Michael Barbella, Managing Editor09.10.21
Contrary to conventional wisdom, humans and robots can peacefully co-exist. They also can work together for the common good, given the right circumstances.
Alas, conditions have been ideal for more than 20 months now, thanks to the novel coronavirus and its brood of highly contagious variants. In its relentless pursuit of hosts, COVID-19 not only has snuffed out millions of lives worldwide, it also has extinguished—albeit temporarily—a longstanding trepidation humans have harbored toward their android comrades.
The anxiety was first triggered by Czech playwright Karl Capek’s 1921 drama “R.U.R.: Rossum’s Universal Robots,” a three-act play about factory-made robots that learn to think for themselves and eventually exterminate the human race. Such conquests have captured the imaginations of countless science-fiction authors over the last century, thereby fueling humankind’s anxieties about artificial intelligence that to some extent, still exist.
Those concerns, however, dissipated in the past year as COVID-19 ravaged the living and depleted the global supply of medical products, particularly masks and ventilators. To replenish the reserve and help meet worldwide demand for the latter item, unusual partnerships formed: Ford Motor Co. teamed up with GE and 3M, General Motors paired with Ventec Life Systems (respiratory care), Medtronic plc worked with Foxconn (electronics contract manufacturer), SodaStream conspired with Hadassah Hospital Ein Kerem (Israel), and Stäubli Corporation banded together with Infiplast (injection molder), among others.
The latter collaboration—part of a larger effort by French manufacturers to design and build a working ventilator—required the expedited creation of an automated assembly line.
“Stäubli’s proactive response helped us build an automated and insulated workstation in less than 10 weeks, from design to operation. That was a real feat, since this type of project ordinarily takes at least 24 weeks to set up,” Stéphane Buttin, sales director at MGA Technologies, told Assembly in July. The custom machine tool builder spearheaded last year’s ventilator project in France. “This was a true example of a successful team effort.”
Stäubli’s automated assembly line built an Infiplast-designed heat and moisture exchanger (HME) filter, which helps address proper humidification in mechanical ventilation. The automated system assembled a filter every few seconds, collecting the plastic parts directly from an injection molding machine and constructing them on a rotary indexing table before handing them off to another station for welding and finally for testing, boxing, labeling, and packaging Assembly reported. Robots placed defective filters in a reject bin.
“We responded to the request from MGA Technologies and Infiplast within 48 hours, and made the robots available in record time,” Jacques Dupenloup, Stäubli’s sales manager for France and Benelux, recalled to Assembly. “Our new SCARA robot is tailored for their application, with an enclosed structure designed for aseptic and confined clean room environments.”
Assembly lines like the kind Stäubli created last spring have been growing in recent years as medical device providers work to improve productivity, efficiency, and manufacturing quality on the shop floor and reduce both labor costs and cycle time. Legacy systems are losing ground to more modern methods that incorporate artificial intelligence, machine learning, and Industrial IoT considerations, while robotics is gaining support for its worker safety prowess and enhanced output capabilities, both of which have been critical during the pandemic.
To better gauge the trends and market forces driving the medtech assembly/automation sector, Medical Product Outsourcing spoke with numerous industry professionals over the last few weeks. Those who provided input included:
Prasad Akella, founder and chairman of Drishti Technologies Inc., a Mountain View, Calif.-based provider of video analytics and video traceability for manual assembly lines.
Robbie Atkinson, CEO of Medical Manufacturing Technologies, a company offering medical device manufacturers process development services, applications and equipment, technical solutions, and aftermarket support. MMT brands include Glebar, Tridex, SYNEO, CATHTIP, and Engineering by Design.
Julie Logothetis, president of Kahle Automation, a Morristown, N.J.-based provider of custom automation machinery solutions for the medical device, pharmaceutical, and healthcare industries.
Al Neumann, automated manufacturing systems manager at contract manufacturing firm SMC Ltd.
Craig Occhiato, market segment/sales manager for Bürkert Fluid Control Systems’ Micro Fluidic Segment. Bürkert manufactures measurement and control systems for liquids and gases.
Mark Paggioli, director of Marketing & Customer Service, and Brian Romano, director of Technology Development at Arthur G. Russell Co., a custom assembly machinery provider in Bristol, Conn.
Thomas Schwoerer, president, and Les Iburg, medical sales manager, at ZELTWANGER, a Charleston, S.C.-based supplier of high-end leak test, automation, and laser solutions.
Michael Barbella: What current trends are shaping the medical device assembly and automation sector?
Prasad Akella: Perhaps the biggest trend is that medical devices are getting increasingly more capable, and consequently, complex. If we layer in the fact that medical device manufacturing is highly regulated, it’s natural to conclude that continuously improving the most fundamental practices—current good manufacturing practices (cGMP)—becomes even more critical to ensure compliance and the safety of these sophisticated products. For example, consider a simple device like a glucose monitor with the patch that constantly transmits sugar levels to one’s smartphone and, very likely, a cloud service. Or the latest and greatest in heart valves: These products are connected to the internet and often use advanced materials with just the right physical properties to keep us all healthy. Manufacturing them well requires deep skills. Now, when one looks at the competitive field, medical device manufacturers are realizing that they have to out-compete and out-manufacture the competition. The cGMP requirements from yesterday aren't good enough for today and certainly not for tomorrow. These manufacturers have to focus on the “current” in the cGMP and go beyond the regulatory requirements to develop even better manufacturing practices that increase efficiency, quality, safety, and ultimately revenue.
