In 2010 the BMEidea competition continued its tradition of supporting student teams in developing devices that can improve healthcare outcomes in the US and around the world. Included in the 2010 cohort were three devices with the potential to save lives: a portable device to induce hypothermia in cardiac arrest patients, a low-cost ventilator, and a device to improve urogynecological procedures by providing surgeons with better visibility and access to deep target tissues. Twelve months later we caught up with members from each of the three winning teams to see what they were up to, how their projects were going, and how participating in the BMEidea competition has influenced their projects and their careers.
First prize winner: Rapid Hypothermia Induction Device, Johns Hopkins University
The biggest killer in the US isn’t cancer, it isn’t diabetes and it isn’t accidents—it’s heart disease, and a significant percentage of those deaths, a full 335,000 per year, come as a result of cardiac arrest.
The numbers surrounding cardiac arrest are stunning: brain damage starts to occur just four to six minutes after the heart stops pumping blood; a victim's chances of survival are reduced by seven to ten percent with every minute that passes without CPR and defibrillation; few attempts at resuscitation succeed after ten minutes. Worst of all, the total survival rate is 5%--which means that 95% of cardiac arrest patients do not make it to the hospital.
Such dismal numbers express two things: the severity of the disease and the opportunity for vast improvements in emergency treatment.
This team, winner of first prize in the 2010 BMEidea competition, is taking on the challenge with the Rapid Hypothermia Induction Device (RHID). The device is based on the idea of therapeutic hypothermia (TH), a medical treatment gaining in popularity in which a patient's body temperature is purposely lowered in order to lessen the risk of tissue damage following a period of insufficient blood flow. TH can be induced by pumping cooling saline through a catheter inserted into the heart via the femoral vein, but this is highly invasive and can only be done in a hospital setting—not in the field, where cardiac arrest claims most of its victims. TH can be induced in the field with chilled water blankets, torso vests and leg wraps, but this is slow and hard to control, and the refrigerated blankets and wraps are hard to store in ambulances.
The RHID team is trying to fill the need, then, for a simple, portable device that can reliably induce hypothermia in the field, keeping cardiac arrest victims alive long enough to make it to the hospital. Led by then-undergraduate David Huberdeau and faculty sponsor Dr. Harikrishna Tandri, the team’s device can be carried in an emergency technician’s handbag and induces TH by blowing regulated air through the patient’s nose.
It works by using the principle of evaporative cooling: when water evaporates from the body, it carries with it a large amount of heat. Nasal cavities have highly specialized vascular heat exchangers, called turbinates, which humidify and warm the air that passes to the lungs. During periods of low temperature, blood flow increases to the turbinates, allowing for high levels of mucus production. RHID forcibly accelerates the evaporation of water from the nasal cavity by continuously flushing cold, dry air on the surface, carrying heat away and cooling the brain.
The device got its start in Johns Hopkins’ Senior Design Team course, in which groups of students pair with a faculty sponsor to take on a biomedical design challenge. Huberdeau led a team of ten undergrads in search of a project, and found Dr. Tandri, an assistant professor in the School of Medicine and a member of the Johns Hopkins Heart and Vascular Institute. “Dr. Tandri had already had the idea for a scalable, portable, rapid hypothermia induction device, and we were put together through mutual contacts,” said Huberdeau.
Dr. Tandri got the idea for the device directly through his work—he could see the need quite clearly. “My background is in cardiac physiology, and I’m a cardiologist by training. I deal with a lot of patients suffering from cardiac arrest and sudden death. The motivation for the device came from there—to improve survival rates.”
The team decided to go forward with the project in September of 2009, and over the next academic year Huberdeau and his team worked in collaboration with Dr. Tandri on developing the device. Said Huberdeau, “Dr. Tandri already had a provisional patent on the idea, and we tried to make improvements to the concept as the year went on.”
At the end of the course they’d reached a level where they could begin pursuing intellectual property and considering paths to commercialization; they submitted for BMEidea and won the competition.
Since then the team has dispersed: Huberdeau entered the biomedical engineering PhD program at Johns Hopkins; four team members went to work in industry; one is working in a hospital; and some were freshmen when the project began and are still undergraduates. That hasn’t stopped the project from moving forward, however, as Dr. Tandri is continuing testing and has applied for an SBIR grant.
