Medical Devices | Page 2 of 2 | Seabrook Technology Group

Medical Devices | Page 2 of 2 | Seabrook Technology Group

Camstar Suite: The Modern MES Choice for Medical Device Manufacturers

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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 By eliminating an outdated paper-based system and implementing Camstar Medical Device Suite, companies soon realize the benefits of a fully electronic, self-auditing MES that streamlines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.

Find this information helpful? Learn details and much more information by attending an upcoming webinar hosted by Seabrook Technology Group and Siemens on Wednesday, April 10 2019 from 11:30 a.m.-12:15 p.m. EST.  Register for this FREE WEBINAR by visiting the link below.

Please join us for this free webinar!

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.   ​

IRELAND OFFICE (HQ):  Mainline Place, Sarsfield Rd., Wilton, Cork, T12 DY80, Ireland  
Tel: +353 21 4800 840 | [email protected]

INDIANA OFFICE: 600 Corporation Drive, Suite # 108, Pendleton, Indiana 46064, USA
Tel: +1 317 426 0699 | [email protected]


John Dzelme Article MES

Seabrook COO John Dzelme writes guest blog for Med Tech Intelligence

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Seabrook’s Global Chief Operating Officer John Dzelme has written a highly informative guest blog on why medical device manufacturers can’t ignore Industry 4.0 for the popular website Med Tech Intelligence.

John Dzelme, who is an internationally recognized expert in MES and lean manufacturing, discusses how advanced software, technology and manufacturing processes will help companies stay competitive in this new era of the global ‘smart’ or ‘digital’ factory.

He describes the four ways Industry 4.0 will impact medical device manufacturing from how the the Internet of Things will be central to why manufacturing processes must support Cyber-Physical Systems.

You can read the full article here.

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PLM and medical device manufacturing in the age of the Digital Factory.

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From advanced robots that can repair roadways and fight fires to 3D printers that can create muscle and bone, modern day smart innovations all have one inescapable force behind them – digitisation. The era of digitisation is already upon us and will only continue to evolve and encompass all aspects and all sectors of manufacturing.

The age of digitisation, also known as Industry 4.0, is the single biggest challenge facing manufacturers. And with smart manufacturing transforming what we produce, we need to transform how we produce to stay on the cutting edge.

This is where the concept of the Digital Factory applies. Put simply, the digital factory is when a digital twin or copy of real production is simulated – and shows the production process in a virtual way. It is especially important for the planning and optimisation of the manufacture of complex products, such as medical devices.

At our upcoming information roadshow on Industry 4.0 for medical device companies, experts from Seabrook Technology Group and Siemens will discuss and showcase the advanced technologies necessary to keep pace with digitisation. In this blog, we will examine the advanced technologies in Product Lifecycle Management (PLM) and the huge role it will play in the transition to digitisation.

PLM is so much more than a piece of software or a technology, it is also a strategic operations process that will ensure sustained manufacturing excellence into the future. PLM facilitates compliance enforcement, enables greater innovation – therefore enhancing product quality, reduces time to market and allows for continuous improvement.

At the very core of PLM is its ability to simulate a digital copy of the end product in which individual components can be inserted in different configurations and thoroughly tested. This is possible along the entire development chain, before a single piece of the product is ever produced. This process is especially significant for the medical device manufacturing sector, where reconfigurations and iterations of a product cost both valuable time and money.

An example is the progress and innovation in the global production of orthopaedic medical devices by the Wright Medical Technology Group. Using PLM Teamcenter®, Wright has been able to come up with less painful and less invasive ways of repairing fractures and other orthopaedic ailments. It has designed and manufactured hip and knee joint implants as well as implants for hands, shoulders, feet and ankles. PLM has allowed for collaboration between all teams in quality, engineering and manufacturing, as well as with the necessary surgeons and medical professionals who could look at virtual 3D models of the device and give instant feedback. With the easy accessibility of the most up-to-date data, PLM Teamcenter also resulted in reducing time to market and cutting delays with FDA compliance and regulations for Wright, who has increased its market share since adopting the technology.

