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.

 

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
desktop_logo

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.