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SPECIAL FOCUS MEDICAL & PHARMACEUTICAL


MICRO MOLDING FOR MEDICAL DEVICE OEMS T


he medical device sector is synonymous with innovation, and much of this is driven


by the requirement for miniaturisation. The move is towards smaller components, thinner walls, and complex and minute features. Micro molding is today the solution used by many medical device OEMs to achieve their exacting manufacturing requirements – it being a technology that can produce tiny, complex, and feature rich components, efficiently, cost-effectively, and in volume. Micro molding in the medical device sector,


however, is often not straightforward. Key to success is that medical device OEMs


partner with the molder at the earliest possible point in the design-to-market process in order to avoid costly mistakes, and requirements for multiple iterations of product design and


even tooling as solutions to micro molding problems are sought. Micro molding for medical device OEMs is an


art form honed after years of expertise and trouble-shooting, and it is vital that micro molders have the business culture, personnel, and equipment in place to provide the service necessary to ensure a successful project outcome. Micro molders for medical device OEMs will be dealing with low, medium, and high volume runs in a variety of different materials, all requiring different levels of validation. They must also have the expertise in handling, storing, and processing often extremely expensive and sensitive materials that in many instances will be used in critical implantable applications. Tooling is a critical area. Features in micro


molded parts often exceed the allowable tolerances in traditional injection molding, and micro molders must be in a position to employ an array of technologies including the latest CNC machining technologies and also EDM. The critical end-use nature of many medical


Accumold’s tool room


devices also requires that micro molding takes place in cleanroom conditions, and indeed the entire manufacturing process must adhere to the internationally recognised ISO 13485 standards. Also a micro molder needs to have a profound understanding of the ever changing regulatory


A micro molded pupil dilator


environment. In general, the FDA has toughened up in the area of product approval, and has started to request information from medical device OEMs never previously required. This has meant that the percentage of first-


round 510(k) submissions requiring more information has gone up dramatically, with a knock-on effect in terms of time-to-market delays and expense. A micro molder must have an innate understanding of the vagaries of the 510(k) process which will save enormous amounts of time and money for medical OEMs.


Accumold www.accu-mold.com


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NOVEMBER 2020 | DESIGN SOLUTIONS


/ DESIGNSOLUTIONS


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