AFFORDABLE RECONSTRUCTIVE SURGERY: CENTRAL …
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AFFORDABLE RECONSTRUCTIVE SURGERY: CENTRAL UNIVERSITY OF TECHNOLOGY (CUT) LEADS THE WAY WITH MEDICAL DEVICE INNOVATION USING 3D PRINTING TECHNOLOGY Elmary Buis Reconstructive surgery is often unaffordable for patients who suffer from severe facial disfigurement caused by birth related defects like a cleft lip; physical injury such as burns and car crash injuries; or illnesses like cancer. For patients in public hospitals, tertiary care – meaning, very specialised medical care with advanced and complex procedures and treatments performed by medical specialists in state-of-the-art facilities - is often not a reality. However, the exciting field of additive manufacturing, also known as three-dimensional (3D) printing is opening a world of possibilities in diverse fields like medicine especially in reconstructive surgery, aircraft parts manufacturing, and even in building construction. This technology uses computer aided design (CAD) and a specialised printer to manufacture three dimensional objects. At the Central University of Technology (CUT), researchers are involved in innovative applications of 3D printing in the medical field to help patients who suffer from severe facial disfigurement caused by cancer or accidents. CUT’s Centre for Rapid Prototyping and Manufacturing (CRPM) have become leaders in the field of medical 3D technology, so that state patients who do not have access to medical aid funds, are able to receive reconstructed limbs, facial features etc. CUT is one of four universities forming the Medical Research Council’s (MRC) Medical Device Innovation Platform that conduct research and development (R&D) into innovative medical devices for the South African and international markets. Most activities of this platform are done in partnership with the 3D printing facilities of CRPM, as the design and production of patient-specific implants are done using 3D printing. The CRPM received international certification (ISO 13485) for 3D printing of medical devices making it the first centre of its kind in Africa. Furthermore, the CRPM was awarded a Research Chair in Medical Product Development under the Department of Science and Technology’s South African Research Chairs Initiative (SARChI). The goal of the SARChI is to increase the research output and innovation in areas that are considered essential to the country’s strategic growth and development. Thus, CUT’s specialised expertise and state of the art manufacturing facilities enable staff and students to be involved in the development and manufacture of patient specific medical devices. In such a cutting edge field, it is very often important to consider the role of intellectual property (IP) protection, given that 3D printing makes it technically possible to copy almost any object, with or without the authorisation of the IP rights holders. A 2017 article in the magazine of the World Intellectual Property Organisation (WIPO), considered how 3D printing technology is protected by law and argued that various laws will provide IP protection. Copyright will protect the originality of a work; laws for industrial design will protect the ornamental and aesthetic appearance of an object; a patent would protect its technical function, and a trade mark allows creators to distinguish their products from those of their competitors. However, the article asserts that while IP law can protect both 3D files (designs) and the people using 3D printing technologies for non-commercial purposes, it recognised the following gaps in IP Law: • Who owns an object that is conceived by one person, digitally modelled by another, and printed by a third? • What protection should be available to the owners of 3D printers whose financial investment enabled the creation of an object? Should they qualify for the same type of rights’ protection
Transcript of AFFORDABLE RECONSTRUCTIVE SURGERY: CENTRAL …
AFFORDABLE RECONSTRUCTIVE SURGERY: CENTRAL UNIVERSITY OF TECHNOLOGY (CUT) LEADS THE WAY WITH MEDICAL DEVICE
INNOVATION USING 3D PRINTING TECHNOLOGY Elmary Buis
Reconstructive surgery is often unaffordable for patients who suffer from severe facial disfigurement caused by birth related defects like a cleft lip; physical injury such as burns and car crash injuries; or illnesses like cancer. For patients in public hospitals, tertiary care – meaning, very specialised medical care with advanced and complex procedures and treatments performed by medical specialists in state-of-the-art facilities - is often not a reality.
However, the exciting field of additive manufacturing, also known as three-dimensional (3D) printing is opening a world of possibilities in diverse fields like medicine especially in reconstructive surgery, aircraft parts manufacturing, and even in building construction. This technology uses computer aided design (CAD) and a specialised printer to manufacture three dimensional objects.
