University helps firm improve medical implants

ACADEMICS from the University of Leeds have helped a company which is set to improve the lives of patients who need implants in their hips and knees.

The university has worked with Simulation Solutions, which is the largest European manufacturer of orthopaedic implant wear simulation equipment.

The company aims to grow its global business.

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Simulation Solutions has started working with the Food and Drug Administration, America’s regulator in the safety of foods, medicines and medical devices, in China, where the medical device industries are being forced to become stringently regulated for the first time.

The regulatory requirement comes after products made in China caused a series of safety scares in 2007 and 2008.

Today, all products manufactured in China have to pass testing standards in the FDA’s independent laboratories before they can be sold and used.

Simulation Solutions sought help from the university, which is a leader in the use and running of joint simulation equipment.

The support package provided to the FDA includes a Standard Operating Procedure (a written manual for complex experimental systems); on-site hands-on training; and one year of specialist support via a helpline from the overseas laboratories.

All of these services are being provided by the university.

Dr Louise Jennings and two post-doctoral research assistants will be delivering training on-site in Tianjin this month.

A University of Leeds spokesman said: “The support will not only provide the staff at the FDA with more confidence in using the machinery but it will allow the authorities to gain more meaningful data from it, ensuring only the best hip and knee implants reach their markets.”

Nick Eldred, director of Simulation Solutions, said: “This is the first in a line of nine FDAs that are likely to need our support in China – the others will follow the lead of Tianjin.

“Our machinery is complex but we’re confident with the expert tuition in using the equipment from the University of Leeds, we can build regulators’ confidence and rapidly increase their learning curve in its use.

“But it’s not just about building confidence, it’s about helping the regulators to get meaningful data from the equipment – ultimately to benefit the safety of implants for their patients”.

Simulation Solutions provides hardware and software-based services to address needs in the fields of bio-engineering.

The company’s range of Prosim bio-engineering simulators are designed for the intensive testing of orthopaedic devices and materials, including wear, fatigue and friction.

The range includes simulators for the testing of hip and knee implants.