Johns Hopkins University 'Rapid Hypothermia Induction Device' Team wins BMEidea 2010!
The winners of the 2010 BMEidea Awards were announced on June 11 at the Medical Design Excellence Awards ceremony in New York.
First place, winning $10,000:
Rapid Hypothermia Induction Device (RHID) (Johns Hopkins University) Improved advanced life support for cardiac arrest victims
Cardiac arrest is a leading cause of mortality and morbidity in the United States, with rates of full functional recovery as low as 4% to 7%. The only known treatment method to improving survival is the rapid induction and maintenance of therapeutic hypothermia (TH), to cool the brain. However, the average delay between the onset of cardiac arrest and the administering of hypothermia in hospitals is about six hours. There is currently a pressing clinical need for a device and method of administering TH in out-of-hospital settings so that this life-saving treatment can be initiated rapidly and safely.
The Johns Hopkins team has developed a device that emergency or ambulance personnel can use to rapidly administer a therapeutic hypothermia treatment to victims of cardiac arrest, to greatly improve their chances of survival upon reaching hospital.
RHID works on the principle of evaporative cooling. When water evaporates from the body, it carries with it a large amount of heat from the body, due to its high heat capacity. 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 humidityand low temperature, blood flow increases to the turbinate’s, 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 its surface, cooling the brain until the patient can be administered intensive care TH treatment at hospital.
A low-cost ventilator designed to treat acute respiratory distress patients in low-resource, pandemic and emergency environments
The recent H1N1 pandemic has ignited concern in the healthcare community over the state of preparedness of our nation's healthcare system in the event of a mass critical care emergency. If a 1918-like flu pandemic were to occur today, tens of millions of people could die from respiratory distress. Unfortunately, the US does not have enough ventilators to support patients with respiratory distress in even a mild flu pandemic, and it is currently cost-prohibitive to stockpile a sufficient quantity of these devices. When considered on a global scale, the disparity in pandemic resources between wealthy and impoverished nations is alarming. Many countries already face an extreme shortage of ventilators, even in the absence of a pandemic. For example, in the United States there are approximately 205,000 ventilators for a population of 300 million. In India, where the population exceeds 1.1 billion, there are only 35,000 intensive care ventilators available.The Stanford team has developed a portable, low cost ventilator ($300) designed for adult and pediatric respiratory distress patients. The device is designed to be easy to repair and intuitive enough for non-professionals to use.
Third place, winning $1,000:
Natural Orifice Volume Enlargement (NOVEL) Device (University of Cincinnati)
This team has developed a device to improve urogynecological procedures, by providing surgeons with better visibility and access to deep target tissues.
Pelvic organ prolapse is a physical condition in which the uterus and/or vaginal vault becomes detached from its normal position in the peritoneal cavity.Patients suffering from pelvic organ prolapse often experience pain, incontinence, recurrent infection, and even loss of sexual function. Pelvic organ prolapse affects over 6 million women worldwide, and most of these patients end up living with the condition due to limitations in prolapse repair surgery. Over 100,000 vaginal prolapse repair surgeries are conducted in the United States annually. These repair surgeries are typically open procedures with limited success and high post-operative revision rate.
Design: A Novel Device for Pacemaker Lead Anchorage, University of MI, Ann Arbor
Global Impact: MRAD - Malaria Retinopathy Automated Detector, Tulane University
Social Impact: Development of a Diagnostic Instrument for Early Pressure Ulcer Diagnosis, Carnegie Mellon University
Improved Eye Drop Applicator, Johns Hopkins University
CervoCheck: Preterm Labor Monitor, Johns Hopkins University
About BMEidea BMEidea is more than just a design competition, Student teams are judged on a complete commercialization strategy—product innovation, market need, regulatory pathway, sales strategy, economic issues. The teams' entries were evaluated by judges drawn from academia and industry. Winning entries must solve a clinical problem; meet technical, economic, legal, and regulatory requirements; feature novel and practical designs; and show potential for commercialization. Submissions are judged on technical feasibility, clinical utility, economic feasibility and market potential, novelty and patentability, potential for commercialization and benefit to quality of life and care.
Prizes include cash awards in the amount of $10,000 (first prize), $2,500 (second prize), and $1,000 (third prize), and product development and commercialization resources and training.
