Product development process

Medical device and product development at ITL

Every world-leading medical device started with an idea.

The first phase of the medical device development process with ITL Group starts with us working with you to generate, develop and refine your product concept to ensure all of the requirements are met for a commercially and technologically viable product.

Typically a medical device development project with ITL Group will result in the delivery of a project-specific mix of:

Concept generation

If you have an idea for a new medical device, or even just a demand that needs to be met, our engineers can help you to generate innovative product concepts.

System requirements specification (SRS)

This document details all of the requirements of your device and becomes the basis of the product design throughout the development process.

System concept design architecture (SCDA)

This is a map of your product showing the function of each element and how they operate as a system.

CAD modelling and Proof of Principle (POP) prototypes

We can develop 3D CAD prototypes and rapid prototypes of your medical device. This allows for both virtual and physical testing of any novel concepts. Because developing medical devices often requires chemistry, both ITL Group and your development team have access to our on-site category II bio-hazard handling laboratory.

Risk analysis and regulatory compliance

Risk identification and analysis are vital inputs into the development of any medical product. We ensure that your product concepts include a consideration of the necessary regulations based on your intended end-user and market.

Find out more about our medical device regulatory consulting services.

Draft cost models

Because we are also a manufacturer, even at the product development stage we are able to generate estimates of the transfer price (the cost for manufacture) of your medical device.

We have worked on product development projects for a range of medical and non-medical devices including:

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