Talk about aiming high. Literally.

European aerospace manufacturer Airbus SE is striving to achieve a lofty goal it set for itself more than half a decade ago: doubling output and halving production time.

The target—20,000 fully constructed aircraft over 20 years—would have seemed unrealistic a mere 10 years ago, but technological progress has turned that erstwhile fantasy into a tangible reality. And that reality is quickly transforming the manufacturing process. 

Industry 4.0 and the Industrial Internet of Things (IIOT) are turning classic manufacturing plants into smart factories with highly interconnected production systems powered by artificial intelligence (AI) and big data analytics. 

One of the newer propellants powering these smart factories is augmented reality (AR), a technology that blends digital content with the physical world in real time. In manufacturing, AR seamlessly incorporates digital technologies into the production operation, enabling workers to perform tasks more efficiently and accurately, reducing the risk of errors, and improving quality control.

Airbus’ introduction to mixed reality manufacturing dates back nearly a decade, but the Dutch firm did not integrate the advancement into its operational workflow until it teamed with Microsoft about five years ago. The company uses Microsoft’s HoloLens 2 headset to help its workers efficiently and ergonomically execute their duties. The headset uses eye-tracking technology to detect the user’s gaze and display relevant content, automatically scrolling as the user reads.

Microsoft’s mixed reality technology has perhaps proven most beneficial for Airbus’ production line staff, as it allows them to access critical data while keeping their hands free. The headset overlays digital information like instructions or diagrams onto real machinery to help workers complete complex or hard-to-reach tasks. Airbus estimates Microsoft’s mixed-reality tool has enabled the company to slash manufacturing time by one-third while simultaneously improving quality.

“Mixed reality can help us increase quality, safety, and security,” Jean-Brice Dumont, now head of Air Power at Airbus Defense & Space, noted upon the start of his company’s more ambitious manufacturing target. “The level of human error is significantly reduced, and in aerospace, increased quality is increased safety—and needless to say, security goes with that. By having the right information at the right time in hands-free mode, not only does quality increase but also safety. This is what we are looking for.”

Dumont isn’t the only seeker of better quality and safety. His counterparts in healthcare are pursuing the same goals with identical tools.

Stereo microscopes, for example, are now equipped with augmented reality (AR) modules that help streamline complicated manufacturing tasks. Much like Microsoft’s HoloLens 2, these AR microscopes overlay text, images, videos, and measurements into the eyepieces’ visual field. Such faculties help improve workflow efficiency by projecting standard operating procedures directly into the microscope’s line of sight, thereby allowing medical device assemblers to check instructions without diverting their focus. 

In addition to its resource utilization prowess, AR microscopes also can help solve manufacturing snafus in real time. Third-party collaboration software such as Microsoft Teams can help diagnose and solve production issues by enabling real-time communication between assemblers and off-site managers or engineers. The software allows both parties to share the microscope eyepiece view and conspire on a solution. 

AR also can be a useful preventative tool. Using AR-enabled glasses or headsets, manufacturing plant managers can walk the factory floor and instantly acquire production data about the parts and/or devices being built and the robots/machine work cell responsible for their assembly. This particular proficiency allows the manager to ensure that production is adhering to quality, regulatory, and output goals, and verify that equipment is operating properly.

Mixed reality isn’t only beneficial to humans, though. The technology can augment robotics by revealing a robot’s next move(s) and where a human operator may join in to perform their duties.

Perhaps one of the most valuable uses for mixed reality manufacturing technology is employee training, as AR can narrow the sizable skilled labor gap in medtech by improving on-site training.

AR microscopes can offer assistance in this area as well. Collaboration software enables both trainers and trainees to share the microscope’s vision field so guidance can be provided in real time and annotations and training videos can be added directly in the mutual sightline.

