Category Archives: Business

04May/18
N9499-0623_resize

WHAT DOES IT TAKE TO WIN AN ERGO CUP®?

THEY SAY IT TAKES A VILLAGE TO RAISE A CHILD, WELL, IT TAKES A VILLAGE OF VOLUNTEERS TO WIN AN ERGO CUP®

By: Mónica V. Matlis, Vice President Ergonomics
2018 Applied Ergonomics Conference ERGO Cup® Competition Co-Chair

Whenever the Applied Ergonomics Conference ends, I leave on a high. Adrenaline is still pumping in my veins. My co-chair, Jeff Hoyle, and I have just finished a “live stream” of the conference award ceremony and announced the winners of the internationally recognized ERGO Cup® competition. After months of preparation, we have finally closed the conference with an excitement that is contagious. We take a few minutes to acknowledge the winners by taking selfies with the teams and thanking them for the months of hard work & preparation.AEC Winning Moment

The internationally recognized Ergo Cup® competition, sponsored by the Ergonomics Center of North Carolina and Edward P. Fitts Department of Industrial and Systems Engineering at North Carolina State University and presented by IISE, provides an exciting opportunity for companies to highlight their successful ergonomic solutions. The general theme across all Ergo Cup® categories is innovation.  Five Ergo Cup® awards are presented annually for outstanding solutions through training, engineering and teamwork.

To be a finalist at the competition is an honor. To win is an achievement of a lifetime! For these teams, it’s like winning an Oscar.

To receive a copy of this complete article, click here.

01May/18
3d printing image1

White Paper: 3D Printing and Digital Twins in the Life Science

Driving Innovation and Improving Quality with 3D Printing

By: Eric Luyer, Market Research Analyst

3D printing is driving innovation and improving quality.  By bridging the gap between the digital and the physical environments, innovative Life Science companies are accelerating the delivery of next generation products that are personalized, more precise and higher quality than ever before.

Request your copy of our latest white paper: 3D Printing and Digital Twins in the Life Sciences here.

In this detailed white paper, we address the following topics:

  • 3D Printing: What is it?
  • The FDA’s view on 3D printing/Additive Manufacturing
  • Current applications – Agile tooling and Healthcare devices
  • Real world examples
  • Bio-Printing
  • How other industries are leveraging 3D printing
  • Digital Twin technology (Simulation and Modeling)
  • Benefits of 3D printing
  • Industry feedback
  • Market potential

With the use of the latest technology, life science companies can break through barriers, using new methods of manufacturing processes, or using new materials to create unique offerings and can achieve market differentiation among competitors.

Axendia content is restricted for personal use only. Reproduction or distribution of Axendia content in any form without Axendia’s prior written permission is forbidden. 

30Apr/18
Jumping

Change is a Constant, Why is it So Challenging…

By: Tamara Briggs, Process Improvement Analyst

History has taught us that the only constant is change, however in today’s industries, the rate of change is happening at an increasingly, unmanageable rate.  Axendia’s research on the future of change and configuration management revealed that over 50% of industry professionals worry that their current processes are too slow and cumbersome.

Daniel Matlis, President of Axendia, and Mike Jovanis, Vice President of Vault Quality at Veeva Systems, shared their perspectives on the challenges of change management in FDA regulated industries during an FDANews Webinar.  Specifically, they discussed the importance of simplifying change management across the product life cycle.  Topics of discussion included:

  • Change Management Challenges
  • Closed-loop Quality Processes
  • Collaborating on Change Management
  • Moving from Documents to Structured Data
  • Becoming a Proactive Quality Organization
  • Transforming Change Management Programs

Continue reading

27Apr/18
Patient

Lot Size: YOU – When YOU are the RAW MATERIAL and the FINISHED PRODUCT

Managing the Chain of Custody and Identity for Regenerative Medicine Products.

By: Daniel R. Matlis, President

According to FDA Commissioner Scott Gottlieb, M.D.  “We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.”

The promise of individualized therapies is why the FDA is encouraging and supporting innovation in this field. To this end, the Agency has released a framework outlining how it intends to apply existing laws and regulations to oversee these products. FDA’s stated goal is to ensure that it is nimble and creative to foster innovation, while taking steps to protect the safety of patients.

In individualized patient-derived cellular gene therapy products, the patient is the raw material, product, and the treatment.  In gene therapy products, cells removed from the patient become the raw material.  They are then genetically modified and returned to the patient as the “finished product”.

Continue reading

09Apr/18
Living-heart-project

Simulation for Product, Nature and Life

With 3D Printing and Virtual Human Modeling and Simulation, Life Science companies have the opportunity to innovate faster and with more confidence than ever before

By: Sandra K. Rodriguez, Market Analyst

SIMULIA is one of eleven brands at Dassault Systèmes.  During their Analyst Day, company executives provided an overview of the brand’s simulation offerings under a common theme: Enabling end-to-end digital design to production processes by deploying all multiphysics simulation technologies to enable clients to start making parts and systems that work, faster.

Print to Perform

3D Printing, also referred to as Additive Manufacturing (AM) is a complex process. However, on the 3DEXPERIENCE platform, users can digitally accelerate AM while creating lightweight, yet functional generative designs.  When moving from powder to working parts, there are significant challenges in the real-world process phase of AM. Using simulation for build planning, virtual printing, post-processing and heat treatment effects can optimize the build and ultimately save time by reducing errors and rework. With virtual printing, users can simulate not just a printing process but post-processing procedures and conduct in-service validation. Rather than relying on static documents and experience from expensive physical builds, establishing a digital thread from design to field performance unites all functionality and eliminates silos via a digital platform.  SIMULIA’s Additive Manufacturing message is clear: Print to Perform.

Virtual Human Modeling

Karl D’Souza, Sr. Solution Consultant, SIMULIA Virtual Human Modeling at Dassault Systèmes, pointed out that simulation is widespread in the development of medical devices but that a lot more is possible. In particular, medical device companies are now creating more realistic models of the human body to understand how a product will perform in its intended environment.  Continue reading