The Power Driving Medtech

With the finale of 2012 just around the corner, a meaningful adage for the medical technology industry to consider is, “Change is inevitable; growth is optional.” Whether it’s a new 2.3 percent excise tax on certain medical devices, a new president of the United States, a new global competitor, or even a new medical innovation that makes your technology obsolete, the reality is that change is a defining characteristic in the medtech world.

How a company chooses to deal with change is what determines if it will survive long term or if they find themselves unable to compete. Organizations that consistently evaluate how they can refocus or revitalize their enterprises are rewarded over time. Conversely, companies that do not embrace change and continue doing the same things over again tend to face very punishing markets.

This especially is pertinent for companies looking to compete on a global scale. In order to stay relevant and add the most value to their customers, medtech companies must adjust their innovations to meet the changing needs of the global healthcare environment.

Reflecting on the past year, it’s clear that many industry leaders are receptive to this and are embracing change. For example, 2012 has revealed that the next wave of medical device innovations is employing power and robotics.

The following observations reflect my opinion as to how innovative medical technology firms are using power and robotics to adapt their existing and emerging medical technologies and positioning themselves for growth in 2013 and beyond.

Power
If you were to ask most people if they’d prefer to use a manual screwdriver or a powered instrument to drive screws into a hard surface, the vast majority would choose the powered device. They would reason that the torque and speed offered through power would make the process more efficient and it would require less physical effort to drive the screws into the hard surface. In most cases, they’d be right.

Nearly all of the reasons supporting the powered screwdriver also apply to surgical procedures that involve setting screws into a bone, which is why the use of powered devices has been customary for decades in traditional orthopedic operations such as hip and knee surgeries.

Even with a powered surgical driver, these orthopedic surgeries often involve a great deal of physical effort associated with drilling, tapping, and securely setting rods, implants, and screws into the bone. If a manual screwdriver was used instead, not only would the surgery be utterly exhausting, but the physical strain from doing surgery after surgery using a manual device would make it impossible for the surgeon to attend to multiple patients, as they do today. In addition, the repetitive motion caused by twisting the screwdriver over and over again would likely lead to carpal tunnel syndrome, or some other injury that probably would impede the surgeon’s career.

Today, power drives most orthopedic surgeries, but there are some exceptions. Until recently, surgeons have been apprehensive about incorporating powered surgical devices in their spine surgeries. Although spine surgeries technically are considered an orthopedic specialty, it’s practiced mostly by neurosurgeons due to its proximity to the long, thin, tubular bundle of nervous tissue that makes up the central nervous system. Too much power or torque could have dire consequences for the patient.

Understandably, most spinal surgeons were inclined to use a manual device to set screws into the vertebral column. But with 24 articulating vertebrae and nine fused vertebrae in the sacrum and the coccyx, this process often is physically laborious.

The need to drill multiple holes and drive numerous screws into the bone is the principle reason behind what led the craniomaxillofacial market to augment their cranial closure systems with powered devices.

“We’ve definitely seen a trend over the past few years with more and more surgeons wanting a powered screwdriver and drill to reconnect the cranial flap after a craniotomy,” said Pat Lemoine, senior product manager at KLS Martin. “Powered devices not only assist them in finishing the procedure more efficiently, saving them time, but they also result in less hand fatigue.”

The Ease of Power
While powered devices have become a staple in some neuro-related procedures, such as cranial closure systems, the reception has been less enthusiastic in spine—until this year. In April, Medtronic Inc. announced the launch of its Powerease System, which is an arrangement of electronic instruments designed specifically for spine surgery.

Approved by the U.S. Food and Drug Administration, Medtronic claims the Powerease system has given spinal surgeons an archetype to interact with so they can experience first hand how a powered device can help them resolve some ubiquitous challenges, including:

• Reducing fatigue and injury caused by the repetitive hand motion associated with manually ratcheting screws;
• Maintaining the surgeon’s ability to “feel” the torque at which bone screws are inserted;
• Minimizing unintended ‘wobble’ and enhancing the control of a surgeon tapping and driving a screw; and
• Ensuring a better experience and outcome for the patient.

