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Bones of Invention

A growing number of orthopedic surgeons are putting their clinical experience to good use designing innovative products and medical procedures.

O for a muse of fire, that would ascend the brightest heaven of invention, A kingdom for a stage, princes to act, And monarchs to behold the swelling scene! — William Shakespeare, Act 1, “Henry V”

Muses long have been the impetus of creative genius. Virtually since the dawn of civilization, man has
attributed his intellectual and artistic pursuits to the influence of a muse, though the deity has lost much of its immortality over the course of history.

Ancient Greeks routinely sourced their bursts of creativity to the nine daughters of Zeus and Mnemosyne (memory personified)—caretakers of the world’s knowledge and innovation. Primordial literature portrays the Muses as intelligent, beautiful divinities with a bit of a vengeful streak. In one myth, for instance, the ennead judged a contest between Apollo and Marsyas, and punished the loser—Marsyas, naturally, for even thinking he could beat a god—by flaying him alive in a cave near the river city of Celaenae. (Apollo, according to legend, then flaunted his victory by nailing Marsyas’ skin to a pine tree). In another parable, the Muses stripped European songbird Thamyris of his talent after he challenged them to a singing contest and (as expected) lost.

While the overall concept of muses has remained largely intact over millennia, the creatures gradually have evolved into more ephemeral beings with many of the faults and foibles Calliope and her sisters reviled. Literary scholars, for example, still question the inspiration for William Shakespeare’s “The Dark Lady.” Some believe he based the mysterious, lusty character in those sonnets on an actual woman while others contend the mistress with raven-black eyes and “black wire” hair is merely the product of an extremely creative mind.

Raven-haired beauty Gala Dali (born Elena Ivanovna Diakonova) served as both muse and model to surrealist artist Salvador Dali and various other artists and musicians, including American singer Jeff Fenholt, who is famous for his portrayal as the title character in the Broadway musical “Jesus Christ Superstar.” Dali repeatedly credited Gala with saving his life, as he oftentimes feared dying young and succumbing to overwhelming insanity.

Such fears were foreign to fellow Spaniard and painter/sculptor/ceramicist Pablo Picasso, but he—like Dali—found a muse who inspired some of his greatest work. Marie-Thérèse Walter, a fair-haired French gem, met the artist outside a Paris department store when she was 17. Immediately smitten, the pair began an affair that lasted nearly 30 years, produced a daughter and induced such renowned portraits as “Nude, Green Leaves and Bust” (which sold for $106.5 million at auction) and “La Rêve.”

For centuries, the role of muse generally has been fulfilled by women (perhaps in keeping with the tradition of the original nine). Long stretches of art and literary history have produced essentially the same story: Boy meets girl; boy paints (or writes about) girl. Fame and/or fortune follow (or not). The End.

But in this post-modern era of gender transcendence, the role of a muse now is much more balanced between the sexes. Fashion designers such as Carri Munden (creator of the menswear label Cassette Playa), Carola Euler, Ute Ploier and Siv Stoldal all draw inspiration for their clothing lines from male relatives, friends or acquaintances. And “Harry Potter” author J.K. Rowling based Hogwarts potions master Severus Snape on her grim instructor John Nettleship at Chepstow Comprehensive School in Wales.

Muses no longer are limited to the art world, either. The aesthetics of medical device design and technology demand just as much creative elegance as a classic painting or a timeless piece of clothing. Crafting safe, efficacious orthopedic implants or instruments that are both simple and technologically advanced is, in its own way, a work of art. Device manufacturers and design engineers would be remiss to overlook muses to provoke and inspire. Anyone can hire a focus group; a muse offers the promise and potential of epiphany.

In most cases, that epiphany emanates from orthopedic surgeons who conspire with their own muses to create devices and instruments that help advance patient care and improve medical procedures.
Over the last several decades, surgeons have become an integral part of the device innovation process, inventing equipment or techniques based on personal preference or overall market need.

“Orthopedic surgeons and neurosurgeons are essential to the [product development] process,” said Michael H. Heggeness, M.D., Ph.D., a spinal surgeon with the Baylor Clinic and a professor of Orthopedic Surgery at Baylor College of Medicine in Houston, Texas. In addition to his medical degree, Heggeness has a doctorate in biochemistry and has conducted research in virology at Rockefeller University in New York, N.Y.

“The surgeon is the one who perceives the needs of the patient,” he noted, “and is best able to come up with creative solutions.”

