March 2016 | Seabrook Technology Group

Monthly: March 2016

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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

MESA

MESA, ISA & Seabrook

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Seabrook was delighted to meet with representatives of the Manufacturing Enterprise Solutions Association at the ISA’s first Food and Pharmaceutical Symposium to be held in Ireland. It was a great opportunity for us to catch up with MESA representatives and to discuss all that they have been doing in Ireland. We have always been extremely proud of our association with the organisation.

Desmond Savage gave a highly informative presentation on MESA during the food segment of the conference which was held at the Rochestown Park Hotel in Seabrook’s native Cork. The President of the ISA Ireland chapter, Alan Bateman, also recognised MESA’s support during his address to delegates. Pictured in the above photo taken at event are, from left to right, Ian Foley of Seabrook along with Wayne Bursey, Siemens, Peter Cullen, Rockwell Automation, Desmond Savage, ATS, and Andrew Daly, VisionID of the Ireland Special Interest Group.

MESA has some exciting events taking place over the next couple of weeks, including the Second International Virtual Internet of Things Conference in April and the Automation Conference and Expo in May. For a full list of MESA’s events, see http://www.mesa.org/en/newsevents/NewsEvents.asp

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4 ways PLM will enhance medical device manufacturing

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Now more than ever before, there are a myriad of challenges facing the life sciences sector. With consumer medical devices beginning to dominate the market, and therefore consumer demands becoming more complex, increasingly stringent regulatory compliance is being insisted on, as well as a near flawless level of product quality. Failure to comply with regulations can be catastrophic, while a reputation for anything less that ‘safety-critical’ quality is equally damaging.

It’s estimated that the wearable medical devices market will exceed $10 billion by as soon as 2017, so now is the time that those who want to stay in the game should seriously contemplate adopting new technologies to remain relevant and competitive.

Some of the key challenges in medical device manufacturing at the moment are:

  • Industry 4.0
  • Regulatory Compliance
  • Cutting Costs

Advanced technologies like Product Lifecycle Management (PLM) Systems facilitate meaningful, result-driven progress towards meeting these challenges. In our upcoming Seabrook roadshow ‘Preparing for Industry 4.0’ we will focus on the key benefits of PLM for the life sciences sector, and the role it plays in the digital factory.

Below is a sneak peek of some of the ways we will demonstrate how PLM will enhance medical device manufacturing, using as a guide the benefits of a global leading PLM system, Siemen’s Teamcenter®.

  • Keeping pace with Industry 4.0. With Teamcenter data can be viewed and exchanged across all components of the business – from research, development and design on the office floor to production on the shop floor. PLM facilitates the communication between the product and the machine and vice versa, with all information accessible at all times to all members of the team. And that is one of the central targets of Industry 4.0. Engineers can conceive of a design, simulate it and send the virtual version to the shop floor where production is in turn simulated – meaning all flaws and issues are ironed out before actual production ever starts. Connecting the real with the virtual world of production is making it possible to enter entirely new dimensions in quality, efficiency and flexibility. In fact, in Siemens own factory in Amberg, Germany where Teamcenter is used, the automated processes have resulted in the number of errors dropping massively from 500 per one million actions, to just 11.
  • End-to-end compliance. Teamcenter PLM features a robust set of compliance management, traceability and reporting capabilities. The system plays an important role in helping medical device companies significantly reduce the time it takes to prove compliance with regulations, such as those of the FDA’s. It tracks all product data connected to product development. By integrating this compliance management into the overall lifecycle management of the product, Teamcenter PLM virtually reduces manual data entry, improves data accuracy and reduces costs associated with compliance and non-compliance.
  • Cutting production costs by reducing design revisions. Teamcenter enables the management and sharing of cross-domain design information, including mechanical, electronics, software and simulation in a single environment. Clear visual feedback allows for faster clearance analysis. The comprehensive system enforces correctness at every step, thereby resulting in fewer design iterations and lower costs overall for design. Its high-level approach with tight time-management controls ensures that all design processes have been deemed suitable for use.
  • Teamcenter enhances teamwork on an international level. It allows for instant collaboration by enabling international teams to connect, communicate and share information on-demand between all of a company’s global offices.. Teams can iterate easily, communicate visually and engage suppliers at an earlier stage. In fact, this can accelerate overall product development by 25 percent.

For more on PLM and its role in Industry 4.0, join Seabrook Technology Group’s Preparing for Industry 4.0 information roadshow in Dublin on April 25th. For further information on this event, or to book your place see https://www.seabrookglobal.com/preparing-for-industry-4-0/.

Sean O'Sullivan founder and CEO of Seabrook

Seabrook founder and CEO shares business advice with The Sunday Independent

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Seabrook’s founder and CEO Sean O’Sullivan was interviewed by The Sunday Independent’s Business supplement and asked to share his business advice and tips for business owners.

He began by saying that all new businesses need to focus; they need to identify one aspect of the business that is performing strongly and concentrate on developing that area. He also encouraged businesses to export, and used the example of the growth and success Seabrook has had in North America since expanding into US markets in 2012.

Sean O’Sullivan is a past Chairman of Business Information Systems Advisory Board at University College Cork and is also past Chairman of the Audit and Risk Committee at RTE. He also sat on the Board of Directors at RTE (Irish National Broadcasting Company).

You can read the full Sunday Independent article by clicking here.

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Making the case for PLM in medical device manufacturing

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by John Dzelme, Global Chief Operating Officer with Seabrook.

The landscape of medical device manufacturing has shifted immensely in recent years. One of the most significant developments has been the endorsement by regulatory bodies, including the Food and Drug Administration (FDA), of the total life cycle production concept.  With this, Product Lifecycle Management (PLM) systems have fast become the barometer for medical device manufacturing, because of their ability to manage the entire process, from conception and design, through to production and on to continuous monitoring once the device has left the shop floor and is with the consumer. In this blog, I make a case for PLM in the medical device and life sciences industries by answering some questions I’m frequently asked about PLM.

What is PLM?

Siemens has a very succinct and clearly defined description of PLM, which it says is an information management system that can integrate data, processes, business systems and ultimately people in an extended enterprise. PLM allows you to manage this information throughout the entire life-cycle of a product – efficiently and cost-effectively.

How can PLM enhance medical device manufacturing?

Quality and product safety is paramount for medical devices, which are nowadays often implanted into the body. In order to create a truly quality product that adheres to the strictest of safety regulations, manufacturers need to employ automated systems that govern the entire process in a more holistic and complete way. To truly understand how PLM can benefit medical device manufacturers, it needs to be thought of as a strategic business approach – rather than a piece of software or a collection of technologies.

PLM promotes the production of safe and quality products because:

  • It facilitates greater levels of integration between each component part of the process, e.g. conception, design, engineering, manufacture.
  • It ensures that all the relevant information is contained in a centralized structure, allowing those working on each stage of the process to have immediate access to all the relevant information.
  • PLM allows for streamlined communication between all departments involved and encourages collaboration, communication and cooperation.
  • With PLM, there will be a progressive move away from departments working in isolation from each other, and the creation of an interactive environment that ensures greater innovation.

As the concept of total life cycle production gathers pace and increasingly becomes the norm, medical device manufacturers must embrace advanced technologies such as PLM in order to compete. The benefits are considerable – not only for the manufacturer but also for the consumer.

To learn more about PLM, join me John Dzelme, Seabrook’s Global Chief Operating Officer, at Seabrook’s first Irish Manufacturing Excellence Forum in Dublin on Monday, April 25 2016. For more information, or to enquire about a place at the forum, see seabrook.ie/preparing-for-industry-4-0