Medical Design Briefs - March 2022 - 10

Rapid Development Centers
ment, as well as those already in market.
Studies indicate that between 70
and 90 percent of manufacturing costs
are linked to basic product design.
In the race to get new medical
devices to market, speed is critical.
According to Industry Week, manufacturing
customers are demanding greater
customization and faster speed to market
at ever-lower costs. One area in
which manufacturers are finding ways
to meet this challenge is in product
design. Innovation in complex product
design techniques can deliver significant
benefits in cost reduction, speed
to market, product quality, and customer
satisfaction.
Additional challenges arise regarding
access to design verification. Device
manufacturers want their manufacturing
partners to offer design validation,
including different configurations and
high- and low-end samples (see the sidebar,
" Design V&V " ).
Finally, unrealistic expectations often
exist during the handoff from design to
manufacturing. Many device manufacturers
work with design firms that have
no manufacturing experience. When
designs are handed off to the component
manufacturer, they cannot be built
" as is, " often requiring significant design
changes, which impacts cost and time to
market.
Additionally, many manufacturers are
not equipped to scale up from prototype
to production volumes. Pro ducing millions
verses hundreds of parts requires
planning and a different ap proach to
manufacturing.
Core Competencies
When medical device makers partner
with component manufacturers in the
design phase, they can ensure cost control
and scalability. Simple changes to a
component's design can have a huge
impact on the tool and part cost, even
affecting the device that it is assembled
into. To navigate these challenges,
many RDCs offer core competencies
suited for medical device and pharmaceutical
parts, including design, toolmaking,
high-precision machining, silicone
and thermoplastic molding, secondary
operations, automation, and
assembly.
A Dedicated Team. RDCs offer a relational
environment as opposed to a
transactional one. RDC experts help
medical device manufacturers discover
what they need and how to get there.
10
DEFINING DfM
Design for manufacturability
(also sometimes known as design
for manufacturing or DfM) is the
general engineering practice of
designing products in such a way
that they are easy to manufacture.
The concept exists in almost
all engineering disciplines, but the
implementation differs widely
depending on the manufacturing
technology.
DfM describes the process of
designing or engineering a product
in order to facilitate the
manufacturing process in order
to reduce its manufacturing
costs. DfM will allow potential
problems to be fixed in the
design phase which is the least
expensive place to address
them. Other factors may affect
the manufacturability such as
the type of raw material, the
form of the raw material, dimensional
tolerances, and secondary
processing such as finishing.
Depending on various types of
manufacturing processes, there
are set guidelines for DfM practices.
These DfM guidelines help
to precisely define various tolerances,
rules, and common manufacturing
checks related to
DfM. While DfM is applicable to
the design process, a similar
concept called DFSS (Design for
Six Sigma) is also practiced in
many organizations.
Source: Wikipedia
hours, delivering sample parts right out
of the tool while retaining additional
samples for potential future analysis.
In addition to prototyping, rapid
development teams collaborate with
device manufacturers on component
design and material selection to
ensure superior quality of the finished
device.
Access to Quality Resources and
Techniques
RDCs also bring value to customers
by providing proven quality control
processes. A good component manufacturer
with rapid development capabilities
gives customers access to raw material
traceability, Class 7 cleanrooms,
and established validation processes.
Facilities are typically ISO 13485:2016
and ISO 9001 certified and meet
requirements from the Food and Drug
Administration (FDA) and European
Medical Device Regulation (MDR).
Perfect Combination of Capabili -
ties. Many component manufacturers
specialize in only one of three critical
development stages: design, prototyping,
or production. Few offer expertise
in all stages and, therefore, do not
understand how design and material
choices can impact long-term manufacturing
costs and efficiencies. It's
critical for medical device manufacturers
to partner with component manufacturers
that understands the design,
material, and production implications
and has the dedicated experts to execute
on every stage of the process.
A Case Study: Accelerating Time
to Market
A diabetes device manufacturer
wanted to be first to market with an
innovative technology that would
change how diabetes patients
track
With a dedicated team of experts and
quality tool-making equipment, RDCs
can support medical device manufacturers
throughout the development
process, from device and component
design to prototyping, testing, scale-up,
and long-term supply of components
and annuity production.
RDC experts can often design and create
certain prototypes in as little as 24
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Cov
ToC
their glucose levels. Speed to market
was essential, as the company's competitor
was working on a similar innovation.
The device manufacturer partnered
with Trelleborg Healthcare &
Medical to utilize Trelleborg's rapid
prototyping and scale-up capabilities,
ensuring the manufacture of the millions
of parts per year required for a
global launch.
Trelleborg created prototypes in just
days, testing multiple design iterations
ensuring feasibility of scale-up of each
option, if chosen by the device manufacturer.
This holistic design approach also
included DfM and assembly testing, which
Medical Design Briefs, March 2022
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Medical Design Briefs - March 2022

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