The electronic executive

Advances in microelectronics have given medical device manufacturers the ability to scale down components, thereby unlocking increasingly innovative and versatile applications. From wearable sensors and next-generation prosthetics, to stretchable electronics, the development of smaller and more powerful electronic components is opening up new avenues of research and improving patient outcomes in the process. But when microelectronic medical devices fail, patient outcomes may be severely impacted, which adds further pressure to ensure reliability in an era of miniaturisation already presenting significant challenges. To name just a few, there’s the need for functional integration of medical electronic assemblies, a lack of redundancy in medical devices, faster product life cycles and the use of new combinational technologies. It’s the need to overcome these challenges that has led to a strong and swift swing from manual to automated processes on the manufacturing floor.

“Microelectronics in medical devices rely on low power, ultra-miniaturisation, combinatorial technologies, a global supply base, stringent change management and long product life cycles,” says Dr. Ravi Subrahmanyan, executive director, Advanced Technologies Group, Micro Systems Engineering (MSE). “Assurance of reliability, quality and supply continuity of these often life-critical, life-sustaining but low volume devices involves capability assessment and control of process technologies through the entire value chain.” The workflow, component and process technologies, as well as the equipment and skills required, are diverse, explains Subrahmanyan. Given the diversity of technologies, specialists are often required in both direct manufacturing and other design or support functions. These specialists have STEM backgrounds, usually in more than one area, which can include expertise in materials, mechanics, electronics, computer science and industrial scale engineering.

Big challenges on a small scale

With miniaturised microelectronics, advanced assembly technologies are required to accommodate the need for reduced development cycle times, higher efficiency, and lower cost – all while maintaining quality and reliability. Factor in the rapidly changing global, political, and economic environment, which demands a manufacturing strategy that is independent of low-cost labour, and scalable and efficient manufacturing processes require increasing levels of automation.

“Some of the most important advantages are the greater operator safety that it brings to the assembly process, and reduction in worker fatigue and improvement in productivity,” says Girish Wable, senior manager, Engineering Services at Jabil – the industry’s largest provider of design, engineering and manufacturing services. “This allows workers the opportunity to up-skill and focus on higher value-add tasks. Once the automation platform is optimised, it can lead to significant microelectronics packaging design enhancement, material savings, energy reduction, product quality and reliability.”

The many steps involved in the production of microelectronics mean that automation can have an impact at several different points in the manufacturing cycle, each of which presents its own challenges, be it wafer handling, the printing of conductive and non-conductive adhesives, die bonding, wire bonding or any other part of the fabrication, inspection and testing stages. Semiconductor automation systems must also be able to adapt in the face of the changing demands placed on semiconductors or any other component.

When done successfully, automation can greatly improve ROI through better and more consistent wafer yields and less material waste. According to a recent IBM study, ‘Why cognitive manufacturing matters in electronics’, 100% of electronics executives – including semiconductor manufacturers – are planning to implement, or are in the process of implementing, artificial intelligence (AI) into their manufacturing process, with 83% reporting moderate to significant ROI due to improved yield predictions.

Automation can also reduce downtime through the reduction of human error, which results in cost and time savings. In wafer transportation, for example, human handling would carry a high risk of human error at each of thousands of steps in the manufacturing process, so automated material handling systems (AMHSs) are frequently used to prevent contamination and ensure that wafers are transported and positioned precisely. Similarly, errors can arise when testing performance criteria, so performance evaluation is increasingly automated for both individual components and assembled devices. Jabil’s medical devices team, which works with some of the leading brands in the industry to design and produce products across various domains, including minimally invasive devices, blood management, cardiology, patient monitoring and neurology, has seen first-hand both the advantages and challenges that automation brings.

Data-driven innovation

Subrahmanyan leads a team for selection and deployment of design and manufacturing technologies for use in high-reliability microelectronics applications, and is the coauthor of a recent whitepaper titled ‘Assuring Reliability in Medical Device Manufacturing Using Automation and a Digital Factory’, which outlines a fail-safe, fast response strategy for manufacturing reliable medical electronics in a controlled, data-rich, and cost-efficient environment.

“Some challenges are assuring supply continuity, especially given ongoing changes to and the obsolescence of microelectronics components technologies, as well as extended incoming data-focused quality control, so we draw on close partnerships with our supply base, proactive obsolescence management, digitally integrated workflow and data-rich manufacturing, among other things,” he remarks.

“We can then unlock the most important advantages of automation in microelectronics production – prescriptive control of quality and reliability, configuration management and improved cycle time,” he adds. “Consequences of this are lower costs and improved efficiency and scalability – both up and down – to dynamically adjust to demand. That helps us to overcome the challenges of miniaturisation, the diversity of technologies and the design constraints, as well as managing a global value stream that requires strict materials controls.” This innovative, data-rich approach used by MSE allows for consistency in microelectronics manufacturing, as it rapidly detects anomalies and enables faster remedial actions. The strategy employs the idea of a digital twin, relying on scalable factory automation and a digital factory concept to eliminate manual handling of product assemblies and data, automate workflow, and preserve traceability information.

“We have seen quality, cost and lead time improvements that meet or exceed customer demand,” observes Subrahmanyan. “Then there is the portability of processes, which are people-agnostic and can be reconfigured close to the next step in the value stream, which improves efficiency.”

As a companion virtual representation of the physical factory, a digital factory has the knowhow to manufacture a product, as well as the quality and transactional data that is unique to each serial number manufactured. The digital factory can identify the right workflow and recipes for that serial number and communicate this information to the physical production line, dynamically prescribing manufacturing operations and validating recipes and inspection parameters, as a product moves through the physical factory. “Advanced digital integration, configurable advanced manufacturing and distributed workflow are the next steps forward in automation,” says Subrahmanyan. “The traditional approach of a connected physical factory – like a conveyorised manufacturing line – is increasingly supplemented with software-control.”

“Manufacturers continually leverage automation capabilities from one industry to another out of necessity,” adds Wable. “Increased modularisation of manufacturing lines with common functional automation platforms built with robotics, sensors, actuators, operating software and artificial intelligence are emerging to be the common core.”

Innovation in medical device design must – and will – be matched by innovation in manufacturing processes. The latest advances enable the production and handling of silicon dies that are thinner than 25 microns, making them flexible enough to be placed in low-profile spaces that could potentially lead to minimally invasive smart catheters or contact lenses that require the placement of microelectronics in the gap between eyeball and eyelid. For all its challenges, automation is the key to designing and manufacturing the next generation of medical devices.

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The current state of electronics manufacturing

It’s been said that we are at the rise of a second machine age. While the first machine age drove industrialisation, this one uses digitisation and the ability of machines to access and put those digital assets to work. It makes machines, and the humans who work with them, smarter. The birth of “cyber-physical” systems combined advanced manufacturing technologies and advanced computing technologies to work together seamlessly. These new systems can exchange information, improve uptime and provide support to each other and their users. This new approach to manufacturing is mission-critical for electronics as seismic shifts occur on multiple fronts. Consider these trends:

• Multiple electronics manufacturing locales are encountering aging workers and worker shortages
• Most economies are seeing a rise in worker wages and difficulty in filling what once were highly desirable manufacturing jobs
• Billions of sensors collect data from machines, but electronics organisations often cannot access it – let alone make sense of it – for manufacturing purposes
• Users want more functionality and personalisation in the electronics produced.
• The downside cost of failure to deliver key metrics is increasing, placing a higher premium on quality, flexibility and throughput.

Source: IBM Institute for Business Value