Investment in assembly and automation for medical device manufacturing is on the rise. And for good reason—by streamlining production through automation, manufacturers can produce high-quality devices at a quicker pace while lowering costs.

Medical device manufacturing necessitates a great deal of precision and accuracy because they affect patient health and well-being. Using automation technology like robotics and machine learning can help manufacturers produce products with minimal intervention by humans. These machines can make assembling tiny components easier.

Automated inspection systems can also make sure every product is checked for quality before being sent to customers, helping reduce errors in production that could cause costly recalls or harm patients.

Automation extends beyond robotics. It’s the creation and application of tech to manufacture with minimal human intervention, which spans from semi-automated to fully automated. In general, automation processes are designed to perform repetitive tasks like sorting, picking, placing, processing, assembling, inspecting, packaging, and labeling.

It can be most effectively used where there’s repetitive motion, a requirement for environmental and process control, or a necessity to minimize the work method’s variation.

The cost of products made using automation is likely to be lower because of a reduced labor overhead as well, allowing for a more competitive price. The likelihood of a quality issue can also be reduced because there’s less of a chance an issue will arise due to a training issue, a variation in skill set, or ability gap in the workforce.

Assembly and automation technology has become accessible to organizations of all sizes, opening up new possibilities in medical manufacturing. In addition to robotics, product lines can be advanced by implementing technologies like intelligent vision systems, smart sensors, digital twins, and energy monitoring. These will be vital to help medical manufacturers future-proof their processes by increasing efficiency and boosting sustainability.

In order to explore this topic, MPO reached out to several industry experts over the past few weeks:

• Sean Blank, sales manager at Automated Industrial Systems (AIS), an Erie, Pa.-based manufacturer of O-ring and seal assembly equipment.
• Charles Klann, director of engineering at Saint-Gobain Medical, a Solon, Ohio-based designer, developer, and manufacturer of custom medical components and engineered systems for medical devices.
• Randy Larson, senior director of global product introduction at Phillips-Medisize, a Hudson, Wis.-based Molex company. Phillips-Medisize is a manufacturing partner for the pharma, in-vitro diagnostics, medtech, consumer, automotive, and defense markets.
• Patrick Mohs, industry manager of medical and dental at Bürkert Fluid Control Systems, a Huntersville, N.C.-based manufacturer of measuring, control, and regulating systems for fluids and gases.
• Al Neumann, automated manufacturing systems manager of SMC Ltd., a Somerset, Wis.-based contract manufacturer of single-use and disposable medical devices.
• Mark Paggioli, director of sales, marketing, and customer service at Arthur G. Russell Co., a Bristol, Conn.-based developer of tailored assembly machinery solutions.
• Dave Pentland, owner of Jefferson Rubber Works, a Worcester, Mass.-based supplier of custom molded rubber products.
• Brian Romano, Ph.D., director of technology development at Arthur G. Russell Co.
• John Wuschner, president of Kahle Automation, a Morristown, N.J.-based provider of custom automation machinery solutions for the medical device, pharmaceutical, and healthcare industries.

Sam Brusco: What market forces are impacting assembly and automation for medical device manufacturing at present?

Sean Blank: We specialize in manufacturing O-ring, seal, and retaining ring installation machines that facilitate automated production for medtech manufacturers and have observed several key market forces impacting this sector. The demand for precision and reliability in assembly processes is rising, driven by stringent regulatory standards and the need for high-quality medical devices. The push for greater efficiency and cost-effectiveness is encouraging more manufacturers to adopt automated solutions.

As a result, we see a significant rise in inquiries about integrating our O-ring installation machines into fully automated environments. This trend highlights the growing recognition of automation as a critical component in enhancing production capabilities and meeting the medtech industry’s evolving demands.

Charles Klann: Automation provides a higher level of production consistency that is more difficult to achieve with a manual process.

There is a need for confirmation that products have been assembled correctly; the automation process provides digital confirmation of that. Cost-down programs have also been developed to replace direct labor and provide a competitive advantage.

Randy Larson: Users of wearable technology, particularly continuous glucose monitors (CGMs), are calling for less obtrusive and smaller products with increased performance and durability. This drives assembly of small components with even smaller critical features.

