Nine blue suits squinted in the spring sun and, no doubt, wished they could pull out the Dockers this past April 23, 2010, in northern New Jersey. But to honor this important milestone in the continuing development of orthopedic biomaterials, the senior executives from Zimmer, accompanied by every employee of the new state-of-the-art training facility AND the mayor and members of Parsippany’s city council wore their Sunday best and big, big smiles. The Trabecular Metal dream, one of the most ambitious and promising in orthopedics, was taking a huge step forward.
It was a truly beautiful day for a ribbon cutting. The sun warmed the cool breezes. The crocus and irises were just showing off their full array of colors. Was it fung shei or just Mother Nature? Whatever it was, the beauty of the day somehow affected the speeches and even inside the facility, it was as if the sun was shining on the future of Zimmer and Trabecular Metal.
Trabecular Metal
The history of orthopedic implants is the tale of many innovative surgeons and engineers. It is also the history of biomaterials. The great John Charnley, for example, might never had solved the problem of an articulating hip implant had his assistant not chased down the polymer salesman (after Sir John kicked him out of the lab!) to get his material tested as an implant. After approximately 300 consecutive implant failures (in humans), Sir John Charnley had a polymer material for his acetabular cup. The rest is orthopedic history, of course.
In the half century since Sir John, biomaterials have continued to advance and in some cases revolutionize patient care. One of the potentially most revolutionary biomaterials since high molecular weight polyethylene is Trabecular Metal.
Imagine, for example, a sponge-like metal foam that can either coat an implant or even be the implant. Now imagine further that the foam, spongy material uses tantalum, one of the most biocompatible metals known to man, and that engineers can tailor the tantalum material to match the mechanical aspects and load-bearing functions of real bone!
That is the dramatic vision that a little New Jersey (yes, also in Parsippany) start-up company named Implex had for its new biomaterial called Trabecular Metal. Of all the major orthopedic manufacturers, only Zimmer shared that vision and like Sir John’s assistant chasing down the plastic’s salesman, Zimmer’s business development execs chased down Implex and convinced legendary skinflint Ray Elliot (Zimmer’s CEO in 2003) to buy Implex.
Looking back today, that deal looks as beautiful and sunny as the day the Trabecular training center opened in Jersey. But at the time, many of the orthopedic industry’s Old Guard thought of Trabecular Metal as little more substantial than a passing cirrocumulus cloud.
The cellular structure of Trabecular Metal is remarkably similar to that of Trabecular bone—the same kind of bone found in the joints of the body and replaced by joint implants. Among the unique characteristics of Trabecular Metal is that it can approximate the physical and mechanical properties of bone more closely than other prosthetic materials.
Trabecular Metal has a high strength-to-weight ratio and low elasticity which delivers to the patient the kind of physiological loading that encourages living bone to grow into the porous structure. Trabecular Metal forms a stronger bond with living bone than with other synthetic porous materials. Bottom line, strong bonds mean longer implant life.
Zimmer’s First OWI Training Facility
Zimmer, the world’s largest supplier of large joint implants (according to PearlDiver estimates, Zimmer holds a 25% market share followed by DePuy at 22%), already had an East Coast presence with its Trabecular Metal manufacturing facility in Parsippany. So the move to New Jersey was almost logical. Still, it is Zimmer’s first training facility outside of Warsaw and, according to Richard Stairs, Zimmer’s SVP of Global Operations and Logistics, about time.
“With its proximity to New York City, it really will be a global destination, ” said Mr. Stairs. The facility is just 20 minutes (by car) outside of NYC and another hour or so from Philadelphia. So surgeons up and down the East Coast will be able to receive hands-on training in the 113, 000 square foot facility (which includes, by the way, a 15, 000 square foot BioSkills lab).