The technology has sparked new conversations about using powered devices in spine surgeries. While change does not happen overnight, this innovation no doubt will change mind-sets about power in spine surgeries. In fact, it already has.

Only a few years ago, approaching a manufacturer of spinal surgery instruments about adding power to their devices was an exercise in rejection. Now, as we near 2013, the tables have turned. Manufacturers of spine-related devices are approaching power specialists at an eyebrow-raising rate. With competition being alive and well in medtech, they also want their powered spinal surgery system.

This is cause for enthusiasm, as well as caution. Just as oncology, neurosurgery and pediatrics are medical specialties, so is the ability to design and manufacture the next generation of surgical devices. It’s a specialized skill-set requiring extensive expertise in mechanical, electrical, and chemical engineering; a unique understanding of the proper regulatory approval process; and distinct capabilities to ensure that the powered device will remain safe and reliable—even after exposure to harsh liquid environments during usage and cleaning.

With an increasing number of patients entering the operating room globally, the demand for powered devices will continue to increase. However, adding power to a medical device is not a one-size-fits-all
approach. Each medical specialty has its own unique needs related to speed, power, torque, and stability.

In order for a medtech company to develop its own innovative powered device for spine and other types of surgery, partners are needed that keenly understand the unique complexities of power and
remain on the cutting edge of related emerging technologies.

Robotics
The field of robotics has the potential to drastically alter how we live in the 21st century. We’ve already seen how robots have enabled us to see places that humans are not yet able to visit, such as other planets and the deepest trenches in the ocean. And in the past two decades, thousands of patients already have experienced how the use of robotics in surgery has improved their outcomes, accelerated their recovery, and reduced scarring, pain and discomfort.

But a key factor in helping ensure the robot’s accuracy and effectiveness is power. A robot’s smooth, steady, stable movement is made possible by power generated from motion controllers, motors and batteries. Today, even the steadiest of human hands cannot match those of a surgical robot. In his book, “The Edge of Medicine: Technology that Will Change Our Lives,” William Hanson, M.D., writes:
“While surgeons are supposed to have steady hands, many don’t, and the robot can filter the tremor out of a surgeon’s movement which can be extremely useful in delicate applications where fine control is critical, such as sewing small vessels or nerves together. The robot also can be programmed to scale movements, typically down, so that a 1-centimeter movement of the surgeon’s fingers is translated, for example, to a quarter-centimeter movement of the robotic hand.”¹

In addition, carefully powered robots can help surgeons minimize the strain on their own bodies associated with performing surgery. As previously mentioned, applying power to surgical procedures, such as hip and knee replacements, has helped surgeons prevent conditions such as carpal tunnel syndrome caused by cumulatively repetitive movements. But even powered instruments still require that the surgeon physically hold the device when performing surgery. With innovations in powered robotics, robots can perform the most physically strenuous parts of the procedure while the surgeon supervises. For a hip or knee replacement, this might entail drilling existing bone, fitting an implant into the new joint, and setting screws.

Called supervisory-controlled robotic surgery, this type of surgery is the most automated. However, just because the robot performs the surgery does not mean that they do so without any human guidance. In fact, surgeons must do extensive prep work with surgery patients before the robot can operate.²

In the article “How Robotic Surgery Will Work,” the authors make the following observation: “Supervisory-controlled systems follow a specific set of instructions when performing a surgery. The human surgeon must input data into the robot, which then initiates a series of controlled motions and completes the surgery. There’s no room for error—these robots can’t make adjustments in real time if something goes wrong. Surgeons must watch over the robot’s actions and be ready to intervene if something does not go as planned.” ³

Supervisory-controlled robotic surgeries are likely to increase in 2013 and beyond as they can be very precise, resulting in reduced trauma and shorter recovery periods for the patient. And because the surgeries only are supervised by the surgeon—not performed by them—a surgeon reduces surgery-related wear and tear on their own body.

