Medical device additive manufacturing technology in South Africa – robust and reliable and up there with the best in the world

Medical device technology innovations in South Africa are improving accessibility to 1 000s.

Not only is access to medical device technology improving in South Africa, but innovations in health care technology are helping to provide medical care and solutions to those living in poverty. There are more cases than there are not these days where it is not so much the accessibility to the equipment in Africa, and South Africa in particular, but that the equipment is not suited to African environments and the day to day living conditions that the majority of the population endure.

With the COVID-19 pandemic not going anywhere, medical research and development to help combat the virus has been under extreme pressure, as have health care workers. Rapidly changing peaks and troughs as the various waves of the virus and its mutations sweep across countries calls for rapid prototyping and rapid tooling in order to bring about solutions to save lives.

The PDTS purchased a DMG Mori 5-axis CNC milling machine, supplied by Retecon, that will be used for post machining operations of additive manufactured components for dental, implants and surgical guides, which is not possible using 3-axis milling machine centers. The machining processes include finishing cuts on specific surfaces of AM components, before the polishing process in order to obtain a smooth surface finish and accurate interface surfaces

The Product Development Technology Station (PDTS), situated at Central University of Technology (CUT), has been at the forefront of this in South Africa and is involved in product design, prototyping and short run production. The PDTS develop new ideas into products, or improve existing products with detailed engineering, and in this way, they support businesses and individuals through the entire new product development process.

The station makes use of first-class engineering expertise from CUT, as well as specialised prototyping equipment from the Centre for Rapid Prototyping and Manufacturing (CRPM).

Funded by the Technology Innovation Agency (TIA), the PDTS assist SMMEs in becoming globally competitive by providing them with the technological support they need to design and manufacture innovative new products.

Some of the services offered include CAD design, 3D scanning and reverse engineering, graphic design and branding, electronic development, advanced machining and tooling, product development, advanced sheet metal and tubing and medical device product development. The PDTS also offers training in introduction to sketching and drawing, SolidWorks essentials and introduction to medical device product development.

The Doosan 3-axis CNC milling machine, supplied by Puma Machine Tools, will be used for the manufacturing of tools and dies used during the development and manufacturing of medical devices. For medical trials and certification of medical components, it is required that the products need to be manufactured in the correct end use material. Using the 3-axis milling machine, injection moulds will be manufactured to produce medical products in the correct material

For so many of us, the pandemic caught us by surprise, and one thing that became apparent early on with its spread was that there would be a shortage of personal protective equipment. None more so than high functioning face masks for clinicians working in a high viral load environment.

Explains Ronald Masheane, the PDTS Project Engineer: “Together the PDTS and CRPM assisted by the Free State Department of Health recognised during the early stages of the COVID-19 pandemic that there would be a shortage of face masks. Globally there was a shortage of appropriate N95/FMP2 masks for clinicians in a high viral load environment. The FMP2 half face respirator project was established.”

“It is very important to note that the developed device is a higher functioning device than a conventional N95 mask. The intended use is for health care workers in a high viral load environment. The developed device is comparable to a 3M Half Face Mask Respirator 6000 Series. The locally manufactured FMP2 mask is a half face respirator comprising of a soft facial interface with adjustable straps and a filter housing that accommodates cost effective FMP2 replaceable discs. The half mask is not only comfortable and safe but results in a cost-effective solution for the PPE shortage.”

The Amob CNC tube bender, supplied by CML Machine Tools, will be used to bend round steel tube ranging from 19mm to 76mm diameters. As with the laser tube cutting machine, this machine will also assist with the prototype development and manufacturing of medical assistive devices such as but not limited to wheelchairs

“The high quality FMP2 half face respirator was developed, manufactured, tested and regulated all in three months highlighting the exceptional product development capabilities in the Free State. In the beginning stages of the project, Old Mutual recognised the impact that the FMP2 mask could have in the lives of Free State clinicians and co-funded with the Central University of Technology the first donation of 1 000 face masks and 1 000 face shields to the Department of Health, Free State. Old Mutual contributed R170 000.00 and the CUT added a further R85 000.00 to manufacture the much-needed PPE. The devices were received by the Free State Health MEC, Ms Motsheng Tsiu and the Free State Premier, Ms Sisi Ntombela on behalf of the Free State Department of Health.”

