ITL Health Group (ASX:ITD) is continuing to build its portfolio of products within the lucrative $3.3b (and growing) global blood culture testing market. Its subsidiary ITL BioMedical launched its latest blood culture testing product earlier this year (March 2018) and there are plans to bring a further pipeline of new products to market in the current financial year.

The growth in this market is due to an increase in the number of sepsis cases, a rapidly ageing population and a growing recognition of the need to test blood samples for the presence of bacteria.

ITL Health Group is a global medical technology company that ranked 16th in Financial Review’s Most Innovative Companies in 2016. It manufactures medical devices for the clinical, blood banking and laboratory markets, and specialist ancillary products for the blood culture testing market, which are sold in more than 55 countries.

Leveraging a Malaysian manufacturing base

Executive Chairman Mr Bill Mobbs says the group – which operates two divisions including ITL BioMedical and MyHealthTest – will continue to pursue high margin blood market opportunities, leveraging the expertise and capability of its Malaysian based R&D and manufacturing facility.

ITL Health Group’s operations are supported by an impressive 100,000 square feet manufacturing facility, strategically located in Malaysia to access and serve major markets worldwide.

End-to-end medical manufacturing solutions

In addition to supporting the R&D and manufacturing needs of the ITL Health Group, the company’s manufacturing facility also works with healthcare organisations around the world to create, design and build medical devices, procedure kits and accessories to meet the growing demand for world-class healthcare devices and products globally.

This manufacturing capability spans the entire product lifecycle, from concept to design, and manufacturing to market, including world-wide regulatory and logistics support. Mr Mobbs said the ITL Health Group offers an experienced R&D team and a world class manufacturing facility that could develop products to specifications quickly and efficiently.

Manufacturing capabilities

Manufacturing capabilities at the facility include:

• injection molding and extrusion
• procedure pack and kit assembly
• tool design and fabrication
• packing and sterilization (sterilization performed externally)
• support for OEM businesses and
• other related activities.

The facility has expertise developing and manufacturing biological sampling systems, surgical and medical products, customised and standard procedure packs, invasive blood pressure monitoring kits, cardiac catherization kits and a range of Class 3 vascular access preparation kits.

World-class manufacturing facilities

This world-class manufacturing facility includes:

• two class 100k cleanrooms (14,850 sqft/1,380 sqm)
• a tool room
• an extrusion room
• a warehouse (11,900sqft/1,100sqm)
• a microlab (with in-house clean room monitoring) and
• packaging machines (with spare capacity available for further ramp up).

It also offers services related to new kit development, assembly and changes, managed by a dedicated team of engineers and technicians. The facility is planning to introduce additional automation and has further capacity for expansion.

Strategic partnerships for worldwide success

ITL Health Group acts as a manufacturing partner to medical device companies, blood product providers, laboratory testing and supply firms, hospitals, healthcare systems, research organizations and universities, animal healthcare providers and government organizations.

This partnership helps to strengthen companies’ supply chains and increase enterprise-wide value with custom design, manufacturing and assembly services.

Quality and environmental quality systems

ITL Health Group maintains a high level of performance by committing to quality and environmental management standards and audits.

It has established, documented, and implemented a quality and environmental management system that is continuously reviewed and audited for effectiveness in accordance with ISO 13485 (Medical Device Quality Management Systems), EC Directive 93/42/EEC (CE Mark), FDA WQSR 21 CFR part 820 (Quality System Regulation), and ISO 14001 (Environmental).

Regulatory Compliance

Its manufacturing operations also comply with all global regulatory requirements, including FDA, ISO or TGA compliance and EC Representative and MHRA (Medicines and Healthcare products Regulatory Agency) in the UK.

Certified clean rooms are also rated for ISO 8 (Class 100,000) in accordance with the requirement of ISO 14644-1: 2015 and ISO 14644-2: 2015 Standards.

The facility also participates in periodic audits and inspections from the following regulatory bodies:

• US FDA
• Canadian Health Authorities
• Taiwan FDA
• TUV SUD – Notified Body for Quality Management System
• SGS – Notified Body for Environmental Management System
• Australia (TGA)
• Japan
• Europe (MDD)

Innovative staffing policies and practices

The ITL Health Group has about 280 employees located at its Malaysian manufacturing facility, with about 195 staff employed on the production floor. The company invests heavily in the recruitment, retention and training of its local staff. Its unique and innovative practices were profiled in CEO Magazine in February 2018.

The company also maintains high standards in relation to workplace safety, efficiency and productivity. Workplace safety is a high priority, and local management works to closed-looped systems to reduce risks and improve workplace outcomes.

Positioned to access world markets

ITL Health Group has made a significant investment in the ongoing development and expansion of its Malaysian-based manufacturing facility, and it sits alongside other leading multinational manufacturing companies accessing world markets from this strategically located Asian gate-way.

Established in 1996, ITL Health’s manufacturing facility is located in the Batu Gajah’s Bemban Industrial Estate in Perak.