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The State of Digital Maturity in Pharma and MedTech Manufacturing.pdf

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The State of
Digital Maturity in
Pharma and Medtech
Manufacturing
2
Research Report
1.
Executive Summary
Life sciences product manufacturing is constantly
innovating to meet new demands in areas such as
personalized medicines and treatments for orphan
diseases. These life-saving advancements in
manufacturing methods get therapies to market faster
and alleviate product shortages.
Advanced manufacturing technologies are necessary to keep up with evolving
trends
in life sciences. The ability of any company to keep pace with the industry
depends
on how well it is taking advantage of these modernized technologies and
achieving
digital maturity. Ultimately, digital maturity is a state where companies adopt
the
technologies that enable them to establish a seamlessly connected, optimized,
and
error-free manufacturing operation.
Overall, there is still an abundant amount of paper and siloed, homegrown
management systems in life sciences product manufacturing. Regardless of whether
companies have some degree of digital manufacturing, paper is still widely used
on the
shop floor and in most other areas of the organization.
MasterControl has been in the life sciences industry for more than 25 years and
has
helped thousands of companies that are developing leading-edge innovations. With
a unique perspective of what it takes to achieve and sustain success in life
sciences
manufacturing, MasterControl set out to identify why manufacturers of regulated
products are not as digitally mature as those in other industries. A central
reason
for this study was to find out why companies are still functioning in a
manufacturing
operation that is largely manual, siloed, and heavily reliant on paper.
To help manufacturers of regulated products get a better idea of where they
stand
on the spectrum of digital maturity in relation to the current trends and their
industry
peers, the study comprised 152 life sciences manufacturing professionals based
in the
following focus areas:
Research Report
3
The study participants are located across the globe. They include a
representative mix
of company sizes ranging from small (less than $10 million in revenue and fewer
than
500 employees) to very large enterprises (over $1 billion in revenue and more
than
5000 employees). The respondents also included a variety of roles, ranging
between
10-14 years of experience across the manufacturing organization.
To better define and measure digital maturity for the study, we designed a
manufacturing maturity model with four tiers:
In this report, your industry peers reveal:
1 Where they are in the maturity model.
2 Where they thought the industry was.
3 What might be holding them back from implementing modernized technologies.
4 What would compel them to pursue digital maturity.
Manual Digital Connected Intelligent
Primarily paper-based. Some processes
digitized.
Manufacturing execution
system (MES)/electronic
batch record (EBR)
on every line.
Real-time, integrated
operational processes.
1 2 3 4
Research Report
4
2.
The Life Sciences
Digitization Picture
The life sciences industry is often considered a digital
laggard as regulatory burdens have historically slowed
the adoption of new technologies. That said, we were
a little surprised when at first glance, the majority of
respondents (57%) reported that they already have an
MES/digital manufacturing solution in place.
Upon closer inspection of what that actually means in terms of digitization at
the
facility and line level, a much different story unfolds.
Of the 57% that indicated they had a MES/digital manufacturing solution in
place, only
9% actually have it implemented at all facilities and sites; 62% have the
technology
fully implemented, but only at some facilities; 25% have it only partially
implemented,
and 3% are in the process of initial implementation.
Taken in aggregate, the vast majority of facilities and lines do not have a
MES/digital
manufacturing solution in place today, meaning many life sciences manufacturers
are
in fact still lagging behind in digital transformation.
The Burdens of Manual/Paper-Based Systems
The fact that life sciences companies are slow to adopt digital technologies
means they
are not reaching their full potential as a contributor to the life sciences
value chain. For
those that try to refute this assertion with the
“if-it-isn’t-broke-don’t-fix-it” argument,
here is what respondents said about their experience with their current
operations:
“Digitalization aids in the collection of additional data and information for
the purposes
of improving the manufacturing process and gaining a better understanding of
customer demands in the future,” said a life sciences product manufacturer.
Common Challenges
With Manual Systems
Companies that adopt a modern MES
overcome these issues.
64%
Siloed Production Systems
64%
Missing or Unusable Data
64%
Compliance Issues 64%
Preventable Human Errors
63%
Excessive Rework/Scrap
59%
Delayed Review/Release
57%
Poor Traceability
55%
01 02 03 04 05 06 07 0
Research Report
5
3.
State of MES Adoption:
Why This Research Matters
Life sciences product manufacturing is one of the most
innovative sectors, making significant contributions
to public health on a global scale. Companies in
this industry continue to push more breakthrough
products and advanced therapeutics into mainstream
health care. Still, companies are pursuing these
developments using outdated methodologies, such as
legacy MES solutions and paper documentation and
reporting processes.
Many manufacturers have implemented traditional MES solutions on only the
largest,
most automated lines and sites. This means these companies have struggled to
adopt
digital solutions across all product lines — even though according to the
research,
most consider it a high priority.
Many of the most innovative pharma and medtech products come from small
companies that understandably function in largely paper-based operations. What’s
surprising is the number of large-scale companies that continue to use paper and
manual processes in all or some parts of their manufacturing operations. Many
leading companies, such as multinational pharmaceutical, medical device, and
biotechnology organizations, might have a traditional MES for their high volume,
blockbuster lines. However, they still keep many product lines manual.
Consequently,
this decision impacts the bottom line as they struggle to meet key performance
indicators (KPIs) and goals.
Only 9% of the 57% that have an MES said they have the system fully
implemented across all sites and lines. The problem is product lines that are
still
paper-based are inefficient as they require more employees and time to complete
all the manual processes.
More than 90% cited that they don't have any digitized processes,
or they have significant gaps in the processes that are digitized.
Research Report
6
4.
Key Findings on Manufacturers’
Progress Toward Digitization
Going digital involves strategic planning. Here are the
stats on the respondents’ current digitization status:
01 02 03 04 05 06 07 08 09 01 00
Striving to increase
digitization in
manufacturing
Have a formal digital
transformation plan
in place
Taking an ad-hoc
approach or have no
digitization plans in
place as of this study
45%
55%
65%














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