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Food for Thought on Quality and Compliance

By Daniel R. Matlis

Would you rather…

Eat Bad Food in a Clean Restaurant?


Eat Great Food in an Unsanitary Restaurant?

I shared this dilemma with Industry Executives and FDA Officials to illustrate the distinction between compliance and quality in a restaurant setting during the most recent MDIC Case for Quality (CfQ) forum in Washington DC.

Restaurant Quality v Compliance

Click on thumbnail to see image full size

The CfQ forums afford FDA and Industry the opportunity to engage in open, candid, and constructive discussions on ways to improve product quality.  Discussion topics range from identifying barriers to investment in prevention and product quality to generating actionable ideas to overcome industry / regulator obstacles.

Since this topic got such positive response, we decided to flesh it out into an infographic.

Think about this dilemma the next time you discuss the distinction between quality and compliance with your management or when you head out to dinner.

Compliance should be the baseline. Quality should be the goal!  

To download the infographic as a PDF, click here.




Delayed Enforcement Provides a Business Opportunity

By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia 

On July 1st, FDA  published guidance stating that: “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act.”

Last December, FDA published guidance informing industry that it did not intend to Supply-Chain-Squares (3)take action against manufacturers, wholesale distributors, or repackagers who did not, prior to May 1, 2015, provide or capture the product tracing information required by the new Drug Quality and Security Act (DQSA).

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From Flip Flops To The Cloud!

The Next Step in the Evolution of ERP

 By David Somers, Senior Industry Analyst, Axendia


Sometimes, there are certain occasions which transcend an otherwise seemingly routine activity of business commerce into something truly insightful and innovative. I was privileged to witness just such an event this past May, the origin of which began nearly 40 years ago from a relationship that emerged from a meeting of necessity by two individuals, creating what is QAD today.


Image courtesy of QAD

Pamela Lopker, Chairman of the Board and President of QAD,  a leader in manufacturing software for industrial businesses and Karl Lopker, Chief Executive Officer, direct all of QAD’s business, including operations, expansion into new markets with a specific focus on a strong regional and industry-specific direction. Formerly Karl was president of Deckers Outdoor Corporation; the makers of the iconic multi-layered rainbow Flip Flops designed to to fill the “Space Below Your Feet.”

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Internet of Medical Things

 Moving Towards Integration of Medical Device Data

By Ellyn McMullin and Daniel R. Matlis

Currently, there is a lot of talk about the Internet of Everything.

RickValenciaColorTo learn about the state of the “Internet of Medical Things,” we recently spoke with Rick Valencia, Senior Vice President and General Manager of Qualcomm Life, Inc. During our briefing, we focused the recently announced collaboration between Cerner and Qualcomm Life, aimed at extending medical device connectivity capabilities beyond the hospital to the home.

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Innovation on a Global Scale. Are you Ready?

Quality, Regulations, Design and the Patient Experience

By Sandra Rodriguez, Research Associate, Axendia

Med-Tech companies are at an innovation crossroads. They must seek new ways to develop, design and manufacture products that meet the needs of both the “masses” and the individual patient – all while increasing quality of care and reducing healthcare costs.

According to our research, 72% of respondents report an increase in the rate of new product introduction (innovation) in emerging markets.

To learn how leading Med-Tech companies are applying innovation practices to address today’s global marketplace, Axendia hosted a discussion with Stuart Karten, Principal at Karten Design, Cathi Crist, Partner and Medical Device Industry Lead at Kalypso, in a webinar moderated by Daniel R. Matlis.Karten-Christ-Matlis Continue reading