Granted, these solutions are not as easy on the eye as Picasso’s “Nude in a Black Armchair” or Dali’s “Portrait of Galerina,” but they are, in a sense, works of art. Consider, for example, the simple Ferris wheel-like design of the Circo-Lectric Hospital bed from Homer Stryker, M.D., founder of Kalamazoo, Mich.-based Stryker Corp. The bed, suspended between two wheels, had an electric motor that turned the bunk to a vertical or horizontal position, as well as various angles in between. The bed could be operated by a patient or a nurse, a feature that helped reduce the amount of time and effort used by hospital staff to physically move patients.

The George Arthroscopic Knee Positioner has a similar simplicity to its design. Shaped almost like an ancient sickle, the 22-inch device provides lateral and superior support during knee resurfacing or replacement procedures. The Positioner uses valgus stress to open the knee’s medial (inside) compartment, but does not squeeze the thigh, making the need for a thigh tourniquet during surgery optional. In addition, the device can be rotated out of the way without disrupting the sterilized area, and, when used with a standard operating room table clamp, the Positioner can be raised or lowered to accommodate all thigh sizes.

“Orthopedic surgeons are very important to the product development process. As users of the orthopedic devices, surgeons are uniquely qualified to evaluate the products,” Michael S. George, M.D., the Positioner’s inventor, told Orthopedic Design & Technology. “Often the only way to discover the nuances, both intentional and unintentional, is to use the product in the field. While a product may work perfectly well in the laboratory, sometimes unforeseen issues are discovered only during real surgery on living tissue.”

Such practical clinical use helped ConforMIS Inc. of Burlington, Mass., hone its iTotal Patient-Specific Tricompartmental Knee Replacement System, a U.S. Food and Drug Administration (FDA)-cleared personalized knee implant made available to select groups of surgeons last year. The system is slated for a full-scale commercial launch later this year.

The iTotal (the “i” stands for individualized) uses proprietary software that incorporates data from computed tomography scans to generate a 3-D model of a patient’s knee. That model then is used to design and manufacture an implant that conforms to the precise area in need of repair (hence the first part of the company’s name—the second part stands for minimally invasive surgery). The 8-year-old company uses computer-driven machining or prototyping tools to fabricate the artificial joint, a process that takes four to six weeks, as well as customized surgical tools (called “iJig”) for implanting it.

Designed as an alternative to traditional total knee replacements which come in a limited range of sizes and shapes, ConforMIS’ customized approach precisely matches each implant to the shape and curvature of the individual joint. The iTotal system also allows surgeons to avoid many of the sizing and fit issues that can compromise surgical results.

The company worked with an Advisory Board of surgeons to develop the implant. As part of the original design team, for example, Raj K. Sinha, M.D., Ph.D., worked on developing the implant concept and participated in the first set of clinical cases as an expert user. The company also tapped other surgeons such as Gregory M. Martin, M.D., and Terry A. Clyburn, M.D., to help refine the iTotal and the surgical technique. The trio of surgeons—all knee replacement virtuosos—participated in a process of providing feedback to the company and reviewing modifications to both the instruments and the technique that resulted in the final launch version of the system.

All three surgeons were familiar with ConforMIS, having been drawn to the privately held company by the promising results of its patient-specific technology. Sinha and Martin had worked with the company on its iUni G2 and iDuo G2 partial knee systems as well, with Sinha designing the iDuo G2.

Like the iTotal, the shape and size of each iUni and iDuo is customized to match individual patient anatomy. But for those with more limited disease (osteoarthritis), the iUni may allow for a minimally invasive procedure with more bone and ligament preservation than a traditional total knee replacement, and the potential for a more natural-feeling joint.

Martin’s contribution to the iUni/iDuo refinement process was a “femur first” procedure that reportedly halves surgery time. His suggested enhancement for the iTotal system was an instrument change to ensure the iJig tool set accommodates the needs of all surgeons.

“There’s two different ways to put in knee replacements and there’s two different schools of thought,” explained Martin, medical director of the Orthopedic Institute at JFK Medical Center in Atlantis, Fla., and an orthopedic surgeon in private practice in nearby Boynton Beach. “One way is what is called a traditional gap balancing technique, where you prepare the bottom part of the femur and the upper part of the tibia. You cut those first and then check your gaps. That’s a good technique, but only half of knee surgeons do their knee [replacements] that way.”

