Abu al-Qasim al-Zahrawi would never have guessed that one day surgical instruments would evolve to become as complex as they are today.
Al-Zahrawi (known in the Western Hemisphere as Abulcasis) lived from 930 to 1013 A.D. and hailed from the city of El-Zahra, Spain. A renowned surgeon and doctor to King Al-Hakam II, he is often
Customers are increasingly calling for surgical instrumentation that is complex and complete. Photo courtesy of Advantage Manufacturing Technologies.
"Al-Tasrif" included descriptions and illustrations of more than 200 surgical instruments, many of which Abulcasis created himself (i.e., scalpels, curettes, retractors, rods, specula and the surgical needle). But they were simple instruments compared to today's surgical tools.
David Parsons, president at Advantage Manufacturing Technologies (AMT) in Monroe, Wash., said he is seeing a trend for more complex-and complete-assemblies in instrumentation. "Customers want the assemblies delivered complete. They are giving us more complex designs that require more complex capabilities," he said, adding that his company is seeing a greater number of designs for five-axis work.
Dean Poulos has noticed similar requests. "There are definitely strong indications that the marketplace is accepting, if not flat out preferring, more sophisticated over the primitive," said Poulos, sales and marketing manager at Gauthier Biomedical Inc., an orthopedic and spinal instrumentation firm headquartered in Grafton, Wis.
One way that Gauthier Biomedical is helping customers get what they want is allowing them to configure the instruments through a "product configurator" on the company's Web site.
Another complex request by OEMs is "a big move toward radiolucent components, so the instrument does not block the view of the surgeon when using different imaging modalities. Carbon fiber is one example specific to this type of application," said Brian McLaughlin, business development manager at Orchid Design.
OEMs have been asking contract manufacturers for surgical instrumentation quicker and ordering smaller quantities at a time, starting about five years ago. Photo courtesy of Paragon Medical.
John Phillips of Phillips Precision Medicraft said designs have become dimensionally complex when geometric schemes are involved. "This is not a problem when it comes to the manufacturing of the designs, but rather it's the inspection of these geometric dimensions that becomes very challenging." Phillips Precision Medicraft constantly researches and adds the latest quality technologies, Phillips added.
With a move toward more complex assemblies comes new materials such as silicone and stainless metals. "We've been making instruments with silicone for 10 years now, but recently there seems to have been an explosion of sorts," said Poulos.
Parsons said procuring quality metal has become challenging recently due to availability.
Shorter Lead Times, Reduced Quantity
Some of the challenges for surgical instrumentation makers include shortened lead times, requests for smaller quantities of instruments and access to those who will use the instruments-surgeons.
Rapid prototyping is one way to help balance an increased request for faster turnaround and safety, according to industry experts.
Parsons said "from the time that the initial print is presented to AMT, prototypes are delivered, changes and alterations made, product is validated and then launched to the market, can take three to six months depending on the need of the customer."
Steve Maguire, general manager of Orchid Design, a division of Bridgeport, Mich.-based Orchid Orthopedic Solutions, said that rapid prototyping is one way to speed up the innovation process and get designs in the customer's hands early, ahead of finalizing designs.
In response to quicker turnaround, Gauthier has added engineering staff, more five-, seven- and 10-axis machinery, a comprehensive computer-aided manufacturing program, rapid molding technology and more sophisticated abilities.
"All of these capabilities together have helped us reduce lead times and increase our capability," said Poulos, who added that his firm delivers fully branded instruments in five to nine weeks.
When Time is of the Essence
With pressure from OEMs for faster turnarounds, contract manufacturers must balance quality, time and safety, according to industry executives.
"Both quality and delivery are figured into the jobs at the time we quote. We quote all jobs as if we will get them and figure them into our system," said Peter Browne, sales engineer at FMI Medical Instruments in Madison, Ala., which manufactures precision machined implants, instruments and devices for the orthopedic industry.
Mike Lushin, quality assurance manager at Orchid Unique, a division of Orchid Orthopedic Solutions that provides single source machining, marking, cleaning, packaging and sterilizing, said that quality always is the top priority in medical manufacturing. To achieve good product quality, he added, manufacturers must follow Lean principles to improve processes and cut lead times. Orchid Design, for instance, has used these principles to build a product (from concept and design to prototyping) in six to nine months, McLaughlin said.
