Instrumental Changes

John “Jack” Michalski is an atypical trendsetter, a leader who’s destined for recognition through his work instead of his name. Puzzling, considering he has the branding power of “firsts” on his side: The Ohio Valley orthopedic specialist claims to be the nation’s top surgeon using Smith & Nephew plc’s 30-year knee (a.k.a., the Legion Knee with Verilast technology). Moreover, he was the first surgeon in the tri-state area of Ohio, Pennsylvania and West Virginia to use multi-lock system cold laser therapy to manage pain inflammation and swelling in the shoulders, wrists, hands, knees, hips, ankles, neck and feet. He also was the first tri-state area orthopedic surgeon to use the Legion Knee in replacement procedures, and last fall became the first in the United States to use disposable instruments for arthroscopic knee surgery.

While not a new concept to the overall medical device industry, disposable instruments are a relatively recent development for the orthopedic sector. Implant surgeons historically have favored costly and hard-to-maintain reusable instruments to replace damaged or worn-out joints, their preference driven mostly by the nature of their surgeries rather than personal choice. Many orthopedic procedures—particularly complex spinal treatments—require a wide range of specialized and highly robust tools, including torque-limiting instruments to secure screws, fasteners and connectors. Spinal torque instruments must withstand multiple actuations and torque set points up to 11 Nm (more than 100 lbs. per square inch), strong enough to secure the implant to the lower back.

Technological advancements over the last decade or so have brought such specialized torque precision to single-use instruments. New ergonomically designed disposable tools with torque-limiting ranges from 0.112 Nm to more than 11 Nm now are being used in various surgeries, including general reconstruction, small bone, extremities, trauma, cervical fusion and vertebroplasty.

“Pent-up demand for single-use procedure instruments is on the rise as both medical device makers and surgeons now have a viable alternative to traditional reusable torque wrenches, which are expensive to purchase, maintain and service,” states a white paper from ECA Medical Instruments Inc., a Thousand Oaks, Calif.-based designer and manufacturer of single-procedure torque limiting surgical instruments and kits. “Implant OEMs are kitting disposable instruments and complete procedural kits with their orthopedic devices, allowing surgeons to use them as substitutes, alternatives or drop-in replacements to traditional surgical tools.”

A growing number of doctors are using these throwaway instruments as much for their lower operating costs as for their versatility. Single-procedure/disposable surgical tools and turnkey sterile packed procedural kits can help curb infections, improve operating room (O.R.) efficiency, reduce hospitals’ carbon footprints and save the nation’s bloated healthcare system millions of dollars annually. A conversion to disposable torque instruments and kits for orthopedic procedures could save U.S.
hospitals and ambulatory surgery centers (ASC) hundreds of dollars per procedure, or more than $1 billion annually, ECA Medical estimates. That includes the reduction in hard and soft dollar costs to purchase the instruments, store in O.R. inventory, sterilize and kit, cost of utilities and cleaning agents, labor, logistics and administrative charges, all of which hospitals and ultimately, patients, the Center for Medicare and Medicaid Services or insurance carriers bear. A typical orthopedic implant and reconstructive surgery hospital/ASC in the United States could save more than $1 million annually in operating and maintenance costs alone, ECA’s whitepaper contends.

Conversely, disposable instrument kits promote higher O.R. uptime and implant device usage. Estimates suggest that a 10 percent increase in operational readiness could spawn 50 to 100 additional procedures per year, generating $2.5 million in extra revenue for the best-prepared hospitals and ASCs.

Operating room efficiency and cost savings also has led some implant firms to develop patient-specific disposable instruments for total knee arthroplasty, one of the largest expenses in the Medicare budget. Smith & Nephew’s Visionaire system, for instance, uses patients’ X-rays and magnetic resonance imaging photographs to create custom surgical instruments for the company’s knee implants (including the 30-year knee used by Michalski). The disposable tools eliminate multiple steps during a knee replacement, decreasing surgical risks as well as the amount of time a patient is under anesthesia. Its computer-guided precision also minimizes misalignments that eventually lead to implant failure.

“They’re not going to fit on Mrs. Jones, Mr. Smith; they’re going to fit directly on you,” Michalski explained to Steubenville, Ohio-based television station WTOV9 last September. “That is definitely a leap ahead. It can make our surgery more precise [with] less bleeding, quicker rehab time and less muscle problems for the patient.”

