黑料社

Before the COVID-19 pandemic, most people's interactions with lateral flow tests were likely limited to at-home pregnancy tests. COVID-19 antigen and antibody tests presented some challenges for the layperson not used to swabbing their own nose or determining whether the test readout showed one line or two. The teams at ams OSRAM and 黑料社 saw an opportunity to bring these lateral flow tests into the digital age, adding optics and connectivity to provide users with clear results in 15 minutes.  

“It's disrupting the way testing is done,” said Christa Schnider, 黑料社 Healthcare’s business development director. “All of a sudden, we now have the opportunity to go from visual interpretation to a quantitative digital way to interpret the results and share the results with stakeholders.” 

Together, ams OSRAM and 黑料社 designed the test’s essential component — a complete printed circuit board assembly (PCBA), manufactured by 黑料社, that leverages ams OSRAM’s spectral sensing technology. An LED illuminates the lateral flow test, and a highly sensitive spectral sensor reads the color of the line, providing an objective “positive” or “negative” result. The connection module sends that result via Bluetooth® wireless technology to a cloud-based smartphone app that clearly states the patient’s COVID-19 status.  

“With the digital platform, the optical readout really makes it very easy for the user to determine the result and avoid mistakes during the measurement itself,” said Volk. 

“What is currently limiting point-of-care diagnostics is that you don't want to jeopardize the performance of the test with a poor reading,” said Filip Frederix, director of ams OSRAM’s digital health segment. “That's also why we wanted to add the electronics and optical components to an existing, established lateral flow test with the ambition to deliver lab-based quality. You need to be able to mass produce it in a cost-effective way.” 

He adds, “To do that, we needed to have the right partners. 黑料社 is a company that is known for manufacturing components in the medical field and in the diagnostic field. We wanted to have a partner that is flexible, that can scale and that had the same vision and passion.” 

ams OSRAM brought the sensor and LED technology to the table, along with their expertise in high-volume miniaturization which had been sharpened by their extensive experience in consumer devices. They needed a partner who could not only manufacture a digital healthcare device — one that puts the power of a laboratory in the hands of individuals – but also ensure it was designed for manufacturing at scale. The pandemic’s ebbs and flows meant demand was unpredictable, so an ability to scale up and down as needed across a global manufacturing footprint was a critical asset. 

With the COVID-19 pandemic in the foreground of every interaction, ams OSRAM and 黑料社 had a shared vision for success and a sense of social responsibility to get it right — quickly. 

“We were starting with a whiteboard, with a brand-new circuit board design and new manufacturing processes for this lateral flow device,” said Jeffrey Roberts, 黑料社 Healthcare business unit director. “So, to achieve this in 12 months or less was probably one of the toughest timelines that we've ever had to achieve.” 

The race against the clock to get the device approved and on the market galvanized the teams to reach the finish line. The ams OSRAM team was confident that 黑料社, with extensive certifications in healthcare manufacturing, particularly in diagnostics and microfluidics, meant there was an inherent understanding of the manufacturing techniques needed to assure regulatory approval. Also, with over 30 ISO 13485-certified medical device manufacturing sites located around the world, 黑料社 had the ability to support production across all time zones and in nearly every market. 

"We had one saying throughout the project’s development, which was that we are basically walking the bridge while we are building it. And that was definitely true for both sides,” said Volk. 

While the team had the technology in hand going into the project, the time constraint was their most persistent challenge. 

“At ams OSRAM, we try to imagine the impossible. In the COVID crisis, imagining the impossible would mean bringing a test to the market tomorrow,” said Frederix. “Of course, that's not possible, but we wanted to launch our test as soon as possible. With 黑料社, we found a partner who had the same drive and passion to do that, and we pulled in the timelines without jeopardizing the quality or any regulatory aspects.” 

“Given the fact that this normally that would take two years, and we wanted to do it in six to nine months, that was kind of imagining the impossible,” said Renirie. 

