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Integrating Quality by Design in Medical Device Manufacturing – Concept, Benefits & Challenges Introduction


Medical devices are the most advanced revolutionary application of technology. This innovation lead to the accomplishment of Industry 4.0 (I4.0) which includes internet of things (IoT), cloud computing, big data, microelectronic applications, cost-effective sensing applications, mobile and communication devices, etc. play major role in this industry with their efficient production, innovation and practical existence in the consumer’s market.

Due to delicate and sophisticated nature of medical devices, they are produced and maintained in their best quality levels. This increased quality of medical devices, they are the most expensive and complex in their construction. The innovative digitization has created a new of change in the market that reduce costs but maintain highest quality. This change enables the manufacturers to produce medical devices in higher volumes at the cost of low documentation and pricing requirements.

Industry 4.0 Technology Enablers

The fourth industrial revolution to production sectors is the Industry 4.0 (I4.0) specialized for smart manufacturing devices.  This novel approach will be a step to change the medical society, but it will take some time to nourish. The major objective of this is to offer the companies with an opportunity in planning and plotting an operational pathway not as a technological evolution but a revolution in processing of devices.

Industries 4.0 vision brings some important basic technologies such as computer power mobility, ability of mass data handling, reducing electronic devices cost and size, and ease of data access from across the world. Miniature electronic sensors are widely available that bring intelligence in the devices and enhances the ground for supply chain. These products have power to communicate with other devices and easy to control which opens new opportunity to open new ways for device to device communication. This property of bi-directional communication ability makes devices to be connected with each other according to choose and desire from anywhere. Also, it greatly eradicates most of the limitations such as controlling, scheduling, and products tracking via manufacturing process and offers ability to multiple plants and greater chain assets for decreasing cost and enhances efficiency of products.

Similarly, cloud computing is a method which provides storage capacity and connectivity from anywhere for data handling. Also, advance analytics also plays an important role in pcb manufacturing process because it leads to transformation of huge structured and unstructured volume of data into intelligence and structured strategic information.  It offers pricing and methods to easy decision making and serious actions to remove blockages, efficiency optimization, capacity enhancement, and eliminate errors processing.  Powerful software tools for data feeding also brings opportunities of scenario predictions in a more impactful methods and making decisions.

Industry 4.0 Technology Enablers

Cyber-Physical vs Cyber-Physical Production Systems

The Industry 4.0 model also includes cyber-physical systems (CPS) and cyber-physical production systems (CPPS). These systems have ability to merge real and virtual worlds and enable intelligent products in CPS and machines enhancement based on software in CPPS to support data from actuating and sensing devices along with self-management tools. Additionally, by the help of these devices, machines will be able to know about their own state, capacity and options of configuration for effective decision making and improved efficiency without operator intervention.

As CPS is a consumer provider and CPPS a service providing system and both have complete communication, organized in a decentralized way for flow of linear production. They offer a highly intelligent and production model with greater flexibility having advantages such as robust behavior, autonomous structure, self-organizing approach, self-maintaining nature, self-repairing ability, new efficacy and interoperability, tracing with UDIs.

Additionally, Industry 4.0 is also a driving source for decreasing the product of cost by making cost-effective devices which offers ability to manufacturers for easy and more sophisticated product lines and ability to easy customization and individualization of products according to specific consumer requirements. This thing is a new agility level for competing and responding to increasingly altering markets and a practical approach for meeting high demands for a huge range of sophisticated cellular and personal solutions such as lenses for glucose detection, inhalers of next generation, medicines based on bioelectronics and system on chip testing.

A Dynamic Production Model

Linear approach is used for customization of current models. Initiating with a general product, some important rules for processing to be considered for meeting the specific customized specs. The industry 4.0 is based on intelligent controls which can be easily programmed as per consumer requirements. It does not need any longer duration to go through the industrial process or interface with machines. It establishes a new way for CPPS to bid the CPS according to the service needed by consumer.

For instance, there is a product A which requires a process X for its manufacturing. There is a communication between the product and machine to let them know about the requirements. The response of “Machine 1” might be on the basis of product to know about the service for reconfiguration requirements and additional material for completing the specific job. The entire process cost shown by the machine is about $50.

The “Machine 2” has maintenance scheduling and unable to meet the service request.  The configuration of “Machine 3” is already correct and $ 30 is the cost for material availability. Therefore, “Machine 3” is selected by the product. After completion of the entire process, the product is distributed to market which is the next processing step. This is the actual method where product gets the most cost-effective and efficient method after following some important steps before coming to the marketing ground.

A Dynamic Production Model

Manufacturing Execution Systems (MES)

MES are being utilized for long time for controlling product flows across the market. An important question is associated with MES. The products are being manufactured by intelligent machines so is there any need of MES in future perspective? The answer is yes, a future prepared MES is probably more crucial component of the plant structure for intelligence-based company.  In other words, it can be said that it is the foundation of Industry 4.0 but future MES requires decentralized logic for giving the related flexibility and agility.

This agility and flexibility of future MES combines amenability, quality, process control based on systems statistics, engineering, and systems which keeps them maintained for proper and smooth operations. A completely loaded MES provides combination of all parts with the plant which can easily be exchanged for best machine capacity optimization, availability of equipment and scheduling of order. Additionally, it also combines CPS and CPPS data in a manner where greater plant gives surety of an automatic action of the system below the rules used for best business practices. Also, it offers the operator with single, plant intuitive view where 3D modelling like concepts can be used for clear seeing of machines status, methods and batches of products.

MES can be designed in such a way that it can handle greater volume and variety of created data from the intelligent plant. It can integrate information coming from several sources that becomes a usable data for proper decision making. Plant’s rapid triggering can be enabled by advanced rapid offline and real-time analytics to tackle the processing problems. Some advance concepts such as in-memory can also be used by it for high quality products and processing of complex event for driving operational efficiency.

Regulatory compliance

One of the major parts in solution providing methods for medical industry is regulatory compliance. Industry 4.0 model has brought revolutionary changes to meet the needs of quality and tracking. Without looking into quality in a process, documented actions are needed to correct the actual problem, the information obtained from the intelligent system which the MES actively eradicates errors before their happening.  This brings a positive shift in the plant from being a structure which is more compliant as compared to focused on quality of the product. It also greatly decreases the product risks and in line with FDA quality rules and opens the decreased on-site audits’ possibilities.

Utilizing big data from the intelligent system, MES holds the important information for a complete product and material tracking. Eradicating records in papers, this real-time data can be brought into use for eliminating errors in the product and pcb assembly process; making inherent quality into product lines which are true with greater reliability and brand reputation.

Regulatory compliance


Having a future-ready MES, Industry 4.0 model of production offers a full manufacturing process visibility, surety of ease, comprehensive tracking, and ability of continuous process improvements utilizing big data obtained from manufacturing process. It provides ability to bring increase in processing of sophisticated devices increase, reducing costs, enhances product flexibility, efficiency improvement, and increasing overall agility of business. It greatly replaces the traditional paper usage with records in electronic forms and advanced analytics that change data into some valuable business information.

In medical industry, it greatly reduces total costs of production, small quantity effective production, greatly customed products, and continuous improvements in the process along with better quality of products, and easy FDA quality assurance rules and documentation.

Finally, Industry 4.0 is difficult to achieve without MES. By combing all the parts, future MES also provides medical companies with a pathway for combining old and new systems and go in a manner that is suitable for a specific business model.