Three Peaks Technologies | Your Ideas Enabled

We convert great ideas into great products.

Three Peaks Technologies was founded by the Three Peaks Medical team — the inventors of the only expandable-retractable cardiovascular sheath platform. This groundbreaking innovation advances large-bore access while reducing vascular injury and bleeding in complex cardiology procedures.

Our innate ability to solve problems through cutting-edge innovation has placed us at the forefront of medical device and technological product development. Today, we are one of Australia’s most trusted partners for quality-driven, end-to-end product development.

ISO13485 Certified: Quality systems aligned with medical device standards.

Clinical Input: Direct access to ensure usability and clinical acceptability.

End-to-End Support: From concept to high-volume manufacturing.

Explore Our Services

Why Choose Three Peaks Technologies?

We’ve been where you are. We understand the challenges of turning a vision into a market-ready product — especially in regulated industries.

Proven Track Record

Founded by the inventors of a revolutionary cardiovascular sheath platform, we bring real-world medtech innovation experience to every project.

ISO13485 Compliance

Our systems and procedures ensure your product meets regulatory requirements with full documentation and traceability.

Clinical Collaboration

We integrate clinical feedback early and often to ensure your product is usable, safe, and effective in real-world settings.

End-to-End Development

From R&D and prototyping to verification, validation, and manufacturing — we guide your product every step of the way.

Vendor Network

We have strong relationships with prototype and production vendors, ensuring quality, scalability, and speed to market.

Customer-Centric Focus

Your objective is our mission. We work collaboratively to deliver ethical, groundbreaking products that make a difference.

Our Expertise & Services

We specialize in transforming innovative concepts into market-ready medical and technological products with precision, compliance, and impact.

Expandable-Retractable Sheath Platform

The only platform of its kind, designed to reduce vascular injury and bleeding during complex cardiology procedures.

• Minimally invasive access
• Reduces complications
• Enables large-bore device delivery

R&D & Early Prototyping

We help you refine your concept, build functional prototypes, and validate feasibility with rapid iteration.

• Concept validation
• 3D modeling & simulation
• Functional prototypes

Engineering Design & Development

Custom engineering solutions tailored to your product’s unique requirements and regulatory pathway.

• Mechanical & systems design
• Risk analysis (FMEA)
• Design for manufacturing

Verification & Validation Testing

Comprehensive testing to ensure your product meets performance, safety, and regulatory standards.

• Biocompatibility testing
• Mechanical stress testing
• Regulatory test protocols

Manufacturing & Scale-Up

We bridge the gap between prototype and production with scalable, cost-effective manufacturing strategies.

• Vendor selection & qualification
• Process validation
• Quality control systems

Regulatory

Regulatory Strategy & Documentation

We prepare all necessary documentation for TGA, FDA, and CE submissions, ensuring a smooth approval process.

• Design history file (DHF)
• Technical file / Design Dossier
• Risk management file (ISO 14971)

Clinical

Clinical Usability & Acceptability

We integrate clinical insights to ensure your product is intuitive, safe, and effective in real-world use.

• Human factors engineering
• Usability testing
• Clinical feedback loops

Innovation

Innovation Consulting

From ideation to commercialization, we help you navigate the innovation journey with strategic guidance.

• IP strategy
• Market analysis
• Funding & grant support

Our Impact

15+

Years in MedTech Innovation

50+

Products Developed

ISO

13485 Certified

1

Revolutionary Sheath Platform

Meet the Innovators

Backed by a proven team with deep industry expertise and a passion for transformative innovation.

Iska

Co-Founder & Innovator

Jamie

Engineering Lead

Adam

Product Development

Steve

Regulatory & Compliance

Frequently Asked Questions

What types of products do you develop?

We specialize in medical devices and regulated technological products, particularly in cardiovascular, minimally invasive, and diagnostic fields.

Are you ISO13485 certified?

Yes, we operate under ISO13485 quality management systems to ensure compliance with medical device regulations.

Can you help with regulatory submissions?

Absolutely. We prepare all necessary documentation for TGA, FDA, and CE submissions, including design history files and risk management reports.

Do you work with startups?

Yes, we partner with startups and innovators at every stage — from concept to commercialization.

Ready to Bring Your Idea to Life?

Let’s discuss your vision and how we can help turn it into a market-ready product.

Contact Three Peaks Technologies

Email: hello@threepeakstech.com

Phone: +61 402 489 835

Location: Unit 44, T8T, 6 MAB Eastern Prom, Tonsley SA 5042

Visit Official Website

It starts with an idea. An idea that could become a product.