Product Lifecycle Management (PLM) for medical device informationization

Release date: 2010-08-25

Lifecycle Management (PLM) is a framework concept in which a company operates a product or service. PLM can effectively solve the complex problems of product information and industry environment in the medical device industry, and also ensure the efficiency of medical device product development, and improve the technical level of the overall management of the enterprise, and ultimately obtain more benefits.
After entering the 21st century, the world's politics, economy and technology have undergone tremendous changes. The competition of medical device manufacturers is also becoming increasingly fierce, and companies are facing many more complicated economic globalization and market competition. One problem that all manufacturers worry about is that many emerging science technologies cannot be quickly transformed into safe, effective and cost-effective medical products. This is mainly because their product development path is not smooth, inefficient and high in consumption. Therefore, medical device companies need more advanced and comprehensive scientific methods to meet these new challenges.
Product lifecycle management (Product L process is unified management, to shorten the product development cycle, improve production efficiency, timely put the best-selling products on the market management philosophy. It can help us out of the old idea of ​​simply improving business efficiency, System-level upgrades for all aspects of enterprise management throughout the life cycle of a product.
1 Product Lifecycle Management (PLM) Introduction 1.1 PLM Generation Product Lifecycle Management PLM has a background in which the manufacturing environment, development model, operational efficiency and activity space have undergone profound changes. Specifically, the first is that the increasingly competitive market has changed from a stable regional market to a dynamic global market. Second, customers have strong requirements for product personalization, production batches have become smaller, and variety changes have increased, requiring products to enter the market faster. The high added value generated by exclusive technology becomes the main component of price; the fourth is that the life cycle of products is shortening, and the market life of many electronic products has been shortened to the monthly calculation.
So what exactly is PLM? The Product Lifecycle Management Alliance also believes that PLM is a concept that describes a collaborative environment that enables users to manage, track, and control all product-related data throughout the product lifecycle.
1.2 Key Features of PLM PLM needs to be planned from the enterprise strategic layer, including its architecture, tools, and implementation methods.
PLM spans all product stages from the production of a product concept to the demise of a product.
The object that PLM manages is product information.
PLM aims to achieve the definition, manufacture and management of synergies in the product lifecycle through information technology.
PLM requires a range of tools and technologies to support the establishment of an information infrastructure to support.
1.3 PLM in the medical device industry
The medical device industry is also dominated by manufacturing. The full life of a medical device is the entire process from the "cradle" to the "grave." For manufacturers, product life cycle management is also a market-driven process, from the original concept of the product to R&D and testing, to manufacturing, then to the market, to start using, and finally to product scrapping replaced by new products (see figure 1). Each of these stages involves product specifications, performance, profit, and cost.
China's medical device industry has developed rapidly since the 21st century, and it has gradually shifted from a factory with a focus on production and processing to a more comprehensive and technologically advanced manufacturing industry. Therefore, we urgently need to use information technology to give full play to the advantages of product lifecycle management, customer relationship management CRM and supply chain management SCM, and enhance the overall management and operation level of the enterprise.
2 PLM and Medical Device Product Development 2.1 Product Development Products are something that companies sell to consumers. Product development is a series of activities from the discovery of market opportunities to the manufacture, sale and transportation of products. Product development is an interdisciplinary activity that requires almost all departments to contribute. In particular, the design department, marketing department and manufacturing department. The stages of product development include:
The Phase 0 plan, called the '0' phase, occurs because the project approval and actual product development process are initiated. Start with corporate strategy, including assessment of technology development and market objectives.
Phase 1 concept development, identifying the needs of the target market during the concept development phase, generating and evaluating various alternative product concepts, and selecting one or more concepts for further development and testing.
Phase 2 System level design, including the definition of the product system, and the decomposition of the product into subsystems and components. Initially determine the final assembly plan for the production system.
Phase 3 detailed design, including the complete specification of each part of the product and the drawings or computer files of the manufacturing tool, the technical requirements of the purchased parts, and the manufacturing and assembly process of the product.
Phase 4 testing and refining, including the construction and evaluation of multiple pre-production versions of the product. Whether the product works as designed and meets the needs of key customers. Determine performance and reliability, and whether necessary engineering changes are required.
