Medical Design Briefs - December 2024 - 38

Contract Manufacturing
DfM Principles
Minimize Part Count
Rationale: Fewer parts generally lead
to reduced assembly time, lower material
costs, and decreased inventory management
requirements.
Approach: Consolidate functions to
eliminate nonessential components and
create multifunctional parts wherever
possible.
Standardize and Simplify Parts
Rationale: Standard parts are easier
to source and replace, often resulting in
cost savings and fewer unique setups.
Approach: Use readily available, offthe-shelf
parts when feasible and design
parts that can be manufactured with
standard processes and tools.
Design for Ease of Assembly
Rationale: Simple assembly processes
reduce the time, labor, and potential errors
associated with product assembly.
Approach: Use modular assemblies,
ensure easy access, and design parts
with alignment features to facilitate
assembly.
Design for Manufacturing
Processes
Rationale: Ensuring that parts are
compatible with common manufacturing
processes (e.g., injection molding, CNC
machining, stamping) reduces costs and
enhances production feasibility.
Approach: Consider the specific manufacturing
method during the design phase
to avoid processes that are overly complex
or require specialized machinery.
Tolerances and Fit
Rationale: Loose tolerances generally
reduce costs and make manufacturing
easier, while tight
tolerances increase
complexity and cost.
Approach: Specify
tolerances
only
where necessary for the function of the
product and allow for looser tolerances in
noncritical areas.
Optimize Materials
Rationale: The choice of material affects
durability, manufacturability, and cost.
Approach: Choose materials that meet
the functional requirements of the product
but are also easy to machine, mold,
or form and are cost-effective.
Design for Quality and Reliability
Rationale: Products need to meet quality
standards consistently to reduce waste,
rework, and customer dissatisfaction.
Approach: Implement design features
that simplify testing and quality control,
and ensure robustness in design to withstand
production variances.
Design for Automation
Rationale: Automation can reduce labor
costs and increase consistency.
Approach: Design parts and assemblies
that are compatible with automation
processes, such as robotic assembly or
automated inspection.
Design for Sustainability and
End-of-Life
Rationale: Sustainable design reduces
waste and can make disposal or recycling
easier, benefiting the environment and
potentially lowering costs.
Approach: Use recyclable materials,
design parts that can be easily disassembled,
and consider the product's life cycle
from manufacturing to disposal.
Consider Cost-Effectiveness
Throughout
Rationale: Cost considerations are
central to DfM to keep manufacturing
within
budget
while
meeting
quality
standards.
Approach: Continuously evaluate each
design decision for its cost impact, balancing
functionality with manufacturability
and cost.
cally ISO certified and meet requirements
of the Food and Drug Administration
(FDA) and European Medical
Device Regulation (MDR).
Many component manufacturers specialize
in only one of three critical development
stages: design, prototyping,
or production. Few offer expertise in all
stages, thus lacking an understanding
of how design and material choices can
impact lifetime product costs. It is critical
for medical device manufacturers'
partners to understand all the critical
development stages of a component
and to provide dedicated experts to execute
on every stage of the process.
The Model in Action
A diabetes device manufacturer wanted
to be first to market with an innovative
technology that would change how
38
patients track their glucose levels. A
competitor was developing a similar
product, so speed to market was essential.
The OEM partnered with Trelleborg
Medical Solutions to take advantage
of 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
to ensure the feasibility of scale-up of
each option. This holistic design approach
also included DfM and assembly
testing, which facilitated bridge tooling,
quality control testing, and high- volume
fully automated production. The manufacturer
achieved the desired launch
date and quality expectations, delivering
to market a device that positively
impacts patients' lives daily.
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Conclusion
The expertise of CDMs that have dedicated
space for innovation are focused
on accelerated development
cycles,
DfM, and the optimal application of
materials science for their OEM partners.
The demand for rapid design and
manufacturing of products at a lower
cost means it is critical for device manufacturers
to collaborate with suppliers
that demonstrate all these capabilities.
It all starts by partnering at the design
stage to create the best quality product
and patient outcomes with a focus on
value and cost-effectiveness.
This article was written by Chris Tellers,
Innovation Center and New Product
Development Director, Trelleborg Medical
Solutions, Plymouth, MN. For more
information, visit www.trelleborg.com/
en/medical.
Winter 2024 Resource Guide
http://www.trelleborg.com/en/medical http://www.trelleborg.com/en/medical http://www.medicaldesignbriefs.com
Medical Design Briefs - December 2024

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