Using PLM to connect the real with the virtual world of production makes it possible to enter entirely new dimensions in quality, efficiency and flexibility.  It’s clear that organisations that adopt these technologies now in order to transition to the Digital Factory, will lead the way in the future.

For more information, or to secure your place at Seabrook’s Preparing for Industry 4.0 roadshow, see www.seabrookglobal.com/preparing-for-industry-4-0

Manufacturing Execution Systems

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Manufacturing Execution Systems

Partnered with Siemens, Seabrook is a valued added reseller of the Camstar Medical Device Suite and has been a Camstar partner since 2006.

10 years on Camstar Medical Device Suite is still a leading solution in the medical device and diagnostics industry for error-proofing processes, paperless manufacturing and electronic device history records (eDHR). Emerging, midsize and global medical device and diagnostics organizations are faced with the challenge of balancing cost reductions and regulatory compliance while consistently producing high-quality products. Camstar Medical Device Suite has a proven track record of helping medical device and diagnostics companies excel in the face of these challenges.

Providing a powerful and flexible tool Camstar Medical Device Suite is a unique configuration of Camstar Enterprise platform. By effectively addressing the full range of business challenges that the industry faces, Camstar Medical Device Suite helps manufacturers become better, faster and cheaper. It does this by enabling you to build quality into the manufacturing process instead of testing quality coming out of the process, a mistake that often occurs in the manufacturing sector. Camstar Medical Device Suite has been deployed with powerful results in a variety of medical device product segments, such as diagnostics, orthopedics, cardiovascular, hospital and wound care, diabetes care, renal, blood care, vision and imaging. The solution is highly functional and flexible and provides an excellent user experience.

Benefits

  1. Proactively build quality into the manufacturing process
  2. Identify, analyze, solve and prevent problems while production continues
  3. Provide visibility into the performance of components, tests, etc.
  4. Enable you to understand fatigue impact, manual operation failure rates and time to ramp to quality
  5. Close the loop on continuous improvement initiatives
  6. Define, distribute and enforce process and engineering changes to any global factory

Quantifiable Value:

  1. $3.7M Recurring in Cost Reductions
  2. $1.6M (one-time) Inventory Reduction
  3. 5%-10% Yield Improvements
  4. 35% Increase in thruput (10k units)

Strategic Value:

  1. 100% reduction in Op Training Errors
  2. 75% Reduction in Field Actions
  3. 64% Reduction in Prod Inquiry Reports
  4. Enforced DFT Lowering Inventory/Lead Time

Key Values:

Paperless manufacturing

Replace manual paper manufacturing processes with proactive manufacturing execution that streamlines the process, delivering cost reductions and improved quality and compliance. The result is a complete electronic audit trail of all manufacturing activity and an electronic device history record. There is no paper, printing, moving or storage.

Automated enforcement and control Collect information and enforce business rules to achieve error-proof processes. Ensure the right procedures, operators, equipment and materials are used within specification and in the right sequence. Move to a review by exception product release process as a result of an automated self-auditing electronic device history record.

Lean and Six Sigma enablement

Lean and Six-Sigma initiatives are driven by data to establish a baseline, identify improvements, analyze results and control processes. Camstar Medical Device Suite provides the foundation by enabling you to collect integrated product, process and quality data in a structured electronic format in a matter of seconds. You can make your processes mistake proof with systemic enforcement to ensure control, closing the loop on continuous improvement initiatives.

Global process data management

Define, distribute and enforce process and engineering changes to any global factory. Complete audit trails make it possible to understand the impact of engineering change orders (ECOs) and the effectivity of corrective and preventive actions. Intelligent root cause analysis enables you to discover the true source of the problem by leveraging a growing knowledge base of granular product design, process design, manufacturing (as-built and inspection), field use and quality event data.

Containment management and forward/backward traceability

Use configurable searches such as where used analysis to identify suspect at-risk material based on unique criteria, such as a component lot, machine, operator, a specific shift, etc. Configure dynamic actions based on your business rules, then take quick action, such as hold, rework, material review board (MRB), quarantine, etc. All products, components and supplied materials are completely traceable.