Delivering the Right Tools
Smaller, more complex and disposable are among the criteria demanded by OEMs when they turn to partners to create next-generation surgical instruments and delivery systems.
|Precision torque-limiting and fixed-driver instruments for securing a range of fasteners, screws and connectors used in orthopedic implants. Photo courtesy of ECA Medical Instruments.
Surgical instrument OEMs and their end-users—surgeons—are very specific about what they want. Instruments need to do more, be smaller and cost less. The Affordable Care Act and the 2.3-percent medical device excise tax are changing research and development priorities for many OEMs, with an increased focus on cost reduction. To meet health reform expectations, hospitals and ambulatory surgery centers (ASCs) constantly are looking for ways to improve patient outcomes and control costs.
It’s difficult to increase instrument complexity and function and still reduce costs. OEMs seek creative collaborations with their suppliers to develop next-generation implants and instruments that speed surgeries, cut costs and improve overall efficiencies and productivity across the hospital and ASC markets. All departments are reviewing their processes and evaluating new tools and methods that will improve patient care while reducing operations and maintenance costs.
“Every area and every process is being evaluated, including the supply chain,” said Jim Schultz, executive vice president for ECA Medical Instruments Inc., a designer and manufacturer of single-procedure torque limiting surgical instruments and kits based in Newbury Park, Calif. “Value-consuming products, processes and methodologies are being replaced. Essentially nothing is off limits. This is especially true at ASCs where physician-owned organizations are all about providing highly efficient and effective healthcare while reducing operational costs.”
Transition toward single-procedure or disposal instruments and disposable procedure kits is gaining momentum and will change the face of the operating theater by reducing cost and eliminating infection. Because of less-invasive (and safer) procedures that require smaller incisions, instruments must be smaller and have more capability once they are inside the body—this typically requires greater cannulation and smaller functional ends.
“What was state-of-the-art two years ago is now oversized and cumbersome,” said David Smith, business development manager for PCC Advanced Forming Technology, a Longmont, Colo.-based provider of metal injection molding services for the orthopedic market. “Thin walls (.010 inches) and extremely small components (less than .01 grams) are being produced, allowing instrument manufacturers to reduce the size of the ports needed to insert these instruments.”
To minimize procedure invasiveness, recent design trends have focused on developing miniaturized products to work in ever-smaller spaces, with enhanced articulation and range of motion.
“For example, linear staplers, used in minimally invasive abdominal surgery, now articulate to allow for increased range of motion,” said Alan Connor, president of Cadence Inc., a contract manufacturer of surgical devices based in Staunton, Va. “Flexible devices such as the TransEnterix Spider system, which enables flexible micro-laparoscopy, have also emerged.”
New materials, or custom grades of materials, such as Carpenter Custom 475, 420B (stainless steels) and Biodur 108 (alloy), are being requested because they provide physical and chemical characteristics that are a better match for the intended use of the instrument. More European material grades such as X15TN and M30NW (also stainless steels) also are being referenced as designs become more suited for global use.
“However, in both situations, these unique materials are more difficult to source from a lead-time standpoint,” said Chris Beatty, business development manager for Precision Medical Technologies Inc., a manufacturer of orthopedic and medical instruments and implants in Warsaw, Ind.
Customers also increasingly are focused on process validation. As designs become smaller, more complex and harder to manufacture, and the U.S. Food and Drug Administration (FDA) increases its scrutiny on supplier quality and supplier controls, OEM process validation expectations have increased. OEMs expect their supply chain to implement process controls that will help the OEMs ensure strong product quality. This includes validation master plans for all equipment and processes, process failure mode and effects analyses (FMEAs), approved control plans, gage repeatability and reproducibility studies, first-article submittals and statistical process control and process capability index data.
