Xueke (Vikrin) Wang
Medical Device Design
- Ratcheting Heart Valve
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My Role/Contribution:
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- Carried out market research and drafted the questionnaire used for stakeholder survey.
- Assisted with idea generation using TRIZ matrix and Quality Function Deployment (QFD) Analysis.
- Reviewed the literature and drafted the protocol for benchtop testing.
- Contributed to the human factors and safety design for product development.
- Collaborated on the FDA strategy, business strategy, and operating plan.
To maximum the number of people who can benefit from our product in terms of heart health. At the same time, the product is expected to be affordable, requires minimal resources in either the development as well as the usage stage in order to benefit a large group of customers.
I. Strategic Focus and Need Analysis
II. Market Research
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Clinical Flow
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Identified User Interests
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Market mapping
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Potential competitors
III. Idea Generation
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• Axiomatic Design Analysis
• Quality Function Deployment (QFD) Analysis
IV. Patent Search, IP Strategy & Draft Patent
V. Engineering Design
VI: Human Factors & Safety Engineering
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Potential users
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Hazards and risks
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Methods to reduce risks
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Ergonomics analysis
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Psychological element
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Potential design improvement
VII: Test protocol & Quality Control
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Control Article (e.g. CoreValve Evolut R TAVR System)
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Overview & Features​
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Indication, Safety & Warning
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2018 coding and reimbursement
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Brochure
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FDA document
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Testing parameters​​
(e.g. geometrical, flow, deformation & force, conditioning .etc.)
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Testing setup and procedure
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Data analysis
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Mean time between failure​
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Reliability
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Animal trails
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Clinical trials
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FDA strategies
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A life-sustaining medical device - Class III, requires Premarket Approval Application (PMAA)​
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