The material contained within this webpage is based in part upon work supported by the National Science Foundation under Grant #0602484. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.
Since 2005, the BMEidea competition has recognized innovative biomedical engineering design with high commercial potential and social impact. The competition is open to both graduate and undergraduate students (undergraduate-only teams may also enter BMEStart).
Strong BMEidea submissions define a problem and demonstrate the development of a device, product, or technology designed to solve it. Examples include but are not limited to: surgical devices, home health care devices, diagnostic, therapeutic, and preventative applications, rehabilitative and assistive technologies, or other innovations that will have a substantial impact on clinical care and patient outcomes.
Multidisciplinary teams are encouraged to apply and may include undergraduate students from diverse fields such as business, nursing, physical therapy, life sciences, physical sciences, or other related disciplines. Inter-institutional collaborations are also encouraged; in these cases we require a faculty advisor from each institution. Each team must include at least one engineering student.
BMEidea awards are presented each year at the MD&M East Medical Device Trade Show and Convention. Competition winners will receive cash awards ($10,000 first place, $5,000 second place, and $2,500 third place) as well as access to resources to be used for further development and commercialization of their products. They will also have the opportunity to present their designs and business plans to representatives of investor organizations. Cash prizes will be disbursed to each of the winning team's departments to be allocated at the discretion of the faculty advisor. In addition, the first place institution will get to display the impressive BMEidea trophy in their winning department for the year.
Team members have rights to all intellectual property, subject to the rules of their home institutions, unless assigned to others in exchange for support, sponsorship, or funding. Teams will be encouraged to retain a significant and motivating interest in their project results.
Competition registration and materials submission take place online via NCIIA’s competition tools. There is a limit of 3 entries per department within an academic institution;it is up to each department to coordinate which entries are submitted.
The BMEidea competition is sponsored by the National Collegiate Inventors and Innovators Alliance (NCIIA); Boston Scientific; MD&DI (Medical Device & Diagnostic Industry), a publication of Canon Communications LLC; and Industrial Designers Society of America (IDSA), in partnership with the Biomedical Engineering Society (BMES) and the Council of Chairs of Bioengineering and Biomedical Engineering Programs.
PLEASE NOTE: A faculty advisor must verify his/her support of this competition entry. Applicants will be prompted to verify the support of a faculty advisor in Step 3 of this online competition application tool. Please allow several days for the faculty advisor to respond. The application CANNOT be submitted without his/her support.
Graduate and undergraduate student teams at colleges and universities are eligible. Each team must include at least one engineering student. Teams are encouraged to incorporate members from diverse fields such as business, law, medicine, dentistry, nursing, physical therapy, life sciences, physical sciences, or other related disciplines. Projects should focus on a new health-related technology, be invented by students, and address a real clinical need.
There is a limit of 3 entries per department within an academic institution, and it is up to each department to coordinate which entries are submitted. Inter-institutional collaborations are also encouraged; we require a faculty advisor from each institution.
The NCIIA supports teams as they work toward commercialization of their inventions. Ownership of discoveries or inventions resulting from activities financed by NCIIA grant and/or competition prize funds will be governed by grantee institutions’ intellectual property policies. If a school does not have an intellectual property policy, then the institution must develop an agreement that establishes ownership of ideas resulting from student team work. The NCIIA takes no financial or ownership interest in the projects recognized by these competitions.
Please read and understand your institution’s Intellectual Property policy before submitting an application.
Submitting an entry to this competition for recognition of innovative design will necessitate public announcement of project summary, photos and/or videos for the 1st, 2nd and 3rd place winners, as well as any honorable mentions. Teams are advised to address intellectual property filings prior to submission and will be given one week from notification of award before the public announcement will be made.
All applications must be submitted online. Anyone on the team may serve as the applicant on a submission. ALL deadlines end at 11:59pm eastern time unless otherwise indicated.
To start, you’ll need to have an NCIIA account. Creating an account is easy, and anyone can do it. To access an existing account or to create a new one, click here. You may start, save, stop and return to your online proposal at anytime before submitting.
You may preview the online application here. PLEASE NOTE: this PDF includes screen shots of NCIIA's five-step proposal process. The proposal shown is an Advanced E-Team grant proposal, but steps for the BMEidea application are the same. This PDF is for preview purposes only.
Required Advisors Your Department Chair and your Faculty Advisor must verify their support of your competition application (verification for Faculty Advisor is waived if s/he is also the applicant). To ensure timely approval of your application by your institution, apprise your advisor of your intention to submit 3-4 weeks in advance of the deadline, and share your application with them prior to submission.
The proposal: Required and optional components
Required components The following documents are required as part of your BMEidea application and must be included in the following order, combined together in a single PDF:
1. Narrative (no more than 10 pages) 2. Key team member resumes (limit of three pages per resume)
Narrative description guidelines The narrative may not exceed 10 pages in length (double-spaced, 12 point font). Please include any images referenced in your narrative in the body of the narrative, NOT as appendices. Please prepare a narrative description that includes the following:
Executive summary (2 pages). An outline of the strategy for commercialization and opportunity statement. See below for additional details.
Description of the problem to be solved (no more than 1/2 page). What is the problem you have solved? What are the market and/or industry needs that you intend to address?
Project objective statement (no more than 1/2 page). How does your team intend to address the problem? How does your final design solve the problem?
Documentation of the final design (1 page). Be sure to include applicable standards and a risk analysis.
Prototype of the final design (1 page). Paste graphical representations and photographs in the document and, if available, provide a link to a video.
Proof that the design is functional and will solve the problem (1 page). Include test data, market research or pre-clinical/clinical trials.
Results of a patent search and/or search for prior art, assessment and patentability (1 page). Two excellent resources for this search are www.uspto.gov, and your institution's technology transfer office. Regarding marketplace competition, what is currently being used to solve the problem and/or what are the anticipated alternate methods that could be in competition with you in the future?
Anticipated regulatory pathway (510(k) vs. PMA, etc.) (1/2 page). Consider researching how the FDA has treated analogous devices.
Reimbursement (1/2 page). Do you expect your device to be reimbursable by Medicare/Medicaid? Why or why not?
Estimated manufacturing costs (1 page). Provide detailed per unit cost breakdown, including volume discount, for components, final assembly, quality assurance, etc.
Potential market (1 page). Who would your customers be (i.e., who will be purchasing the product) and who would the end users be (i.e., who would be using the product? If possible, quantify the number of potential users and the benefit they would receive from use of the product. Define the potential market size, selling price, and distribution channels.
What's in an Executive Summary? An executive summary summarizes all of the above and serves as a stand-alone justification for why this idea should be pursued. Be sure to address the essentials, including:
Problem: What is the problem you aim to solve?
Solution: How will you solve it?
Competition: What are alternate methods of solving the problem or anticipated methods that could be in competition with you in the future?
Differentiation: Why will people choose your solution over others?
Technical Feasibility: Have you done it and can it be done?
Regulatory and Reimbursement: What FDA approvals will be required? What Medicare/Medicaid strategy is needed?
Sales and Marketing: What is the estimated size of the market (with rationale)? Who is the buyer/customer/user? Who will they buy it from? At what pricing?
Additional (optional) supporting documents Up to five additional appendices may be included in your proposal and must be uploaded as one merged PDF. Appendices may include but are not limited to:
Letter(s) of support. Applicants are strongly encouraged to include at least one letter of support from an industry mentor and/or faculty advisor, if applicable, who has worked with the team, attesting to the quality of the work they have done.
Any data collected as part of testing your technology
Any other relevant supporting materials
Note: Sheer volume of material is not an asset. Reviewers are directed to use supporting materials only to supplement the 10-page narrative. Therefore, key information should included in the narrative.
Weblinks and/or videos In addition to the appendices mentioned above, teams may upload no more than four weblinks, which may include online articles, videos and/or other relevant online data.
You are encouraged to submit a brief video pitch about your innovation. A link to the video may be added as an appendix item. These product demonstration and/or video pitches will help judges differentiate between the team's idea and those presented in other submissions. We recommend keeping the video to 60 seconds or less. State the problem, the innovation, why it is better than what currently exists, and the impact of the team's solution. Please submit this as a link on YouTube or a similar web-accessible site. NCIIA reserves the right to use submitted videos for public promotional purposes (on its website, in promotions for future BMEidea competitions). Videos should not contain proprietary information about the innovation. It is the team's responsibility to ensure the video is appropriate for public use.