For some firms, such as Phillips Precision Medicraft, building a quality device to spec is automatic. "The key for us is to be efficient in our use of information technology, enabling us to manufacture custom product in a predetermined time frame," Phillips explained.
Factors to Consider
Other considerations for companies that design instruments include: functionality, efficiency (to help
Contract manufacturers are using Lean principles to help with reduced lead times. Photo courtesy of Advantage Manufacturing Technologies
cut costs yet still maintain quality), in-process checks, material selection, coatings, tolerance requirements, finishes, ergonomics and weight.
"Functionality is always going to rank No. 1. If a product doesn't perform, nothing else matters," said Poulos.
Other considerations include single-use instruments versus reusable. "If [an instrument is] reusable, cleanability and sterilization are key," said Maguire."
McClaughlin claimed that autoclavability also is important when it comes to reusable instruments. (Direct metal laser sintering, for example).
"Apparency of use," or ergonomics, human factors and industrial design, are important factors, too.
"Industrial design is something that maybe hasn't been included much in orthopedic instrumentation as in other specialties, perhaps because of the need for reuseability doesn't allow for injection molded parts," said Maguire.
Surgical Instrument Delivery
Companies that make delivery systems for surgical instruments have been seeing smaller orders with shorter lead times over the last five years, a trend that also is occurring in surgical instrumentation.
Companies that make custom delivery systems for surgical instruments and implants have been seeing smaller production orders with shorter lead times over the last nine years or so, a trend that has also occurred in surgical instrumentation and implants. "Clients seem more inclined to order lower or exact quantities rather than risk having excessive inventory. Lower quantities then result in shorter lead times," said Mike Phillips, also of Phillips Precision Medicraft (PPM), referring to production re-orders. This is not the case with the initial launch of new products.
"In our industry (delivery systems), we have an obligation to our clients to provide them with the most innovative products possible in order to decrease cost and lead times. This is why engineering and research and development are very important. If the delivery systems cost goes up, so does the cost of the instruments and implants to cover the cost of delivery systems. PPM has always developed products with three things in mind, aesthetics, weight and cost," he added.
Another trend that several delivery system companies have noticed involves modularity and a greater focus on light weight. Van Flamion, director of Paragon Medical's Orthopaedic Instrument Global Design Center, said there are various factors to consider when designing instruments and delivery systems, including surgical technique, cleanability/sterilization, materials, weight, intellectual property, branding, cost, surgeon feedback, predicate device complaint history log and cross-system utilization.
Challenges include clear design input, timely feedback on prototypes and functionality versus cost targets, Flamion said. Companies also must deal with keeping instruments "frozen" long enough to finalize the delivery system, and the desire to contain costs by getting as many instruments as possible in a delivery system, which can cause weight and sterilization issues, said Cory Colman, Paragon Medical vice president of business development.
Colman explained that the future of instruments and delivery systems will be on patient-specific instruments, which will be manufactured in very short time frames.
He added that other opportunities for lower-cost alternatives include penetrating countries such as Brazil, Russia, India and China.
"Lightweight, modular systems that allow the customer flexibility in configuration will continue to gain in popularity," said Mike Librot, vice president of sales at Medin Corp., a Passaic, N.J.-based manufacturer of custom and standard instrument trays, cases and sterilization containers.
"Weight is a major factor with customers wanting to put more and more in a lighter case, but these cases still need to be structurally sound. Modularity, especially the ability to change configurations at the customer location, is a design feature increasingly demanded. Instruments also have become more complex and multi-purpose, presenting design challenges to the sterilization validation we must help our customers attain with our delivery systems," he added.
Surgical instruments have come a long way since the time of Abulcasis. Surgical instrumentation executives agree that the long-term viability of this sector depends on lowering manufacturing costs and making simpler surgical instruments that offer less risk. McLaughlin said more robust designs also will be considered. He envisions more robotics, navigation and integrated single-use instrumentation. Though device OEMs are calling for increasingly complex designs for surgical instruments, they want the instruments to be simple to use. Stainless steel and silicone are increasingly popular materials for instruments, yet availability of quality metals has been a recent challenge.