“A lot of surgeons perform what is known as a measured resection technique, where you usually prepare the whole femur first, and then do the tibia and then do the balancing,” he continued. “I find this to be a much more efficient technique. There was a lack of that kind of efficiency in the [iTotal] technique.
So we changed the instrumentation to accommodate both kinds of users. We went from a knee device that could only meet the needs of half of knee surgeons and now we’ve made it acceptable to all knee surgeons regardless of the technique they are familiar with. In the process of doing that, we were able to engineer and simplify the iJig instruments and make the process of putting in the knee more efficient.”

Innovation Takes Time, Teamwork

Martin, Clyburn and Sinha did not work in a vacuum during the iTotal’s final metamorphosis. The trio collaborated with each other and with a team of joint replacement surgeons to identify deficiencies with the system and agree on improvements. To be successful, the collaborators must work together as a team toward a common goal—a concept that appears easy to accomplish but can be difficult to execute due to the mix of personalities, opinion, eccentricities, experience level and product knowledge of participants. “It’s not always easy because surgeons tend to be very opinionated and decisive,” one knee replacement specialist confided to ODT.

Personalities and egos aside, one of the most challenging aspects of teamwork is scheduling. Many surgeon innovators who have worked with other physicians to develop implants or instruments have found it difficult to coordinate schedules, particularly with those in private practice.

“From a surgeon standpoint, the biggest challenge in working with a team is time,” noted Sinha, a board-certified hip and knee replacement specialist with STAR Orthopaedics Inc. in La Quinta, Calif. “Being able to find the time to get together with the other design members and surgeons, taking time away from our practice, is difficult. Every time you meet, there’s a follow-up meeting that needs to occur or should occur to talk about things that haven’t been addressed or something that came up when a new idea was suggested. And then, once you get that done, we always get antsy to have whatever improvements or enhancements that have been made in hand. From that perspective, it’s challenging to have to wait.”

It also can be challenging to work with product engineers, who generally lack the clinical experience to know the types of artificial joint or instrument designs that will work best in the operating room. For example, most engineers are unaware that a drill designed a certain length will hit a patient’s head when he or she is placed in the beach chair position. Likewise, orthopedic surgeons are probably unfamiliar with the hydrophilic coating process that gives silicone devices both a dry and wet lubricity, or the ion implantation method involved in the manufacture of wear-resistant hip and knee joints.

The keys to success in any business partnership—whether it is between surgeons or between physicians and product engineers—is mutual respect for the others’ knowledge, flexibility and a willingness to compromise. Martin likened the collaboration between surgeons and product engineers to the home builder-architect relationship, noting that well-designed homes that are incorrectly constructed obviously are inferior to those that are designed and built well. Both architects and home builders—not unlike surgeons and engineers—must work harmoniously to create a long-lasting, well-functioning, high-quality product for users, he said.

Clyburn agreed, but offered a more lighthearted take on the working relationship between surgeons and engineers.

“My joke is the operating room is a lot different than the cubicle,” Clayburn said in a typical southern drawl (he’s a Houston, Texas, resident as well as a professor of orthopedics at the University of Texas Medical School at Houston and a clinical associate professor at the Baylor College of Medicine in the same city). “When you’re sitting there in your cubicle looking at a three-dimensional image on a computer or you’re holding a rapid process prototype in your hand, that’s a whole lot different than being in the operating room working inside a wound that has blood, bone, a hole in the bone and various other things. Certain little knurled knobs, screwdrivers and things like that don’t necessarily work very well in the operating room.”

“But everybody on the team brings input,” he explained. “We know what is necessary. We are the boots on the ground doing the work in the O.R. We know what the issues are and what issues need to be resolved, and we depend on bright engineers to help us come up with answers that we may not have. We may be able to identify the problem and make some suggestions about how things can be done but very few of us are engineers or metallurgists. We don’t know exactly how to solve the problem, we just know what the problem is and we want it fixed and these guys know how to do that.”

While teamwork can be both exhilarating and gratifying, Clyburn advises against involving “too many brains” in a product development project. He suggests limiting surgeon-engineer teams to a maximum of four members to avoid hampering the development process, at least in the initial phases. But as the product gets closer to commercial release, broader surgeon involvement can help determine whether the device is ready for all users.

Working alone can be problematic as well. Clyburn flew solo in 1984 when he created an external fixator for radius bone fractures that allowed patients to move their wrists while their injury healed. Prior to that invention (appropriately named the Clyburn Dynamic External Fixator), orthopedists traditionally treated radius fractures by casting the injury or attaching pins above and below the break to immobilize it. Such treatment often resulted in permanent wrist stiffness.

