​Medical Device Changes for 2020

Medical Device changes are driven by several factors. Often medical device quality directives such as ISO 13485 as well as European and Canadian directives impose new requirements that force change and sometimes obsolescence. The FDA has also revealed a vision for the transition to ISO 13485 and to maintain a voice in shaping the 13485 standard. Therefor what were once “guidelines” will become more of a requirement. And then there are other things that facilitate change such as advances in technology, more efficient methods, more cost effective concepts, and added features. These are more evolutionary in nature and this is where technology implementation and feature rich devices originate.

Below are near term changes we will see soon

1) Wearable devices – Dialysis, Pain Management and Insulin Pumps will be common devices.

2) Wearable Breast Pumps

3) Smart Inhalers - Bluetooth inhalers that send data to their smart phone to analyze usage

4) Robotic Surgery – Surgical robotic systems improve cost, availability and accuracy.

5) Artificial Intelligence for More Accurate Diagnoses

6) Prosthetics – Improved 3D Printed

7) Bio-printing artificial organs

12th Nov 2019 Joseph Mariano

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