Unless you work in manufacturing or product design, you probably haven’t spent a lot of time thinking about how plastic shapes are made. Look around you — see anything with a plastic casing? It was probably injection-molded, and the tool used to make the plastic was probably a royal pain in the ejector pins to manufacture. Atomic Industries is taking an industry that’s currently part science and part art, powered by skilled artisan toolmakers, and adding a layer of software to the mix in an attempt to make toolmaking cheaper, faster and more repeatable.

Globally, as many as 425 million people, which is 9% of the world adult population, are affected by diabetes. The persistent high blood sugar levels of diabetics can lead to serious complications, including strokes, heart attacks, amputations, blindness and the necessity for dialysis treatments. Early diagnosis and proper diabetes management are critical.

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Currently, insulin cannot be administered orally with sufficient precision, so must be injected directly into subcutaneous tissue. Insulin is preferably administered in the smallest quantities tolerated (a few milligrams at a time), as precisely and regularly as possible. Precise measurement – or even better, continuous monitoring – of the blood sugar level is an important prerequisite for this.

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Key components of the insulin pen are used for fixing the injection needles and for protecting the patients against accidental injury by the needles © Schöttli

The manufacturing tools are extremely costly, and a critical bottleneck in the production of most goods. Factories generally cannot produce parts without complex tooling (molds, dies, castings, etc.) engineered by skilled artisans whose knowledge keeps the industry alive. Atomic’s approach will introduce automation to traditional workflows that enhance productivity by orders of magnitude. The company is focused on reducing as many barriers in tool and die-making as possible. The team’s long-term vision is to make manufacturing accessible, scalable and repeatable. Automating tool and die making, the company posits, is a crucial part of that journey. The plan is to start with something valuable but a little less ambitious for now.

High-performance injection moulds for challenging applications in medical technology require precision and skill. Schöttli, a Husky Company, constructs high-performance moulds in large quantities for medical applications including modern diabetes therapy, producing moulds for syringes to artificial pancreas devices.

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With these products the needles, which protrude out of the hub on both sides, are subsequently glued in place in a fully automated process. This is a particularly challenging application, as the needles have very small outer diameters of down to 34G (34 gauge equals 0.18mm). This requires correspondingly small cylindrical openings in the injection moulded part and accordingly, tremendous precision in the injection mould. Each of the 192 cavities is centered individually so that the forming pins (gauge pins) do not break. Only in this way can the reliability of the molds, which Schöttli is known for, can be achieved. The resulting high level of availability and, depending on the application, unmatched number of cavities, leads to a significant increase in productivity per square meter of production area for the customer.

Supply chains have gone under the microscope since the COVID-19 pandemic hit, and investors and startups alike have started to pay attention to industries and sectors ripe for disruption, and strong demand for new manufacturing technologies will continue to increase as supply chain issues persist.

A pen needle-shield protects both the needle and the user from injuries immediately before and after use. For further protection and packaging, the pen needle cover is sealed with a film during transport (Fig. 1).

Today, the company announced it raised $3.2 million from Point72 Ventures, 8VC and Toyota Ventures to automate and evolve the existing workflows. At first, the software Atomic is creating will be for its internal use, but the plan is to eventually make it available to other companies.

“Despite being a fundamental process in manufacturing, tool and die making is an outdated, time-consuming, and labor-intensive process that has resisted innovation,” says Jim Adler, founding managing director of Toyota Ventures. “By leveraging software to automate the most difficult parts of the human tool and die designer’s workflow, Atomic enables a future where mass manufacturing is as agile and distributed as software development. The team’s expert ability to tackle this critical industry bottleneck is why we are so excited to join their mission to unlock the full potential of injection mold design.”

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Insulin pumps available on the market today are usually worn on the body, with a ‘patch’ housing an appropriate injection needle stuck directly onto the abdominal wall. With these patches, which are usually worn for four to ten days, the needle remains under the skin. However, even when using pumps, the blood sugar level must be measured and controlled separately.

Disposable syringes for the administration of insulin usually consist of a cylinder with a firmly glued-in injection needle and a plunger. Here, Schöttli offers productive and reliable mould solutions with hot-edge nozzles and dual side gating for syringe cylinders, syringe plungers and similar applications, usually made of polyolefins.

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“This is particularly important because our customers do not want to produce two to three million plastic parts per year, but two to three million a day," says Adolph Keller, managing director sales & marketing at Schöttli, "and with consistent accuracy." Schöttli  aims to produce moulds that offer maximum accuracy, consistency and adherence to the tightest tolerances. This is critical to ensure the high quality demands of the final product.

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The manufacture of pen needle components and safety pen needles requires moulds that precisely produce these components, usually made of polyethylene or polypropylene. Schöttli provides expertise in high-cavity injection moulds for medical components. The company can offer corresponding single-face moulds for pen needle-shields with up to 256 cavities. Pen needle covers and similar components can be produced on stack moulds with up to 192+192 cavities, maintaining the highest precision and highest performance (Fig. 2). Schöttli delivered the world's first 192-cavity mould for pen needle hubs with side gate hot runner technology.

