Category Archives: Technology

07Feb/18
veeva logo

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 (www.veeva.com) 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

29Jan/18
Living-heart-project

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

24Jan/18
3d printing image1

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.

18Jan/18
woman with fitbit

How the Internet of Medical Things (IoMT) Supports Improved Patient Outcomes

Webinar Recording Available On-Demand

By: Sandra K. Rodriguez, Market Analyst, Axendia

The Internet of Medical Things (IoMT) and the transition to outcomes based reimbursements are changing the way medical device companies approach new product development. IoMT and connected healthcare can enable the transition to patient-centered, preventative care.  IoMT connected devices are going to play an important role in supporting improved quality of care, patient outcomes, and also improving the business of healthcare in the outcome economy.  Yet with smart, connected products comes a new level of complexity throughout the total product lifecycle

In a recent FDANews webinar, I was joined by David Wolf and Jordan Reynolds, both Senior Managers with Kalypso.  We discussed the impact the increased number of connected IoMT devices is having on outcome based healthcare models, the potential benefits and pitfalls, and how to best leverage PLM solutions and IoT in a changing healthcare environment. Continue reading

11Jan/18
2017 Year end review

Award Winning Year for Axendia – Looking at the 2018 Crystal Ball

By Daniel R. Matlis

2017 has been an exceptional year for Axendia.  We were recognized by CIOReview magazine as one of the 20 Most Promising Pharma and Life Sciences Solution Providers.  We also had the opportunity to address audiences around the globe, including Asia, Europe, North and South America.

Our analysts had the privilege to provide insight and trusted advice to leaders across the Life Science and Healthcare ecosystems including executives in industry, technology & service providers as well as policy makers and regulators.
In the last year we advised our clients on critical topics such as: