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Summary: Medical device design standards have undergone a digital transition, providing the industry with various tools for increasing organizational agility.
FREMONT, CA: The manufacturing industry's growing pressures from rising costs, new regulations, and supply chain unpredictability have expedited medtech's digital transformation. COVID-19, in particular, has prompted manufacturers of medical devices to embrace more resilient and agile work procedures. New technology enables process improvements and business strategies that enable medical device producers to adapt to changing market conditions. This is how digital transformation is assisting in the improvement of agility and the design of medical equipment.
Modern Manufacturing Execution Systems (MES) Contribute to the Streamlining of Manufacturing Processes
Assembly procedures are becoming much more adaptable as a result of the digital transition. Adopting current MES fueled by Industry 4.0 technologies such as IoT and AI analytics can significantly increase plant agility. Compared to traditional MES, these new platforms are often cloud-based, decentralized, and aid in integrating manufacturing with other digital business systems.
The MES collects data from IoT sensors, manufacturing machines, and other plant data sources to offer medical producers a single source of truth. As a result, the technology makes this information considerably more accessible by integrating it with other systems and enabling remote access via the cloud. Data accessibility enables teams to react swiftly to changing manufacturing conditions.
Additionally, the MES enhances manufacturing visibility. The data collected from a plant enables managers to view and follow manufacturing operations more efficiently, making bottlenecks and process failures more visible.
MES can also result in further process benefits, such as assisting firms in increasing traceability and transitioning to paperless operations. It may generate manufacturing process documentation automatically, allowing the system to serve as the facility's comprehensive electronic device history record (eDHR). Businesses can utilize this record to decrease or eliminate the requirement for paper documentation.
Digital documents are more easily accessed, stored, and analyzed than paper documents, enabling manufacturers to comply with audits and conduct process reviews. Additionally, they can integrate the development of papers required for manufacturing traceability into daily corporate processes. This enables workers to collect more data on the manufacturing process of individual products without interfering with existing procedures.
Enhancing Decision-Making Through the Use of MES Data
Data collection can give further benefits over time. Numerous MES can display business intelligence indicators such as facility volume, throughput, and cycle time in simple-to-understand reports or dashboards. This knowledge can aid in the decision-making process by simplifying or streamlining it.
For instance, the decision between silicone and latex when developing a novel medical device can substantially impact the device's ultimate manufacturing cost, biocompatibility, insulative properties, and thermal characteristics. Taking all of these elements into account without the appropriate tools can be a challenging and time-consuming procedure.
When manufacturing plant visibility, historical product data, and other plant information are offered in cloud-based formats, managers and product engineers may more quickly identify which material would be best for a new product.
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