Submitted applications are reviewed by external panels of reviewers made up of individuals from academia, industry, nonprofits & NGOs, and venture capital with experience in the technology areas and in the commercialization of early stage innovations.
NCIIA notifies applicants of the status of their submissions via email within 90 days of the submission deadline.
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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 that 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."
First prize: Nanografts, University of California, Berkeley
With over 500,000 performed each year, coronary artery bypass surgery is the default procedure for people with severe heart disease. But the surgery, in which doctors remove a healthy blood vessel from the patient’s arm or leg and use it to build a detour around a blocked artery in the heart, isn’t without its drawbacks: 50% of vein grafts fail in 5-10 years, the surgery to harvest the vein is expensive and invasive, and some patients have veins that simply aren’t strong enough to act as a coronary bypass graft.
Synthetic grafts have long held promise as a way to improve on the vein graft, but have yet to be widely implemented. The biggest reason? They’re too big. The smallest currently possible diameter for a successful synthetic graft is around 5mm—too large to replace most coronary arteries, which range from 2-6mm. Additionally, many of today’s synthetic grafts are made from foreign materials that can be rejected by the body’s immune system, rendering them ineffective. It all adds up to a problem; or, looked at another way, an opportunity for innovation.
Craig Hashi is the innovator. The Berkeley bioengineering Ph.D. student, leader of the Nanografts team that grabbed first place in the 2006 BMEidea competition, has come up with a novel approach to synthetic grafts. He creates sheets made from polymer nanofibers, then seeds the sheets with the patient’s own bone marrow stem cells. The stem cells allow the sheets to mimic the native blood vessel tissue, reducing the risk of being rejected, and the nanofibers allow the building of grafts as small as .7mm in diameter. After letting the cells grow for a couple of days, the sheets are rolled into a tube, similar to the shape of an artery. Once implanted, the nanofiber tube degrades, leaving a fully functioning blood vessel.
Sound clean and simple? Not so much. Although Nanografts has certainly made progress since winning BMEidea funding, continuing their lab research and talking with venture capitalists, the biggest challenge remains the technology itself. This is radical stuff—giving the body the capability to grow wholly new veins—and will take time to develop. Says Hashi, “Right now, the biggest challenge we face is getting the technology to work—understanding what’s really going on with it. I’ve been finishing up a paper on the project, but we want to make sure we’re confident about the technology before we present something to the research community—we want to be able to show exactly how these stem cells work and what they do.”
Beyond the technical challenges, there are problems with using stem cells themselves. Due to the surgery timeline (the patient may not be able to wait several days for stem cells to grow), potential cost factors, and strict FDA regulations, the team believes moving away from a stem cell-based approach for the moment gives them the best shot at commercialization. “We understand that in order to commercialize this in the near future we’ll have to steer away from cell-based therapy,” says Hashi. “Adding stem cells is an extra step that slows down the implantation process, to say nothing of regulatory issues. But if you have a synthetic graft that’s readily available off-the-shelf, the surgeon can use it right away and implant it directly.”
Although the science is still in the early stages, Hashi has a plan for how to commercialize Nanografts. “Ideally, we’ll start with some small seed rounds, about 150-200k,” he says. “We’ll work six to nine months with that, and then hopefully talk to some more VCs, get a term sheet, and get in contact with people that can provide us with more corporate experience, more managerial direction. From there we take it to market.”
Participating in the BMEidea competition has given Hashi a way to connect with those VCs. “Getting national exposure as a result of winning the competition has gotten us a lot of attention that we wouldn’t have received otherwise,” says Hashi. “It really gives me credibility when I walk into a VC’s office. I can say, ‘I just won BMEidea, a national biomedical design competition. My team went through a rigorous competitive process and we were fortunate to win first place.’ It gives me not only confidence and credibility but a great way to begin the conversation.”
Update: The team, now incorporated as Nanovasc, received $4.7 million in venture capital funding in 2008.
