Instrumental Abilities
A host of factors—from market forces to new cutting-edge development processes—are shaping the next generation of orthopedic instruments, cases and trays.
If there’s one thing that’s certain for manufacturers of surgical instruments and medical implants, it’s how quickly their markets change—new regulations, advancing technologies, more supply chain management responsibility, more validation risk and a steady stream of new demands from clients as their products evolve and mature.
In an increasingly competitive marketplace, orthopedic manufacturers are eager to deliver what surgeons and healthcare systems want: instruments and devices that are high-quality, U.S. Food and Drug Administration (FDA)-compliant, lightweight, ergonomic and durable (withstanding high pH and numerous autoclave cycles, for example). Not to mention, they have to lead to shorter, less-invasive procedures, reduced surgeon fatigue and faster patient recoveries—all with shorter lead times and lower costs. Easy, right?
“There’s even an expectation today by OEMs that parts should have a sleek look, with mirror finishes, high-precision, intricate radii and more,” said Mark Travis, operations manager for Autocam Medical, a precision machining manufacturer of orthopedic implants in Plymouth, Mass. “Customers are looking for a smooth, mirror-quality finish, free of blend lines and chatter lines.”
Many of these new demands are putting a strain on manufacturing production lines, making accuracy and efficiency the keys to remaining competitive.
Surgical instruments and devices also are expected to come with top-notch delivery systems that maximize surgeon efficiency in the operating room by shortening procedures and easing fatigue. These include just-in-time sterilization, sterile tray and kit delivery systems or flat-fee instrument replacement programs.
“Surgeons can use a sterile kit for an entire procedure and safely dispose of all non-implant components,” said Douglas Slomski, vice president of sales and marketing for ECA Medical Instruments, a Newbury Park, Calif.-based global manufacturer of single-procedure, torque-limiting drivers. “Sterile kits help reduce infection and contamination, eliminate the need for the autoclave and always provide a brand-new and calibrated instrument, saving the surgeon time and reducing overall costs.”
Surgeons, however, are less likely to call the shots today regarding customized instruments. More surgeons are leaving private practice to join HMOs and larger hospital groups and must go along with the purchasing decisions these organizations make—which tend to emphasize variability of use, simpler design, better ergonomic features, little or no inventory and lower purchasing and operating costs.
“OEMs are trying to develop instruments that can be more flexible in a variety of surgical situations and also address specific surgeon preferences and technique,” said Jodie Gilmore, managing director of business and quality operations for Onyx Medical Corp., a contract manufacturer of surgical implants and instruments in Memphis, Tenn. “If an OEM can slightly modify or add a feature to an existing instrument so it meets the personalized needs of one group of surgeons, while still benefitting the larger audience, this can be implemented with minimal cost impact.”
Many hospitals and surgeons don’t purchase the instrumentation to perform orthopedic implant procedures—forcing OEMs to bear the costs and logistics of supplying instruments to assist the surgeons who use their implant systems—an approach that Slomski feels is ultimately unsustainable.
One way to keep costs down is utilizing reimbursed sterile single-procedure kits that are less than a third of the cost of a reusable set of instruments and the cost of maintaining, tracking, transporting, cleaning, calibrating and repairing them after each procedure.
“Single-procedure instrumentation is a fraction of the cost of reusable instrumentation,” he said. “When combined with single-procedure kits, the cost savings is even greater.”
Delivery systems absolutely are essential to customer satisfaction—they must secure the instrumentation safely, withstand the rigors of the environment and meet specific operating room requirements. The trend to “lighten up” and “streamline” is here to stay.
“Weight and size is typically synonymous with cost and the amount of logistics, care and handling,” Slomski added. “We use thin-gage thermoform trays and breathable films that cost far less than anodized aluminum, stainless steel or heavy-gage molded trays. The move to single-procedure trays, kits and instrumentation will continue to drive delivery systems toward disposable materials due to cost, weight, flexibility, guaranteed sterility and improving waste reclamation. Most importantly, these systems enhance patient safety and surgeon efficacy, while reducing cost to the healthcare system.”