Robbie Atkinson: Our customers desire for more customized and integrated solutions is only increasing. The desire is for “lights-out” operation, smaller diameter and thinner walled materials, steerable catheters, and diagnostic guidewires. These are more difficult to automate; however, our equipment and applications can meet those demands. As an example, Glebar offers automation in the manufacturing of diagnostic guidewires—grinding, cleaning, gauging, closed-loop process adjustment, and pass-fail binning. CathTip and SYNEO offer automation for catheter tipping and hole making.
Julie Logothetis: As a result of COVID-19, there has been an increase in demand for the basic items such as syringes, needles and PPE. We have seen a lot of companies looking to bring manufacturing back to the U.S. and not be as dependent on their offshore manufacturing partners for these products, who were not reliable suppliers and in many instances diverted their inventory to higher-paying customers and internal country needs as the worldwide demand for these products increased.
Craig Occhiato: Outsourcing has increased as resources in people and products has become a challenge. We are working more with contract design and manufacturing firms, and we are being asked more by OEMs and contract design and manufacturing firms to deliver not just our quality components but higher-level assemblies as well as to collaborate early in the design process. This aligns with the need to increase speed to market, supplier reduction, and improved quality.
Thomas Schwoerer and Les Iburg: Our customers manufacture many different types of medical products, components, and surgical instruments, and are continually looking for ways to improve their manufacturing efficiencies and process data capture through automation. Our solutions address these needs—from automated robot/cobot work cells designed to present parts to existing or retrofitted laser marking stations to fully integrated systems that combine material flow automation, assembly, and laser process steps in a one-box-solution. Another trend we are seeing is requests for functional testing. For example, in the past we only produced leak test solutions for devices like heart-lung oxygenators, renal dialysis filters, and catheters/luers/flow valves, but we now also build tooling and automation to support and perform product stress and life cycle integrity testing. Assembly, joining, handling, testing—how process automation is integrated into the production workflow is key to its quality. ZELTWANGER standardizes such processes and therefore ensures seamless workflows, reliability, and planning certainty right from the start.
Barbella: What factors are driving the need for automation in medical devices?
Akella: The need for automation in medical devices is driven by the same factors all of manufacturing is driven by—cost, volume, speed, quality and personalization. Automation is inexorable! That said, I believe that there is a fundamental underlying assumption in the question: That the primary path to scale is automation, since we have maximized what we can do with manual processes. I flag this as being especially important since every medical device manufacturing line I have seen—from blood pressure monitors to heart valves to MRI machines—is manned by people. Because people can easily perform tasks that a piece of automation might be challenged to do, certainly at a viable price point.
So, in addition to automation, the bigger need is to drive a lean culture and impact the 70-plus percent of your lines that are manual. To provide them with the tools and processes to build these medical devices safely and at scale—while simultaneously empowering them to make better and quicker decisions. Tools and processes that augment humans and help them perform manual assembly tasks to the best of their ability. This could be augmented reality, poka yoke systems or, in Drishti’s case, data, analytics, and insights from AI and computer vision systems.
Atkinson: The continued increase in precision, coupled with cost, quality, skilled labor gap, need for consistency, repeatability and increased throughput, and the desire to build a “connected” factory floor to measuring overall equipment efficiency.
Logothetis: In addition to the products that have been in demand due to COVID-19, the entire platform of drug delivery and diagnostics has been evolving over the past few years. As the wearable devices for drug delivery for at-home treatments and at-home testing become more mainstream, the need for the automation to manufacture these types of devices becomes a focus. Most of these devices consist of intricate multicomponent designs that may not require high-speed automation, but the critical character of the design and the intricate assembly process requires fully automated systems with a high level of automation expertise to achieve.
Al Neumann: Automation is not only a labor-saving tool, it also offers repeatability, in-line inspection and tracking. Many of the workcells designed by our in-house Automated Mfg. Systems group feature redundant inspections that check to make sure previous assembly steps were completed rather than finding non-conforming parts at a final inspection station. Machine vision systems and sensors that return analog results spot shifting trends in the assembly process and catch potential issues early.
Mark Paggioli: What’s driving the need for automation? Aside from the typical drivers—volume requirements, complexity, and costs, the other drivers are more topical. It’s the broader business issues that have people looking at how automation can help. Specifically, in the case of reshoring, people are looking at how automation can make reshoring feasible…how automation can make the numbers work. The outlook for finding and retaining talent is also an issue driving discussions. There’s been more focus on business resiliency, flexibility, and contingency. The pandemic has changed how companies think and how they prepare for the future.
Schwoerer and Iburg: The shortage of skilled manufacturing personnel is very real. Manufacturing companies must adapt and move towards automation to remain competitive despite those challenges. Very repetitive manual or complex assembly work are also motivators for using automation. Robotics and automation produce consistent measurable quality, improve throughput, and capture critical process capability data (Cpk).
Barbella: What new innovations have been developed within the medical device assembly and automation space? What specific market needs do these innovations address?
