Category Archives: Latest

01Mar/16

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?

 

26Feb/16

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

 

17Feb/16

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.

 

11Feb/16

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

08Feb/16

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.