Stage 5 production starts and the product is manufactured using a predetermined production system. The aim is to train workers and solve remaining problems in the production process. Gradually changed to normal production.
2.2 Medical Device Development and PLM
Whether it is a large company or a small medical device manufacturer, they face considerable pressure to continuously improve the safety and effectiveness of their products. At the same time, manufacturers are also worried about huge investment in development, especially if they do not meet the losses caused by the product or process. Companies with long-term goals will leverage PLM system technology and optimize the organization of their value chains to make product development more effective. Development is a process that continually cycles, and design development inputs need to take advantage of the information provided by all stakeholders. PLM systems require information to be shared across departments at all stages of the system. And through information sharing, PLM systems can detect problems earlier and adopt more preventive actions than Corrective Actions. This can solve the problem before the problem occurs, greatly reducing the loss of the manufacturer.
For example, the device development team should conduct a trial design. The experimental design determines the key production process parameters and acceptable limits. After that, the device development team should test the production process with the process parameters set to the limit conditions. If the product fails at this time, preventive measures should be taken to change the product or production process. According to the TPLC concept, all information in the test design must be submitted to the production department. Only then can the production department engineers and other personnel truly understand the production process.
In order to make product development activities more proactive, manufacturers must promote the exchange of data for each product and process. If each department stores important information in its own independent system, this will make any activity of the entire enterprise very difficult. At least the design and development department should have access to all the information and data. If a design engineer is ready to improve the instrument, improve performance, increase functionality, or reduce costs, he should be able to get all records of improvement, non-compliance records, complaint records, and preventive action records (CAPA). Only in such a PLM system can engineers get enough information to design and improve medical devices.
3 PLM and medical device after-sales management and organization management 3.1 Medical device after-sales management Usually, medical device companies in China only pay attention to the design and manufacturing process of products, while ignoring the use process of products. There are actually huge profit opportunities in the use phase of medical devices. For example, with the support of information technology, some medical device manufacturers can provide users with various value-added services, through which they can create more economic value, and sometimes even exceed the profits from product sales. The opportunities presented here are enormous, and PLM can provide maximum data support and decision guidance for after-sales service of medical device products through powerful specification management functions and customer relationship management system functions, and can provide customers with the best quality solutions.
3.2 Organizational recommendations for implementing PLM systems There are currently PLM-related software systems on the market. Manufacturers and suppliers can use these software to solve design and quality control problems. Engineering and technical teams create most of the most valuable intellectual assets for the organization—customer requirements, engineering calculations, detailed CAD design, and product documentation. While manufacturers have a wealth of solutions to create and transform these diverse messages, they still face major challenges. For example, sharing these resources efficiently with a wider range of teams.
In order to more effectively integrate PLM and quality systems, consider the following recommendations for assigning organizations: design inputs from product managers; development engineers working on designing next-generation devices; quality engineers presenting change requirements; production engineers issuing engineering change notices; suppliers Quality engineers conduct impact assessments; customer complaint managers conduct impact assessments; properly report product adverse events; IT managers provide integrated system support, eliminate isolated systems; and chief engineers analyze and evaluate the actual results of shortening the development cycle.
4 Conclusion The rapid development of medical technology has led to the emergence of more and more medical products in the world. However, medical devices are very different from pharmaceuticals because they often have long patent terms and can only be changed very little. Therefore, both medical device manufacturers and government authorities face enormous challenges. How to effectively improve product performance? How to ensure product safety and quality? How to shorten the development cycle? How to ensure that the company can get the profits it deserves?
Based on the product life cycle for development management, enterprise operation management, organization management and continuous research and application, it can effectively solve the complex problems of the medical device industry product information and industry environment, and also ensure the speed and efficiency of medical device products entering the market. The technical level of the overall management of the enterprise will eventually gain more benefits. In addition, the improvement of PLM system in the enterprise can help improve the supervision of medical devices in China and promote the safety and effectiveness of medical devices in China.

Source: Wanfang Database

Ear Thermometer

Medical Ear Thermometer,Ear Thermometer,Infrared Ear Thermometer

Dongguan Keyutai Mask Co., Ltd. , https://www.maskkytai.com