Inside Look at the Classrooms
The training center is set up in two parts. Part one is a state-of-the-art dental facility that offers training in both surgery and prosthetics. “The biggest benefit here is our accelerated learning where clinicians get the chance to work on simulated patient models in a two-day course that would take six months with a patient, ” says Michael Collins, Vice President of Research and Development for Zimmer Dental.
The second part of the training facility is the BioSkills center which focuses on orthopedic procedures and the implementation of the Trabecular Metal in surgery. Here, physicians have the opportunity to work in cadaveric-based training in a space designed to mimic every feature of a typical operating room. Audrey Beckman, Senior Vice President, Zimmer Institute and Grants Office, explained that the training sessions themselves are designed to maximize the physician’s educational experience.
Each surgeon gets to perform at four levels of exposure, first they listen and watch in the lecture room, but it is much more about the hands-on experience and this is where the surgeons have the chance to watch and learn from each other while having the chance to work on procedures themselves. I think this type of sharing of ideas and techniques makes the facility’s educational possibilities limitless.
Beckman adds that there is a uniquely low ratio of physicians to lecturers. Expense was not spared when it came to the technological features of the room. “We’ve installed a high definition camera system with 1080-pixel monitors that allow for better identification of different tissue. This is essential for physicians because when we are talking hip, knee, and shoulder revisions, because of soft tissue, we really need that fine definition for orthopedic surgeries such as these.” Beckman adds that these surgeries can then be broadcast over the intranet and possibly the Internet. “For the physicians, this is all about learning how to minimize damage and enhance their performance during surgery. By having the opportunity to use anatomic tissue, the physicians can really fine-tune their skills on a model that is the closet they can come to an actual patient.”
Ok, one more item. Stepping into the spanking new training center is like walking into a posh hotel complete with rich colors of tans, blues, and metallic in a subdued, modern even hip environment. The furniture is sleek and comfortable (we sat in all the chairs, fell asleep once). Lighting is toned down and there’s a spacious feel to each room.
Keeping Things Compliant
Zimmer, which has taken an industry lead in ensuring surgeon and company compliance, took special care to put proper compliance mechanisms in place to make the center fully transparent to all regulatory agencies and that there were no “red flags”. As we all know, surgeon and company compliance with all industry and federal regulations can be challenging. But Zimmer has made a very public corporate priority to building a safe regulatory environment for surgeons.
“The biggest concept was the creation of a firewall that literally divided the company into two sections, ” says Zimmer Institute Director of Medical Education Mark Serafino. “Sales and marketing are on the commercial side and on the corporate side is anything to do with the institute, consultants and contracts. Separating the commercial from the corporate was key.” But aside from this main distinction, the training institute itself also has safeguards in place. “The institute handles the process of selecting and hiring consultants, which is important because these are people we are paying and they could very well be someone who is also buying the product. So the corporate side handles all of the selection of the faculty members and we manage their contracts and the payment process.”
According to Serafino, Zimmer moved away from faculty developed training content to a model where the institute itself developed course content with the faculty. “By controlling content, we ensure that it is consistent. The FDA of course requires safe and effective training which gives us our basis for offering training. Although we pay for attendees’ minimal expenses, we set up the training site at a non-resort location (Parsippany, New Jersey? Not a resort?). We make sure that anything we provide is modest and we keep to a strict timing schedule.” Serafino told OTW that there’s no time for recreation on these training trips and each surgeon spends six or seven hours in training, with only brief breaks for meals.
A Great Environment for Surgeons
Ajey Atre, General Manager of the Trabecular Metal Technology Facility sums up the new training center as “a state-of-the-art-facility that uses state-of-the-art-material.” He says he looks forward to seeing it become a hub of education and innovation on the East Coast and potentially the world.
“This is a great environment for surgeons to learn from each other, ” adds Beckman. “That’s so important in the field of orthopedics, where technique is so important and can be so individualized, that dialogue and interaction is so essential.”
As we said, it was a great day in Parsippany, New Jersey. Almost resort-like…Almost.
