Medical Design Briefs: 2021 Technology Leaders - 84

TECHNOLOGY LEADERS Contract Mfg./Outsourcing
product failures or manufacturing inefficiencies
downstream. Potential issues
addressed early in the design phase will
save time and money and minimize wasted
resources.
The process should start with a financial
analysis and cost breakdown for
manufacturing and assembly, with a
focus on internal components that have
the potential to be produced with alternative
manufacturing processes. At the
same time, it is essential for a CMO to
carefully assess the intended use of a
product, relying on the OEM to explain
what the functionality and goal of the
project are for the end user. It is critical
to understand the surgeon's perspective
and insights based on market research
that the OEM has conducted. For singleuse
instruments, manufacturers need to
understand the properties that are
essential to the optimal functioning of a
product. Consider such factors as:
* Will the product need to articulate or
stay rigid during procedures?
* For articulating instruments, how
often will the tube articulate and to
what degree?
* Is the component or device used for
dissection, sealing, or wound closure?
* Will the device be multi-function, performing
different functions during
procedures?
* Will it be used for hot or cold cutting
during surgery?
Understanding the functionality and
project goal, along with any commercial,
technical, and compliance factors,
will enable OEMs and their CMO partners
to identify a manufacturing solution
that best meets the needs of the
project and results in efficiency and
quality. In addition, these factors will
impact material selection, laser cut
geometry, and whether any postprocessing
will be needed.
Prototyping and Validation
Prototyping and feasibility testing are
used to test a functional product design,
evaluate material,
and refine design
and production elements.
Prototyping
can help manufacturers
scale up to
mass production
using the most efficient
processes that
also meet federal
regulatory requirements.
OEMs that
fail to engage a
CMO skilled at prototyping
and controls
risk having to
go back and revisit a
design if and when
issues arise once production
ramps up.
Revisions of this
nature can be costly
and cause development
and production
delays.
Volume
Precision tooling for high-speed precision stamped, formed, and machined components
can be achieved to support the requirements of a single-use instrument
development program. (Credit: MICRO)
84
Considerations
DFM allows manufacturers
to optimize
designs to be
produced at high
volumes. The prowww.medicaldesignbriefs.com
cess
provides the blueprint for ramping
up with a validated, evidence-based
development program that saves time
and money downstream.
For higher volume projects, automated
processes like stamping dies, machining,
laser cutters and welders, vision systems,
and injection molding can all be
considered. A stamping press can produce
several mission components in a
week. Initial capital requirements of a
stamping tool can be amortized over
time. For volumes closer to a few thousand
pieces a week, along with tolerances
of ±0.0005 in., machining is a better
choice. Articulation joints are well
suited for laser cutting. The key is to
identify the processes based on a program's
specific design needs.
Lower volume projects are better suited
for less-automated technologies.
Machining is more versatile and can
accommodate volume needs that shift
mid-project. Part geometry is another
factor in process selection. Some part
shapes are simply unable to be stamped
due to the load required to pierce the
materials required for thick diameters.
Machining generally has greater accuracy
with geometry and enables starting
with a larger billet and adding material
to create desired features. Part geometry
can also dictate whether secondary
processes will be needed.
Minimizing Progressive Tool Costs
Minimizing progressive tool development
costs is an important component
of the design process. It's essential to
design tool and safeties in order to prevent
breakage and misfeeds, which can
increase costs.
Stock lace-up point. Design the stock
lace-up point so that it can be laced up
without creating half slugs that could get
stuck in the die and cause breakage.
Press stroke. Minimizing press stroke
is often an overlooked simple fix. For
example, running 200 strokes per
minute with a 2-in. stroke equates to
running a 1-in. stroke at 400 strokes per
minute.
Slug controls. Factoring slug controls
such as notches, vacuums, punch roof -
tops, and slug darts, into product design
helps ensure a robust tool design.
Die features. Often die features can
increase cost but making sound deciMedical
Design Briefs 2021 Technology Leaders
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Medical Design Briefs: 2021 Technology Leaders

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