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Risk Mitigation Strategies for Designing & Manufacturing Micro-Sized Implantable Devices

Donna Bibber  (Vice President, Business Development, Isometric Micro Molding, Inc.)

Location: 210C

Date: Wednesday, February 12

Time: 2:05 pm - 3:00 pm

Track: MD&M Conference: Materials, Testing & Risk Management Solutions

Vault Recording: TBD

Class III micro devices require extreme tolerances (single micron) and developing risk mitigation strategies starts with a plan and heightened awareness of where to find and control each micron. This session will focus on peeling the onion back with micro devices to design robust processes and validation plans for implantable devices. From mold, fixture, datum structure, molding, drying, material testing, CT scanning, and gage R &R, these processes all contribute to error in some way, and mitigating this error is critical to understanding and preventing gaps in design history filings.

Topics covered include:

  • Common process and product design challenges for micro device design
  • Materials and testing to achieve robust validation
  • Scalability DFM strategies through detailed PFMEA