“The half face mask is fully developed and tested. Positive test results of the mask tested at Protechnik Laboratories had a particle penetration of only 1% and a breathing resistance of 160 Pa. Production and assembly are conducted at UV Tooling, which created 12 new jobs. The mask is currently production ready and 2 000 units can be manufactured each day.”

“The half face mask and face shield are a celebration of innovation and solidarity in the Free State showcasing the opportunities to manufacture medical devices locally in the times to come.”

The PDTS was launched during 2000 at the Central University of Technology, Free State (CUT). Originally funded by Tshumisano as the Metal Value Adding Technology Station (MVATS). The name was changed to the Product Development Technology Station (PDTS) at the end of 2003 due to the nature of the work conducted at the Technology Station (TS). PDTS was since then funded by the Technology Innovation Agency (TIA) through the Technology Station Programme (TSP). TSP’s primary objective is to increase innovative activities amongst targeted sectors, specifically SMEs through Higher Education Institutions (HEI) and, at the same time strengthen and upgrade institutional capacity and infrastructure to service the needs of these sectors.

The Bodor CNC laser tube cutting machine, supplied by WD Hearn Machine Tools, will be used during the prototype development and manufacturing of medical assistive devices (such as for example wheelchairs), manufactured from hollow steel tube sections. The CNC laser tube cutter refers to a machine in which laser cutting operations are performed on tubing to produce specified intersection profiles and end conditions for joining of the tubes during manufacturing

PDTS is a collaborator in the CUT established Medical Device Additive Manufacturing Technology Demonstrator (MedAdd). The MedAdd project aims to bridge the innovation chasm in the use of additive manufacturing (AM) for the innovation, development and final manufacturing of medical devices by enhancing the current equipment and capabilities at CUT. The R71 700 000.00 Department of Science and Innovation (DSI) High-end Infrastructure project was approved in February 2019. The PDTS and Centre of Rapid Prototyping and Manufacturing (CRPM) have greatly benefited from the MedAdd project as multiple high-end advanced manufacturing machines have been procured. These machines have been strategically purchased to support the development of medical devices in South Africa.

Various components produced on the new machines

The Central University of Technology (CUT) is the leading South African university in the application of AM for the design and production of customised medical implants. However, the impact of this expertise and resources on the development of a medical device manufacturing industry has been limited, mainly because of a lack of equipment specifically for medical device manufacture, for both prototyping and development as well as small-scale manufacture to de-risk innovation. In addition, there are limited skilled people who can develop local companies. If South Africa is to compete internationally, and is to develop a local medical device industry with appropriate infrastructure, expertise and skills, a technology demonstrator for additive manufacturing of medical devices is required.

There are two manufacturing sectors that the PDTS is targeting within the Free State: Medical devices and plastic components manufactured through injection moulding. PDTS’ core staff comprises of 18 individuals and five interns.

Injection moulds will be manufactured to produce medical products in the correct material

The newly purchased equipment at the PDTS include an Arburg Injection Moulder, a Doosan 3-axis CNC milling machine, a DMG Mori 5-axis CNC milling machine, a Bodor CNC laser tube notcher and an Amob CNC tube bender.

Other success stories that the PDTS has been a part of include a sustainable wheelchair tailored to African conditions and challenges. This new wheelchair features an attachable hand cycle or free wheel to help with mobility and reliability in rural areas and during long distance travelling. A person with a disability will have a reliable wheelchair to move around indoors, but has a clip-on hand cycle or free wheel to improve mobility on rough rural roads and over long distances.

A large scale 3D printer developed at the PDTS was used to prototype a cost-effective multi-functional walking frame for the elderly. The product, a commode – a movable toilet – combines a walking frame and toilet.

For further details contact Ronald Masheane on