Category Archives: Business

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.

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11Jul/16
Image courtesy of Camstar

A Single Source of Truth for Combination and Diagnostic Products

By: David R. Somers, Senior Industry Analyst

Control of the Manufacturing Process Requires a Unified Approach

While the convergence of devices drugs, and/or biological products used in therapeutic and diagnostic applications has grown significantly, the process used to manufacture them have not kept pace. “Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products1.” As medical technology advances, combination products continue to blur the historical lines of separation between drugs, devices, and/or biological products.

Traditionally, Life-Science companies have fallen into two camps, those manufacturing pharmaceutical and biotech products using the “formulation approach” and those manufacturing devices using a “discrete approach.” That growth in combination products has created a challenge for companies manufacturing them.

From an operational standpoint, MES solutions have focused on addressing the needs of either process or discrete manufacturing approaches. As a result, manufacturers of combination and diagnostic products have had few options for MES technologies that enabled them to consolidate electronic batch history records (eBHR) and electronic device history records (eDHR) in support of a single manufacturing, quality and regulatory process.

Read the article in its entirety.

06Jun/16
connected-world

The User Experience in an IoT Connected World

By: David R. Somers, Senior Industry Analyst

2016 QAD Explore 

Core Concept

The 2016 QAD Explore Conference, held during the first week in May in the heart of Chicagoland, was certainly an event to remember. It was memorable both in terms of the stunning changes in process and for the future, as well as the challenges facing companies attempting to adjust, adapt and advance their enterprises within a new age of technological development and shifts in markets.

Karl Lopker, CEO of QAD, expressed his concerns for that future by reflecting upon the past year with a host of challenges we all faced – including oil price flux, the value of the dollar world-wide, the China “slow-down” of their GDP, and both European and domestic social issues affecting corporate manufacturing strategies for the near future.

This Is Now

More specifically, several key developments directly affecting QAD and their Effective Enterprise concept in the form of “disruptive technologies” were not necessarily a negative.

QADpic1

For example, the Internet of Things (IoT) is, in fact, a manifestation of a capability to interface and react to literally all aspects of common life; that connectedness of devices, sensors and machines governing the aspects of our daily lives by the interchange of data parsed, collected, and analyzed to render intelligence decisions affects the operation of even the most mundane of daily activities. Continue reading