By Mark Crawford, Contributing Writer | September 9, 2015 – MPO Magazine
Product design and manufacturing for traditional medical devices are well established, using standard methods of assembly and automation. These methods have proven to be effective and cost-efficient over the years for these types of devices. Assembly challenges, however, arise with the onset of more complex devices that are smaller, geometrically complex, made from advanced materials or have multiple functions. Medical device companies expect their partners to know how to manufacture and assemble these devices in the most efficient way, and at the lowest possible cost.
OEMs are spending more time evaluating all the factors that drive total cost. Automation and assembly are key parts of the cost equation. OEMs want to align product development with automation strategies that cut time to commercialization by minimizing design iterations and/or tooling design revisions, and maximizing production and assembly.
“With this in mind, a contract manufacturer’s technical expertise and ability to shorten time-to-market, proximity to key markets, regulatory support infrastructure and willingness to invest in capital equipment and technology needed to support emerging products are typically more important than automation strategy alone,” said Ronald Lilly, vice president of business development for the Americas and Europe for Singapore-based Forefront Medical Technology Pte. Ltd., a specialty medical device contract manufacturer focused on disposable drug delivery systems, diagnostic devices and complete (packaged and sterile) devices.
“Given that every project is unique in terms of customized automation strategy and end-market logistics, it is difficult to predict cost savings. However, historically we have been able to reduce customer costs by a double-digit percentage in projects where we had a baseline cost to measure against.”
Part of this overall cost-reduction strategy includes using smarter equipment.
“Production can be optimized by bringing together groups of information that access data, enable intelligent decisions and execute a steady production rate with reliable results,” said Erv Fringer, director of sales and marketing for Aspect Automation, a St. Paul, Minn.-based provider of custom automation equipment, systems and related engineering services.
An assembly board used to help employees ensure that tube segments are accurate. Photo courtesy of Command Medical Products. Contract manufacturers that want to stay ahead of the game are investing in more sophisticated controls systems and improved assembly and automation technology to maximize quality, production, validation and speed to market. For example, Command Medical Products Inc., an Ormond Beach, Fla.-based provider of subassembly and turnkey contract manufacturing for disposable medical devices, has made significant investments over the last two years in core technology upgrades for its radio frequency (RF) welding and extrusion equipment. These improvements provide automated process controls that adjust processing variables such as speed and current in real time, resulting in tighter and more consistent overall control of the output.
“Better outputs feeding into assembly improve overall quality and efficiency, including improved test values, stronger CpK values [process capability index] and reduced scrap,” said Stephanie McGee, vice president of sales and marketing for Command Medical.
Medical device manufacturers also seek more testing and validation—not just for enhanced quality and process control, but also to meet U.S. Food and Drug Administration (FDA) expectations. This is especially important for advanced product designs and/or materials that are new to the FDA. The application process is always smoother when agency reviewers can quickly understand the underlying science and manufacturing technology behind the product.
“OEMs want reliable equipment with the capability to add feedback loops such as in-line test and inspection equipment to ensure the process has been completed within specifications,” said Lilly.
“Clients also have an increased level of awareness regarding regulatory scrutiny of automation and assembly systems,” noted Anthony Sanzari, director of medical products for East Hanover, N.J.-based Weiss-Aug Company, which provides insert injection molding, precision medical and automotive metal stamping and automated assembly solutions. “Controls and validation requirements have been at the forefront of our most recent program discussions with medical device OEMs, with greater emphasis on the security of those systems and their importance to final product quality.”
OEMs are bringing increasingly complex designs to their manufacturing partners—challenges include miniaturization, articulation, complex geometries, advanced materials, electronics and wireless capabilities. These all create challenges for assembly and automation—even for something as simple as how a component or part is held.
Bürkert Fluid Control Systems is a Charlotte, N.C.-based global manufacturer of fluid handling systems for the medical device industry. It provides clean-room assembly, welding, electronic integration and automated assembly and testing. Products include fluid handling sub-assemblies such as valve/manifold assemblies with fittings, electrical harnesses, mounting brackets and other sheet metal and machined parts. Higher-level assemblies include printed circuit boards and reliability testing.
“Customers are often looking for automation solutions that increase throughput, reduce the number of times a lab tech handles samples or combine two or more instruments into one—for example, designing sample prep on board an IVD (in-vitro diagnostic) analyzer,” said Craig Occhiato, director of segment management-microfluidics for Bürkert Fluid Control Systems. “We reduce customers’ assembly time by providing assembled and fully tested sub-assemblies that can be dropped into their designs.”
Some of the most complex devices are combination products, such as sophisticated drug delivery products that combine both the drug and the delivery system into one device. These device/delivery systems range in complexity from a manual injection to a wearable, electronically controlled disposable pump. As these products become more difficult to manufacture, assembly and automation vendors must step up to meet these challenges in time- and cost-efficient ways.
