Process, design and manufacturing FAQs

Answering your frequently asked questions

Do you make microfluidics in glass?

No, MiniFAB specialises in microfabrication in polymer materials. We have found that this significantly reduces development time and cost without compromising functionality. Polymers are available to suit almost all optical, chemical and biological user requirements. We can incorporate glass elements into polymer systems – we call this hybrid packaging.

How can we work with you?

MiniFAB has numerous methods for engagement. Often the first step would be the creation of a mutual NDA to allow open confidential discussion of your specifications and needs.

Next, MiniFAB would design a program to suit your requirements. This may be a simple transfer of designs to a polymer manufacturing technique, a staged development program, early feasibility work, cost model analysis, concept generation, integration of functionality to an existing system and a whole lot more.

Do you offer a rapid prototyping service?

Yes, MiniFAB has a vast set of equipment for rapid prototyping.

Processes include micro milling, laser processes, lithography, lamination, electroforming, injection molding, solvent bonding, etc. Each of these processes allow for a rapid turnaround from design to fabrication and dispatch.

Do you have volume manufacturing capabilities?

Yes, MiniFAB specialises in volume manufacturing. Dedicated manufacturing lines are governed by ISO13485:2003 and ISO9001 standards in clean rooms built to ISO 7 standards (class 10,000). We have extensive expertise in warehousing and dispatch of products, even under specified storage conditions (e.g. cold chain).

I have a design already, can you fabricate my microfluidic design?

Yes, MiniFAB's engineering team will review designs with you, make recommendations to streamline the fabrication process and develop a quotation for transfer of your designs into prototype or production devices.

I have a biosensor, can you make a disposable diagnostic for me?

Yes, MiniFAB has a Clip Chip™ technology which allows easy and rapid integration and testing of various functional elements, including biosensors. Our engineers will develop the ideal solution for the integration of the biosensor with you, and allow you to test the fluidic functionality without long waiting times.

How much does it cost?

Costs vary between projects and programs and are often driven by the complexity of the solution required.

MiniFAB employs a rigorous cost modelling exercise early in the development program, which allows our clients to make informed decisions about materials, disposable cartridge, the instrument, capital expenditure, production volumes and labor.

In this way, our clients are able to determine the best development path to reach the market in the shortest possible time.

Can you assist in the development of regulatory required documentation necessary for taking a medical device or diagnostic through to market?

Yes, MiniFAB has a comprehensive Design Control strategy which governs design and development projects for products in the regulated markets.

Documentation is developed during the design and development stages to ensure a Design History File is available to you at the end of the project.

What regulatory standards do the Design Control procedures at MiniFAB comply with?

The Design Control procedures implemented at MiniFAB are designed to meet both ISO 13485:2003 and the FDA's Code of Federal Regulations 21 CFR 820.30.

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