Clyburn sold his external fixator design to Zimmer Holdings Inc., which manufactured, marketed and sold the device for at least a dozen years before small screws and plates improved radius fracture treatment in the late 1990s.

Though freedom from obligatory group meetings, ego clashes and creative compromise might seem attractive, independent inventors face a host of their own challenges, including time (again), funding, research, product approval, intellectual property (IP) protection, marketing and commercialization.

“The invention of a specific product is the easy part, actually. It is a rare tool or technique that cannot be improved upon,” Heggeness asserted. “Likewise, very new concepts and ideas occur to the specialist very frequently. There is, however, enormous cost to developing an idea. A simple patent application for a new device will cost between $5,000 and $20,000, depending on the complexity. Laboratory research is necessary to prove a concept, and almost always both animal and human trials are required. For any human work, we are obligated to work through an FDA-approved study. The FDA is a very dense federal bureaucracy that often will grant you only a one hour meeting every few months. It is a spectacularly slow and inefficient [approval] process.”

That currently may be the case, but the FDA Safety and Innovation Act signed into law on July 9 could very well expedite product approvals. While it doubles the cost device makers must pay for the FDA’s blessing over the next five years, the Act also provides the agency with an additional 200 case reviewers and loosens conflict-of-interest regulations that will let authorities use more outside scientists in the device approval process. As promising as these moves sound, however, they are still five or six years from implementation, a lag that is likely to agitate already-frustrated device manufacturing executives and orthopedic craftsmen. Minneapolis, Minn.-based attorney Mark DuVal predicts the delay also will spawn a petition from the industry that asks FDA Commissioner Margaret Hamburg to review her agency’s overall operations and focus on short-term fixes as it prepares for broader changes.

Temporary regulatory repairs may not be much help, though, to the surgeon trailblazer who encounters a previously unpaved path to product innovation. Mark Flood, D.O., encountered such a passage during the development of RegenaDISC, a spinal disc regeneration procedure that uses stem cell tissue to treat the root causes of back pain.

RegenaDISC enables surgeons to repair painful disc problems while promoting regeneration and healing using the patient’s own stem cells. The procedure involves extracting adult stems cells from a patient and transferring them to the affected discs to facilitate pain reduction and tissue regeneration. There is minimal risk associated with this procedure because doctors use a patient’s own stem cells to rebuild damaged tissue.

RegenaDISC uses a low-level laser to stimulate the cells and encourage regeneration. The procedure can treat degenerative, torn, ruptured, herniated or bulging discs and annular tears, and it gives patients who have not responded well to conservative treatments a minimally invasive alternative to spine fusion or other invasive procedures.

One of the most daunting challenges of inventing a product or surgical technique independently of a team is the inability to share responsibility for the research, funding or regulatory approval process. Flood, for example, spent more than one year researching the concept of biological treatments for disc pain—he attended seminars, talked to scientists throughout the United States, researched professional journals and traveled to both Moscow, Russia, and Dubai to find an alternative to conventional back pain therapies. Though his travels yielded a plethora of data on the science of back pain treatment, Flood discovered little, if any, practical methods to apply the knowledge.

Upon completion of his research, Flood spent an additional year concocting the RegenaDISC potion of stem cells, platelet-rich plasma light incubation and a low-level laser.

“There hasn’t been anything like stem cell procedures in the past so there’s no template, if you will, to go from,” explained Flood, chief of surgical innovation at the Laser Spine Institute, an outpatient surgery center specializing in minimally invasive spine procedures. The Institute operates facilities in Oklahoma City, Okla., Philadelphia, Pa., Scottsdale, Ariz., and Tampa, Fla.

“Assembling all the materials and putting them into a single procedure was very arduous,” Flood continued. “There were simple things—a catheter, a connector or a way of transferring the cells in a closed system—these steps required planning, devices and materials. This technique has not been done before, so it had to be started from scratch. There’s no clearing house to buy these products—you have to search them out, conduct the research, talk to individuals, and understand how people in a different field are doing something similar. It took a lot of time, effort, travel and research to assemble all of those components into a single outpatient procedure.”

Incorporation vs. Partnership

Most inventors, at some point during their careers, are oblivious to the obvious.

Thomas Alva Edison’s moment of oblivion occurred during his tenure as a telegraph operator during the mid- to late 1860s. His boss, a railroad superintendent, reportedly asked all telegraph operators to send short messages to the central office on the strike of each hour to ensure they remained awake on their shifts. The number for this message was “6.”

