Materials that survive sterilization and scrutiny.
Resin choice, chemical resistance and design for gamma, EtO or autoclave, reviewed discreetly and under NDA before design freeze.
Book a confidential review →
Medical Device Polymer Engineering
ISO 13485-Aligned Polymer Engineering
Material selection, design review, and failure analysis for medical device OEMs and their polymer supply chains — where biocompatibility, sterilization compatibility, and a defensible design rationale are not optional. Forty years of engineering practice, brought to the most scrutiny-driven market in plastics.
Request a Discreet Consultation →Built for R&D engineers, quality engineers, and regulatory affairs teams who own the risk file — not the brochure.
Gamma IrradiationEthylene Oxide (EtO)Steam Autoclavee-BeamDesign Controls
Why Device Polymers Are a Different Discipline
Medical plastic injection molding is one of the few plastics markets still compounding — independent market analyses put it on a growth curve of roughly 4.4% a year — and the OEMs driving it are not boutique shops. Global device makers of Stryker's scale buy engineering judgment, not molded tonnage. In this market, a resin that passes a mechanical test can still fail a biocompatibility panel, and a part that molds beautifully can be unsterilizable. The ETS discipline: qualify the material for the body and the sterilization cycle it will actually see, before it ever reaches a submission file.
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Material Selection & Biocompatibility
Resin candidates screened against biocompatibility expectations, sterilization exposure, and mechanical duty — in that order. A material choice made for the wrong reason is the most expensive document in your design history file.
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Sterilization Compatibility
Gamma, EtO, steam autoclave, e-beam. Every method attacks polymers differently — embrittlement, residue, hydrolysis, repeated-cycle degradation. We teach your team to qualify the material for the cycle it will actually see, not the one on the datasheet.
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Design Review Before Tooling
Draft, sink, weld lines, stress risers — caught while the fix is a CAD change, not a tooling change. In a regulated program, the cheapest revision is always the one that happens before steel is cut.
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DFM for Clean Manufacturing
Part consolidation, snap-fits, bosses, and living hinges designed for molding in a controlled environment — with validation, lot traceability, and cleanroom handling reality in mind from the first sketch.
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Failure Forensics & Root Cause
Weld-line cracks, environmental stress cracking, creep, sterilization embrittlement. When a component fails — in validation or in the field — we find the root cause and document it to hold up under quality-system scrutiny.
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Regulatory Pathway Support
Design rationale, material justifications, and risk documentation your regulatory affairs team can carry into 510(k) discussions, ISO 13485 quality-system reviews, and ISO 14971 risk files — engineering evidence, not engineering hope.
What Your Engineering Team Takes Back
Our seminar, training, and consulting packages are built for device engineering organizations that need working methods their quality system can live with — not theory.
Live Seminar
Designing Plastic Parts for Assembly — 3 Days, 1,300+ Slides
Structural analysis, material screening, and DFM decision tools, taught by Paul A. Tres — SPE Fellow and author of the industry-standard text, now in its 10th edition. Case histories drawn from four decades of production programs, including Mercedes-Benz, BMW, GM, Chrysler, and Delphi — the same failure mechanisms your devices will face, minus the regulatory shortcut of ignoring them.
Consulting Retainer
Design Review & Program Support
Fixed-price design reviews, material-selection second opinions, and a senior engineer on call for the sticky questions — a resin change your team can't close, a sterilization interaction nobody predicted. An NDA is in place before we see anything confidential.
ETS Academy
Institutionalize the Method
100+ hours of structured training with monthly coaching, so design, materials, process, and quality engineers align on one methodology across your organization — not just the three people who attended the seminar.
ChatETS
The Plastics Answer Engine, Free
Trained on 41 years of ETS failure data. Ask it about a gamma-sterilized enclosure, an EtO-exposed channel, or an autoclave warpage question and get DFM-grade materials and failure answers in seconds. One real question, free, no credit card.
The Credibility That Holds Up Under Scrutiny
In a market where design decisions end up in audits, submissions, and occasionally courtrooms, credentials matter more than claims. This is the part of plastics engineering where "we've seen this fail before" is a compliance asset.
41 years of Failure Analysis That Has Survived Litigation
Our data comes from real production programs — and from expert-witness work where a root-cause conclusion had to withstand cross-examination. The same documented discipline is what your quality and regulatory teams pick up.
The Standard Text Your Engineers Already Reach For
Paul A. Tres, SPE Fellow, authored Designing Plastic Parts for Assembly — the reference engineers across the industry, medical included, cite when a design decision has to be defended. We teach the method behind the book.
41+
Years of Engineering
500+
Companies Served
19,800+
Engineers Trained
10th
Edition of the Standard Text
Built for the people who decide
Whoever signs off, the answer holds up.
A medical-device decision crosses four desks before it ships. Here is what ETS gives each of them.
Risk you can put a number on.
A fixed-price pre-tooling review starts at $3,500. One line of the failure ledger costs $10K–$75K once steel is cut. Seats, training and engineering hours can share a single annual agreement.
What a review covers →An expert built for cross-examination.
Fellow of SPE and author of the field’s standard text. Expert-witness work since 1997. A conflict check comes first, and availability, a CV and fees follow within one business day.
Request a conflict check →Simple to buy, easy to audit.
Pay by check, ACH, purchase order or card. Fixed price where applicable, with scope, timeline and quote agreed before work begins, and an NDA signed on request before we see anything.
Start the paperwork →Ready to Pressure-Test Your Next Device Program?
Tell us where you are — a material decision your team can't close, a design headed for tooling, a sterilization interaction nobody predicted, or a failure you need explained. A senior engineer replies within one business day with a scoped, fixed-price next step where applicable. Consultations are discreet by default: nothing you share leaves ETS, we'll sign an NDA before we look at anything, and we don't manufacture or compete with your supply chain.
Contact Engineering →