Acumen Research Laboratories Pte Ltd: Medical Innovations Go Global with ISO 13485

ARL is a contract research company that provides customised, high-quality R&D services and IP technologies in molecular diagnostics. Since 2010, it has developed various in vitro diagnostic products to diagnose diseases or medical conditions. 
 
For example, its AcuSept biomarkers detect changes in a patient’s immune system that are indicative of sepsis, which is a severe disease with poor prognosis and can bring a fatal outcome. CEO of ARL Dr Ong Siew Hwa, said, “Accurate, quick and early diagnosis of sepsis is highly needed for effective treatment.”

Most recently, to address the pandemic, ARL developed polymerase chain reaction (PCR) tests that are able to detect infectious diseases such as pneumonia and the COVID-19 virus.

With the development of these devices, ARL wants to make them available globally to benefit the medical industries all over the world. Therefore, to get its diagnostic tests to be widely and globally accepted, the company adopted the International Organisation for Standardisation’s (ISO) 13485 Medical devices — Quality management systems — Requirements for regulatory purposes to meet the strict requirements set by governments worldwide.

“These (strict requirements are harmonised in ISO 13485 through a common, international language. It makes sense for us to adopt this standard at the start of our product development,” said Dr Ong.

Efficiency in Product Development

At the initial stage, it was a challenge for the company. ARL spent several years doing research, trial and error, creating multiple standard operating procedures (SOP) and getting feedback from different groups and consultants before successfully implementing ISO 13485 in 2018. 

“Few people around us were experts at it,” said Dr Ong. “We knew little and had to learn it all ourselves. In fact, our learning journey involved lots of online sources, including YouTube!” 

With the successful implementation of ISO 13485, the company has demonstrated its ability to provide medical devices and related medical services that consistently meet customers and applicable regulatory requirements.

Speeding up Good Decision-Making

While developing AcuSept, ARL referenced ISO 13485 at every step – from kick-starting the project to the manufacturing method and validation – which helped the company make sound corrections and decisions along the way with the standard’s frameworks and improved traceability.

With this experience, ARL was able to speed up the creation of the Acu-Corona test kit, spending only three weeks for Acu-Corona, compared to six years for AcuSept.

“We have become so familiar with ISO 13485 that we could speed up the entire value chain of product development,” commented Dr Ong.

“Guidance from the standard offered us confidence that our data and thus strategies are correct,” said Dr Ong. “Our decision-making, such as in the areas of procurement, documentation and the planning of resources and manpower, hinge on frameworks from the standard. We can now quickly decide between what is ‘nice to have’ and a ‘must-have’.”

Mitigating Risk 

The ISO certification also confirmed that ARL has adopted the right risk management approach for related processes in their quality management system.

Dr Ong said “I now think that it is a high risk not to adopt standards in upstream product development. Errors happen. Without some formula or process management guidance, it can get very costly to re-do parts in the development or validation process. Nobody wants to waste time or money.”

 
Commercialisation and Internationalisation

Additionally, adopting ISO 13485 has helped ARL to work with the right partners to ensure successful and fast commercialisation of its innovations.

For example, ARL collaborated with local manufacturer Sunningdale, which is also ISO 13485-certified, to manufacture its products as soon as they are designed. The partnership has grown to a joint set-up of a manufacturing facility to further expand its operations.

Meeting International Regulations

AcuSept is currently undergoing registration with Singapore’s Health Sciences Authority (HSA), while Acu-Corona is exported to Indonesia, Malaysia, Mexico and the United Arab Emirates.

These would not have been possible without ISO 13485, as HSA and most countries have made it mandatory for companies to put in place a quality management system before they can register medical products in the local markets.

Entering More Markets

In addition, the swift development of Acu-Corona and demands for the test kit due to the pandemic have led to a rapid growth of the company, with a five-fold increase in revenue in 2020.

With a good reputation grounded by standards, where quality is a fact rather than a promise, ARL has also been successful in forming partnerships in major markets like China and Germany, where it anticipates more co-creation and tapping into a greater talent pool.

Growing Singapore’s Standards Community

Standards are ultimately best implemented with a strong management support. Through her leadership, Dr Ong has been able to create a culture of excellence by prioritising standards.

She remarked that one could call standards a “bible of sorts,” as the guidelines are extremely mission-critical for innovators who want to develop a product that truly works, while reducing time-to-market and redundant costs.

“Today, it is very natural for the team to work with standards, which have become a daily part of our company’s culture,” said Dr Ong. “My advice for scientists is to take this necessary first step of adopting standards from the beginning even though it is very demanding, as the rewards will last a long time.”

She believes in standards so deeply that she is advocating for them as the chairman of the Technical Committee for Biotechnology, which is overseen by the Singapore Standards Council.

“More people can benefit from adopting standards,” she said. “It would also be great to have a stronger ecosystem of ISO-certified partners in Singapore, so that we can work together on world-class solutions.”