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 11th 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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