Category Archives: Latest


FDA and Industry Embrace Highest Quality for Medical Products

By:  Daniel R. Matlis, President

Historically, interactions between industry and the FDA have been described as complex, challenging and even adversarial. Many a time, our firm has been asked to serve as an “anonymizer” for a medical device company that had a question for the FDA, but was concerned about interacting with the agency directly.

Would interactions be different if meetings between the agency and industry shutterstock_195838178 HUG FOR MDIC Article
stakeholders started with a hug? They did at the most recent Case for Quality Forum where industry and the FDA literally embraced, stating that providing medical products of the highest quality is their main focus.

The Case for Quality (CfQ) Forum consistently provides an open venue to discuss and exchange ideas on improving medical device product quality. The Case for Quality program was created to facilitate ongoing dialogue that will ultimately benefit patients, providers and the medical technology community. The initiative brings together industry stakeholders – including the U.S. Food and Drug Administration, medical device manufacturers, payers, providers, industry advisors and patient advocates. Continue reading


IBM’s Grand Vision for Better Healthcare

By: Ellyn McMullin, Research Associate and Daniel R. Matlis, President

How IBM Wants to Transform the Healthcare Industry – Part 1 

IBM has made a number of key announcements recently regarding the formation of a new business unit called Watson Health as well as a Watson IoT unit.

It is the vision of IBM Watson Healthto bring together clinical, research and social data from a diverse range of health sources, creating a secure, cloud-based data sharing hub, powered by the most advanced cognitive and analytic technologies and fed by the Internet of Things.  As we previously discussed in “IBM wants to use Watson to fix a Disconnected Healthcare System” Watson’s unique capabilities have tremendous potential in the Healthcare industry.

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Shift is Happening Now

By Daniel R. Matlis, President

What Can Pharma CIOs do to Enable Innovation

What is the role of a CIO in a Pharma / Life-Science company?  Traditionally, the role of the CIO has been to manage the IT portfolio, implement systems, manage infrastructure and control IT costs to support the business.

With the unprecedented rate of shift the industry is experiencing, CIO’s can no longer simply be tasked with managing portfolios and budgets.

This was evident at the 2015 CIO Innovation Summit in Kyoto, Japan on October 20th.

There, Executives from leading organizations across the Life-Sciences ecosystem in Asia converged at the Ritz Carlton in Kyoto to learn about industry trends and share success stories and current best practices (cBPs).

Key themes at the event included innovation, transformation, collaboration and connectivity.  The event was hosted by BIOVIA – Dassault Systemes and brought together top executives from:

  • Astellas Pharma
  • Bridgestone
  • Bionet
  • Daichi Sankyo Biovia
  • Everlight Chemical
  • Genesis Genetics Asia
  • IPCA Laboratories
  • Samsung Biologics
  • Shionogi &Co
  • Sumitomo Danippon
  • Takeda Pharmaceuticals
  • Mitsui Chemicals
  • WuXi Apptech

Max Carnecchia, BIOVIA’s CEO, set the tone for the event in his opening remarks. His message: “By transforming the pharmaceutical industry through innovation, collaboration and connectivity, we can streamline end-to-end manufacturing, enhance quality and improve compliance in today’s challenging regulatory and risk environment.”

To learn more about illuminating dark data, please click here for a PDF copy of the entire Event Brief.


SURVEY CLOSING SOON! The Future of Change and Configuration Management

Your Input to Med-Tech Survey Donates to Children’s Miracle Network Hospitals®

Axendia is conducting a research study to identify change and configuration management trends in the Medical Device Industry.  The survey will close on December 13, 2015.

Medical devices are in a constant state of evolution: providing new capabilities, addressing defects, adapting to changing markets or regulatory demands and reacting to competitive threats.

To access the survey, please click here.

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Beyond Compliance – Accelerating Medical Device Innovation

Webinar Now Available On-Demand 

Accelerating medical device innovation in the midst of increasing regulations and global expansion requires new business strategies.

Daniel R. Matlis, President at Axendia and a panel of industry experts, including Dave Hadfield of Kalypso and Arieh Halpern of Dassault Systèmes discuss:

  • FDA’s shift from compliance to quality
  • Challenges and opportunities in today’s global and outsourced environment
  • Designing, sourcing, manufacturing and marketing in a global marketplace
  • Personalized and customized device development
  • Device traceability and managing UDI proactively
  • Managing the total product lifecycle
  • Designing for manufacturability and building quality by design

Please use this link for on-demand access to the webinar in its entirety.