All posts by Administrator

25Jan/17
wakup call

Rapid Regulatory Changes Will Impact Medical Devices and Diagnostics Industry

By: Hugo Felix, Director Design Quality Assurance, Bard Access Systems

This is Your Wake Up Call!

The Medical Device and Diagnostics Industry is experiencing rapid regulatory changes.  To deal with these changes there are certain key areas that need to be addressed so we can thrive, rather than just survive.  Quality Systems need to account for that, deal with the rapid pace and help us manage it.

New standards, regulations and guidances will have a significant impact in our industry:

  • The International Organization for Standardization (ISO) published ISO 13485:2016.  This represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices
  • ISO 13485:2016 has a 3 year transition period and no new accreditations to the 2003 version after year 2
  • TC210 just approved changes to ISO 14971, Application of Risk Management to Medical Devices and an update to the accompanying ISO TR 24971 and a new TR for Post Market Surveillance

For its part, the US FDA issued guidances late last year on Benefit Risk Analysis for Pre and Post Market and draft guidances for deciding when to submit a 510K for device changes and another for software changes. MDD/IVDD to MDR/IVDR change is slated for May 2017 with full implementation deadlines of 2020 for MDR and 2022 for IVDR.

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06Jan/17
WP2 Main Image Strategic Leadership

Industry Executives Discuss Change in a Complex Environment

By: Sandra K. Rodriguez, Market Analyst

Life Science Industry Executive Roundtable – Event Brief

ert-picComplex – the one word that accurately describes the current environment in Life-Sciences. As products and manufacturing processes become more complex, managing change comes with a higher level of risk.  To discuss the importance of managing change in this complex environment, as well as examine key findings from our latest research on Change and Configuration Management, Axendia brought together a select group of executives from leading Life Science companies for a roundtable in Princeton, NJ.

A primary thread of the discussion was the need for closed-loop Change and Configuration Management (C&CM) strategies.  Closing the loop is becoming critical to ensuring product quality throughout the product lifecycle.

The research shows that:

  • 63% of survey respondents say their C&CM process is only somewhat effective or useless
  • Not a single respondent reported they have an idealC&CM system in place
  • 55%report that a slow and cumbersome C&CM process keeps them up at night
  • 62% rateregulatory and government agencies as their TOP business disruptor

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04Jan/17
quality

Is Your Quality Unit Ready to Submit Quality Metrics Data Across Your Supply Chain?

By: Sandra K. Rodriguez, Market Analyst

FDA “Encourages” Industry to Volunteer for e-Inspections Program

Based on Quality Metrics, FDA’s e-Inspections program is encouraging industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.    In response to stakeholder feedback, the agency issued a revised draft guidance document in November 2016 titled “Submission of Quality Metrics Data[1].”

The draft guidance explains how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.  For more background on the evolution of this initiative see ISPE, FDA and the Metrics Future and FDA to Grade Industry on a Curve – Are You Ready?
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12Dec/16
veeva-logo

Unifying Applications to Drive Effectiveness, Efficiency and Compliant Collaboration

By: Sandra K. Rodriguez, Market Analyst

Using a Cloud Platform to Connect the Life Science Value Chain

Pharmaceutical, Bio-Tech and Medical Device companies are increasingly adopting cloud platforms to drive effectiveness and efficiency throughout the value chain.  These organizations are unifying applications that support the total product lifecycle in a compliant manner, without losing sight of what matters most – product quality.

This shift from disconnected point solutions to a platform approach became clear at the Veeva Systems Global Summit for Clinical, Regulatory, and Quality in Philadelphia on October 17-19, 2016, where I joined over 600 attendees representing 154 companies.  Client presentations ranged from start-up to multi-national Life-Science companies including Regeneron, Shire and Johnson & Johnson. A list of presenters can be found here.

Jennifer Goldsmith, Senior Vice President, Veeva Vault

Jennifer Goldsmith, Senior Vice President, Veeva Vault

Jennifer Goldsmith, Senior Vice President, Veeva Vault kicked off the event by celebrating the five-year birthday of Vault.  This was my first time covering the event and I was immediately surprised by the opening keynote delivered by Peter Gassner, CEO at Veeva Systems.  He revealed that over the past three years, the company has consistently doubled its customer base across all three of its product offerings – Vault Clinical, Vault Quality and Vault Regulatory.  Sessions were offered across all three areas including a track on platforms and a focus on small and mid-size organizations. Continue reading

11Oct/16
closed-loop-process-with-copyright-wp5

Does Having a Closed Loop Process Really Matter to Your Business?

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

Recalls are on the rise. How can you avoid them?

Analysis shows a 97% increase in the annual number of medical device recalls for the 10-year period, increasing from 604 recalls in FY 2003 to 1,190 recalls in FY 2012. 

Want to learn how a Closed Loop Process can prevent recalls, drive accelerated innovation, improve product quality and enhance company performance?  Does Having a Closed Loop Process Really Matter?

Download the white paper to find out how Med-Tech Innovators are avoiding recalls by implementing closed loop change and configuration management processes.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.