BB&T Contributing Editor

Ran Bronstein.jpg


Founder of Simbionix

Ran Bronstein has been a pioneer in the field of medical simulation for nearly 15 years, having started as one of the three founders of Simbionix in 1997, creating the vision for the Israel-headquartered company and leading the development of the technologically advanced medical simulators. The company s U.S. headquarters are in Cleveland. Today, as company president and chief operating officer, Ran oversees company operations both internally and externally.

Prior to the founding of Simbionix, he co-founded and managed the R&D team of Kidum Multimedia, a software company focused on 3-D technologies, which was acquired by SEA in 1997. At Tecnomatix Corp., which provided manufacturing process managements, Ran was 3-D and simulation project leader.

Bronstein talked with BB&T Contributing Editor Jim Stommen on growth and changes in the medical simulation sector.

BB&T: Before we get into the specifics of what your company supplies, could you give me an overview of what s involved in what I think of as the simulation/training sector? I m wondering, for example, how the segment sees itself today versus the training of the past.

Bronstein: Medical simulation has been under development for about 20 years, specifically in terms of hands-on training that can be done with computerized simulation. We ve gone from animals to cadavers to real patients each one of them has its drawbacks. Cadavers are limited in numbers and they do not always represent the human body the same as when they were alive. Animals have the same challenges, and also there are a lot of problems in the use of animals. Training with live patients is obviously problematic. Using computerized simulation, you can create certain scenarios, train yourself over and over again, record your actions, review your results and decide on next steps as to how to improve your skills. There are many virtual education options. The limitations of the current training practices are obvious, and the advantages of using computerized simulation are clear.

The barrier for computerized education is coming from two elements. One is the technological aspect. We compare it to flight training, where a flight simulator has a design document. The physics of flight are pretty well known, the environment in which an airplane is active can be well simulated, so you can insert all these formulas into the computer and get a pretty accurate rendition of what is going on in actual flight. Even the airplanes in any given class, say the Boeing 737, are the same. But human beings don t have such menus, and there is no one-size-fits-all design document. Each human being is different in anatomy and behavior from another; there are no two that are alike. To create a good simulation in such an environment is a big technological challenge.

The other challenge, which ties to it, is the matter of validation. In order to make a useful simulation tool, you have to validate it with the medical community, which is a very important process. This takes time. So the barriers for this technology to grow are pretty clear.

BB&T: Tell me how Simbionix got started its early development and its vision for where the company could go in what is obviously a very rapidly evolving space.

Bronstein: Simbionix was established in 1997. The vision was to create hands-on training devices based on computer simulation in order to enhance patient safety and to improve the skill level of physicians. All our products are similarly named GI Mentor, URO Mentor, ANGIO Mentor and so on and are specifically targeted to specific types of procedures, like the GI field, the cardiovascular field, the laparoscopic field. So the first was GI Mentor, and it was introduced to the medical establishment in 2000. Competitors started development in the 1995 to 2000 period as well. Prior to that time, this field did not exist at all. Over the years, it has become more and more valid as a way for physicians to train, and today, Simbionix has more than 100 validation studies that prove the efficacy of its products.

The company was established in a government-backed incubator in Israel near the Sheba Medical Center. We understood that for the minimally invasive therapy field, in which the physician is not touching the human body but is watching his actions on a screen, computer simulation is a good way to mimic the reality and give the physician a good environment to improve his skills and to train in new and innovative procedures.

As the medical field progresses, more and more modalities are introduced ultrasound, 3-D, MRI, navigational systems, tracking systems and the environment within which the medical team is operating is getting more and more complicated. Another good example is the robots that are being used in surgeries, and it will almost be impossible to train for that without simulators. With that understanding in mind, Simbionix was established, and from then until today, we are concentrating on developing the best hands-on training machines we can in order to fulfill our goals.

BB&T: I have seen the phrase complete educational solutions used in company press releases. What s involved in that?

Bronstein: We have understood that only the device itself is not enough, that in order to be able to train the physician and be part of an educational framework, we need to create envelopes that will give our product and the educational cycle more value. It starts from didactic material, the testing with the procedure. It can be curriculum that includes the didactic material and hands-on training, and it can be a physical training offering as part of an all-around course.

Today we are even talking about communities of physicians that will include the ability to exchange knowledge and to educate through collaboration. So all this ties together with hands-on training to provide a bigger picture of the educational cycle from the time a student starts to study in the medical field until he retires as a physician. With the evolution of the Internet as an online content delivery system, we are aiming today to equip all our simulators with an online system that can deliver all of the things I have mentioned to give more power and be part of a larger educational picture.

BB&T: The company has distinct offerings in hardware, software and online training. Do they always tie together in a linear relationship, or do some applications stand alone?

