Micro manufacturing for medical device

Thanks to micro manufacturing, complex components with previously unheard-of miniaturisation can be produced, transforming the fields of medical devices. 

What is micro manufacturing?

Micro manufacturing is an advanced technology enabling the precise creation of miniature parts, components, and structures, often measuring less than one millimetre. This field requires intricate design, specialised production and inspection equipment, and high-precision processes to ensure superior quality and consistency in the final product.

Common practices in micro manufacturing include advanced techniques like micro welding, micro over-moulding, micro EDM, micro insert moulding, micro assembly, etc. 

Micro manufacturing applications for medical devices

Many medical devices today incorporate micromachined components, benefiting from micro machining techniques. As the human body has limited capacity for larger components, devices used in areas such as medication administration, neurostimulation, and cardiac pacing must be compact. Advances in technology are demanding more functionality within smaller containers. Miniaturisation and micro manufacturing enable the assembly of medical devices at previously unattainable dimensions, reducing patient intrusion and promoting faster healing times.

Some examples include:

• Components of implantable medical devices that use microfluidic technology to regulate or stop the flow of fluids or medications
• Parts of DNA Analysis
• Lab-on-a-Chip apparatus, Microfluidics chips

Micro manufacturing and micro mould manufacture 

With the requirement to precisely produce medical parts in a large quantity without differences, the initial step is to design and manufacture micro moulds with the highest level of accuracy. High-speed micro milling is one of the most widely utilised micro machining processes for the production of micro moulds. During micro milling operations, a fixed workpiece’s surface is generally traversed by a diamond tool that revolves on a spindle. The tool revolves along an axis perpendicular to the workpiece as it is being milled. Depending on other factors like mould material or geometrical complexity, other micro manufacturing methods like micro EDM are also applied. 

Micro Systems provides turnkey solutions for ultra-precision medical mould design and manufacture, pilot to full production mould validation. Typical component sizes range from 0.0003g – 2.5g for micro components, or up to a few hundred grams for medical device components.  Some of micro manufacturing machines at Micro Systems include: 

• Kern Pyramid Nano Micro Milling machines: less than 0.5 micron repeatability, less than 10 nm Ra surface finish
• EDM machines: 1 micron repeatability, 30 micron diameter wire for hardened steel cutting
• Cylindrical Grinding machines: for mould inserts manufacture for 16 and 32 cavity fast cycling ophthalmic and IOL moulds 

Micro injection moulding for medical devices

Micro moulding enables the production of parts as small as a single pellet or weighing a fraction of a gram. Micro injection moulding can process various materials, including high-performance engineered thermoplastics like PEEK, PSU, or PEI, as well as bioresorbable materials such as PLA and PLG. This process offers advantages such as reduced raw material usage, quick changeovers, and faster cycle times. While cleanrooms are not required for all micro-moulded parts, medical components must be produced and packaged in a controlled cleanroom environment to meet ISO Class 7 or 8 standards and comply with GMP and FDA regulations.

Micro Systems specialises in the ultra-precision injection moulding of parts for the medical device and life sciences sectors. Each production cell is equipped with a robotic handling system for component separation or tray packaging, coupled with an in-line camera vision system for component integrity and quality control before packaging. Our micro-moulded products for the medical and pharmaceutical sectors include:

• Bioabsorbable implant for cancer treatment
• PEEK implant
• Soft mist inhaler
• Injector pen
• Drug delivery system
• Microfluidics diagnostic system

Micro Systems also utilises our moulding expertise, the latest injection moulding technology and quality assurance to provide solutions for microfluidic analysis products. We can manufacture advanced microfluidic moulds with tolerance as low as +/-0.001mm, with integrated optics.

With more than 20 years of experience in mould design, mould manufacture and injection moulding, especially for the medical and pharmaceutical, ophthalmics, diagnostics and F&B, our team at Micro Systems can support you closely at every step of the project. We use the latest technology available on the market, together with the expertise from our experts based in the UK and Singapore, to lead your projects to success.

We are going to exhibit at COMPAMED 2023 at Hall 8a, Booth F35.3. Come visit us to discuss your medical projects!

Contact us today for more information.