All posts by Daniel R. Matlis

04Oct/21

Digital Transformation: The Business Imperative for Life-Sciences

By Daniel R. Matlis, President

“Necessity is the mother of invention,” says the ancient proverb.  In my opinion, the corollary is: “disruption is the matriarch of transformation,” especially for the Life-Sciences industries.

The COVID-19 epidemic has been the biggest global disruption in our generation. It represents a watershed moment for transformation throughout our industry.

Disruption is the new normal. This new paradigm is forcing Life-Science companies to re-imagine the way they operate; transforming and accelerating product development, regulatory review, manufacturing, and distribution cycles aimed at improving patient outcomes.

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27Sep/21

“Orchestrating” the Sales-to-Manufacturing Process

KBMax Briefing Note

By:  Eric M. Luyer, Industry Research Analyst

Axendia was recently briefed by the executive team at KBMax about their offering to the Bio-Pharma Industry.

KBMax offers innovative and engaging technology in the visual “Configure, Price, Quote” (CPQ) and Visualization market, “orchestrating” the sales-to-manufacturing process in an engineer-to-order environment.  KBMax was acquired by Epicor in May 2021. This acquisition will continue to drive growth for Epicor as they now have the ability to offer KBMax software as a stand-alone system or integrate it into the Epicor ERP suite to generate new, cross and up-sell revenues.

Steve Murphy, CEO of Epicor commented on the acquisition:It’s a perfect time for businesses to reach our customers in new and compelling ways. The integration of KBMax’s technology into our platform will solve that challenge for our customers, enabling them to create an information-rich and immersive online buying experience. The integration of next-gen CPQ tools with our ERP system will enable vital connectivity points to our customers across inventory, costs, pricing, and customer data”.

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19Mar/14

Show FDA Your Commitment to Quality

By Daniel R. Matlis

The “Case for Quality Initiative” is a strategic priority for the US Food and Drug Administration. To support this initiative, the agency is working to implement policies that go beyond compliance with regulations and provide an enhanced focus on the manufacturing quality.

To learn more about this strategic shift at FDA, I spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health.

We are publishing the interview in a series of articles covering our discussion on the Case for Quality Initiative. Continue reading

06Feb/14

What Keeps Terumo Executives Up at Night?

By Daniel R. Matlis

In this exclusive interview with Terumo Cardiovascular Group Executives, Mark Lincoln and Chris Zarecki address key issues and trends impacting the Medical Technology industry in particular as well as the broader Life-Sciences industry.

Find out which industry trends keep Terumo Executives up at night in this three part “Executive Vision” interview series addressing:

  • Managing price and cost pressures
  • Dealing with the Excise tax
  • Adding value beyond quality and compliance
  • Tapping Emerging Markets for growth
  • Managing Med-Tech globalization, outsourcing and offshoring
  • Complying with increasing global regulatory pressures
  • Preparing for FDA’s Risk-Based Approach

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09Dec/13

FDA Driving Industry "Beyond Compliance" to Promote Manufacturing Quality

By Daniel R. Matlis

ADVAMED 2013 lived up to its reputation as “the leading MedTech conference.” One highlight of the event for me was the panel: “Case for Quality FDA & Industry Progress Update”

The “Case for Quality Initiative” is a strategic priority for the US Food and Drug Administration. To support this initiative, the agency is working to implement policies that go beyond compliance with regulations and provide an enhanced focus on manufacturing quality. Continue reading