Category Archives: Events

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

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16Oct/17
Image Courtesy of Forbes

When it Comes to 3D Printing, the Future is Already Here

Webinar Availalbe On-Demand – Experts Share Real World Insights 

By:  Eric Luyer, Market Research Analyst

According to the FDA, when it comes to 3D printing, you might say that the future is already here. Due to its versatility, the agency is evaluating the applications of 3D printing in devices, drugs and biologics and to medical applications across the entire ecosystem.

To gain first hand insight on the use of 3D printing in Life Sciences and Healthcare, Axendia assembled an expert panel for a roundtable discussion:3d printing panelists

  • Thomas Marchand, Co-Founder & CEO of BIOMODEX provided the industry perspective
  • Jenny Chen, a trained neuro-radiologist and founder/CEO of 3DHEALS, shared the physician’s perspective
  • Stavros Stefanis, leader in Deloitte’s Product Development practice, shared insights on the use of 3D printing across the product development lifecycle

The webinar was held on September 28th and sponsored by Dassault Systèmes (3DS).

3D printing in Life-Sciences is NOT Science Fiction, it is Science FACT

To date, FDA has cleared over 85 applications for 3D-printed medical devices which span across many product lines such as prosthetics and implants and last year, FDA approved the first 3D printed Drug – Aprecia’s Spritam. Continue reading

11Oct/17
SIAC17

New Versions of Everything, New Expectations

Realizing the Digital Twin – 2017 Siemens Analyst Conference

By:  Sandra K. Rodriguez, Market Analyst

The Siemens Analyst Conference took place in Boston from September 6 – 7, 2017.  Dr. Jan Mrosik, CEO Siemens Digital Factory Division, opened the conference with a clear message:

“Digitalization changes everything and a common digital thread enables continuous business transformation!”

Siemens has invested $6.5B since 2013 in its digital enterprise suite, beginning with the acquisition of LMS International which expanded its strategy for system validation and verification.  The company is also seeking to establish a leadership role in electronics and semiconductor product and process simulation by adding Mentor Graphics to its Digital Factory division.

A Digital Twin is not a concept, it is a disruptive technology.  It enables companies to competitively change the way products are realized, come to life and evolve.  Adding digital twin technology within a smart factory offers companies three unique benefits:

  • The ability to predict profitability through analysis of production scenarios
  • Improved efficiencies through the digital thread and virtual commissioning
  • Optimized production through the comparison of real and digital production systems

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06Jul/17
Mind-Boggling-Change

Thriving in the Age of Mind Boggling Change

By: Daniel R. Matlis, President Axendia, Inc.

Thriving in the Age of Mind Boggling Change

“Change is the Only Constant” said Heraclitus of Ephesus two and a half millennia ago.  While change has been the constant throughout human history, the rate of change seems to be accelerating exponentially.

Change, and the need to adapt to “Mind Boggling Change” was a key theme at QAD Explore 2017 in Detroit last month.  “Adapting to this rapid change is an imperative,” said Pam Lopker President of QAD. Ray Kurzweil, inventor, futurist and Director of Engineering at Google explained that while the human brain operates linearly, the rate of change growing is exponential. In information technology, this is represented by Moore’s law. Correspondingly, the rate of information processing is growing exponentially.

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01Jun/17
webinar pic

Webinar Announced: How Connected Devices Improve Patient Outcomes

Designing and Manufacturing Devices that Excel in an Internet of Medical Things (IoMT) World

register

Daniel Matlis, President of Axendia and Jordan Reynolds, Senior Manager, Kalypso, will discuss how innovative companies should navigate the perilous intersection of FDA approval, quality manufacturing and support for superior patient outcomes during a live webinar at 1:30pm Eastern on June 20, 2017.

The device industry is changing rapidly — and with change you have winners and losers. Today’s winners are embracing connectivity and the quickly emerging internet of medical things (IoMT) movement.  They understand that the future is continuous glucose monitoring systems that connect to handheld meters, sensor-embedded hospital beds that proactively alert providers to problems, wearable mHealth devices which can send information to caregivers or a multitude of other remote patient monitoring technologies.

Getting these new products approved by the FDA is hard enough, making sure they connect properly with patients, physicians and healthcare centers is even harder.

Register today to learn how smart, connected devices are changing the device ecosystem in support of patient outcomes.