Akella: Significant energy is being focused on increasing quality, gaining visibility into operations, and supporting decision making at all levels, and for good reason. The risk to end users is massive, and the fines and penalties that may be levied against an organization with defective products are hefty.
A new advancement in this area is computer vision and AI (“AI-on-video”), which can help detect defects as they occur, rather than wait for an end-of-line inspector to catch and flag them. The economic value stems from the fact that the longer a defective unit goes down the line, the more value is being added to a fundamentally useless unit. This new inspection methodology can, therefore, avoid significant scrap and rework, which is expensive for manufacturers. It also alleviates the heavy burden on the inspector to catch the defect, because having prevention mechanisms in place upstream increases the likelihood that problems will be caught earlier. This system also helps manufacturers identify opportunities to train the team, either in the moment with feedback (think of your spell checker running behind the scenes in your email client) or in a training station (think of your golf swing being videotaped for you to learn from after the fact).
Atkinson: We are constantly innovating. Our equipment technologies and service offering are all tailored meet the needs of our customers. The technologies address the demand for minimally invasive devices for cardiovascular and neurovascular surgeries—Steinman pins and K-wire.
Logothetis: These newer devices in many instances consist of numerous micro-components, they require delicate assembly and can incorporate reagents and filters into the process. That is not traditionally a requirement in older generation devices and the automation equipment to manufacture those devices.
Schwoerer and Iburg: The largest contributors to new innovations would be Industry 4.0 (Industrial Internet of Things), process monitoring, smart vision systems, advanced laser applications, and predictive maintenance.
Barbella: How is Industry 4.0 affecting medical device assembly and automation?
Akella: Industry 4.0 is having a profound effect on all manufacturing sectors, and medical device manufacturing is no exception. At Drishti, Industry 4.0 is all about providing manufacturers and their employees with more data and insights, better training for their front-line teams, and, most importantly, reducing their decision making time. In the medical device world, that means four things:
Atkinson: Driving innovation and forcing a more connected manufacturing floor—these are bringing inefficiencies to light.
Logothetis: We have been integrating SCADA Systems into our equipment software to collect, monitor, and analyze data coming from our equipment and the plant that allows our customers to monitor their manufacturing in real time for many years. Isn’t that essentially the same thing as Industry 4.0?
Paggioli: In order for Industry 4.0 to have teeth and be something more than just an industry buzzword, the result of the program needs to result in either a cost savings or higher yield through increased productivity. The largest premise surrounding the program is application of learned information back onto the factory floor. The overarching facets of data collection and storage are not new. Although relatively recent, the bi-directional flow between the factory floor and the enterprise system exists and provides the backbone to connect the IT and OT layers of an enterprise. The pieces that are the biggest hitters are the data analytics and the digital twin. Here the information on the floor is collected, run through a series of AI and other machine learning methodologies and data analytics that reveal hidden information that tells stories about the production as well as predict down time and the need for replacement and spare parts. With most equipment having both a CAD based model design and PLC driven logic, the digital twin provides a digital way to hypothesize changes to the equipment or process, import the CAD model and the PLC logic models to ultimately run a simulation to prove out the hypothesis. At the completion of this step, design changes that run successfully can be implemented with a reduced risk and an accelerated schedule.
Brian Romano: The answer to this question answers the first part of the last question…the convergence of the IT and OT infrastructures. This means a high level of connectivity and along with it, a diverse skill set that is not readily available in the marketplace. Coming in a close second is the AR/VR implementation. This facet of Industry 4.0 allows companies to use AR and VR devices as well as devices like phones and tablets to more readily enable remote support, dedicated purpose training and live process data. This area of Industry 4.0 shortens the response time and provides a way to bring a fine focus on process details instantly as well as any training or support documentation related to the equipment showing through the glasses.
Schwoerer and Iburg: The topic of Industry 4.0 or IIoT is being tackled by most companies. Implementing it, however, is another huge challenge. On-going development of the OPC-UA server interface architecture has been an integral part of ZELTWANGER since 2016, and it has now become standard for all our devices and systems. Whether it’s machine learning, predictive maintenance, machine-to-machine communications (M2M), programmable robot control, or interface architectures, we are continually working to overcome the challenges posed by the fields of artificial intelligence and Industry 4.0. We not only focus on mechanical innovations, but are consistently investing in software, and work on sustainable and innovative solutions to support our customers as they step into the future.
Barbella: What are some of the challenging aspects of medical device assembly and automation?
Akella: Medical device assembly is, in many cases, very precise. Whether it’s threading a mesh implant or packaging the Spanish language instructions in the box that’s heading to Mexico, this type of assembly requires focus and accuracy 100 percent of the time—as the impact on a patient’s life is direct and significant. That’s a hefty ask for human beings. That’s why augmentation from computers is so important; computers don’t fatigue or get distracted.
Atkinson: Materials, low durometers, and thin walls make material handling and assembly increasingly more challenging.
Neumann: One of our current workcells produce products that will be inspected to USP 788 and 790 requirements. Very little particulate can be generated by motion of workcell components, workcell component interaction with parts to be assembled, or interaction between assembly parts themselves. Special considerations must be made in selecting mechanisms used for our build.
