Category Archives: People


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.


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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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, 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?


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.



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?



Siemens Industry Analyst Conference 2015

By Sandra K. Rodriguez, Research Associate

Digital Twins Enable Time Travel

If you had a time machine, would you rather take a peek in to the future or change something in the past?   If you could build a digital twin that enabled time travel, would you?

The theme of this year’s Siemens Industry Analyst Conference was Realizing Innovation.   Virtualization and digitalization capabilities throughout the product lifecycle are giving industry the opportunity to do something new – time travel.

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Earning Your Trust for Ten Years

By Daniel R. Matlis, President

Axendia Turns Ten!

Ten years ago, Axendia was founded on the premise to provide trusted advice to Life Science and Healthcare Industry Executives on Business, Technology and Regulatory matters.

Over the last ten years, we have had the privilege to earn the trust of executives across Life Science and Healthcare ecosystems.  As a result, we have advised industry, technology & service providers, policy makers and regulators.

We are committed to building, nurturing and growing long term relationships based on our core values: Respect, Integrity and Passion.

This commitment to our clients, partners and team members has fostered a spirit of cooperation, coordination and trust that is essential to ensuring success.

How do we measure success?

Our success is based on yours.  We measure success based on the contributions we have made to you and your organization as well as the commitment to our mission: “to be trusted advisors to Industry Executives.”

During the last ten years:

  • We have had the privilege of advising Life-Science, Healthcare and Food companies ranging from startups to Fortune 100 companies.
  • We have had the opportunity to work with leading technology and service providers.
  • We have published numerous primary research studies, whitepapers, articles and infographics.
  • We have been invited to present at leading industry conferences and at the FDA.
  • We have conducted briefings for audiences around the globe, including Asia, Europe, North and South America
  • We began writing a blog in 2006, before blogging was cool. Today, we have thousands of subscribers to Life-Science Panorama, and you can also follow us on Twitter and LinkedIn.

I hope that over the past ten years we have earned your trust and that Axendia hastrust become a source of trusted advice for you.

Thank you for your support and we look forward to continuing to build long-term relationships based on our core values: Respect, Integrity and Passion.