June 1st, 2011This Issue's Articles
Manufacturers marketing medical devices in Europe need to be able to demonstrate compliance with the newly clarified usability requirements introduced by Directive 2007/47/EC. This article discusses European usability requirements, relevant European standards and important ethical considerations.
To handle active baby boomers and rising longevity, Skeletal Dynamics selected a self-locking fastener from Spiralock that withstands up to 1 million loading cycles for its new elbow replacement implant.
By stamping rather than fully machining a laparoscopic part, a supplier of contract services was able to reduce production costs while maintaining design specifications.
EMDT’s interviews offer personal perspectives on the diverse industries that serve the medtech sector. Here, we talk to Jürg Haefeli of Lamineries Matthey.
Implants made from open-cell porous metal materials promote bone regrowth and achieve strength and stiffness levels that match the surrounding bone. The technology can be used in permanent and resorbable applications.
You don’t have to establish a regional hub to successfully market medical products in the Asia-Pacific region, but it helps.
MEMS-based systems can significantly improve accuracy in aligning hip and knee implants with a patient’s anatomy, reducing discomfort and the need for revision surgery.
Moulding silicone parts and successfully integrating them into a medical device is technically challenging, but the material’s many desirable properties make the effort worthwhile.