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Camstar Medical Device Suite: The Class of the Industry for Medical Device Manufacturers

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Companies are moving faster than ever before.  Although product quality, regulation compliance, and risk mitigation are at the forefront of manufacturing, speed and innovation are becoming ever more important as companies seek to maintain pace with competition and customer demand.  These demands, when balanced with the need to contain cost, can be daunting for today’s medical device manufacturer. 

Introduction of a Manufacturing Execution System (MES) can ease these pain points, and CamstarTM Medical Device Suite is industry top-of-the-class.  Specifically, CamstarTM Medical Device Suite enables medical device and diagnostics manufactures the ability to meet the challenges of product quality and compliance – without sacrificing profit. 

CamstarTM Medical Device Suite creates a paperless manufacturing environment, enforces industry best practices and compliance, eliminates non-value-added activities, and creates a self-auditing electronic Device History Record (eDHR) and electronic batch record (eBR) – leading to a more efficient and effective production.  Specifically, Medical Device Suite can help manufacturers by offering the following benefits:

Reduced Cost and Risk of Compliance.  Medical Device Suite creates and electronic device history record (eDHR) and electronic batch record (eBR), thereby eliminating the cost of labor for manual creation, review, research etc. of a paper-based DHR.  In addition to the lowered cost, there is also a significant reduction in product quality issues and customer complaints. 

Increased Productivity and Profit Margin.  The CamstarTM Medical Device Suite eDHR and eBR enables operators to focus time on product production and quality rather than collecting data, reviewing documents, and completing paperwork.  In addition to a more-efficient manufacturing floor, costs are also reduced by elimination of paper, scrap reduction, and increased manufacturing velocity.

Enhanced Decision Making.  Because CamstarTM Medical Device Suite includes actionable intelligence from dashboards, preconfigured reports, and the collection and correlation of data, companies utilizing this MES gain significant knowledge regarding the entire manufacturing process – allowing for enhanced, accurate decision making.

Increased Throughput and Yield.  Real-time visibility of the entire manufacturing process and work in process (WIP) is a significant advantage of CamstarTM MES.  This visibility allows for better process enforcement and right-first-time production – leading to a reduction in scrap and rework.

Product and Process Traceability.  With CamstarTM Medical Device Suite, a product, lot or unit can be traced across the supply chain, factory, multiple factories, or entire enterprise.  Traceability data includes forwards and backwards genealogy of materials consumed, processes and equipment utilized, exceptions, rework, signatures, and more. 

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.  CamstarTM Medical Device Suite is by far the most widely used and well-known MES in the industry.  It allows an organization to improve its competitive position, ensure compliance, and reduce product risks – all while significantly lowering costs.  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. In addition to the many benefits, the ease of implementation is often easier than expected, regardless of the size of implementation.

As a leader in the industry, CamstarTM is very small-business friendly and serves a large customer base with great success! Details and much more information will be presented in a webinar hosted by Seabrook Technology Group and Siemens on Thursday, June 20 from 11:15 a.m.-12:00 p.m. EST.  Register for this FREE WEBINAR by visiting https://www.eventbrite.com/e/paperless-manufacturing-webinar-tickets-61428515343

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]

Camstar Medical Device Suite: Top of the Class in Paperless Manufacturing

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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.

See why Camstar Medical Device Suite is the choice for Medical Device Manufacturers throughout the world.

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.

Paperless Manufacturing: Your End-To-End Solution

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As small-to-medium medical device and biotech manufacturers are aware, the outdated paper-based manufacturing process is time-consuming, inefficient, and costly.  Stepping into the paperless revolution creates a more secure and more accurate process – while leading to greater revenues. There are several advantages to MES implementation, including
1. the elimination of the need for paper and paper storage (saving literally thousands of dollars)
2. full traceability of the manufacturing process in an electronic format
3. inherently less review time, as the MES tracks and reviews processes
4. quick analysis and characterization of the manufacturing process

Implementation of a paperless Manufacturing Execution System is at the heart of an efficient end-to-end manufacturing process.  Think of the MES as a system of authority for how a product is manufactured – as it works in alliance with Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM).  Implementation of MES is an outstanding opportunity for small to medium sized manufacturers to increase effectiveness and efficiency. 

Look for an important FREE webinar for Medical Device Manufacturers coming in June! Learn about the importance and benefits (and ease) of paperless manufacturing implementation and maintenance! Stay tuned for details! Can’t wait? Contact us any time at [email protected] or +353 21 4800 840!

Two Years Later, and The Urgency is Even Greater

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In July of 2017, then-Executive Director of Seabrook Technology Group, Sean O’Sullivan, published a piece in MedTech Intelligence spotlighting the need for Medical Device Manufacturers to transform their production to paperless manufacturing (MedTech Intelligence, July 5, 2017). 