Second prize (tie): UltraMed Ultrasound, Pennsylvania State University
Cancer experts believe that early detection is the best way to prevent the disease from turning fatal. Yet despite great advances in cancer research, early detection remains a significant challenge and mortality is still high—in 2006, cancer accounted for 25% of all illness-related deaths.
This Penn State team hopes to bring that number down with UltraMed Ultrasound, an improved ultrasound technology that makes the early detection of cancer easier.
The team, led by materials science PhD student Ioanna Mina and her professor, Susan Trolier-McKinstry, is concentrating initially on the early detection and diagnosis of breast cancer, particularly in women with high breast density. At present, doctors do not use ultrasound for routine breast cancer screening due to a high rate of false-positives (the machine detects cancer when in fact there is none). Mammography is the most popular breast cancer screening procedure, but comes with a major drawback: it fails to produce reliable results for women with dense breast tissue. Using mammography alone, only 55% of women with dense breast tissue and breast cancer are actually found to have the disease, meaning that almost half of all cases slip by undetected.
UltraMed will be able to detect cancer in those types of tissue by upping the ultrasound frequency, which in turn increases the image resolution. Current ultrasound transducers (the part that generates the sound) operate at a frequency of 1-16 MHz; the team’s new transducer will operate between 50 MHz and 1 GHz. At such high resolution, individual cells will be able to be distinguished as benign or cancerous no matter how dense the breast tissue, making early detection possible.
Like many BMEidea projects, this is complex (and promising) technology that will take time to develop. Since winning funding, the team has concentrated on developing a prototype of the transducer array, as well as designing and fabricating second-generation electronic systems for the device. According to Trolier-McKinstry, they are now in the process of testing those systems.
As far as commercialization is concerned, Trolier-McKinstry and Mina are working with Penn State to investigate establishing a start-up company in the area. The company would provide both a means of generating funding for research as well as a vehicle to commercialize the results. The business plan that the team developed for the BMEidea competition is being used as part of the basis for Penn State’s decision. A patent application on the technology was submitted in early May.
Prototype development and commercialization efforts aside, Trolier-McKinstry believes the BMEidea experience has thus far been educational. “As a professor,” she says, “it’s been a great learning experience for me. It’s also given Ioanna a chance to explore beyond the typical the typical bounds of a graduate student in the field of engineering.”
Mina agrees. “Participating in this competition and attending the NCIIA conference has, more than anything else, put me in contact with a lot of different people with a lot of different perspectives,” she says. “Through them I’ve been able to step back from the project a little and see how important this device really is—how important it is to commercialize it.”
Second prize: AnemiCAM, Brown University
Anemia, a pathological deficiency in hemoglobin, the oxygen-carrying component of the blood, can cause fatigue, organ dysfunction, poor pregnancy outcomes and, in children, can impair growth and motor and mental development. While the disease affects an estimated 3.5 million Americans, it is an epidemic in the developing world, affecting 50% of the population in some countries. Although easily diagnosable with a simple blood test and highly treatable thereafter, screening for anemia is a significant challenge in the developing world because physicians often lack the necessary laboratory infrastructure for blood testing—and even in areas with the right facilities, needle reuse is a serious problem.
The AnemiCAM team is looking to change all that. Winners of second place in the 2006 BMEidea competition, AnemiCAM is a simple, handheld device that enables physicians to quickly and non-invasively assess hemoglobin levels in the blood. No more needles, no more risk. And the device can be manufactured for less than $100.
AnemiCAM is based on simple principles. To do a quick anemia check, doctors typically pull down a patient’s lower eyelid and check the conjunctiva, the tissue that covers the front of the eye and lines the inside of the lid. If the tissue is pale, hemoglobin levels in red blood cells may be low, indicating anemia.
But this check isn’t definitive; accurate diagnosis still requires a blood test. Using a white LED, proprietary liquid crystal technology, photodetector, battery pack, and simple processing microchip, AnemiCAM examines the conjunctiva spectroscopically, allowing diagnosis to be made in less than ten seconds and with an estimated 95% accuracy when compared with needle-based blood tests.
The AnemiCAM team has made big strides since winning BMEidea (and NCIIA Advanced E-Team grant) funding a year ago. They have developed a second-generation prototype, performed a clinical trial, and will publish the results shortly. In 2006 they founded Corum Medical, a company built around the product, and on January 1, 2007 signed a license agreement with Brown to manufacture and sell AnemiCAM.