Though dominant, cost savings and operating room efficiency are not the only factors impacting orthopedic instruments and delivery systems. To better assess the trends and market forces driving instrument design, Orthopedic Design & Technology spoke to nearly a half-dozen manufacturing professionals and suppliers over the last few weeks. They included:

• John MacDonald, vice president at AIP Precision Machining, a Daytona Beach, Fla.-based machining facility. The firm machines plastics and carbon fiber PEEK/PEKK materials into products with complex geometries and extreme tolerances for the orthopedic, energy and aerospace industries.
• John Phillips and Jack Neenan, president of operations, Implants and Instrumentation Division, and vice president of sales/business development, respectively, at Phillips Precision Medicraft. The Elmwood Park, N.J., company manufactures orthopedic implants, instruments and sterilization delivery systems.
• Sean Miller, manager of the Global Design Center at Paragon Medical Inc. The Pierceton, Ind.-based firm supplies cases and trays, surgical instruments (reusable and single-use), implantable components and design/development services to the medical device industry.
• Hal Hurwitz, president of Irvine, Calif.-headquartered Pro-Dex Inc., a designer and producer of powered solutions for the medical, dental, factory automation and scientific research markets.

Orthopedic Design & Technology: Please discuss the trends in orthopedic instrumentation and delivery systems.
John MacDonald: Pricing, pricing, pricing…wait did I say pricing? This seems to be the flavor of the past year or so. Our OEM partners are being squeezed by their customers for cost reductions. They are all dealing with additional costs in the form of the medical device tax and additional regulatory compliance costs in a very competitive marketplace. In turn, today’s contract manufacturer is being asked to provide cost reductions but not at the sacrifice of capability, technology, quality, delivery, or any other performance-based metric. Companies on the forefront of machining technology such as AIP Precision Machining are being asked to reduce these costs in an environment of increasing regulatory costs. Not to mention the ever-increasing costs of maintaining the most talented and capable team and equipment. The machined instrument business is nothing short of extremely challenging and not for the faint of heart as we continue to deal with lower quality and capable competition who tend to get attention due to lower costs. At times these lower cost options turn out to be too good to be true for a customer and result in a major “fire drill” for the higher-end shops to come in and pick up the pieces. We have had a few of these “fire drills” this past year where we were working with little or no lead time remaining to still salvage the customer’s product launch dates.

John Phillips: From a supplier’s perspective, customers are asking for things faster and at a reduced price. With this in mind, we’ve made an addition to our executive leadership team in the form of a Director of Continuous Improvement. This new position was specifically created to lead our corporate performance improvement programs. We have also been extending the purchasing horizon for our customers in order to aid them in achieving a lower price point with better lead times since we can effectively better utilize our capacity by level loading the request over a longer period of time.

Sean Miller: Orthopedic instrumentation and delivery systems currently have an amplified focus throughout development and launch as orthopedic manufacturers are differentiating their product by performance, appearance and efficiency in their instrument design, gaining operating advantages in reduced set costs, and protecting their brand by mitigating risk within the procedure and supply chain. Delivery system designs are being influenced by a customer shift, requiring outputs that meet the AAMI [Association for the Advancement of Medical Instrumentation] recommended guidelines on sterilization cycle and dry times.

Hal Hurwitz: Demographics in the United States with the aging population and the emphasis on outpatient, non-invasive procedures to get the patient active as soon as possible are the overriding global market forces. There also is an increased scrutiny in the overall cost of all implantables and procedure codes within the healthcare system, particularly in the United States.

ODT: What market forces are driving the trends in orthopedic instrumentation?
Phillips: Price is one of the things driving the trends in orthopedic instrumentation but it’s also a trend itself, as more and more clients are taking advantage of our Vendor Managed Inventory program, which helps them plan a good part of their business for the year.

Jack Neenan: Instruments are key to selling the implant. The more effective the instrument is, the easier it will be to use and the greater success the surgeon will have. While this is certainly important, in the end it really comes down price since more often than not the instrument becomes a giveaway so the company can sell the implant.

Miller: Cost compression is a major force driven by decreased procedural reimbursement requiring surgeons to be more efficient to complete additional procedures with the same clinical outcome to maintain the same level of revenue. There is also the anticipated procedural volume increase due to patient population expansion through baby boomers and newly-eligible ACA [Affordable Care Act] patients. Finally, the industry is experiencing increased regulation throughout the development process and supply. From a different perspective, there appears to be a market shift with emphasis on instrumentation as one of the primary methods of product differentiation. With the history and effectiveness of hip and knee implants, designs have not been radically changed. But that is not the case with instrumentation systems. Surgeons critically evaluate the tools that enable their craft, and the accuracy and efficiency in which a unit can be repeatedly implanted directly affects the patient’s outcome.

Hurwitz: We believe there will be an increase in miniaturization as well as more multi-functional powered surgical instruments. Surgeons are asked to seek ways to increase productivity at their facilities without decreasing the quality of care. As demand rises for an increased patient load, we are seeing requests for more ergonomically designed, lighter instruments that provide power and torque, allowing for use of the products in a variety of bones, joints and other soft tissue.

