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.

 

10Aug/16
PharmaceuticalOnline_Small (1)

Can You Support Quality Metrics with Lobotomized Data?

By: Daniel R. Matlis, President

Vast Amounts of Process and Product Intelligence Go Unused

Life science companies are obsessed with collecting dumb data. We assemble it, retain it, and hoard it to support regulatory and legal requirements.

But what happens to these vast amounts of collected data?  Unfortunately, most of the data is “lobotomized” as soon as it hits the paper it was printed on or the electronic document it was saved to — vast amounts of product and process intelligence that could be used to improve control over manufacturing and product quality go unused.

FDA intends to drive life science companies to harness some of that intelligence. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) provides FDA with the ability to conduct electronic inspections (e-inspections) and target onsite inspection based on quality metrics.

Read the rest of the article in Pharmaceutical Online.

05Aug/16
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Medtech Strives to Get a Handle on 3D Printing

By: David R. Somers, Senior Industry Analyst

The Industry and FDA Explore 3D Printing Applications for Medical Devices

Not since the development of electron beam (e-beam) evaporation and thin layer epitaxy for silicon wafer manufacturing has the industry of small-scale (down to the nano-substrate level) applied technology been so exciting for the development of products that, until now, were very difficult to even produce, much less improve. The technology I refer to is that of 3D printing.

The FDA is seeking to understand the applicability of 3D printing for medical devices. Their recent offering on July 14th made a presentation through a Grand Round webcast as part of a larger program sponsored by the U.S. Navy and FDA to present a frame of reference and thinking behind the effects of such technology within the context of medical devices.

Continue reading the full article in Medical Product Outsourcing.

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.