All posts by Administrator

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:

11Dec/17
Moped

Compliance vs Quality – India Edition

By Daniel R. Matlis

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

GroupThis visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry.  Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance.  In addition streamlined processes result in operational efficiencies and reduce waste.  Investing in improving product quality lowers costs and improves outcomes

Continue reading

07Nov/17
CIO Logo square - smaller

Axendia Recognized by CIOReview in Pharma and Life Sciences Issue

Company Named to 20 Most Promising Pharma and Life Sciences Tech Solution Providers – 2017

From CIOReview’s special issue: A distinguished panel composed of CEOs, CIOs, VCs, analyst and the editorial CIOReview board, has selected the top pharma and life sciences tech solution providers. In our selection process, we looked at the vendors capability to fulfill the need for cost-effective and flexible solutions that add value to the pharma and life science landscape.

“We believe that there is no one standard solution that fits all clients, therefore our approach is to offer tailored solutions that take into consideration each client’s present, as well as their future needs,” said Daniel R. Matlis, President and Founder at Axendia.

To be recognized by CIOReview as a Most Promising Pharma and Life Sciences Solution Provider is powerful evidence of the effectiveness of our approach.

Axendia’s imposing reputation in the Life Sciences and Healthcare space can be attributed to our dynamic work culture built on the values of respect, integrity and  passion.  As a result, we offer a unique combination of hands-on experience, coupled with strategic vision. We are committed to building and nurturing long-term relationships with our clients and fostering a spirit of cooperation, collaboration and trust with every single engagement.

Pharma & Life Sciences CIOReview

It is an honor to be named to the 20 Most Promising Pharma and Life Sciences Tech Solution Providers – 2017.

Full Page Article Here.