Precision BioMed Malaysia has achieved ISO 13485 certification for its Penang-based additive manufacturing facility, making it the first Malaysian company authorized to produce 3D printed medical devices for commercial sale. The certification enables the company to manufacture custom orthopedic implants, surgical instruments, and anatomical models for hospitals across Southeast Asia.
The facility specializes in titanium implants for spinal, cranial, and joint applications. Using selective laser melting technology, the company produces patient-specific implants designed from CT scans. Each implant is customized to the patient’s anatomy, potentially improving surgical outcomes compared to off-the-shelf devices.
“Malaysia has strong capabilities in medical device manufacturing, but most production has been for Western companies under contract,” said company founder Dr. Ahmad Rashid. “Our vision is to develop Malaysia’s own medical device brands and serve the regional market, where demand for orthopedic solutions is growing rapidly due to aging populations.”
Achieving ISO 13485 certification required extensive documentation, process validation, and quality control system implementation. Precision BioMed worked with international consultants and invested approximately 15 million ringgit in equipment upgrades and quality infrastructure.
The company has secured distribution agreements with hospitals in Malaysia, Thailand, and Indonesia, with plans to expand to other markets pending regulatory approvals. Pricing for custom implants is approximately 30-40% lower than products from established Western manufacturers, making them more accessible in price-sensitive markets.
Malaysia’s government has identified medical device manufacturing as a strategic growth sector. The Malaysian Investment Development Authority (MIDA) provides tax incentives for companies investing in advanced manufacturing technologies, and regulatory agencies are working to streamline approval processes for innovative products.
The success of Precision BioMed could encourage other Malaysian manufacturers to explore AM for medical applications. The country has a growing ecosystem of contract manufacturers, material suppliers, and engineering talent that could support expansion of the sector.
The company plans to add polymer printing capabilities to produce surgical guides and anatomical models, and is exploring bioprinting research in collaboration with local universities. Long-term ambitions include developing proprietary implant designs and building an international presence.
