services. There is a steady supply of new materials for AM and
3-D printing. Other advances are tighter tolerances and the
increased size range of parts (some of which, in limited cases,
can be production ready—ideal for personalized devices and
implants). Additive material processing continues to grow as
a real alternative to heavy material removal by traditional machining. Depending on the material properties required, additive processed components can sometimes be used to replace
hard-to-machine parts (material or shape), or even multiple
components, in a more complicated device.
“There are additive materials available now that are true drop-
in replacements of several traditional medical-grade plastics and
stainless steels,” said Glass. “The processes applying them are
mature and are even being combined with machining and lasers
for some truly remarkable manufacturing capabilities.”
Unfortunately, there are still significant limitations that pre-
vent broader usage of AM. For example, it is hard to beat the cost
and rate of an injection-molded part, especially for companies
that already own the die base. Some product designers are unfa-
miliar with how far these materials have come from the days of
brittle plastics and rough surface finishes. Others are wary of the
slow acceptance of new materials by regulatory committees. Ven-
dors are worried about the real dangers of working with metallic
powders while those that accept the risk might not be able to
justify the high cost of processing equipment. Despite all of this,
said Glass,“the technology is continuing to evolve so quickly that
you almost need to check every month to see what new thing
you can make.”
Medical device companies are turning to their manufacturing
partners to provide innovative solutions to design/manufacturing
challenges. Suppliers with deep manufacturing know-how, combined with medical device experience, can provide much needed
guidance to product developers. This trend is likely to accelerate
as the gap between the product designers and the manufacturing
technologists grows. OEMs will continue to outsource specialty
manufacturing services, while staying closely involved with their
proprietary product designs.
Nanotechnology has led to innovative laser and machining
technologies that now produce smaller and tighter tolerance
parts than ever before. Advanced, non-ablative techniques singu-late devices, especially glass wafers, at much faster cutting rates.
This is achieved by creating micro pressure gradients or fissures
that initiate self-induced, controlled cracking. Additive manufacturing capabilities will continue to become more refined, especially at the micro scale.
Machining suppliers are committed to working with materials that are newer to the medical device industry, or new to the
material additive/removal method being used. More expensive/
exotic materials are typically used to create a specific physicial
characteristic, such as ultra-high wear or high flexibility.
“The wide range of laser tools now available makes all ma-
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