Agile medical device design

Bespoke is a word that originated centuries ago to describe tailored clothing. Today bespoke means custom-made for one customer.

Is there an orthopaedic instrumentation solution you need to deliver, but lack the resources, time or expertise to bring to life? Allow our experienced team to provide a complete medical device solution encompassing all aspects of design, engineering, manufacturing and regulatory compliance.

Whether your need is regional or global, we can create instrument solutions that are unique to you and help differentiate you in todays competitive market.

With over 30 years of experience, you can trust Enztec to solve your problems and extend the reach of your internal team.

Knowledgeable

Orthopaedic instruments is all we do. This allows us to offer unique insights and experience.

Exclusivity

Exclusive instrument designs that give you a competitive edge.

Complete

Agile delivery of complete end-to-end solutions, on time, and on budget.

Scalable

From regional to global demands, we can scale to meet your needs.

Our capabilities

Our bespoke medical device service provides you with a broad and complete package to bring products to market efficiently.

Design

With 30 years of experience in orthopaedic instrument design, our team work with you to develop the best solution for your problem.

Verification & Validation

Draw on our predicate biocompatibility, cleaning and sterilisation data, as well as device-specific V&V activities.

Documentation

Reduce the burden on your team; all technical and regulatory documentation is provided, along with support for in-market regulatory listings.

Manufacturing

From prototyping to short and long production runs, we offer competitive lead times utilising our wide range of in-house validated processes.

Bespoke surgical instruments we've created for our customers

Dual Offset Broach Handle

Graft Shaper

Cobb

Gap Balancer

Inserter

Femoral Sizer

Straight Broach Handle

Inserters

Cutting Blocks

Cup Impactor

Quality & Regulatory Assurance

We recognise that delivering a new product is more than just design and manufacturing. Regulatory and quality considerations have to be built in from day one.

We own these spaces. When we commit to delivering you a Bespoke product, you can rest assured that we will handle everything, including compliance activities for all key markets such as CE, FDA, and TGA.

Learn More

Our Recent Projects

Case Study: Smith+Nephew X-Wing™

S+N identified a need to develop a new generation ligament tensioning solution. Learn why they utilized Enztec, a trusted partner to design and manufacture X-Wing™ when speed to market mattered.