Until recently, surgical remedies for certain spinal and orthopedic conditions were risky for the physician and inconvenient, at best, for the patient.
A hammertoe, for example, is one condition that can be repaired surgically. It occurs when the toe is bent at the middle joint and resembles a hammer. To correct the problem, an incision was made into the toe, the bad joint was removed, the bones were put back together and a metal rod or pin was inserted into the end of the toe to keep it all in place until it healed. During the healing process, patients had to be extremely careful of the exposed pin and were monitored closely for infection.
A new option to correct hammertoes is available now from Marquette’s Pioneer Surgical Technology. The StayFuse Inter-Digital Fusion System eliminates the need for a pin and its resulting complications.
Pioneer Surgical Technology, headquartered in the River Park business complex, is a state-of-the-art company that researches, designs, develops, manufactures, tests, packages and markets specialized surgical implants and instruments. Its products provide solutions for surgical procedures that have proven difficult for both surgeons and their patients.
Pioneer was founded in May 1992 by Dr. Matthew Songer, an orthopedic surgeon at Marquette General Hospital. Lawrence Mosca, vice president of administration and new business development, has been with Pioneer since its inception.
“Pioneer’s design rationale is to provide niche products that answer a lot of problematic things that orthopedic surgeons get into,” Mosca said.
Pioneer’s initial business model focused on cable-based systems for spinal and orthopedic implants, a contrast to the more popular wire-based systems. Such systems are used in a variety of surgical procedures that include closing the sternum after a heart or lung surgery, securing bones after a fracture and realigning the spinal column after an injury.
“As you’re twisting a monofilament wire, it forms a stress riser at the base of that twist,” Mosca said. “When you put a lot of pressure on it, especially in the [operating room] with the bright lights, you can actually see the metal flash blue and what it’s doing is getting soft. When it gets soft, it produces a place where it’s going to fail with constant fatigue and pulling. Because of that part of the wire system where it has that possibility of failing, especially if its not used properly or over-tightened, it could be problematic.”
Pioneer introduced its first product, the Songer (Spinal) Cable System, in November 1992. It provides a number of advantages over a traditional wire system to fix spinal conditions that result from a traumatic injury or diseases like scoliosis.
The system uses either stainless steel or titanium cable that is wrapped around the bones of the spine and secured using a tensioner/crimper device.
“You can attach it without having any failure or pre-weakening of the system, so it will work better,” Mosca said. “Cable is real flexible and easy to use. If you have a stiff wire, you have to be very careful how you maneuver that around the bone. With the cable, it’s very soft and malleable and you can pass it more easily.”
The first tensioner/crimper device originally was designed by Songer’s father in the late 1980s. He began the design process with a wire crimper used in electrical work and, with the help of a friend, produced the first jaws of the instrument using a guitar tuner as a tensioning device.
“One of the things that we’ve done is enhance all the things that are out there and what I feel are good improvements to the instrumentation that surgeons use to put the implants in place,” Mosca said.
The newest version of the tensioner/crimper is stainless steel and ergonomically designed with a narrow nose to reach deep into the human body.
The success of the Songer (Spinal) Cable System prompted Pioneer to expand its line of products. The company that began designing one product per year now designs four products per year; a medical advisory board of physicians from around the country oversees development efforts.
The StayFuse Inter-Digital Fusion System was developed thanks to a cooperative effort between Pioneer and designing surgeon Dr. Gregory Anderson of Salt Lake City (Utah). Used mostly to correct hammertoes, the system consists of a two-piece screw that holds the bones in place during healing. It is manufactured from titanium and available in a variety of sizes to achieve the best possible outcome for the patient.
StayFuse is an example of Pioneer’s process of seeking out surgeons and their ideas to develop new products. Pioneer licenses patent rights from a designing surgeon and improves upon the original idea.
“A lot of times, we’ll meet with a surgeon over dinner and he’ll pull out a napkin and sketch an idea,” Mosca said. “We have an integrated process where we involve engineering and manufacturing people pretty early on in the process because you want to make sure that not only is it a good design, but it’s something we can manufacture easily and in an economical way.”
Another important product is the Pioneer Sternal Cable System. It works similarly to the Songer (Spinal) Cable System, but is marketed to cardiothoracic surgeons to close the sternum after an open-heart surgery or lung procedure.
The Cable-Ready Bone Plate is a revolutionary design in the field of orthopedic surgery. It incorporates the cable component of the system that wraps around the bone in addition to screws that are drilled into the bone. This allows for both internal and external fixation. With Pioneer’s design, cable can run through the plate as opposed to competing products that feature crimp devices molded on top of the plate.
Pioneer’s orthopaedic cable systems are manufactured for two major companies: Zimmer and Synthes.
“These [companies] are competitors to each other,” Mosca said. “That’s kind of our history, but they trust us that we do a good job and produce good quality. They came to us because we’re recognized as experts in surgical cable applications.”
Pioneer also produces other products and product variations that are distributed around the world by other medical supply companies.
