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
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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
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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

18Jul/16
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Next Steps in FDA’s Global Transformation

By: Ellyn McMullin, Research Associate

The Agency Continues to Take Measures to Ensure the Safety and Quality of Imported Medical Devices

Five years ago FDA unveiled its new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain. According to the agency, in 2011 half of all medical devices used in the United States were imported, while 80% of the active pharmaceutical ingredients in medications sold here were manufactured elsewhere. It was optimistically estimated that imports of FDA-regulated products would triple between 2007 and 2015; of course, with the severe recession, the results did not quite reach that projection. However, the increase in imports was still significant.

A key component of the FDA’s new approach (as detailed in a special report “Pathway to Global Product Safety and Quality”) was to partner with its counterparts worldwide to insure and improve global product safety and quality. As reported in 2014, the FDA had at that time more than 60 agreements with their counterparts to share some information in inspection reports.

Continue reading this article in MedTech Intelligence.

11Jul/16
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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.