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WHITEPAPER 1:
Enabling Closed-Loop Manufacturing in the Medical Device Industry
WHITEPAPER 2:
Enterprise Intelligence that Drives Operational Excellence
WHITEPAPER 3:
Paperless Manufacturing in achieving Operational Excellence through a Smart Factory
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Enabling Closed-Loop Manufacturing in the Medical Device Industry

Siemens presents a whitepaper on the benefits of implementing closed loop manufacturing into the Medical Device and Diagnostic Industry.  As a Siemens technology sales partner, Seabrook Technology Group improves customer business processes and manufacturing efficiency by sharing knowledge and supporting operational excellence. Our focus is on the use of modern technology and software for business optimization. This whitepaper is of relevance to those in medical device manufacturing.

Abstract

“The changing healthcare landscape poses enormous pressure for medical device manufacturers. While they already operate in a complex, highly regulated industry, market dynamics are driving the need for innovation at consistently high quality and controlled cost levels.

In this environment, it is clear that the underlying internal development and manufacturing processes and systems also must innovate.   

The foundation of manufacturing in this new era must be anchored in intelligent, connected, collaborative systems that accelerate the exchange of information across the entire product lifecycle, driving quality, safety and reliability from idea inception through production and into service, and continuously feeding back relevant intelligence to optimize quality in real time at every step. (Manufacturing Execution Systems and Closed-Loop Manufacturing in Medical Device.  ©2019 Siemens Product Lifecycle Management Software Inc.)

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Enterprise Intelligence that Drives Operational Excellence

Seabrook Technology Group’s former COO and MES expert, John Enterprise Intelligence: What it is and Why do you need itDzelme, has written an insightful whitepaper into Enterprise Intelligence and how it drives Operational Excellence. John has vast experience in Manufacturing Systems including MES implementations and Solution Designer for extensions to the InSite MES platform by Camstar (aka Camstar Manufacturing). He has managed development projects and lead a development team from Scope, through validation, to implementation and user training. John also has a very strong LEAN and Medical Device Manufacturing background.

Abstract

“There is so much discussion in the industry about Big Data at this moment in time. Some of it is  myth and hype, and some are real examples of how data can be used to add value to an organization. This whitepaper provides some insight into how organizational data can be used to not only provide value but return huge savings to an organization. Big Data is about turning data into value that organizations can use to lower the costs of goods sold and to improve and optimize processes so they can ultimately save money, provide a better product in the right  quantity, and at the right level of quality to a consumer that is willing to pay for it.”

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Paperless Manufacturing Required to Achieve Operational Excellence Through a Smart Factory

Seabrook Technology Group presents a whitepaper on the topic of ‘The Requirement for Paperless Manufacturing in Achieving Operational Excellence through a Smart Factory’. Seabrook Technology Group improves customer business processes by imparting knowledge and excellence. Our focus is on the use of modern technology and software for business optimization. This whitepaper is of relevance to those in the medical device manufacturing

Abstract

“Additional standards, regulation and greater levels of competitiveness are changing the medical device manufacturing industry.  Further industry drivers include demand for electronic medical records for collaboration and improved patient care. Medical Devices/Equipment is one of the most highly regulated industries, requiring intensive reporting to support internal and external reporting requirements. Medical device manufacturers have reported the changing regulatory environment as the biggest challenge facing them today (Emergo, 2017).  In 2017, 61% (up from 35%) of respondents in Europe and 36% (up from 30%) of respondents in the U.S. felt that the current process of obtaining regulatory approval for a medical device as more difficult (Schorre, 2017). Medical device companies continue to look for cost efficient methods to ‘navigate the increased regulatory burden’ (Hughes and Valyko, 2012).  Increasingly stringent standards place a requirement on medical device manufacturers to produce more detailed labeling, dating, use-by dates, sourcing, detailed manufacturing records and accountability. Industry discussion forms on overcoming these challenges through the investment in an Industry 4.0 centre, otherwise know as a ‘Factory of the Future’ or ‘Smart Factory’.

At present, many medical device manufacturer floors are paper-driven. This operation simply cannot compete efficiently and effectively whilst in compliance with new regulation. In fact, publications have shown that paper-driven processes increase costs, introduce errors and thus contribute to compliance issues. Applied in industry, 75.9% of medical device companies reported business risks due to inefficient paper-based document driven processes (Oeters, 2013). Further studies on the topic by the Association for Information and Image Management (AIIM) found the true cost of paper-based manufacturing on the floor line to be ‘$20 in labor to file a document, $120 in labour to find a misfiled document and $220 in labour to reproduce a lost document’ (Oracle, 2009).

The following paper will look to explore how going paperless in a manufacturing process for a medical device manufacturer can lead to operation excellence through the implementation and investment in a factory of the future.”

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