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COURSES

There was focused skills development through three courses, which support vital industrialisation competencies currently not forming part of the curriculum. These courses are called: Course 1: Medical Device Sector Essentials (MDSE), Course 2: Introduction to Systems Engineering and Product Lifecycle Management (SEPLM) and Course 3: Tooling, Manufacturing and Industrialisation (TMI)

Course 1: Medical Device Sector Essentials (MDSE)

Medical Device Sector Essentials is a course geared to highlight important aspects about the production and commercialisation of a medical device. This course will present a detailed working of relevant and critical standards such as ISO 13485, ISO 27001, ISO 62366.

Three major regulatory authorities and their regulatory compliance measures will be explored which will equip the learner with knowledge about routes to follow in acquisition of medical device approval. Students will learn about the importance of integrating usability engineering into the design phase, how to construct and conduct a usability test on a device and how to identify and assess usability related problems.

“

This first Course was super great to me since it spoke to what i am passionate about. The course highlighted the need for our own regulations in Africa and also the required need for expertise within the space.

Cliff Lowan
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Provided knowledge on Usability Tests which I was able to use in my Final Year Project.

Aliya Singh
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I really enjoyed learning about the medical device sector and the specific standards that need to be met. The ability to do lectures and course content at my own pace was also a major benefit

Stewart Gibson
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It was really helpful to become more acquainted and familiar with some of the ISO Standards that we are likely to use frequently. I also enjoyed the assignments in that they were based on real life scenarios and we got to use templates from a company

Joel Philpott
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I really enjoyed the courses, structure and sequence. I was impressed by how well the goal and aims of the MediVentors were translated throughout the courses. The key highlights for the MDSE course were the first few modules with the introduction to the IS0 13485. I had recently completed some research for one of my university course and had mentioned the ISO 13485 as one of the standards I would need to consider for my dissertation. I however didn't know what the standard entails. I was really happy to be taken through the content in the standard and it helped me think about how it will be translated to my dissertation.

Ntokozo Magubane

Course 2: Introduction to Systems Engineering and Product Life cycle Management (SEPLM)

Systems Engineering and Product Life Cycle Management is an interdisciplinary approach and means to enable the realisation of successful systems.

The objective of:
• Systems Engineering is to satisfy the needs of their customers, users, and other stakeholders.
• This course is to provide students with an understanding and description of the key systems engineering and product life cycle processes and activities used and performed during the design, development, industrialisation, and production phases to ensure requirements of affordability and performance objectives of a product are met.

“

I enjoyed learning about how technical processes are used to enhance SE. I also got to under the value of SE and PLM.

Thulani Maziko
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Content- understanding the comprehensive role played by systems in medical device development; in the product lifecycle right from idea conception to translation to the market. In addition is understanding how costs can be minimised and profits realised in device development.

Maureen Etuket
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This course has great applications, I feel, to familiarizing students with system engineering and product life cycle management. However, I found the content to be quite dense and theoretical, although I could see the value in its implementation in industry. I really enjoyed the project and found it gave a practical understanding of the content. I feel the project could be refined and developed further to give students a better practical understanding of more of the SEPLM concepts through a more structured assignment with perhaps less document management and more change control etc.

Jonathan Oehley

Course 3: Tooling, Manufacturing and Industrialisation (TMI)

Tooling- Manufacturing & Industrialisation is the study of the progressive development and transformation of the manufacture of tooling to industrialised competence.

Some of the topics to be addressed include:

  1. Tooling and implications of the 4th Industrial Revolution;
  2. Tooling Design and Life-cycle;
  3. Tooling optimisation and service integration;
  4. Tooling Supply chains; and
  5. Project to develop your own tool.
“

The course was very informative and useful. The course demonstrated tasks and tools that would be vital in the working environment.

Kerina Virasamy
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Understanding the state of toolmaking in SA relative to the rest of the world was quite fascinating. Also understanding the critical need for toolmaking in medical device development. I enjoyed the research project because it allowed for application of the toolmaking notes to a practical scenario.

Pragesh Govender
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The TMI course gave a good context for the environment of manufacturing in South Africa and possible chances for improvement.

Izak Minnie