The role of best-in-class and integrated manufacturing operations management solutions for Medical Device Manufacturers
With the questions of whether and when to begin implementing manufacturing digitalization already substantially answered – yes and now – both big and small medical technology companies must navigate the question of how their digital evolution will take place.
Attend this webinar to discover the role of best-in-class and integrated software solutions for manufacturing operations management, and explore the key benefits they generate for medical device and diagnostics firms.
Enabling Closed-Loop Manufacturing in Medical Device and Diagnostic
changing healthcare landscape poses enormous pressure for medical device
manufacturers. The industry is – in itself – highly complex and highly
regulated. Combine these with market
dynamics such as an aging global population, drastic increases in chronic
diseases, healthcare reimbursement issues, and evolving patient expectations, and
it becomes obvious that Medical Device manufacturers must operate with great
quality, controlled cost, and high levels of innovation.
The foundation of innovation in the new Medical Device and Diagnostic era must be anchored in intelligent, connected, collaborative systems that accelerate the exchange of information across the entire product lifecycle.
The link below connects to a Siemens whitepaper designed to explore the process and systems innovation that is inevitable for medical device manufacturers ― Closed-Loop Manufacturing. At the heart of the digital enterprise is this closed-loop manufacturing (CLM), which synchronizes and optimizes product quality and production efficiency across design, engineering and execution.
Change. Transitive Verb. a: to make different in some particular : ALTER b: to make radically different : TRANSFORM c: to give a different position, course, or direction to
Change. It’s inevitable. As digitalization has arrived in most industries, it is changing almost everything. This evolution is seen throughout the manufacturing industry, and nowhere is it more vital than in the Medical Device Manufacturing field. As seen in the video below, Siemens Opcenter Execution Medical Device & Diagnostics (formerly Camstar Medical Device Suite) is the MES of choice for Medical Device Manufacturers looking to keep pace with change in the industry. By eliminating an outdated paper-based system and implementing Siemens Opcenter Execution, companies soon realize the benefits of a fully electronic, self-auditing MES that streamlines the process, reduces cost and enforces product quality and compliance.
Siemens MDD has been deployed with impressive results in a
variety of medical device product segments, and the solution is highly function
and flexible – and provides the most advanced and intuitive user experience in
Questions? As the most experienced MES implementation partner in Medical Device Manufacturing, Seabrook Technology Group offers thirty years of expertise. We believe that MES and cloud-based MES are vital to the success of medical device manufacturers. We have recently been recognized by CIO Review as a Top Ten Manufacturing Technology Solution Provider, and our team of experts seeks to come alongside manufacturers to provide the best solutions in the industry.
Our MES Services include Readiness Assessment, Implementation Assessment and Support, Integration, Deployment Services, Upgrades, and more! We are honored to utilize our expertise to serve a wide variety of medical device companies, including Cardinal Health, Carl Zeiss, Cepheid, Cook Medical, Illumina, LivaNova, Stryker, Terumo, ThermoFisher Scientific, Zimmer Biomet and Zoll Medical.
Embrace change! We would be honored to serve you as you look to make this transition to paperless manufacturing. For more details, email Ian Foley, Director of Global Sales and Marketing, [email protected] You may also view details at www.seabrookglobal.com
manufacturing industry continues to evolve toward the fourth generation of the industrial
revolution. Industry 4.0 has arrived for
those at the leading edge of manufacturing, as terms such as “Integration,
Automation, Real-Time Data, Smart Factories, AI, and Digital Enterprise,” are
becoming commonplace in manufacturing articles, websites, and boardrooms throughout
this revolution continues to evolve (a Revolution Evolution, if you will), it
is expected that Medical Device Manufacturers will be a highly involved force
for change. For any medical device organization still manufacturing and
processing with paper, it may be time (actually it IS time) to consider jumping
into the wave of digital transformation.
deserves credit for modernizing the sharing of information throughout the ages.
Paper in the modern factory, however, is quickly becoming obsolete. If an
organization still utilizes paper as the primary driver of their processes,
they have certainly experienced several pain points, including security issues,
labor inefficiencies, regulatory challenges, and the extreme cost of paper
purchase, use, and storage. On the digital side of manufacturing, paperless
environments created through the implementation of a Manufacturing Execution
System (MES) realize a high level of return on investment (ROI) through improved
regulatory compliance, better agility and time to market, improved supply chain
visibility, reduced manufacturing cycle time, elimination of paperwork and
manual data-entry processes, reduced order lead time, lowered labor costs, reduced
work-in-progress (WIP) inventory, and increased machine utilization. All of these factors lead to greater
According to a Patricia
Panchak, MESA1 contributing writer and independent tech journalist, “As
real-time data collection, integration, and analysis continue to become more
critical to manufacturing business success, MES continues to evolve to address
the challenge – and to become more integral to an overall smart manufacturing
transformation. Put simply: MES has become a foundational element of smart
manufacturing, [and] any company cannot create its digital thread or complete
its smart manufacturing transformation without it.”2.
