2009 BMEidea Winners: What are they up to?

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