ResMed has global Objective

ResMed, Australia's largest manufacturer and exporter of medical respiratory devices, has renewed its license to Objective Corporation's knowledge and process management solution.

The updated system will help speed products to market and meet stringent biomedical regulations.

David D'Cruz, ResMed's vice-president, quality assurance and regulatory affairs, said that with the company growing at such a rapid rate, it needed to resolve the issue of managing large amounts of information stored both electronically and in hard copy.

ResMed develops, manufactures and markets products for the diagnosis and treatment of breathing disorders during sleep to more than 50 countries worldwide. It exports around 90 per cent of its Australian-manufactured products and is listed on the New York stock exchange and the ASX.

"One of the biggest advantages for ResMed is Objective's automated document approval capability during the design and manufacturing phases," D'Cruz said.

Before they incorporated the program, he said, "documentation was either couriered or e-mailed to international offices for approvals and changes." Transporting documents between the US and Australia could take up to two weeks.

"This [system] has really helped us streamline our document approval process," he said.

Meeting the requirements of audits by international regulatory bodies such as the Food and Drug Administration (FDA) in the US, and the Therapeutic Goods Administration (TGA) in Australia has also been made more efficient for ResMed using Objective's management system.

"When auditors call we can provide any document they request within seconds, instead of leafing though hard copy folders," D'Cruz said. "Since Objective was installed every version of [the design and manufacturing] document has an audit trail.

"Our ability to effectively track documents and share information means that we can continue to improve the development of respiratory products and comply with regulatory requirements. Approving a document faster may help expedite the time to market for new products," he told Australian Biotechnology News.

Objective general manager Adrian Rudman said ResMed was forward-thinking, as it recognised the need for the knowledge management early on in the development phase of their technology.

"Now they've moved into the marketing and growth of the business, where their capital has started to grow and they've got all that information available and in a useful form," he said.

"ResMed has continued to update the knowledge management software since it was first implemented three years ago, and their plan is to roll it out to their global operations. Its new system would allow third parties to get access to their marketing and clinical information using our products to manage their web content."

Rudman said Objective would like to work with other biotech companies.

"The challenge is making them realise the value of their information and knowledge, and that managing it well will give them a competitive edge," he said.