According to *MedTech Europe, the European trade association for the medical technology industry, more than 500 000 different types of medical devices are produced worldwide.
These range from everyday products (glasses, dentures, patches, etc.) to implants and advanced diagnostic systems such as MRI scanners and X-ray machines.
The manufacture of these products and the instruments required for invasive surgical procedures increasingly uses state-of-the-art manufacturing processes, such as laser processing i incremental manufacturing, and involves innovative materials such as cyclohexanone. In fact, 3D printing kit can be found just as often in a medical device facility as in an advanced aerospace engineering environment.
This is partly because materials engineering has made it possible to develop products with specific features, such as for hip implants, but also because manufacturing methods based on data-driven diagnostics make it possible to produce personalised solutions for patients. And with the advancement of artificial intelligence, the impact of data analytics on this market is likely to grow.
Need for fume extraction
What you will also see in these environments, alongside lasers and 3D printers, are fume extraction technology, such as that developed by Donaldson BOFA. These systems help to capture the particles and vapours associated with these processes, which, if not properly controlled, can affect product quality. Furthermore, some airborne contaminants can be harmful to human health.
Lasers have played a transformative role in this sector over the past few decades. For example, stents are typically manufactured by splicing or knitting thin metals using a laser welding process, which offers a fast, high-quality and reproducible manufacturing solution.
At the same time, the adoption of incremental manufacturing processes from metal powders and polymers is becoming increasingly apparent, whether for the rapid creation of tooling for mass production methods or prototyping and customisation of equipment.
Fume extraction changing production methods
Graham Mattok, Donaldson BOFA's sales manager for the UK and Ireland, works with customers in the sector and has seen the transformation of production methods.
„Fume extraction technology is a key enabler for the growth of this market, whether in equipment manufacturing, finishing or helping to maintain a clean room environment.” - Graham says.
„For example, one of the volatile organic compounds (VOCs) often used to improve mechanical properties is cyclohexanone. This VOC is used as an adhesive and bonding agent in polymer processing and surface treatment, as well as a sterilising and cleaning agent, but it is associated with a National Institute for Occupational Safety & Health (NIOSH) recommended exposure limit of 25 ppm averaged over a 10-hour work shift.
„Consequently, manufacturers using cyclohexanone will need to consider the use of filtration technology to support their health and safety obligations as part of their atmospheric management strategy.”.
When it comes to incremental manufacturing, 3D printing offers a combination of speed, affordability, personalisation and design flexibility in the production of devices such as prostheses.
The results could be groundbreaking for patients when processes such as selective laser sintering (SLS), stereolithography (SLA) and fused deposition (FDM) are combined with data-driven diagnostics and imaging. At the same time, 3D printing can enable the production of operation-specific tools for complex procedures. However, many incremental manufacturing processes will also emit air pollutants that must be controlled to avoid contaminating equipment or to help maintain a healthy working environment.
Meeting the needs of the medical device sector for fume extraction
To meet the vapour extraction needs of the medical device sector, Donaldson BOFA has developed a a three-tier system architecture, which includes a pre-filter, a HEPA (High-Efficiency Particulate Air) filter and a carbon filter to help remove dust, airborne microbes, aerosol particles and chemical vapours.
The exact design and configuration of the system will depend on a number of factors, including the process used, the materials treated and the chemical composition and volume of emissions produced.
„The rapid pace of innovation, driven by data, automation and process improvement, is driving huge expansion in the medical device sector.” - Graham says. „The ability to harness the power of lasers and 3D printing, supported by vapour extraction, provides large-scale efficiencies while enabling a more personalised approach to patient-centred products.”.
To find out more about Donaldson BOFA technology for 3D printing processes, visit https://www.donaldsonbofa.com/applications/3d-printing-fume-extraction/ .