18Jul/16
connected-world

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
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.

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