Infographic: FDA Medical Device Quality System Data

Inspections, FDA Form 483 Observations and Warning Letter Citations

In support of the FDA’s Transparency and Case for Quality Initiatives, the Center for Devices and Radiological Health (CDRH) provides annual data on inspections, inspectional observations, and Warning Letter (WL) citations issued.

Production and Process Controls, followed by Corrective and Preventive Actions continue to be the most frequently cited QS subsystems.

The infographic below breaks down foreign v. domestic inspection data for Calendar Year (CY) 2015.  Continue reading


QAD Reinvents the ERP User Experience

By: David R. Somers, Senior Industry Analyst 

Exploring Channel Islands  


The need to Explore is a strong human characteristic. Off the coast of Santa Barbara sit four islands which are visible from QAD’s headquarters office; On the Channel Island of Santa Rosa, scientists have confirmed that 13,000 years ago human explorers crossed over to the New World from Asia and settled the earliest widespread culture in North America.

Today, building on this same characteristic of exploration, QAD has set out to reinvent the way people use their products; not just a superficial “glossing up” of an existing platform, but a major and “deep” exploration into what users not only want –but need –from their experiences with the applications.


Image Courtesy of QAD

Image Courtesy of QAD

Historically, ERP systems have been designed and built strictly for function. The relationship between function and the user experience has been lacking, and navigating through these systems often requires memorization of function keys and bulky “Reference Sheets.”  In a world where most device interfaces are Swipe, Tap, and Click, traditional ERP interfaces left a lot to be desired. QAD has set out to reinvent the ERP User Experience, to revolutionize the way people interact with their ERP products. The result is not a superficial patch of an existing platform but an in-depth examination of what users require from their applications to support an effective enterprise.

Continue reading


IoT in the consumer space provides insight into the functionality that’s coming in Medtech

By: Sandra K. Rodriguez, Research Associate

My Printer and The Internet of Medical Things 

If your organization has been working on an IoT strategy for more than three years with little progress, you’re not alone. IoT continues to be a concept for many companies. In reality and simply stated, it is connected intelligence. After all, what did the internet really give us? Connectivity. Access to data at anytime and anywhere became a reality. Perhaps if IoT had been named Connectivity of Things (CoT), the definition would have been as self-explanatory as SaaS still is. A subset or by-product of CoT would be IoT but with a new name—“Intelligence of Things” (e.g., my printer).

What did my printer teach me about IoT? Full article available here.

Golden key in keyhole

Innovation Through Digital Continuity

By: Ellyn McMullin, Research Associate and Daniel R. Matlis, President

The Key to Bio-Pharma Transformation? 

As Pharmaceutical / Biotech (Bio-Pharma) companies look for opportunities to accelerate innovation, continuous improvement is a strategic imperative.  To fast-track innovation, companies need to be open to new ideas and have awareness of new and emerging systems and technologies.

While most Bio-Pharma companies have complex stage-gate product development and change management and investigation processes, they lack the ability to connect decision loops across the total product lifecycle.  Or stated another way:   They lack a harmonized, integrated and closed loop approach to product lifecycle management (PLM).  As a result, they are often unable to easily manage and respond to post-approval issues resulting from product, supplier or process changes as well as customer inquiries, adverse events and regulatory findings.  Consequently, there is an inconsistent utilization of post-approval change management processes to improve products and processes.  Continue reading

Source:  perspectives.3ds.com

New FDA Commissioner Adamant About Unique Device Identifiers (UDI)

By: Ellyn McMullin, Research Associate and Daniel R. Matlis, President

UDI Implementation – The Key to Unlock Personalized Medicine? 

The Senate has confirmed Cardiologist Robert M. Califf as FDA Commissioner.

Source: Medscape.com

Source: Medscape.com

During his confirmation hearing, Dr. Califf stated that “he is adamant about the use of identification numbers on medical devices (UDI) that will enable the FDA to spot whether device issues are minor glitches or major safety-endangering malfunctions.”

The implementation of Unique Device Identification (UDI) is having a profound effect on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient. The 7-year compliance timeline reached its second milestone on October 24, 2015.  As of that date the labels and packages of implantable, life-supporting and life-sustaining devices must bear a UDI and date.  Furthermore, software that is classified a life-supporting or life-sustaining device must include a UDI.

Could UDI be a key that unlocks the potential of personalized medicine for the masses?

Please click here to request a copy of the white paper: UDI Implementation – the Key to Unlock Personalized Medicine?