Even with the advancements of CAD renderings and virtual reality simulations in medical design and development processes, there is still no better way to initially assess a design than to have it in your hands.

Designing, developing and manufacturing a medical device can be complex, and prototyping is a fundamental part of the process. It is therefore essential to work with a medical device development team that has prototyping and 3D printing capabilities.

Bringing Your Bright Idea to Life

Having early samples of your medical product provides you with the opportunity to test and evaluate the concept and work on future iterations without the need for investing in expensive production tools.

Mi3 can help you test and validate your prototypes, helping you to accelerate the process of turning your innovative idea into a market-ready product through a realistic development and scaling plan. We understand the critical differences between a prototype and the finished device and will advise you on the steps required and physical differences to consider when printing prototypes compared to your final product.

3D Printing

Since its conception in the 1980s, 3D printing has been utilised across many different industries for multiple applications. 3D printing for medical devices is typically associated with the design & development stages and is often also referred to as additive manufacturing.

Medical 3D printing is a process that creates a three dimensional version of your product by building successive layers of raw materials.  Each new layer is attached to the previous one until the product is complete. The products are produced from a digital 3D CAD drawing.

The key to knowing when to use 3D printing is understanding which 3D printing method is most beneficial for your application. Mi3 have the experience to understand the technicalities of 3D printing prototypes and finished products, and understand the benefit of not only providing a printed component, but a full package of knowledge around this technology. This makes us ideally suited to being the partner of choice to advise our customers on the best 3D printing and prototypinh methods available and their suitability to their specific applications.

Prototyping Stages

Stage 1: First-off Prototypes

There are often two main stages in the prototyping process: the first is your first-off medical device prototype based on initial design drawings and specifications. This prototype is crucial to get a better understanding of the look and feel of the device and how it will work. This is an essential part of the medical device design process and is used to improve and enhance the design.

There may be many iterations at this initial prototype stage.

Stage 2: Testing and Evaluation

The second stage is the final prototype at the end of the design process – this often also involves manufacturing a small batch of the prototype medical device to be used for testing and evaluation.

This prototype can also be validated and compliant with regulations.

Resource Centre

Mi3 News

Regulatory Update - IVDR Implementation Amendment

EU Commission’s proposed amendment to transition period of the In Vitro Diagnostic Devices Regulation (IVDR) calls for a progressive roll out.

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Mi3 News

Student Placement Blog

In July 2021, Mi3 took on four students from different universities to participate in “A Year in Industry”. Over the course of the year, the students will post multiple blog entries here, to showcase their experiences, highlighting some of the key activities they are involved in.

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Mi3 News

Amendment of MDR (EU) 2017/745|OJ L241/7 on 8th July 2021

On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official Journal of the European Union with some changes and corrections, including, misprints, typos and translation errors.

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Speak to our experts about your Prototyping requirements