Schwoerer and Iburg: While every automation request is seriously considered, there are some products that are difficult to automate. The challenge is to find a solution that aligns with realistic customer expectations.
Another challenge is being flexible when customer requirements constantly change. Finding an appropriately skilled workforce can also present a challenge. Our automation systems include intuitive touch screen programming for robot sequence training steps which eliminates the need for programming skills.
Barbella: How did COVID-19 impact medical device assembly and automation processes or technology, if at all?
Akella: The coronavirus had a profound impact on all sectors of manufacturing, and medical device was one of the hardest hit for a few reasons. First, because the industry is still highly manual, the introduction of personal protective equipment (PPE) on the line had an impact on production. Steps that were previously done bare-handed had to be done while wearing rubber gloves, and that lengthened cycle time. Second, with non-essential personnel away from the line, visibility into production was severely limited; making it hard to manage to the desired KPIs. Essential personnel were forced to quarantine or leave the workforce, making absenteeism spike. Finally, many medical devices saw a drop in demand as many procedures were put on hold, while demand for other devices, like respirators, ventilators and PPE, skyrocketed.
Medical device manufacturers had an unprecedented need to pivot production without their full staff and with many variables in assembly that hadn’t previously existed. Drishti was able to support manufacturers during this time by giving non-essential personnel remote access to assembly operations, helping them rapidly train and onboard line associates and providing the data and tools needed to meet changes in demand.
Atkinson: Like everyone else we definitely felt the impacts of COVID-19. We were able to weather those impacts on the strength of our people and great relationships with our customers.
Neumann: COVID-19 has of course, impacted many medical device manufacturers. Overcoming the labor shortage and high demands for testing equipment kits and components was only possible with automated assembly and inspection cells. Outside automation integrators and in-house teams all stepped up to meet world-wide demands though machine component delivery times were, and still are, longer than usual.
Occhiato: COVID has definitely played a factor in accelerating automation for molecular-based technologies and devices, mainly with increased funding from governments and the private sector. The increased funding leads to motivation, momentum and speed. Since we are in the middle of a pandemic with many uncertainties of the timeline and path of the virus, many government bodies have lowered some hurdles, understanding that the time to market must be shortened, which means less validation. There’s a new view on benefits vs. risk to save lives.
With added funds and lower hurdles, resources are still needed to develop solutions, which is challenging during a pandemic. In these pandemic times I’m delighted to witness the increased transparent collaboration of information being exchanged within the genomic community based more for the quality of life than for business/profit.
Paggioli: One of the trends we have seen since the pandemic and shutdowns has been more focus on reshoring, risk avoidance, and geographic vulnerabilities. There’s been more conversations about facilities of smaller square footage yet with consideration for layout that can adjust to potential changes in “distancing” requirements. That’s in addition to the usual focus on overall machine performance and OEE.
Romano: Because medical device and diagnostic companies were at the heart of the COVID-19 response, we were pressed into service to build equipment in record times and designed specifically for these purposes.
Schwoerer and Iburg: The FDA approved recent vaccine submissions in record pace. We have experienced some accelerated product development cycles for products requiring automation. The workforce shortage and COVID-related illness is directly tied to getting products to market slower/more difficult, which ultimately requires higher level of automation. Supply chain shortages for critical components was an issue a few months back, but has dramatically improved.
Barbella: How might medical device assembly and automation evolve over the next half-decade?
Akella: When the tasks are complex and require cognition, robots simply aren’t up to the challenge. And that’s not going to change any time soon—meaning, not in our lifetimes. So companies will need to deliberately design for human assembly. A few examples to highlight this:
In the near future, Drishti systems will be the norm on every line, in every factory around the world. And they will focus on empowering humans who are building the products we need to be safe and healthy.
Atkinson: As machines become more connected and manufacturers make capital investments, the drive for a more dynamic and comprehensive solution to managing the manufacturing floor will be needed. We are well-positioned to bring that connected partner platform to our customers. Where we can solve their most complex production challenges, ensure those machines stay up and running with our Total Care offering, and ultimately help them drive better patient outcomes as a result.
Logothetis: Medical device assembly will evolve as the product designs evolve and as new device technology is introduced and needs to be manufactured. Keep in mind that medical technology does not change that rapidly as every new technology requires years of design, testing, and FDA approvals before it is introduced.
Romano: The results of the Smart Factory program through the implementation of Industry 4.0 practices are meant to elevate the efficiencies and productivity abilities of machinery through the application of advanced learning. Over the next five years, the industry will have moved well into the “early majority” phase on innovation diffusion and, if the results of the implementation are as planned, companies will begin to enjoy the fruits of their efforts and investments in the technology. The exposure of KPI’s and the application of predictive maintenance will allow companies to be more efficient with downtime and allow the equipment to be more effective overall.
Schwoerer and Iburg: Reduced staff in factories requires more automation. We are continually exploring ways to further our technology for remote services, consolidation of process steps in fewer machines, predictive maintenance, cobot solutions working hand-in-hand with operators, and ease of use to simplify user interfaces and artificial intelligence (AI) software.
Alas, conditions have been ideal for more than 20 months now, thanks to the novel coronavirus and its brood of highly contagious variants. In its relentless pursuit of hosts, COVID-19 not only has snuffed out millions of lives worldwide, it also has extinguished—albeit temporarily—a longstanding trepidation humans have harbored toward their android comrades.
