BACKGROUND
Needle stick Injuries are a major concern to healthcare workers in South Africa. That means that all needle stick injuries expose healthcare workers to the risks of contracting HIV and other diseases. In a recent study, needle stick injuries accounted for 58 new HIV, and 53 Hepatitis B cases per year. Currently, no manufacturer of a needle-free medical device exists on the African continent, where HIV is most prevalent. Needle-free valves are standard in the rest of the world and currently used in a number of private hospitals in South Africa. The WHO estimates that ~170 million injections are administered in South Africa, per year.
Unfortunately, all needle-free medical devices are imported, and the cost poses a barrier to entry in most public hospitals. The estimate is that a mere 40% of public hospitals are using needle free valves to protect their healthcare workers and patients. The complexities of importation are that these valves are costly (+- 1US$ each) and they incur customs duty of up to 20% as they are imported as plastic components.
TECHNOLOGY DESCRIPTION
All South African manufacturers of IV administration sets currently import needle-free valves to build into their infusion administration sets. A local South African company has developed a prototype needleless IV injection valve and will go to market in July 2025. The most appropriate designs have been integrated into the design that will comply with international standards, be less expensive to manufacture, easier to use and greater flexibility to adapt for adults and paediatric patients with a single device.
Figure 1: adaptation process of the VIVASite Needleless IV Injection Site
VALUE PROPOSITION
The project aims to localize the manufacturing of needleless IV injection sites, thereby eliminating import costs and reducing the imbalance of trade. By collaborating with world-class specialist anesthesiologists and other relevant stakeholders, sufficient due diligence and market research has been completed. Therefore, a locally manufactured, low-cost, and highly-effective and safe product will be available shortly.
CURRENT STATUS
The first prototypes for non-clinical evaluation have been produced. The project is therefore completed, with only testing to be done which will be an ongoing task. Once the final product has been completed, additional assistance will be needed for the testing of our device and appropriate regulatory requirements.
By Lindsay Curran,Managing Director of Vivaline Medical
Lindsay has been involved in the medical devices industry since 1976.
Educated at SACS, Lindsay studied light current electronic engineering at CPUT, General Management at Damelin Business School and Project Management at University of Stellenbosch.
Lindsay joined Marcus Medical Pty Ltd in 1976 and moved up the ranks from junior technician to sales and marketing manager to General Manager of the IV Therapy Division at Marcus Medical – a total of 21 years of service.
In 1997, he was approached by the American multinational to set up a local affiliate and was appointed as the Country Manager and Director for the IVAC Corporation in South Africa.
In 2007 he was headhunted to the role of General Manager/Director at Smith and Nephew South Africa but was lured back to his engineering roots in 2012, Lindsay entered the field of local manufacture by launching VIVA Medical in Somerset West.
Professional Memberships/Associations;
- Member of the South African Medical Device Industry Association (SAMED) – Board Member for 6 years – Chairman of the Portfolio Committee – Code of Business Conduct.
- Member of CEASA – the Clinical Engineering Association of South Africa.
- Finalist in the Nedbank Small Business Accelerator 2020 4. Recipient of the SAMRC MeDDIC innovation grant 2020
- Achieved ISO13485 licence in 2020.
- Member of the South African Institute of Management.
- Industrialisation Committee Chair and Member of MDMSA – The Medical Devices Manufacturers of South Africa.
- Chairman and Director of the WCMDC – the Western Cape Medical Devices Cluster.
- Diamond Class Member of the National Sea Rescue Institute of South Africa.
- Vice Chairman of EBEDAG – the Elands Bay Environmental and Development Action Group.
- Chairman of the Mustang Owners Club of South Africa
Personal Status;
Married to Marisa (40 years) who is employed as the Clinical Director at VIVA Medical.
3 children – Kerry (39), Helen (39) and Paul (30)
Lives in Somerset West, Cape Town
Fully Bilingual in English and Afrikaans – speaking, reading and writing.
