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Geometric: PLM Saves Lives

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DQI Bureau
New Update

The medical devices market in Asia is one of the fastest growing industries, with India contributing significantly both as a consumer, and manufacturer of medical devices. The medical devices industry has fared well in the past 2 years of recession, but not without some challenges, globally including increasing number of product recalls due to supplier and design control issues, and competition increasing in the growing markets. With the global healthcare industry under reforms due to the unsustainable cost acceleration in healthcare, the pressure is on the medical device manufacturers to innovate new products, while keeping the costs down.

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With the element of human well-being and life being at the core, there is a greater need for precision in the product development process, along with the need to comply with regulatory requirements of each geographical market for the medical devices.

Key Drivers

According to recent market research, the top drivers influencing the adoption of new software technology in the medical devices industry are for:

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  • Reduction of costs
  • To ensure regulatory compliance
  • Reduction of internal effort
  • Reduction of cost of quality
  • To decrease time-to-market

The medical device industry also requires documentation, and intensive record keeping. While the industry is looking for software applications, reports also indicate that more than 50% of the companies maintain their records manually in paper formats, in spreadsheets, etc. Approximately 2540% of operating budgets are allocated to quality and compliance management, and yet there are challenges.

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The PLM Advantage

Product Lifecycle Management (PLM) applications present an answer by providing a process and system backbone for product quality and safety, compliance, product innovation, and operational efficiency across the product lifecycle.

Product development for medical devices, happens with globally dispersed teams involved in the New Product Development and Introduction (NPDI) process. In a highly competitive market, where rapid time to market and product quality is of utmost importance, it is imperative that all NPDI stakeholders work in collaboration. Leading PLM solutions can manage the basic activities of the NPDI process, while more advanced solutions can handle the entire portfolio of programs.

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For launching a new product, medical device manufacturing companies rely on partner manufacturing organizations, and Indian companies play major role here. PLM systems can greatly aid in this regard with the ability to facilitate collaborative innovation, communication, and performance management. Teams needing to collaborate can easily access relevant data, and participate in automated business processes and workflow.

PLM applications enable the medical devices companies to manage the need for product localization by managing configuration and calibration of similar devices for the local requirements in terms of language, user interface, features, and more to cater to a very different consumer behavior with regards to energy resources, cost appetite, and infrastructure.

PLM applications provide complete data traceability for all activities by automatically linking compliance requirements with engineering and specification data, and provide the structure for document and change record management in the same intuitive system. This considerably reduces the cycle time to process regulatory enquiries, complaints, and audit requirements which is probably the single largest consumer in the medical device industry. PLM applications take the medical device industry towards establishing one system of records One Version of the Truth.

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