Class I, II & III Medical Device Manufacturing

An Injection Mold Alternative for Medical Device Manufacturing

DI Labs enables accelerated, compliant medical device development from concept to commercialization using digital manufacturing. Our advanced additive manufacturing technologies and highly controlled digital workflows empower teams to move quickly and efficiently through each development phase with unlimited design iteration and injection-mold-quality parts from concept to commercialization.

Example Medical Device Applications:

  • Minimally Invasive Surgical Devices
  • Cardiovascular Delivery and Retrieval Systems
  • Medical Robotic Components
  • Medical Device Housings & Assemblies
  • Robotic End Effectors 
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DI Labs Additive Manufacturing vs Injection Molding

Biocompatible
Materials

DI Labs

Wide variety of biocompatible materials including polymers, elastomers & metals

Injection Molding

Wide variety of  biocompatible materials including polymers, elastomers & metals

Tool-Free
Manufacturing

DI Labs

No tooling required, eliminating capital expense & long wait times

Injection Molding

Tooling required with significant capital expense & long wait times

On-Demand Batch Production

DI Labs

Short lead times to support acceleration through testing & clinical trials

Injection Molding

Long lead times for mold changes through testing & trials

Unlimited
Design Iteration 

DI Labs

Tool-free enables responsive design iteration based on user feedback

Injection Molding

Expensive, design-locked tooling limits responsiveness & abilty to iterate

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Our Biocompatible Materials 

We offer a wide range of biocompatible materials – including polymers, elastomers, and metals – to serve a full spectrum of Class I, II, & III medical device applications. See our biocompatible materials table for more details.

Materials Table

Medical Device Housing & Assembly: Benefits of Additive Manufacturing

Medical Device Assembly

Use Cases for Additive Manufacturing Through the Medical Device Development Cycle

Concept & Strategy

  • Concept mock ups
  • Early prototypes
  • Show & tell models

Feasibility & Risk
  • Functional prototypes
  • Idea validation
  • Design of experiment models
Design & Development
  • Functional prototypes
  • Design validation
  • DOE models
  • Benchtop models

Preclinical Testing
  • Repeatable production
  • Human factors optimization models

Clinical Trials
  • On-demand production 
  • Responsive design updates
  • Regulatory-ready documentation
Manufacturing at Scale
  • Bridge production
  • Permanent low-volume prod.
  • Post-launch  improvements (Class I Devices)
Step-by-Step PPAP Process

Biocompatible Materials Table

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What Medical Device Teams Really Want to Know About Additive

The questions following DI Labs’ technical session at MD&M West 2026 reflected a noticeable shift in how medical device teams are thinking about additive manufacturing. DI Labs CEO Carl Douglass delivered the session, which provided a deep dive into the realities of using additive manufacturing within regulated medical device programs. See the detailed Q&A in our LinkedIn newsletter.

Q&A Recap

Solutionology Stories Podcast Episodes From DI Labs

Opportunities & Risks: The Traditional vs Adaptive Path in Medical Device Development | Ep #34

Everywhere we go, medical device development teams are asking how they can accelerate their journey. Learn how additive can support that goal by enabling a more adaptive development path for medical device programs.

Why PPAP Is the Key to Scaling Additive Manufacturing | Ep #33

While highly responsive, additive manufacturing carries more variability than traditional methods. Learn more about our Production Part Approval Process (PPAP), the risk management tool we use to align with clients.  developers, managers, and innovators.

Supporting Transformational Innovation in Medical Device | Ep 11

Medical device makes up over 50% of our business. Learn how we meet the high standards around tight tolerances, exacting quality, unique geometries, design flexibility, and sealed surfaces to support transformational innovation.

Example Medical Device Projects

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Reach out for support or more information!

[email protected]  |  320-403-9483

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FDA Medical Device Classification*

Current Stage in Medical Device Development Cycle*

DI Labs Client Testimonials

"We would have run out of funding if it weren’t for the DI Labs partnership and support in guiding us to additive manufacturing.”
 
- Medtech Innovator
"DI Labs is the perfect fit - I know I can rely on you to talk through my project and deliver on time. I intend to work with DI Labs for everything I can.”
 
-Medtech Innovator
"We were initially headed down the wrong path and didn’t realize it. I don’t know where we’d be if we hadn’t worked with DI Labs."
 
-Consumer Product Innovator
"We wouldn’t have known where to start this project without DI Labs. We knew we could trust you to dig in and develop a solution."
 
-Industrial Manufacturing Innovator

Contact Us Directly

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Carl Douglass, PE

Solutionologist
CEO of DI Labs

Mobile: 320-403-9483
Email: [email protected]

 

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