The anxiety was first triggered by Czech playwright Karl Capek’s 1921 drama “R.U.R.: Rossum’s Universal Robots,” a three-act play about factory-made robots that learn to think for themselves and eventually exterminate the human race. Such conquests have captured the imaginations of countless science-fiction authors over the last century, thereby fueling humankind’s anxieties about artificial intelligence that to some extent, still exist.
Those concerns, however, dissipated in the past year as COVID-19 ravaged the living and depleted the global supply of medical products, particularly masks and ventilators. To replenish the reserve and help meet worldwide demand for the latter item, unusual partnerships formed: Ford Motor Co. teamed up with GE and 3M, General Motors paired with Ventec Life Systems (respiratory care), Medtronic plc worked with Foxconn (electronics contract manufacturer), SodaStream conspired with Hadassah Hospital Ein Kerem (Israel), and Stäubli Corporation banded together with Infiplast (injection molder), among others.
The latter collaboration—part of a larger effort by French manufacturers to design and build a working ventilator—required the expedited creation of an automated assembly line.
“Stäubli’s proactive response helped us build an automated and insulated workstation in less than 10 weeks, from design to operation. That was a real feat, since this type of project ordinarily takes at least 24 weeks to set up,” Stéphane Buttin, sales director at MGA Technologies, told Assembly in July. The custom machine tool builder spearheaded last year’s ventilator project in France. “This was a true example of a successful team effort.”
Stäubli’s automated assembly line built an Infiplast-designed heat and moisture exchanger (HME) filter, which helps address proper humidification in mechanical ventilation. The automated system assembled a filter every few seconds, collecting the plastic parts directly from an injection molding machine and constructing them on a rotary indexing table before handing them off to another station for welding and finally for testing, boxing, labeling, and packaging Assembly reported. Robots placed defective filters in a reject bin.
“We responded to the request from MGA Technologies and Infiplast within 48 hours, and made the robots available in record time,” Jacques Dupenloup, Stäubli’s sales manager for France and Benelux, recalled to Assembly. “Our new SCARA robot is tailored for their application, with an enclosed structure designed for aseptic and confined clean room environments.”
Assembly lines like the kind Stäubli created last spring have been growing in recent years as medical device providers work to improve productivity, efficiency, and manufacturing quality on the shop floor and reduce both labor costs and cycle time. Legacy systems are losing ground to more modern methods that incorporate artificial intelligence, machine learning, and Industrial IoT considerations, while robotics is gaining support for its worker safety prowess and enhanced output capabilities, both of which have been critical during the pandemic.
To better gauge the trends and market forces driving the medtech assembly/automation sector, Medical Product Outsourcing spoke with numerous industry professionals over the last few weeks. Those who provided input included:
Prasad Akella, founder and chairman of Drishti Technologies Inc., a Mountain View, Calif.-based provider of video analytics and video traceability for manual assembly lines.
Robbie Atkinson, CEO of Medical Manufacturing Technologies, a company offering medical device manufacturers process development services, applications and equipment, technical solutions, and aftermarket support. MMT brands include Glebar, Tridex, SYNEO, CATHTIP, and Engineering by Design.
Julie Logothetis, president of Kahle Automation, a Morristown, N.J.-based provider of custom automation machinery solutions for the medical device, pharmaceutical, and healthcare industries.
Al Neumann, automated manufacturing systems manager at contract manufacturing firm SMC Ltd.
Craig Occhiato, market segment/sales manager for Bürkert Fluid Control Systems’ Micro Fluidic Segment. Bürkert manufactures measurement and control systems for liquids and gases.
Mark Paggioli, director of Marketing & Customer Service, and Brian Romano, director of Technology Development at Arthur G. Russell Co., a custom assembly machinery provider in Bristol, Conn.
Thomas Schwoerer, president, and Les Iburg, medical sales manager, at ZELTWANGER, a Charleston, S.C.-based supplier of high-end leak test, automation, and laser solutions.
Michael Barbella: What current trends are shaping the medical device assembly and automation sector?
Prasad Akella: Perhaps the biggest trend is that medical devices are getting increasingly more capable, and consequently, complex. If we layer in the fact that medical device manufacturing is highly regulated, it’s natural to conclude that continuously improving the most fundamental practices—current good manufacturing practices (cGMP)—becomes even more critical to ensure compliance and the safety of these sophisticated products. For example, consider a simple device like a glucose monitor with the patch that constantly transmits sugar levels to one’s smartphone and, very likely, a cloud service. Or the latest and greatest in heart valves: These products are connected to the internet and often use advanced materials with just the right physical properties to keep us all healthy. Manufacturing them well requires deep skills. Now, when one looks at the competitive field, medical device manufacturers are realizing that they have to out-compete and out-manufacture the competition. The cGMP requirements from yesterday aren't good enough for today and certainly not for tomorrow. These manufacturers have to focus on the “current” in the cGMP and go beyond the regulatory requirements to develop even better manufacturing practices that increase efficiency, quality, safety, and ultimately revenue.
Robbie Atkinson: Our customers desire for more customized and integrated solutions is only increasing. The desire is for “lights-out” operation, smaller diameter and thinner walled materials, steerable catheters, and diagnostic guidewires. These are more difficult to automate; however, our equipment and applications can meet those demands. As an example, Glebar offers automation in the manufacturing of diagnostic guidewires—grinding, cleaning, gauging, closed-loop process adjustment, and pass-fail binning. CathTip and SYNEO offer automation for catheter tipping and hole making.
Julie Logothetis: As a result of COVID-19, there has been an increase in demand for the basic items such as syringes, needles and PPE. We have seen a lot of companies looking to bring manufacturing back to the U.S. and not be as dependent on their offshore manufacturing partners for these products, who were not reliable suppliers and in many instances diverted their inventory to higher-paying customers and internal country needs as the worldwide demand for these products increased.
Craig Occhiato: Outsourcing has increased as resources in people and products has become a challenge. We are working more with contract design and manufacturing firms, and we are being asked more by OEMs and contract design and manufacturing firms to deliver not just our quality components but higher-level assemblies as well as to collaborate early in the design process. This aligns with the need to increase speed to market, supplier reduction, and improved quality.
Thomas Schwoerer and Les Iburg: Our customers manufacture many different types of medical products, components, and surgical instruments, and are continually looking for ways to improve their manufacturing efficiencies and process data capture through automation. Our solutions address these needs—from automated robot/cobot work cells designed to present parts to existing or retrofitted laser marking stations to fully integrated systems that combine material flow automation, assembly, and laser process steps in a one-box-solution. Another trend we are seeing is requests for functional testing. For example, in the past we only produced leak test solutions for devices like heart-lung oxygenators, renal dialysis filters, and catheters/luers/flow valves, but we now also build tooling and automation to support and perform product stress and life cycle integrity testing. Assembly, joining, handling, testing—how process automation is integrated into the production workflow is key to its quality. ZELTWANGER standardizes such processes and therefore ensures seamless workflows, reliability, and planning certainty right from the start.
Barbella: What factors are driving the need for automation in medical devices?
Akella: The need for automation in medical devices is driven by the same factors all of manufacturing is driven by—cost, volume, speed, quality and personalization. Automation is inexorable! That said, I believe that there is a fundamental underlying assumption in the question: That the primary path to scale is automation, since we have maximized what we can do with manual processes. I flag this as being especially important since every medical device manufacturing line I have seen—from blood pressure monitors to heart valves to MRI machines—is manned by people. Because people can easily perform tasks that a piece of automation might be challenged to do, certainly at a viable price point.
So, in addition to automation, the bigger need is to drive a lean culture and impact the 70-plus percent of your lines that are manual. To provide them with the tools and processes to build these medical devices safely and at scale—while simultaneously empowering them to make better and quicker decisions. Tools and processes that augment humans and help them perform manual assembly tasks to the best of their ability. This could be augmented reality, poka yoke systems or, in Drishti’s case, data, analytics, and insights from AI and computer vision systems.
Atkinson: The continued increase in precision, coupled with cost, quality, skilled labor gap, need for consistency, repeatability and increased throughput, and the desire to build a “connected” factory floor to measuring overall equipment efficiency.
Logothetis: In addition to the products that have been in demand due to COVID-19, the entire platform of drug delivery and diagnostics has been evolving over the past few years. As the wearable devices for drug delivery for at-home treatments and at-home testing become more mainstream, the need for the automation to manufacture these types of devices becomes a focus. Most of these devices consist of intricate multicomponent designs that may not require high-speed automation, but the critical character of the design and the intricate assembly process requires fully automated systems with a high level of automation expertise to achieve.
Al Neumann: Automation is not only a labor-saving tool, it also offers repeatability, in-line inspection and tracking. Many of the workcells designed by our in-house Automated Mfg. Systems group feature redundant inspections that check to make sure previous assembly steps were completed rather than finding non-conforming parts at a final inspection station. Machine vision systems and sensors that return analog results spot shifting trends in the assembly process and catch potential issues early.
Mark Paggioli: What’s driving the need for automation? Aside from the typical drivers—volume requirements, complexity, and costs, the other drivers are more topical. It’s the broader business issues that have people looking at how automation can help. Specifically, in the case of reshoring, people are looking at how automation can make reshoring feasible…how automation can make the numbers work. The outlook for finding and retaining talent is also an issue driving discussions. There’s been more focus on business resiliency, flexibility, and contingency. The pandemic has changed how companies think and how they prepare for the future.
Schwoerer and Iburg: The shortage of skilled manufacturing personnel is very real. Manufacturing companies must adapt and move towards automation to remain competitive despite those challenges. Very repetitive manual or complex assembly work are also motivators for using automation. Robotics and automation produce consistent measurable quality, improve throughput, and capture critical process capability data (Cpk).
Barbella: What new innovations have been developed within the medical device assembly and automation space? What specific market needs do these innovations address?
Akella: Significant energy is being focused on increasing quality, gaining visibility into operations, and supporting decision making at all levels, and for good reason. The risk to end users is massive, and the fines and penalties that may be levied against an organization with defective products are hefty.
