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MedTech Strategic Convergence Set for 2014

Fri, 01/17/2014 - 12:28pm
Deb Kacera, Regulatory & Industry Strategist, Pilgrim Software Inc.

Q: What’s in store for the medical device sector in 2014?

In 2014, we will see the next evolution of the most effective utilization of resources across the medical device industry, based on “smart” information that will touch almost every healthcare stakeholder, where key data will have a tighter linkage from design through patient safety monitoring.

The strategies discussed over the past decade are culminating tactically in 2014 to help shape this paradigm shift:

  • The Unique Device Identifier (UDI) Rule will link a device to its manufacturer for ease of use by healthcare professionals, user facilities, and international regulators
  • Real-time monitoring of patient vital information will allow healthcare professionals and even patients to be more proactive in their day-to-day care
  • The Medical Device Single Audit Program (MDSAP) Pilot through which key countries are moving toward an alignment of regulatory approaches and oversight of quality management systems to divvy the work of international regulators and minimize burden on industry
  • Continued focus on supply chain quality
  • Focused investigations driving to root cause that can be effectively mitigated and then shared for new product design

Industry is focusing on defining leading indicators of quality measures, both internal and external, to an organization to move beyond compliance, where the patient is the winner and the use of “smart” information is...just the beginning.

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