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MARKET PLACE

Getting Medical Devices Faster to Market

Rapid injection moulding provides speed and cost advantages say three medical device companies.

Benefits of aluminium

It is now possible to manufacture fully functioning plastic parts made from aluminium moulds, instead of traditional steel. The process delivers a shorter development phase and lower cost, say its developers, and fully functioning prototypes that can be tried and tested in real world scenarios. “The traditional (steel) tool manufacturing process is labour intensive and time consuming, which can have a negative impact on a product development project. Quite simply, time is money and not getting your product to market before the competition can have a lasting and often disastrous impact,” commented John Tumelty, Managing Director of rapid injection moulding specialist, Protomold.

Parts can be ordered from the company’s web site using proprietary ProtoQuote and Part Tester software. Part Tester analyses the 3D CAD model and provides the designer with information to improve and update the product design before the mould is manufactured. ProtoQuote includes the tool price, the price of samples, the price of the part based on various batch sizes and a calculator for specific part prices based on a different batch sizes. The prices are accurate, he says, not merely estimates, thus there is less risk of going over budget. Some of the companies that have utilised the service, and their products, are described below.

Microfluidics

Stokes Bio Ltd (Limerick, Ireland) used the service to manufacture fully functioning prototypes of a polycarbonate (PC) tray for a new product. The company develops technology based on the amplification of genes that over-express because of disease. Part of the solution developed by the company is the creation of microfluidic systems based on protected concepts in fluid-to-fluid control. A major component of the systems is the microfluidic card: a PC tray that houses 48 wells and caps. “From design finalisation through to supply of the injection moulded prototypes took just 15 days,” says the company’s senior engineer, Dr Kieran Curran. “We supplied a CAD file and the ProtoQuote system made recommendations about how the design could be improved to suit injection moulding,” he explained. “We placed an order with the company to supply sets of prototypes components, each set comprising the PC card/tray together with 48 FEP polymer wells and caps. All the tolerances were met and we assembled the parts with ease.”

Pulse oximeter

Engineers at GE Healthcare (Centennial, Colorado, USA) used the rapid injection moulding service to create the outside bumpers of its pulse oximeter, TruSat. The company was able to evaluate three prototype batches within 10 days of each order. The pulse oximeter, which is designed to be more durable and easier to use than similar products on the market, provides early information to clinicians on problems regarding oxygen delivery to a patient’s tissues. While waiting for the steel production moulds, the GE Healthcare engineers used rapid injection moulding to manufacture approximately 500 parts, which allowed them to introduce the product to market and satisfy immediate end-user demand.

Incontinence device

American Medical Systems (AMS) (Minnetonka, Minnesota, USA) is often required to provide physicians with a prototype that has the polished look, feel and function of a finished product; these are features that rapid prototyping and machined parts generally cannot provide. Robert Lund, principal development engineer for the company says that rapid injection moulding offers a clear advantage. “For us, machine tooled moulds deliver a high-quality product, but they present challenges in terms of costs and time,” said Lund. “Different options have their individual pros and cons. For example, rapid prototyping can get results practically overnight, but it does not provide the material strength we need for functional testing. Similarly, a conventional moulding vendor can provide good quality, but may take six to eight weeks to create a finished product. The process of creating moulded parts is a crucial part of the development cycle. If we can find a way to reduce the time or costs associated with it, well, that is a huge deal.” Using the rapid injection moulding service, AMS was able to create 1000 parts of production grade quality for its BioArc sling system. The system utilises a polypropylene mesh for fixation and a biologic for the suburethral support to treat female urinary stress incontinence in a minimally invasive procedure. The rapid injection moulding service provided the company with a fast, economical alternative to traditional moulding methods.


For more information, contact John Tumelty, Managing Director of Protomold Company Ltd, Telford, UK, tel. +44 870 723 0000, e-mail: info@protomold.co.uk, www.protomold.co.uk   

 

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