“Customers want to see FDA facility registration and FDA product listings, with full documentation,” said Dean Poulos, sales and marketing manager for Gauthier Biomedical Inc., a Grafton, Wis.-based manufacturer of surgical instruments for the orthopedic market. “They want to know their suppliers have validated processes and registered quality systems in place for design controls, documentation and process testing.”
Disposable vs. Reusable
Healthcare reform is pushing healthcare systems and hospitals to improve patient outcomes and contain costs. One of the best ways to do this is reducing the risk of surgical infections—which is driving growing interest in single-use instruments (SUI). The costs to re-sterilize components and repackage them, combined with the liability if the parts are not cleaned correctly, are high. Although they do minimize the risk of post-operative infection, SUIs are relatively expensive when used only once, so reducing the costs of each SUI is paramount.
“It’s been estimated that disposable torque instruments and procedural kits can save over $400 per procedure, or more than $1 billion per year in U.S. healthcare cost alone,” said Schultz. “Disposable procedural kits will be more common in the operating rooms of America starting early next year.”
ECA Medical Instruments collaborates with its OEM customers to produce single-procedure torque instruments, fixed drivers and kits, which save upfront and life cycle costs and insure the surgeon will have a calibrated instrument for every implant. Also, disposable procedure kits for cranio-maxillofacial, trauma, small bone and general reconstruction surgery will improve the operating theater by reducing cost, eliminating infection and insuring accurate torque for every patient implant.
Even though it is clear that disposable or single-use instrumentation will reduce risks associated with sterilization, patient infection and product traceability, the specialized nature or customization of these instruments can make single-use or disposable components less practical or affordable. “Many of our customers are interested in achieving longer useful lives of the instrumentation, rather than going the disposable route,” said Beatty.
One way to make surgical instruments lighter weight, reusable and more cost-effective is improving presentation and performance by replacing metal with plastic. “We have been able to assist clients with this effort and have produced some exceptional results, especially for joint reconstruction,” said Cory Colman, executive vice president of business development for Paragon Medical Inc., a provider of cases and trays, surgical instrumentation and implantable components based in Pierceton, Ind.
High-temperature engineered polymers are especially suitable for multiple sterilization cycles. One of the biggest challenges in going from metal to plastic is redesigning tooling strategies and being certain that performance is not compromised.
“An issue that is becoming more visible in the delivery system area is compliance with the reduced weight of the delivery system, as well as being compatible with decreased sterilization and drying cycle times,” continued Colman. “The product must be compatible with current parameters within the hospitals and surgery centers.”
Some OEMs also are starting to modify the design of their single-use devices so they can be reprocessed more easily. A typical third-party medical device reprocessor of single-use devices is registered with the FDA, which requires a 510(k) for each specific product it reprocesses. Devices go through disinfection/cleaning, testing, refurbishing to “like new” functionality and sterilizing to 10-6 sterility assurance level.
“Some OEMs continue to design to prevent reprocessing,” said Connor. “Others are thinking in terms of designing devices that can be used for multiple aspects of a procedure for a given patient or for reprocessing. All these emerging requirements will have an impact on the design, manufacture, and validation of many medical devices.”
Technology Leads the Way
Quality system expectations and basic economics are driving OEMs to look for key suppliers that can provide a broader range of services. This means having current technologies in place that will increase operational efficiencies and speed time to market.
“In response to this need we have added metal joining, Swiss- and laser-based precision machining and extensive assembly capabilities to our core cutting and piercing sharps manufacturing technologies,” said Connor. “We also expanded our cleanroom finished device assembly capabilities. This helps minimize customers’ supplier management overhead costs, reduces validation risk and, in most cases, reduces the cost of the overall device.”
An innovative manufacturing technology that is gaining traction in the surgical instrumentation field is metal injection molding (MIM), which is becoming a viable alternative to standard machining. MIM especially is popular for small, complicated, stainless-steel instruments. Other materials that work well with MIM are F-75, cobalt chrome and other high-strength alloys.