Annoyed with the directive, Edison created a device that relayed the “6” message at each appointed hour. The superintendent noticed that Edison’s “6” arrived precisely on the hour but when messages were sent to his office, he failed to respond (Thomas usually reserved that time for catnaps and catching up on his reading). The invention was banned upon discovery but the future “Wizard of Menlo Park” was not fired for the ruse (Edison’s dismissal came about when he failed to pass orders to a freight train, nearly causing a head-on collision).

Jeffrey Gelfand’s instant of inadvertence took place about four years ago as he toyed with an idea to treat unstable distal clavicle (collarbone) fractures.

“The idea involved the combination of two different commercially available products together to treat these [distal clavicle] injuries, which historically have been very challenging,” recalled Gelfand, M.D., founder of The Helping Hands Foundation, a nonprofit agency providing humanitarian surgical relief to the developing world. “I had some good early clinical results and when someone commented that it was a ‘really good idea,’ I decided to file a patent application. The early design work resulted in a platform technology that allowed precise tensioning and maintenance of that tension for soft tissue repair.”

Thus was the drive behind Suspension Orthopaedic Solutions Inc., a privately held company in Arnold, Md., that develops products for treating traumatic musculoskeletal injuries. Founded in 2008, the firm’s two debut devices, the Suspension Clavicle Fracture Fixation System and the Suspension AC Joint Injury Repair System, both are designed to address injuries to the shoulder suspensory area.
Gelfand is not the first surgeon inventor to form a company based on an orthopedic device or surgical technique. Proud Texan Clyburn founded Innovative Global Orthopaedic Technology in Texas (a.k.a., IGOTIT) to help commercialize and market a bone cement dispenser and a hip vice, among other products. The hip vice is described as an apparatus that attaches to an operating table as a support device for positioning a patient in the lateral position during hip or pelvic surgery. It has a removable top platform for supporting surgical instruments and an arm support attachment that supports the arm of the patient.

While invention-inspired firms enable their founders to control the product development process and maintain ownership of IP, forming a medical device company can be a daunting task for those unfamiliar with the business world. Surgeons, for the most part, are trained to treat disease and save lives; as such, they are unlikely to recognize all the steps involved in establishing a company: filing a business plan, for instance, or acquiring a license, appointing officers, obtaining product and/or liability
insurance, forming a corporate board, and raising capital. Physicians with truly novel ideas also must consider protecting their concepts through patents, which can spawn its own set of challenges (utility or design rights?).

“You used to be able to draw a picture on the back of a napkin and get a patent. But the bar for obtaining a patent is much higher now and it requires a skill set that most orthopedic surgeons just don’t have,” noted Jon B. Tucker, M.D., an orthopedic surgeon and sports medicine specialist with his own practice in Pittsburgh, Pa., who has participated as a team member in the development of several patentable medical devices. “We’re surgeons, not engineers. The engineering that goes into many of these devices is amazing, it’s not limited to simple drawings. The process is time-consuming and expensive. To try to do it yourself these days is very difficult…it takes a team of surgeons, engineers, and capital partners. Surgeons need to understand that, and they need to understand that they will not in most cases own any patents that evolve from a team effort."

Surgeons also need to realize that FDA matters are better left to business experts. Though they may have a general familiarity with the agency, many surgeons are not aware of the minutiae associated with device registration, review or approval. OEMs and established orthopedic manufacturers, on the other hand, work with the FDA on a regular basis, and therefore have amply mastered the complicated regulatory matters of premarket notification, substantial equivalence, and device classification exemptions.

Such proficiency in FDA guidelines and other areas like patents, copyrights and venture capital funding make OEMs and smaller, more established firms a viable business partner for surgeons looking to market their creations. Many ingenious physicians, in fact, are more willing to partner with a company than they are to start one of their own.

“To start a company, you need to have a product that is a real game-changer or you need to have a host of products. Companies nowadays are not going to survive with one product unless it’s a truly unique product,” explained Lonnie Paulos, M.D., a top-rated knee surgeon with a private practice in Salt Lake City, Utah, and owner of more than a dozen patents for braces, frames and fixation devices.

“The more common approach is taking your product to company engineers and development people to see if they are interested in a certain product. You don’t start your own company. If you think about it, one of the largest companies in the world for orthopedics is Stryker. Dr. Stryker started the company in his garage. He went into surgery and decided he needed some instruments so he went back to his garage, made them, gave them to the nurses to sterilize and then put them in people. You can imagine what would happen to him nowadays. But that’s how Stryker Orthopaedics and other companies started—physician tinkerers doing it themselves, and then building.”

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