Medical device manufacturing

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Chapter 2
Medical device manufacturing
Wai Yie Leong
1
The fourth industrial revolution, often known as Industry 4.0, is the source of
Quality 4.0. The first revolution began with the development of machine manu-
facture, steam power and the emigration of farmers to urban areas before the fourth
revolution [1,2]. Production was mechanised during the second industrial revolu-
tion, and the cost of consumer and industrial goods was reduced through mass
production. The third industrial revolution includes the introduction of electronics
and control systems, which helped reduce prices while increasing product com-
plexity and lowering expenses. New quality paradigms, methods and technologies
are being driven by the fourth industrial revolution of today (Figure 2.1).
There are many obstacles to designing and manufacturing safer products,
particularly in the medical device manufacturing industry. Regulatory requirements
are only one factor; if device companies want to stay competitive and use cutting-
edge technologies, including the Internet of Things (IoT), artificial intelligence
(AI), machine learning, augmented reality and even robotics, they must step up
their game and incorporate emerging and constantly evolving technologies
(Figure 2.2). These modern manufacturing technologies have come together to
form Quality 4.0.
2.1 Restructuring the market and industry
with technology
The third revolution, which connected the natural and physical worlds, marked the
beginning of the digital transformation, and version 4.0 is where it is now. This
fourth industrial revolution is powered by the influence of digital data, analytics,
connectivity, scalability and collaboration, which also inform Quality 4.0 plans.
The democratisation of technologies is bringing transformative capabilities in
analytics, material science and networking as we discover new ways to connect
people, devices and data. Such solutions enable a high-quality change of culture,
leadership, collaboration and standards for the medical device business.
1
The Institution of Engineering and Technology, Malaysia

Device designs, functionality, manufacturing procedures, supply chain
management, customer service and ways to keep quality systems compatible with
regulatory bodies such as the FDA and ISO are all being changed by Quality 4.0.
Intelligent and linked technologies are being used more and more frequently as
businesses look for a competitive edge to offer innovative items before their
rivals [3,4].
The four industrial revolutions
Industry 1.0
Mechanisation and the
introduction of steam
and water power
Mass production
assembly lines using
electrical power
Automated production,
computers, IT systems
and robotics
The smart factory
autonomous systems,
IoT, machine learning
Industry 2.0 Industry 3.0 Industry 4.0
Figure 2.1 The industry evolvement has changed the competitive landscape of
many industrial processes [1]
Autonomous
Robots
Simulation
Industry 4.0
System
Integratio
n
Internet of
Things
Big Data
Augmented
Reality
Additive
Manufacturing
Cloud
Computing Cybersecurity
Figure 2.2 Modern manufacturing technologies have come together to form
Quality 4.0
10 Medical equipment engineering design, manufacture, and applications

2.2 Digitalisation
By 2030, the medical device market is expected to reach $850 billion, according to
[5]. The global medical devices market was valued at US$550 billion in 2021 and is
expected to reach US$850 billion by 2030, poised to grow at a compound annual
growth rate (CAGR) of 5.5% during the forecast period 2022–2030 (Figure 2.3).
The state of healthcare is being improved through the development of smarter,
more automated, linked technology that enables remote procedures with medical
professionals from across the world. The success of medical device companies on
the market in the coming years will depend on their ability to utilise Quality 4.0
technologies. Quality 4.0, the use of Industry 4.0 technology to quality initiatives,
is seen by LNS Research as following in the footsteps of IoT. In fact, according to
industry experts, a quarter of medical device manufacturers use digital transfor-
mation technology to boost quality. The design and delivery of items are both done
using the same technologies. What does this signify for companies that make
medical devices?
To begin with, Quality 4.0 plans were developed with the aid of digital
transformation trends to do away with the need for various paper-based quality
management systems (QMSs) and procedures [5]. Eliminating manual systems
lowers errors, silos, hurdles to collaboration and traceability problems.
Additionally, small and international businesses may swiftly grow their design and
supply chain processes thanks to the digitisation and automation of production and
design processes (Figure 2.4). RefleXion Medical, a pioneer in biology-guided
radiation systems for the treatment of cancer, is one such business that was aware
of the need to build a fully linked QMS that could grow to support its route to
digital transformation and greater compliance. They needed a platform that was
MEDICAL DEVICES MARKET SIZE, 2021 TO 2030 (USD BILLION)
$550
2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
$577.26
$605.86
$635.89
$667.4
$700.48
$735.19
$771.63
$ 809.87
$850
Figure 2.3 Global medical devices market was valued at US$550 billion in 2021
and is expected to reach US$850 billion by 2030 [5]
Medical device manufacturing 11

