Balancing Competing Priorities in Medical Device Manufacturing

In healthcare technology, industrial markets, logistics, manufacturing, medical device, medtech, mfg, Quality System Management by Generis0 Comments

Medical device manufacturers must consistently work to balance competing priorities; everything from product development, regulatory compliance and quality to marketing.  Managing these priorities in disparate individual silos leads to a lack of efficiency, communication and productivity.  As a result, many manufacturers are turning to holistic enterprise operation solutions to streamline their processes from innovation through to the product end of life.

Dassault Systèmes Industry Solution Experiences for Life Sciences powered by the 3DEXPERIENCE® platform provide a major leap forward with a Single Source of Truth (SSOT) environment that spans the entire product lifecycle from conceptual design to end of life. These solutions for Life Sciences enhance global collaborative sharing, making compliance and innovation complementary processes that contribute to each other’s and the company’s success.

The Dassault Systèmes whitepaper “TRANSFORMING MEDICAL DEVICES WITH SUSTAINABLE INNOVATION”outlines some of the key benefits of this integrated technology for medical device manufacturers:

  • Manage and facilitate innovation without compromising quality and safety through one cohesive platform that allows collaboration of design information and visibility across the product lifecycle from ideation to end of life.
  • Increase patient safety by reducing the number and severity of recalls and field actions
  • Increase business agility by streamlining design collaboration and managing team activities to align project goals and user requirements.
  • Speed compliance processes by integrating regulations into product development (design for compliance) and e-submission.
  • Accelerate time-to-market by streamlining the complete regulatory submission and approval process (dossier assembly, review, submission, tracking, and renewals through end of life) by geo-global regions.
  • Reduce engineering re-design time and cost through simulation testing that can help expedite clinical trials and reduce product failure recalls.
  • Expedite product design transfer with current released documentation to facilitate the manufacturing process while maintaining end-to-end traceability throughout the product lifecycle.
  • Develop strategic suppliers and partners by bringing supplier quality history into the sourcing process.
  • Balance speed versus control by improving common enterprise processes, then tracking and measuring them as a basis for improvement.
  • Maintain complete product requirement traceability from ideation through development, design verification and validation, to commercialization and product obsolescence.
  • Drive part costs down by publishing part specifications across product lines, brands, and regions to create efficient procurement processes.
  • Achieve cost savings through lean and efficient re-use of Intellectual Property (IP).
  • Enable design and manufacturing outsourcing by creating centrally-managed global work teams and using a single repository to store all product information throughout the product lifecycle.

Dessault Systemes

Join Dassault Systèmes and Generis Group as we explore the challenges and opportunities in product development, quality management, speed to commercialization and manufacturing at the American Medical Device Summit 2015 taking place Next Week in Chicago!


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