In a perfect world, medical devices would be manufactured in a process with zero errors. Today, customers’ expectations for zero defects are higher than they have ever been and medical device manufacturers are looking for error-reducing solutions.
Automation offers great promise. While automation is frequently thought of as a cost-savings solution, and it does reduce defects and scrap, what is less understood are its risk-reducing benefits that result from the consistency of parts and consistency of process.
Reaching for Zero Defects
In the medical device industry, minimizing errors is the single greatest opportunity — above cost savings and faster turnaround — that comes from automation. Whether it’s variability in the raw materials, the processes, or the assembly of finished product, variability must be minimized to reach the goal of zero defects.
Manual labor offers a significant source of variation. Many of the parts used in medical device manufacturing are visually inspected by operators at manufacturing facilities. Visual inspection through human labor creates numerous opportunities for variation — the environment and lighting of the inspection facility, the eyesight and magnification capability of the inspector, the distance at which the inspector is viewing the part, and inspector fatigue. With these types of variabilities, inevitably come errors.
To remedy those errors, automated vision inspection now takes place at device manufacturing facilities to minimize upstream human variability and the impact it causes downstream. Each piece is held to the same criteria, under the same lighting, in the same environment, magnification and lighting, and without the risk of inspector fatigue. This leads to consistent decision making related to the integrity of device parts.
Automated vision inspection is just one aspect of an integrated approach to manufacturing. New technologies, such as the Industrial Internet of Things (IIoT), enhanced machine sensors and machine vision, machine learning, and artificial intelligence (AI) are working and communicating with each machine within a plant in unison to reduce manual labor and manufacturing errors.
Can an Entire Manufacturing Process be Automated?
In the past, automation concepts were very primitive and began with simple work, such as moving parts from one place to another. As technologies advanced, automation has progressed to include integrated measurement systems, defect identification, and performance of manufacturing operations within production lines at high speed to minimize cycle times. An inspection that may have been performed manually in the past can now be automated using vision inspection technology at the same high speed as the production line. For instance, a naked-eye inspection — a 3- to 5-second inspection of a part under 120-foot candle lighting without a scope — is common, but this type of inspection allows a percentage of parts to be missed by the operator. A vision system can be implemented into robotics to pick parts from a molding press and inspect not only parts, but view specific areas of parts for defects. If there was a void, the vision system would find it and the robot would automatically reject it. Then, the operator’s only task is to retrieve good parts containing no voids. Similarly, labeling and packaging can also be automated at high speeds, thus improving delivery timing.
High-end automation equipment today has few limitations and nearly the same capabilities as humans thanks to sophisticated AI. In some ways, AI has even better capabilities than humans. Although it requires an up-front investment in teaching machines “the rules,” once AI understands parameters and requirements, AI simulates human logic and gives direction to the automation system. After an automation system is taught, it makes the right decision every time. Over time, AI benefits accrue by knowing what happened, being able to predict what is going to happen, and ultimately deciding what needs to happen.
The level of sophistication of automated systems continues to improve. In the recent past, robots could not perform the seemingly simple task of picking up one part from a random pile of parts because they could not “see.” Without vision, parts would have to be in a predictable arrangement for robots to know where the next part would be and how to orient their picking hand/gripper to handle the next part. Now, with the development of vision systems, AI robots can “see” a random display of parts, choose which part to pick up, and properly orient the picking hand to successfully grab a part. Robots are receiving information from a vision system, understanding how to pick a piece up, and even knowing how much it weighs. That is the power of today’s technologies, and the capabilities are only improving with time.
Another example is the advancements in collaborative robotics. In the past, robots had to have guarding around them. Today, robots work collaboratively with humans – even sensing their presence, allowing them to slow down or stop and interact – without a protective barrier present.
While automation systems do require an initial investment in equipment and in training the AI systems, the benefits of fewer defects can lead to patient safety and avoidance of recalls, reduced labor costs, fewer defects and scrap, and faster production speed.
