Contract manufacturing
Transform development with 3D-printed injection mould tooling
Investments in injection mould tooling is a formidable barrier in many development projects. Freeform injection moulding (FIM), a process invented by Addifab, combines 3D-printing and injection moulding to enable the development and testing injection-moulded parts without investing in metal tooling.
F
or decades, injection moulding has been an indispensable part of medical device manufacturing. And for decades, tooling costs and lead times have challenged medical device developers wanting to get their injection-moulded products to market. Tool designs, tool investment decisions, tool manufacturing and tool run-ins may easily take months to complete. They then follow tool reworks, which may add further weeks to already over-stretched timelines.
Complexity adds costs
The tool procurement challenge increases with component complexity, and medical devices frequently include components that are complex. Even a seemingly simple syringe may include a threaded needle adapter (Luer lock), which requires that a twistable, slidable core be included in the tool design. And such a core may easily double or triple the costs of the tool, as well as the tooling lead time. Lead time challenges further increase with the number of injection-moulded parts that are required to make a device. Most devices will include parts that have different lead times – and the complex parts are usually the ones defining the critical path. Device testing efforts may be held back until the last-to-arrive component is received (as shown in table).
A new approach
Addifab has developed freeform injection moulding with the needs of the medical device developer at the forefront. Four essential requirements have been set out: 1. Medical device developers should be able to use the same materials and
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production processes for product development as for manufacturing of the finished medical device.
2. Medical device developers should be able to use the same design features in product development as in the manufacturing of the finished medical device.
3. Medical device developers should not have to overinvest in tooling or production of test parts during product development.
4. Medical device developers should be able to move effortlessly between low- volume prototyping and high-volume production without having to change production processes.
Addifab has met these requirements with the introduction of FIM soluble, 3D-printed injection mould tooling. Lasse Staal, co-founding CEO of Addifab, explains: “Solubility is the game-changing backbone of freeform injection moulding. With soluble tooling, we can mold even the
most sticky and abrasive materials – in the most challenging geometries – without having to worry about getting the parts out of the tools,” he said. “Properly supported single-use soluble cavities can handle the same pressures and temperatures as conventional tools. We can tool up for exactly the number of parts we need for a given design stage, instead of investing in metal tooling with excessive capacity for development purposes. And we can gradually freeze and unfreeze a design to increase production volumes and levels of customisation by mixing 3D-printed tool elements with metal tool elements as the product evolves,” he added. The process itself is a deceptively simple, four-step procedure, that may deliver injection-moulded parts in as little as a day. Preparation is the first stage. Occurring in the CAD domain, this turns the desired part design into a mould design. For rapid prototyping, the mould may be a software-generated one-piece cavity with an inlet and a vent, whereas
Medical Device Developments /
www.nsmedicaldevices.com Most devices include parts that have Part 1 – straight pull tool
Part 2 – single slider Part 3 – snap fit Part 4 – text
Part 5 – insert bushings
Part 6 – over-molding, snap fit
Time (weeks)
different lead times – and the complex parts are usually the ones defining the critical path.
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