Category Archives: Business

22May/18
EU MDR LSP Tile

INFOGRAPHIC: Digital Transformation is a Journey to Support EU MDR and Beyond

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry. Executives we’ve talked to have stated:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

Are you lost? Access our Infographic for a road map to sustainable, positive disruption and see for yourself why Digital Transformation is a journey to EU MDR and beyond.  We’ve identified some road hazards and areas of interest along the way.Digital Transformation EU MDR

With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.

Register to receive the Infographic today and keep an eye out for additional information.

09May/18
Magician Palladium

Are Spreadsheet Wizards Doing Data Alchemy to Transform Your Data into Intelligence?

Bigfinite Brings a SaaS Platform that Uses Big Data, Artificial Intelligence (AI) and Machine Learning (ML) to Capture Data in the Cloud via IoT Technologies

By: Daniel R. Matlis, President

Life-Science companies are obsessed with hording documents.  These documents are filled with meaningless data.

Axendia research shows that 85% of companies surveyed rely on document driven processes.

Much of these meaningless data are unstructured, untagged and untapped.  Data are spread across countless repositories. They are saved in PDF documents and spreadsheets, in portals, share drives and email systems, in ERP, QMS, LIMS, MES, and PLM in process control systems and historians, etc.

However, data, even Big Data, on their own are not enough.  What is needed is intelligence.  Intelligence can be applied to answering scientific questions about product or process changes and the potential impact to both the product and the patient.

Unfortunately, many Life Science companies are suffer from DRIPPPP_INATU_CLP_WaterDroplet_B

DATA

RICH

INTELLIGENCE

POOR

Data Alchemy is NOT the Fix for DRIP

Until recently, the challenge has been the ability to turn these vast amounts of meaningless data into actionable intelligence, while supporting compliance with regulatory requirements.

Magician PalladiumHistorically, transforming meaningless data into actionable intelligence required hordes of spreadsheet wizards performing data alchemy. Data alchemists would hoard, compile, purify, distill, and perfect vast amounts of meaningless data and turn it into quasi-actionable intelligence.  Often working with months old data, the job of a data alchemist is tedious, resource intensive and often non-reproducible.

What if you could throw your data into a qualified data lake and use every technology buzzword to transform it into actionable intelligence?

Can Big Data, AI, ML, Cloud and IoT Fix the DRIP?

bigfinite logoAxendia was recently briefed by Bigfinite management to learn how the firm’s platform can address Life Science manufacturing problems that cannot be easily solved with current solutions. Continue reading

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