According to *MedTech Europe, the European trade association for the medical technology industry, more than 500,000 different types of medical devices are produced globally.
These range from everyday products (spectacles, dentures, sticking-plasters, etc.) to implants and advanced diagnostic systems such as MRI scanners and X-ray machinery.
The manufacture of these products and the instruments needed to undertake invasive surgical procedures increasingly embraces leading-edge production processes such as lasering and additive manufacturing, and involve novel materials such as cyclohexanone. In fact, you’re just as likely to find a 3D printing set-up in a medical devices facility as in an advanced aerospace engineering environment.
In part, this is because materials science has made it possible to develop products with specific characteristics for, say, hip implants, but it’s also because production methods informed by data-driven diagnostics make it possible to manufacture personalized solutions for patients. And with the march of artificial intelligence, the influence of data analytics on this market looks set to grow.
What you’ll also see in these environments, alongside lasers and 3D printers, is fume extraction technology, such as that developed by Donaldson BOFA. These systems help capture the particles and fumes associated with these processes which, if not adequately controlled, could impact on product quality. Moreover, some airborne contaminants have the potential to be harmful to human health.
Lasers have been transformative in this sector over the last few decades. For example, stents are typically manufactured by braiding or knitting thin metals using a laser welding process, offering a high-speed, high-quality, and repeatable production solution.
At the same time, the adoption of metal powder and polymer additive manufacturing processes is increasingly in evidence, whether for rapid tooling for mass production methods, for prototyping and for device customization.
Graham Mattok, Donaldson BOFA UK and Ireland Sales Manager, works with customers in this sector, and has seen a transformation in production methods.
“Fume extraction technology is a key enabler for this market, whether for device manufacture, post-processing, or helping to maintain a clean room environment,” says Graham.
“For example, one volatile organic compound (VOC) frequently used to enhance mechanical properties is cyclohexanone. This VOC is used as an adhesive and bonding agent, in polymer processing and surface treatment, and as a sterilization and cleaning agent, but it carries a National Institute for Occupational Safety & Health recommended exposure limit of 25 ppm averaged over a ten-hour work shift.
“As a consequence, manufacturers using cyclohexanone will need to consider employing filtration technology to support their health and safety obligations as part of their atmosphere management strategies.”
When it comes to additive manufacturing, 3D printing offers a combination of speed, affordability, customization, and design flexibility for the production of devices, such as prosthetics.
The results can be transformative in outcomes for patients when processes such as selective laser sintering (SLS), stereolithography (SLA), and fused deposition modeling (FDM) are combined with data-driven diagnostics and imaging. At the same time, 3D printing can enable the production of surgery-specific tools for complex procedures. However, many additive manufacturing processes will also emit airborne contaminants that will need to be controlled, whether to avoid equipment contamination or to help maintain a healthy work environment.
To meet the fume extraction needs of the medical devices sector, Donaldson BOFA has developed a three-stage system architecture that includes a pre-filter, High-Efficiency Particulate Air (HEPA) filter, and carbon filter to help remove dust, airborne microbes, aerosol particles, and chemical vapors.
The exact system design and configuration will depend upon many factors, including the process employed, the materials being worked, and the chemical composition and volume of the resultant emissions.
“The rapid pace of innovation, led by data, automation and process improvement, is driving a huge expansion in the medical devices sector,” says Graham. “The ability to harness the power of lasers and 3D printing, enabled by fume extraction, is delivering efficiencies at scale while at the same time enabling a more personalized approach to patient-centered products.”
To find out more about Donaldson BOFA technology for 3D printing processes go to https://www.donaldsonbofa.com/applications/3d-printing-fume-extraction/ .