Making Surgery Easier
According to the “2011 Orthopedic Outlook” report by William Blair, extremities, cervical artificial disc, sports medicine and trauma were productive markets last year. Biodegradable implants also are set to drive growth of the trauma fixation devices market. The extremities market was marked by increased shoulder replacement procedures and foot and ankle arthroplasty and fusion cases. Knees and hips will continue to be the most popular reconstructive joint replacements; new technologies and surgical techniques also are expected to increase demand for spinal implants.
These are all complex, time-consuming procedures and surgeons want the latest technologies in implants and instrumentation that will allow them to perform at their best.
“Surgeons want to provide optimal efficiency during the surgical procedure and allow for the fastest practical recovery to activity for their patient,” said Michael Phillips, president of operations delivery systems for Phillips Precision Medicraft, a manufacturer of advanced orthopedic implants, instrumentation and sterilization delivery systems based in Elmwood Park, N.J. “Instruments that are ergonomic, easy to use and multifunctional are the rule and can evolve regularly; implant technologies evolve more slowly as years of study and development are required before they can change in any significant manner.”
Surgeons and healthcare organizations are eager to invest in ergonomic, lightweight, reliable andprecise instrumentation with an ease of use that enhances surgeon performance and comfort.
“For example, battery-powered surgical drivers offer an alternative to the time-consuming and arduous placement of screws and plates in a variety of surgical procedures, such as small bone, neuro, spine and cranial maxillofacial,” said John Vargas, engineering manager for Pro-Dex Inc., an Irvine, Calif.-based firm that designs, develops and manufactures surgical devices, metal components and sub-assemblies. “These types of devices help surgeons reduce fatigue and compress time in the operating room.”
According to Shawn Schafer, vice president of sales and market development for Oberg Medical, a Pittsburgh, Pa.-based full-service contract manufacturer to medical device OEMs, robotic-assisted surgical procedures—technologies developed by companies like Mako Surgical Corp. and Blue Belt Technologies—also are growing in popularity.
“In addition, minimally invasive surgery versions of OEM flagship systems are also being offered as product-line extensions, which we are seeing in the large joint, extremity and spine segments,” Schafer added. “Laser metal sintering (LMS) is a technology that may provide surgeons with options for fully functional prototypes or implants that can be quickly custom-matched to the patient.”
Orthopedic OEMs are asking contract manufactures to design medical devices that can withstand harsher environments (autoclave, high pH, etc.) such as arthroscopy handpieces, cranio-maxillofacial handpieces and oral surgery devices.
For example, a few years ago Pro-Dex was supplying an arthroscopic shaver system to an OEM customer. Due to changes in European regulations, the manufacturer informed the company that the device needed to be engineered to withstand higher pH balances when exposed to autoclaving in a dishwasher. The change meant that the current coating for the surgical device needed to withstand this new, harsher environment which the current coating could not survive. To solve this challenge Pro-Dex formed a strategic alliance with a new coating partner.
“We were able to collaboratively develop a stronger proprietary coating that ensured the surgical device would withstand the higher pH balance process required,” said Daniel Santos, engineering manager for Pro-Dex. “This is a good example of how strategic alliances, if done carefully, can add greater value to contract manufacturers and the OEMs that they serve.”
Technological Advancements
Most OEMs are trying to achieve time and cost savings with new or revised surgical instrumentation. For cutting instruments, saving time is a function of cutting accuracy, speed and efficiency. “We ask our customers what the surgeon is trying to accomplish with each specific cutting tool so that we can work collaboratively to develop optimal cutting geometries,” said Gilmore. “Then we do some quick, iterative production runs to manufacture and test out the various options to find the one that best meets the design needs.”
During the process the team evaluates various materials and cycle times to understand the cost implications of each permutation and ultimately selects the best performance/cost combination. Other key trends in orthopedic surgery are protecting the integrity of the bone from heat damage or necrosis and ensuring optimal alignment in order to achieve the best patient outcome with an implanted device.
“With trauma procedures, good targeting and proper alignment is important and can be challenging,” added Gilmore. “In order to insert screws, rods or fixation pins, surgeons will often pre-drill a hole. Cutting instruments that do not skive and stay targeted where the doctor requires them reduces the risk of drill breakage or damage during surgery and creates a better-aligned hole for implant insertion.”
