Category Archives: Research

11Oct/16

Does Having a Closed Loop Process Really Matter to Your Business?

Business, Latest, Quality, Research

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

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?  Does Having a Closed Loop Process Really Matter?

Download the white paper to find out how Med-Tech Innovators are avoiding recalls by implementing closed loop change and configuration management processes.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.
27Sep/16

Don’t Solve Quality Problems, Avoid Them

Business, Latest, Quality, Regulatory, Research

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

Can you distribute poor quality products while complying with all applicable regulatory requirements? 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 comply with all FDA requirements and yet make a high-quality device.”

Is your organization focused on Solving Quality Problems or Avoiding Them?  Download the white paper to find out how Med-Tech Innovators have been able to shift their focus on improving market presence, manufacturing processes and product quality.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.
16Aug/16

Drowning in Meaningless Data? Time to Fix the DRIP!

Business, Latest, Research, Technology

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

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.

Does your organization need to Fix The DRIP? Download the white paper to find out.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.

 

02Aug/16

The Continuing Failure of Strategic Leadership in the Med-Tech Industry?

Business, Latest, Research

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry 

Many people who have worked for a mid- to large-sized company learn that company politics or the corporate culture 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.
 

We are pleased to announce the release of the 2nd white paper in a series sponsored by Siemens PLM and Deloitte to help you identify and close the commitment gap. Axendia is publishing its research under the “The Future of Change and Configuration Management in the Med-Tech Industry” umbrella.

Please register to download this white paper.  Contact research@axendia.com to see if you qualify for a complimentary access code and save $499.

For additional information or to schedule a briefing with the study’s lead researchers, please contact: research@axendia.com.

26Jul/16

Are You a Med-Tech Innovator or Laggard?

Business, Latest, Research, Technology

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry 

Innovators, those with mature Closed Loop Change and Configuration Management (C&CM) processes and platforms, are 4 times more likely to monitor analytics and use connected device data to monitor C&CM and 80% have a fully integrated approach to design transfer most of the time.

By contrast, Laggards, those with Open Loop C&CM processes, are 2 times more reactive.  82% are fixing problems as they occur and not a single one indicated they have a fully integrated approach to design transfer most of the time.  Which category do you fall in?

Download the first of five white papers under The Future of Change and Configuration Management in the Med-Tech Industry umbrella to find out.

We are pleased to announce the release of a five (5) white paper series sponsored by Siemens PLM and Deloitte to help you understand whether you are an Innovator or a Laggard (and to learn what the above statistics are based on).   Axendia is publishing its research under “The Future of Change and Configuration Management in the Med-Tech Industry” umbrella.

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