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Regulatory Affairs, Medical Devices

REPORT: Adoption of AI and Digital Solutions in the MedTech Industry

Posted by on 03 December 2020
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Explore or download the report above (or here). 

The advancement of the 4th industrial revolution including the Internet of Things, Artificial Intelligence, robotics and big data, coupled with the pivots undertaken as a result of the pandemic have created new human health risks associated with digital technologies at a product, operational and personal level.

MedTech Summit in association with NSF conducted one of the biggest surveys of its kind (Nov 2020) across medical device and IVD professionals around the world to understand where the MedTech industry is in its journey towards digitalisation. This final report based on 107 responses reveals unique insights into the status of implementation and the barriers to successful adoption whether from market access or patient safety.

Key Insights

  • 87% have already implemented or are planning to implement AI/digital solutions in their regulatory/quality management system, and 89% in their product range.
  • 48% quote 'improvement or expansion of intended use' as a reason for introducing AI/digital solutions- higher than any other single reason.
  • 35% say that clinical validation has been very challenging when introducing digital solutions - the highest of any challenge.
  • 47% say regulatory compliance/market access is an obstacle to fully implementing digital solutions - higher than any other issue.
  • 57% say their company doesn't understand the quality and regulatory landscape around augmented reality.

Explore or download the report above (or here). 

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