2008

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.”