Titan Medical Teams with Ximedica to Bring a Novel Robotic Surgical System to Life
Robotic surgery has become a widely-accepted medical procedure over the past decade, offered by an increasing number of hospitals worldwide. The tele-manipulator and software of robotics restore intuitive movement control to the surgeon, providing the right/left hand synchronicity that standard minimally invasive surgery (MIS) lacks. Growth of sales in life sciences robotics was in the double digits in 2013, according to the Robotics Industry Association (RIA). Global annual medical robotic revenues are currently about $4 billion and are expected to continue to grow at a 12% annual clip, reaching $19.9 billion by 2019. RIA calls surgical robots “revolutionary tools” for surgeons that help transcend human limitations by providing reduced invasion (less trauma), tremor reduction, repeatability, precision and accuracy.
As a new technology advances, innovative thinking can refine performance. Such was the case for a group of researchers at Columbia University College of Physicians and Surgeons. Seeking to overcome the size, cost and dexterity issues of large, multiple-incision robotics systems, they envisioned a smaller, less-expensive, more nimble device that could perform minimally-invasive surgery (MIS) through a single port of entry into the body and be moved between operating rooms as needed. The goal was to deliver the advantages of instinctive robotics controls on a compact platform that could be adapted to a wider variety of general surgery operations than is currently available.
Device developers Titan Medical recognized the opportunities presented by the researchers’ single-port concept, tested the academic prototype (at Vanderbilt University, where one of the inventors had relocated it) and licensed the intellectual property (IP) from both universities. A public company headquartered in Toronto, Ontario, Titan has a medical advisory board of leading surgeons as well as partnerships with academic institutions and hospitals around the globe.
“We were already well-aware of the complexities inherent to medical device development,” says Joe Talarico, Titan’s VP of business development. “When we decided to explore the potential of this innovative robotic system the challenges we were facing included manpower, product knowledge expertise, human interface engineering, clinical-regulatory interface, overlap of system and protocol management—as well as subsequent bench, pre-clinical and clinical testing schedules.”
OVERVIEW OF THE TITAN SURGICAL SYSTEM
Titan’s Single Port Orifice Robotic Technology (SPORT) Surgical System, currently under development, comprises a surgeon-controlled single incision patient cart and a separate surgeon workstation for performing minimally invasive surgery (MIS) procedures. Estimated cost upon commercialization: $600,000.
The patient cart includes two multi-articulating instruments, each capable of moving with seven degrees of freedom, and an intra-abdominal 3D high-definition image capture, processing and display system. The workstation provides the surgeon with a direct interface to the robotic platform for one-to-one control of interactive instrument arms, tips and end-effectors and for a high-definition, 3D view inside the patient’s body during MIS procedures.
Once inserted, the device is deployed into a working configuration controlled by a surgeon at the workstation.
For the Patient
For the Surgeon
For the Hospital
Managing the Complexity of Medical Device Development
Deciding to try to commercialize the single-port system, Talarico says, “We realized this was not something we could do in-house. We needed one firm that would partner with us to manage not only the physical product development but also every other aspect of delivering a complex piece of equipment to the marketplace with all of the appropriate information for FDA and EU approval.”
After considering a number of candidates, Titan chose Ximedica, an ISO-certified, FDA-registered, full-service development firm that focuses exclusively on the medical industry. “We had narrowed our search down to two potential vendors and ultimately chose Ximedica because of their capabilities, feedback from references, product understanding, communications and management skills as well as an overall feeling that they could handle all aspects of the project under one roof,” says Titan CEO, John Hargrove.
With over 25 years of experience with medical devices, combination products and consumer healthcare products, Ximedica has a portfolio of clients ranging from lean startups to industry leaders. Projects have included the first-ever wearable sleep monitor, a device for facilitating the delivery of a complex gynecological procedure, an enhanced bedside respiratory system, and a number of novel drug-delivery platforms. Headquartered in Providence, Rhode Island, Ximedica was founded by Rhode Island School of Design graduates Aidan Petrie and Steve Lane, and now has offices in St. Paul, Minnesota and Hong Kong as well.
Titan engaged Ximedica in the summer of 2012 to bring to life what is now known as the SPORT (Single Port Orifice Robotic Technology) Surgical System [see sidebar]. Dr. Dennis Fowler, one of the co-inventors of the licensed technology who is a known thought-leader in the adoption of MIS techniques, worked closely with Titan and Ximedica as a consultant. Now Director of Clinical Affairs for Titan, Dr. Fowler is also Professor of Surgical Science and Director of the Center for Innovation and Outcomes Research in the Department of Surgery at Columbia.
Since larger, multi-port robots are usually employed for specialized operations such as hysterectomies and prostatectomies, Dr. Fowler and his co-inventors had initially targeted the more straightforward procedure of gallbladder removal (a.k.a. cholecystectomy, which is performed for approximately one million people annually in the United States alone). As the complete system takes shape, Fowler points out that the SPORT Surgical System is essentially a platform from which the technology can advance still further.
“Once we have the platform fully developed for cholecystectomy, we can refine it for other general surgeries such as appendectomies and ear, nose and throat procedures,” he says. “In subsequent generations we will be able to add additional sensors, tools, and software enhancements. But first we need to perfect the platform.”
Under Ximedica’s wing, development of the SPORT Surgical System reached the critical milestones of user-needs research, achieving technical feasibility and live-tissue testing in just 15 months. Development and building of the pre-production prototype is now underway, to be followed by pre-clinical and clinical trials, regulatory submission, and a pilot launch. Initiation of U.S. and outside-U.S. regulatory clearance processes is currently scheduled for 2015, followed by limited commercial launch. Titan is planning to introduce the SPORT Surgical System in Europe and the United States—the world’s two largest markets for robotic surgery.
Planning Before Engineering
“This kind of fast, cost-effective design cycle is essential for a new company trying to enter a market with a more efficient product at a lower price point,” Ximedica co-founder and chief innovation officer Petrie says. “But you must start from complete information so that early decisions are made intelligently and accurately. Extraneous, nonessential features in a design can impact engineering and production costs and, ultimately, time-to-market.”
Ximedica began the SPORT Surgical System project by bringing all parties together to visualize the full scope of the challenges that lay ahead. “Before anyone even picked up a pen or started putting together a schematic we needed to understand every segment—the IP landscape, the clinical procedure, the users, the economics, competitors and so forth,” says Petrie.
Meeting in person with Titan as often as once a week, with daily update phone calls and emails in between, the Ximedica team went to work. Human-factors engineers, information architects, regulatory specialists, and R&D-, design-, software- and mechanical engineers (some 60 people in all have worked on the project to date) put their heads together with the client. “Ximedica’s proprietary process development and management system marries lean development best practices with the rigors of regulatory requirements to create a smooth path toward commercialization,” says Petrie. To this end, Ximedica’s “Opportunity Assessment Evaluation” examines design, manufacturing, regulatory, market forces, resources, planning, and both client and competitor IP, then identifies associated risks and offers targeted mitigation solutions.
“Risk management is critical in this business,” Petrie says. “Do you know who your competitors are, how long product development is going to take and how much it’s going to cost? It’s our job to accurately forecast, and then answer, every one of these questions as we proceed.” Ximedica provides Titan with ongoing reports that track time and expenses throughout the project.
Read Part II of this case study, which reviews the process of identifying users and their needs.