Fast prototyping and turnaround are critical for developing new instruments and parts. Quality control also is crucial, with much tighter tolerances and more stringent surface finish requirements being required (for example, tolerance between +/-.002 inches and +/- .0005 inches and Ra [surface roughness] between 32 Ra and 16 Ra). To achieve this level of precision more companies are investing in five-axis vertical machining centers.
For example, Autocam Medical, which specializes in precision titanium andstainless steel trauma plates and bone screws, manufactures approximately 50,000 plates and more than 300,000 bone screws annually to support those plates. Often, the location of bone fractures poses challenging obstacles for surgeons. Plates, in particular, are complicated parts with complex geometries and contoured surfaces.
With standard machining, the average cycle time to manufacture a complex trauma plate is about one hour and requires multiple machining operations with numerous loads/unloads. Hand deburring and polishing also are required to achieve the desired level of surface finish. To maximize its competitiveness on both price and lead time, while satisfying complicated, high-tolerance part geometries, Autocam Medical invested in four Matsuura 5-axis vertical machining centers from Methods Machines Tools Inc.
The machines have glass scales that can achieve .0001-inch repeatability and are equipped with pallet changers that complete jobs in one or two operations (instead of the typical four to five setups on a traditional vertical machine center). The new equipment has reduced the average machine cycle time by 50 percent using just one operation versus the multiple operations used previously.
“Because we are now machining parts to near-net shape, post-processing throughput has increased 25 percent due to decreased manual deburring and polishing requirements,” explained Dave Francis, general manager for Autocam Medical.
Oberg Medical’s proprietary non-contact grinding procedure called MDP, or molecular decomposition process, is a form of electrochemical grinding that also tightens feature tolerances on instruments and eliminates secondary processes like deburring.
“We have several instances where we provide close-tolerance ‘hex’ or ‘torx’ drivers from very hard, wear-resistant conductive materials,” said Schafer. “The MDP process (which doesn't generate any heat in the manufacturing process) can create these variously shaped features while holding profile tolerances on the lobes to .00025 inches. As a result, OEMs can save cost by loosening the tolerance of the hex or torx feature in screws or other implants, which are much higher volume compared to the instruments.”
Harder, more advanced materials continue to challenge machining equipment. For example, special materials such as carbon fiber and other reinforced polymers are used to make instruments and devices radiolucent, a quality that allows surgeons to seedevices and tools on X-ray.
“Cutting these materials requires high-strength, long-wearing cutting tools,” said David Cabral, president of Five Star Manufacturing in New Bedford, Mass., a provider of contract machining and assembly of medical devices for OEM and hospital clients. “For high-precision work, tolerances of less than one-thousandth of an inch are commonly expected.”
Material science continues to deliver new materials, polymers and blends that enhance the performance and functionality of certain devices or procedures, such as the delivery of biologics or the insertion of human tissue, bone and/or cartilage to replace degraded components currently in place.
“In these cases the manufacturing challenge is finding (or creating) the best method for machining these materials into the right shapes and tolerances,” Cabral said.
Advanced materials continue to be engineered for implants that are longer-lasting and provide higher bioactivity and biocompatibility. For example, Ceram, a United Kingdom-based international materials technology consultancy, is developing a new series of multi-element-substituted hydroxyapatites for implant surfaces.
“Our goal is to provide a method that can be easily adapted to produce a hydroxyapatite (HA) that has different elements within the lattice structure that will elicit specific responses for the target environment,” said Xiang Zhang, principal consultant for medical materials and devices with Ceram. Solubility of the lattice can be varied, thereby allowing the HA to have specific characteristics (less soluble HA is ideal for oral applications such as bridges and caps, whereas higher solubility is preferred for rapid bone growth). Different substitutions also can change how cells respond to the implant material. It is well-known, for example, that silver can be an effective coating for anti-microbial action; by incorporating silver into the HA structure it is possible to create an anti-microbial and bio-conductive finish for an implant. Even more advanced are certain element combinations that help control cell response either by stimulating or suppressing osteoblasts and osteoclasts.
The biggest R&D challenge for HA is its lack of mechanical similarity to natural bone.
