Made in Singapore, Sold to the World
NUS inventors have played a key role in the global fight against the COVID-19 pandemic in myriad areas. One area of contribution: the nasopharyngeal (NP) swab, a flexible stick with a tip section that is carefully designed to collect and retain nasopharyngeal fluid samples from patients, to test for viral DNA.
The NUS-developed NP swab, IM2, has recently reached another milestone by receiving CE certification, which allows it to be marketed internationally.
Developed by Professor Freddy Boey, NUS Deputy President (Innovation & Enterprise), IM2 features a tip section designed with small blades that extend parallel to its longitudinal axis. When the swab is rotated, the perpendicular motion of these edges will scrape and collect the necessary fluid from the nasopharynx area. A clinical study by the National University Hospital revealed that the IM2 swab was comparable in terms of safety and performance to the standard-of-care swabs used to test for COVID-19.
In order to scale up production rapidly, IM2 swabs were designed in a way that could be injection moulded, which is faster and more cost-effective than 3D printing. 3D printing is another manufacturing process that has also been used to quickly manufacture NP swabs to meet the global shortage. Initially, the 3D printing process was faster, as it did not require one to make a mould. However, once a mould is made, injection moulding proves to be the more cost-effective process, with a considerably faster cycle time for mass manufacturing.
“Injection moulding as a manufacturing process is inherently faster than 3D printing as multiple units of the swabs can be produced in a given cycle. Several hundred swabs can be produced in a few minutes using the moulding process,” shared Prof Boey.
“The use of injection moulding ensures a secure source to supply high volumes of swabs at a low cost, to meet the needs of our community and beyond. This is crucial in our continued fight against the pandemic.”
NUS partnered with local contract manufacturer, Meiban Corporation, to mass manufacture and sterilise the IM2 swabs. Together, the NUS-Meiban innovation team collaborated on the selection of a suitable biocompatible nylon material, and the necessary tests to verify the cytotoxicity level of the material, as well as whether it was able to withstand the sterilisation process. In order to facilitate the commercialisation of these new swabs, Meiban set up a subsidiary, MB Medical & Healthcare, which licensed the technology from NUS and subsequently renamed the IM2 swabs AccuSwab®.
The first customer of AccuSwab® was Temasek Holdings, which has purchased and secured millions of units for the Singapore market. In view of the global demand for NP swabs, MB Medical & Healthcare then applied for CE marking, in order to market AccuSwab® within the EU and globally.
“Getting MDR with CE certification was not a simple process. There was significant documentation to complete, and this process took MB Medical & Healthcare about six months. We were delighted to receive CE marking in January 2022, as it confirmed that our AccuSwab® has met EU safety, health and environmental protection requirements,“ said Ms Helen Ho, R&D Director of Meiban Corporation.
“In fact, we are one of the first companies to receive CE certification for nasopharyngeal swabs. Now that we have received the certification, we will soon start selling AccuSwab® internationally.”
MB Medical & Healthcare is also in discussions with a distributor in Germany to sell AccuSwab® in the EU this year. In addition, it is also looking to form regional distributional partnerships to handle the Asia market.
“The development, localised manufacturing and sales of AccuSwab® has been a multi-organisational effort. In order to ensure that Singapore had sufficient supply of nasopharyngeal swabs during those pressing times, Temasek Holdings brought Meiban together with NUS, to look at the design and manufacturing of nasopharyngeal swabs. NUS’ proposed design is inventive and ideal for large scale manufacturing. Meiban was delighted to work with NUS on the innovation process to design and develop these swabs, and then with NUH on the clinical trials to demonstrate their safety and efficacy. We are grateful for the opportunity to work with NUS and NUH,” said Ms Ho.
“The AccuSwab® is now manufactured under MB Medical & Healthcare’s ISO13485 facility with 100 per cent quality control, to meet Singapore’s strict manufacturing requirements for medical devices.”
By NUS Enterprise