To discover the other benefits of mixed reality and artificial intelligence in manufacturing assembly/automation as well as the other market forces impacting the sector, Medical Product Outsourcing spoke to more than a half-dozen experts over the last few weeks. They included:

• Miguel Ballesteros, senior technical operations manager at Command Medical Products, a medical device contract manufacturer in Ormond Beach, Fla.
• Brett Freeman, president of Providence Enterprise USA Inc., an Irvine, Calif.-based medical device contract manufacturer with operations in China, Vietnam, and Mexico.
• Dave McMorrow, technical director, MMT Automation; and Michael Wall, technical director, MMT/Somex Automation. MMT (Medical Manufacturing Technologies) is based in Charlotte, N.C., and provides automated, process-driven medical device manufacturing solutions.
• Ryan Moran, director of Automation; and Al Neumann, manager, Automation, at SMC Ltd., a Somerset, Wis.-based contract manufacturer of single-use and disposable medical devices. 
• Mark Paggioli, sales and marketing vice president; and Brian Romano, director of technology development at Arthur G. Russell Co., a Bristol, Conn.-based developer of tailored assembly machinery solutions.
• David Wolgemuth, molding/manufacturing specialist; and Griffin Doak, automation engineering manager at Phillips Medisize, a Hudson, Wis.-based Molex company. Phillips Medisize is a manufacturing partner for the pharmaceutical, in-vitro diagnostics, and medtech markets.

Michael Barbella: What market drivers are impacting medtech assembly/automation trends? 

Miguel Ballesteros: The biggest drivers we’re seeing are rising labor costs, the need for more consistent product quality, and a major industry shift toward reshoring manufacturing to the United States. Automation helps mitigate labor shortages, reduce variability, and maintain competitiveness—especially when trying to match the cost structure of offshore facilities.

Brett Freeman: There are several key market drivers that are shaping trends in medtech assembly and automation. With the ongoing demand for efficiency, accuracy, and cost reduction in healthcare manufacturing, companies continue to implement more automation which would include robotics and AI. With the increase in patients, the continuous complexity of medical devices, and the shift toward minimally invasive treatments, there is an increasing need for flexible production capabilities, which automation can potentially support. With continuous regulatory pressures to ensure traceability and compliance, automation investments can help to improve processes related to maintaining documentation and reduce human error. Additionally, supply chain disruptions and the trend toward reshoring or nearshoring manufacturing have led OEMs and suppliers to invest in automation for greater control and resilience. This can also work in parallel with OEM efforts to reduce waste and minimize energy consumption. Lastly, the growing prevalence of chronic diseases, an aging population, and the need for improved patient outcomes are fueling the demand for automated systems that can deliver high-quality, reliable, and scalable production in the sector.

Dave McMorrow: Increasing numbers of catheter devices now have electrical aspects to them. Examples include use of high frequency electrical energy for therapeutic benefit or use of sensors in the product to monitor or control the procedure. The need to write data to devices contained in the product is also becoming more commonplace. 

Michael Wall: Continual innovation with regards to minimizing the size of catheters and design of delivery systems and devices for minimally invasive procedures.

Ryan Moran: There are several market drivers with relevant impact. Regulatory and compliance requirements, and increasing complexity in products, along with the continued push for high quality manufacturing continue to play big roles in trends overall. With the increasing pressure from regulatory and compliance, rightfully so, automated systems are turned to in efforts of aiding with more reliable traceability of product, consistency in documentation, and overall compliance across the board. And as devices become more complex with increasingly smaller components, automation is a great means to feed or handle components as well as assemble the devices with high precision with verifications throughout the process. This essentially boils down to the rising demand for high quality manufacturing to ensure the overall safety of patients, doctors, and everyone handling the products. Whether it is improved process control, improving repeatability, or ensuring accuracy overall, the goal is always zero-defect manufacturing. 

Al Neumann: High-quality builds and speed-to-market are both frequent requirements and using pre-programmed and tested code and modular automation cells help meet both. 

Mark Paggioli: Labor and workforce implications—both the availability of people and what workforce is available, tends to be less skilled than what was available over the past few years. This is having an impact on what manufacturers are looking for in equipment and in some cases, we’ve also seen (heard) considerations of outsourcing labor. Additionally, what it means for companies that are looking to increase or bring more production back to the U.S. Also, meeting/understanding demand and production performance levels, the cost of things while taking an approach to meet demand vs. exceeding it like years ago or having additional capacity that they would fill down the road as demand comes up. 

