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Webinar Announcement hosted by FDANews

Managing Quality and Compliance in a Global and Outsourced Ecosystem

Please join Axendia and Veeva Systems for a complimentary FDANews webinar on March 30th at 1:30 pm EDT.

Are suppliers and contract organizations putting your product’s quality at risk? Learn about industry trends and strategies your company can leverage to gain better control and visibility in our webinar.

Read More or Register to Attend



Does Playing by the Rules Guarantee a Win?

By Daniel R. Matlis

Is Your Team Focused on Quality or Compliance? 

Super Bowl 50 was right around the corner when we gathered in Washington DC for MDIC’s most recent Case for Quality (CfQ) forum.   While discussing the important differences between quality and compliance, the below sports-related analogy came to mind:

  • Following the rules does not guarantee improved team performance
  • Teams can not make the proper adjustments without looking at all of the performance data
  • It is very difficult to win by only avoiding penalties

Football Quality Compliance-Final Feb2016


To download a PDF of this infographic, please follow this link.

We would also welcome your ideas or suggestions as they relate to this topic in the comment box below.


E Luyer IBM ARticle

Practical Use of the Internet of Things in Healthcare

By: Eric Luyer, Market Research Analyst

Reading my daily newspaper as well as checking Social Media, there is a lot of information around the new concept of “Internet of Things” (IoT). This term encompasses the latest technology around connected devices within a network and includes all the valuable, collected information from data and intelligence from all kinds of different devices.  Linked to these new developments, you will find companies that are focusing on this data and building new, highly relevant applications in specific markets or for specific communities.

This is for sure the case within the medical and healthcare environments.  In fact, it is interesting to see how the concept of IoT is changing healthcare strategies, business models and affecting healthcare operations. In this environment, we are talking more and more about the Internet of Medical Things.  Let’s look at some examples that have been discussed in the media and are currently available in daily healthcare practices. Continue reading


PART 2: IBM’s Grand Vision for Better Healthcare

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

How IBM Wants to Transform the Healthcare Industry – Part 2 

As changes in Healthcare reimbursement moves from a fee-for-service to a fee-for-value model, there is a growing need to capture tremendous amounts of data to be analyzed and communicated in an uncomplicated manner.   It is the vision of IBM Watson Health bring together clinical, research and social data from a diverse range of health sources, creating a secure, cloud-based data sharing hub, powered by the most advanced cognitive and analytic technologies.

As IBM’s vision continues to evolve we spoke with Pete Karns, IBM VP, Offerings, Internet of Things, Michael Fahey , Offering Manager for Exogenous Data,  IBM Watson Health and Andy Stanford-Clark, IBM (UK) Distinguished Engineer, Master Inventor, Internet of Things to learn about the impact of the Internet of Things (IoT) and Internet of Medical Things (IoMT) on Healthcare.

Part 1 of this 2 part article concentrated on how the Healthcare industry will benefit from transforming itself; Part 2 looks at what is needed (both technologically and otherwise) and what challenges are ahead to improving patient outcomes and quality of care while lowering cost.

To continue reading, please register to receive a PDF of this article in its entirety.


FDA and Industry Embrace Highest Quality for Medical Products

By:  Daniel R. Matlis, President

Historically, interactions between industry and the FDA have been described as complex, challenging and even adversarial. Many a time, our firm has been asked to serve as an “anonymizer” for a medical device company that had a question for the FDA, but was concerned about interacting with the agency directly.

Would interactions be different if meetings between the agency and industry shutterstock_195838178 HUG FOR MDIC Article
stakeholders started with a hug? They did at the most recent Case for Quality Forum where industry and the FDA literally embraced, stating that providing medical products of the highest quality is their main focus.

The Case for Quality (CfQ) Forum consistently provides an open venue to discuss and exchange ideas on improving medical device product quality. The Case for Quality program was created to facilitate ongoing dialogue that will ultimately benefit patients, providers and the medical technology community. The initiative brings together industry stakeholders – including the U.S. Food and Drug Administration, medical device manufacturers, payers, providers, industry advisors and patient advocates. Continue reading