The manufacturing industry is experiencing its first radical change in decades. While the traditional engineering cycle from design to manufacturing can take months or even years, smart manufacturing practices are empowering engineers to bring their designs from concept to prototype more quickly, thus, enabling them to experiment and innovate more often.
 
The medical technology industry is growing rapidly and is a critical part of the larger global healthcare field—Statista reports the global medical technology industry’s market size as of 2019 is $430 billion. As medical treatments, systems operations, and preventative care become more technology-based, there is a higher demand for electronics prototypes and the use of materials and assembly methods like 3D printing and printed circuit boards (PCBs). These products require fast development and turnover to meet the highly competitive, growing medical technology market. To meet these demands, medical device engineers require the ability to generate high-quality prototypes for complex electronics products in record speed—a process that can be achieved more quickly through the process of software-powered PCBA (printed circuit board assembly) manufacturing.
 
What Role Does PCBA Play in Medical Technology?
From technology like electroceuticals (referring to the concept of delivering pharmaceuticals to patients via small electronic implants) to new sensor-based wearables that track the activity of patients—medtech is evolving to rely more heavily on embedded computing to provide new levels of functionality. Over the last couple of years, a number of innovative medical devices have been introduced to the market to aid medical practitioners in performing testing that was traditionally limited to large medical facilities.
 
At the heart of the advancements being made in the Medtech field are the PCBs found within electronic medical devices. As technology has matured in healthcare, PCBs have become increasingly important to the development of new devices; the internal computers are often so small that they require high-density interconnected PCBs to properly function. These PCBs can be used in anything from a pacemaker or heart monitor, to MRI and CT scanner equipment.
 
It’s imperative for engineers working on new medtech to be able to produce more iterations of their designs with efficiency and speed. The faster that engineers and designers from medtech manufacturer companies are able to receive prototypes back and learn from data provided to them through the manufacturing process, the quicker they are able to make valuable changes that ultimately create better end-products and further advance the Medtech field.  
 
The legacy contract manufacturing (CM) process for PCBA utilizes what is known as the black box approach—a slow process that offers little-to-no insight on the outcome of their designs prior to manufacture and one that can take weeks or months to complete. With a black box approach, PCBA design and manufacturing requires considerable time to make corrections to the design files before the board layout specifications are synchronized with the equipment capabilities and processes of the CM. A white box approach, on the other hand, utilizes software-powered electronics manufacturing and data to fill the communications gap between engineers and CMs by providing information gleaned directly from the connected factory floor and software to accelerate the end-to-end PCBA process.
 
Advancing Medtech Electronics with Smart Manufacturing
The white box approach leverages software and smart manufacturing using a network of connected devices on both the front and back end of the PCBA process to automate the flow of information in a continuous cycle of design, build, and test. A PCBA smart factory that connects customer engagement, order processing, parts sourcing, factory operations, and shipment of finished PCBAs into one continuous cycle, is the future of prototype electronics manufacturing for Medtech and other industries. The ability to build and deliver high complexity printed circuit board assemblies in just days instead of the weeks typical of other manufacturers often cuts the total project time in half, and by leveraging software on both the user front-end for quoting and ordering, and on the backend for factory operations, a smart factory is able to create an unbroken data flow from customer to manufacturer.  
 
GE Healthcare is one example of the power of smart manufacturing in accelerating the production of PCBA for medical product design. The GE Healthcare Microscopy Imaging Systems team needed to manufacture a set of complex designs and construction and programming of a test fixture for design testing. For GE Healthcare, quality and precision are very important as the products they make contribute to life-saving discoveries by hospitals, research laboratories, institutes, and universities. These high standards can only be achieved when their engineering teams have time to quickly fail and iterate. 
 
Before working with a smart factory CM, the team had to routinely wait up to an entire month to receive finished boards back and even longer for new designs. These long wait times compromised their chances of meeting design deadlines. Using a software based smart PCBA manufacturing approach, GE Healthcare was able to receive complex boards back within five days, which significantly shortened the ‘fail and iterate’ process. Being able to fail faster had a direct impact on the team’s timeline and resulted in a better-quality prototype—for both the testing and revision process as well as the final product.
 
Conclusion
Due to strict compliance rules from the FDA and other medical regulatory bodies, PCBA for medical devices requires the ability to design, build, and test until the device meets a set of strict performance requirements such as reliability, quality, safety, and other factors. Engineering teams should consider switching to a new model of design and development for PCBAs that leverage software and automated systems to not only provide PCBs back quicker, but also offer data that can provide important insight into their design process and product lifecycle.
 
The implementation of PCBs in medical devices will continue to expand as the technology grows: Zinnov.com reports that research and development (R&D) expenses in the med-tech industry are expected to reach 36.4 billion USD by 2021, largely due to investments made into advanced technologies. To help further expedite this growth, engineering teams and key decision-makers alike for medtech manufacturers should consider a more streamlined approach to electronics development using software-powered smart manufacturing.
 

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Sudeep Goswami is the vice president of sales for Tempo Automation. An accomplished business leader with over 20 years of operational experience, Goswami's work spans corporate strategy, inbound product management, outbound product marketing, technology implementation, and new business development. Prior to Tempo Automation, he held leadership positions at Cisco and Cumulus Networks.