“Manufacturing lines for combination drug-delivery products typically utilize traditional device assembly equipment integrated with pharmaceutical processing equipment, such as washing and filling,” said Julie Logothetis, president of Morristown, N.J.-based Kahle Automation, a global supplier of custom-built automation equipment for the medical device and pharmaceutical industries.
“This is extremely challenging as you cross from different levels of sterility and handle expensive, delicate components. Automation is required for these products because they cannot be manufactured any other way. There is no room for error—a product malfunction could result in serious injury, or even death to the user.”
Another important area to consider with combination delivery systems is the need for high equipment outputs along with the integration of the glass container into the manufacturing systems.
“The feeding, handling, processing and assembly of glass is significantly different to the way plastic components are handled, and require an expertise not traditionally available in the assembly machine market,” added Logothetis.
Other medical devices still may require hand assembly. For example, some products—such as complex gusseted bags with integrated filter media, custom-designed winged infusion sets and peristaltic pump tube sets—do not lend themselves well to traditional automation and still require some technique-based hand assembly.
“For these operations, we develop robust assembly stations and processes that incorporate semi-automated operations to complement and support hand operations,” said McGee.
More Command Medical clients also are requesting increased bag (IV bags, blood bags, etc.) automation to reduce cost and improve yields. To achieve this, clients can initialize production with semi-automated turntable manufacturing while running parallel in development of a fully automated system to allow smoother transition to initial production and faster ramp-up.
“This also allows for redundancy/backup once the fully automated line is in operation, which can be placed in an alternate facility to further mitigate supply risk, as well as provide excess capacity,” McGee added.
Smaller, more complex products also are driving micro-molding demands. Specialized applications such as implantable medical devices often have unique material requirements that can affect assembly. The technical challenge becomes aligning a highly precise technology with materials that are not always optimal for that process.
Polyether ether ketone (otherwise known as PEEK) is a prime example.
“Injection molding machines must be capable of injecting at higher pressure and speed when micro-molding parts with small shot sizes,” said Lilly. “For a specialized material like PEEK, the mold and screw material must be hardened to withstand a melting point at least 100 degrees over the melting point of normal resins.”
Robots increasingly are used in innovative ways in medical device assembly, such as part feeding. For example, automated assembly platforms now can receive raw materials without the need for traditional feeding equipment such as tray feeders. Compact, flexible, automatic assembly cells also can be designed for parts that require high-position accuracy. Other automated assembly processes include splicing, welding and application labelling.
Weiss-Aug Company recently fixed a packaging issue for a medical client with a robotics solution. The company manufactures a small metal part that is sent out in bulk to be barrel-plated. When parts return from plating they are tangled in clumps. Efforts to separate them often resulted in physical damage.
“The solution for separating them and packaging them without damage was using a vision-guided robot and a Flexomation feeder that shakes and bounces the parts,” said Mark Weissenrieder, IT and automation manager for Weiss-Aug Company. “The feeder breaks them up and presents them to the vision-guided robot so that it can find them, pick them up, properly orient them and place them in the tape and reel packaging machine in the right orientation.”
Robotics are becoming increasing modular—cells can be custom-designed that are ideal for the specific product and volume run, reducing product costs dramatically. Automation scale-up or scale-down is easy to do for assembling and testing. Additional modules also can be added during the ramp-up phases to take advantage of market opportunities.
Engineers are improving the ability of robots to learn from environmental cues within their work spaces. When robots can perceive and adapt to changes in their surroundings, they don’t have to be reprogrammed, which consequently increases efficiency and saves time.
“I’m seeing better advancements in collaborative robots,” added Weissenrieder. “Because they can work safely beside people, collaborative robots don’t need any guarding. This will start to reduce the need for operators. We use many traditional SCARA robots, but we have yet to be able to use any collaborative ones because they don’t yet have the precision and speed that we need for our processes.”
Control systems also are becoming more sophisticated and encompass more of the manufacturing process. Beyond simple sequencing, machine control systems “inspect product quality at multiple stages in the manufacturing process, track materials, product characteristics and integrate with enterprise data systems to provide robust product tracking and lot traceability,” said Fringer. “Automated process control systems can monitor machine behavior and predict mechanical failure before they become destructive.”
The ethernet quickly is becoming the communication standard of choice in automation.
The ethernet is used to interconnect all the hardware, including the programmable logic controllers (PLC), human-machine interface, input/output and cameras, etc. As a result, the machines and the control cabinets are simpler and less cluttered with wires. An ethernet connection helps in terms of flexibility and integration, but it can also create a challenge for security and reliability.