MIM technology combines the shape-making capabilities of plastic injection molding with the material flexibility of powder metallurgy. Metal powder is combined with a polymer binder, granulated into a feedstock, and then injection molded. After injection molding the binder is removed from the part, which then is sintered at high temperatures. The final part is reduced in size by about 20 percent.
“If you are currently using stampings, investment castings, powder metal, screw machine components or even machined parts, metal injection molding may improve your quality and reduce your costs,” said Smith.
There also is a growing need for laser welding for more complex designs, according to industry experts. Laser welding is a non-contact process that only requires access to the weld zone from one side of the part, making it ideal for different joint geometries and angles. The weld is formed when the laser light rapidly heats the material—typically taking only milliseconds. Laser welding is effective across a range of materials including steels, nickel alloys, titanium, aluminum and copper. Some materials are difficult to laser weld if they don’t meet specific characteristics such as reflectivity; the tolerances of the parts being welded also must be fairly tight and provide an accurate fit.
Computer numerical control (CNC) laser welding can include micro-weld technology, which uses the smallest weld spot diameters for fine applications. Dual-beam technology allows welding to happen on opposite sides of a part at the same time. Double-closed loop power control creates high stability from pulse to pulse (less than a 1 percent variance), which results in better joints and less variation from part to part.
“Laser welding can also be integrated with other technologies, such as automation and multi-axis CNC control, to create an overall production system that delivers a more complete product under one roof,” said Connor.
According to John Phillips, president of operations for the implant and instrumentation division for Phillips Precision Medicraft, an Elmwood Park, N.J.-based manufacturer of advanced orthopedic implants, instrumentation and sterilization delivery systems, laser welding must have intelligent robust validations associated with its results.
“The process cannot be checked due to the destructive testing necessary to do the job,” said Phillips. “Therefore, in the interest of patient safety, the equipment and process must be understood very well. The best situations for laser welding are small-component assemblies that are plated in some way, but still need to be precisely welded and be aesthetically pleasing.”
|An in-situ rod bender used for spinal surgery.
Image courtesy of Gauthier Biomedical.
When it comes to advanced materials, nitinol continues to attract lots of attention. This nickel-titanium alloy increasingly is popular for miniaturized products with increased articulation because of its special properties—shape memory, superelasticity and high damping capability. Shape memory is nitinol’s remarkable ability to shrink in size at one temperature and regain its original size and shape when heated above its transformational temperature. At a narrow temperature range above this transformational temperature, nitinol also becomes extremely elastic, stretching up to 30 times more than ordinary metal.
“Nitinol’s shape memory and superelasticity enable many elements of design that require miniaturization and articulation,” said Connor. “These materials can be formed into a shape that will ‘spring back’ into the original shape after being deformed.”
Medical applications include catheter shafts, stents, orthodontic guide wires, endoscopic guide tubes, occluders, retrievers and laproscopes.
Nitinol can be a challenge to machine because the titanium oxide surface is so abrasive. Carbide tooling is recommended for milling and grinding. It also can be worked with electrical discharge machining, laser cutting and water jet cutting. How well it responds to manufacturing depends on its exact chemical composition, heat treatment and selected machining method. Nitinol can be micro-machined from wire, sheet or ribbon stock and laser-welded if the joint consists of two nitinol parts—nitinol cannot be welded to stainless steel or other metals.
A change that Phillips Precision Medicraft (PPM) has noticed regarding delivery systems is a steady increase in customers moving away from traditional silk-screening and toward digital contact graphics technology (DCG). The shift is due largely to DCG technology being both a validated and safe process, as compared to silk-screening.
“Major companies in our industry are now questioning the integrity of silk-screen inks and how safe they really are,” said Michael Phillips, president of operations for delivery systems for PPM. “The instruments and implants in these cases and trays ride above and/or on ink materials that may scratch off during use or sterilization and taint the instruments or implants before they are used. We are aware of one major ink provider that has added a clause to their product statements this year that states the ink(s) are not meant for our industry and are not designed to withstand the harsh cleaning environments during use, and as such will not be guaranteed. DCG ‘metal-fused technology’ avoids this issue altogether, while at the same time making the graphics remarkably scratch-resistant for less than the cost of silk-screening.”
