Category Archives: People

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?

 

08Oct/15
Time-Travel

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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05Oct/15
images

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.

08Jun/15
Qualcomm-Life

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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13May/15
Global-Puzzle

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