A new advancement in this area is computer vision and AI (“AI-on-video”), which can help detect defects as they occur, rather than wait for an end-of-line inspector to catch and flag them. The economic value stems from the fact that the longer a defective unit goes down the line, the more value is being added to a fundamentally useless unit. This new inspection methodology can, therefore, avoid significant scrap and rework, which is expensive for manufacturers. It also alleviates the heavy burden on the inspector to catch the defect, because having prevention mechanisms in place upstream increases the likelihood that problems will be caught earlier. This system also helps manufacturers identify opportunities to train the team, either in the moment with feedback (think of your spell checker running behind the scenes in your email client) or in a training station (think of your golf swing being videotaped for you to learn from after the fact).
Atkinson: We are constantly innovating. Our equipment technologies and service offering are all tailored meet the needs of our customers. The technologies address the demand for minimally invasive devices for cardiovascular and neurovascular surgeries—Steinman pins and K-wire.
Logothetis: These newer devices in many instances consist of numerous micro-components, they require delicate assembly and can incorporate reagents and filters into the process. That is not traditionally a requirement in older generation devices and the automation equipment to manufacture those devices.
Schwoerer and Iburg: The largest contributors to new innovations would be Industry 4.0 (Industrial Internet of Things), process monitoring, smart vision systems, advanced laser applications, and predictive maintenance.
Barbella: How is Industry 4.0 affecting medical device assembly and automation?
Akella: Industry 4.0 is having a profound effect on all manufacturing sectors, and medical device manufacturing is no exception. At Drishti, Industry 4.0 is all about providing manufacturers and their employees with more data and insights, better training for their front-line teams, and, most importantly, reducing their decision making time. In the medical device world, that means four things:
- You have more information on your manual assembly lines than you’ve ever had before.
- The information is presented to you when, where and how you need it to take decisive action.
- Every data point available to you is also backed by video to simplify root cause analysis, training and collaborating across the company on problems now made visible.
- Your people, including your line associates, are empowered to make better decisions, faster, on a continuous basis.
Atkinson: Driving innovation and forcing a more connected manufacturing floor—these are bringing inefficiencies to light.
Logothetis: We have been integrating SCADA Systems into our equipment software to collect, monitor, and analyze data coming from our equipment and the plant that allows our customers to monitor their manufacturing in real time for many years. Isn’t that essentially the same thing as Industry 4.0?
Paggioli: In order for Industry 4.0 to have teeth and be something more than just an industry buzzword, the result of the program needs to result in either a cost savings or higher yield through increased productivity. The largest premise surrounding the program is application of learned information back onto the factory floor. The overarching facets of data collection and storage are not new. Although relatively recent, the bi-directional flow between the factory floor and the enterprise system exists and provides the backbone to connect the IT and OT layers of an enterprise. The pieces that are the biggest hitters are the data analytics and the digital twin. Here the information on the floor is collected, run through a series of AI and other machine learning methodologies and data analytics that reveal hidden information that tells stories about the production as well as predict down time and the need for replacement and spare parts. With most equipment having both a CAD based model design and PLC driven logic, the digital twin provides a digital way to hypothesize changes to the equipment or process, import the CAD model and the PLC logic models to ultimately run a simulation to prove out the hypothesis. At the completion of this step, design changes that run successfully can be implemented with a reduced risk and an accelerated schedule.
Brian Romano: The answer to this question answers the first part of the last question…the convergence of the IT and OT infrastructures. This means a high level of connectivity and along with it, a diverse skill set that is not readily available in the marketplace. Coming in a close second is the AR/VR implementation. This facet of Industry 4.0 allows companies to use AR and VR devices as well as devices like phones and tablets to more readily enable remote support, dedicated purpose training and live process data. This area of Industry 4.0 shortens the response time and provides a way to bring a fine focus on process details instantly as well as any training or support documentation related to the equipment showing through the glasses.
Schwoerer and Iburg: The topic of Industry 4.0 or IIoT is being tackled by most companies. Implementing it, however, is another huge challenge. On-going development of the OPC-UA server interface architecture has been an integral part of ZELTWANGER since 2016, and it has now become standard for all our devices and systems. Whether it’s machine learning, predictive maintenance, machine-to-machine communications (M2M), programmable robot control, or interface architectures, we are continually working to overcome the challenges posed by the fields of artificial intelligence and Industry 4.0. We not only focus on mechanical innovations, but are consistently investing in software, and work on sustainable and innovative solutions to support our customers as they step into the future.
Barbella: What are some of the challenging aspects of medical device assembly and automation?
Akella: Medical device assembly is, in many cases, very precise. Whether it’s threading a mesh implant or packaging the Spanish language instructions in the box that’s heading to Mexico, this type of assembly requires focus and accuracy 100 percent of the time—as the impact on a patient’s life is direct and significant. That’s a hefty ask for human beings. That’s why augmentation from computers is so important; computers don’t fatigue or get distracted.
Atkinson: Materials, low durometers, and thin walls make material handling and assembly increasingly more challenging.
Neumann: One of our current workcells produce products that will be inspected to USP 788 and 790 requirements. Very little particulate can be generated by motion of workcell components, workcell component interaction with parts to be assembled, or interaction between assembly parts themselves. Special considerations must be made in selecting mechanisms used for our build.