“IT departments and engineering departments in many companies have struggled with best practices, hardware standards and general ownership of ethernet-based industrial networks,” said Fringer.
The ethernet also has had a significant impact on machine safety. Ethernet-based safety systems offer robust monitoring and diagnostics that make machines much safer, but do so in a manner that is highly flexible and much easier to commission and troubleshoot than traditional hardwired systems. For example, Aspect Automation built a series of machines in a 15-year period for a medical customer. During that time Aspect transitioned from a hardwired safety system to an ethernet-based safety PLC system.
“This has saved over 100 hours of labor in machine wiring,” said Fringer. “Using a Safety PLC has allowed a more comprehensive safety strategy that is tailored to operator access requirements, such as overlapping safety zones and conditional safety states.”
Advancements in controls technology allow the automation and assembly equipment to provide more data and more information from the shop floor to the top floor. For example, the functional differences between personal computers and programmable logic controllers are becoming less significant. PLCs and their peripherals increasingly are offering database integration and other tasks that were traditionally handled by PCs—and PCs are available now in more rugged form factors suitable for plant-floor installation.
“Real-time operating systems and development environments are powering industrial PCs that can perform real-time control functions using ladder logic and other IEC 1131 languages, as well as high-speed data handling and graphics using traditional PC-based programming languages—all on the same hardware,” said Fringer.
Automation software allows medical device manufacturers to combine discrete and batch processes in their operations, creating a track-and-trace platform that vastly improves the ability to track their products and materials. The same platform also can help assemblers improve throughput by quickly identifying the correct components and providing assembly instructions. Order-management and electronic device history records also can be used to document the assembly process for every medical device that is manufactured.
A recent study from the Aberdeen Group discovered that material sourcing takes on average about four months—which likely is even longer in the medical device market. Just over half of this total time is consumed by search and discovery. In other words, companies spend a lot of time and money looking for information. This situation also is getting worse for OEMs because they often do not have enough staff to properly handle their sourcing responsibilities across an ever-increasing range of components.
Material providers are becoming more aware of the need to shorten this time for their OEMs—especially for newer and/or composite materials, which are more complex and often require longer search and discovery times.
“Vendors and manufacturers must have a strong understanding of how each component of a composite material contributes to the overall function,” said Brianna Sporbert, an engineer with Boyd Technologies Inc., a Lee, Mass.-based supplier of advanced flexible materials. “Sometimes one seemingly insignificant modification can ripple through the design process and cause large, costly revisions—including automation and assembly processes.”
To improve this situation, Boyd Technologies has created Sourcebook, a tool that allows customers and their supply chain partners to easily access both component and overall function characteristics of commercial flexible materials. This allows OEMs to efficiently and effectively compare many composite materials when specifying their new products.
The cloud-based material-sourcing platform automates the process of material sourcing—specifically search and discovery—at the front end of the product life cycle.
“This automation has tremendous potential impact, especially in medical and life sciences markets, where mistakes and delays can be extremely costly,” said Matt Boyd, chief operating officer for Boyd Technologies. “The Sourcebook platform is a single destination for searching and discovering flexible materials. Any flexible materials supplier in the world can put their material specifications into our system and any user in the world can go find them and request a sample that shows up the next day.”
“Sourcebook decreases the material sourcing process from three months to less than a day,” Sporbert told Medical Product Outsourcing. “The platform also allows OEMs to connect with Sourcebook engineers who are devoted to assisting the organization’s product development process. This can benefit assembly and automation because more time can be spent working with a raw material manufacturer to optimize the material for the ideal assembly process.”
Contract manufacturers can improve their automation and assembly processes by working with the customer in the earliest stages of design.
“OEMs will often solicit a partner for manufacturing and pitch over the prints and quality criteria and that is it,” said McGee. “This can limit the contract manufacturer’s optimization process. One of Command Medical’s strengths is our deep-dive project review with clients at the onset to really go through desired outcomes/performance of the product we are making. If we can collaborate with our client, and they are open to some process or slight product modifications, we can help design in process improvements that will result in a more efficient process and better end output.”
The use of robotics in medical device manufacturing continues to grow. Even smaller medical device manufacturers are seeing the benefits that robotics can have in their operation such as small part assembly, material handling and machine tending.
“In order to be cost-competitive in the marketplace, automating one, two or three manual processes makes a huge impact to the bottom line and ROI (return on investment) can be less than 12 months,” Aspect Automation’s Fringer noted. “Not only can scheduled recipe data be transferred from the enterprise to the plant floor in real-time, but the pervasive use of ethernet to integrate multiple machine modules means building blocks of automation can be manipulated to reconfigure the mechanics of entire production lines in days, rather than weeks.”