Medical Device Polymer Design & Sterilization

Designing polymer device components for the regulatory reality: ISO 10993 biocompatibility in the supplier-data era, EtO/gamma/e-beam sterilization effects on polymers, device-scale part design, and the design-control documentation chain.

Private cohorts & on-site
Format: 2-day (8:30 a.m.–4:30 p.m.)
Level: Intermediate-Advanced
Location: Scheduled on demand · on-site at your facility or a regional venue
Date(s): Not yet scheduled for open enrollment. Get notified when it is, or book it privately for your team.
Includes: Certificate of Completion · printed slide binder · take-home reference text

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Faculty

Faculty details for this seminar will be announced with the full schedule.

Fees

Early: $1,895 (payment 4+ weeks ahead)
Standard: $2,095 (check/ACH) · $2,165 (card)

Group discount: $200 off per attendee for 3+ from the same organization.

Also Available

  • Corporate on-site delivery at your facility
  • Private cohort sessions
  • Digital curriculum licensing

Seminar Overview

Medical device polymers live under a dual burden: the part must survive sterilization and 10 years of shelf life, and every material decision must survive a design-control audit. This seminar teaches device polymer design from both ends: the engineering (material selection against sterilization compatibility, device-scale part design, joining and assembly in cleanroom reality) and the regulatory chain (ISO 10993 biological evaluation in the 2025 supplier-data era, master files, and the documentation that connects a datasheet claim to a submission annex).

The sterilization half is quantitative: EtO residuals and aeration, gamma/e-beam dose and the oxidation/embrittlement cascade in PP and POM, steam compatibility, and the material-specific limits that decide a device's sterilization strategy before the first part is designed. The design half covers device-scale DFM: thin walls, micro-features, LSR components (cross-list M-03), ultrasonic welding for hermetic housings (cross-list C-11), and the cleanroom transfer questions every CDMO relationship raises.

The 2025 ISO 10993 revision moved biocompatibility from the test lab to the supplier file — the supplier-data burden is now the bottleneck, and this course teaches the document architecture that manages it: what to demand from resin suppliers, how to assemble the biological evaluation plan, and how to keep the file alive through change control.

Ideal Learner

  • Device design engineers specifying polymer components
  • Materials/RA engineers owning biocompatibility files
  • CDMO engineers managing multi-customer device programs
  • Process engineers in cleanroom molding and assembly

Learning Objectives

  • Select polymers against EtO/gamma/e-beam/steam compatibility with dose/residual limits
  • Build the ISO 10993 biological evaluation plan in the supplier-data era
  • Design device-scale features: thin walls, micro-features, weld-joined housings
  • Manage the supplier-file architecture through change control
  • Anticipate cleanroom transfer questions in design decisions

Consulting Sessions

Seminar attendees can sign up for individual consulting sessions with the instructor. Sessions are free for registered attendees, first-come first-served — sign up when registering by calling 248-539-0473 or during the seminar.

Seminar Outline

  • Material families and their sterilization compatibility table
  • The 2025 ISO 10993 shift: biocompatibility as a supplier-data problem
  • Master files, change control, and the documentation chain
  • EtO: residuals, aeration, product/launch implications
  • Gamma/e-beam: dose mapping, oxidation, embrittlement (PP/POM cases)
  • Steam and low-temp methods: where each is honest
  • Choosing the strategy before the part exists
  • Thin-wall and micro-feature DFM at device scale
  • Weld-joined hermetic housings (C-11 linkage)
  • Assembly in cleanroom reality: particulate, contamination, handling
  • Packaging interaction (M-05 linkage): what the part does to the barrier
  • What to demand from resin suppliers: the data packet that survives audit
  • Biological evaluation plan assembly workshop
  • Change control: when a resin tweak becomes a submission question
  • CDMO/multi-customer data segregation
  • Case files: the embrittled PP tray, the ESC'd housing post-EtO
  • Design-control audit trail on material decisions
  • Workshop: build the material section of a design history file

More in Track M — Regulated-Product Design

Full Course Catalog