Category Archives: Technology


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.

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

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.


Augmented Reality in Today’s Operating Rooms

By: Eric M. Luyer, Senior Market Analyst

New Technologies Are Improving Surgical Efficiencies and Aiding in Education and Compliance 

In the past I have discussed the Internet of Things—specifically, the Internet of Medical Things. I explored how new technologies are being successfully used in healthcare by doctors or healthcare centers, providing more efficiency, ease of use and data collection to ultimately increase benefits for patients and staff.1 I’ve also written about wearables and how new technology items can be used on the wrist (e.g., e-watch), the head (e.g., special spectacles), or in implants or clothes, all for data information exchange.

An example I want to explore here is augmented reality and Google Glass. Various surgeons have already used Google Glass during operations. Sharing videos or images allows them to seek real-time assistance from other specialists who may be halfway across the world. They are able to receive instant feedback and provide input to improve efficiencies and results.  During operations, the augmented reality Heads-Up Display (HUD) can provide important images to surgeons, while allowing them to stay in close proximity to the patient.

“With a wearable device like Google Glass, the surgeon or physician is able to conduct an audio/visual recording [in] any part of the operating room, as well as the conversations between surgeons and operating assistants. This might be one of the major advantages,” said one of the leading surgeons in a major Dutch hospital. He sees this modern technology as a means to “connect all things together that we do individually in the room”.

To continue reading the full article in MedTech Intelligence, please click here.



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.


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