Bronstein: The goal is for the physician in China to be able to see the curriculum of his colleague in the United States; they can exchange curriculum and materials as well as share cases on the simulators and knowledge related to certain actions gall bladder laparoscopy, for example. So each of these pieces can stand alone, but in the bigger picture they all tie together as one platform. In this platform, we also update physicians with new content, new curriculum, new cases, along with appropriate technical services.

BB&T: How do you go about developing a new simulation product? How important is the role of physician feedback in developing those products?

Bronstein: It goes back to what I said before you cannot develop a medical simulator without the involvement of physicians, period. Their role is crucial; it s irreplaceable. There are no technical specifications of a human being all the knowledge we have from seeing an operation is valuable, but without the feedback from the physician, both on what s happening and on how to do things, we cannot develop these simulators. We don t have physicians on staff with the company because we need a wide network of physicians to collaborate with on a daily basis. Not one physician can do it all, so we work very closely with a large number of physicians in order to develop our simulators. In thinking about what is the right product for the market, or what physicians need at a certain point, we define the product and then go through all the development cycles where we rely heavily on physician involvement as part of our product development process.

BB&T: Women s health, in general, has been an area that has seen substantial development of new products over the past decade or more, and that looks to be true for simulation products as well. Tell me about your company s new offerings in that sector.

Bronstein: Women s health is a very important sector and an evolving area for us. We recently launched two new products one is the PELVIC Mentor, a hybrid hands-on training device, while the second is a Hysterectomy module for the LAP Mentor which we developed with the University of South Florida. These two products help build our presence in this clinical area. We already have two other products there, including one manufactured by a Swedish company that we have acquired distribution rights to. We recognize the importance of this area, so we re putting a lot of effort and a lot of focus on women s health. There is a lot of demand there, especially in the United States.

BB&T: What other areas of medicine offer the greatest opportunities for simulation offerings today, and are there others that are underpenetrated today that may grow into future markets?

Bronstein: The simulation sector will grow dramatically over the next 20 years, especially with the introduction of newer technologies in the operating room. There are human patient simulators, which is not something that Simbionix is concentrating on today but we ll be entering in the future. What we are doing now are procedural simulators that simulate mainly minimally invasive therapy procedures like laparoscopy, gynecology, cardiovascular and others. The combination between human patient simulation, which are team processes, and procedural simulation, which is our focus, is an area of growth.

Other areas might include ultrasound simulators, which are evolving today because ultrasound is an important and growing modality, simulation for robotic surgery, simulation that enables remote training, and also any simulator that enables a physician with lesser experience but within a so-called mini environment, a smaller-sized system. Not an X-box, say, because that s a gaming system, but something that s smaller and can employ sophisticated simulation technology to wider areas and wider numbers of physicians. So I can see growth coming from the whole range from smaller simulators to procedural simulators to human patient simulators the combination of all these providing big opportunities.

I would say the best near-term opportunities are in ultrasound and new cardiovascular procedures like valve repair and others, also new laparoscopic procedures. There is a lot of work for us to do as a company in order to take advantage of all the opportunities we have in front of us. On top of that, you have to have all these plugged into an online system by which people can share knowledge and experience in order to enhance the hands-on training.

BB&T: Let s come back to a point we touched on earlier. I m wondering how you go about formulating training programs and if that has involvement by the medical societies.

Bronstein: Again, a crucial factor. Working with physicians on development of products is important, and working with the societies is even more important, because all these developments should be going through the societies in order to be part of the program. Societies such as SAGES, ACOG, ACS and others are extremely important to the development of medical simulators. Their adoption of our products and programs is very important, and is very much a part of the growth of these technologies.

BB&T: How does the forecast of doctor shortages in many parts of the world affect the outlook for the simulation sector?

Bronstein: Medical simulators are really just for physicians to improve themselves. That s a differentiator between simulator manufacturers and what all the other medical device companies are doing. Generally speaking, medical devices are sold to physicians and hospitals, but a good many of them go into the patient and home with the patient. Our goal is not to improve the procedure itself, but to improve the physician s skills.

The number of physicians delineates our market, so if there is a shortage of physicians, we ultimately will have an issue with our market. But I think our industry will have a greater role in making the training of physicians more efficient and medical societies can utilize simulators to differentiate between different skills. We can help deal with the physician shortage through improving the training of physicians.

BB&T: How did you come to select Cleveland as the location for your U.S. operations?

Bronstein: We were lucky to be able to locate in Cleveland. The collaborations with the Cleveland Clinic, Case Western Reserve and the entire northern Ohio community have been wonderful. The connection with Cleveland has been great for our company, going on 10 years now.

BB&T: Is there a question I haven t asked that you wish I had?

Bronstein: I would add just one thing, and that is that our work with medical simulation is a commercial venture, but by pioneering this opportunity and creating this market, one of the most important things for us is that we know we are creating value for society by improving physician skills. Quality of life is becoming all the more important, so medical simulation and hands-on training is something that contributes to that, and that in turn helps us get the good employees we need in order to advance our work.