Robotics and vision systems are also coming down in price and are easier to program and use—many are basically “plug and play.” Not only can they do more, many automation systems are also modular and scalable. They can be put together quickly to meet new market opportunities, or be adjusted as volume demands fluctuate.
For large-volume production, automation integrators and OEMs tend to build high-volume production systems dedicated to a single product line. Because they will be making large volumes of the same device, the automation systems are designed for long-term use with manufacturing needs that will likely not change much over that time.
“Smaller companies or end-user manufacturers, however, often need to anticipate growth and therefore plan expansion or adaptation into their systems,” said Richard Hansen, senior automation engineer for Bosch Rexroth Corporation, a Charlotte, N.C.-based provider of automation drive and control technologies. “They typically need lower costs to start, with adaptable machines to perform simple automation. These smaller machines must be designed to be easily tailored to the application at hand.”
The expansion of automation capabilities, driven by advances in the Internet of Things, big data, robotics, and artificial intelligence, have medical device manufacturers (MDMs) and contract manufacturers (CMs) very excited—as a result, integrators are incredibly busy trying to keep up with demands.
“This trend is also evident in the economics,” said Steven Jacobsen, process development engineering manager for Micro, a Somerset, N.J.-based contract manufacturer of medical devices and sub-assemblies. “As costs for systems that integrate advanced robotics and machine tending systems continue to go down, capabilities and flexibility continue to increase. The hardware is there, but integrators are struggling to keep pace. This rapidly changing climate has left many integrators programming systems like they did 15 years ago, while advanced algorithms, integrated machine vision, and other advanced tools are right at their fingertips.”
What OEMs Want
OEMs have a keen interest in “connected automation” and are eager for the speed, quality, and lower costs it can bring. Companies want complete automation solutions, with a strong focus on ease of use and interoperability—for example, real-time monitoring of process data from machine inputs. “Combined with predictive analytics, real-time monitoring allows us to scale back on in-process component or assembly inspections, in favor of real-time closed loop systems that will notify you before an issue occurs,” Jacobsen said. “This process, when combined with a historical database, allows us to combine the input and output data streams leading to an even greater level of control.”
These and other communication protocols promise simplified work cell construction, more powerful sensor utilization, and a more foolproof work cell component replacement strategy.
“For example,” said Al Neumann, automated manufacturing systems manager for SMC, a Somerset, Wis.-based contract manufacturer of single-use devices for the healthcare, pharmaceutical, and diagnostics industries, “sensors can be adjusted using the work cell’s human-machine interface, instead of relying on a technician to reach sometimes hard-to-access sensor amplifiers. When a sensor is replaced, stored values are automatically downloaded to the new device, eliminating possible inputting errors. The control system will also alert the technician if a replacement sensor is not exactly like the original.”
Of course, OEMs also want the usual: shorter time to market from initial design to commercial production, higher quality and repeatability in manufacturing processes, and traceability on product testing and raw materials. They also want top product quality and more consistent throughput with as little deviation from spec as possible. Part tracking and data logging are also expected for automated work cells.
To achieve more complexity, faster speed to market, and lower costs, MDMs must design their products for manufacturability.
“Innovative medical devices that are built to prove a concept or win a patent must often be completely redesigned—materials, dimensions, production and handling processes, everything—to incorporate the design for manufacturability (DFM) criteria that will enable high-volume automated assembly and inspection,” said Tom Hoover, Emerson senior medical market segment manager for Branson, a Danbury, Conn.-based provider of material joining, precision cleaning, and liquid processing technologies. “Transitioning a product design from low-volume manual assembly to high-volume automated assembly is a huge source of failure for medical device startups. We work constantly with medical device OEMs to help them meet DFM challenges.”
Part of that DFM process includes designing for automation. This includes working with the CM to create cost-effective solutions for proof of concept. This allows OEMs to verify their concept and reduce risk, prior to investing in expensive equipment.
“As in design for manufacturing, planning for automation during the product design phase is as important as the planning of any other segment of the manufacturing process,” said Neumann.
There are still segments of the medical device industry that are not extremely advanced when it comes to assembly and automation—electronic devices, for example. Typically, for volumes of less than 50,000 pieces, investments in full automation have a relatively long return on investment period. “Also, because traceability is essential in coordination with small lot sizes, the use of bar coding is increasingly common for every step of manufacturing,” said Joe Rocco, president and CEO of Eastek International, a Lake Zurich, Ill.-based contract manufacturer of medical devices. “In fact, the visibility it provides the manufacturing and delivery process is now seen as a productivity improvement.”
And, although there has been significant increased use of automation in medical device manufacturing over the last decade, many of those automation solutions were for high-volume production situations that were easy to justify and implement.
