A culture based on innovation in medical tubing extrusion | Plastic Technology

2021-11-25 04:09:17 By : Mr. Hongming Zhao

Microspec was born out of innovation. 28 years later, through the development of high-precision multi-lumen catheters and other tubing products, it refused to believe that "it is impossible" and continued to set global standards for medical tubing. #planttour #bestpractices #dies

Microspec manufactures a wide range of medical catheters for a global customer base.

Timothy Steele is the practical founder and CEO of Microspec. In a typical day, he will set up, verify, run or supervise the production line in the production workshop.

Microspec's manufacturing and QC are located on the same floor, so quality defects can be identified and corrected immediately.

Microspec designs and manufactures all his own tools in the department headed by Bruce Gordon (pictured). When he had his own tool shop, he used to supply Microspec.

Microspec's product range is diverse, but its advantage lies in high-precision multi-lumen tubes.

Microspec has 18 extrusion lines ranging from 0.5 to 2 inches. diameter

Timothy Steele's plan when he was attending Lehigh University in Bethlehem, Pennsylvania may not include squeeze. As a history major widely regarded as an excellent engineering school, his plan obviously does not include engineering. In fact, Steele was recruited to Lehigh because of his strength as a long-distance runner. If it weren’t for Steele’s misfortune to step on a piece of wayward glass during training, the two-time national team became the U.S. Olympic team in 1976. good chance.

I find that the best course is hands-on, learning by doing on the machine.

Today, in a journey of almost 50 years—a long journey—Steer runs Microspec in Peterborough, New Hampshire, as its founder and CEO. Microspec manufactures various tubes and profiles for medical equipment OEMs. Its strength is the miniature, tight tolerance multi-lumen medical tube. It has commercialized 36 lumens of tubes and has cited as many as 42 jobs. Its commitment to breaking new ground through innovative products extends to the way these complex products are brought to market: all Microspec sales representatives are engineers.

Steele worked for four consecutive summers while in college, and he experienced extrusion for the first time when running PVC profiles.

"What I learned about squeezing was self-taught," he said. "At first, I read everything I could access, various textbooks, technical journals, and papers on extrusion. But I quickly discovered that the best course is hands-on, on a machine, learning by doing. "

After graduating from university, Steele went to work in product development for a multinational company that manufactures FEP catheters in New Jersey. He moved to the same company in New Hampshire and was responsible for new product development. Then he went to work in Ireland for three years, helping his employer to establish a production business there.

When he returned to the United States, Steele brought a business plan. His vision is to start a tubing company focused on doing things that have never been done before: complex multi-lumen tubing made of various TPU, fluorinated polymers, nylon and elastomers. As Steele recalled, his business plan had a basic and fatal flaw-it did not include finances. So his employer rejected him. In response, Steele gave six months' notice; cashed in $125,000 of Nike stock (he still wears Nike); rented out a room in New Hampshire; and bought an extruder and two After the downstream equipment, Microspec was born.

Questions about medical tubes? Visit the pipe, profile and pipe area.

Today, Microspec has 80 employees, operates a two-shift system, and has annual sales of approximately US$10 million. It has grown rapidly, adding 25 people in the past three years alone. Since it has established sales channels in Europe, China and India, most of its growth is international. Interestingly, Microspec has a strong customer base, and they are also competitors-mature tube processors use Microspec for more complex multi-lumen tubes, and they don't like to run them on their own. According to Norman Langevin, Microspec’s customer service and project manager, “Of the 30 leading medical equipment OEMs, we provide services to 25. We are not the cheapest. Of course, we are not manufacturing goods, but manufacturing complex and highly sophisticated products. Precise parts. When our competitors say'no', we will say'yes'."

Microspec may be known for its expertise in multi-lumen catheters, but it has also produced a long list of other types of medical tubes and profiles, including balloon catheters, bumps and reverse bumps, multi-rigid tubes, and microporous and Slightly squeeze. Microspec also produces intermittent extruded tubes, where the tubes are extruded with different hardness, radiopacity and/or color. Each product is developed in cooperation with customers to meet specific needs.

"We work closely with our customers from concept to product realization," Steele said. "We are not afraid to accept the challenge. We will take over a project that others say "it is impossible to complete". We will place an order and develop an effective process. In the 28 years of our business, there may be two or three projects that fail Success. This is a pretty good batting rate."

Microspec operates in a 28,000 square foot original factory. It runs lean and green. Microspec's manufacturing workshop (approximately two-thirds of the facility) includes 18 extrusion lines for production and R&D, as well as other equipment for R&D and quality control. This saves time and reduces production waste-technicians do not have to go to another room or building to see if the product does not meet specifications. Steele pointed out that this method has an additional benefit: "Technical production and QC personnel on the same floor allow people to learn from each other."

In terms of "green", rooftop solar panels account for 20-25% of the company's electricity consumption. It also uses heat exchangers, allowing its process water to be cooled by ambient air outside. And plans to develop a geothermal power building near the existing factory for business development and research and development.

"We are not afraid to accept the challenge. We will take over a project where others say'this is impossible'."

