Ori Hadomi, CEO of Mazor, discusses the process his company went through to develop, release an improved product to the market.
1. Focus on research and development. As more focus is being placed on clinical effectiveness for new products, it has become increasingly important for device companies to allocate resources for research and development. Companies must keep track of the biggest trends in orthopedic and spine devices to make sure their platforms are headed in the right direction.
Companies can also stay ahead of the curve by developing products that are a first of their kind in the market, as Mazor was the first company to bring robotics to spine surgery in the United States. Now, the company is developing implants that fit with its robot so the technology can complete a whole minimally invasive spinal procedure. “Later this year, we will be introducing a lumbar spine implant set, which will be the first time implants can be placed by the robot minimally invasively,” says Mr. Hadomi.
2. Gather input on new technology over several years. Once a product has been developed and shown safe for treatment, gather critical input over several years from surgeons using the technology. “Mazor introduced the original product for the first time six or seven years ago,” says Mr. Hadomi. “During those years, we’ve kept communicating with our users, listening to their needs and requests and accumulated lots and lots of input on areas where they wish to see further development. We’ve been able to address many of these areas that were requested by our users.”
The surgeons working with the original robotic technology and software found they needed the system to correspond with various surgical approaches and imaging modalities. The surgeons also wanted to reduce radiation exposure during the procedure. The company was able to address these issues and receive FDA clearance for the revised product.
“We learned about several aspects of the product that we felt we could now develop new generation product that will take the spine robotic to its next stage, addressing many of the requests and concerns that been mentioned by users,” Mr. Hadomi says. “We accumulated these to develop a new platform with new computing capabilities and a completely different system to interface with software and hardware that expands clinical applications. We believe this is a system that actually addresses a wide range of issues that surgeons have shared with us throughout the years.”
3. Choose surgeons for partnerships with care. When you want good critical feedback on new developments or systems, partnering with surgeons is important. “For us being a small company, when you develop a sophisticated and sensitive product, there are always a lot of problems in the beginning,” says Mr. Hadomi. “You can’t afford to work with people who aren’t critical thinkers. You have to work with someone who will tell you what they think, whether they like the product or not, and share with you any concerns.”
Partnering surgeons should also be friendly, nice to work with people, whom you can work with on a professional level and have a straight forward line of cimmunciation. In these types of relationships, surgeons and device companies spend several hours together overcoming issues with the technology. Beyond those qualities, the surgeon should also be competent. “We might come to a surgeon with the most accurate robotic system in the world, but if the surgeon uses the tools to approach the spine in the wrong way, we sacrifice the benefits of using the robotic system,” he says.
4. Test the technology in several settings by diverse surgeons. It’s important to test new technology in several settings with a wide spectrum of surgeons to assess all aspects of the product. This means having surgeons conduct trials in cadaver labs as well as real-person cases, and these cases should run the gamut of complex, simple and deformity surgeries.
Companies should also have both experienced and new spine surgeons testing their products to assess the learning curve for different types of physicians. “We wanted to have experienced and new surgeons testing the technology because we wanted to make sure the learning curve was appropriate,” says Mr. Hadomi. “Once that was complete, we felt we had a system that was simple and addressed all the concerns surgeons would have. Only after all that was finished, we decided we were ready to introduce the product to the market.”
Learn more about Mazor Robotics.
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