David Wolgemuth: A significant transition in medical applications is shaping the market, moving from traditional laboratory and clinical settings toward personal care solutions. This evolution drives demand for smaller, single-use or reusable devices with disposable components. As a result, rising production volumes and increasing cost pressures compel organizations to adopt automation strategies. Automation has become a critical enabler, addressing the dual need to scale operations efficiently while managing the complexities of advanced device designs and maintaining cost competitiveness. 

Barbella: What new innovations have been developed for medical device assembly and automation? What specific market needs to they address? 

Ballesteros: Cobots—or collaborative robots—have made a big impact, especially in cleanroom environments where space and flexibility are key. We’re also seeing a lot of advancement in machine vision systems, which can detect defects and validate component orientation in real time, improving both efficiency and product quality. They’re directly addressing labor efficiency, cost control, and the need for consistency. What used to take five operators in a manual manufacturing cell can now often be done with one or two. These technologies reduce the chance for human error and improve throughput without compromising quality.

Griffin Doak: Recent innovations are transforming operational efficiency and reducing risks across processes. AI-powered inspection systems enhance quality control by eliminating human error, with the ability to detect defects such as cracks or damaged seals with precision. Asynchronous systems equipped with servo-actuated technology bring greater flexibility to assembly operations, enabling more adaptable manufacturing workflows. Additionally, digital twin technology provides a virtual environment for testing and validating software updates before deploying physical equipment, minimizing risks and accelerating time to market. These advancements drive smarter, more reliable and cost-effective solutions across industries.

Freeman: From a contract manufacturer’s perspective, having flexible automation platforms allows us to adapt quickly so we can customize and reduce downtime. Automation through the use of robotics and AI drive software can help to ensure quality control while minimizing scrap and ensuring consistent throughput. The implementation of MES systems has enabled real-time monitoring, predictive maintenance, and data-driven decision-making, all of which positively impact reliability, efficiency, and traceability. The outcome of these advances results in lower cost, consistent throughput of medical devices that meet regulator requirements, OEM’s requirements, and patient needs. 

McMorrow: There is a significant increase in the level of machine control and software sophistication, including robotics, vision systems, in-built test and calibration functions, as well as reporting data to MES systems.

Wall: Also related to size—the continual drive for smaller delivery systems and devices requires increasingly sophisticated equipment designs and precision tooling.

Brian Romano: We have been experiencing market hesitancy where companies are looking more to go through proof of concept and value, taking the project is smaller, and more risk averse stages. This may not be an innovation but is rather a recall from proven methods. AGR, both in Bristol and through its new acquisition in North Carolina, has the ability to provide all the POC, manual, semi-automatic, and fully automatic stages that the customer requires. Additionally, the further utilization of flexible machinery based on increased robotic integration combined with start of the art AI vision inspection provides the customer with a system that is adaptable to their needs, at whatever stage of the automation roadmap they may be on.

Barbella: What challenges do medtech companies typically face when scaling automated assembly lines in regulated environments?

Ballesteros: One of the biggest challenges is justifying the cost—especially at low volumes where the ROI takes longer. Regulatory validation becomes much more complex when you automate. Every system variable needs to be accounted for in your OQ and PQ. And of course, you need the right people—skilled technicians and engineers who can support and troubleshoot these systems.

Freeman: Maintaining quality when scaling up becomes increasingly complex. When production volumes rise, there is an increase in the risk of defects that can lead to recalls, regulatory action, and potentially patient harm. Medtech companies must continue to ensure proper documentation, traceability, and the validation of automated processes. When scaling up automation, it typically requires large amounts of investment so if the documentation, traceability, or validation isn’t robust, it can lead to exponential problems that can be very costly and time consuming. It is important to get it correct from the start. Then, there is the added complexity of different regulatory requirements depending on the intended markets to be served (i.e., U.S. FDA vs. EU MDR). As automation is scaled up, there is an ever-increasing need to train the workforce on how to ensure proper implementation as well as the integration of any robotics and/or AI. There is also the challenge of ensuring that the automation will work for the purpose intended. We have worked with an OEM customer in the past that invested significant amounts of capital in expensive automation equipment only to find out that a simple process could not be automated due to dimensional intricacies of the part. 