Regarding exterior appearance, Gauthier Biomedical has also observed a shift toward more corporate branding of the instruments—typically the company logo—as well as making them look more eye-catching, such as textures and multi-colored handles.
“We design our own molds and use rapid manufacturing technologies for applying textures and colors to the final product,” said Poulos. “This allows us to embed custom textures, raise or recess logos and text, and provide handles with multiple colors and durometers. These options are rigorously tested to withstand 500 autoclaves without degradation.”
If it is not in real time these days, it is too slow. Providing all the services an OEM needs is a great way to get on its good side—but staying there requires more than technologic prowess. Each phase of the project must be backed up with rapid-response communication and full transparency and access to the entire process—even if it’s 3 o’clock in the morning. That means customers must have the ability to find whatever they need, quickly. Many companies are spending considerable time developing these unique customer interfaces and making sure communication expectations are met—especially early in the relationship.
“Manufacturing involvement early in the design phase for manufacturability is essential for top quality at the lowest possible cost,” said Beatty. “Our manufacturing engineers are experts at determining cost-effective manufacturing methods. Getting us involved early will save 15 to 20 percent of the cost of the instrument. It also improves communication and deepens long-term relationships.”
Cadence uses a unique customer engagement approach called Outcome-Based Manufacturing, which also allows its customers to connect with its engineers early and often, helping ensure that a high level of communication and collaboration happens throughout the product development life cycle. Paragon Medical promotes its New Product Introduction program, which spans multiple disciplines and maximizes communication and collaboration between program management, product development, engineering, quality and procurement.
Paragon also maintains an onsite cadaveric lab that enables its engineers who are co-developing instrumentation for clients to have access to specimens and all the surgical instruments and equipment needed to evaluate the impact on surgical outcomes. “Our clients also use the lab for development purposes as well as for surgeon training,” said Colman. “It has become an integral part in our abilities to provide our clients with confidence that what Paragon Medical is developing for them will exceed their expectations in the operating room.”
Phillips Precision Medicraft promotes its Vendor Managed Inventory (VMI) program to help clients plan well into the third quarter of the business year. The VMI platform inherently addresses cost, scheduling and individual quality standards and provides on-demand product availability.
“This helps clients, who are able to forecast well enough into the future, to experience the benefits of lower price and better availability of the instrumentation they need,” said John Phillips.
OEMs are consolidating to gain market share and reduce costs to maintain margins. Even so, there is sometimes a tendency to want to “add unneeded features and functionality, sometimes called design creep or line extensions, to differentiate products,” said Schultz. “Only applying true value-add solutions that improve the OEM brand and patient outcomes will provide competitive advantage and gain customer loyalty—the physicians’ mindshare.”
John Phillips agreed.
“Implants and surgical instrumentation continue to be designed with very close feature and GD&T (geometric dimensioning and tolerancing) schemes—some can be about the thickness of a piece of paper,” he said. “These complex plans repeatedly show up on all types of products, such as broach handles for example, that are struck with a mallot during the hip replacement procedure. While we advocate precise instrumentation that creates a better fit and finish for the final device, in some situations these tight tolerances may not actually be required. Once the instrument is struck once during the surgery, it is far from the original geometry, and thus negates the rationale to manufacture at such tight and costly tolerances. With the price pressures OEM and medical device manufacturers face these days, we encourage our customer base to use complex dimensioning schemes only when its necessary. In all other cases, avoiding them allows us to keep the cost of manufacturing down for the benefit of all.”
is a full-time freelance business and marketing/communications writer based in Madison, Wis. He can be reached at firstname.lastname@example.org