“We have helped many customers automate their highest-volume tasks, with significant return on investment,” said Ryan Weaver, manager of robotics for Axis New England, a Danvers, Mass.-based provider of automation solutions for the medical device industry. “However, a large amount of low-volume, high-mix tasks have yet to be automated. There are also a large number of tasks that are simply difficult to automate with a traditional solution [fixed industrial robots, integrated work cells, and custom-built servo driven Cartesian systems] due to the nature of the product. Sometimes we will see a product that has very long and flexible tubes, or a component that requires a high amount dexterity to handle. In these cases, it’s very hard to eliminate the human element entirely.”
Speaking of the human element, a number of medical devices are still assembled and tested by hand. With variable production demands, nearly every U.S. medical device manufacturer has trouble staying fully staffed; integrating automation is an effective way to handle fluctuations in labor needs due to changes in product demand. It is expensive to onboard new employees, especially if they don’t work out over the long-term because of economic variances in the market. “In many cases, it is much more desirable to automate the simplest tasks in a process, and then re-purpose the human talent involved into a more complex or subjective task,” said Weaver. “These kinds of tasks are ideal to target for automating.”
Latest Trends and Advances
Automation is essential for efficient production and data collection. The objective is to maximize productivity and quality by reducing the human factor in many of the repetitive tasks involved. For example, error reduction and process stability are key factors when performing typical lab automation. This can be in simple, tabletop lab processes on a small scale, or in large, high-volume production environments. Also, more companies are automating processes to simply keep up with demand and reduce turnaround times to their customers.
One such situation, noted Hansen, is the area of blood testing. This involves material sorting, pipetting, transferring, testing, and other steps. “With the extensive work required per sample,” he said, “24 x 7 x 365 capabilities are required just to keep up with skyrocketing demands. For medical device manufacturing, we are seeing large up-front investments in total factory automation—deemed necessary to consistently meet the strict regulatory quality requirements dictated by the FDA or similar governing agencies. Automation is also increasingly used for product inspection, testing, packaging, storage, and retrieval.”
With the increase of connected devices, there is more integration of electronics assembly and 100-percent verification of device function. It is also critical to factor packaging requirements into the assembly process flow; for example, there could be multiple layers of packaging such as the primary pack (heat-sealed bag), secondary pack (custom corrugate pack with multiple devices), and tertiary packaging (placing the custom corrugate packs into a larger corrugate box). The packaging steps, and the placement of devices, literature, labeling, and tamper evidence, must all be taken into account when determining the scale of automation needed to keep up with the assembly equipment.
Robotic arms are seeing more use in medical device manufacturing because of the improved efficiency and precision they provide. This is especially true for applying sealants and adhesives. They can also be a huge advantage when it comes to revalidation. For example, re-designing an existing process can be a big challenge because the new manufacturing approach must be validated. If the existing process relies on human operators for assembly, any major change will have to be re-validated from scratch by the engineering team. “Some of our customers have found that the simplest way around this challenge is to have a robot arm perform the task, following the same process the human operators would,” said Weaver. “Since the procedure is unchanged, the process doesn’t require re-validation—saving a substantial amount of engineering time.”
“The cost of robotic arms is becoming more affordable,” added Rocco. “They are also more easily programmed, with better compatibility linked to any optical sensors.”
Another trend is the increased use of collaborative robots. These are becoming easier to deploy, thanks to the simplification of the programming process, which makes it easier for more engineers to use them. They can also work along human colleagues safely.
“An easy programming interface puts the power of automation in more hands, since the tech isn’t restricted to the most advanced robot programming experts,” said Weaver. “This way, more of the automation process is controlled by the device manufacturer, since it does not have to rely completely on integrators to build dedicated machines for them. Collaborative safety also enables the automation of processes that still require the human touch, since operators can safely participate in the process along with the robot.”
Consider, for example, a grinding process performed on a suture cutting needle, where the majority of the application is a repetitive load and unload to the centerless grinding machine. A robot can handle the dull task of loading the machine, while still leaving the work cell open to allow skilled technicians to set up the machine, and do periodic quality inspections. “Not only does this increase throughput, but quality as well—the result of high repeatability from the robot and additional technician attention to fine process changes,” said Weaver.
An automation improvement that is starting to emerge from all major robotics and automation vendors is high precision force sensors integrated into end-of-arm tools on six-axis robotics. This technology is incredibly useful for assembling extremely small and delicate components that, up until now, have been nearly impossible to assemble with traditional systems.
“The sensors allow the automation to feel forces in multiple axis of around 0.1 Newton,” said Jacobsen. “The automation has the ability to interpret this closed-loop force feedback and iteratively adjust its joint paths and motor torques to fit components in a similar way to the process a human would. Advances like this are allowing automated assembly processes to expand into the realm of high dexterity work, which was previously thought to be impossible to automate.”
