As healthcare IT increasingly leverages mobility and cloud technology to connect with medical devices and fitness apparel and to monitor patient conditions, traditional life science manufacturers are under pressure to deliver innovation that improves patient outcomes.
Automation is not new to the life sciences industry; life sciences companies have been connecting to shop-floor automation devices and sensors via local area networks for some time. Remote data capture has been active in clinical trials and in field service instances over telemetry, and biologics has been managing cold chain products for long period. However, the industry’s shift from selling products that connect with end users to selling services is creating a catalyst for change and a renewed interest in the Internet of Things in the pharma and medical device industry. This is reinforced by recent acquisitions of on-premise manufacturing execution systems (MES) vendors by big automation players in the market.
Life sciences companies today are challenged by the inability to monitor temperature efficiently during transit. The goal is to record any temperature variances and note failures at any stage of the distribution chain, from wholesalers, third-party logistics (3PL), and retail pharmacies or hospital clinics, where products are dispensed to patients. Inside the manufacturing shop floor and warehouse, refrigeration is a critical parameter that needs to be monitored constantly, as it can critically impact product quality. Sensor providers can help achieve this from a hardware and data capture perspective, whereas an IoT platform with adapters/connectors to edge level providers has a big role to play from a communication, workflow, alerting and analytics, and mobility perspective.
Effective process validation is essential to ensuring drug quality. Process validation is the collection and evaluation of manufacturing data, from the process design stage through commercial production, which establishes scientific evidence that the process is capable of consistently delivering quality product. Process validation involves a series of machine-learning activities, along with manufacturing and quality processes, over the life cycle of a product.
Life sciences companies require that processes remain in constant control, so they must consistently check for intra- and inter-batch variances while maintaining product quality and quantity. Full functionality of all critical manufacturing attributes and quality parameters must be assessed for their role in processes, along with any impact on products. Customer returns and drug product recalls have severe cost implications. IoT tools with graphical user interfaces that connect to the laboratory information management system instrumentation layers such as chromatography machines will help manufacturers discover new insights in Big Data and leverage predictive analytic to improve business processes.
Manufacturers need strong collaboration with partners like hospitals and other healthcare providers that monitor and record patient data from medical devices and products used in the field, as this information enables them to address any problems or issues that could affect patient heath. Business challenges include collecting equipment usage data from patients, identifying equipment requiring maintenance or calibration, updating technology based on patient performance data, and devising the right value-added services.
Connecting manufacturers with medical equipment in the field will enable providers to easily recognize patients and ensure that the correct treatment is being administered. This in turn can help improve outcomes and reduce readmissions by engaging both patients and caregivers, customizing protocols based on progress, and identifying potential areas of improvement.
The digital economy offers the life sciences industry new opportunities to boost market share by reimagining business processes and pushing value-added services beyond manufacturing and service and into the extended supply chain.
Explore how to bring Industry 4.0 insights into your business today by reading “Industry 4.0: What’s Next?“