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Manufacturing Execution

Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers
January 29, 2016
Soapbox

The Big Data and Big Content Disconnect for Medical Device Manufacturers

By Mika Javanainen
Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers

Take a metadata-driven approach to information management.

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Every business appreciates the need for instant access to information, but companies that operate in the highly-regulated medical device manufacturing industry are drowning in a sea of Big Data and Big Content that gets larger and murkier every day.

What exactly is the difference between Big Data and Big Content?

Big Data refers to the structured data that resides within database applications. Typical Big Data systems in the medical device manufacturing environment include ERP and product lifecycle management (PLM) systems, but also all kinds of specific systems that collect data and analytics related to device use and calibration.

Big Content refers to unstructured content, which can be anything from emails and videos to spreadsheets, reports, presentations, photographs and even call center recordings. In short, the realm of Big Content includes every file, document or bit of raw data that doesn’t adhere to a standard database model.

Dissecting the Big Challenges

Effectively managing and harnessing Big Data and Big Content can be challenging. Unstructured content assets are typically not stored in centralized repositories–they’re often stored in disconnected business systems, platforms and devices–both on-site as well as in the cloud.

The absence of relevance and context further complicates the management of unstructured content. Without the ability to identify relationships between unstructured content and their associated Big Data (structured data) counterparts, medical device manufacturers are left with only a fragment of the entire information puzzle.

Many device manufacturers lack an information strategy that fully addresses the complexities of scope of their Big Data and Big Content. IT teams are frustrated with the lack of visibility and control for enterprise-wide information assets, and employees are forced to spend a lot of time trying to manually organize, leverage, and securely share both structured data and unstructured content assets.

A Little Answer to the Big Challenges

A metadata-driven approach to information management can help medical device manufacturers unify their Big Data and Big Content assets and harness the value across disparate information silos in order to achieve specific organizational goals, whether it’s research and development, distribution and logistics, or sales and marketing. With the ability to intelligently link content and context across structured data systems and unstructured content repositories, metadata can expose hidden value by mapping previously disconnected information assets that reside in separate information silos.

Enterprise information management (EIM) solutions that leverage metadata can address the unique challenges that medical technology companies face when striving to capitalize on the opportunities of Big Data and Big Content. Metadata-driven EIM solutions help to drive operational efficiencies across many industries, and the ability to effectively use all structured data and unstructured content has been proven to bolster competitive strength and allow every functional area to tap into the true value of the company’s total digital assets.

A metadata-driven approach can serve to create harmony across day-to-day business operations, improve operational efficiencies and, ultimately, empower companies to improve their ability to innovate life-saving and life-enhancing treatments and technologies for patients.

With unprecedented competitive and economic pressures, medical device manufacturers are looking for technologies that can help them get more value out of their Big Data and Big Content. A best-in-class EIM platform can lend additional value by automating quality processes and reducing regulatory risk. With centralized management of all data assets, compliance and audit managers can track manufacturing workflow, such as change controls, CAPAs and training, ensuring that quality standards and FDA compliance are maintained.

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About The Author

Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers
Mika Javanainen
Senior Director of Product Management
M-Files Corporation

Mika Javanainen is senior director of product management at M-Files Corp. Javanainen manages and develops M-Files’ product portfolio, roadmaps and pricing globally. Prior to his executive roles, Javanainen worked as a systems specialist, where he integrated document management systems with ERP and CRM applications. A published author, Javanainen has an executive MBA in International Business and Marketing. Follow him on Twitter @mikajava or email him at mika.javanainen@m-files.com

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