BMEIdea 2012: CryoPop, An Affordable Cryoablation Device for Cervical Lesions (interview)

• Tweet

The BMEIdea is an innovative and increasingly competitive contest for biomedical engineering students.  It’s been hosted by the National Collegiate Inventors and Innovators Alliance (NCIIA) since 2004, and the winners were announced in May.  The grand prize of $10,000 was awarded to the team from Johns Hopkins for an innovative device that utilizes dry ice to treat cervical pre-cancerous lesions.

We had the opportunity to ask the team a few questions:

Team Hopkins: First, a point of clarification from the team as it seems there has been some confusion with some people they’ve spoken with:

… our device is not a screening system but rather a component of the screen-and-treat approach, required to achieve meaningful screenings by enabling point-of-diagnosis treatment. When pre-cancerous lesions are detected, by visual inspection with acetic acid (VIA), our device will freeze the surface of the ecto-cervix, killing the pre-cancerous cells and preventing the onset of invasive cervical cancer. What we’ve really done here is simplified the proven technology of cryoablation to make it low-cost, durable, and reliable; by doing this we believe this treatment method can be scaled up to start treating the women who only have access to remote, rural health posts because they live so far off the grid, and it is these women who are dying from cervical cancer in large numbers.

Justin Barad, Medgadget: Who are the members of your team?

Team Hopkins: Our team includes three bioengineering master’s students, within the Center for Bioengineering Innovation and Design (CBID) program (actually, we just graduated last Wednesday): Shuja Dawood, John-William Sidhom, and Marton Varady. We are advised by Dr. Soumyadipta Acharya (our graduate program director at Johns Hopkins), Dr. Ricky Lu (Director of Family Planning and Reproductive Health at Jhpiego), and Dr. Harshad Sanghvi (Vice President Innovations and Medical Director at Jhpiego).

Medgadget: How did you come up with the concept for your product?

Team Hopkins: Before we began conceptualizing ideas to solve the problem, Dr. Sanghvi introduced our CBID class to some big health care problems that Jhpiego was looking to solve in the developing world; the costliness and reliability of current cryoablation technology was one of the problems. As part of our program, we spent three weeks immersed in the developing world. Our class was split into four countries (India, Nepal, Tanzania, and Ethiopia); John and Shuja went to Nepal and I went to India. The point of the immersion was to gain a deeper understanding of the problems that Dr. Sanghvi pointed out to us by talking to clinicians, nurses, and midwives, and following them around as they cared for their patients. The immersion enabled us to understand the constraints of the environment for which we would be designing solutions for. This is key, because many of the problems that Dr. Sanghvi pointed out to us have been solved in the developed world, but the constraints of the developing world healthcare infrastructure prohibit the existing solutions from having the necessary impact.

When we returned, the three of us identified the issue of a lack of treatment for pre-cancerous lesions as the problem we most wanted to work on. We brainstormed on conceptual ways in which the pre-cancerous lesions could be removed or destroyed; we thought about chemical ablation, a simplified form of LEEP, some form of reactive chemistry that could be targeted based on the vinegar used to screen for the lesions, and a few other solutions. One of our driving criteria for this project, however, was developing a technology that could be quickly brought to market, and basing the technology off of the concept of freezing appeared to have the lowest barriers to adoption. Additionally freezing technology has been around for a long time. So we looked at different methods that could be used to freeze the cervix to the appropriate temperatures. We assessed Peltier devices, thermo-acoustic refrigeration, Carnot cycles, and dry-ice creation. The dry-ice concept appealed almost immediately because it didn’t require any new resources and it was simple, it required nothing more than the expansion of the liquid portion of the CO2 tanks.

Medgadget: How does your device compare with current standard of care treatment in terms of cost, effectiveness and availability in developing areas?

Team Hopkins: There are actually numerous ways to measure the cost savings achieved with our device. The first is in the capital cost of the device: existing cryoguns cost approximately $2,000, but we expect that we can sell our CryoPop for approximately $200 and maintain a sustainable business. The second measure of cost savings comes from our efficiency in using the CO2. Current equipment can only treat approximately 10 women on a 50lb tank of CO2, but based on testing our device will treat approximately 30 women using only a 5lb tank of gas. This is significant because the CO2 is not cheap: the 50lb tanks cost approximately $250 per tank and additionally, they are very difficult to transport, especially to the remote settings that we are targeting. Based on these numbers we expect that we will be lowering the cost of treatment from approximately $47 per treatment down to under $2 per treatment.

Throughout our bench testing we’ve seen that our device with the dry-ice achieves a lower freezing temperature than the existing cryoguns used with CO2. This in turn should yield slightly better tissue necrosis on surface of the cervix. In our animal testing with goat cervixes when we did a comparison study, our results showed comparable results in each of the cohorts. We haven’t done any testing on human cervixes, but we are confident that we will see comparable results in the human trials between existing equipment and our CryoPop.

Our device is not yet out on the market so availability is non-existent. We expect that our price point and lack of maintenance required will make it an attractive solution for ministries of health to purchase and make available to all their health posts.

Medgadget: Can you describe one of the obstacles you had to overcome to get this far?

Team Hopkins: One of the obstacles we had to overcome was how to build a device that would consistently form dry-ice inside of our chamber (or applicator). We needed the ice to fill consistently, which we just couldn’t get to happen. There was often a big air-bubble that would form within the chamber—it wouldn’t happen all the time but often enough that we were concerned. We’ve actually gone through many different iterations of the design, and one thing we realized was that when we extended the length of the mold lock, the dry-ice snow would form much more consistently. Because we didn’t fully realize how this worked we were advised to talk to some industry professionals and after some cold calls we got some very good input on how to design our mold lock, or what people in the dry-ice industry call a snow horn. It is still being refined but the guidance we got was invaluable.

Medgadget: When do you anticipate this device will come to market?

Team Hopkins: We’ve recently put together a project timeline for next year, and currently we expect that we can begin an initial human clinical trial, or case study series, in the summer of next year (2013). Commercialization would probably follow in the months afterwards assuming that the case series goes as planned with good results.

Medgadget: Any advice for the aspiring inventors and entrepreneurs?

Marton Varady: I’m not really old and gray enough to be giving any world-changing advice but I guess my advice would depend on your age, if you’re still in high school, focus on learning math and science because these subjects are the building blocks that I’ve used throughout my short career as an engineer. If you’re my age or older, then pursue what you love and find the problems that are worth solving in the field you’re working in, where you can impact people’s lives. There is no shortage of problems in the world, but simple solutions are hard to come by.

John-William Sidhom: While I am still early in my career as an inventor/entrepreneur, I’ve been fortunate to have worked on the design and development of a few medical devices that had commercial feasibility. What I will say to anyone looking to engage in innovation and entrepreneurship is that one of the more important things I’ve learned is being able to accept failure as part of the process. Not every idea you will have will be great, but it doesn’t mean that should hold you back from pursuing it. I think as an engineer/entrepreneur, if you are able to enjoy the innovation process more so than focusing on the “successful” end point, you will be more likely to engage in that innovation process more and more times. Eventually, these experiences should assist in truly creating innovation that does make the world a better place. And maybe to add on to what Marton said, if you are young and “inexperienced,” do not let that be an excuse to get started solving big problems in the world. Talking to many individuals, I’ve often heard them say, ‘How can I invent something? I’m not creative enough,’ or, ‘If no one else could solve that problem, how can I?’ I think getting beyond these misconceptions is the first step to becoming a great problem-solver and entrepreneur.