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BIOMEDevice Boston 2019 Schedule Viewer

 

Welcome to the Biomed Boston & ESC Boston 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Resolving Early Design and Testing Issues by Addressing Contradictory Requirements

Len Malinin (Partner, Gen5 Group)

Location: 160B

Date: Thursday, May 16

Time: 2:00pm - 2:45pm

Track: BIOMEDevice Boston, Track B: Research & Development

Vault Recording: TBD

Innovation trailblazers in R&D know novel devices are expected to meet diverse and increasingly stringent requirements in order to ensure dependability in scenarios that can be life-critical. Medical device companies use a validation plan to define the process requirements in terms of test criteria, calibration and maintenance requirements, cleanliness requirements, particle count criteria, etc. But, what if your new product has contradictory requirements (i.e., high tensile strength causing poor performance in the flex test, and vice versa), and your product doesn’t meet the critical validation elements? Come hear how contradictions can be resolved using simple tools and compromise-based design methods.

Topics covered include:
  • Problem framing
  • Exacerbation of contradictory requirements
  • Methods of resolving engineering contradictions by separation in space, in time, in the space of parameters
  • Validation with FEA modeling



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