Axendia provides Executives with strategic advice on key initiatives. We understand the issues and priorities facing Industry Executives.
Axendia offers a complete view into the needs and challenges facing the Health and Life-Science ecosystem.
Medical devices are in a constant state of evolution: providing new capabilities, addressing defects, adapting to changing markets or regulatory demands and reacting to competitive threats.
Actively managing products across the total product life cycle (including design, manufacturing and service management) drives improvements in product quality and accelerates new product introductions in a timely and cost-effective manner while supporting regulatory compliance.
BUT have you asked yourself:
Many people who have worked for a mid- to large-sized company learn that corporate politics or culture can create the biggest barrier to performing any process effectively. This is not to say overcoming organizational issues is easy but companies need to recognize and commit to addressing them because it's central to being an innovative organization. Closed Loop technology tools are critical to overcoming the silos, gaps, and barriers that exist within an organization.
This white paper, the second in "The Future of Change and . . .
The Med-Tech industry is obsessed with collecting data, retaining and hoarding it to meet statutory and regulatory requirements. Unfortunately most companies do not harness this data to produce better quality products. As a result, companies suffer from DRIP and are Data Rich but Intelligence Poor.
"Want to learn how to fix the DRIP? Then download the third White Paper in "The Future of Change and Configuration Management . . .
Sure! After all, you can conduct a recall of poor quality products in compliance with all applicable regulations.
FDA’s Top Medical Device official agrees. Jeff Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), put it this way: “…one device manufacturer can meet FDA requirements and still make a poor quality device; whereas, a second manufacturer may not . . .
Recalls are on the rise. How can you avoid them?
Analysis shows a 97% increase in the annual number of medical device recalls for the 10-year period, increasing from 604 recalls in FY 2003 to 1,190 recalls in FY 2012.
"Want to learn how a Closed Loop Process can prevent recalls, drive accelerated innovation, improve product quality and enhance company performance?
Then download the fifth paper in "The Future of Change & Configuration Management in the . . .