Category Archives: People

04May/18
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WHAT DOES IT TAKE TO WIN AN ERGO CUP®?

THEY SAY IT TAKES A VILLAGE TO RAISE A CHILD, WELL, IT TAKES A VILLAGE OF VOLUNTEERS TO WIN AN ERGO CUP®

By: Mónica V. Matlis, Vice President Ergonomics
2018 Applied Ergonomics Conference ERGO Cup® Competition Co-Chair

Whenever the Applied Ergonomics Conference ends, I leave on a high. Adrenaline is still pumping in my veins. My co-chair, Jeff Hoyle, and I have just finished a “live stream” of the conference award ceremony and announced the winners of the internationally recognized ERGO Cup® competition. After months of preparation, we have finally closed the conference with an excitement that is contagious. We take a few minutes to acknowledge the winners by taking selfies with the teams and thanking them for the months of hard work & preparation.AEC Winning Moment

The internationally recognized Ergo Cup® competition, sponsored by the Ergonomics Center of North Carolina and Edward P. Fitts Department of Industrial and Systems Engineering at North Carolina State University and presented by IISE, provides an exciting opportunity for companies to highlight their successful ergonomic solutions. The general theme across all Ergo Cup® categories is innovation.  Five Ergo Cup® awards are presented annually for outstanding solutions through training, engineering and teamwork.

To be a finalist at the competition is an honor. To win is an achievement of a lifetime! For these teams, it’s like winning an Oscar.

To receive a copy of this complete article, click here.

27Apr/18
Patient

Lot Size: YOU – When YOU are the RAW MATERIAL and the FINISHED PRODUCT

Managing the Chain of Custody and Identity for Regenerative Medicine Products.

By: Daniel R. Matlis, President

According to FDA Commissioner Scott Gottlieb, M.D.  “We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.”

The promise of individualized therapies is why the FDA is encouraging and supporting innovation in this field. To this end, the Agency has released a framework outlining how it intends to apply existing laws and regulations to oversee these products. FDA’s stated goal is to ensure that it is nimble and creative to foster innovation, while taking steps to protect the safety of patients.

In individualized patient-derived cellular gene therapy products, the patient is the raw material, product, and the treatment.  In gene therapy products, cells removed from the patient become the raw material.  They are then genetically modified and returned to the patient as the “finished product”.

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14Feb/18
thinking

What is FDA Thinking? We Asked, They Answered!

An Interview with Francisco (Cisco) Vicenty – US FDA

By: Daniel R. Matlis, President

That is a question I often hear from industry executives around the globe.

To answer this question, I sat down with FDA’s Francisco Vicenty, for over an hour, to discuss a wide range of topics and gain an understanding of FDA’s current thinking on these topics. Cisco Vicenty is the Case for Quality Program Manager at FDA’s Office of Compliance, CDRH.

FDA-Axendia-Webinar

Driving a Culture of Quality in Industry

The overarching drive at FDA is enabling high levels of product excellence and innovation across industry and to provide patients with access to high quality, safe, and effective medical devices.  The agency wants to incentivize industry to adopt quality best practices; to adopt product quality excellence that drives improved patient outcomes.


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26Jul/17
New Idea

#newidea or #throwbackthursday?

By: Giselle C. Matlis, Research Assistant

Outcome based Medicine

On Monday June 26th 2017, Medtronic announced that they will be using a “new outcomes-based [payment] agreement with Aetna (NYSE:AET) for type 1 and type 2 diabetes patients”. Hooman Hakami, president of the Diabetes Group at Medtronic stated that “this agreement reinforces our shift towards value-based healthcare. We know technology alone isn’t enough and ultimately improved outcomes are what matter…Our goal is to continue to lead by driving innovation that demonstrably improves patient outcomes, elevates patient experience and lowers the total cost of care”.

This sounds like a great new idea.

Ironically, Axendia President, Daniel Matlis, predicted this ten years ago!

In a June 4, 2007 blog post on Axendia.com, Mr. Matlis noted that Sear’s Craftsman line of tools had a lifetime guarantee. This was a business decision by Sears to gamble that the high quality of their tools would minimize warranty costs. He then suggested that a similar approach could work in the healthcare industry and projected that out-come based billing would be the next big thing for the pharmaceutical world. He stated that this approach could, “enable a new health care paradigm, where all involved have the proverbial ‘skin in the game’. Patients get access to drugs that are nearly certain to be effective. Health care payers can ‘afford’ to make new, and let’s face it, expensive, treatments available to patients since they are provided a degree of confidence of treatment effectiveness, and limited downside through a refund”.

So, you decide: #newidea or #throwbackthursday?

01Mar/16
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?