Green Technology: Biomedical device industry set to improve healthcare

10/10/12 NST 

According to the Ministry of Health, Malaysia’s medical device industry is valued at about RM3.5 billion last year and is expected to reach RM5.3 billion by 2015. This seems likely as the global medical device industry is valued at US$320 billion (RM977 billion), which represents 25 per cent of the overall healthcare market.

The growth will be fuelled by an aging population, increase access to healthcare especially in Asia Pacific, changes in lifestyle, and a trend towards health tourism.

SIRIM has a long history of research and development of useful products that take advantage of Malaysia’s rich natural biodiversity. Advances in biotechnology and materials help produce more environmentally friendly solutions than traditional industrial process.

Medical technology has been identified as one of SIRIM’s three flagships areas along with energy and environment, and plant and machinery. Research teams in SIRIM are now working on developing biomedical devices and products that are safe for both the society as well as the environment.

Research and development are conducted in pilot plants that are designed to achieve good manufacturing practices (GMP) certification to ensure the quality of the products.

“We produce these biomedical devices in pilot plants before clinical trials because we can control everything in this scale in terms of the environment of the production,” explains Dr Ahmad Hazri Abdul Rashid, the General Manager of the Industrial Biotechnology Research Centre in SIRIM.

Advanced wound management systems

There are two biomedical pilot plants in located at SIRIM’s Branch in Sepang which focus on advanced wound management systems. The team, led by researchers Dr Ahmad Hazri and Dr Kartina Noorsal, develops six medical-grade products using chitosan in the form of thin film, sheet, paste, scar cream, sponge, and skin regenerating template (SRT).

Chitosan is naturally abundant and can be obtained from the exoskeleton of crustaceans, which also makes it cost effective. Because of its biocompatibility, biodegradability, hypoallergenic, and antibacterial properties, chitosan is suitable for open wound protection and for encouraging cellular regeneration.

The product is currently under clinical trial and samples are tested for biocompatibility and toxicity studies as part of the process of obtaining Good Laboratory Practice (GLP) certification.

According to Dr Ahmad Hazri, the trials have so far shown favourable response from the patients, with some patients even specifically requests for SIRIM’s chitosan medical products. He adds that the progress is a step towards the right direction, although new advancements are still waiting to be unleashed.

“We used to rely on synthetic wound dressing products. In the future, perhaps we can even use products made out of our own body. This can significantly reduce or eliminate the chances of rejection,” he explains. On top of that, this process would take nothing from external resources, which make it a lot more environmentally friendly.

Medical injection moulding

Another key research and development project by SIRIM in medical device focus on the use of metal injection moulding (MIM) to manufacture stainless steel surgical implants. SIRIM is one of the first institutions in the world to utilise this technique.

MIM is ideal for making intricate and precisely measured medical implants as the process begins with a soft and malleable metal paste unlike traditional metalwork. 

It produces practically zero waste and has a very low defect rate compared to conventional machining processes, making it ideal for high-value objects made of expensive metals such as components in micro-machines, automotive and aerospace applications.

The project is currently focused on producing simple, six-hole dynamic compressions plates (DCPs) designed to fix bone fractures. Although DCP is one of the most widely used metal implants to repair fractures, imported plates from Europe or the US tend to be designed for Caucasian bones. This makes some imported DCPs an ill-fit for the Asian bone structure. With locally made DCPs, this will soon be an issue of the past.

The project is conducted in two of SIRIM’s pilot plants in Penang, and is led by Dr Afian Omar, an award-winning researcher from Advanced Materials Research Centre, SIRIM.

As with any medical devices, the product will have to undergo a successful clinical trial, which is scheduled to commence soon, before it enters the market.

Providing a total solution in medical device

The teams behind SIRIM’s research and development efforts in biomedical are made up of material scientists, engineers, and chemists. The pilot plants are designed by SIRIM’s engineers. In addition, the researchers work with medical faculties in local universities to develop and test products in the lab as well as on clinical trials. SIRIM’s primary contribution is in the product development, while the universities oversee the medical aspects of the research.

“This type of collaboration takes into account the materials, engineering, as well as the patient’s need. It’s a total solution for the medical device products,” says Dr Ahmad Hazri.

New technology will also pave the way for new or improved medical devices to be developed in the future. There is a big potential in stem cell research and genetic engineering that can propel the biomedical devices industry towards this advancement.

Since the field of medical devices is still relatively new everywhere in the world, Dr Ahmad Hazri believes that it is an ideal time to be a key player in the industry, or risk losing opportunities.

In order to do that, it is important to keep up with the fast-paced nature of the industry and develop human capital. “Our people need to be of the right competencies. We need to invest in research and have the right facilities to enable the studies to be carried out,”he says.

It also has to be a joint effort between the government, local industry players, and the research institutes, as well as the consumers to develop this industry. The government is already taking the step in the right direction by focusing on biotechnology economy as one of the National Key Economic Areas, establishing ‘green lane’ policies for local biotech products, and introducing the Medical Device Act 2012.

The Act requires both imported and local medical devices to be registered with the Ministry of Health. Under this new act, medical devices are well regulated by assessing the safety, effectiveness and quality of the products before being placed in the market.

Presently, there are very few products that go into the market because most of the products are imported. There are also not many institutes doing research in medical devices.

“SIRIM has a role to play to fill in this gap and develop new devices and methodologies to test these products,” says Dr Ahmad Hazri. With the pilot plants, SIRIM can kick start the production of medical devices to help the local industry in terms of production capacity, which brings products into the market much quicker. In addition, SIRIM’s efforts pave the way for local companies to achieve sustainability faster as the companies need only to focus on the marketing of the products.

On top of that, Dr Ahmad Hazri expresses his hope that SIRIM’s research efforts in biomedical devices will help healthcare practitioners provide the best options for patients to heal faster and better.

Read more: Green Technology: Biomedical device industry set to improve healthcare - Extras - New Straits Times http://www.nst.com.my/nation/extras/green-technology-biomedical-device-industry-set-to-improve-healthcare-1.155066?cache=ynzfkhhlsup%3Fpage%3D0#ixzz2tZ9reCZj