Michael Barbella, Managing Editor12.21.21
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. Mark Paggioli, director of Marketing & Customer Service, and Brian Romano, director of Technology Development at Arthur G. Russell Co., 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 factors are driving the need for automation in medical devices:
Mark Paggioli: 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.
Barbella: How is Industry 4.0 affecting medical device assembly and automation?
Paggioli: In order for Industry 4.0 to have teeth and be something more than just a 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.
Barbella: What new capabilities have been added to automated medical device assembly in recent years?
Romano: The introduction of IO Link devices feeds in nicely to the ability to expose IIoT data and look at parameters that otherwise would not be available without the installation of discrete instrumentation.
Barbella: How did COVID-19 impact medical device assembly and automation processes or technology, if at all?
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 response, we were pressed into service to build equipment in record times and designed specifically for these purposes.
Barbella: How might medical device assembly and automation evolve over the next half-decade?
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.
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. Mark Paggioli, director of Marketing & Customer Service, and Brian Romano, director of Technology Development at Arthur G. Russell Co., 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 factors are driving the need for automation in medical devices:
Mark Paggioli: 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.
Barbella: How is Industry 4.0 affecting medical device assembly and automation?
Paggioli: In order for Industry 4.0 to have teeth and be something more than just a 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.
Barbella: What new capabilities have been added to automated medical device assembly in recent years?
Romano: The introduction of IO Link devices feeds in nicely to the ability to expose IIoT data and look at parameters that otherwise would not be available without the installation of discrete instrumentation.
Barbella: How did COVID-19 impact medical device assembly and automation processes or technology, if at all?
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 response, we were pressed into service to build equipment in record times and designed specifically for these purposes.
Barbella: How might medical device assembly and automation evolve over the next half-decade?
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.