Category Archives: Technology

cyber security

The Need for Cyber Security in the Healthcare System

Cyber security may be expensive, but the cost of a life is more

By: Giselle C. Matlis, Research Assistant

Imagine someone hacks your Facebook account.  You freak out, then figure a way to get the hackers out of your account, notify Facebook, change your password and move on.  Problem solved.

But what if the hacked system isn’t your Facebook?  Instead it’s a pacemaker in someone’s heart, or an entire hospital’s records and devices.  What would you do then?

In recent years, there have been many life-changing medical devices innovations that have helped thousands of people.  Connecting devices to the internet and hospital networks has contributed to this influx.  Medical device connectivity enables doctors to monitor and administer drugs to their patients from a far, allowing patients to live more normal lives.  Connecting them to the internet also helps to electronically update patient charts, minimizing the risk of transcription errors and drives improved patient outcomes.The goal of connected medical devices and aggregated data is to assist physicians in making informed decisions for treatment. Continue reading

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New Research: Driving a Culture of Quality Within the Medical Device Ecosystem

Axendia conducted a study focusing on the medical device induCulture of Quality Infographicstry’s ability to build a “Culture of Innovation and Quality.” The goals of this research were to identify and analyze trends, requirements and initiatives organizations are undertaking to proactively manage products and platforms across the product lifecycle.

In support of the research, we surveyed 110 medical device professionals representing 59 medical device manufacturers from 12 countries, and engaged in one-on-one interviews and group discussions with industry thought leaders.

The research resulted in an e-Book: Driving a Culture of Quality Within the Medical Device Manufacturing Ecosystem.  In it, we discuss the value, challenges and opportunities of transitioning medical device companies from the current regulatory and compliance focus – to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.  We also reveal how the Industry is prioritizing investments in technology in support of quality initiatives.

See the Infographic to learn more.

Read the e-Book.

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Modernizing Quality Management with Veeva Vault QMS

Veeva Systems Analyst Brief

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality at Veeva Systems.  Veeva Systems ( is a cloud computing company focused on the pharmaceutical and life sciences industry.

Veeva Vault Quality customers – companies who own Veeva Vault QualityDocs or Vault QMS – continue to increase in numbers and now include five of the top 20 largest pharmaceutical companies. Launched just a little over a year ago, more than 40 companies have selected Vault QMS ­— and is quickly displacing its competitors.

Historically, quality management solutions have been implemented in a reactionary manner, were on premise, and required extensive configuration to meet user requirements.  “The success of Vault QMS rests on the fact that we are committed to providing best practices, not just infinite configurability,” said Jovanis.  “The true value in using the Vault Quality Suite of applications is that they support end-to-end processes across functional areas and internal and external stakeholders for greater visibility and control,” he added. Continue reading


SIMULIA is Modeling Humans from Head to Toe –Literally!

Dassault Systèmes SIMULIA Analyst Brief

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by executives of the SIMULIA brand of Dassault Systèmes. The SIMULIA brand is responsible for developing realistic 3D simulation and design optimization applications that complement the integrated solutions of Dassault Systèmes 3DEXPERIENCE® platform..

Dassault Systèmes purpose is to provide business and people with 3DEXPERIENCE universes to imagine sustainable innovations capable of harmonizing product, nature and life.   Proof of the company’s long-term commitment to simulation comes with it latest acquisition, Exa Corporation.  A Boston-based company, Exa has a global presence and customer base with reported $72M in revenue for the fiscal year ending January 2017.  Exa is focused on serving the ground transportation,  aerospace, and oil & gas industries and has deep experience in fluid mechanics and simulation.  Dassault Systèmes acquired the company on November 17, 2017.

As part of Dassault Systèmes’ Life Science and Virtual Human Modeling (VHM) update, Steven Levine, Senior Director, SIMULIA Virtual Human Modeling, stated, “SIMULIA VHM is based on two principles:  If you want to design a great user experience, you must include the user in the design.  Healthcare is still in the 1D or 2D world, it’s time we bring them in to 3D to help demystify the complexity of  the human body.”

Continue reading

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FDA Is Ushering In a New Era for 3D Printed Medical Products

3D Printing and the Precision Medicine Revolution 

By:  Daniel R. Matlis, President

“Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality,” stated FDA Commissioner Scott Gottlieb, M.D. in his announcement.

“Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements,” he added.

Today, there are more than 100 3D printed devices on the market reviewed by the FDA. These include knee replacements, cranial and facial implants.  The Agency also approved the first drug produced on a 3D printer, which is used to treat seizures and has a more porous matrix than the drug manufactured in the traditional way, enabling the drug to dissolve more rapidly in the mouth to work faster.

“This is likely just the tip of the iceberg given the exponential growth of innovative research in this field. We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs,” said Gottlieb.

Read the full article in FDAnews Device Daily Bulletin.

Related:  On January 10, 2018, the FDA held a webinar for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions.