Category Archives: Technology

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.

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

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.