Leeds expertise helps company reach worldwide markets

Expertise at the University of Leeds has helped Simulation Solutions, the largest European manufacturer of orthopaedic implant wear simulation equipment, to grow its international business.

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*.

But the company was only able to offer the machinery itself, and further expertise in how to run and use the equipment and provide customer support was required. With the University of Leeds being a leader in the use and running of joint simulation equipment, it was the natural choice to partner Simulation Solutions.

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 which are being provided by the University.

Dr Louise Jennings and two post-doctoral research assistants will be delivering training on-site in Tianjin during January 2013. 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.

“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” said Nick Eldred, Director of Simulation Solutions.

“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”.

Read the story in the Yorkshire Post

Reference

* http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284461.htm