Design & Testing

There’s no doubt that additive manufacturing (AM), including emerging 3D printing technologies, is booming. Despite its promise though, AM still has far to go to in understanding the impact of subtle differences in manufacturing methods on the properties and capabilities of resulting materials....

The FDA is seeking comments of a new draft guidance that it recently issued for industry called “Adaptive Designs for Medical Device Clinical Studies.” An “adaptive design” for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications...

Using nanowires, Purdue University researchers has created a new implantable drug-delivery system that can be wirelessly controlled. The nanowires respond to an electromagnetic field generated by a separate device, which can be used to release a pre-loaded drug. The engineering team says that...

The U.S. Food and Drug Administration has withdrawn 47 draft guidance documents published before December 31, 2013, which were never finalized or acted on. The announcement was posted in the Federal Register, stating that this move was made to improve the efficiency and transparency of the guidance...

This invention places a drug delivery system inside a prosthetic implant to circumvent the physical issues encountered after fitting the implant. Implants being relatively large in size would be able to house the drug-carrying device inside them without compromising the structural integrity or the...

Medical device regulators at the FDA have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

AAMI, the Association for the Advancement of Medical Instrumentation, is leading the small-bore connectors initiative, an international effort to decrease tubing misconnections and increase patient safety. Recently, AAMI has released two additional standards focusing on how to design connectors...

Health Canada, the Canadian medical device market regulator, is set to require all reprocessed single-use medical devices to Canadian Medical Device Regulations (CMDR) by September 1, 2015. According to MEDEC, the national association created for the Canadian medical technology...

A Ruhr-University Bochum researcher has developed a plasma sterilizer that is specifically suited for ridding medical instruments of germs efficiently, without damaging the material.

The FDA recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes, which requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology...