Category Archives: Business

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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11Oct/16
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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.
29Sep/16
gudid

Hear Directly from FDA: Are You Done with UDI or Is This Just the Beginning?

Webinar Announcement 

Are you done with UDI… or is it just the beginning?  Hear directly from FDA’s Senior Advisor for UDI and Industry Experts the profound effect UDI implementation will have on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient.

On Oct. 13th at 1:30pm Eastern, join Terrie Reed, Senior Advisor for UDI Adoption at the FDADaniel R. Matlis of Axendia, and Jean Colombel of Dassault Systemes as they discuss UDI and how its value resides in the ability to optimize meaningful data collection and analysis.

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27Sep/16
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Don’t Solve Quality Problems, Avoid Them

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

Can you distribute poor quality products while complying with all applicable regulatory requirements? Sure! After all, you can conduct a recall of poor quality products in compliance with all applicable regulations.  FDA’s Top Medical Device official agrees.

Jeff Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), put it this way: “…one device manufacturer can meet FDA requirements and still make a poor quality device; whereas, a second manufacturer may not comply with all FDA requirements and yet make a high-quality device.”

Is your organization focused on Solving Quality Problems or Avoiding Them?  Download the white paper to find out how Med-Tech Innovators have been able to shift their focus on improving market presence, manufacturing processes and product quality.

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