“The lack of solubility, while desirable for some applications such as hip implant coatings, cause issues when wanting to fill a bone void, for instance,” said Zhang. “A lot of work is being done right now to produce a composite that accurately represents natural bone, and is biocompatible. Research approaches involve impregnation of a polymeric lattice, ceramic/glass, and ceramic/ceramic composites, metal alloys coated in calcium phosphates, precise 3-D structures, etc. By changing the chemical composition of HA we can also change its mechanical characteristics. With multi-substituted HA we hope to make it possible to not have to compromise between strength and bioactivity by providing both characteristics in the same material.”
Substituting different elements into the HA crystal lattice is, however, not an easy thing to do. Ceram overcomes these technical challenges by developing new synthesis methods. This research is supported by a new chemical reactor that can control all the parameters within the experiment from temperature to pH (by the automatic addition of an appropriate acid or base) to running the reaction under non-standard atmospheres (high/low pressure, CO2, N2, etc).
Then there are the final “finishing” touches that add aesthetic appeal and make the instruments easy to identify and group. For example, high-definition, scratch-resistant graphics can be produced at the same or lower costs, with shorter turnaround times, compared to traditional silk screening and color anodizing.
“This innovative process dramatically enhances the looks of a product,” said Phillips. “Even better, the graphics are scratch-resistant, which increase the longevity of the product in the field—in some cases reducing the price of the delivery system by a staggering 25 percent.”
In order to make instrumentation more easily identifiable during surgery and to reduce wasted time and potential error, color identification, specialty coatings and laser markings are in higher demand by customers.
“Epoxy inking in various colors and multiple colors per part is becoming more widespread,” said Gilmore. “We have also seen increased use of laser-marked depth or locating lines on a variety of guide wires and drills, as well as TiN coatings and color anodize for easy size identification.”
Always Thinking About Quality
The FDA requires that OEMs monitor and control their entire supply chain; therefore a contract manufacturer’s quality systems must be just as comprehensive and effective as the OEM’s if it wants to stay in the supply chain. Not only does this sort of rigor improve the overall quality of surgical instrumentation and lower costs, it creates a tighter, more effective supply chain.
This, however, can be a challenge for smaller companies.
“Compliance with ISO 13485 not only supports efficient medical device development and manufacturing processes, it’s also seen as the first step in achieving compliance with European regulatory requirements,” noted Santos. “Unfortunately, many smaller contract manufacturers lack the funding and time to get their quality systems in place. As a result of not complying with ISO 13485, they are finding that they must opt out of working on critical medical device projects.”
Essential for success is a robust, highly monitored quality system that goes beyond dimensions and surface finishes to tracking things like correctness of paperwork, documentation of manufacturing methods and validation of manufacturing processes.
“This includes material traceability, material contact lists, certificates of compliance for outside services (heat treat, coatings, etc.) and calibration of all measurement devices used to verify a product’s conformance,” said Cabral. “Quality software is used for calibration and metric measurement.”
Even with the best quality systems, the latest technologies and equipment and a highly compliant supply chain, it’s still difficult for contract manufacturers to keep up with the demands from OEMs and their end users, because they always want more functionality with less cost and often expect the contract manufacturer to figure out the details. As both the healthcare and medical device industries struggle to contain costs, the trend toward single-procedure instrumentation and delivery systems will continue to gain momentum.
“We now have multiple choices in each polymer family, whereas 10-20 years ago there was only a handful of materials to choose from, with less reliable supply chains and more inconsistent performance,” said Slomski. “Today’s new materials are of high structural integrity, in good supply and reasonably affordable. Not all instruments and systems need be cut from steel or molded with heavy or limited polymer choices anymore.”
Hospitals also are discovering more environmentally friendly and cost-effective methods and options for discarding operating room waste—making administrators more interested in disposable instruments and products.
“Services that are affordable and can recycle metals, plastics, papers and textiles for non-medical uses are beginning to line up to demonstrate their services, logistic management and environmentally friendly technologies,” said Slomski. “This is a huge positive impact for our industry, and specifically single-procedure instruments and delivery systems. It puts quality supply into the economy and helps govern costs and logistics by giving materials second, third, and fourth utility and function.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders such as Kohler. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net.