The medical device company in question, let’s call them, ‘MedDevicesCo’, was established more than ten years ago in Shanghai, China, and has gained experience and market presence as a provider of medical diagnosis equipment. They have specialised in cancer detection, but also used their expertise to provide COVID-19 detection during the pandemic. Their first oncology tester hit the market around five years ago and this device was the successor, detecting a newly identified biomarker in the bloodstream of patients. MedDevicesCo has investments from global venture capital and private equity firms as well as private investors and banks. The device is for use in laboratories rather than in the home and does not need CE or FDA approval which again shortened the time to market substantially.

FVG’s first role was the PCBA (Printed Circuit Board Assembly), which they picked up after the first prototype had been built to prove the concept. They provided DfM (Design for Manufacture) services, while making quick turn prototypes, to ensure a speedy transition from prototype to low volume and eventually to full production numbers. At FVG, the DfM process is essential to the success of a product launch, minimizing redundant designs and retesting at each stage. Good DfM means a product’s entire life cycle is both consistent and reliable.

As part of the DfM FVG works closely with the customer and external agencies to make sure the test solution is appropriate and that the design makes that test process as simple as possible. In this instance the test was provided by an external test partner, which FVG collaborated with to create a robust and efficient solution that would guarantee every product was fit for purpose and would be reliable once in the field. These products are really in FVG's "sweet spot"; their SMT lines are configured for these volumes and this kind of product. The PCBA has more than 650 components of all shapes and sizes, both SMT and through-hole. The PCB is an 8-layer board which was designed in collaboration with FVG and the customer to ensure functionality, reliability, and ease of manufacture. The PCB design also had to consider the thermal relief management of the product and the higher-than-normal impedance requirements. Both things FVG is experienced in managing.

As with any new product, this tester needed a robust and well managed supply chain. Recently, component shortages have eased, but knowing when to get the parts needed and ensuring multiple vendors could supply them has become increasingly important. Essentially, FVG has moved from a JIT (Just in Time) strategy to something that is much more JIC (Just in Case). Supply chain reliability and security really is the order of the day and FVG has an excellent network, vertically integrated resources, and expertise in this area. Their supply chain helped accelerate the prototype and lower volume phases of the product and will continue to create a smooth and rapid transition to higher volumes delivered globally. They are actively ensuring that FVG and all customers are unaffected by any impending component shortage. This is something they have been doing for the last few years and it has been of great help to the entire customer base, as well as allowing them to maintain production and shipment consistency in turbulent times.

In essence this story is one of intimate collaboration, alongside the kind of detailed production planning that creates the fastest and most efficient route to market for a new product. FVG worked closely with the whole customer team and leveraged the skills and experience in DfM and product life cycle management to achieve the best outcomes for the customer while ensuring they received great value. FVG leveraged their global experience, design and test expertise, and manufacturing footprint throughout Asia to deliver a product that is right for the market and has a robust and scalable supply chain.

For more information on FVG’s medical device expertise or simply to learn more about FVG contact Victor Wong – victorwong@flexisb.com.my

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