We are pleased to welcome Beth Werner to the Ximedica Research and Strategy team. 

Ximedica honors World Usability Day!  For more information on today click here:  http://www.worldusabilityday.org/

A risk management plan documents how a project team will identify and evaluate potential risks with a product. The plan outlines the process and the criteria the team will use to determine if mitigation is required for a particular risk. This document becomes part of the complete Design History File (DHF). This activity is an integral part of Ximedica's product development process to satisfy the requirements of HE-75, 21 CFR 820.30(g), and ISO 14971:2007, (i.e., the guidelines and regulation published by the FDA and the international standard for risk management in the medical device industry).

As an electrical engineer at Ximedica, I derive much personal satisfaction from solving difficult problems, something we do every day. But “I think, therefore I am” does not fully convey the sense of positive being I find here. Ultimately, I work in the medical field because it contributes to a greater good:  helping others. These two important aspects of medical device design recently converged at Ximedica in the form of a wireless dental polishing tool for hygienists.

With the Food & Drug Administration’s (FDA) increased scrutiny on device usability, being able to understand and demonstrate the importance of human factors and intuitive use in device design has become a critical work tool. 

In the case of trauma, the focus of course is on getting the patient to medical care as safely and as quickly as possible. This is particularly critical in the case of head trauma, where early care can mean the difference between brain damage and a full recovery — or life and death.

A recent article in The Wall Street Journal sparked spirited debate on care for emergency department (ED) patients. The story titled, ERs Move to Speed Care; Not Everyone Needs a Bed, by Laura Landro sheds light on a major challenge facing hospitals nationwide: Improving hospital care and efficiency takes much more than cost cutting efforts. 

Medical device manufacturers must file a new 510(k) only when the changes significantly impact a device’s safety and effectiveness or if the revision constitutes a new intended use. Many medical device products undergo incremental changes even after they are introduced into the market, and most of those changes do not require a new 510(k) submission. This is good news for device manufacturers who are concerned about delays in speed to market while striving to improve the use and safety of their products.

The FDA’s Center for Devices and Radiological Health recently published their “Analysis of Premarket Review Times under the 510(k) Program” in which they attribute the recent increase in total review time “primarily due to companies taking more time to respond to requests for additional information.”[i] This analysis was prompted by recent industry-sponsored reports, which attribute problems with the 510(k) program to lack of predictability, disruptions, and delays due to staffing turnover and inconsistency in reviews.[ii]

These days, the medical device industry is developing more devices with software or graphical user interfaces (GUI) than ever before. In my experience, the interface features are often considered too late in the process, rather than early and iteratively throughout the development cycle.