All posts by Daniel R. Matlis

19Mar/14
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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
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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

Continue reading

09Dec/13
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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

15Oct/13

The Many Sides of Process Improvement 1-Minute Video Briefing

By Axendia Staff

While Medical Technology companies claim to embrace process improvement initiatives, our research shows that they are still firefighting. They are using brute-force approaches to eliminate defects and support regulatory compliance.

Key findings, analysis and recommendations from this research are available in a series of four white papers under the umbrella: “Is Med-Tech Improving Processes or Chasing Defects.” Continue reading