Engineer at a medical device startup testing a 3D printed handheld device at a lab bench, with a laptop displaying the device’s digital design.

Bring Your Medical Device to Market Faster

Affordable, rapid medical device prototyping to prove your concept and secure funding.

ISO 9001 · ISO 13485 · AS9100 · ITAR Registered · Secure & Compliant

ISO 13485 Certified

Meeting strict safety and traceability standards for medical devices.

Medical Materials

ABS-M30i, Somos® BioClear, MED615RGD™, and more medical-grade choices

Parts Printed

6+ Million medical 3D printed parts produced

Full-Service

25+ post process production finishing and inspection services

Emerging medical startups must move quickly from concept to proof of viability — often with limited resources and pressure to attract funding or clinical validation. Stratasys Direct helps you accelerate early-stage prototyping and design iteration with certified, production-grade 3D printing — giving your team the speed, quality, and reliability needed to demonstrate function and move confidently toward regulatory milestones.

Two colleagues reviewing printed technical medical device drawings at a table, discussing design details with a laptop and whiteboard in the background

Challenges in Early-Stage Medical Device Development

Limited funding and resources make it difficult to iterate quickly or access specialized manufacturing capabilities.
Proving functional performance requires production-quality prototypes that inspire investor and partner confidence.
Transitioning from concept to validation introduces design, material, and manufacturability hurdles that slow momentum.

Engineer smiling while holding a handheld 3d printed medical device prototype, with the device’s digital rendering displayed on a laptop and design sketches on the desk.

Solutions for Early-Stage Medical Device Development

Accelerated medical device prototyping with ISO 13485-certified 3D printing to help you move from concept to validation faster.
Production-grade materials and precision builds that demonstrate real-world function for investors and partners through design validation support.
Collaborative engineering to refine designs for manufacturability and scale — from prototype through pilot production — while staying on budget and schedule.

Talk to an Expert

Two team members at a medical device startup reviewing product design sketches at a desk, with a handheld device prototype and its 3D rendering displayed on a nearby laptop.

Why Startups Trust Stratasys Direct® for Medical Device Development

ISO 13485-certified production provides confidence in quality and regulatory alignment — supporting FDA medical device design validation as your product matures.
In-house additive manufacturing eliminates outsourcing risk and accelerates turnaround for rapid iteration.
Collaborative engineering support helps refine designs for performance, manufacturability, and scalability.
Decades of experience in medical applications ensure reliable results across prototypes and pilot production.
Secure handling of design files and IP protects your innovation from concept through validation.

Ready to Prove Your Concept and Build Momentum?

Bringing a new medical innovation to life requires speed, precision, and credibility. Stratasys Direct helps startups accelerate early-stage medical device prototype development with production-grade 3D printing and hands-on engineering support — enabling you to demonstrate performance, secure funding, and move closer to market readiness with confidence.

Work with an Expert

Related Resources

Medical Materials Resource Guide

Medical Materials Guide with PolyJet, SLA, MJF, SLS, SAF, P3 DLP, and FDM, plus biocompatibility, specs, certifications, and sterilization data.

Loctite MED 413 White 3D Printed Medical Device

Biocompatible Materials at ISO 13485 Facility

Stratasys Direct is accelerating medical device manufacturing with ISO 13485 certification, innovative biocompatible materials like LOCTITE MED 413 and Somos BioClear, and advanced additive manufacturing solutions for high-performance medical applications.

ISO 13485-Certified 3D Printing for Medical Device Manufacturing

Stratasys Direct offers ISO 13485-certified 3D printing services, ensuring precision and compliance for medical device manufacturing. From prototyping to scalable production, we streamline the entire development process with cutting-edge additive technology.

Biocompatibility and Sterilization in 3D Printed Medical Devices

Discover biocompatibility and sterilization impact 3D printed medical devices. Learn ISO 10993 testing, sterilization methods, and validated workflows to ensure safety, compliance, and patient-ready additive manufacturing.

Collection of 3D printed ribcage and spine models for surgical planning

From Scan to Scalpel: The Impact of 3D Printed Models in the Operating Room

See how hospitals improve surgical planning, reduce OR time, and enhance patient communication with 3D models. Real-world impact from UK & Spain case studies.

Medical Materials Guide with PolyJet, SLA, MJF, SLS, SAF, P3 DLP, and FDM, plus biocompatibility, specs, certifications, and sterilization data.

Stratasys Direct is accelerating medical device manufacturing with ISO 13485 certification, innovative biocompatible materials like LOCTITE MED 413 and Somos BioClear, and advanced additive manufacturing solutions for high-performance medical applications.

Stratasys Direct offers ISO 13485-certified 3D printing services, ensuring precision and compliance for medical device manufacturing. From prototyping to scalable production, we streamline the entire development process with cutting-edge additive technology.

Discover biocompatibility and sterilization impact 3D printed medical devices. Learn ISO 10993 testing, sterilization methods, and validated workflows to ensure safety, compliance, and patient-ready additive manufacturing.

See how hospitals improve surgical planning, reduce OR time, and enhance patient communication with 3D models. Real-world impact from UK & Spain case studies.