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 By eliminating an outdated paper-based system and implementing Siemens Opcenter Execution, companies soon realize the benefits of a fully electronic, self-auditing MES that streamlines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
Seabrook Technology Group will be on site at the 2019 Med in Ireland event. Visit us in the Exhibitor Area as we showcase the latest in manufacturing technology for medical device manufacturers! Innovation in healthcare and manufacturing will be the focus as you network with innovative Irish medtech companies that are transforming the future of the industry. More information can be found at https://medinireland.ie/
Digitalization is changing 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 this video, Camstar Medical Device Suite is the MES of choice for Medical Device Manufacturers. By eliminating an outdated paper-based system and implementing Camstar Medical Device Suite, companies soon realize the benefits of a fully electronic, self-auditing MES that streamlines the process, reduces cost and enforces product quality and compliance.
Learn Camstar details and gain greater knowledge about paperless manufacturing solutions by attending an upcoming webinar hosted by Seabrook Technology Group on Thursday, June 20, 2019 from 11:15 a.m.-12:00 p.m. EST. Register for this FREE WEBINAR by visiting this link.
manufacturing industry is often regarded as one at the forefront of technology
adoption. There are many manufacturers,
however, who continue to rely on a paper-driven process. This is especially prevalent in the small-to-medium
medical device and biotech manufacturing industries.
by nature, is a process-centric industry, so the transformation from
paper-driven processes to paperless can seem daunting, but the
benefits of incorporating a Manufacturing Execution System (MES) are numerous,
The elimination of the need for paper, saving endless time and financial resources
Full traceability of the process in an electronic format
Inherently less review time, as the MES is self-auditing
Quick analysis and characterization of the manufacturing process
Implementation of a paperless
Manufacturing Execution System allows the operators to focus on the quality of
the product and process – not on the paperwork.
An implemented MES enforces that the product is manufactured per the
Device Master Record (DMR) and captures the actual manufacturing history
regarding material consumption and production detail records (the “who, what,
Exploring further, as MES is an end-to-end software manufacturing
solution, what additional benefits are there to implementing this system into
your shop floor? How else can
decision-makers justify MES adoption and implementation? Although the following may not be at the top
of an organization’s priority list now, these additional features/benefits of
MES implementation will pay dividends in the future, and include:
NCR Execution Management and Defect Tracking. Because MES is directly on the shop floor, there is no better system to track defects and prevent mistakes in your production process. Additionally, MES will automatically stop production if defects are discovered so that the error/defect doesn’t continue to be passed through the manufacturing process.
Enforcing Procedures and Quality Specifications in Real Time. One of the worst things a manufacturer can do is pass defects down the line. This causes major issues in production, resource management, and public (and B2B) image – especially if the defect or error is passed on to the customer.
Systematic Go/No-Go. Systematic Go/No-Go can be applied to MES, which allows for the discovery of defects, procedure enforcement and immediate staff operator notification if error occurs. Because of this systematic go/no-go, ambiguity is removed from the manufacturing process.
Close Gap Between Detection Point and Point of Failure. If there are defects in the process, MES detection minimizes the cost and resource loss of the defect.
Controlled Rework Process Flows. When defects occur, they are often salvageable – with the correct re-work. Implementation of the MES system adds structure and control when a rework is required.
Adding Statistical Processing Control. For process monitoring and/or characterization, an SPC can be added to the MES system.
Utilizing MES data for metrics and root cause analysis for failures – or to drive perfect quality.
Exploring paperless manufacturing is
an opportunity for small-to-medium manufacturers to increase their competitive
advantages. Stepping into the paperless revolution creates a more secure and more
accurate process, while leading
the way to greater revenues.
In partnership with Siemens, we at
Seabrook recommend utilization and implementation of the CamstarTM
Medical Device Suite. Camstar™ Medical
Device Suite is a leading solution in the medical device and diagnostics
industry. Known for error-proofing
processes, paperless manufacturing and the creation of eDHR (Device History
Records) and eBR (Batch Records), CamstarTM Medical Device Suite has
a proven track record of helping companies excel in achieving their goals. CamstarTM Medical Device Suite
helps companies to accelerate innovation, reduce cost, and achieve the highest
quality products – all while making compliance a by-product of the excellent
It has been our experience that
companies that utilize the CamstarTM Medical Device Suite can
quickly realize significant reduction in paper cost, cycle times,
manufacturing-related complaints, scrap, and product review and release time.