Manual data scribing
and early computers.
Walk files through
the process. Filing
cabinets store docs.
PROCESS
1980 1990
MANUAL DATA eQMS CLOUD
2000 2010 2020
QUALITY 4.0
A PRODUCT-CENTRIC
QMS
QUALITY PRODUCT
MED DEV
EVOLUTION
Electronic docs
shared via email, fax,
and directories.
Physical reviews and
signatures required.
Product development
isolated in multiple
design tools.
Electronic docs in
early cloud solutions.
Majority of quality
systems are
doc-centric and
disconnected from
complete product
design stored in
relational databases.
Cloud-native
solutions. Connected,
digital quality and
product processes.
Closed-loop design
control.
Separate, distinct
products: mechanical,
drug,
electromechanical.
Electromechanical
devices with simple
software. Manual
monitoring and
calibration.
Sophisticated,
complex products
with onboard
technology and
data-share interfaces.
Connected, complex
products.
Crowd-sourcing data.
Artificial intelligence,
loT, augmented and
virtual reality. Digital
therapeutics.
A product-centric QMS solution
enables complete control and
traceability throughout the new
product development and
introduction (NPDI) process with
unified quality and product record
management.
Figure 2.4 Quality 4.0 for medical equipment manufacturing [6]

adaptable and could expand along with their workforce, their goods and their road
towards quality compliance.
2.3 Supply chain quality standards
Today’s medical device makers rely on distributed teams and supply chains,
including contract manufacturers, design partners and tier-based component sup-
pliers, to speed products to market. The particular advantages that digital trans-
formation technologies may bring to a device manufacturer’s product requirements,
product capabilities and regulatory compliance objectives are understood by busi-
nesses that have embraced new technology and cloud-based systems.
Digital treatments, medical diagnostic tools, implantable devices and dis-
posable devices are just a few examples of the large range of devices used in the
life sciences industry that aim to be error-free while delivering higher throughput
and preserving compliance.
2.4 Linking to connected teams
To satisfy the needs brought on by Quality 4.0 trends, a networked or more
product-centric QMS can be used. Quality teams need a unified system to spot
problems, handle audits and address quality incidents as product complexity rises
due to AI, IoT, robotics and associated 4.0 technologies. This makes sure that a
single system contains the entire, intricate product design, which consists of elec-
trical, mechanical and software components.
As teams communicate through each stage of new product development and
introduction, this foundation makes it possible to keep complete, integrated quality
and corrective action records. It also increases visibility and transparency.
More intelligence-driven product and quality process insights will provide
medical device companies a competitive edge. Better data-driven decisions and
cross-functional visibility with the supply chain, engineering and quality teams will
follow from this. Meeting stringent criteria for medical device compliance is made
more difficult by these Quality 4.0 transformative technologies:
●ISO quality system standards
(a) FDA 21 CFR Part 11
(b) Complaint Management and Corrective and Preventive Action (CAPA)
(c) ISO 13485
(d) FDA 21 CFR Part 820
●A product-centric QMS solution makes it possible to:
(a) Establish quality production processes to avoid audit issues
(b) Ensure traceable design and change controls
(c) Manage product bills of materials linked directly to quality records
(d) Encourage closed-loop quality and CAPA processes to accelerate resolution
(e) Boost quality compliance and supplier management processes
Medical device manufacturing 13

The final aspect of supplier management is crucial because the correct QMS
solution can integrate quality and product record management to provide total
control and traceability, streamline audits and lower risks.
2.5 Use cases by device manufacturers
Swan Valley Medical is a producer of surgical tools and add-ons used in the dis-
cipline of urology. They had to deal with ineffective paper-based manual processes
that exposed them to significant compliance risks since they lost important docu-
ments. When missing or incorrect information was discovered during audits,
recovery was challenging and could require hundreds of hours or even many
months.
Accelerated root cause analysis and risk management observation processes
were developed using a cloud-based product-centric QMS technology. Through
linked product and quality records, this made it possible for various processes to
communicate with one another, supporting audits with cross-linked evidence
chains.
Quality teams can identify, examine and fix problems with quality more
quickly with the aid of closed-loop CAPA processes. As an illustration, Pulse
Biosciences implemented a closed-loop quality system throughout their business.
With a product-centric QMS, all team members were able to collaborate on the
most recent product definition and quality records. Pulse Biosciences was able to
resolve important corrective actions quickly and with stronger audit trails because
to streamlined CAPA processes.
The first doctor-recommended and FDA-cleared smart thermometers are
available from Kinsa. To aid in the creation of the first-ever linked gadget for the
company, they established a product-centric QMS. Kinsa has revolutionised how
healthcare may be reimagined in an IoT world through connected technology to
speed up product development, enhance quality control and reduce the amount of
time it takes to resolve customer complaints.
2.6 Maintaining Quality 4.0
More intelligent devices are being delivered at a rapid clip. Newer technologies
such as IoT, AR and robotics are being used by both large, established medical
device businesses and smaller innovators in a race to enhance healthcare by linking
people and data and providing better outcomes to patients around the world.
Industry 4.0 innovations have influenced Quality 4.0 technologies and
approaches to enhance quality compliance. In order to compete in the modern
global economy, it is essential to be able to synchronise complicated product
development and quality processes. We can now execute surgeries and do healing
when patients and doctors are separated by various time zones thanks to clever
robotics and augmented reality technology. We can build products virtually with
remote teams.
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So, think about your objectives and constraints for developing and delivering
complicated products that adhere to standards set by the FDA and ISO. To safe-
guard your patients’ health as well as your revenue and long-term viability, be sure
you can provide a completely traceable, low-risk environment.
Smarter, linked tactics are needed to keep up with Quality 4.0 developments
and prevent your business from falling behind.
References
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2018].
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[5] Precedence Research. Medical Devices Market (By Type: Cardiovascular
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