Flexible Automation: The Answer for Low-Volume Manufacturing
While automation and high-speed production are now applicable to low-volume medical device manufacturing, you may wonder how to justify high-speed automation concepts in a lower-volume industry. That is being solved as well.
To justify the cost of automation for medical devices, a different strategy is needed than what is used for high-volume industries. Achieving ROI with medical devices requires flexible automation. When automation systems are flexible enough to be used for multiple product lines, high volume can be achieved across multiple product lines to share the cost of the investment.
If automation is designed correctly within a system, the same automation cell can be used on different product lines. This provides the ability to meet customers’ needs simply by changing specifications within the program and adjusting fixtures within the automation cell. For instance, if overall capabilities on dimensions of products are not where they are needed, quality checks can be formed at regular intervals. However, holding product and checking that entire lot for quality is a costly endeavor. Reprocessing a product line is also a solution, but not a cost-effective or efficient one. Instead, programming robots to work together with a vision inspection system is effective for detecting and minimizing out-of-spec products. These systems, working in conjunction with manual operators and inspectors, are able to ensure high-quality finished product.
Offshore Cost Incentive is Disappearing
The large gap between U.S. and offshore labor rates that made offshore manufacturing attractive in years past, and to a lesser degree now, is closing. The gap in labor rates between the U.S. and China is projected to close within the coming decade, coinciding with the standard of living increase in China. As the gap in labor rates narrows, the incentive to produce overseas diminishes.
In an automated process, the need for manual labor is minimized and levels the playing field as wage rates are not a significant factor in manufacturing location decisions. The major costs associated with automation, such as the equipment and the power to operate it, are virtually the same no matter where the automated manufacturing is done. Run times and technologies are also the same regardless of location. In addition, automation offers the advantages of fewer defects and less scrap than the same process done manually. Fewer defects reduces the risks of recalls – both patient and financial.
Automation Meets the Capabilities of Micro-manufacturing
As medical devices and their components continue to become smaller – into the micron sizes – a point is reached where humans can no longer successfully inspect or handle the parts. Parts at the micron size require automated processes for movement between processes, quality checks, and consistency of output. Micro-manufacturing is a significant trend in the medical device world. Learn more about the unique requirements of micro-manufacturing.
The Challenges of Automation: Resources and Expertise
Finding skilled laborers within the realm of automation who can teach machines what to do is a significant challenge, as there is a gap between the skills needed and talent available in the industry. And it’s not just an academic gap, but also an experiential gap. The students who have studied automation at the university level now need years of experience to become efficient at knowing what works and what does not in a real-world manufacturing setting.
There is also the need for familiarity with manufacturing processes that you are trying to automate. The medical device industry is extremely complex. Seamless labor crossover into medical device manufacturing is rare, and a significant learning curve of the industry can be expected. For example, a person who makes poker chips for the gambling industry may not have to go through rigorous documentation, step-by-step procedures, or qualify machines to ensure the final product is made. However, the medical device industry must follow strict federal regulations — Quality System Regulation — regarding manufacturing processes.
Automation can be complicated. Any time automation is added to a medical device manufacturing process, a qualification for the machine must be completed, as well as validation performed for the task being automated for a final, error-free product. Automation must be given a lot of forethought in the design process to avoid constant revalidation and re-quantifying.
A related challenge is staying up to date on the rapid pace of technological change. One way to do this is by working with manufacturing technology vendors who are developing intelligence products. This requires extra resources, but it is an effective way to keep up with the continually evolving technologies, to know where technology is heading, and to influence future development. Innovative and industry-leading contract manufacturers understand this and use it as a competitive differentiator to their advantage.
At Donatelle, being proactive in learning about technologies in development prepares our technicians for the future and helps us provide the latest in automation solutions for our customers. In a time of rapid change, it is important to select a progressive manufacturer who stays up on the latest technologies, leads change with their automation vendors, and can provide you with the benefits of the latest technologies.