Minitab Webinar - 5 stages of FDA verification statistical solution for medical device industry

The Webinar named “5 stages of FDA verification statistical solution for medical device industry (医疗器械行业FDA验证5个阶段的统计解决方案)” was organized by Minitab on 11^th Aug 2020. In the beginning, Ms. Chan was MC and Mr. Ming Dong was the speaker.

In the beginning, Mr. Ming Dong introduced the classification of medical devices in FDA that separated into three classes:

Class I – General Controls

Class II – General Controls with Special Controls (Remark: Class IIa & IIb in EU)

Class III – General Controls and Premarket Approval.

And then Mr. Dong introduced FDA Drug and Device Development Life Cycle that separated into 5 stages.

Stage 1: Device Discovery / Concept

-       Research an unmet medical need

Stage 2: Preclinical Research – Design & Prototype

-       Translate user needs into technical requirements (test the prototypes)

Stage 3: Pathway to Approval – Testing & Validation

-       Verify that the device is both safe and effective

Stage 4: FDA Review and Deployment

-       File an application with FDA to market the device to the public

Stage 5: Post-Market Safety Monitoring, Maintenance and Support

-       Provide continual assurance that the process remains in a state of control

In stage 1, Mr. Dong suggested to use Multi-vari Graph for creating a concept or an idea. And then us Project Prioritization Matrix to rank potential projects.

In stage 2, he proposed to employ DOE and Predicting the Product Life Cycle for optimizing parameters.

In stage 3, Minitab Tool – 95/99 Tolerance interval was introduced to evaluate the reliability of the device.  Monte Carlo Simulation employed in a model of DOE was discussed.

In stage 4, Control Charts, Distribution Identification and Capability Analysis were employed to interpret the result.  Finally, Mr. Dong introduced Classification Tree that could identified the key sensors for closely monitoring.

In stage 5, Real Time SPC system was proposed to monitor the device in post-market

Lastly, Mr. Dong demonstrated different Minitab tool such as process map.  At the end, he concluded that manufacturers can ensure the quality and durability in each stage of the product life cycle by applying Minitab statistical tools.

Reference:

Minitab – www.minitab.com

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