Strait Access Technologies
Malcolm Applewhite, M.Sc, is a seasoned professional in medical device quality assurance and regulatory affairs, currently serving as a consultant at regZAmed Solutions Pty Ltd and Strait Access Technologies, along with a role as Regulatory Affairs Manager at GLYCAR. With extensive experience from previous positions, including Regulatory Affairs Consultant and Risk & Regulatory Compliance Lead at Radic8 Global and QA Manager roles at Cerdak (Pty) Ltd and Dakot Milling Media, Malcolm has demonstrated expertise in establishing quality management systems, maintaining ISO accreditations, and managing regulatory submissions for products. Academically, Malcolm holds a Master of Science in Synthetic Chemistry and a Bachelor of Science in Chemical Biology, complemented by relevant certifications in regulatory practices for medical devices.
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Strait Access Technologies
Rheumatic Heart Disease (RHD) is an easily preventable type of heart disease caused by streptococcal bacteria. This bacteria is responsible for a common throat infection known as strep throat. When left untreated, a patient’s immune system can turn against his own heart while fighting the infection. This can lead to an acute inflammation of the heart accompanied by high fever (acute rheumatic fever). The inflammation can damage heart valves irreversibly. The disease mainly affects children between the ages 5 -15, and occurs approximately 14–28 days after symptoms of strep throat or scarlet fever appear. According to conservative and outdated WHO estimates, 15 million people are affected by the disease globally. Newer statistics argue that the number could be up to five times higher, at 60–75 million people worldwide. Rheumatic Heart Disease is much more prevalent among those living in developing countries, especially sub–Saharan Africa, due to limited access to quality healthcare and antibiotics. Rheumatic Heart Disease claims the lives of 1.4 million people per annum, with up to 70% of patients will dying before the age of 26. Although Rheumatic heart disease affects mainly the poor, all current heart valve technologies are focused on developed first world applications. These devices are highly sophisticated and make use of advanced monitoring equipment that requires highly specialised operators. Overall, neither skilled surgeons or cardiologists nor monitoring or imaging equipment and hospital facilities are available in the countries where Rheumatic Heart Disease is most prevalent. Due to this, of every 100 patients requiring heart valve replacement, only two patients are treated worldwide. With SAT’s technology this could change.