Medical Design Briefs - September 2023 - 14

Overcoming Blockers
Model, the participants were able to accurately
derive their level of digitization
(digital maturity) in their manufacturing
operations in comparison to their
industry peers.
The research shows that digitization is
a high priority for companies. The majority
of respondents cited that they are
actively pursuing a digital transformation
but still have not advanced to their desired
level of digital maturity to achieve
optimal production performance.
Paper Imposes Limitations on a
Manufacturing Operation
Companies that are slow to adopt
digital technologies risk not reaching
their full potential as a contributor to
the life sciences value chain. Data from
the survey revealed that 64 percent of
the participants cite the ineffi ciencies
of a manual, paper-based operation as
one of their biggest challenges in meeting
key performance indicators (KPIs)
and production demands. Given the urgency
of getting devices to patients, life
sciences products are time sensitive.
The challenges inherent in product
manufacturing are further compounded
by having to navigate a diffi cult regulatory
pathway.
Medtech product manufacturers are
under signifi cant pressure to meet the
numerous regulatory and good manufacturing
practice (GMP) guidelines.
Compliance involves factoring in a variety
of aspects that impact their product,
including quality, human factors, safety,
reliability, environmental conditions of
where the device will be used, etc. Stakeholders
from the organization's multiple
business units all need to understand the
full scope of the product's life cycle. Part
of this includes making effi cient use of
data - an added challenge when the
data is siloed in various locations.
Gathering and analyzing critical data
from disparate paper sources creates
unnecessary obstacles. For starters, key
stakeholders don't have information until
it comes to them, so they lack workin-progress
visibility of key areas along
the supply chain. Unless the data is current
and accurate, it's diffi cult to identify
trends, leading to delayed and uninformed
decisions. Also, unstructured
data in paper form often doesn't include
the data's history or context. Locating
this information is time- consuming,
which extends lead times on critical
14
changes. Certain tasks such as coordinating
resources and production schedules
require precise timing. Companies can
actually lose money when they can't get
data to the right place at the right time.
added expense because it's not incorporated
into the production cycle.
The quality staff commonly need
It's surprising
that a large
number of
companies
are still using
manual,
paper-based
processes.
Records management in a paper-based
environment is diffi cult. Production records
can contain 1,000 or more manual
entries - using up reams of paper.
Various team members need to review
the records multiple times to ensure
completeness and accuracy, which pulls
them away from research and development
and other business-critical projects.
The risk of errors on production reports
increases with each human touch
point, such as illegible penmanship, numerous
changes that need to be noted
and signed, and smudged ink. The costs
of the production setbacks, product
damage, and waste resulting from these
issues add up quickly. All of this leads to
life-changing products not reaching patients
in a timely fashion.
A Paper-Based Operation Impacts
Quality
Ideally, quality should be embedded
in every phase of manufacturing. However,
manufacturing and quality departments
commonly have competing priorities.
Regardless, these business units
need to have clear, holistic visibility of
how the project is progressing as well as
maintain transparency and communication
to achieve their objectives. If quality
doesn't come in until near the end of
production, it's an added process and an
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to spend an extensive amount of time
double- checking spreadsheets and paper
documents. Issues are often discovered
that should have been identifi ed much
earlier or should not even exist, resulting
in the product being scrapped or reworked.
Because quality issues stem from
variables that become more complicated
as products progress through development
and manufacturing, the cost of fi xing
problems increases incrementally the
further the product is in its life cycle.
It's overwhelming to track every aspect
of quality events across the organization
and know how they aff ect the production
process - especially when quality
data is isolated in an unstructured format.
In the event of a deviation, corrective
action/preventive action (CAPA),
or some other quality event that results
in process changes, the related work instructions
need to be updated and approved,
which can take up to 30 days or
longer. Then all previous versions need
to be found and taken out of circulation.
Updates to documentation means employees
must be trained on the new processes
before performing the tasks or it
becomes a compliance issue. Meanwhile,
production slows or comes to a halt until
all the issues are resolved.
What Blocks Manufacturers from
Transitioning to a Digital Operation?
Despite the incentives and benefi ts of
digitizing operations, the survey indicated
that many companies are delaying or
opting out of modernization for a number
of reasons. For starters, the survey
showed that 47 percent of the participants
cited that the price of a new solution
is the primary reason for not pursuing
a digital transition.
A technology upgrade requires some
changes to your current environment
and processes. The survey showed that
43 percent of the participants considered
the disruption of operations their main
impetus for not upgrading. Completing
the setup, confi guration, transferring
data, and training staff on the new system
requires a lot of eff ort - not to mention
pulls people out of their comfort zone.
Another reason for postponing a digital
migration is that change can be timeconsuming,
as cited by 34 percent of the
participants. For example, a traditional
Medical Design Briefs, September 2023
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Medical Design Briefs - September 2023

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