As MES (Manufacturing
Execution System) implementation is the foundational element to smart factory
transition, it’s important to look at the four stages of system implementation. Before we do so, however, it is important to
note that Seabrook Technology Group looks holistically at the digital
manufacturing enterprise, regardless of the phase of the MES transformation
journey. We believe that people, processes
and technology formulate the tenets of any digital transformation. We focus on the continuous coordination and
alignment of these tenets to ensure the enablement of operations excellence and
strategic transformation for our manufacturing partners (in other words,
without the proper processes and people in place, the technology
alone will not provide the solution sought by the manufacturer).
FOUR STEPS TO MES
MES IDEATION. In this phase, the MES vision formation occurs. The transforming organization must answer the following questions: “Is MES right for us? Is our business ready? Are our people ready? Where do we start?” This phase is critical to the long-term success of any MES transformation, and includes:
Business Process Review and Readiness Analysis
People Readiness (executive approval, stakeholders, etc.)
Technology Readiness (IT landscape and system review)
Transformation Readiness (business case, ROI analysis, manufacturing mapping)
MES DEFINITION. In this phase, the MES begins to be realized. An organization has formulated it’s MES transformation strategy and has the desire and goal of implementing the MES. Key elements to a successful implementation include:
Alignment of manufacturing and supply chain processes
MES DELIVERY. In this phase, the MES will be implemented, and the organization will begin to realize the benefits of MES. Specific steps include:
Implementation and rollout strategy for product lines, areas, and factories
Design, configuration, development, and deployment of MES
Change management and training
Additionally, during the MES DELIVERY, solution tools can include: Business Process Analysis, People Process
Analysis, Technology Analysis, and Transformation Analysis
MES OPERATION. In this phase, the MES has been implemented and is in “maintenance” mode. Don’t be fooled, however, as “maintenance” is an active term when used here. MES transition can never be implemented as “status quo.” It is important to understand that complete MES transformation and utilization is never fully complete, as it is not a project with a fixed project timeline, discrete set of deliverables and ultimate completion. MES transition and operation is a constantly-evolving, ongoing journey that includes:
Building and improving governance and organization best practices
KPI monitoring and refinement
As with the MES Delivery phase, solution tools can include
Operations Management in the areas of Business, People, Technology, and
Transformation. Examples of these tools
would be continuous improvement analysis, future site readiness, managed
services, KPI reporting and monitoring, and system roadmap reviews.
Implementation is an exciting process for the transforming factory that
embraces the future of manufacturing.
Transition – as with any change – can also cause feelings of anxiety and
trepidation. However, our experience has
been that companies utilizing MES quickly realize that the benefits outweigh
the potential challenges. As it can be
daunting to undertake such a transformation, it is recommended that any manufacturing
entity considering such transition find a caring and dedicated solution
provider to solve pain points and assist with MES implementation. For more information on MES Implementation
Strategy and Solutions, please visit the “Services” tab at www.seabrookglobal.com. Best of luck to those who
are beginning this MES journey – welcome to the evolution!
Questions about transforming your manufacturing to a digital
environment? Let Seabrook help! Seabrook
Technology Group celebrates its 30th year in 2019! Consisting of a team of global experts and
industry thought leaders, Seabrook brings end-to-end manufacturing solutions
(people, processes, technology) together in a harmonized fashion to enable
operational excellence for medical device manufacturers. Our team consists of MESA Certified
Consultants, a CamstarTM Certified Team, APICS, CPIM Certified
Consultants, PMP Certified Consultants, and FDA Regulation Experts. Our entire team brings their passion for
Integration, Manufacturing Intelligence and DHR Requirements skillsets to their
work. Seabrook Technology Group is a
global, privately held company which was founded in 1989.
INDIANA OFFICE: 600 Corporation Drive, Suite # 108, Pendleton, Indiana 46064, USA Tel: +1 317 426 0699 | [email protected]
References and Resources:
MESA (Manufacturing Enterprise Solutions Association) International is a global community of manufacturers, producers, industry leaders, and solution providers who are focused on driving business results from manufacturing information.
The State of MES in the Age of Smart Manufacturing. MES is Now (or Should Be) Viewed as a Foundational Enabler of Manufacturing’s Digital Transformation.” Patricia Panchak. In-Tech Magazine. www.isa.org/intech/20180805. July-Aug 2018.