In the current ISO 13485 certified factory, Microspec's extrusion line is located in a controlled environment. Their size ranges from 0.5 to 2 inches. diameter. And mainly provided by Davis-Standard, LLC, Pawcatuck, Conn. and American Kuhne, York, Pa of Graham Engineering. The rest is used for R&D and verification. The two production lines are used exclusively for research and development.

Microspec extrudes one to three layers of outer diameter, ranging from approximately 0.08 mm to 15 mm. Downstream systems are provided by various suppliers, including Conair Group in Cranberry Township, Pennsylvania; RDN Manufacturing Co., Inc., Bloomingdale, Ill.; and GF Goodman & Son, Inc., Warminster, Pa. Depending on the product being operated, the water tank can be arranged between 8-10 feet to 100 feet. Generally, the more lumens in the tube, the more cooling required to extract the heat from the tube. Each lumen has its own air supply line. Before cutting or winding, the outer and inner diameters of the tube are checked by the instruments provided by Beta LaserMike, Dayton, Ohio and Zumbach Electronics Corp., Mt. Kisco, NY

Microspec uses an extremely wide range of materials, including various TPU, nylon, fluorinated polymers and bioabsorbable resins. Microspec is considered a pioneer in extruding high-heat engineering plastics (such as PEEK, PEI, and polysulfone) and fluorinated polymers (including FEP). "We can run almost all materials except PTFE or silicone," Langevin points out. Microspec operates at line speeds ranging from 5-10 ft/min to 400 ft/min.

Regardless of whether the material absorbs moisture or not, Microspec will dry it before processing. The factory has 14 adsorption dryers arranged along the back wall of the production/QC floor. Materials such as nylon, PC, and ABS must be dry because they tend to absorb moisture. But Microspec has also experienced the trouble of drying PE and PP to remove surface moisture, otherwise it may cause voids and other surface defects in the pipe.

To make a good squeeze tool, some things cannot be done on paper.

Microspec's QC field includes laser measurement equipment, high-precision electron microscopes and needle gauges. The pipes are evaluated at the start of each run, during and after the run, and before shipment. In fact, the pipes are inspected before the actual production run starts: technicians usually set up the production line, start producing the product, and perform quality checks on three pieces before the production volume increases. Microspec has tensile and elongation testing equipment from Instron Corp., Norwood, Massachusetts, and relies on various other material testing machines to analyze moisture content, melt flow, annealing, and other properties, depending on what is needed. It maintains a historical record of each run.

Last month, Microspec was implementing an ERP system from IQMS in Palo Alto, California. Steele said, "To compete on a global scale, you need these types of tools. But I have seen ERP systems do a lot of damage to the company, mainly because they try to do everything at once. We are taking more gradual, A phased approach."

Considering that Microspec uses complex tools and various resins to make very complex parts, it is a bit surprising that the company did not implement simulation software to simulate the flow of materials in its tools. Langevin put it this way: "At Microspec, our simulator is Tim's brain and Bruce's skill."

"Bruce" is Bruce Gordon who runs the Microspec tool room. He has his own mechanical workshop near Microspec and makes tools for pipe manufacturers. Then he decided that running a business was not something he particularly liked. So he told Steele that he was going to quit the industry, and Steele responded by buying his equipment and hiring Gordon.

Today, all tubing manufactured by Microspec is made with extrusion tools designed and developed by Gordon and his in-house team. The company describes its tool operation as "a unique fusion of traditional designs using pencil and paper on a drawing board, combined with modern CAD programs running on our state-of-the-art wire cutting machine." Roughly speaking, it will most Good art and science are combined. Steele said: "To make a good extrusion tool, there are some things you can't put on a piece of paper."

The Microspec machining shop uses MasterCAM and SolidWorks software and two wire cutting machines, as well as metal processing and punching equipment. The machining shop has a tool bench for cleaning and maintaining all tools. Extrusion equipment is also maintained and repaired here.

The founder and CEO of Microspec learned about squeezing through "practice". This method also applies to his management style. Within a day, Steele will transition from technical brainstorming sessions involving engineers and key customers to setting up trials, running production lines, and everything else in between. He developed his own training methods for new employees. He likes to make technical demonstrations from time to time; the last two are about handling PEEK and how to minimize gels, which he calls "every extruder's nightmare."

Therefore, it is not surprising that Steele takes a hands-on approach to teach newcomers about squeezing. He respects universities that offer polymer education courses, but based on his experience, "These students usually have bad habits that are hard to get rid of." That refers to what he believes is the gap between theory and practice.

So Steele developed a 75-page book by himself, requiring all technical staff to read it, mainly focusing on process design and process design. "That book is our training plan," he said. "When a line needs to be put together, I tell my people,'Remember what you read in that book.' But of course, sometimes we have to set it up in a different way than the content in the book. So , The important thing is that we explain why to them and make sure they understand."

About three dozen, mainly European processors are promoting the commercial development of high-speed single-screw extruders. They installed more than 100 small super-drive machines with screw speeds up to 1500 rpm, which is about 8 to 10 times faster than standard extruders. At least two German machine manufacturers are developing machines with speeds of 2000 rpm or higher. The goal is to increase output without increasing the size of the extruder.

Mold stacking, also known as mold drooling, mold leakage, or demolding, can affect any extrusion process.

Gel is a common quality problem in film and tube extrusion. To solve them, learn from their sources.

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