Today, 26 e-motion injection moulding machines – each with a clamping force of 2200 kN – are deployed in the cleanroom. They all operate 24/7 with a utilisation of well over 90%.

"In-house production makes us more flexible," as technical director Thibaud Robin-Rivoire explains. "We can very easily adapt products to our customers' requirements, especially since these requirements regularly change."

"The e-motion machines ensure high dimensional accuracy across all cavities," as Branchereau points out. "This is all the more important because we assemble the cartridges in a fully automated process."

As part of its effort to strengthen those capabilities, Nissha also announced on Nov. 7, 2023, a capital and business partnership with Nashville-based EndoTheia Inc., specialized in the design and development of endoscopic devices. The acquisition of Isometric greatly enhances this partnership “as we expand our CDMO business through manufacturing technology, intellectual property, and vertically integrated capabilities,” commented Nissha.

Established in 1990 as a supplier of tooling and manufacturing services for small, precise, and complex applications, New Richmond, WI–based Isometric added precision micromolding to its portfolio in 2013. The company was purchased by Donna Bibber and Wayne Shakal in 2021, becoming CEO and president, respectively. Isometric has established itself as a leading supplier of micromolding services to the medical device industry. Through the acquisition, it will become a subsidiary of Nissha Medical.

"iQ clamp control is particularly interesting for us," says Philibert citing an example. The smart assistance system determines the optimum clamping force for the injection moulding process in question. In most cases, the optimum clamping force is lower than the value set manually. Clamping force correction then not only improves quality consistency, but also saves energy. The trend towards greater sustainability has long since arrived in medical technology, too, and not just following the rapid rise in energy prices.

“Isometric’s proprietary tooling and process technologies for micromolding have positioned them as trailblazers in achieving single-micron tolerances,” said Nissha Medical in the announcement. “Their micro-formed products have significantly contributed to the miniaturization of endoscopic and surgical devices, enhancing functionality and driving improved patient outcomes,” the company added, citing Isometric’s in-house expertise in tool making, molding process controls, advanced metrology, micro 3D printing, and micro-assembly automation platforms.

Six moulds, for three different cylinder diameters, are currently deployed in cylinder production at L'Arbresle. In total, the FX dialysers are available in five sizes. The version used depends on the patient's size and weight. A mould change is scheduled at least once a week. This was already taken into account in the design of the machines. The e-flomo electronic temperature control water manifold systems, for example, were installed outside the mould area to allow flexible mounting of different sized moulds. Each mould has a different number of cooling circuits.

At the time of writing, Isometric is scheduled to exhibit at Medical Design & Manufacturing (MD&M) West in Anaheim, CA, on Feb. 6 to 8, 2024. MD&M is part of IME West 2024, which also includes Plastec West.

The material poses a further challenge because PP has a lot of shrinkage. On the other hand, it offers benefits in other areas. While filter housings are often produced from polycarbonate, Fresenius Medical Care deliberately chose polypropylene because it is significantly lighter and therefore boosts efficiency in both logistics and waste management.

"E-flomo helps us respond quickly if the flow stalls in a circuit," says Branchereau. "That gives us a good safety margin, especially at night when there are fewer machine operators on duty."

In the production of plastic components for dialysis products in the cleanroom, maximum precision is required for every shot. The task is to combine precision with process stability and cost effectiveness. Fresenius Medical Care masters this challenge with all-electric high-performance injection moulding machines by ENGEL.

Energy efficiency, but also material efficiency, is a focus of continuous product development at Fresenius. You can see one example of this by following the path of freshly injection moulded dialyser housings. After a short interim storage period, they are filled with the hollow fibres, which are also produced on-site, and tightly sealed with yellow lids made of polyurethane. It is only after steam sterilisation that the yellow lids are replaced by functional closures in blue polypropylene. The polyurethane lids are disposable parts, and that is precisely what is due to change.

Nissha Medical Technologies’ Japan-based parent company sees “immense growth potential” in contract design, development, and manufacturing services for the medical device market.

"We have to be able to rely on the machines' repeatability, and we need maximum precision and absolute cleanliness," says Laurent Branchereau, head of the injection moulding shop at the plant, explaining the choice of machines. Every four hours, random samples of the parts are visually inspected and the critical dimensions are measured.

"ENGEL also customises the machines to meet highly individual requirements. That's what characterises our collaboration with ENGEL." emphasises Robin-Rivoire. Digital solutions, such as the iQ smart assistance systems from the inject 4.0 program, are currently being evaluated.

The lives of two and a half million people with chronic kidney failure depend on what look like inconspicuous plastic cylinders at first glance: dialysers are the central element in dialysis (artificial kidney) machines. On closer inspection, the FX-class series dialysis cartridges by Fresenius Medical Care are highly sophisticated. They contain up to 20,000 hollow fibres as wide as a hair with microscopic pores, through which toxins, urea, excess salts and water are removed from the blood during haemodialysis. The process takes four hours. The patients need to be connected to the machine three times a week.

The top priority is uncompromising quality, and it was also a quality-driven decision to exclusively equip the location with all-electric injection moulding machines from ENGEL's high-performance e-motion series.

Focusing on one type of machine also contributes to the goal of maximum production stability. "The CC300 control unit of the ENGEL machines with its large display is genuinely intuitive to operate and helps us achieve great process stability. And at the end of the day, that gives us better quality." points out Eric Biguet, a set-up technician responsible for smooth production operations. "

"We have developed new closures with a core made of glass-fibre-reinforced polypropylene," Alain Philibert reports. "They are so robust that we can reuse them up to 50 times."

A contract design/development and manufacturing organization (CDMO), Wisconsin-based Nissha Medical Technologies is part of Japan’s Nissha Co. Ltd. The acquisition, which is expected to close later this month, will bolster Nissha Medical’s capabilities in the design, development, and manufacture of minimally invasive surgical devices and medical wearables, and further expand medtech innovation, said the company.

Nissha Medical’s parent company said that it sees “immense growth potential” in the medical CDMO market and plans to expand its pipeline by broadening its capabilities to better serve the development of minimally invasive surgical instruments. It also expressed an ambition to explore possibilities within the surgical robotics field.

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.

The cylindrical filter housings are particularly demanding. They are injection moulded from polypropylene in a 4-cavity mould. The wall thickness is 1.5 mm throughout, but the filigree structures at the ends, each with a circular undercut, require a sophisticated injection profile to be completely filled. Injection takes place from two sides at the centre of the cylinder. There are two core pulls for each cavity that move out to the left and right respectively for part removal.

According to its own statements, Fresenius Medical Care is the world market leader in the treatment of kidney disease. "At least one Fresenius Medical Care product is involved in every second dialysis performed worldwide," explains the project manager, Alain Philibert.

Nissha Medical Technologies has formalized a definitive agreement to acquire majority equity in micromolding company Isometric Intermediate LLC.

Each FX-class filter cartridge needs six thermoplastic components, which Fresenius Medical Care SMAD injection moulds in L'Arbresle, about 20 kilometres northwest of Lyon. The components include the transparent cylindrical housing and the blue caps that seal the cylinder with the hollow fibre bundle at the top and bottom and house the connections for the dialysis fluids.