Category Archives: Regulatory


Axendia Turns 15: Thank You for Your Trust!

By Daniel R. Matlis

15 years ago, Axendia was born of a need for trusted Life-Science advise and insights rooted in deep, firsthand industry experience and primary research “Straight from the Source.”

Over the past 15 years I have been privileged to work with a team of fellow “Axendians” who are experts in their respective fields.  These Axendians are committed to exceeding our client’s expectations and providing insights, perspective and context that support informed decisions for today and the future. The credit for our success goes to them!

Watch this video to learn Axendia’s Origin story

Thank you for your trust and we look forward to continuing to be your source of trusted advice based on Axendia’s core values: Respect, Integrity and Passion.


3D Printing Body Parts: This 24th Century Technology is Only a Few Years Away!

By: Jared N. Matlis, Research Assistant

Science fiction is humanity’s prediction of its own future, but is often the inspiration for it.  Star Trek is a prime example of this irony, from computer tablets to flip phones, this show inspired the technological advancements it had envisaged.  

While some of these creations, like starships and teleporters, are still out of our reach, others are closer than we expect. Especially in the field of medical devices.  

For instance, in the Star Trek: The Next Generation episode “Ethics”, Lieutenant Worf is paralyzed from the waist down because of damage to his spinal cord. Despite the severity of his injury, Worf recovers due to Dr. Crusher’s implementation of a synthetic spinal cord which replaced his damaged one. Even in the 24th century, this is considered an experimental procedure, so it must be centuries ahead of us now, right? With 3D Printing, this level of medical device may only be a few years away. 

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eBook: Digital Transformation and Manufacturing Mondernization

Is The Gain Worth The Pain?

By: Sandra K. Rodriguez, Market Analyst

Pharmaceutical organizations are continuously seeking to implement mature manufacturing technologies to ensure the availability of products for their patients.  Unfortunately, once a facility has been approved for manufacturing by regulators, it is often frozen in time for decades.   This has been one of the unintended consequences of regulatory enforcement and has led to the slow uptake of modernization and digital transformation in Pharma.  

Pharmaceutical business models are changing, and supply chains have become tightly integrated supply networks.  In addition, regulatory agencies, although often seen as the industry’s biggest business disruptori, are actually encouraging innovation in manufacturing.  Life-Science companies are cloud curious and most are in the pilot phase of implementing emerging technologies such as Artificial Intelligence (AI), Machine Learning (ML), Augmented Reality (AR) and Virtual Reality (VR).   

Based on Axendia’s primary research and interviews with executives on the adoption of modernization and digital transformation in the Life-Science industry, we determined that digital transformation and modernizing manufacturing often do not go hand in hand.  In fact, through our discussions and interactions with industry executives for this report, we quickly determined that digital transformation and modernizing manufacturing are not synonymous and often take different paths.    

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Where Does Your Organization Fall on the Cloud Comfortable Scale?

By: Sandra K. Rodriguez, Market Analyst

Based on our conversations with Life-Science executives and quantitative research, it is clear that many companies fall into one of four categories:

  • Cloud Averse
  • Cloud Curious
  • Cloud Comfortable
  • Cloud First

While many companies are uncomfortable with change, a significant portion of the lndustry is developing a digital transformation/integration strategy and becoming cloud curious.  

With many GxP applications already available in the cloud, the cloud comfortable and cloud first companies are more resilient and better equipped to overcome current and future business, technology and regulatory challenges.  These companies are also lowering the compliance costs with multi-site cloud native GxP solutions.

Request your copy of our Cloud Comfortable Scale to determine which category you fall into.  Need more information? We’re here to help!


Medical Device Development Cannot Be Managed With Documents

Jama Connect for Medical Device Development Briefing Note

By Daniel R. Matlis

The Jama Software executive team recently briefed Axendia on its new Jama Connect for Medical Device Development platform.   The new solution is designed to help engineering teams manage medical device requirements, risk and design control in a single platform. The medical device offering also aims to make regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment while supporting device quality.

“We’re excited to introduce our new solution designed specifically for medical device developers which,  will help ease the development process from the start,” said Josh Turpen, Chief Product Officer at Jama Software.  “Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving engineering teams from the cumbersome and often frustrating process of filing paperwork,” he added.

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