Kistler’s piezoelectric sensors and systems measure, analyze cavity pressure during injection molding at Tessy Plastics.

Custom medical device and consumer component contract manufacturer Tessy Plastics, with several facilities in Central New York, engineers, manufactures, assembles, and distributes a range of products. Using a scientific injection molding (SIM) approach allows Tessy engineers to define and optimize the company’s molding process from start to finish. Ben Passetti, research & development engineer at Tessy, takes the quality of their molded parts seriously.

“Our product portfolio is split 50/50 medical/consumer. We focus primarily on value-added, high-dollar items with very complex manufacturing and tight toler- ances – everything from 720 tons down to micro-molding – so our molding portfolio is large from a versatility standpoint,” Passetti says. “We focus on micro-molding in the medical sector because it is challenging and difficult. We accomplish tight tolerances because of the tooling partners we have.”

Continuous process monitoring and control of the entire production measuring chain are essential in meeting requirements, and Swiss sensors and equipment company Kistler’s cavity pressure systems and sensors handle the task – from measurement through documentation of cavity pressure. Customized monitoring of tolerance limits by piezoelectric sensors results in visible process deviations, detectable at an early stage, minimizing rejects and scrap. Combining Kistler’s process monitoring systems and sensors optimizes process efficiency, offers quality assurance, and gives Tessy a competitive edge.

“There has been a visible shift in the plastic molding market within the past 5 years. Customers are more educated and understand a lot more about the injection molding process than in the past and they are actively searching for more technological, savvy solutions,” Passetti says. “They are more willing to accept risk with applications to gain technological reward in order to advance in this competitive market.”

After reviewing Kistler’s product portfolio, Tessy engineers decided to implement and combine products.

“Tessy has been using several Kistler products,” says Jay Sklenka, field sales engineer at Kistler. “This includes the Kistler ComoNeo, maXYmos, load cells, and pressure sensors. They are also using our amplifiers mounted on the injection molding machines to bring the pressure signals back into the machine controller.”

Understanding how versatility among several components can be integrated to achieve maximum success, Passetti notes that, “Bridging the gap from technology to manufacturing; integrating current technology into our customer’s parts design, is the primary goal of our daily operations.”

Passetti adds that he and his team must ask themselves how they can speed up part production with higher quality and more cost-efficiency for the company and the customer. The answer, Passetti says, is Kistler process monitoring sensors and systems.

“Prior to the implementation of Kistler products, we were seeing process inconsistencies. We had used pressure sensors in the past but never on a micro-scale. We decided to test Kistler’s pressure sensors on a micro-scale to see if we could identify the variation between the machines,” Passetti says. “Once we saw how effective Kistler’s pressure sensors were, we chose to implement them on our machines. They have proven invaluable for seeing the variation between the molding machines, preventing the mold from being overpacked, and detecting short-shots in real-time. From an assembly standpoint, Kistler pressure sensors allow us to detect the force that drives the components back and forth so we can make any necessary adjustments with reliable, visible, sustainable results.”

The maXYmos gives a better understanding of what components look like, ensuring they are fully formed and can move into the production stage with 100% zero-defects. Implementing Kistler’s ComoNeo process monitoring system revealed what was happening in the mold to achieve accuracy and repeatability.

Kistler maXYmos and ComoNeo process monitoring and control systems, combined with Kistler pressure sensors, offer injection molders options for optimizing production. Benefits include zero- defect production, quality assurance, optimized cycle times, and increased production efficiency.

ComoNeo: Process monitoring system uses cavity pressure profile to monitor, evaluate quality of an injection-molded part; system analyzes quality-relevant sections of measurement curves, segregating bad parts

maXYmos: XY monitors enable checking, evaluating product quality or production, step-based on a curve; users can apply evaluation objects to adapt the curve evaluation to the individual monitoring task; based on this specification, maXYmos BL, TL, and NC can check each workpiece, deciding if the part is good or bad

Mold cavity pressure sensors: Piezoelectric pressure sensors measure highly dynamic, dynamic, and quasi-static pressure curves, pulsations

“In one of the first stages of the molding process for our medical components, the parts are inserted with the automation directly into the medical component. Here, we are monitoring the cavity pressure to ensure parts are fully formed and that we do not overpack the mold using a visible envelope/reference curve over the injection profile so that we can monitor the fill,” Passetti says. “Sometimes, we will see a spike in this curve because we are injecting the mold so fast that the machine cannot slow down in time to prevent mold damage. To overcome this issue, we are watching that pressure sensor data on the Kistler process monitoring system, waiting for the curve to start rising, and if it rises too soon, we stop the machine.”