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As an alternative to disposable syringes, high-precision pens are often used for the subcutaneous administration of insulin. These ‘disposable pens’ consist of several precise plastic parts with a fixed insulin cartridge, with sufficient volume for several treatments. Slightly more expensive, but also readily available, are long-term pens with replaceable insulin cartridges. In either case, a new injection needle, which is screwed onto the pen-housing in conjunction with a pen needle-hub, should be used for each administration. A needle is intended for a single administration and is then disposed of together with the pen-needle hub.

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All moulds for the medical components presented here are equipped with Schöttli hot runner systems. Moulding is normally done in a cleanroom environment, with fully automated production surroundings.

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In the future, the control of blood sugar levels and the administration of insulin will increasingly be carried out by so-called ‘closed-loop systems’, which are precisely adapted to current requirements. With these systems, blood sugar level is measured with a sensor worn on the skin (Continuous Glucose Monitoring = CGM) and transmitted wirelessly to the pump. The pump doses the correct amount of insulin at the right time. As in other medical fields, the classical treatment method and modern online diagnostic systems are gradually converging in diabetology. Since too much insulin can be as dangerous as too little insulin, this innovation contributes to greater patient safety and fewer complications, thus reducing the global cost of diabetes treatment.

In a nutshell, Atomic is attempting to replace human intuition and the ineffable experience of an expert toolmaker with software that uses physics and algorithms.

A hundred years ago, a quarter litre of blood was required to determine accurate blood sugar levels. Today, there are devices as small as a smartphone and test strips that use only 0.3 μl of blood to provide an accurate blood sugar measurement. Syringes and pens allow diabetes patients to inject themselves with the precise quantities of insulin required to manage the disease. Insulin pumps work directly on the body, with complex sensors to determine and dose the insulin required.

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Getting any product to market involves a number of steps that include product research and development. But once it gets down to the actual phase where you want to produce a prototype or move into the production of that item, you have to figure out how you’re going to manufacture it. Depending on the volume of parts that you need to make, tool and die making becomes a crucial role for pretty much everything that we use on a day-to-day basis. Toolmaking is incredibly complex — as Elon Musk points out, in many cases, the tools used to make plastic parts are more complicated than the parts they are making. Curiously, it’s often done by people who have a lot of experience and learned their craft through apprenticeship.

Disposable syringes or pens are often preferred for insulin dosage, ensuring cleanliness and accurate dosing. In Germany, for example, about 80% of all patients administer their insulin with pens, while in North America or Asia, disposable insulin syringes account for around 80% of insulin administration.

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“Instead of doing a simulation and then iterating that design, our software means that simulation and design all happen simultaneously. It’s orders of magnitude faster, and it’s more scalable,” explains Slodov. The scalable part is because software can parallelize a lot better than humans. “You cannot put more than one human designer onto a job; adding more designers doesn’t make it go faster in this type of work.”

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“You don’t typically go to college to learn this kind of stuff, and nobody really trusts you until you have gray hair,” notes Aaron Slodov, CEO and co-founder at Atomic Industries. “You have to know how manufacturable something is, and a lot of that has to do with the machinery that actually pumps out your parts. These machines have constraints, and the only people that really know how to apply those constraints are the ones that design the tool in the dye, or the injection mold, or whatever you’re using.”

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“A tool and die maker will generally receive a CAD file from a customer, for something they need to manufacture. Their task is to design the mold or tool for that part. You have somebody who designs this complex injection mold, which then has to be fabricated. Finally, it needs to be tested to make sure that parts that are coming out of that mold fit the specification of the customer’s needs,” explains Slodov. “They might specify very tight tolerances, for example. To do that, you have to have really good design, which is something that is driven by human intuition and experience a lot of the time.”

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An advanced needle type (safety pen-needles) is a slightly more sophisticated variant; these components are characterised by a special safety mechanism. A protective cap or shield automatically moves over the injection needle as soon as it is removed from the skin surface. This effectively prevents needle prick injuries caused by carelessness. Because insulin is typically administered in a home environment as opposed to a doctor’s office or a hospital, ease of use and consumer protection for diabetes management is important. Another advantage of this type of protection mechanism is the effective prevention of multiple uses.

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The International Diabetes Federation (IDF) estimates that one in two cases of diabetes in adults has not yet been diagnosed. Novo Nordisk, a global healthcare company, goes even further and describes a ‘Rule of Halves’. Of diagnosed diabetics, approximately only half are treated and only 50% of those treated actually receive the right amount of insulin at the right time. However, if diagnosed diabetics pay attention to their body, check their blood sugar level regularly and supply insulin accordingly, they can tolerate the disease well and live healthy, active lives. In the case of type 1 diabetes insulin must be administered, whereas type 2 may require insulin depending on the stage of the disease.

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