Schwoerer and Iburg: While every automation request is seriously considered, there are some products that are difficult to automate. The challenge is to find a solution that aligns with realistic customer expectations.
Another challenge is being flexible when customer requirements constantly change. Finding an appropriately skilled workforce can also present a challenge. Our automation systems include intuitive touch screen programming for robot sequence training steps which eliminates the need for programming skills.
Barbella: How did COVID-19 impact medical device assembly and automation processes or technology, if at all?
Akella: The coronavirus had a profound impact on all sectors of manufacturing, and medical device was one of the hardest hit for a few reasons. First, because the industry is still highly manual, the introduction of personal protective equipment (PPE) on the line had an impact on production. Steps that were previously done bare-handed had to be done while wearing rubber gloves, and that lengthened cycle time. Second, with non-essential personnel away from the line, visibility into production was severely limited; making it hard to manage to the desired KPIs. Essential personnel were forced to quarantine or leave the workforce, making absenteeism spike. Finally, many medical devices saw a drop in demand as many procedures were put on hold, while demand for other devices, like respirators, ventilators and PPE, skyrocketed.
Medical device manufacturers had an unprecedented need to pivot production without their full staff and with many variables in assembly that hadn’t previously existed. Drishti was able to support manufacturers during this time by giving non-essential personnel remote access to assembly operations, helping them rapidly train and onboard line associates and providing the data and tools needed to meet changes in demand.
Atkinson: Like everyone else we definitely felt the impacts of COVID-19. We were able to weather those impacts on the strength of our people and great relationships with our customers.
Neumann: COVID-19 has of course, impacted many medical device manufacturers. Overcoming the labor shortage and high demands for testing equipment kits and components was only possible with automated assembly and inspection cells. Outside automation integrators and in-house teams all stepped up to meet world-wide demands though machine component delivery times were, and still are, longer than usual.
Occhiato: COVID has definitely played a factor in accelerating automation for molecular-based technologies and devices, mainly with increased funding from governments and the private sector. The increased funding leads to motivation, momentum and speed. Since we are in the middle of a pandemic with many uncertainties of the timeline and path of the virus, many government bodies have lowered some hurdles, understanding that the time to market must be shortened, which means less validation. There’s a new view on benefits vs. risk to save lives.
With added funds and lower hurdles, resources are still needed to develop solutions, which is challenging during a pandemic. In these pandemic times I’m delighted to witness the increased transparent collaboration of information being exchanged within the genomic community based more for the quality of life than for business/profit.
Paggioli: One of the trends we have seen since the pandemic and shutdowns has been more focus on reshoring, risk avoidance, and geographic vulnerabilities. There’s been more conversations about facilities of smaller square footage yet with consideration for layout that can adjust to potential changes in “distancing” requirements. That’s in addition to the usual focus on overall machine performance and OEE.
Romano: Because medical device and diagnostic companies were at the heart of the COVID-19 response, we were pressed into service to build equipment in record times and designed specifically for these purposes.
Schwoerer and Iburg: The FDA approved recent vaccine submissions in record pace. We have experienced some accelerated product development cycles for products requiring automation. The workforce shortage and COVID-related illness is directly tied to getting products to market slower/more difficult, which ultimately requires higher level of automation. Supply chain shortages for critical components was an issue a few months back, but has dramatically improved.
Barbella: How might medical device assembly and automation evolve over the next half-decade?
Akella: When the tasks are complex and require cognition, robots simply aren’t up to the challenge. And that’s not going to change any time soon—meaning, not in our lifetimes. So companies will need to deliberately design for human assembly. A few examples to highlight this:
- Design for the resolution of the human eye or for the dextrous capabilities of the human hand.
- Continue investing in the training of people.
- Present information so even those of us not trained in probability and statistics can make quick and informed decisions on behalf of our employers.
In the near future, Drishti systems will be the norm on every line, in every factory around the world. And they will focus on empowering humans who are building the products we need to be safe and healthy.
Atkinson: As machines become more connected and manufacturers make capital investments, the drive for a more dynamic and comprehensive solution to managing the manufacturing floor will be needed. We are well-positioned to bring that connected partner platform to our customers. Where we can solve their most complex production challenges, ensure those machines stay up and running with our Total Care offering, and ultimately help them drive better patient outcomes as a result.
Logothetis: Medical device assembly will evolve as the product designs evolve and as new device technology is introduced and needs to be manufactured. Keep in mind that medical technology does not change that rapidly as every new technology requires years of design, testing, and FDA approvals before it is introduced.
Romano: The results of the Smart Factory program through the implementation of Industry 4.0 practices are meant to elevate the efficiencies and productivity abilities of machinery through the application of advanced learning. Over the next five years, the industry will have moved well into the “early majority” phase on innovation diffusion and, if the results of the implementation are as planned, companies will begin to enjoy the fruits of their efforts and investments in the technology. The exposure of KPI’s and the application of predictive maintenance will allow companies to be more efficient with downtime and allow the equipment to be more effective overall.
Schwoerer and Iburg: Reduced staff in factories requires more automation. We are continually exploring ways to further our technology for remote services, consolidation of process steps in fewer machines, predictive maintenance, cobot solutions working hand-in-hand with operators, and ease of use to simplify user interfaces and artificial intelligence (AI) software.
