Category Archives: Business

21Sep/16
Data Integrity in LS

Data Integrity – A Requirement for FDA Compliance, Quality and Beyond

On Demand Webinar Announced

Data integrity and quality are foundational for regulatory compliance and good science, an issue that was recently highlighted by the new “FDA Guidance for Data Integrity and Compliance with cGMP”. This guidance was issued to address a growing number of data integrity violations and underscores the importance of data quality and integrity to support intellectual property protection and patient filings in regulated and non-regulated spaces.

DownloadData Integrity in Life Sciences a PDF of this inforgraphic.

We discuss what Goldilocks and Life-Sciences companies have in common during the webinar. An on demand recording is available here.

23Aug/16
Thingworx-solutions-for-medical-devices

Is IoT Vital to Well-Care?

By: Daniel R. Matlis, President

Improving Healthcare in the Outcome Economy

The Internet of Things (IoT) and the transition to the Outcome Economy were key themes at PTC’s LiveWorx16.  The focus on IoT and Product Lifecycle Management (PLM) and the shift to outcome based models, sparked this analysis on the applicability of these trends in our “sick-care system.”

The traditional healthcare model could better be described as “sick-care.”  Historically, healthcare has been episodic and reactive — primarily aimed at addressing a malady, illness or injury after it has already happened.

Here are a few examples:

  • Have a fever?                    →          Take an antipyretic.
  • Have an ache?                           Take an analgesic.
  • Have a damaged hip?                Have an arthroplasty.
  • Have angina?                              Have coronary artery bypass graft surgery.

This sick-care approach has it backwards, though. As the refrain goes, an ounce of prevention is worth a pound of cure. Furthermore, sick-care is expensive and unsustainable.  But, can we apply the IoT, PLM, and outcome-based models to healthcare? Continue reading

16Aug/16
Drip Data with copyright WP3 for LSP

Drowning in Meaningless Data? Time to Fix the DRIP!

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
WP2 Main Image Strategic Leadership

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

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
Stopwatch - shutterstock_99873074

Are You a Med-Tech Innovator or Laggard?

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.

Continue reading