September 22, 2016      

Joanne Pransky, associate editor of Industrial Robot, recently sat down with Jacob Rosen, a professor of medical robotics at the University of California, Los Angeles. The surgical robotics pioneer has developed systems for minimally invasive surgery, telesurgery, and exoskeletons.

Rosen got a B.S. degree in mechanical engineering, followed by an M.S. and Ph.D. in biomedical engineering, from Tel-Aviv University. He currently directs the Bionics Lab at UCLA’s Department of Mechanical and Aerospace Engineering.

In addition, Rosen is the director of surgical robotics engineering at the UCLA School of Medicine’s Center for Advanced Surgical and Interventional Technology. He has served as an expert witness and consultant on design, intellectual property, and malpractice.

Rosen has also filed eight patent applications and is co-founder of Applied Dexterity Inc., ExoSense Inc., and SPI Surgical Inc. Here, he talks about his research and how the process of getting federal approval affects the medical device market.

This interview is available free to Robotics Business Review readers until Oct. 21, 2016. Here’s a preview:

Pransky: How did you first come up with the concept of the Raven [telesurgery device]?

Rosen: When I started my postdoctoral studies at the University of Washington in 1997, along with my mentors Professors Blake Hannaford and Surgeon Mika Sinanan, we studied algorithms that could objectively assess surgical skills in minimally invasive surgery [MIS].

We used, in part, Hidden Markov Models, a method that was previously applied in speech recognition. This unexpected association of the modeling approach led me to the conclusion that MIS is essentially a spoken language with various words and different pronunciations used by all surgeons trying to tell the same story as they operate, regardless of their skill level.

The research challenge was to identify the words, pronunciation and the rules of grammar of surgery and use this framework to assess surgical skills objectively.

By analyzing hundreds of hours of surgical procedures, we managed to develop a model of specific surgical tasks for each skill level representing the training or expert levels.

Surgical robotics pioneer Jacob Rosen helped develop the Raven teleoperation system.

Two surgeons collaboratively teleoperate the Raven IV robotic system located 900 miles away.

A byproduct of this massive data collection of quantitative data that was recorded from instrumented surgical tools allowed us to gather the engineering specifications of a new surgical robot.

The Raven was later developed based on this unique data with the help of an award by the U.S. Army.

Pransky: Do you have any plans for clinical trials?

Rosen: Applied Dexterity is seeking funding for the commercialization of the Raven as a clinically approved system. All the clinical trials, which are necessary for commercialization in the U.S., will be part of this effort.

It’s also interesting to look at how the Food and Drug Administration is viewing surgical robotic technology given the experience accumulated in the past two decades.

Back in 2001, the FDA approved Intuitive Surgical’s Da Vinci system through their 510(k) premarket notification program, with the FDA classifying it essentially as a system that is not significantly different than minimally invasive surgical tools already on the market. However, each surgical procedure had to be approved individually.

In the summer of 2015, the FDA held a workshop on robotically-assisted surgical (RAS) devices. They invited experts in the field to better understand what should be included in approving or disapproving robotic surgical systems since this process can affect in part, the price point of such systems.

The FDA approval of medical devices and drugs philosophically reflects the conservative field of medicine, since human lives are at stake. The FDA process for a RAS device is exorbitant, costing approximately $100 million. RAS manufacturing companies are going elsewhere around the world where regulations are less stringent.

Historically, the U.S. market was considered the primary, the biggest, and the most prominent but now is not as strong as it used to be. The Asian market is emerging, where China, for instance, is three times the [size of the] U.S. market or even more.

The implications are that technology which is developed in the U.S. in part by taxpayer money eventually ends up in other countries because other countries are more receptive to it and willing to approve it at a lower cost. The cost of running clinical trials in the U.S. is about $100,000 per trial on a single subject. In China, for example, it’s $5,000.

Since Asia is such a large market, with 5 percent of the cost for essentially gaining the same approval, why should a company insist on operating and trying to get products through such an expensive and highly rated system as the U.S.? The [American] public should be the first to benefit from the technology that was funded in part by its own tax money. The FDA is receptive to having discussions on these issues.

Pransky: Can you talk about the funding and intellectual property of your other companies — ExoSense and SPI — and about the greatest challenges you faced with each of these companies?

Rosen: They are essentially all startups, but each one is evolving in a different direction driven by different market forces. The challenge — and all have IP and potential for commercial products — is to find investors, which is certainly not unique.

Surgical robotics pioneer Joshua Rosen discusses the evolution of the EXO-UL exoskeleton.

The evolution of various generations of the EXO-UL exoskeleton.

Investment in medical devices is particularly problematic for two reasons: The time to market is typically longer than other products, and the FDA approval is a costly process.

Products developed by Applied Dexterity and SPI are classified by the FDA as Class II devices — devices that penetrate through the skin and [are] removed at the end of the procedure — which are subject to premarketing approval.

However, ExoSense, which is trying to commercialize the exoskeleton, is not, because the exoskeleton is classified by the FDA as a Class I — devices that do not penetrate the skin — similar to say, gym equipment that is used for rehabilitation, which means they can be sold even without FDA approval as long as no claims are made for any therapeutic qualities to it.

As a result, the regulatory barriers for the exoskeleton to get into the market are much lower than surgical robotic systems.

The business dynamics in surgical robotics is currently under rapid change given the significant commercial success of these systems. Well-established companies in the field of surgical tools with an existing presence in hospitals are getting into the market with new surgical robotic platforms.

They view the surgical robot platform as an incentive to sell more surgical tools and to rely more on yearly contracts of supplying tools than the current model in which the initial sale of the surgical robotic system itself is the source of about half of the revenue.

More on Surgical Robotics:

Pransky: What is the greatest mistake or the greatest lesson that you have learned?

Rosen: Early in my graduate studies, I was involved in designing orthopedic implants. I worked with an orthopedic surgeon on a new approach for a spine fusion system of a broken sacrum — a.k.a. the tail bone — with a single implant that applied to a very wide spectrum of human anatomies to allow the fracture in the sacrum to heal.

The mistake that we made in an attempt to meet the design requirements was putting too many features into a single implant instead of designing multiple implants for various anatomical dimensions.

The take-home message from this experience is that incorporating many features that the user will never use is a result of a bad design process. I learned this lesson the hard way, but, since then, minimalism in design is the mantra that I teach my students.

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