The push for minimally invasive devices that have more data collection capabilities has led to development of smaller, more flexible cables needed for those devices that can be used in delicate procedures. The pace of innovation has also increased demand for custom cables—either with special connectors or standard connectors—at a wide range of volumes.

Patrick Mohs: Cost pressure in healthcare systems and differentiation from the competition through innovation are typically the main drivers for medical device manufacturers. New standards and regulations such as ISO 13485 and the EU’s Medical Device Regulation (MDR) pose new challenges for manufacturing processes and supply chains, These also impact medical device design due to the demand for documentation and monitoring, as well as redundant safety.

Al Neumann: Precision, accuracy, high machine uptime, data acquisition, and on-time equipment delivery.

Work cells we build in-house feature redundant checks that make sure our equipment performs tasks accurately at every station. Multiple tests initiated along an automated assembly exposes machine and component problems early in the process. Intuitive machine display screens identify and log these problems.

Other technologies help speed up and improve machine performance, as well. Information and changeable parameters from IO-Link sensors, for example, are displayed on a workcell’s HMI for easy reference and adjustability. Replacing cumbersome sensor cable wiring with an IO-Link fieldbus greatly simplifies machine electrical integration and offers noise immunity. Parameters can be backed up if a sensor is damaged and those values can automatically be downloaded to the replacement sensor.

Besides intuitive troubleshooting and status screens, equipment like ours features remote machine monitors to maintain a high level of uptime. These monitors screen a machine’s health and allow us to help troubleshoot equipment that’s placed in any SMC facility in the world from our central location in Wisconsin.

Digital twins also promise to accelerate delivery of workcells. You can watch a simulation of the real machine and spot changes needed before starting construction on actual equipment. Watching your CAD-based machine work virtually on your computer while also reducing the amount of programming required will certainly shorten build times of custom automation.

Reusable verified programming function blocks also save workcell build time. Function blocks that have been tested and used on other projects can be incorporated into new control strategies, saving programming time and shortening test procedures.

Dave Pentland: One of the key trends in assembly and automation services for medical device manufacturers is the increased use of robotics and automation technologies. These technologies allow for faster and more precise assembly of complex medical devices, reducing the margin of error and improving overall product quality. Robotics also enable manufacturers to increase production speed and volume, leading to higher efficiency and lower costs.

Another trend is the move toward more customized and personalized medical devices. As the healthcare industry shifts towards more personalized care, medical device manufacturers are under pressure to develop products that are tailored to individual patient needs. This requires assembly and automation services that are flexible and able to accommodate a wide range of product variations.

Brian Romano, Ph.D.: We see a trend of medtech assembly companies “de-risking” capital expenditures by starting with a more organic development of their product lifecycle. With the current cost of capital, companies want to ensure their investment will have the real ROI and ROA baked into the overall product manufacturing scope. Aggressive marketing projection estimates have caused companies to react to buying full-scale automation without taking the progressive steps of development related to their product lifecycle, while also considering their ability to sustain the complexities related to higher levels of automation.

Part of the reason for this is the workforce shortage and skills gaps. With the baby-boomer “silver tsunami”, Covid, and the “great resignation,” there’s a shortage in the workforce that had been in place to set up and sustain automation equipment operations. Coupled now with the skills gap, resulting from the lack of students going to schools with automation curriculums (at any level), there’s a large hole in the overall workforce needed to design, operate, and sustain automation machinery.

There are initiatives to solve the delay between today and when a properly educated and trained workforce is available and a gap has formed between these. This gap has forced companies to rely more on OEMs and systems integrators to control the equipment’s maintenance and operational upkeep.

John Wuschner: The shortage of skilled labor to operate and maintain medtech automation is an area we must continually invest in, both in terms of support for local STEM curriculum and making our facilities available to young people for tours and engaging directly with them through sponsorship of hands-on opportunities like FIRST robotics. Apprenticeships and partnerships with local universities for internships must have a higher focus to have any hope of sustaining manufacturing in the long-term.

