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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.


Siemens Industry Analyst Conference 2015

By Sandra K. Rodriguez, Research Associate

Digital Twins Enable Time Travel

If you had a time machine, would you rather take a peek in to the future or change something in the past?   If you could build a digital twin that enabled time travel, would you?

The theme of this year’s Siemens Industry Analyst Conference was Realizing Innovation.   Virtualization and digitalization capabilities throughout the product lifecycle are giving industry the opportunity to do something new – time travel.

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Earning Your Trust for Ten Years

By Daniel R. Matlis, President

Axendia Turns Ten!

Ten years ago, Axendia was founded on the premise to provide trusted advice to Life Science and Healthcare Industry Executives on Business, Technology and Regulatory matters.

Over the last ten years, we have had the privilege to earn the trust of executives across Life Science and Healthcare ecosystems.  As a result, we have advised industry, technology & service providers, policy makers and regulators.

We are committed to building, nurturing and growing long term relationships based on our core values: Respect, Integrity and Passion.

This commitment to our clients, partners and team members has fostered a spirit of cooperation, coordination and trust that is essential to ensuring success.

How do we measure success?

Our success is based on yours.  We measure success based on the contributions we have made to you and your organization as well as the commitment to our mission: “to be trusted advisors to Industry Executives.”

During the last ten years:

  • We have had the privilege of advising Life-Science, Healthcare and Food companies ranging from startups to Fortune 100 companies.
  • We have had the opportunity to work with leading technology and service providers.
  • We have published numerous primary research studies, whitepapers, articles and infographics.
  • We have been invited to present at leading industry conferences and at the FDA.
  • We have conducted briefings for audiences around the globe, including Asia, Europe, North and South America
  • We began writing a blog in 2006, before blogging was cool. Today, we have thousands of subscribers to Life-Science Panorama, and you can also follow us on Twitter and LinkedIn.

I hope that over the past ten years we have earned your trust and that Axendia hastrust become a source of trusted advice for you.

Thank you for your support and we look forward to continuing to build long-term relationships based on our core values: Respect, Integrity and Passion.


An Anti-DRIP Campaign

By Ellyn McMullin, Research Associate

Unlocking Big Data to Achieve Business Value

Of the many workshop type of meetings I have attended, this is the best one I have gone to…there was an actual success story!  This is the feedback from one participant at the Executive Roundtable on Big Data in Life Sciences.

That’s what happens when a leading business transformation company provides an environment for its clients and partners to discuss mutual concerns and potential solutions.  On August 27th, Trace3 brought together Executives from Merck, Novo Nordisk, NNIT, BMS, and J&J Janssen to discuss Big Data in Life Sciences in Princeton, NJ.

Trace3 is a business transformation partner, helping organizations through high-end consultancy.  The company empowers organizations to keep pace with the rapidly changing IT landscape by leveraging innovative technologies and organizational health.  Trace3 has a Big Data practice and had one of their principals, Carey Moretti, moderating the roundtable.

The Executive Roundtable explored the challenges and rewards of implementing Big Data and analytics within the complex regulated Life Sciences space. Axendia’s President discussed industry wide trends and FDA’s perspective on Big Data.  He offered insight on how to leverage a multitude of varying data sources from new and legacy systems to gain greater visibility and how to improve product quality while improving revenue and lowering costs.

Jerry Megaro, Merck & Co.

Jerry Megaro, Merck & Co.

The keynote speaker, Jerry Megaro, Director of Innovation and Analytics at Merck & Co. has a degree in Chemical Engineering from NJIT and 15 years of experience of working in Merck’s Manufacturing arena.   He is currently leading initiatives to transform Merck Manufacturing into a data driven organization to enhance Merck’s performance across the Supply Chain.

Reverse the DRIP

Remember GIGO (Garbage in, Garbage out)?  It refers to the fact that computers, since they operate by logical processes, will unquestioningly process unintended input data (“garbage in”) and produce undesired, often nonsensical, output (“garbage out”).  The issue about the quality of the data generally is no longer a major concern, but the use of the data output is.  Unfortunately many companies are the sufferers of DRIP!  DATA  RICH  INTELLIGENCE POOR

Life-Science companies have vast amounts of data (Big Data) generated by a multitude of systems (SCADA, Historian, MES, ERP, EAM, LIMS, etc.) but unfortunately have very little Intelligence on how this information can be harnessed to produce a better quality product.

To request a copy of the Executive Roundtable event note and learn how Merck & Co., Unlocked Big Data to Achieve Business Value, please click here.

Image Courtesy of Forbes

Intelligence Based E-Inspections

By Daniel R. Matlis, President, Axendia

Are You Ready to be Graded on a Curve?


The Food and Drug Administration Safety and Innovation Act (FDASIA) provided the agency with sweeping new statutory authorities, which have not garnered much attention by industry.  A key FDASIA provision is the ability to conduct electronic inspections (e-Inspections) and target onsite inspection based on metrics.

By shifting to a metrics based approach the Agency seeks to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.

“…we want to encourage firms to prioritize quality and encourage their boardrooms and their pocketbooks because quality costs money,” stated Howard Sklamberg, J.D., FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

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