“Later in this molding stage, it gets an actuator placed in it and then a retainer clipped over the entire product. It then goes to a final inspection station, where we use a Kistler sensor and the maXYmos to fire that sled and drive all those components into place. We then measure the forces to actuate and retract the medical assembly so that we get a complete profile of the actuation to determine the pass/fail percentage and the actuation numbers that we need to form a quality assured, repeatable medical assembly,” he adds,

Passetti says they use Kistler process monitoring systems and sensors to glean information from processes, and without this, they would likely struggle to meet the demands of today’s market.

TESSY PLASTICS CORP. recently acquired NuTec Tooling Systems Inc., Meadville, Pennsylvania, and Custom Tool & Design (CTD) headquartered in Erie, Pennsylvania. Nutec has partnered with Tessy for the past 15 years, and with this acquisition, Tessy will have increased capabilities to support customer needs by providing state-of-the-art custom robotic automation and assembly solutions.

CTD, a full-scale injection mold manufacturer, brings more than 45 years of experience to design and build of high-volume plastic injection molds for consumer products and medical markets, with a focus on innovation, education, and quality.

Tessy made the grade as a global leader on corporate climate action on the Carbon Disclosure Project (CDP) Climate Change A List.

Every year, thousands of companies disclose data about their environmental impacts, risks, and opportunities to CDP for independent assessment. Tessy has been recognized for its actions in the last reporting year to cut emissions, mitigate climate risks, and develop the low-carbon economy, based on its 2018 disclosure to CDP.

Tessy Plastics’ Director of Environmental Health & Safety Cindy Bush states, “We have been working toward achieving an ‘A’ rating for quite a while now. This is our first year to receive an ‘A’ rating. We are proud to contribute to lowering emissions and preserving the environment, especially working in the plastics industry.”

“The presses that we purchase for our medical assembly line now have Kistler amplifiers built directly into them; they are integrated into the human machine interface (HMI) so that the reference curves and data can be transferred directly. We also have a stand-alone ComoNeo unit with its own monitoring system and a maXYmos with its own monitoring unit for other purposes,” Passetti explains.

Since implementing Kistler products, Passetti says the company has experienced success in terms of efficiency, repeatability, quality assurance, and cost-effectiveness.

“We are definitely reducing scrap because we can identify when we are making scrap in real-time,” Passetti says. “Being able to see what is going on directly in the mold – identifying non-conforming parts sooner – reduces scrap and improves our efficiency across the measuring chain.”

“Our plan is to integrate more Kistler pressure sensors and systems into future molds and to retrofit our existing molds. Process systems and sensor technology from Kistler, integrated into our core processes, helps us stay ahead of the competition from a quality assurance and efficiency standpoint,” Passetti concludes.

The future of the medical tubing sector is highly dynamic because of pressures on organizations to provide high-quality solutions that deliver cost savings throughout the product life cycle. This is mainly driven by the global healthcare market, which continues to demand products and solutions that push the boundaries of what is possible at a highly competitive price point.

For neurovascular and other complicated techniques, catheter manufacturers are being pushed for solutions that cost-effectively deliver complex procedures efficiently. In highly cost-conscious markets, peelable heat-shrink tubing products enable catheter manufacturers to advance efficiencies through streamlining workflows.

Peelable heat-shrink tubing (PHST) addresses unmet healthcare needs, such as ultra- small PHST that supports progressively smaller catheter-based procedures. PHST technology reduces total cost of ownership (TCO) because manufacturers don’t have to skive heat-shrink material from the catheter. Removing skiving allows companies to produce more quickly, improve yields, and lower inspection levels while increasing economic safety.

Junkosha’s 2.5:1 PHST solution provides catheter manufacturers with the highest shrink ratio currently possible in a fluorinated ethylene propylene (FEP). Catheter manufacturers save time and money through a reduced number of shrink processes. In addition, thanks to PHST’s take-up, it uses cost-effective, lower tolerance, baseline materials in the manufacturing process, enabling easy reflow into a single, smooth construct.

According to Robert LaDuca, CEO of medical device tubing and catheter components manufacturer Duke Empirical, high-ratio PHST technology will enable better processes and cost savings in neurovascular catheters which have tapered diameters for the floppy distal segments and proximal sections with larger diameters for pushable support. Catheters are typically braid-reinforced proximally and coil-reinforced distally, so PHST solutions must accommodate the compression required to provide significant bond strength of the materials in a single step.

