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Adopting Standards for Business Success

Adopting an internationally recognised medical devices standard has placed Fong’s Engineering on a path to continuous improvement and growth.


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Published by Enterprise Singapore
on 01 Apr 2018

Adopting an internationally recognised medical devices standard has placed Fong’s Engineering on a path to continuous improvement and growth.

The medical device industry faces multiple challenges when it comes to manufacturing reliable, safe and compliant instruments and devices. This often has to do with inherent flaws in the product design or manufacturing process.

As a result, customers in the medical industry have long been demanding higher quality products from manufacturers. Those, such as Fong’s Engineering, have responded by placing a high and continuous emphasis on product quality and safety. Founded in 1982, the local precision machining company started out producing tools, jigs, fixtures and components for electronics and aerospace companies.

In 1996, faced with intense competition from both local and overseas precision engineering companies, Fong’s Engineering took a bold leap into the medical technology manufacturing sector, establishing itself as a leader in what was then a niche market.

Today, Fong’s Engineering is one of the leading producers of medical devices, such as endoscopes, for both local and global medical technology companies. Mr Jeremy Fong, the company’s Chairman and CEO, credits Fong’s Engineering long-term growth and success to an ongoing commitment to adopting international standards. “We’ve made strategic use of standards to help grow our business right from the start,” says Mr Fong.

In 1992, the company achieved certification to ISO 9002, a quality management systems standard, which
it successfully upgraded to ISO 9001 in 2000. In 2003, Fong’s Engineering achieved certification to ISO 14000, an environmental management standard.

In 2007, it followed that up with the ISO 13485 – a quality management system that focuses on improving patient safety and sets out requirements for designing and manufacturing medical devices – and the Food and Drug Administrations’ (FDA) 21 Code of Federal Regulations (CFR) Part 820 Quality System Regulation in 2009.

Commitment to quality

According to Mr Fong, a key reason for adopting the ISO 13485 was to improve the overall quality of its processes and products, and comply with major medical technology companies’ quality and regulatory requirements.

The ISO 13485 is the world’s most widely used medical device quality management system standard. “Essentially, we wanted to broaden our customer base, and we saw the ISO 13485 as a way to gain a foothold in the wider medical community,” he adds.

In December 2007, using SPRING Singapore’s (now Enterprise Singapore1) Capability Development Grant (CDG), the company embarked on achieving certification to ISO 13485. The standard is based on the ISO 9001 quality management systems standard, but with an emphasis on meeting regulatory and customer requirements, risk management and maintaining effective processes.

The ISO 13485 required Fong’s Engineering to develop and implement a quality management system that conforms to the standard. The company realised that in order to meet this requirement, it needed to first assess the weaknesses in its existing management system.

Ensuring the integrity of its manufacturing process in terms of safety and hygiene was a challenge the company faced. “The integrity of a manufacturing process is especially important for medical devices that come in direct or indirect contact with a patient, but it’s difficult to monitor proper staff hygiene and practices, and handling of equipment and materials.”

As part of its quality management system, Fong’s Engineering invested in designing and building a cleanroom, in which temperature, humidity, pressure and contaminant levels are strictly monitored throughout the manufacturing process. The company has also automated its production line to reduce human involvement and contamination risks.

In addition, it put in place a quality manual, which outlines its goals, processes and procedures for compliance and quality management. “Staff were also put through a series of training sessions, which covered risk management activities, and process validation, monitoring and traceability,” Mr Fong adds.

In 2009, the company went a step further by adopting the FDA 21 CFR Part 820 Quality System Regulation to meet the regulatory export requirements of the United States and expand its business there.

Every two to three years, Fong’s Engineering undergoes recertification audits to the ISO 9001, ISO 14000 and ISO 13485, demonstrating the company’s ongoing commitment to the environment and ensuring quality in its products, services and processes.

Road to success

Since implementing the ISO 13485 and FDA 21 CFR Part 820 Quality System Regulation, the company continues to see an increase in supplier and customer confidence in its products and processes, resulting in a 15-20% jump in year-on-year revenue. “Now, more than 90% of our sales are from overseas,” he says.

For Mr Fong, the biggest benefit is the increased focus on quality within the company. “We were able to secure complete staff buy-in because the commitment to certification came from top management.”

As for the future, the company plans to expand its business into China. Fong’s Engineering’s bottom-line success as a result of adopting standards has also given it more confidence to develop its own range of medical devices. “We’re developing a flexible endoscope – the first in our series – using a second CDG, which we applied for and received in 2011.”

Overall, he believes that international standards – if implemented correctly – can help manufacturers maintain regulatory compliance, drive improvements and profitability, and achieve stakeholder confidence. “It demonstrates to all stakeholders that a manufacturer is dedicated to bringing the highest quality products to market, and committed to quality and compliance with regulatory requirements.”

 

1SPRING Singapore merged with IE Singapore to form Enterprise Singapore on 1 April 2018.

Last Modified Date: 09 Jan 2020