At the Central University of Technology (CUT), researchers are involved in innovative applications of 3D printing in the medical field to help patients who suffer from severe facial disfigurement caused by cancer or accidents. CUT’s Centre for Rapid Prototyping and Manufacturing (CRPM) have become leaders in the field of medical 3D technology, so that state patients who do not have access to medical aid funds, are able to receive reconstructed limbs, facial features etc.
CUT is one of four universities forming the Medical Research Council’s (MRC) Medical Device Innovation Platform that conduct research and development (R&D) into innovative medical devices for the South African and international markets. Most activities of this platform are done in partnership with the 3D printing facilities of CRPM, as the design and production of patient-specific implants are done using 3D printing.
The CRPM received international certification (ISO 13485) for 3D printing of medical devices making it the first centre of its kind in Africa. Furthermore, the CRPM was awarded a Research Chair in Medical Product Development under the Department of Science and Technology’s South African Research Chairs Initiative (SARChI). The goal of the SARChI is to increase the research output and innovation in areas that are considered essential to the country’s strategic growth and development.
Thus, CUT’s specialised expertise and state of the art manufacturing facilities enable staff and students to be involved in the development and manufacture of patient specific medical devices.
In such a cutting edge field, it is very often important to consider the role of intellectual property (IP) protection, given that 3D printing makes it technically possible to copy almost any object, with or without the authorisation of the IP rights holders.
A 2017 article in the magazine of the World Intellectual Property Organisation (WIPO), considered how 3D printing technology is protected by law and argued that various laws will provide IP protection. Copyright will protect the originality of a work; laws for industrial design will protect the ornamental and aesthetic appearance of an object; a patent would protect its technical function, and a trade mark allows creators to distinguish their products from those of their competitors.
However, the article asserts that while IP law can protect both 3D files (designs) and the people using 3D printing technologies for non-commercial purposes, it recognised the following gaps in IP Law:
• Who owns an object that is conceived by one person, digitally modelled by another, and printed by a third?
• What protection should be available to the owners of 3D printers whose financial investment enabled the creation of an object? Should they qualify for the same type of rights’ protection
as that enjoyed by music producers whose investment enables the creation of sound recordings?
• Is the digitisation of a pre-existing object considered an act of infringement simply because it is printed or its base file is loaded onto an online sharing platform for downloading?
These issues still need to be resolvedi.
The beneficiaries of the CUT medical devices who now receive reconstructed limbs, facial features etc. that were unaffordable for them in the past, bear testimony to the CUT’s vision to impact socio-economic development.
One beneficiary of 3D printing medical technology was a 31-year-old man having a facial swelling on the left side of his jaw. After the tumour was removed, the patient’s jaw was reconstructed with a customised prosthesis produced by 3D laser printing process. This approach significantly reduced the cost of this advanced surgical procedures and the cost of the operating room timeii.
Figure 1. Before the operation.
Figure 2. The computer-assisted design of the prosthesis.
Figure 3. X-ray after the operation showing the prosthesis in place.
Figure 4: Patient 1-year after the operation
To date, sixty-five (65) patients around the country have been assisted through the CUT’s support of state and private hospitals. Some of these medical devices were first of their kind in the country; placing CUT at the forefront of innovation in this field.
The CUT’s vision for 2020 states their commitment to “be an engaged university that focuses on producing quality social and technological innovations for socio-economic development”. In other words, by 2020, CUT aims to “be a centre of knowledge, innovation and excellence producing a critical mass of innovators that directly contributes to prosperity-creation”iii.
The CUT’s vision and their innovative medical devices give effect to the National Development Plan’s intend that “innovation should also focus on improved public services and on goods and services aimed at low income sectors”iv
i Article: 3D printing and IP law (February 2017), Elsa Malaty, Lawyer, Associate in the law firm Hughes Hubbard & Reed LLP, and Guilda Rostama, Doctor in Private Law, Paris, France. http://www.wipo.int/wipo_magazine/en/2017/01/article_0006.html ii http://www.crpm.co.za/wp-content/uploads/2017/07/Customized-reconstruction-of-an-extensive-mandibular-defect.pdf iii http://www.cut.ac.za/vision-2020-2/ iv http://www.dac.gov.za/sites/default/files/NDP%202030%20-%20Our%20future%20-%20make%20it%20work_0.pdf
