking to capitalize by creating a vitamin D tester that’s cheap, easy to use and produces immediate results.
Current methods of vitamin D testing suffer from the same drawbacks as any other laboratory test: they’re expensive and take a long time (several days) to get the results. A take-home vitamin D test kit is on the market, but requires users to mail in a special blotting paper containing a few drops of their blood to a lab and wait even longer for the results—two to three weeks.
The Brown University team is instead measuring vitamin D using electrochemical detection technology similar to a commercial glucose meter. The user inserts into the hand-held device a disposable testing strip with a small blood sample on it; the sample is analyzed and the results are displayed qualitatively and quantitatively within minutes. No waiting for days, and the test is estimated to cost about half as much as a traditional vitamin D test performed in a laboratory.
It works not by measuring the actual amount of vitamin D in the blood sample, but rather by measuring how much current is used during catalysis of a certain enzymatic vitamin D precursor. Measuring how much current is drawn by the enzymatic activity correlates to the amount of vitamin D available.
The Brown team consists of Steve Rhieu and Vince Siu on the technology development side and Matt Doherty, Lei Yang, Moses Riner, and Michael Kreitzer on the business development side. The latter four students are from the Program in Innovation Management and Entrepreneurship (PRIME), a one-year management program at Brown in which students learn entrepreneurship and venture development skills, then take research from Brown laboratories and try to find commercial value in it. And they’ve been doing just that with the novel vitamin D biosensor, carefully building a compelling business case for the technology.
It hasn’t come without challenges. Their original business strategy was to sell the device as an off-the-shelf home-testing kit, but, according to Doherty, they “soon found out that wasn’t the best way to market it. People would have to prick themselves, which no one likes, and they wouldn’t necessarily be savvy about the way they implant the blood onto the testing strip.”
The team changed gears to market the device directly to doctors and physicians. Their plan now is to outsource the manufacturing and sales of the device itself and make a profit selling the disposable strips. Said Doherty, “That would be a continuous buy as opposed to people buying the device just once.”
Another challenge has simply been getting people aware of why they need vitamin D testing, not only in the general population but among doctors as well. “The product has real benefits,” said Kreitzer, “but one of the challenges has been finding individuals in the market who understand not only the value of vitamin D testing but the value of the product as well.”
The growth of vitamin D awareness, however, makes Kreitzer optimistic about the device’s future. “The good thing is that people are becoming more and more educated about vitamin D. Awareness is growing. More and more diseases are being linked to vitamin D deficiency, so as we progress the venture, so does the readiness of the market.”
The technology development is ongoing, with both Rhieu and Siu as part of the process. The device, which originated as part of Rhieu’s doctoral research, is being optimized as the team works toward a fully functional prototype. They published a preliminary study of their findings last July, which was well received, and Rhieu and Siu meet periodically with the PRIME students, “so we can continue to understand the point of view of healthcare personnel and physicians—understand the real need we need to meet,” said Rhieu.
As far as the experience of the BMEidea competition is concerned, both the technology development students and the business students found it valuable. Said Rhieu: “More than anything, it encouraged us to continue working on this project. It was good way to see the other aspects of the project as well; for example, I never thought this project would be significant for businesspeople; I never thought about figuring out how to actually sell a product. So it was good for me as a scientist to be exposed to that aspect of the project.”
According to Riner, the experience of figuring out how to commercialize a new technology has been valuable in and of itself. “It’s been a great experiential learning experience.”
Over the next year, the team plans on continuing development of the core technologies as well as marketing efforts.
1. From http://news.stanford.edu/news/2009/july22/nanolab-diagnostic-tool-072309.html
2. From http://www.usatoday.com/news/nation/2005-05-21-doctors-sunshine-good_x.htm
Open Minds is the annual showcase of the NCIIA's best student teams and their innovations. The exhibition takes place each year during Open, NCIIA's Annual Conference, and is an opportunity for the best student innovation teams from around the country to demonstrate their products and technologies.
The Open Minds 2011 public exhibition will be held at the Smithsonian National Museum of American History, Washington, D.C., on Saturday, March 26, 10:00 am-2:00 pm EST.
Working with D-Rev, a nonprofit technology incubator based in Palo Alto, the Enabling Effective Management of Neonatal Jaundice in Rural India team signed a licensing agreement with Chennai, India-based Phoenix Medical Systems Private Ltd for the manufacturing and distribution of Brilliance, a novel phototherapy device that enables the treatment of severe neonatal jaundice in low-resource hospitals.