Medical Design Briefs: 2021 Technology Leaders - 82

TECHNOLOGY LEADERS Contract Mfg./Outsourcing
Prototype to Mass Production for Single-Use
Instruments: What OEMs Need to Know
T
he surgical instrument market
today is dominated by products
that offer multi-functionality as
well as ease of use. The market
has seen an increase in demand for a
variety of increasingly complex and
sophisticated surgical products and
tools capable of performing multiple
functions while also improving the user
experience during procedures. Handheld
surgical instruments need to be
designed to allow surgeons to access
hard-to-reach areas of the body with
precise, seamless tip positional control,
especially during minimally invasive
surgery.
Single-use surgical instruments designed
to be disposed or recycled following
use offer many benefits over reusable
products. Prepackaged, individually
wrapped and presterilized, single-use
devices offer a convenient, off-the-shelf
option for surgeons and other operating
room staff. By contrast, reusable products
can malfunction or wear down over
time. Single-use instruments won't chip,
dent, rust, or become dull or damaged
with repeated use. Single-use scissors and
other cutting instruments are new and
optimally sharp out of the package every
time. In addition, instrumentation that
allows surgeons to deliver care more efficiently
and safely translates to faster
recoveries and improved outcomes for
patients.
One of the significant advantages of
single-use instruments is that they do not
require sterile processing, involving disinfecting,
sterilization, reprocessing,
and restocking best practices. These are
costly, time-intensive operations for hospitals.
Some healthcare facilities outsource
sterile processing and maintenance
to a third-party vendor, which is
also a costly line item.
Even with rigorous protocols in place,
thoroughly disinfecting, sterilizing, and
removing biological debris and other
microorganisms from reusable products
can pose challenges. Some reusable surgical
tools, such as articulating laparoscopic
devices, have complex or elabo82
Surgical
instruments need to be designed to allow surgeons to access hard-to-reach areas of the body with precise,
seamless tip positional control. (Credit: MICRO)
rate parts that can be especially difficult
to clean. If they are not disinfected and
sterilized properly, pathogens can be
introduced to patients, increasing risk of
healthcare-associated infections (HAIs).
Use of disposables reduces the risk of
surgical patients being exposed to HAIs
from reusable instruments that are
reprocessed inadequately.
What OEMs Need to Know: Single-Use
Instruments
Original equipment manufacturers
(OEMs) want to provide high-quality
single-use instrumentation options to
their customers and want to know that
robust disposables and components can
be produced cost-efficiently with quick
turnaround. Working with an experienced,
full-service contract manufacturing
organization (CMO) is often the key
to optimal product design support and
analysis for manufacturability. Choosing
the right engineering company staffed
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by experienced, innovative design engineers
can help OEMs realize their goals
in a timely, cost-efficient manner.
A critical success factor is the CMO's
ability to design, produce, and maintain
the dies and associated tooling that will
be used to produce an OEM's parts and
products. Precision tooling for highspeed
precision stamped, formed, and
machined components can be achieved
to support the requirements of a singleuse
instrument development program.
Design for Manufacturability
Establishing a design for manufacturability
(DFM) process is a critical
early step that aims to simplify and
reduce the number of steps needed to
manufacture a product. DFM considers
cost, time, and other factors early in the
design phase to ensure that a product is
optimized for production. If done properly,
DFM can help identify potential
problems early on that could result in
Medical Design Briefs 2021 Technology Leaders

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Medical Design Briefs: 2021 Technology Leaders

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