“We’re moving along, slowly but surely, but in the right direction,” he said.
Meanwhile, simply submitting for BMEidea was worthwhile, according to Huberdeau. “Submitting the application forced us to get our thoughts in order. It really helped us organize our project.”
For Dr. Tandri, the most important thing about winning the BMEidea competition is credibility. “Now when we talk to people—investors, venture capitalists, etc.—it helps us move the business end forward. Knowing that this device was recognized by the NCIIA in a national competition absolutely gives us credibility.”
Winning the competition has given Huberdeau much more confidence to pursue a career in translational medicine, including entrepreneurship, in the future. “The basic and clinical science research coming out of academic medical institutes such as Johns Hopkins is breaking new ground in our understanding of disease, biology, and medicine,” he said. “Biomedical engineers like myself, in close partnership with researchers and clinicians, are uniquely positioned to facilitate the widespread adoption of these discoveries to medical practices the world over.”
Second prize winner: OneBreath, Stanford University
One aspect of entrepreneurship that’s about as close to a universal law as you can get is this: making something cost less is a good thing. Making it cheaper by an order of magnitude? Even better. Saving lives in the process? Perfect.
The second prize-winner of the 2010 BMEidea competition is shooting for all three of those targets with OneBreath, a low-cost ventilator that keeps critically ill patients breathing when their respiratory systems are unable to function.
OneBreath is designed to address two distinct problems: emergency readiness in developed countries and the shortage of ventilators in developing countries. The buzz about emergency readiness in the US started during the flu pandemic scare several years ago; people realized that, in a worst-case scenario, hospitals would not have enough ventilators to meet the anticipated demand. More than 740,000 would be needed, but the US has only 205,000—meaning that in a crisis, hospital staff would have to decide who gets a ventilator (and lives), and who doesn’t get a ventilator (and dies). Meanwhile, in developing countries, millions die each year from lack of access to a common ventilator—India has 35,000 ventilators for a population exceeding 1.1 billion.
The biggest reason for the shortages in both cases is the current cost of ventilators. Ventilators cost hospitals from $3,000 up to $40,000 for state-of-the-art models, making it impractical for most hospitals to stockpile them for emergencies and completely pricing them out of the vast majority of clinics in the developing world.
The OneBreath team, led by Stanford post-doc and device designer Matthew Callaghan, is well aware of this dilemma and is going low cost in response. A OneBreath ventilator costs a mere $300, a massive price reduction, and the device is rechargeable, portable, and disposable—perfect for one-off emergency situations no matter what country you’re in.
Callaghan achieved the cost reduction with slick engineering. The no-frills device, smaller than a toolbox, runs on a twelve-volt battery for six to twelve hours at a time. Whereas most ventilators use expensive flow sensors, servo motors and other specialized components to push air in and out of the lungs, Callaghan started from scratch with a basic pressure sensor, typically used in devices like blood-pressure meters, that costs about $10. Callaghan also replaced the single permanent air valve on expensive respirators, which requires time-consuming cleaning between patients, with two—one that is exposed to patient air and one that never comes into contact with it. When the inner valve opens as the patient inhales, air forces the outer valve closed, keeping air that the patient expels from contacting the pristine inner valve. The contaminated outer valve can be thrown out and replaced with a new one.
The team has made impressive strides since the BMEidea competition in 2010. While Callaghan is still a physician at Stanford, the rest of the time he’s working on OneBreath. The team is now officially incorporated, with a CEO, VP of business development, Chief Medical Officer (Callaghan) and several engineers. They’ve continued development of the device, are seeking regulatory approval after successful animal tests, and have partnered with GE Healthcare to stockpile ventilators for the US government to use in pandemic situations.
That takes care of the first half of OneBreath’s mission. In the meantime, the other half of the project was emerging markets and developing nations. “To that end,” said Callaghan, “we’re finishing up our grant funding and looking to raise funds from private, local venture firms, and hopefully be able to close on that round of funding by the end the summer. After that we’ll start on the CE mark process, which is the outside-the-US, non-FDA approval for selling in India, China, and the Middle East.”
Along the way Callaghan is taking a typical entrepreneur’s path, working hard and performing whatever tasks are required. “Between me and the CEO and the VP, we kind of wear all the hats. It’s a startup, so you do what you have to do—I made business cards the other day. You end up doing things that you never imagined would make up your job, but they do.”
