03Dec/19

Quality Creates Leadership – Quality Creates Differentiation

ETQ 2019 Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Team of ETQ.  Headquartered in Boston, ETQ has 27 years of quality management experience.  The company believes that competitive advantage grows when companies take a differentiated and agile approach to quality management.

“Our highly regulated customers in Life Sciences and Food and Beverage are aware of the regulatory consequences of poor quality and are looking to address these issues across all phases of their supply chain and manufacturing process – starting with product design,” began Nina McIntyre, Chief Marketing Officer at ETQ.

The actual management of quality from a sales perspective and the entire complaints management aspect of the product life cycle, is something that is critical in Life Sciences and all of the Industries in which ETQ does business.  ETQ’s flagship Quality Management System – Reliance, is assuring quality outcomes for some of the world’s most demanding brands in medical devices, pharmaceuticals, food and beverages, etc.

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02Dec/19

FDA Discusses Challenges and Opportunities for 3D Printing in Life Sciences

A Straight from the Source Webinar 

The interest in 3D Printing (a/k/a Additive Manufacturing) has risen spectacularly the last decade.  The use of 3D Printing technology has wide-ranging applications across the Health Technology Ecosystem, including surgical, healthcare, pharmaceutical and medical devices.  In fact, over 100 medical devices using 3D printed components have been cleared by FDA. 

With the rise in utilization of 3D Printing in Medical Devices, FDA’s interest in additive manufacturing has significantly increased.  To address how the technology can affect the quality, safety and effectiveness of these products, FDA published guidance for industry titled: Technical Considerations for Additive Manufacturing Devices by Dr. Matthew Di Prima.

Join FDA’s Matthew Di Prima and Axendia’s Eric M. Luyer in for a live webinar on November 20th at 11am ET.  This webinar is now available on-demand.

Meet Your Trusted Sources 

Di-Prima-Luyer-Webinar-Twitter

In this webinar, we discuss FDA’s perspective on: 

  • Current capabilities of 3D Printing in Life Sciences 
  • Challenges and opportunities for 3D Printing in Life Sciences 
  • Case studies on FDA reviewed and approved devices on the market 
  • Collaborations Industry, Universities and Standard Development Organizations 
  • Regulations, guidance and Standards for 3D Printing  
  • Vision for future uses of 3D Printing in Healthcare  
  • Point of Care  
  • Personalized Medical Devices  

Register and watch this webinar on-demand.

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21Nov/19

Samsung Biologics CIO Shares Vision for Modernizing Manufacturing Quality

By: Daniel R. Matlis, President

Samsung Biologics is a world-class contract development and manufacturing organization (CDMO) located in Songdo, South Korea.

James Choi, VP and CIO, Samsung BioLogics

James Choi, VP & CIO Samsung Biologics

Founded in 2011, Samsung Biologics has the largest total plant cell culture capacity in the world from a single location:  364,000 L.  The company employs more than 2500 employees including 100+ global expats from 12 countries.

To discuss the company’s vision for modernizing manufacturing quality, I sat down with James Choi, VP and CIO, Samsung Biologics, at the 2019 Veeva R&D Summit.

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13Nov/19

Inventing New Horizons with Science as a Catalyst

Event Brief: Science in the Age of Experience 

By: Sandra K. Rodriguez, Market Analyst

I had the opportunity to cover “Science in the Age of Experience” in Boston in October.  The annual Dassault Systèmes conference brought together 500 attendees, representing 250 companies.  This year customer presentations focused on new ways of experiencing and shaping science in Life (better living), in Engineering (product innovation) and in Nature (sustainable planet).

Bernard Charlès, Vice Chairman and CEO of Dassault Systèmes opened the event by stating, You can’t have knowledge if you don’t have knowhow.” Charlès continued with, “The biggest challenge in innovation is over-communicating and under-understanding.”  The agenda was filled with presentations by members of MIT and Harvard, plus Dassault Systèmes’ clients who are seeking to not just understand the correlations between product, nature and life… but are inventing new horizons with science as the catalyst.

Standing on Solid Ground with SOLIDWORKS

Hugh HerrHugh Herr, Professor of MIT Media Lab and co-director of the MIT Center for Extreme Bionics; Founder of BionX, Inc., had both legs amputated from just under the knee after suffering from frostbite during a mountain climbing accident in the early 1980s. He pointed out the surgical procedure that doctors performed following his accident had not changed since the late 1800s.  As a result, although he could walk again with the help of his first set of prosthetics, he was unable to associate the feeling of pressure or movement in his ankles or feet.  With both pant legs rolled up to expose his bionic limbs he stated, “From the knee down, my legs are a bunch of nuts and bolts.”   He then informed us that in addition to the nuts and bolts are sensors, and an entire bionic ecosystem that gives him the ability to move, walk, jump and pivot naturally.  Continue reading

05Nov/19

Transforming Quality, a Top Priority for Customers at Veeva Summit 2019

Veeva Summit 2019 Event Brief

By: Daniel R. Matlis, President

Veeva has become a strategic technology partner to more than 775 customers across the globe, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

Veeva-Summit-Check-In

I had the opportunity to cover the 2019 Veeva R&D Summit in Philadelphia, PA in September.  The event brought together more than 1,700 life science professionals and experts to share the latest market trends in the industry, experience innovative technology, and share best practices. The annual event has experienced 25% attendance growth compared to 2018.

This brief focuses on my first-hand interactions with leading industry executives leveraging Veeva’s quality offerings to modernize quality management in the cloud.

The following executives shared how they are leveraging modern cloud-based solutions to transform quality management:

  • James Choi, VP and CIO at Samsung BioLogics, shares his vision for modernizing manufacturing quality.
  • Chris Lamont, Director, Global QMS Programs at Bristol-Myers Squibb presents the company’s journey to achieve enterprise quality with Vault QMS.
  • Jennifer Trundle, Associate Director, Quality Management Systems at Gilead discusses the successful expansion of Vault QualityDocs across the global enterprise.

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