McMorrow: There is a critical need to manage risk to ensure processes are robust and no unforeseen issues arise when the process is integrated into automated equipment and run at scale. MMT provides concept development and proof-of-concept testing prior to scaling to mitigate risk. Choosing an automation partner specialized in the medical device industry, providing in-depth experience combined with a large portfolio of past projects and COTS equipment is invaluable. 

Wall: Existing processes which are carried out manually using skilled labor are not always sufficiently stable and understood. Engineering capabilities are required to ensure that processes and materials are well understood and controlled—capabilities must also be strong to support sophisticated equipment through the entire lifecycle. 

Moran: Although there’s a much longer list, I would say choosing the proper automation partner(s), investing the necessary time upfront to fully understand specifications and expectations, ensuring the processes will be scalable to future throughput needs, and having the proper support staff to not only operate by maintain the equipment are at the top of it. Selecting the proper automation partner is crucial in the overall success of the project. Whether it’s their experience with similar product and scale, overall technical aptitude, confidence in solution presented, overall dynamic between the teams, and/or build location, they are a big part of the team and play a pivotal role in ultimate success. 

Investing time at the beginning to understand and define specifications (URS) and communicate expectations continues to be time well spent for all parties involved. Understanding specifications can and do change along the way, this allows for a methodical and documented process to track changes and overall impact at each revision. This investment pays dividends as it typically flushes out what would have been issues much further upstream, so they can be handled systematically opposed to reactively. Ensuring processes are scalable to the future desired throughput is extremely helpful when higher speed lines are built as the product needs ramp. In some cases, a Proof of Principle (POP) may be executed prior to equipment design to confirm cycle time and increase overall confidence in solution. Finally, having the proper support in-house for automation operation as well as maintenance overall. Having this trained and educated team on staff ensures the processes are well executed and equipment is maintained to the level required for precision operation. 

Neumann: Completing early paperwork clearly helps when those pieces of equipment and strategies evolve into higher throughput systems. Lessons learned on small, modular cells certainly are valuable during scale-up.

Wolgemuth: Businesses face key challenges in balancing investment decisions with market demand and the timing of regulatory approvals. Companies often need to commit to production readiness ahead of market approval, which can lead to idle investments if approvals are delayed. Additionally, late-stage design changes during equipment procurement can drive up costs and disrupt timelines. To overcome these obstacles, strong collaboration between engineering and commercial teams is essential. Aligning on timelines and priorities ensures smoother execution, optimized resources and a more efficient path to product readiness. Phillips Medisize collaborates closely with customers, production teams and automation vendors during the initial manual clinical assembly phase. This collaboration helps in developing and refining the assembly process, making it easier to transition to higher volume automated production.

Barbella: How is AI and/or machine learning being integrated into medical device assembly and automation?

Ballesteros: We’re seeing AI integrated into vision systems that detect quality issues like gels in extruded tubing as products come off the line. It’s not just about inspection anymore. In some cases, AI is influencing how the product is actually manufactured in real time, making the process smarter and more adaptive.

Freeman: AI-powered tools are being used to simulate device performance without having to rely on physical prototypes as these simulations can be done virtually. In addition, data is being analyzed from a variety of sources including manufacturing-related data and clinical data and matched with intended use to ensure proper patient outcomes. On the manufacturing line, machine learning enhanced automation is being implemented to inspect for misalignment, cracks, critical imperfections, and assembly-related errors. This is having a positive impact on manufacturing yields, cost reduction, product consistency, compliance, and doing right by the patient.

Neumann: Ease-of-use makes technical integration much more attractive. AI technology, used in many machine vision products, for example, allows an integrator to apply hardware with expected results easier.

