Research and Development

ARTICLES

GAO Flags Technical Challenges for Disease Diagnostic Devices

Government Accountability Office researchers visited eight devicemakers in connection with a new report on diagnostic medical devices and found that the regulatory review process poses an obstacle to applying the technology in the marketplace. Read More

Early Ergonomics Studies Can Help Combination Product Development

Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly & Co. Read More

FDA Recommends Risk-Based Animal Testing of Organ Preservation Devices

Developers of medical devices designed to preserve organs for transplant should carefully evaluate the risk of injury to the organs as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA says in new draft guidance. Read More

FDA to Expand High Performance Computing to Boost Clinical Trial Efficiency

The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate device clinical trials as part of an agency… Read More

WHO to Develop Essential Diagnostics List

The World Health Organization is developing an Essential Diagnostics List to help countries create their own national lists of essential diagnostic tests and tools. Read More

Australia Maps Out Aggressive Device R&D Plan

The Australian government has unveiled an ambitious plan to boost the country’s ability to turn inventions into medical devices. Read More

FDA Cites 22 Failed Trials, Makes the Case for Phase III

The FDA has compiled 22 case studies — including for two medical devices — that showed promise in Phase II clinical trials but later failed in larger Phase III trials. Read More

HHS Mandate to Publish Full Trial Results Backed Up With Funding Sanctions

Starting in 2017, HHS will require that all clinical trials must register and publish their results in the public database in a timely manner. Read More

India Greenlights First Medical Device Park

India has approved funding for the country’s first medical device park. It will have specialized laboratories, warehousing, testing centers and up to 150 independent manufacturing units. Read More

Study Cites Flaws in Approvals Of High-Risk OB-GYN Devices

A number of high-risk women’s health devices gained FDA approval based on inadequate data, according to a new study from Northwestern Medicine. Read More