How are you influencing orthopedic devices?

Jim Stertz
Director of Quality/Technology, Lowell, Inc.

Lowell Inc., a contract manufacturer of implantable medical devices is faced with a dual challenge—how to reduce costs and how to retain experienced employees. We are achieving both those goals through automation.

In 2008, Lowell invested in a sub-micron accuracy PMM from Leitz of Germany (this same equipment is used to calibrate gages at NIST) to add inspection capacity to the existing Brown & Sharpe CMM. However, we soon found inspectors couldn’t keep up with demand in spite of doubling their capacity. I recognized the problem; these two highly sophisticated and very expensive pieces of equipment sat idle while a Lowell associate loaded and unloaded parts into the machines by hand. This down time meant that fewer parts were inspected as both customers and machinists waited for their parts. Clearly this was not the fault of the operator—a human can only work so fast before they tire or start to make mistakes, but what about a robot?

Now, instead of an associate laboriously tending the two machines, a Motoman HP20 robot does the work. We did the entire project ourselves—selecting the robot; programming its operation and interface with the inspection software; and choosing the racking, palletizing, and barrier systems that allow the robot to work safely. The robot runs virtually 24/7, freeing the operator to perform higher level tasks such as creating test programs and conducting data analysis. In addition, throughput increased dramatically. Our investment in our Motoman robot is part of our automation strategy here at Lowell—not to reduce the number of employees, but to allow our associates to perform higher level tasks

Robert Stanton
Director of Technology, Omnetics Connector Corporation

Orthopedic technology is always fighting to reduce blood loss and time in the surgery process. Sensors and detectors are being used to view pre-scanned mapping of the area to be visited. To assist the surgery processes, Omnetics has developed a line of new Nano 360 medical connectors that allow reduced diameter and weight of drill and cutting tools. This allows the surgeon to maneuver his process and even improve the chance of partial replacement over complete replacement of damaged joints. The new nano-cable systems are also being used in spinal pain management devices that help mask vertebrae pain signals. Customized nano-connectors are being designed into use for the very new orthopedic implant sensors and monitors that will provide real time data monitoring after surgery. The U.S. military has expanded its focus into post-orthopedic surgery devices that are more correctly called inter-active prosthetics. These include miniature electronic sensors and even nerve signal carrying wiring that are using Nano 360 connections. This allows rapid disassembly and repair on these very portable devices attached to the patient.

Bruce Fine
Market Segment Leader, Medical and Consumer Products, Polycarbonates, Bayer MaterialScience LLC

OrthoSensor developed the Knee Balancer device, which allows for greater precision and superior surgical results from knee replacement surgery. Previously, surgeons subjectively determined the amount of pressure that would be applied to the implant’s prosthetic bearing. The Knee Balancer intelligent device uses sensors and wireless technology to provide real-time, evidenced-based data to the surgeon. It optimizes the positioning and balance of implants by giving surgeons the ability to quantify adjustments intraoperatively and providing patient-specific kinematic information. The device contributes to improved patient comfort by reducing malalignment and improving prosthetic longevity.

OrthoSensor needed to select a thermoplastic for the device. Criteria for the device included biocompatibility, superior strength, and support from the supplying company. Bayer MaterialScience LLC’s Makrolon Rx1851 polycarbonate was chosen. This medical grade meets FDA and ISO 10993-1 biocompatibility requirements for a wide range of medical applications. It has excellent strength and toughness, which helps protect the electronic components of the device. The advanced formulation of Rx1851 polycarbonate ensures flexibility to incorporate intricate design features and easy moldability. Makrolon Rx1851 can be colored both as a transparent tint or an opaque color. For the Knee Balancer, the ability to be colored is important, because different colors signify specific device sizes.

Erik Novak
Director of Technology Development, Nano Surfaces Division, Bruker Corp.

As human lifespan continually increases worldwide, large numbers of people are receiving orthopedic implants. More than one million joint implants are currently produced every year, with a growth rate of nearly 9%. Lifetime and safety expectations continually increase, which place ever tighter requirements on the development and manufacturing processes. Both shape and roughness are critical parameters that must be controlled to ensure proper function and lifetime of orthopedic implants.

Bruker’s three-dimensional microscopes using specialized interferometric objectives provide the most rapid and accurate surface quality control of any technique. Surface roughness can be measured in seconds with sub-nm repeatability and accuracy over fields of view of many square millimeters. This allows large areal coverage of samples to quantify microscale finish, radius of curvature variations, scratches, and other defects. All of these factors can affect the tribological behavior of implants and must be tightly controlled.

Stage automation to handle trays of parts, simplified operator interfaces, and integrated part-scanning capabilities allow easy integration into production lines for continual process feedback and operator-independent results. Such systems are employed in most major manufacturing lines and are a critical element to maximizing implant lifetime for a wide variety of implants, including hip balls and cups, knees, elbows, and spinal implants.