While Callaghan and his team have participated in a number of business plan competitions and written many grants, the BMEidea competition sticks out for him as being “very engineering-focused. It forced us to put our thinking caps on on the engineering side. There’s really no other competition that I’ve seen that focuses on the engineering like that—on making something real.” According to Callaghan, most competitions tend to be focused more on the research hypotheses, “So BMEidea was nice. It gave us a chance to do something real.”
Look for OneBreath to make a real impact on the world in the near future.
Third prize winner: Natural Orifice Volume Enlargement (NOVEL) Device, University of Cincinnati
When the muscles and ligaments supporting a woman's pelvic organs weaken, the organs can slip out of place, known as prolapse. Pelvic organ prolapse can worsen over time and eventually some patients need surgery to fix it.
It’s the surgery for this condition that the third prize winner of the 2010 BMEidea competition is looking to improve.
Currently, surgeons looking to fix pelvic organ prolapse have at their disposal two options: sacral colpopexy, the most commonly used procedure, which requires opening up the patient fully, introducing complications and increasing pain and recovery time; and a newer, less invasive natural orifice (transvaginal) approach.
The problem with the transvaginal approach? No device currently on the market can provide enough tissue retraction and visibility to perform it well—surgeons are stuck with old style retractors to move tissue out of the way. The retractors, essentially simple levers, are hard to use and don’t do their job particularly well. Even with the simultaneous use of multiple retractors and packed towels, the surgical workspace provided to the surgeon is still small, dark, and shallow; target structures are obstructed, and the lack of visibility and access impedes progress and affects success.
This team, developers of the Natural Orifice Volume Enlargement (NOVEL) device, is filling the need for a better transvaginal surgery tool. The design is based on two components: a reusable handle and blade system made of stainless steel and a disposable membrane placed over the blade system comprised of biocompatible elastomer. When deployed, the device, which looks like a large pair of scissors connected by a smooth steel tube, locks into place and provides constant support to soft tissues while being self-retained in the patient. Surgical workspace is greatly increased, making a newer, better procedure more feasible than before.
Mary Beth Privitera, a faculty member in the Medical Device Innovation and Entrepreneurship Program at the University of Cincinnati where the device got its start, said that the novelty of the device “is that it’s a one-person device. Most of the devices available today need an assistant to hold it and provide the actual retraction. This does it all in one. It enables the physician to have complete control over it.”
One unique aspect of the project, according to Privitera, is that UC faculty requested at least a few female team members on it from the very beginning. Said Privitera: “Normally we don’t specify whether we want men or women to work on these projects, but in this case we did. We made a big push to get women on the design team, and ended up with a female engineer and a female designer.”
The focus on female participation had a positive net influence on the project, according to Privitera. “It absolutely helped,” she said. “It gave the team balance. The product’s form and function are inherently tied together, so understanding the problem, understanding what it’s like to be a gynecology patient, was paramount to creating an appropriate solution.”
Since winning BMEidea funding, the device has been pulled back in-house by the company it was sourced from, Cincinnati-based medical device development company Device & Implant Innovations. Immediately after winning the competition, Privitera said the company “reigned it in and said, ‘This is great, now we need to make it real.’” They are moving the device forward with the idea that it could form the foundation of a completely new procedure.
And while the team has since dispersed, Privitera said that the project “was successful from the academic standpoint of meeting curricular goals and the experience the students had. Our clinical partner was extremely happy with the students’ work, and all in all it was one of the best possible experiences for the team and it provided value going forward.”
The BMEidea competition itself continues to up the ante on UC campus, according to Privitera. “BMEidea puts things in a different perspective. It elevates the student’s perspective—a lot the time you think you’re doing a good job and you hear from your faculty that you’re doing a good job, but to hear it nationally is tremendous from the students’ perspective.”
Lastly, much like many BMEidea winners in the past, Privitera has found that the competition lends credibility. In Privitera’s case, it helps her form connections at UC and beyond. “The competition has really assisted me in forming a new host of relationships for the entire program here,” she said. ”When we go to talk to new partners, they know that the students can actually do what we say they can do. And that’s invaluable.”
