Robert Kavanagh, Author at Seabrook Technology Group

All posts by Robert Kavanagh

Seabrook exhibit at IMDMC State House Day 2018

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Seabrook Technology Group were delighted to attend and network at the Indiana Medical Device Manufacturing Council on Wednesday 31st January 2018. The event was intended to create awareness for government officials of the medical device business in Indiana. Seabrook were joined by medical device manufacturers including Cook Medical, Roche Diagnostics, Boston Scientific, Depuy Synthes, Zimmer Biomet, Genesis and Fort Wayne Metals.

The IMDMC brings together Indiana’s medical device sector to cultivate a business environment. The medical device industry is one of Indiana’s most valuable economic assets, generating more than $10 billion of annual economic output. A recognized leader in the field, Indiana’s medical devices sector is highly diversified and offers a broad depth of products used throughout the world. Major companies such as Zimmer Biomet, Boston Scientific, Cook Medical, DePuy Synthes, Medtronic and Roche Diagnostics are either headquarted or maintain major operations within the state and develop a wide variety of medical devices from cardiovascular to urological to diagnostics and orthopaedics.

Seabrook Technology Group look forward to attending future meetings and training events over the coming year.

Enabling Operational Excellence Through Manufacturing Intelligence

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The single source of truth in enabling operational excellence through manufacturing intelligence is does your data tell the same story regardless of who is looking at it? Or is it easily misrepresented? Data should be guiding your organization for strategic as well as operational decisions and direction. The data visualization should clearly show the health of your organization.

Seabrook define Enterprise Intelligence as “The Execution of a Technological Strategy enabling Integrated process and environmental knowledge to be leveraged in standard practices to achieve operational excellence”.

Transformation does not happen overnight and your data and analytical maturity will not either. The following are the foundational pieces to progressing a BI initiative:

  • KPI’s and Detailed Definitions
  • Inventory of System of Records
  • Canonical Definitions to clear up any discrepancies across business units, systems, etc. so that every system is speaking the same language at the BI level.
  • Action plan
  • What is to be measured, used, and communicated
  • What will be open for discover models
  • Alert & Notifications scenario definitions
  • Business Rules for automated responses and actions based on certain KPI violations

To learn more, click here to request a recording of the presentation.

Building a Case for Paperless Manufacturing

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This Building a Case for Paperless Manufacturing blog will discuss two areas:

  1. What are the areas where we have seen high levels of return on investment.
  2. How do you go about creating a roadmap towards paperless manufacturing.

The biggest cost reduction we see when eliminating paper is the cost of “operator Handling and Document”. The review, inspection, and transportation of paper can require several full-time people.

The second biggest area we have seen related to paper costs is customer complaint processing. This includes any analytical processing that is done on the data stored in the paper DHR.

The third largest expense we encounter because of paper is storage space. In some cases, companies are required to keep paperwork up to 10 years following the products lifecycle, and many companies have over 100 years of paperwork in storage. Federal guidelines require that paperwork be stored in such a way that the information won’t become degraded. That means facilities must be climate controlled and secure which further adds to the cost of storage.

The final paper related costs that are sometimes overlooked are directly related to the paper itself. This includes the pens and transport equipment.

Medical device manufacturing is faced with many complexities. Product lifecycles are becoming shorter and shorter. If you are going to be able to compete in the industry, you need to be able to change your manufacturing process quickly. With products becoming more complex, it is increasingly more difficult to meet regulatory pressures. This means that each manufacturing process change is likely to be a change that increases the number of steps involved and the information that needs included.

By automating your manufacturing process, you also automate a portion of your manufacturing process changes. If you are using a PLM or Product Lifecycle Management system, you can automate the design and development of your product for an even more efficient process of managing manufacturing changes.

To learn more, click here to request a recording of the presentation.

Process Changes and Quality Control for Medical Device Manufacturers

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When we talk about managing process changes in an environment using MES the first benefit we see is the environment already has tighter controls in place. This means the process of changing our environment has to be more tightly controlled.

The second key element is the process changes are enforced. This prevents an operator from reverting to a previous method, tool, or material. An operator that hasn’t been trained on the new operation, is restricted from continuing the manufacturing process.

A strong validated MES is one that has been configured to include key data collection, well defined specifications, and a complete product workflow. A strong validated MES, can provide more effective real-time enforcement and make training simpler.

The ultimate goal of a paperless manufacturing solution is to have compliance be a by-product of operational excellence. Because MES can maintain device history in real-time, you are able to provide batch history records and/or device history records quickly and efficiently. Beyond the BHR and DHR, MES provides greater visibility into the history of manufacturing. Unlike a paper solution, your stored information is structured. From structured information a variety of reports can be generated on demand. Reports such as preventative maintenance, operator training, and non-conformance resolutions. All of this information becomes very valuable when showing your process well defined and followed.

To learn more, click here to request a recording of the presentation.