According to team leader, graduate student in BME and Corum co-founder John McMurdy, there are two main areas of concern for the team right now: getting the prototype ready, and getting further funding. As far as the technology is concerned, McMurdy says they are “working on getting the second prototype cut down to size. Our current prototype cost about $2,000; the next prototype, using our proprietary liquid crystal technology, will see a huge reduction in price and size, to about the size of an iPod shuffle.”
Other concerns for the prototype include power management (making sure the battery is long-lasting and doesn’t have to be replaced often), and making sure the device is easy to use, requiring little-to-no technician training.
The team is also making strides in its initial target market of Nigeria, employing an African trade consultant and a handful of PR people. “Right now we have two people in Lagos, Nigeria,” says McMurdy. “They’re talking to doctors, getting exposure for the device, collecting information, and generating word-of-mouth interest.”
And what has been the response to the device so far?
“Overwhelmingly positive,” says McMurdy. “Most people say that the device would be incredibly useful—but only at a certain price point. Our main focus is on making it affordable. We have to hit a certain price point before the device can have a widespread impact in our target markets.”
The team is actively pursuing funding, meeting with angel groups and venture capital firms. “We’ve had several follow-up meetings so far,” says McMurdy. “There is definitely a lot of interest around the device.”
In the meantime, BMEidea and Advanced E-Team funding has been, according to McMurdy, “absolutely crucial” for AnemiCAM. “[BMEidea and E-Team] support has helped us continue moving the project forward before getting the major angel or VC funding. It’s helped us bridge the gap between having little-to-no funding and significant seed money. Without that extra help, the engineering would not be moving forward right now.”
Update: Corum Medical won SBIR Phase I funding in 2008, as well as $25,000 from the Charles E. Culpeper Biomedical Initiative Pilot Program.
Third prize: Robopsy, Massachusetts Institute of Technology
The Robopsy team is making an inefficient process much more efficient.
A typical lung biopsy today takes two hours to complete, with doctors using a CT scan to find a suspect mass in a patient, inserting the needle, and taking a sample. The problem is that the doctor can’t be in the room during the scan due to radiation; instead, they watch the scan through a computer monitor and then return to the room to find the right spot for the biopsy manually. As the needle is gradually inserted, the doctor and support staff continually shuttle between the radiation-shielded control room (during scanning) and the CT room (when manipulating the needle), moving the patient in and out of the CT machine again and again.
A little invention that could simplify the process is Robopsy, a lightweight, disposable, dome-shaped device that holds a biopsy needle and sits on a patient's chest during a CT scan. Sitting in the CT room, the doctor uses a laptop to manipulate the needle remotely, putting an end to shuffling between rooms and guesstimating where the needle should go. The team believes Robopsy will not only cut down on procedure time, but also give doctors the ability to target very small lesions (~5mm) that cannot be targeted by hand, and reduce instances of pneumothorax (partial or full lung collapse) caused by missed punctures.
The team has made good progress since winning third place in the BMEidea competition. The two main team members, MIT mechanical engineering graduate students Conor Walsh and Nevan Hanumara, have dedicated themselves full time to the project. After nailing down the design specifications, they’ve started testing the device using CT machines at Massachusetts General Hospital.
They’ve also found other sources of funding, including $5,000 from the Boeing Prize at the 2005 MIT IDEAS competition and $4,000 from the Cambridge-based Center for the Integration of Medicine and Innovative Technology. In an exciting development, the team took first place in the MIT 100k Business Plan Competition, securing $30,000 for business development.
Challenges still remain, involving both the technical and business aspects of the project. Says Hanumara, “As far as the product itself goes, we’re designing a disposable robot as opposed to a more expensive, more durable one that would be retained from procedure to procedure. From one point of view it seems that designing a disposable robot is quite simple—if you’re throwing it out, why put a lot of care into the design? But we’ve discovered it’s actually much more difficult than that: you have to make sure it’s 100% reliable, just over a short period of time. So the mechanical design has been surprisingly challenging.”