LaDuca adds that the technology supports tapered cardiovascular devices such as multi-lumen, braid reinforced, peripherally inserted central  catheters (PICC) and various next-generation catheters with varying diameters, such as cardiac implant delivery systems where the implant is located in a distal segment of the catheter that is usually larger than the proximal portion of the shaft.  Faster, more forceful recovery of the 2.5:1 PHST products reduces or eliminates air entrapment, which can cause bubbles and product defects such as fish eyes, voids, and insufficient strength of bonded layers.

Although these various challenges differ around the world, they all require one thing: innovations that improve service for patients and provide clinicians and other end-users with technologies that make their lives easier, reduce costs, and save time. Continuous innovation must be at the heart of the healthcare sector’s requirements. Without this, unmet needs will continue.

About the author: Joe Rowan is president and CEO Junkosha USA and Europe. He can be reached at jrowan@junkosha.com or 949.825.6177.

The range of applications, material types expands as ceramic additive manufacturing (AM) processes are continuously researched, validated, and implemented.

Strong compound annual growth rate (CAGR) in end-use part production, application, and hardware revenues

4% Traditional parts 8% Technical parts 21% General services 34% Specialized services 4% Traditional materials 5% Technical materials 22% High-end hardware 2% Low-cost hardware

4% Traditional parts 14% Technical parts 8% General services 30% Specialized services 3% Traditional materials 7% Technical materials 28% High-end hardware 6% Low-cost hardware

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Intelligent laser power modulation (LPM) permits laser power control and rep rate as a function of cutting speed, directly and/or path directly from the MM9 I/O.

The LaserLathe also includes tapped mounting hole tooling features for attaching end-user guide systems to control workpieces at user-defined laser-processing points. Modular component attachment enables integration of configured guide bushing, liquid flush, and gas-assist systems.

The majority of AM medical devices are implants, with about 79% being titanium, according to recent FDA analysis. Pioneers are now getting clearance for third or fourth implants. Titanium acetabular cups recently achieved 10-year clinical history.

Patient-specific cutting guides made from nylon also have more than 10 years of clinical history. At EOS, we are seeing more orthosis and prosthesis applications due to the ability to print reliable patient-specific devices

As one of the earliest suppliers of additive technology, EOS has gathered a long history of user needs, which we used to develop a new polymer machine, the Integra P400, showcased at RAPID + TCT.

Customers have been pushing technology providers for faster build times. In response to this, Integra P 400’s novel dual recoating system design can spread preheated powder across the build platform at 0.4m/sec. Preheating decreases the time between layers, traditionally needed to create thermal homogeneity. A new scanning strategy using a 120W CO2 laser and digital galvanometers further decreases layer time, speeding the build process.

Polymer powder bed systems had required warm-up and cool-down time to address thermal warping and part accuracy. The Integra P 400’s laser window enables rapid turnover to increase machine production time. Parts still need to cool to ensure accuracy, but equipment doesn’t sit idle during cooling.

The Integra P 400’s built-in monitoring system uses an IR camera to identify cold or hot spots in the build chamber. Consistent temperature is essential for polymer AM, so this monitoring demonstrates that what you expected to build was built – without destructive testing.

In addition, independently adjustable quartz heating in eight zones promotes uniform thermal distribution for homogenized part production. This greatly increases system reliability and reduces scrap.

So far, regulators have cleared devices, not materials. So, it’s a misconception to say a material has FDA clearance or approval. EOS approaches biocompatibility with some initial biocompatibility testing according to ISO 10993. This gives customers an indication that a printed part is biocompatible, but as always, it’s up to the device manufacturer to ensure the final, finished, serialized device is biocompatible. Several customers have device clinical history with our polymer and metal materials, such as PA2200 and PA1101 or our titanium alloys.

Two challenges are common for device manufacturers new to AM. The first is not taking the manufacturing process into account during design. The design team can not work in a silo from the manufacturing team; it’s critical both teams have input during the design stage for part orientation with respect to critical features, for example.

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The second would be adding AM into the quality system. Since AM is new and does not have many standards to reference, many manufacturers see this as a hurdle. Our applied engineering consultant team, Additive Minds, can help customers identify gaps in their quality systems.

Our philosophy is to teach the customer what they need to know so then they can apply it to the next product in their pipeline.

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