Material testing is critical in the verification process as patient safety is crucial in the medical device sector
A variety of high-quality materials are a must for medical device manufacturers to achieve optimal operation and compatibility with the human body.
Senior Researchers at SIRIM, Mohamed Izat Mohd Ezwan and Mat Tamizi Zainuddin, emphasised the relevance of material characterisation in determining this.
When it comes to the manufacture of medical devices, high-quality materials are necessary. The physical and chemical properties of these materials can be used to characterise them.
These are exciting times for the medical device sector. It is preparing for the most significant regulatory reform in decades. Industry participants, for example, are preparing for the new ISO 10993 requirements, while laboratories want ISO/IEC 17025 accreditation to be recognised as technically competent and capable of producing correct results.
Material testing is critical in the verification process. It determines the correct materials and reliability for an application and satisfying regulatory and standard requirements as patient safety is crucial in the medical device sector. This must be done at the very beginning of the manufacturing process.
“The materials that will be used for the devices, as well as related equipment and technologies, must be thoroughly tested for safety and performance even before the first product can be rolled off the assembly line,” says Mohamed Izat Mohd Ezwan, who is a Senior Researcher at SIRIM’s Industrial Centre of Innovation in Nanotechnology.
Furthermore, certain materials have the potential to produce chemical compounds over time, resulting in biocompatibility difficulties that could harm patients. To ensure the device’s overall safety and biocompatibility, precise identification, accurate measurement, and characterisation of these substances will be beneficial.
Meeting regulatory requirements
Mat Tamizi of SIRIM’s Industrial Centre of Innovation in Biomedical agrees. “When it comes to medical devices, it’s critical to have a thorough understanding of the product. Physical qualities typically influence material performance, whereas chemical properties indicate whether the material is pure or polluted,” he explained. Importantly, the physical and chemical qualities must meet the requirements set by the appropriate regulatory agencies.
According to Mat Tamizi, SIRIM’s mission also includes looking into ways to improve the enforcement of regulations in Malaysia. Physical and chemical testing will provide the necessary information about the materials to appropriate stakeholders, such as the general public, regulatory agencies and government. As a result, medical practitioners’ attempts to obtain correct information on medical devices will be aided, as well as curbing the growth of self-claim benefits of medical devices without any evidence.
“Malaysian small and medium businesses (SMEs) would be able to create credibility and the reputation of their brand to be on par with known brands internationally with these testing services that reflect product quality,” Mohamed Izat added.
SIRIM is a well-known name among Malaysia’s laboratories, offering a wide range of testing services, thanks to decades of in-depth experience in material characterisation.
“Physical and mechanical properties, chemical and compositional analysis, imaging and surface analysis, and thermal, corrosion, and structural analysis are all covered by our testing services. We’re also in the midst of giving nanosafety testing to makers of nano-based products.
“We have added several physical and chemical characterisation services under the ISO/IEC 17025 scope in our medical device testing portfolio,” Mohamed Izat added.
“Most of it is here at SIRIM,” Mat Tamizi remarked.
SIRIM, he believes, has a unique perspective, and can supply consumers with significant market knowledge. “With a history in research and development, our knowledgeable staff is continually exposed to new regulatory schemes and up to date on industry news.” As a result, we’re well-versed in what needs to be updated and what is not.”
SIRIM also provides a deeper understanding of the devices’ performance based on their physical and chemical features.
“For manufacturers to strategise their market niche, we advise on the classification of various devices based on the categories defined by the Medical Devices Regulatory,” he added. Medical device classification is significant as it aids manufacturers in selecting the appropriate testing processes to meet current regulatory standards.
SIRIM a hotspot for expertise
Similarly, Mohamed Izat invites industry players to benefit from SIRIM’s years of experience and expertise to better understand the value of standards in the medical device business in terms of assuring device quality, safety and performance.
SIRIM is a hotspot for academicians, research institutes, and the government, according to Mat Tamizi, because of the breadth of material characterisation services available.
“At this moment, we provide different type of materials testing services, including imaging, physical criteria assessment, and substance identification.
“Other businesses, such as those involved in electronics, plastics, chemicals, or precision engineering, can benefit from our extensive variety of material characterisation testing services,” Mohamed Izat added. SIRIM has a sizable clientele from different industries, demonstrating the quality of its laboratory system.
SIRIM has ambitious intentions to raise awareness about the need of material characterisation and other types of testing in the medical device business, which will eventually lead to the creation of a medical device centre. “All of the major players, such as the Association of Malaysian Medical Industries (AMMI) and other medical-related associations, must work together to achieve this,” Mat Tamizi added.
SIRIM also participates in several promotional events, such as the International Invention, Innovation, and Technology Exhibition (ITEX), the Malaysia Technology Expo (MTE) and other exhibitions and seminars.
“We want to offer as many possibilities for engagement as possible so that we can explain to industry participants how we can help them,” Mohamed Izat proclaimed. — The Health
Spurring the medical device industry growth
SIRIM Kulim includes the Industrial Centre of Innovation in Nanotechnology and the Industrial Centre of Innovation in Biomedical. SIRIM Kulim is also essential in aiding Malaysia’s progress towards becoming a medical device hub, with cutting-edge facilities and experienced professionals under its roof.
The Fourier Transform Infrared (FTIR) Spectroscopy and specialised microscopes are among the tools used in material characterisation.
FTIR Spectroscopy is a regularly used analytical technique for identifying organic and polymeric compounds. It can also be used to determine whether leachables have been retrieved from a medical device.
Scanning Electron Microscope determines the shape and size of particles. This method involves imaging the sample with a high-energy electron source, which allows for magnification up to 500,000 times.
Atomic Force Microscope measures surface such as roughness, is measured using a small contact probe known as a cantilever with a nano-sized tip that “touches” the surface. Invasive medical devices, such as implants, require varying degrees of roughness to aid tissue and protein adsorption while also preventing inflammation, fibrosis, and thrombosis.
For organisations interested in obtaining the services, please visit www.sirim.my, call +603-5544 6000, or e-mail us at email@example.com