Modular and Scalable
OEMs are interested in cost-effective automation cells that can be built quickly and are easily adapted to product design revisions or production changes, such as the ability to produce multiple products or product variations on the same line, or to vary/increase production rates.
Flexible manufacturing cells take the form of both advanced robotics and modular smart assembly stations. In the robotic space, integrators are developing assembly or machine-tending cells that can be moved from one work cell to another. “These cells, once rigidly anchored, can then run through calibration routines which will recognize the work center and automatically adjust positioning for the inevitable variation in setup,” said Jacobsen.
Smart workstations with modular fixture plates can be swapped in minutes to reduce set-up times and limit floor space. These cells keep costs down because they only need one controller, pneumatic system, and safety controller. The fixture plates will often contain radio frequency identification tags that allow the controller to load the correct program with no input from a set-up technician or operator required.
These modular work cells are also increasingly using single-connection utility couplers that carry both input/output and pneumatics within one quick connect device. “This is one example of how the SMED [single minute exchange of dies] methodology is applied to assembly and automation,” added Jacobsen.
Vision-based error proofing of manual assembly operations within these cells is also becoming mainstream. These low-cost integrated vision systems are often used to track an operator’s movements and ensure that all process steps are followed in the correct order. The system will analyze a new image of the work cell after the completion of each process step. “If it detects a deviation from the programmed process, it can then notify the operator or supervisor that an action is needed and the current component or assembly may need to be reworked or scrapped,” said Jacobsen.
Software is a critical factor in how quickly the potential of new technologies and equipment can be exploited in medical device manufacturing. Much of this potential is rooted in the Internet of Things and Industry 4.0 applications—for example, part traceability, machine interfaces, remote process control, safety, and predictive maintenance are all enhanced via connected technologies. This type of information access allows users to further reduce machine downtimes, better plan production, and manage associated costs.
Industry 4.0 especially requires fast, open, and platform-independent environments based on easy-to-use software. In an effort to create greater ease of use for customers, Bosch Rexroth programming engineers created the Open Core Interface, which bridges the gap between IT and automation. It allows access to the control “core,” which in turn, lets programmers design motion control programs using tools such as Java, LabVIEW, CATIA, and others. The result is that machine programmers (and their users) can now communicate effortlessly between their preferred language and Bosch Rexroth software.
“This eliminates the need for the software engineers to learn Bosch Rexroth language or ladder logic,” said Hansen. “Rather, it allows them to use a familiar software tool of their choice to control their machine. This greatly reduces the development time of the machine builder and allows for flexibility in machine programming. It also more easily opens up the realm of factory automation to the world of handheld, wireless devices, as well as remote access and communication with the equipment itself.”
Another software-driven advance is the development of machine vision deep learning. Several top-tier machine vision suppliers now provide systems that utilize specifically designed graphic processing unit intensive processors and artificial intelligence like neural networks to teach a system the difference between a good and bad part or an assembly. This is proving especially useful for products with large amounts of input variation, difficult surface finishes, and complex surface geometry.
Other possible future applications include programming machines to call maintenance personnel to inform them of potential problems, or to have a machine send a text with the latest production values from last night’s shift before the production engineer even enters the building.
In addition to making manufacturing faster and more robust, software is also critical for record keeping and staying compliant with regulatory requirements. In the past, this has typically meant large amounts of paperwork, filled out manually and or semi-electronically. Now, aided by Industry 4.0 sensor and software technologies, more companies are moving toward electronic and automated record keeping. “This type of data collection is becoming more and more necessary, desired by not only the regulatory agencies but the manufacturers themselves,” said Hansen. “Collecting data is not only invaluable for record keeping, but also offers great benefits in proactive process management, such as trend spotting, predictive and preventive maintenance, and error prevention.”
The Internet of Things and Industry 4.0 will continue to revolutionize the capabilities of factory automation and test equipment, including data stream process reports to a centralized factory network, enabling individuals or groups to monitor every aspect of production and making real-time, decentralized process decisions. Technology continues to push the limits of robotics and automation in manufacturing. Improvements range from the component-scale (better drivers and motors) to the device-scale (new robotic packages, new robots) to the cell-scale (new integrations with third-party devices, new capabilities built around existing robots). Furthermore, new versions seem to come out every month.
“Changes to the way we think about, and enable, machine interfaces is the biggest trend we see in cutting-edge equipment manufacturing,” said Hansen. “This interfacing is the root of data collection, and from there, how the data is used is the true benefit of the Industry 4.0 revolution. The ability to push or pull data from production equipment into a multitude of functions within an organization will eventually become the expectation of the next generation of machine builders and manufacturing system engineers.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.