MacDonald: The market is demanding less expensive and more capable products. Many smaller operations are popping up with quite innovative concepts which will provide solutions faster than the larger OEMs. These operations tend to lean heavily on the contract manufacturing marketplace for effective manufacturing solutions, design assistance and proven expertise.

ODT: What are some of the challenges in developing and designing orthopedic instruments? How can companies overcome these challenges?
Miller: One big challenge is the required tolerancing of instrumentation based on predicate designs. As an instrument must be equivalent or better than its predicate device, the tolerance band left to design and manufacture within is extremely tight after decades of this practice. At the cost of time and money, engineering studies can be completed to determine the tolerance required to achieve the outcome needed, but the number of variables that must be accounted for across an entire set has made this difficult to date. The demand for set cost reduction has also been a challenge as engineering teams are being asked to develop instruments for multiple procedural preferences, improve accuracy and outcomes, and incorporate marketing all for a significantly lower cost. This is the force driving the innovation in design and it looks different than the past. Another challenge affecting the manufacturing side is having time to develop a robust process to accommodate the design requirements in anticipation of a system launch. In most projects, the allotted time for this activity has been compressed to make up for lost time at the start and middle of the project plan.

Hurwitz: As with any company, and especially important for a company like Pro-Dex, understanding the needs of the surgeon—the end user—is critical. While we depend upon the feedback from our clients, the surgical company OEMs who seek us for new design and manufacturing improvements, we bring added value to the conversation by understanding the needs of the physicians. Listening and watching the process provides critical insights to product design. The physicians’ use of powered instruments, however, is evolving; thus too, are their needs.

MacDonald: The challenge of making instruments less expensive and more effective would be greatly helped if both parties could engage in an open discussion regarding the OEM’s goals early in the design phase. Laying it all out on the table in terms of cost, deadline, responsibilities, expectations, and functional goals of the product tend to solidify the partnership between the manufacturer and customer. Clear and honest communication of each party’s responsibilities and goals will only result in a loyal relationship based on more than cost alone. The trust and loyalty gained in an effective partnership between a contract manufacturer and the OEM is second to none in this business.

Neenan: This is where DFM [design for manufacturability] comes into play. That can be achieved in any number of ways—maybe it’s minimizing the number of touch points in the process or the number of times you’ll have to retool a part. It all comes down to understanding the particular component you’re making and trying to make it in the most efficient way.

ODT: Please discuss some of the latest technological advancements in orthopedic instruments.
Neenan: There’s been a big push in recent years to create instruments that can accurately be repositioned during the procedure.

Phillips: Doctors also want instruments that can handle caseload. I know surgeons who do 18 knees a day, and that’s only possible if you have an instrument that is easy to use and is strong enough to allow you to do the case turnover that you need. The implant is set, it’s really all about the instrumentation. If there’s an instrument set that allows a doctor to do 18 knees a day but there’s a problem with the alignment, then that set becomes ineffective. It’s like putting the wrong tires on a car.

Miller: Innovation in orthopedics is being realized in reducing cost and time to develop and launch systems while optimizing function. This takes a modified approach to the development process by making it more of a commercialization process and incorporating all functional areas into the team and addressing instrument cost up front, where a majority of the price is determined. Also, as technology works its way into every industry, the same is true for orthopedics. There are many examples in the field today of smart instruments used for targeting, alignment and feedback. Their true effectiveness will be demonstrated as we move into the future, but they will eventually find a place in this space. Polymers are likewise migrating into orthopedics as their robustness can now withstand the demands of reuse and reprocessing while other plastics are making single use instruments not just feasible, but maybe even preferred for specific application within this segment.

ODT: How will orthopedic instrumentation change over the next five years?
Hurwitz: We are witnessing new and innovative manufacturing techniques in creating medical devices on all fronts. We should see a continued interest in consumer and digital applications in orthopedics as well. In most medical devices, including our field, making the process foolproof and not dependent on secondary operations can often improve the procedure. Some end-users prefer single-use, disposable devices.Combination kits and instruments to reduce inventory needed in the O.R. by the healthcare facility are more common. New power sources and battery-operated instruments, including rechargeable options, will become more prevalent.

MacDonald: Hopefully continued expansion into the use of polymers and carbon fiber materials for weight reduction and increase visual access under fluoroscopy. At times moving from metals to polymers and carbon fiber results in cost increases. However, the savings garnered from the reduction in weight, speed of surgery, and reduction of infection risk results in a net cost savings for the entire medical community.