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.

change ahead for hugoThe ever increasing rate of change seems to have been sent into overdrive.  After the MDD 2007 updates implementation date of 2010, or some may argue after the update of ISO 14971 in 2007, this rapid pace was set and is here to stay. Regardless of which date triggered it, we are now in a state of rapid regulatory changes.  Our quality systems need to account for that, deal with the pace and help us manage it.

In order to deal with this change, there are certain key areas that need to be addressed so we can thrive, rather than just survive.  These are:

  • Risk based Quality Management Systems (QMS) and Processes – There is an ever-increasing need to efficiently act on a safety signal or an issue impacting quality, whether the impact is positive or negative. The updated ISO 13485:2016 calls for the QMS and its associated processes to take risk into account during its design. Managing risks and data is paramount to successful compliance and quality improvements.  Risk management is now solidly entrenched throughout ISO 13485:2016 and both FDA and notified bodies are driving for risk management of product and processes to help drive the Safety and Quality of products and processes.
  • Regulatory Intelligence – The pace of change is here to stay. Is your organization prepared to stay ahead of it to avoid costly remediations and hurried haphazard implementations? Fumbled or delayed implementations cost time and money you could deploy elsewhere.  Proactive change management is needed.  The days of reactive change management should be behind us.
  • Predictive Analytics – The Case for Quality is coming. FDA will eventually set the systems to look at healthcare manufacturers through the lens of a quality scan.  Is your business prepared to monitor and act in the same way FDA is gearing to look at it? Is the EU registry database driving at the same thing?  Forward looking systems are key to help you thrive in this regulatory environment.
  • Digital Transformation Strategy and Robust Systems – Well thought out and integrated electronic systems will be a minimum requirement to deal with the massive data and be able to make sense of it and turn it into actionable information. As Daniel Matlis of Axendia puts it, do you have a DRIP (Data Rich Information Poor) problem and how are you going to fix it?  That requires a vision of a robust system aided by integrated digital platform.

This is Your Wake Up Call!

It is clear that the Medical Device and Diagnostics Industry are experiencing rapid regulatory changes. While this article is not intended to provide a comprehensive roadmap or set of instructions, it is intended as a wake up call!

In order to thrive in this changing regulatory environment, the Medical Device and Diagnostics Industry need to adapt to the new landscape.  We need to re-evaluate the way we do business and assess our Quality Systems to look for opportunities to help stay ahead of the changes effectively and efficiently.

About the Author: 

Hugo Felix, Director Design Quality Assurance at Bard Access Systems
Hugo Felix, Director Design Quality Assurance at Bard Access Systems

Hugo Félix is currently the Director of Design Quality Assurance at Bard Access Systems in Salt Lake City leading a team that develops vascular access, ultrasound and long term implantable port access devices.  He has over twenty years of experience in Medical Devices, Pharmaceuticals and In Vitro Diagnostics with companies such as Johnson & Johnson, Roche Pharmaceuticals and Siemens Healthcare Diagnostics as well as startup experience. Hugo has a Bachelor of Science degree in Mechanical Engineering from Massachusetts Institute of Technology (MIT).  He has held multiple industry certifications from ASQ including Certified Biomedical Auditor, Certified Quality Engineer, Certified Quality Auditor, and Certified Reliability Engineer.

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