The deep impact of digital transformation in medical device manufacturing

Making the case for digitally mature medical device manufacturing, John Danese, industry director, lifesciences, Birlasoft points out that currently, manufacturers use numerous paper-based maintenance manuals, which usually takes a lot of time to read and memorise. With AR, organisations can simplify maintenance. For instance, operators will be able to see the status of the device using AR headsets and access procedural content, including process steps, audio and video instructions

In today’s digital era, medical device manufacturers mostly rely on paper-based operations and systems that are long past their shelf life. Increasing production requirements are posing difficulties for manufacturers, because most processes are manual and the systems function in silos. Workers today don’t have quick access to the right information to perform their jobs. This significantly increases compliance and quality risks in the shop floor.

There is a growing need for centralised systems that can track and distribute content, and mobile applications that offer easy access to manufacturing processes. As a result, companies are integrating advanced mobile applications and cloud solutions that bring shop floors online. According to IDC, 77 per cent of manufacturers view digital transformation as an opportunity, while only 23 per cent see it as a risk, making digital transformation a top priority among most manufacturers. Sensing this trend, organisations are now digitising their shop floor, warehouses and supply chain network to improve quality, flexibility and efficiency in operations.

With a connected shop floor, facilities can support manufacturing 24/7 and improve productivity. Capabilities such as real-time analytics/monitoring, and BI systems can help manufacturers gain enhanced visibility into the processes. They can discover and act on insights faster, while making smarter decisions on the move.

This holistic, data-driven approach can help improve agility and efficiency of manufacturing processes, while maintaining quality and compliance.

Industry 4.0 and Quality 4.0: Two pillars of a smart ecosystem

Complex devices, small batches, rising demands, high mix orders and increasing costs add to the complexity of shop floor management. Industry 4.0 is a manufacturing model that enables businesses to solve these issues, increase production capacity and improve process efficiency. At the crux of this model lies a modern manufacturing execution system (MES) that can equip medical device manufacturers against quality issues, regulatory compliance issues and change.

Quality 4.0, on the flip side, is derived from Industry 4.0. It is defined as the adoption of smart technologies to improve operational efficiency and product quality. Quality 4.0 enables smart systems to integrate seamlessly with traditional systems such as manufacturing execution (MES), enterprise resource planning (ERP), product lifecycle management (PLM), or compliance training systems across the value chain. It enables end-to-end processes that help resolve issues faster.

Analysing operational data (or quality information) enables proactive risk management, by addressing quality issues early on. Real-time quality data can be analysed to increase productivity and allocate resources based on risk and need.

Next-Gen regulatory compliance

Digital processes enable the shop floor to rapidly align with production needs and to be more responsive to new regulatory requirements. Cloud applications, delivered with built-in mobility, advanced analytics and user-friendly and tailorable user interfaces, enable enhanced agility and visibility for decision makers.

These modern applications are developed for continuous uptime. It enables companies to make configuration changes on the move while reducing the burden of episodic and large validation efforts.

Training for improved quality management

A connected shop floor supports training methods that provide the flexibility and versatility needed in smart manufacturing. Information, delivered as relevant digital procedures and work instructions, can be presented to workers seamlessly at specific points in the manufacturing process. This reduces learning complexity and builds alignment with new processes.

Companies can expect better results from training programmes that are shifting from individual, content-driven events to a deeply contextual, social learning experience embedded into everyday workflow. Mapping training content based on job functions, then delivering it through a content-centric experience simplifies training, while making it more cohesive and integrated with quality goals. This approach ensures that the workers are trained and always accessing the latest procedural content to do their jobs.

Role of Augmented Reality (AR) in device assembly, quality control and maintenance

In a smart manufacturing scenario, AR can be used to access digital twins of the devices on the shop floor. The technology can effectively assist workers in assembling products/devices with high accuracy. And to achieve this, all they need is head-mounted AR headsets and/or tablets. This essentially changes the entire dynamic of spending hours on assembly and quality control. AR makes the process seamless, and fixes issues on the first try. As a result, AR not only reduces the rate of errors in assembly, but also minimises paperwork.

Maintenance plays an integral part in medical device manufacturing. Currently, manufacturers use numerous paper-based maintenance manuals, which usually takes a lot of time to read and memorise. With AR, organisations can simplify maintenance. For instance, operators will be able to see the status of the device using AR headsets and access procedural content, including process steps, audio and video instructions.

 A truly digitised manufacturing facility is a holistic ecosystem. It moves beyond the shop floor and influences organisations and the ecosystem in its entirety. It is integral to the broader supply network and has multiple aspects that manufacturers can leverage to adapt to the rapidly evolving marketplace.

In 2020 and beyond, digitally mature manufacturers will be able to create smarter and more agile facilities. They can bring people, processes, and technology together to establish a robust and seamless manufacturing environment that benefits all.