Romano: AI allows companies to use historical data to predict future events using real time data. Driven by IIoT sensors, derived or soft sensors, and existing process information, AI can look beyond KPIs of process into the machine health. One of the components of OEE is availability, and the ability to predict when to bring down a machine, and do so gracefully and planned, yields a quicker turnaround time to bring the machine back into operation. This planned action can help to mitigate rush shipments of parts due to catastrophic failure while also allowing JIT delivery of spare parts, thereby minimizing spare parts inventory. As an OEM, AGR preps a machine for this level of AI analysis by installing the needed KPI sensors along with a layer of machine health IIoT sensor, coupled with PLC programming to generate soft sensor information. 

Wall: AI/machine learning faces a lot of challenges for acceptance in a highly regulated environment—typically, validated processes need to be completely defined and proven to be repeatable without change. There is some potential in regard to process development in areas such as machine vision for collecting data prior to Validation. 

Wolgemuth: AI plays a growing role in inspection systems, helping to enhance defect detection and reduce human error for improved quality outcomes. However, ensuring the consistent reliability of AI algorithms remains a significant challenge, particularly in validating their performance to maintain stringent quality standards. There are also exploratory efforts to apply AI in equipment design, including optimizing station placements for greater efficiency, though these applications are still in the early stages of development. The primary focus continues to be on refining AI validation processes to prevent defective parts from slipping through, ensuring quality and operational excellence.

Barbella: How has medtech automation impacted workforce skills requirements?

Ballesteros: The workforce needs to be more technically proficient across the board. Operators need to understand electronics, robotics, and mechatronics. Engineers and managers must collaborate to support and optimize these complex systems.

Freeman: Automation is an increasingly important part of the medtech manufacturing process as well as supporting the performance of the medical devices themselves. Regardless of whether we focus on the manufacturing process or the development of the medical devices, the respective workforce will equally need to be trained to scale up their abilities to stay ahead of the automation curve. This involves design, development, usage, and testing of the automation platforms, involving both hardware and software. There are concerns about automation having a negative impact on the number of workers needed. However, while automation may make medtech production more efficient, there is an ever-increasing need for the workforce to be properly trained to ensure that the automation performs processes consistently in order to achieve repeatable, traceable, and precise manufacturing steps to reduce the risk of defects and ensure compliance. 

McMorrow: Automated manufacturing creates the need for advanced requirements for higher-skilled workforce among medical device manufacturers. Skill and experience are required for medical device manufacturers to clearly define requirements for new equipment. 

Wall: Engineering capability and skillsets need to be increasingly sophisticated and resourced for introduction and support of automated equipment. 

Neumann: Skills required in medtech automation seem to require more focused expertise. Finding the best programmer, mechanical designer, machine vision expert, controls engineer, and safety specialist is a continuing challenge.

Paggioli: Seeing a bit of two camps here. Some companies are continuing to train and invest in employees, both to train up to fill the skills gap created by those retiring and to provide training specific to technologies that are changing. These companies leverage the partnership with their machine builders to provide training and to keep it specific to the needs of the equipment they’ll operate and troubleshoot. The other camp, their approach is to ask for machine builders to provide equipment that is designed around the acceptance of a workforce that is less skilled and where employee turnover will be an ongoing problem. Their solution is to accept this reality and instead to focus on minimizing the issue through the design. 

Romano: Additionally, the leaning on OEMs to provide support moves to support using field service or company onsite technicians instead of field service engineers through the employment of technologies such as augmented reality. Here the onsite technician has rapid access to subject matter experts at the OEM, thereby reducing response time for a downtime event or other issue. Here the technician donned in VR provides the onsite technical extension to the remote support engineer. Many technical high schools and community colleges around the country have begun to implement mechatronics or automation system curriculums, providing a path for the needed technician level of onsite support. Control Systems Engineering is currently experiencing approximately a 1% unemployment rate, so this higher level of skills and knowledge are still very difficult to attain.

Wolgemuth: Automation is reshaping workforce requirements by reducing the dependency on direct labor operators and increasing the demand for skilled engineers and technicians to maintain, troubleshoot and optimize equipment. This shift highlights the critical need for workforce upskilling to equip employees with the expertise needed to manage advanced systems and handle more complex, value-added tasks, ensuring the organization remains competitive and operationally efficient.