29Jun/16
quality

FDA and Quality Metrics in Biopharma

By: David R. Somers, Senior Industry Analyst

Moving Right Along 

The continuing efforts by biologic and pharmaceutical manufacturers to join the FDA in improving product quality, reducing inspection costs, increasing the effectiveness of product monitoring, and streamlining reporting requirements have crossed the Rubicon of mere theorizing, discussion, and contemplation into firm and proactive steps. Those efforts have been aimed at the establishment of acceptable and realistic standards of measurement for product development, testing, implementation, distribution, and monitoring. These activities are in concert with the broader effort by FDA to promote innovation, increase stakeholder involvement in quality, and enhance the safety of the supply chain.

To support this initiative, the International Society for Pharmaceutical Engineering (ISPE) created a cohesive, comprehensive series of criteria for the measurement of critical parameters needed to define and control quality in biologic and pharmaceutical manufacturing.  Subsequently, using many of the metrics developed by the ISPE, the FDA submitted a draft guidance document called Request for Quality Metrics.

Continue reading the full article in Outsourced Pharma.

22Jun/16
GoogleGlass_OR

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.

 

06Jun/16
connected-world

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.

QADpic1

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

31May/16
Werum_IT_Solutions_Logo.svg

The Rubber Meets the Road with MES

By: Sandra K. Rodriguez, Research Associate

14th Werum PAS-X User Group Meeting 

It’s hard to image that attending a MES User Group Meeting would make you walk away with the impression that successful MES implementations are not simply about the best technology, but that was the case at Werum’s User Group Meeting (UGM) in Morrisville, NJ on May 12-13, 2016.  Rudiger Schlierenkampf, CEO, Werum IT Solution and Benjamin Pieritz, Senior Vice President Operations, Werum IT Solutions, kicked off the meeting by providing a company update and announcing 15 years of success throughout North America.

Clients and prospects gathered to share best practices, success stories and the challenge of automating a historically paper-driven process.  Overall, the hot button topics were business process harmonization and cultural change management.  While great technology is required, it is not sufficient to ensure a favorable outcome.

TECHNOLOGY IS NOT SUFFICIENT TO ENSURE MES SUCCESS

Software companies are beginning to understand that their products are only as good as the requirements they are built to meet.  Input from the user community is critical not only to maintain market share, but to ensure the product is future proof.  As life science companies move from point solutions to platforms and streamline their IT operations and consolidate enterprise systems, Werum is working on ensuring the adoptability of their solutions to this new IT landscape. Continue reading

27May/16
future-technology-3d-printer

3D Printing is the New Supply Chain Disruptor

Navy Officials: 3D Printing To Impact Future Fleet with ‘On Demand’ Manufacturing Capability

By John Joyce, NSWC Dahlgren Division Corporate Communications

DAHLGREN, Va. – Is it possible to produce parts and equipment from scratch for Sailors – aboard ships and on demand?

Can the Navy rush deliver parts and high-tech gear such as customized unmanned systems, avionics components, and improvised explosive device detectors to its warfighters?

“Yes we can,” say Navy officials and when Additive Manufacturing – also known as 3D Printing – fully hits the Fleet, Sailors could receive their orders within a substantially reduced time frame.

Remarkably, Sailors and Marines are already inventing new products, expanding the realm of possibilities made real by 3D printing while saving time, resources, and money. Continue reading