For Walsh, the business end of the project has its own challenges. “We’re trying to hash out the best commercialization plan possible for the device,” he says. “We know it’s a valuable medical device that can improve patient care, but we also have to figure out the value proposition. We have to determine exactly how much time the device is going to save, and how much hospitals are willing to pay for that improvement.”
But while challenges still lie ahead, Walsh and Hanumara believe they have already benefited from taking part in the BMEidea competition. According to Walsh, the competition was “a great match for both of our interests. It’s definitely given us a platform to build on. I think the great thing about the competition is that it allowed us to gather our thoughts and put them into a coherent document. We were lucky enough to be recognized for that when we took third. And when other people see that we’ve been recognized, it makes a great stepping stone for meeting people.”
Hanumara echoes Walsh’s sentiments. “I thought that just going through the application process—just submitting to the contest—was very worthwhile. I know there were only thirty entries to BMEidea in 2006, which doesn’t sound like a lot, but that’s because the requirements are very strict. You really need to have your ducks in a row before submitting to BMEidea. Sitting down and thinking everything through beforehand was valuable in itself.”
Update: Robopsy went on to win first place in the 2008 ASME Innovation Showcase, a Massachusetts Technology Technology Transfer Consortium Award, and first place in the MIT MechE Excellence in Medical Device Design Prize.
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.”
First prize: A Novel Treatment for Cerebral Aneurysm
- Stanford University
Fifteen thousand people die in the US each year from ruptured brain aneurysms, and many have to choose between the risks of treatment or of rupture. The Embolune, a microporous balloon device, reduces the risk of treatment. The MedGen team has developed a novel method to safely deposit a hardening polymer material into the aneurysm space, creating a permanent clot that prevents the aneurysm from further growth.
Second prize: Bioimpedance Probe to Detect Preterm Labor
- Johns Hopkins University
Premature birth is the major determinant of long-term health problems in children. This team has designed a bioimpedance probe that measures subtle changes in cervical hydration, enabling accurate, tissue-level analysis toe predict the onset of preterm labor.
Third prize: The Halo-Pack: A Low-profile Cervical Spine Orthosis
- Washington University
The Halo device immobilizes a patient’s head, allowing the cervical spine to heal after a fracture or a surgery—its design has remained essentially unchanged for 45 years. This team’s novel Halo design significantly reduces the profile of the apparatus and allows for easier access to the head and neck. Patients can wear normal clothing and sleep comfortably, with safer access to the airways and chest.
A tissue engineering approach that constructs “smart,” adaptable vascular grafts (Nanografts) from bone marrow stem cells for coronary artery bypass procedures.
Second prize (tie): Ultramed Ultrasound Breast Cancer Detection
- Pennsylvania State University
A breakthrough in ultrasound technology using multi-element, high frequency transducers with scalable frequency ranges to allow real-time tissue biopsies and non-destructive imaging for breast cancer detection.
Second prize (tie): AnemiCAM
- Brown University
A device that allows doctors to quickly and accurately detect anemia (low hemoglobin) in patients by reflecting light in the conjunctiva, within the lower eyelid.
Third prize: Robopsy
- Massachusetts Institute of Technology
A telerobotic biopsy system that uses a small, disposable actuator device to grip, orient, and insert a biopsy needle from within a Computed Topography (CT) gantry.
First Prize: Rotavirus Vaccination via Oral Thin Film Delivery
- Johns Hopkins University
This team has developed a unique vaccine delivery system to take on a virus that kills 600,000 children in the developing world each year. This dry form vaccine will eliminate problems associated with refrigerating and distributing liquid form vaccines in less-developed countries.
Second Prize: enLight: Enabling Life with Light
- Stanford University
This novel treatment for Parkinson’s Disease enables the effective and reliable control of neural activity using light. The device combines gene delivery of a light-sensitive ion channel with an implantable optical stimulator to directly and specifically control the neurons affected by Parkinson’s.
Third Prize: Bioactive Nanopatterned Grafts for Nerve Regeneration
- University of California, Berkeley
This team’s nanofiber graft enhances and guides nerve regeneration in people suffering from peripheral nerve injuries. The Nano Nerve Graft is a tubular graft composed entirely of nanoscale polymer fibers and loaded with bioactive molecules that provide growth cues for regenerating.