Two years later, the urgency has increased greatly for companies to manufacture products in a paperless environment, as they realize that digitization is key to transforming their enterprise to meet the demands of Industry 4.0.  Transformation to Industry 4.0 won’t be easy, as pain points exist – including quality control, cost, data management, complex production pressures, and compliance. With the ever-growing complexity of medical devices and the evolution of digitalization, manufacturers need to embrace these changes, or they will find themselves left behind as their competitors continue to make strides.

Let’s revisit the benefits of transformation to a paperless environment, as discussed by Mr. O’Sullivan:

Paperless Manufacturing: Five Key Benefits for Medical Device Manufacturers (originally published 7.5.2017;  summary; edited).

MES is a digital production management system that enables integration and communication of real-time data from the inception of the product all the way through the manufacturing process. It also systematically enforces your device manufacturing requirements at the point of use to immediately detect defects and prevent errors.

The following are five quantifiable benefits for medical device manufacturers who make the switch to paperless.

1. Improved Quality Control

Increased data collection and process automation greatly improves full product traceability.

Real-time product traceability information provided by digital display can prevent a product recall by quickly isolating a bad batch or device. In addition, paperless manufacturing can facilitate a fast response to any issue that arises. A fast response rate is key to reducing the amount of product lost, keeping recalls at a minimum.

2. Reduction in Costs

The primary benefit of paperless manufacturing is the significant reduction in operational costs. Eliminating the need for a paper trail, the software can lead to marked reductions in paperwork costs and the time needed to complete them. In a recent post-MES assessment undertaken for a cardiac resuscitation device client, we found that there was an annual reduction of $88,000 in paperwork management as well as an annual drop of $32,600 in paper costs, storage and boxing costs.

In addition, when all the maintenance, planning and production processes within paper-based systems are streamlined or eliminated, staff can be freed up from the operating line. Our report also showed that in one year, the same company saved $6,000 in operator training.

3. Enhanced Productivity

Paperless manufacturing systems record real-time data and share it with all relevant departments. This data can then be examined. If any steps in the manufacturing process are unprofitable or inefficient, measures can then be taken to improve productivity.

For example, the assessment at a cardiac resuscitation company revealed a 6% increase in productivity in one year. In simple terms, these systems allow for the right information to be viewed by the right people, at the right time. This data collection can also reduce human error, reducing the time and money spent correcting these mistakes.

4. Fostering Manufacturing Excellence

Paperless systems facilitate improved collaboration, creating a platform for employees across functions and departments to access and work with real-time data, with the ability to edit, revise and share ideas. Employees also benefit from having access to accurate and up-to-date information, allowing them to effectively respond to customer demands and material shortages.

Considering the amount of paper that can pile up between orders, schedules and reports as well as their subsequent disposal, eliminating unnecessary paper can improve an organization and increase team morale. Moving to a digital system also allows for remote access to documents, creating new opportunities for a global workforce.

5. Enforcement of Regulatory Compliance

By facilitating accurate and easily accessible documentation of both actions and results, paperless manufacturing enforces compliance with standard procedures and regulations.

Paperless manufacturing provides full traceability throughout the manufacturing process while the enhanced reporting capabilities increase responsiveness in providing critical information during audits. It also makes it virtually impossible to lose track of a document and enforces systematic capture and management of abnormal events. As regulations evolve, a paperless system can be easily updated to meet any new requirements.

With constantly changing regulations and growing device complexity, medical device manufacturers need systems such as MES to ensure quality and compliance. Companies that introduce paperless manufacturing have fewer non-conformance issues, increased efficiency and more consistent product quality, allowing them to focus on innovation and improving the end-user experience.

Let’s talk about the benefits of paperless manufacturing!

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 skill sets to their work.  Seabrook Technology Group is a global, privately held company which was founded in 1989.   ​

Let’s Talk!

We offer expert products and services for medical device manufacturers.  Let us help you experience the benefits of paperless manufacturing.  Please contact us at:

IRELAND OFFICE (HQ):  Mainline Place, Sarsfield Rd., Wilton, Cork, T12 DY80, Ireland 

Tel: +353 21 4800 840 | [email protected]

End-to-End Manufacturing Solutions for Medical Device Manufacturers: Camstar Medical Device Suite

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The 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. 

Manufacturing, 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, and include:

  • 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, and when”). 

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 manufacturing processes.

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.

As a leader in the industry, CamstarTM is very small-business friendly and serves a large customer base with great success! Details and much more information will be presented in a 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 https://www.eventbrite.com/e/camstar-mes-for-medical-device-manufacturers-tickets-55155024162

FREE WEBINAR: Camstar MES for SMB Medical Device Manufacturers
DATE:  Wednesday, April 10 2019 / 11:30 a.m.-12:15 p.m. EST

Questions about Camstar MES or the FREE webinar? Simply email us: [email protected]