Michael Barbella, Managing Editor12.30.21
The timing couldn’t have been better.
Three years ago, NuTec Tooling Systems Inc. began building a syringe coating machine for a large pharmaceutical firm. The client wanted to mass produce plastic syringes with a glass-like coating to provide an alternative to the more costly glass versions typically manufactured by its competitors.
The machine NuTec constructed included four Epson Cleanroom SCARA robots (developed by Epson Robots), each of which were strategically placed at various points in the apparatus to precisely and cost-effectively automate the syringe manufacturing process.
The automated process coats syringes at a rate of 38 parts per minute, passes the parts through various inspection stations, then siliconizes the hypodermics before changing temporary caps to final caps and subjecting them to a final X-ray inspection. The robots handle the syringes both before and after their glass-like coating is applied; in the final stages, the robots apply inner and outer covers to full containers of syringes and applies labels with a laser marker.
The machine was operational in November 2020, enabling NuTec’s pharmaceutical customer to work with the government and manufacture massive quantities of syringes for use in battling COVID-19.
“Epson’s high-speed G6-Series SCARA robots with Epson RC+ software enable precision processes with exceptional repeatability assembly pick and place capabilities,” Brent Martz, NuTec Tooling Systems sales and marketing director, said in an Epson news release. “The ease of use and application versatility within the Epson RC+ development environment plus an ISO-3 rating and compliance with cleanroom standards makes them ideal for this project and the medical sector in general, where speed and precision are vital to the manufacturing process.” Bürkert
Indeed, speed and precision are vital to medtech manufacturing, particularly as the types of medical devices that can be automatically assembled are constantly expanding. MPO’s feature “Complex Coupling” details the trends and market forces impacting the medtech assembly/automation sector. Thomas Schwoerer, president, and Les Iburg, medical sales manager at ZELTWANGER, were among the more than half-dozen experts interviewed for the feature; their full input is provided in the following Q&A:
Michael Barbella: What current trends are shaping the medical device assembly and automation sector?
Thomas Schwoerer, 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?
Thomas Schwoerer, Les 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 to these innovations address?
Thomas Schwoerer, Les 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?
Thomas Schwoerer, Les 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 new capabilities have been added to automated medical device assembly in recent years?
Thomas Schwoerer, Les Iburg: Combination of assembly, laser processes, advanced vision systems, and test steps in one integrated platform (one-box-solution). One example is that we are enabling our customers to become FDA compliant for laser marking and automation—automatic identification and data capture (AIDC), unique device identification (UDI) standards for laser marking, black marking, passivation layer, resistance, and data matrix code (DMC) marking. More examples: Multi-channel leak testing to increase throughput (i.e. 8-channel parallel product leak testing and related tooling/automation). Modularity, (self) exchangeable sensors that can be integrated into various platforms throughout the plant, and can sent back to us for calibration, eliminating the need for on-site service calls.
Barbella: How is the design of assembly systems being impacted by the kinds of medical devices produced?
Thomas Schwoerer, Les Iburg: Many medical devices being developed today require a higher level of automation and robotics, and smaller components must be leak tested with lower leak rates. We have experienced a requirements increase from air-based leak test solutions and extend into automated helium based test systems, requests go all the way through to hermetically sealed components.
Barbella: What are some of the challenging aspects of medical device assembly and automation?
Thomas Schwoerer, Les 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?
Thomas Schwoerer, Les 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?
Thomas Schwoerer, Les 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.
Three years ago, NuTec Tooling Systems Inc. began building a syringe coating machine for a large pharmaceutical firm. The client wanted to mass produce plastic syringes with a glass-like coating to provide an alternative to the more costly glass versions typically manufactured by its competitors.
The machine NuTec constructed included four Epson Cleanroom SCARA robots (developed by Epson Robots), each of which were strategically placed at various points in the apparatus to precisely and cost-effectively automate the syringe manufacturing process.
The automated process coats syringes at a rate of 38 parts per minute, passes the parts through various inspection stations, then siliconizes the hypodermics before changing temporary caps to final caps and subjecting them to a final X-ray inspection. The robots handle the syringes both before and after their glass-like coating is applied; in the final stages, the robots apply inner and outer covers to full containers of syringes and applies labels with a laser marker.
The machine was operational in November 2020, enabling NuTec’s pharmaceutical customer to work with the government and manufacture massive quantities of syringes for use in battling COVID-19.
“Epson’s high-speed G6-Series SCARA robots with Epson RC+ software enable precision processes with exceptional repeatability assembly pick and place capabilities,” Brent Martz, NuTec Tooling Systems sales and marketing director, said in an Epson news release. “The ease of use and application versatility within the Epson RC+ development environment plus an ISO-3 rating and compliance with cleanroom standards makes them ideal for this project and the medical sector in general, where speed and precision are vital to the manufacturing process.” Bürkert
Indeed, speed and precision are vital to medtech manufacturing, particularly as the types of medical devices that can be automatically assembled are constantly expanding. MPO’s feature “Complex Coupling” details the trends and market forces impacting the medtech assembly/automation sector. Thomas Schwoerer, president, and Les Iburg, medical sales manager at ZELTWANGER, were among the more than half-dozen experts interviewed for the feature; their full input is provided in the following Q&A:
Michael Barbella: What current trends are shaping the medical device assembly and automation sector?
Thomas Schwoerer, 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?
Thomas Schwoerer, Les 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 to these innovations address?
Thomas Schwoerer, Les 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?
Thomas Schwoerer, Les 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 new capabilities have been added to automated medical device assembly in recent years?
Thomas Schwoerer, Les Iburg: Combination of assembly, laser processes, advanced vision systems, and test steps in one integrated platform (one-box-solution). One example is that we are enabling our customers to become FDA compliant for laser marking and automation—automatic identification and data capture (AIDC), unique device identification (UDI) standards for laser marking, black marking, passivation layer, resistance, and data matrix code (DMC) marking. More examples: Multi-channel leak testing to increase throughput (i.e. 8-channel parallel product leak testing and related tooling/automation). Modularity, (self) exchangeable sensors that can be integrated into various platforms throughout the plant, and can sent back to us for calibration, eliminating the need for on-site service calls.
Barbella: How is the design of assembly systems being impacted by the kinds of medical devices produced?
Thomas Schwoerer, Les Iburg: Many medical devices being developed today require a higher level of automation and robotics, and smaller components must be leak tested with lower leak rates. We have experienced a requirements increase from air-based leak test solutions and extend into automated helium based test systems, requests go all the way through to hermetically sealed components.
Barbella: What are some of the challenging aspects of medical device assembly and automation?
Thomas Schwoerer, Les 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?
Thomas Schwoerer, Les 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?
Thomas Schwoerer, Les 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.
