Growing pressure on the manufacturing industry from rising prices, new regulations and supply chain uncertainty have accelerated medtech’s digital transformation. COVID-19, in particular, has encouraged medical manufacturers to adopt more resilient and agile working practices. New technology can enable process changes and business strategies that help medical manufacturers become more flexible and responsive to changing market conditions. This is how digital transformation is helping improve agility and medical equipment design.
The digital transformation is making assembly processes much more flexible. The adoption of modern manufacturing execution systems (MES), powered by Industry 4.0 technology like IoT and AI analytics, can make plants much more agile. Unlike traditional MES, these new platforms are typically cloud-based, decentralized and help integrate manufacturing with other digital business systems.
The MES draws information from IoT sensors, manufacturing machines and other plant data sources to provide a single source of truth for medical manufacturers. In turn, the system also makes this information much more accessible, providing integration with other systems and cloud-based remote access. Availability of data helps teams respond quickly to changing manufacturing conditions.
The MES also improves manufacturing visibility. Data gathered from a facility allows managers to visualize and track manufacturing processes more effectively, making bottlenecks and process errors easier to spot.
MES can yield other process improvements, like helping manufacturers improve traceability and go paperless. It can automatically generate manufacturing process documentation, allowing the system to serve as a complete electronic device history record (eDHR) for a facility. Companies can use this record to reduce or eliminate the paper documents they would typically need.
Digital documents can be more easily accessed, stored and analyzed than paper, helping manufacturers comply with audits and review manufacturing processes. They can also make the generation of documents needed for manufacturing traceability a part of day-to-day business operations. This allows workers to capture more data on how each product is manufactured without disruption to existing workflows.
Over time, the collection of data can provide further benefits. Many MES can present business intelligence metrics in easy-to-interpret reports or dashboards, like facility volume, throughput and cycle-time. This information can simplify or streamline the decision-making process.
For example, the choice between silicone and latex for a new medical device can significantly impact its final manufacturing cost, biocompatibility, insulative properties and thermal characteristics. Taking all these factors into account can be a difficult and time-consuming process without the right tools.
When presented in cloud-based formats, manufacturing plant visibility, historical product data and other plant information can help managers and product engineers more easily determine which material would be right for a new product.
Historical data can also enable advanced predictive models powered by analytic technology like AI. Predictive analytics can allow more accurate demand and facility forecasting and let manufacturers better estimate future demand and facility throughput.
New predictive analytics can also enable techniques like predictive maintenance, which allows manufacturers to use data from machine sensors to detect unusual behavior and predict machine failure.
Real-time data allows the system to automatically alert technicians when a machine may be on the verge of failure. Analysis of this information enables identifying patterns of behavior that may suggest future shutdowns or damage that could cause equipment to perform less efficiently. Leveraging the approach can help businesses reduce maintenance costs and minimize downtime.
COVID-19 revealed that much of the medical manufacturing supply chain isn’t ready for a crisis. The storage conditions required by vaccines also exposed weakness in the industry’s cold chain and ability to control the environmental conditions in which products are shipped. One survey report found that only around 10% of respondents from seven industries, including health care, felt their supply chain strategy had performed well during the crisis.
Other threats—like the growing frequency of cyberattacks targeting health care-related organizations—have also encouraged medical manufacturers to reevaluate supply chain resilience. Already, the transformation has resulted in several key changes for medical manufacturing supply chains.
Visibility, enabled by digital transformation, has become more important than ever for manufacturers. Technology helps manufacturers track raw materials, components and finished products as they move through the supply chain.
More accurate supply chain forecasting can also help businesses minimize costly inventory buffers without creating the risk of stockouts or material shortages.
New supply chain technology has also helped manufacturers and logistics providers maintain the environmental conditions products are placed in during shipping. IoT sensors can track the conditions a shipment is exposed to at all times, providing manufacturers and logistics companies with real-time information on temperature, humidity, vibration and vehicle speed.
Suppose a sensor begins to detect environmental conditions beyond a certain safe threshold. In that case, the system can automatically alert drivers, dispatchers, managers and other relevant employees, enabling a fast response that can prevent spoilage. The same system can also track shipment location, providing the manufacturer with greater cold chain visibility. Over time, data analysis from these systems also enables process changes that reduce spoilage and damage to shipped goods.
As these technologies become more widely adopted, they may work together to produce a supply chain that is more resilient and agile. It will be capable of flexibility but also hardened against potential future crises.
The COVID-19 crisis has medical manufacturers reconsidering how they do business. Agility, flexibility and resilience have become more essential characteristics for companies wanting to respond to changing market conditions and prepare for potential future crises.
The digital transformation of medical device design standards has provided the industry with various tools for improving organizational agility. Modern MES, IoT and analytics technology like AI can help companies streamline operations and gather more information on manufacturing and logistics processes. In practice, these technologies can help businesses improve traceability, deploy predictive analytics and build a more flexible supply chain that’s better prepared for disruption.
How can AI become a beneficial medical device manufacturing technology? This article reviews some examples of how it excels.
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Emily Newton is the editor-in-chief of Revolutionized Magazine. She has more than three years experience writing articles in the industrial sector.
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