Being in compliance means operating your business in a manner that means less risk, better quality, safety and governance. Compliance management software is designed to help foster this concept, so what do you need it to be?
The accuracy of mammography is often not good and requires improvement. One source of hope to address this includes phase-contrast imaging, a procedure based on x-rays which is of special interest for breast cancer diagnosis, and has wider applications.
Prototyping is expensive. But creative construction and use of prototypes can dramatically improve the development process and save the development team a significant amount of time and money.
This column discusses two critical requirements involving silicone tubing for medical device applications.
“If you are doing a wound care dressing, what is unique about the product, what are you doing differently than what is already in the market, what is it intended to be used for, who is using it, and where is it being used… All of these pieces of information help you decide how to proceed.” – Jeff Kaminski , President of MBK Tape Solutions. Excerpts from an interview.
How stakeholders in a global value chain can create an innovation environment that leverages product lifecycle management to drive today’s most important health sciences business initiatives.
In order to compete globally, companies must be proactive in their business plans and anticipate the challenges they may face, concur three med-tech executives.
There is a pressure on medical device product development teams to come to terms with new types of users, environments, distribution and sales models as opposed to more traditional scenarios of device use and sale, says ide’s Richard Sokolov.
When developing highly complex medical devices, the mountain of “interesting” ideas that result from traditional brainstorming all too often buckles under technical scrutiny. A more efficient and effective way to generate and refine ideas that are technically viable is needed.
Data reporting can be a very tedious process for medical device manufacturers. The functionality of the device needs to be spot-on for it to be considered viable in the medical community. Because there is little to no room for error in this process, medical devices must help decrease error prone manufacturing activities, and in many cases also help companies meet the desired Six Sigma goal for process control.