Category Archives: Quality

13Jul/18
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Lucky 13! What’s in a Number?

At Axendia, We Consider 13 More Than a Lucky Number!

We are quickly approaching our 13 Year Anniversary!  Since 2005, we have been providing trusted advice to Life-Science Industry Executives on Business, Regulatory and Technology Matters. It’s more than just luck, our analysts help a diverse set of clients achieve positive disruption through primary research and deep industry experience in a complex and highly regulated Industry.  Not only is our staff passionate about what they do, they average 20 years of Life-Science industry experience.

As a result, Axendia has proudly built long-term relationships across a broad industry ecosystem including:

Life-Science and Healthcare Organizations 68530 Connected Doctor

We provide strategic advice on key initiatives and understand the issues and priorities facing Industry Executives. We architect strategic road-maps to support positive disruption.

Examples include:

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29May/18
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FDA: Consumers and Patients Deserve Six Sigma Quality Products

Compliance vs. Quality – Interphex Edition

By: Daniel R. Matlis, President

Last month, I had the privilege to heaYU-Interphex-2018r Lawrence Yu, PhD, FDA Deputy Director of CDER’s Office of Pharmaceutical Quality (OPQ) at INTERPHEX 2018.

The theme of his presentation “The Future of Pharmaceutical Quality and the Path to Get There,” was that consumers and patients deserve six sigma quality products.

To encourage this effort, the Agency began the drive to modernize its regulation of the pharmaceutical industry to emphasize Quality more than a decade ago with the 21st Century Initiative.

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30Apr/18
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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

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04Apr/18
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Quality: STOP Working on Compliance

Excessive focus on compliance can create hurdles in cultivating quality and innovation

By: Daniel R. Matlis, President

What is the role of Quality in MedTech? 10% said the primary role of quality is to drive product / process improvement. In sharp contrast, 85% indicated the primary role of quality is ensuring compliance

No wonder, the industry has to overcome some many hurdles when cultivating a culture of quality and innovation.

To compete in today’s global markets, Med-Tech companies must change their approach to Quality, from meeting compliance requirements, to driving product and process improvements across the product life-cycle.

A closed loop approach can help MedTech organizations make this crucial shift by enabling better collaboration, visibility and product quality across the product life-cycle.

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Read my latest Soapbox column in MedTech Intelligence for key takeaways from Axendia’s research on this topic.

06Mar/18
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CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

What’s In It For You?

By: Sandra K. Rodriguez, Market Analyst

On February 27th, the Medical Device Innovation Consortium (MDIC) provided a quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.  The program aims to build a culture of quality across the entire organization while producing measurable results including:

  • Reduce defects/re-work
  • Reduce costs
  • Accelerate time to market
  • Increase customer satisfaction

The pilot was announced in the Federal Register on December 28, 2017.  During the recent webinar, Kimberly Kaplan of CMMI Institute reviewed how the pilot program leverages the CMMI framework as the standard maturity model by which medical device organizations can measure their capability to produce high quality devices and improve patient safety.  To date, 13 organizations have enrolled in the pilot program.  She pointed out early indications show industry is having a hard time shifting from an inspection or audit mindset, to an appraisal approach – which is more conversational in nature. Continue reading