With the expansion of the product line, Pioneer was able to expand its facility and work force.
“You don’t just add one piece of the wheel, you have to add the entire wheel,” Mosca said.
Pioneer doubled the size of its facility from 35,000 square feet to 70,000 square feet in July 2003. Currently, it employs 130 people on two shifts (a third shift is computer-controlled and unattended).
“We’re located in the great north not close to supporting companies, so we have to do it ourselves,” Mosca said. “We’re very vertically integrated and most of the processes are here in-house.”
Pioneer also has a cooperative relationship with Northern Michigan University in an effort to employ the highly skilled employees that are needed to produce its niche products. NMU offers a one-year certificate program for future Computer Numeric Control (CNC) Technicians.
Chris Dykstra is a CNC Turning Operator. He received his certificate from NMU in 2002 and has worked at Pioneer ever since. Dykstra originally was enrolled in NMU’s Industrial Technology program, but saw the CNC program as a way to work with new technologies and stay in the area to work in a promising career.
“I can see what new advances are out there and I’m helping people feel better,” Dykstra said.
Throughout the program, Dykstra took classes on NMU’s campus, but spent time at Pioneer observing processes and learning techniques hands-on.
“It taught me the fundamentals of machining and programming in order to start a career,” Dykstra said.
Since he’s been at Pioneer, Dykstra has regarded his job as the ultimate learning experience.
“I’ve been here three years and I’m still learning,” Dykstra said. “I’ve seen how a manufacturing facility works because I’ve watched all the steps all the way to the paperwork.”
Dykstra’s work also makes a worthwhile contribution to countless individuals.
“We make quality products that help people out,” Dykstra said. “We’re helping people in pain to improve their lives and their lifestyle.
“I feel good about what I do.”
The process for creating a product at Pioneer is highly efficient.
It begins with research and development. Designing engineers, quality people and product managers working on the same project are grouped together.
“The idea promotes communication,” Mosca said. “Instead of having to call a meeting, you just turn around and there’s your team. We look at that as the ability to enhance the design process. It gets us from conceptual to product a lot quicker.”
Once a product is designed, it is drawn on a Computer Aided Drafting (CAD) system using finite element analysis. The mathematical model can be subjected to stresses and altered as necessary.
“We can actually test it before it’s produced,” Mosca said.
Once the design is complete, it is sent to the prototype shop where it is produced. It is then subjected to physical tests that are developed by Pioneer staff.
When the products pass the tests, they are ready to be manufactured and assembled.
Individual parts for each product are manufactured on Swiss-style lathes and palette mills. On a lathe, the material turns while the tools remain stationary. A mill holds the material still while the tools turn. Although both types of equipment can cost between $170,000 and $250,000 each, the technology allows for the production of high-quality and high-precision parts.
“The capital investment to do something like this is huge,” Mosca said.
Pioneer’s manufacturing process is streamlined. Workers use mills that contain two palettes that keep the machine in a constant state of production. While one mill is working, the other is being readied for its next task. Raw materials needed for production are located throughout the facility and are easily accessible to eliminate unnecessary steps.
“Part of what we do is process control and evaluation,” Mosca said. “You save five minutes here and five minutes there, but throughout the course of the year it costs the company less and it’s more profitable.”
Machine operators are the first line of quality control with the operator being responsible for the quality of the part he is producing. Product inspection is done with a highly sensitive computer check system that can inspect the part without coming into physical contact with it.
“We have the ability to design very high-tech, high-precision parts,” Mosca said. “Video inspection allows us to check them with the same precision.”
Maintenance is a top priority at Pioneer. The closest repair facility for the company’s manufacturing equipment is located in Milwaukee (Wisconsin), eight hours away.
“We take maintenance real serious with the idea that if you do a good job of preventative maintenance, things don’t break,” Mosca said.
After parts are manufactured, they are put together into the final product. Each must be assembled in exactly the same way.
“All of the mating surfaces on the instrument have to be matched with a high degree of accuracy so that when they do function, they don’t wear each other out,” Mosca said.
After they are assembled, the products are cleaned and sterilized in a very controlled and certified process where each product is subjected to its own specific set of standards. It is then packaged and shipped.
At this point, Pioneer continues to distribute their products through major medical companies worldwide. The company is in the process of branching out to include its own sales staff.
The employees at Pioneer are rewarded for their role in the company and its cutting-edge technology. Each year, they are given the opportunity of sharing the company’s profits through stock options.
Pioneer’s future looks bright. It continues to add new products, new processes and new employees. The facility itself is even ready for growth. When the new building was constructed in 2003, the plumbing, heating and electrical systems and building connections were set up for the next two expansions. The contractor already has those plans.
“We’re all dedicated to the idea that we’ll become a full-service spine company,” Mosca said. “It’s everybody’s desire. Everybody’s working really hard to accomplish that goal.”
For more information on Pioneer Surgical Technology and its products, visit www.pioneersurgical.com
MM

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