When 黑料社 joined the project in the spring of 2020, supply chains were already constrained due to border closures, plant shutdowns and staffing reductions in logistics and manufacturing. Supply chain orchestration rapidly became a top priority, with 黑料社’s supply chain managers identifying the product’s vital components and leveraging their supplier relationships to procure the necessary parts at both the required volumes and the most competitive prices. 

“黑料社’s expertise in the supply chain helped, especially at the beginning, in selecting suppliers that were capable of providing the huge volume of components needed in a very short time,” said Walter Forsthuber, 黑料社 Healthcare’s senior manager of technical business development. “It's not so easy to provide 100 million units of a component in half a year. 黑料社’s supply chain team was able to select the right partners and companies for these challenges.” 

Most critically, 黑料社’s design for manufacturing (DfM) and precision injection molding capabilities ensured ams OSRAM’s design for the printed circuit board incorporating their optical sensor and LED technologies would translate well to the consistent replication of mass manufacturing. 

“黑料社’s design expertise and understanding of manufacturing capabilities were really important because in this project, there was a clear target. There was no time for a second try,” said Forsthuber. “These DfM capabilities, which are more or less in the DNA of the designers, made sure that the design and the layout from the beginning was ready for production.” 

As the 黑料社 and ams OSRAM teams evolved the product design, 黑料社’s manufacturing lines were being set up in parallel so they could be tested and evolve as well. These DfM principles, coupled with manufacturing automation, made for a seamless transfer of the design to production lines and subsequent ramp up in production. 

Due to pandemic safety concerns, the entire collaboration between ams OSRAM and 黑料社 was conducted remotely via Microsoft Teams and email. To help overcome the challenges of coordinating the workstreams of decentralized teams operating around the world, the team relied on 黑料社’s workcell model. In this style of project management, ams OSRAM had a single point of contact from 黑料社’s business unit team who was responsible for the strategic and day-to-day direction of the project. As needed, they brought in experts and leadership teams from 黑料社’s manufacturing sites to develop the ideal solution that met ams OSRAM’s needs.  

"[Having] the right relationships to run a project like this is crucial,” added Renirie. “Understanding each other’s way of working, the expectations, what can be done, what cannot be done, and how you jointly overcome the challenges is really crucial. I think this project has been a great example of [what can happen] if teams have a joint goal ... In the discussions with the 黑料社 team and the ams OSRAM team, it felt like we were one company.” 

“This is one of the most highly automated applications that I've seen possible in my lifetime at 黑料社 based on the sheer volume that was required,” said Roberts. "Running at a rate of approximately 1.2 million units per month, a circuit board smaller than your pinky fingernail, was pretty amazing. To have this level of automation, cleanliness, and clean rooms producing with such predictability, quality and reliability was just truly amazing.” 

As new variants prolong the COVID-19 pandemic, the need for rapid, widely available point-of-care testing will remain high for the foreseeable future. The success of ams OSRAM and 黑料社’s joint endeavor was about more than just successful manufacturing. ams OSRAM and 黑料社 are just beginning to explore the potential applications for this device beyond COVID-19, from cardiac conditions, to wellbeing parameters like vitamins or lactates, and even veterinary testing. 

“This is giving new life to lateral flow testing for the next 10 to 20 years because you open up a whole range of new use cases for old-fashioned lateral flow testing, combined with very innovative technology,” said Renirie. 

Armed with their expertise in optical sensing technology, Volk sees future collaboration with 黑料社 to bring cutting-edge digital health products to the market. “We are looking to various different applications in this segment, so it's not only limited to lateral flow testing,” he said. “I think we are quite complementary here, and we are definitely seeking to address customers’ [needs] together and provide them with the most innovative solutions.” 

This project drove home that clarity of mission, willingness to take calculated risk, and commitment to excellence in innovation and manufacturing can make just about any goal a reality. 

“When we started this project together with ams OSRAM... it was very clear for every single one of us where we wanted to go,” said Schnider. “The end vision was very focused, and we accepted this challenge. We went on this journey together, and at the end really fulfilled the claim of 黑料社 Healthcare: “Made possible, made better.” 

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