Reshoring is also causing many companies to reconsider automating processes that were once considered low ROI. Automation companies, in general, are consolidating into larger entities and providing a wider breadth of capabilities in terms of technologies and industry segment knowledge. This provides a different financial structure to support larger projects but also changes the way risk is assessed.

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DEEPER DIVE: The Role of Automation in Medical Device Manufacturing—A Medtech Makers Q&A

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Brusco: What new innovations have been developed for medical device assembly and automation? What specific market needs do these innovations address?

Blank: Recent innovations in medical device assembly and automation have focused on enhancing precision, efficiency, and adaptability to meet the stringent demands of the healthcare industry. Several advanced features of our O-ring installation machines address these needs.

For our clean room and medical package options, we ensure our machines meet the highest cleanliness and sterility standards required for medical device manufacturing. This includes use of all stainless-steel parts for the feeder bowl, magazine, discharge chute, stripper jaws, and the machine’s housing. Stainless steel construction minimizes particulate shedding and facilitates easy cleaning.

To cater to medical applications where traditional oils are unsuitable, our machines can be equipped with alcohol lubrication systems. Isopropyl alcohol is frequently used in clean room environments to meet stringent hygiene standards while ensuring smooth operation. Another critical innovation is the option to route exhaust air from the compressed air used in the machine’s operation. This feature prevents contamination in clean room environments by directing potentially contaminated air away from the sterile area, maintaining the integrity of the production environment.

Klann: We are now able to utilize 3D printing for metal and plastics, which enables us to iterate more quickly and support speed to market.

Larson: Advancements in deep learning vision, high-resolution vision, and vision-guided assembly have been very instrumental in our ability to assemble and inspect ever-shrinking components and features that are critical to performance and user experience with confidence.

Fine wire termination technology related to soldering and laser ablation are a couple of areas where we have seen innovation that helps manufacturers rise to the challenge of assembling smaller and more dense medical cable assemblies.

Mohs: To meet the current market requirements in terms of cost pressure, innovation, and new approvals, we’ve increased the intelligence of our products and solutions. This enables those products and solutions to monitor themselves, a medical device’s processes and functions, and predict potential future failures. ValveInsight technology enables clear identification of an installed elastomer diaphragm and the valve’s real-time monitoring and diagnosis. This allows detection of anomalies in the valve’s switching process in the process of a customer’s device.

The brand-new miniaturized analysis sensors, which have been specially developed for the requirements and conditions in medical devices, are the perfect complement to Bürkert solutions, enabling the next level for documentation and monitoring in assembly for quality assurance and in use of the medical devices.

Mark Paggioli: The increased focus on the use of data and optimizing OEE with monitoring being provided to help maximize value has become more popular. We see more need for obsolescence assessments, especially now as tech is changing more rapidly.

The desire to better understand production, outputs, and paybacks have also become more common. Product change and shorter lifecycles changed the way companies evaluate automation equipment. Remote service has become more sought after to help customers rapidly address any issues, keep things running, and minimize downtime while keeping production levels high.

The market needs, as I have been seeing it, a way to help companies with automation equipment needs and an approach that accounts for the speed of product change when accurate product forecasting is getting harder to do. There’s more demand for new lines that are smaller or producing lower volumes than was once wanted and the higher costs for smarter products has caused a more conservative approach to new lines. It’s part of the de-risking approach, which has companies wanting to better understand productivity and volumes, especially if tech will change more rapidly in the products they supply.

Wuschner: Artificial intelligence (AI) is all the rage; we continue to evaluate its value in our space. We’ve been approached many times to discuss how AI could be implemented in our machine software; however, in the medical device arena we must always consider the validated status of the machine. Most of these discussions come to a quick conclusion after posing this question.

Recently, we have begun using AI to train our vision systems on more complex attribute testing (e.g., surface imperfections, particulate size, “damage”). This process reduces development time and the samples required to a fraction of what it required in the past. Once the system has “learned,” we can disconnect from the AI system, validate using our normal measurement system analysis processes, and place the inspection into production without concern that the algorithm will change on its own.

