Medical Manufacturing & Outsourcing - Version A. April 2021 - 6

Quality and Reliability
in the Assembly and
Manufacturing of
Medical Electronics PCBs

W

ith COVID-19 continuing
to rage across the United
States and the world,
hospitals and medical
centers are relying on their medical
electronics equipment, including
ventilators, to help improve COVID-19
patients' health. EMS providers, contract
manufacturers (CMs), and printed circuit
board (PCB) fabricators are the strongest
link in the supply chain critical for building
medical electronics equipment including
ventilators. These PCB companies help
design, assemble, and manufacture
the PCBs that are at the heart of these
lifesaving medical instruments.
At this time of urgency, medical
electronics OEMs must keep in mind the
basic, yet critical requirements demanded
by all medical electronics products:
quality, repeatability, and reliability.
This trio of requirements must be
completely and conscientiously exercised
at layout, fabrication, and assembly.
The ISO 13485 standard and U.S.
Federal Food & Drug Administration
(FDA) regulations fully support those
6 APRIL 2021

three requirements. As defined, an
EMS provider or CM that has ISO 13485
certification holds the " proof of Quality
Management System compliance to
the standard involved in the Medical
Device industry. " Similarly, the tightly
controlled FDA approval process
requires precise documentation, audits,
design capability evaluation, and
verification, including clinical trials.
For example, this means that when
information for a ventilator PCB design
is not properly documented, there are
flaws in clinical studies, or the design is
incorrect or incomplete, then adverse
effects arise during PCB assembly,
leading to challenges in obtaining
FDA approval of the finished device.

No Failures

With that backdrop, medical venti-
lators and other medical equipment
cannot afford failures whether it's in the
lab or in the field. The burden is on the
EMS provider to ensure that PCBs are
designed to be extremely reliable and
that they deliver quality time after time.

This means that the EMS or CM
must have well-disciplined quality
measures throughout the assembly
and manufacturing process, such as
automated optical inspection (AOI).
Figure 1 shows an AOI system verifying
every component on a PCB and then
" passing " the board. Other quality
control (QC) steps include first article
inspection (FAI), x-ray, and multiple
sets of QC checks along the way.
Therefore, maintaining high-quality
manufacturing translates directly into
high reliability. The EMS provider or CM
must always be checking, evaluating,
tweaking, and streamlining that process
to make it as strong as possible. With
such a stringent manufacturing process,
quality and reliability come at a price:
an EMS provider must diligently pursue
each and every step to ensure that it
is attaining quality and the resulting
reliability. Here, a highly experienced
reliability manager on the assembly
floor is a valuable asset to make sure
there are no shortcuts, cutting corners,
or short-changing each quality step.

MEDICAL MANUFACTURING AND OUTSOURCING SPECIAL REPORT
Medical Manufacturing & Outsourcing - Version A. April 2021

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