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Medical Diagnostech (Pty) Ltd   


As a qualified biotechnologist, Ashley Uys registered his first business, Real World Diagnostics, in March 2010. He later formed Medical Diagnostech as the production arm of his business. The company manufacturers disposable medical test kits, which use blood, urine and saliva to test for HIV, malaria, pregnancy, or evidence of drug abuse. The products are known as rapid point of care test kits and provide results within 15 minutes. All products are sold locally, except for malaria test kit which is exported via a distributor to 25 countries.

The challenge

Medical Diagnostech approached Seda for assistance in growing the business. A Seda Business Advisor assisted with a CPE assessment, including a financial analysis. It became evident that the only way to grow the business was to increase sales and this could be achieved by supplying products directly to the global market, rather than through a distributor.

Seda intervention

In order to supply the global market with medical products, the company needed to become compliant with ISO 13485:2003, a quality standard specifically pertaining to medical devices. Seda assisted the company to in attaining the certification, which in turn brought it a step closer to being able to become registered as a preferred supplier by the World Health Organization (WHO).

The result 

  • Sales increased to the extent that additional production was required, necessitating the appointment of an additional eight employees – the company now employs 25 people;
  • ISO 13485:2003 certification has allowed Medical Diagnostech to participate in, and pass, the first phase of the WHO evaluation of malaria tests, towards becoming an approved supplier – the second phase in now under way;
  • Annual turnover grew by 25% in one year;
  • Ashley was named as one of the ’30 under 30: Africa’s Best Young Entrepreneurs’ on the Forbes List.


Advice to other SMMEs

“When starting your own business you need to identify opportunities in the market. Then analyse and understand your identified market. What you offer needs to be unique and different. To grow a sustainable business you need to identify rewards (for example government programmes such as Seda) as well as risks in pursuing these rewards”, says Ashley.