The possible applications of robotic surgery are as extensive as the uses of minimally invasive surgery. Robotic surgery already has become a successful option in orthopedic, urological, gynecological, cardiothoracic and numerous general surgical procedures.

Taking Surgery to New Depths
This next generation of power also will play a vital role in telesurgery, which is the ability of a doctor to perform surgery without being in the same physical location as a patient. In fact, the potential for telesurgery already has been realized.

“On Sept. 7, 2001, Dr. Jacques Marescaux, operating from New York, successfully removed the gall bladder of a woman on the other side of the Atlantic, in Strasbourg, France, using a remote-controlled robot-assisted laparoscopic device. Since then, surgeons have performed more complex operations on remote patients using a variety of surgical tools,” Hanson wrote.⁴

Hanson goes on to write about NASA’s Extreme Environment Mission Operation (NEEMO), which is based on the ocean floor off Key Largo, Fla. The NEEMO project places astronauts in an undersea environment to simulate living and working conditions that they may face on the International Space Station, and could one day encounter on the moon and Mars. One of the goals of the NEEMO project is to use technology to enable doctors to perform surgery in environments that are too dangerous or remote to reach in person.

The base unit, called Aquarius, is an underwater laboratory and home to scientists for missions up to 10 days. At present, Aquarius is located in a sand patch on the ocean floor at a depth of 63 feet.

On a mission a few years ago, Mehran Anvari, M.D., founding director of the Centre for Minimal Access Surgery (CMAS) at McMaster University, used a surgical robot located at the university’s home of Hamilton, Ontario, Canada, to suture a laceration on one of Aquarius’ underwater aquanauts. The device he controlled was a small portable robot, equipped with a camera and pincers that easily would fit aboard a space shuttle.

From a console at the university, Anvari repeatedly has been successful in using surgical robots to operate on patients hundreds of miles away—and, in the case of NEEMO, almost 100 feet below the earth’s surface.⁵ Furthermore, he’s teaching and mentoring dozens of other surgeons to be able to do the same.

By combining power, robotics, and pioneering communication technology, telesurgery not only would extend health services to remote rural areas in the United States, but even to other countries where quality medical care is hard to come by.

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There’s no doubt that advances in power and technology will help shape and expand the future of medicine. Medtech companies that want to be on the cutting edge of meeting global healthcare needs in 2013 and beyond will be well served to prepare now—even before 2012 comes to a close. As American statesman Dean Acheson wisely stated, “Always remember that the future comes one day at a time.”

By evaluating how power and robotics can enhance their existing or emerging technologies, medical device companies position themselves to benefit more people in the future and do so safely, reliably, and economically.

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References:

1. William Hanson, M.D., The Edge of Medicine: Technology That Will Change Our Lives (New York: Palgrave Macmillion, 2008), 90
2. Kevin Bonsor and Jonathan Strickland, “How Robotic Surgery Will Work,” How Stuff Works (2011) http://science.howstuffworks.com/robotic-surgery.htm
3. Bonsor, Strickland, “How Robotic Surgery Will Work,” http://science.howstuffworks.com/robotic-surgery2.htm
4. Hanson, The Edge of Medicine, 36-37
5. Ibid, 37

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Michael J. Berthelot is CEO and President of Pro-Dex Inc., a publicly traded Irvine, Calif.-based company that designs, develops and manufactures powered surgical devices for world-class medical device OEMs. In addition to his duties at Pro-Dex, Berthelot currently serves as a director of Fresh Del Monte Produce Company and has served as a member of more than 30 public and private boards in the United States, Canada, England, Brazil, Spain and Germany during his career. He also is an adjunct professor at the Rady School of Management at the University of California San Diego, where he teaches a graduate level course on the CEO, the board of directors, and corporate governance.