Four Reasons to Use Additive Manufacturing in Medical Device Development
by Derrick Corea Technosoft Innovations, IncAdditive manufacturing is experiencing an unprecedented
period of growth in the medical device industry. No longer limited to prototyping,
additive manufacturing is being used to create everything from patient-specific
surgical guides to custom-fit prostheses to implants and 3D-printed tissue.
In the meantime, the stringent necessities posed by medical
device developers remains a contest. Customization and novel uses have made
meeting present FDA guidelines surprisingly uncomplicated for additive
manufacturers thus far, but medical device developers are still accountable for
final product performance—and additive manufacturing vendors that specialize in
medical materials are few and far between.
Despite these challenges, modern and versatile additive
manufacturers can expedite, and improve the R&D. Additionally, advances
that sound like they’ve jumped right out of the pages of a science fiction
novel are manipulating materials and methods in ways that could transform even
more conservative applications.
Consider these factors—creativity, advances in materials,
science and research in medicine; they make clear that now is the perfect time
to explore how additive manufacturing can benefit the medical device industry.
1. Create A Product
Real Customers Want To Buy
The need to please a diverse customer base, coupled with the
highly regulated and specialized nature of device development, has driven
industry leaders to ditch the traditional approach to getting a product to
market. Instead, they’re not only saving time and money, but also are
presenting products that are more appropriate to meeting the demands of a
complicated group of clients and users: By replacing the linear path from
design to manufacturing to marketing with an iterative or evolutionary design
process.
Vendors that marry old-style manufacturing knowledge with
rapid prototyping via improver manufacturing offer a lithe approach to device
design. This experience allows developers to provide multiple mechanical
answers to a single problem or to pivot development to suit the most
appropriate manufacturing methods and demands of the market.
Devices created completely by additive manufacturing can
also progress based on real-time feedback from customers. Short production runs
of specialized products are both affordable and attainable with additive
manufacturing, giving medical device developers the freedom to release a beta version
into the market and move it back into the design cycle before committing to a
larger production run.
2. More Accuracy in
Biomimicry
When simulated use of a medical device is required for
complicated or dynamic internal functionality, anatomical models are an ideal
way to challenge a design. No two individuals are the same, nor are their
organs.
Precise replicas of human anatomies that capture unique
internal and external features can be created with 3D-printing techniques.
Multiple simulated anatomical models that represent a range of “normal”
environments can be created quickly and affordably for medical device design
evaluation as well as for form, fit and functional testing.
3. Deliver
Exceptional Comfort
With additive manufacturing techniques, medical device
designers and engineers can create extremely lightweight, small or low-profile
designs to maximize comfort and freedom of movement for patients or physicians.
Intricate yet durable honeycomb patterns and parts with
open, rather than dense interiors are achievable and enable the reduction of
weight without sacrificing strength or shape. Complex geometries with tight
tolerances or exceptionally small builds can also be fashioned, keeping
surgical tools streamlined or devices that are worn as sleek and unobtrusive as
possible.
4. Break Through
Barriers With New Materials, New Methods
The number of materials currently certified for use in and
around the human body is limited. In addition, the cost for expert materials
specific to additive manufacturing use is expressively higher compared to
old-style manufacturing processes. However, because materials are seen as a
major constraint for additive manufacturing, they have become the focus of
research and development efforts across the industry.
How materials and binding agents react to clinical demands
and affect biological processes are continual concerns and a particular target
of innovative advances. For example, 3-D printed parts are notoriously
directionally dependent when it comes to strength and resilience. New resins
that express strength in all directions can offset challenges related to the
layered nature of additive manufactured parts, and new methods are producing
better homogenization and enhanced durability in final products.
The most common materials for end-use medical devices today
are stereolithography (SLA) resins that are USP Class 6 certified; a number of
metals, including stainless steel, titanium; and some super alloys used in
direct metal laser sintering (DMSL). Medical SLA resins are expert for contact
applications such as custom-designed surgical tools or device components but
not for embedded applications.
For medical devices that have zero contact with internals or
fluids—such as robots that bring medication or cases that house electronics for
functional prosthetics—certified medical-grade materials aren’t necessarily
required. However, finding more materials that are not just medical grade, but
biocompatible and sterilization-stable is a key priority for advancing the usability
of additive manufacturing in Medical Device Development Services.
The Future of
Additive Manufacturing
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Created on Jan 3rd 2018 03:22. Viewed 655 times.