Turn innovative concepts into manufacturable products—faster, smarter, and with less risk.

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DESIGN FOR MANUFACTURABILITY

Partner with our experienced engineering team to optimize your medical device design for reliable, scalable, and cost-effective production.

  • Improve Manufacturability
    Optimize part geometry, tolerances, materials, and features for consistent production.
  • Reduce Cost and Risk
    Identify potential design and process challenges before investing in production tooling.
  • Accelerate Your Path to Market
    Streamline the transition from initial medical device product development through validation and full-scale manufacturing.
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SELECTING THE RIGHT MATERIALS

Select the right medical-grade material to achieve the performance, manufacturability, and regulatory requirements of your device.

  • Optimize Device Performance
    Evaluate strength, flexibility, durability, chemical resistance, and sterilization compatibility.
  • Improve Manufacturability
    Match material properties with part geometry, tolerances, tooling, and production requirements.
  • Reduce Cost and Risk
    Identify suitable materials early to prevent performance issues, production delays, and costly design changes.
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RAPID PROTOTYPING

Transform your design into functional prototypes quickly, allowing your team to evaluate performance, refine features, and make informed decisions before production.

  • Validate Designs Earlier
    Evaluate fit, form, function, and usability before committing to production tooling.
  • Iterate with Speed
    Incorporate feedback and design changes quickly to keep development moving forward.
  • Reduce Development Risk
    Identify potential design and manufacturing challenges early, minimizing costly revisions and delays.
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COST OPTIMIZATION

Reduce total manufacturing costs without compromising device performance, quality, or regulatory requirements.

  • Optimize Design and Materials
    Identify opportunities to simplify part geometry, refine tolerances, and select cost-effective materials.
  • Improve Production Efficiency
    Evaluate tooling, automation, assembly, and packaging strategies to reduce labor, waste, and cycle times.
  • Lower Total Cost of Ownership
    Balance upfront investment with long-term production volumes to deliver sustainable cost savings.

Why Medtech Companies Choose Red Star

25+ Years in Medical Device Product Development

25+ Years in Medical Device Product Development

The engineers at Red Star have decades of experience manufacturing innovative medical devices for highly specialized, heavily regulated applications.

Full-Service Design & Manufacturing

Full-Service Design & Manufacturing

In addition to product design, Red Star offers a full range of manufacturing services under one roof, so you can get to market faster with less complexity and risk.

Product Consistency & Quality at Scale

Product Consistency & Quality at Scale

Our 40,000 square-foot facility has the equipment you need to deliver market-ready medical devices at high volumes, without sacrificing production speed or product safety.

Medical Device Product Development FAQ

Is Red Star ISO-13485 certified?

Yes, our manufacturing facility is ISO certified to meet the highest standards of regulatory compliance and product safety.

Can Red Star support FDA applications and regulatory documentation?

Our engineers are highly experienced in new product introduction to the medical technology market. We can work with your team to ensure complete, accurate design and manufacturing information on FDA documentation.

What types of medical devices does Red Star manufacture?

Red Star is proud to manufacture critical components and medical devices across orthopedics, vascular, women’s health, and drug delivery applications. Our expertise includes cannulas, suture delivery devices, needles, surgical instruments, procedure kits, bone pins, auto and pen injectors, and more.

Can Red Star design from early-stage concepts?

Bring Red Star into your design and development process as early on as you need. Our experienced engineers are skilled at transforming ideas into tangible products that meet tight tolerances, safety standards, and high performance requirements.

How do you ensure complex product reliability through the development process?

Each product we design undergoes rigorous testing and validation to ensure consistent, reliable performance. If needed, we’ll go back to the drawing board to make sure your medical device is truly ready for market before launching full-scale manufacturing.

Product Expertise Built Over Decades

From orthopedic devices to vascular access components, we’ve helped OEMs bring a wide range of medical devices to market.

Tell Us About Your Device

Partner with Red Star to streamline your path from development through production.