Should there be a shift in process or new defect discovered later, the process can be repeated by reconnecting to the AI system and providing “continuing education” to modify the algorithm. This is also done faster and with less samples than before, and once completed, the AI is once again disconnected, the inspection re-validated, and production can move forward again.

Brusco: How can medical device manufacturers leverage Industry 4.0 technologies to build flexible, agile factory floors?

Blank: Medical device manufacturers can leverage Industry 4.0 technologies by harnessing the power of data. By collecting and analyzing data from sensors on the assembly floor, manufacturers can identify trends, predict potential issues, and implement preventative measures before problems arise.

Our O-Ring installation machines are packed with sensors and are designed for simple integration, playing a crucial role in this process. These sensors provide real-time monitoring and feedback, ensuring precise and efficient operations. This proactive approach enhances operational efficiency and provides valuable business intelligence for upper management.

Integrating advanced automation and IoT devices allows for real-time adjustments, creating a more flexible and agile manufacturing environment that can quickly adapt to changing demands while maintaining high-quality production standards.

Klann: By utilizing the paperless system for batch records and processing data, we can capture a digital footprint of the entire production process.

Larson: Designing modularly into our assembly processes and testing has given us the ability to rapidly and reliably reconfigure processes to support quick-turn prototyping cycles needed for product development activities, reduce investment cost for products new to the market, and meet customer needs quickly.

The insights and learning made possible from our connected processes have given us deeper understanding at a faster pace than traditional methods, which has enabled us to continually improve operational performance and cost competitiveness.

Mohs: Industry 4.0 technologies help us increase efficiency and flexibly optimize capacity utilization during production. Networked applications on a machining platform support continuous process improvements and profitability analyses. Digital shop floor management with real-time data collection, digital dashboards, and advanced analytics enable managers and employees to make data-based decisions, increase efficiency, and achieve production targets.

A digital machine manual provides relevant assembly and training documents directly at the assembly station, enabling more flexible employee deployment and quality assurance. Unmanned transport systems in order-related assembly ensure efficient logistics. Systematic data backup of test bench results also ensures traceability and quality assurance.

Dr. Romano: Industry 4.0 and Lean manufacturing have common elements where data-driven decisions are key and where Deming’s Plan, Do, Check, Act and Lean Six Sigma’s DMAIC (Define, Measure, Analyze, Improve, and Control) emulates the technology needs to acquire data, analyze it, and apply the learning. This iterative learning cycle, in my opinion, is a key differentiator between what is now defined as Industry 3.0 capabilities and Industry 4.0 outcomes. Of the nine accepted pillars of Industry 4.0, seven can be directly applied to the support of the medical device manufacturing floor, with the last two, autonomous robots and additive manufacturing, having possibilities to augment production. The premise of Industry 4.0 technologies is to connect the full enterprise by connecting the supply chain and the customers. This is an all-encompassing proposition requiring buy-in and resources.

Additionally, by leveraging the network and data infrastructure needed for an Industry 4.0 implementation, medical device manufacturers can monitor production data while using tools like AI to provide insights into production anomalies and bottlenecks, as well as recognize trends based on historical data to generate predictive maintenance and prescriptive handling of the identified issues.

This connectivity also enables OEMs and systems integrators to provide remote support for the production equipment. One of the pillars of Industry 4.0 is augmented reality; this functionality allows plant floor technicians to engage with the engineers at the OEM or other support personnel. This provides more rapid support, reducing downtime and retaining higher OEE levels.

Wuschner: Partner with an automation provider who has Industry 4.0 technology within their organization and builds their systems ready to connect. Our sister company ANT Solutions understands the unique requirements of the medical device/pharma space and how Industry 4.0 technologies must be tailored to ensure strict adherence to industry-specific regulations such as Good Manufacturing Practice (GMP). These systems need to facilitate accurate record-keeping, traceability, and audit trails, which are paramount in the pharmaceutical domain.

Unlike many industries that focus on continuous production, pharma often operates in batches. ANT systems are adept at managing complex batch processes, ensuring consistency and quality in every batch. For quality checks there’s a heightened emphasis to facilitate real-time monitoring of production parameters, ensuring any deviations are promptly identified and addressed.