Originally published by:tctmagazine.com
M4S Take

Dinsmore's polymer additive manufacturing cuts stent validation time by 80% for cardiovascular applications.

  • Traditional metal stents require 12-18 months for regulatory validation
  • Polymer AM enables rapid iteration — design changes tested in weeks, not quarters
  • The 80% time reduction could accelerate patient access to next-generation stent designs

Device OEM

A blocked artery demands a fast, reliable fix. For the patient, that means a stent. For the medical device company making that stent, it means proving the device works before it ever touches human tissue. One interventional therapy OEM found that proving ground in an unlikely place: a polymer 3D printer in Dinsmore's shop. The Problem: Metal Stents Need Plastic Twins

Artery stents are metal mesh tubes, laser-cut from cobalt-chromium or nitinol, deployed via catheter to prop open narrowed vessels. The procedure carries real risks. Bleeding, clot formation, and stroke are documented complications. Regulators and clinicians demand exhaustive preclinical validation.

Traditionally, that validation meant machining metal prototypes or pulling parts from pilot production lines. Both routes are slow and expensive. A metal prototype stent can take weeks and cost thousands per unit. When a design iteration fails, the timeline and budget bleed out. The OEM needed a faster, cheaper way to produce anatomically accurate test articles for benchtop and animal studies, without committing to full metal production until the design was locked. The Solution: Photopolymer Stents That Mimic Metal Behavior

Dinsmore, an AM service provider based in the US, proposed a different path: print the stents in polymer using microstereolithography. The technology builds parts layer by layer from a liquid resin, achieving feature resolutions down to 25 micrometres. For this application, Dinsmore selected a high-temperature photopolymer formulated to match the mechanical properties of the target metal, specifically the radial strength and expansion characteristics critical to stent performance.

The polymer stents were not implantable. They were test doubles. But they were geometrically identical to the final metal design, including the intricate strut patterns and connector links that determine how a stent flexes and expands. The OEM could run radial compression tests, deploy them in simulated arteries, and iterate geometry without touching a CNC machine or metal tube stock.

Dinsmore delivered first articles in days, not weeks. The per-part cost dropped by roughly an order of magnitude compared to metal prototyping. Design changes that previously triggered a two-week procurement cycle now moved in 48 hours. The Results: Faster Validation, Lower Burn Rate

The OEM compressed its preclinical validation schedule by approximately 80%. More iterations in less time meant the engineering team identified a strut fatigue issue in week three that would have surfaced months later under the old process. They fixed it, reprinted, and retested before the original timeline would have produced first metal parts.

Cost savings extended beyond prototype production. Reduced metal machining demand freed CNC capacity for fixture and tooling work. The regulatory submission package included more comprehensive mechanical data because the team had run more tests, not fewer.

Dinsmore's polymer AM capability did not replace metal stent production. It front-loaded the risk, letting engineers fail fast with plastic before committing to expensive metal. For interventional device development, where a six-month delay can mean a competitor beats you to PMA submission, that front-loading is worth more than the material cost savings.

The stents are in clinical trials now. The polymer prototypes that got them there sit in a drawer in Ohio, their job done.

M4S TAKE

My take: AI claims need scrutiny. The useful implementations reduce cycle time or defect rates in measurable ways. Vague promises about 'optimization' without specific metrics are usually marketing.

Simon McLoughlin

SM

Simon McLoughlin

Founder & Editor, M4S News

20+ years in manufacturing and engineering. I started M4S News to cut through the noise and deliver real intelligence to the people who actually make things. When I'm not writing or editing, I'm talking to engineers on factory floors.

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