Medical Devices : Few facts: Africa is one of the bold countries to quantum leap the healthcare facility and that accommodates sophisticated Medical devices in its regulation system. Persistently increasing indulgence of private sector in medical and healthcare facility has not only revised the mortality and morbidity figures, but also has altered financials of the nations. Temperate climate and wide weather diversity, neighboring with equatorial forests and traditions & customs make the land happening but augment this challenge on governance in the African continent. South Africa, a more than 50 million people’s nation, is no exception to healthcare challenges of a developing nation. Both; subsidized and mainly insurance driven private segments of African healthcare management have widely evolved and expanded. There is still a wide scope of penetration of the root deeper in the soil looking towards yet-to-be-met grass-root level beneficiary. Percolation of the secondary and tertiary healthcare facility in relatively difficult areas such as remote locations, geographically difficult areas, low socio-economic status, lower literacy rate, higher elderly population has always been a challenge. Sequential unfolding of challenges is required strategy to connect financial constraints and deployment of healthcare solution. One of the impediments in easy spread of tertiary healthcare is its major dependency on sophisticated medical devices. Technological advancement is adding number of medical devices and hence their budget in our healthcare system. Advancement in drugs was relatively easier for regulation. Unlike that, Medical Devices is one of the gray aspects of healthcare for most of the countries in world. Focus of this article is majorly oriented around and about medical devices pertaining to assess exploitation, penetration, challenges and possible solutions for South Africa vision 2020. Why medical devices differ from drugs in healthcare aspects? Medical Devices are majorly different from drugs in several aspects. Finances are definitely not the only aspect. Figures of contribution of medical devices and drugs in healthcare by their financial and utility as per the a coarse data collected from several data points worldwide shows that trend of attributes attribute in last 3 years and approximate forecasts in next 2 years are closely similar to each other with medical devices slightly in upper part of finances. With new tertiary healthcare units coming up and rapidly changing format of healthcare basics (such as diagnostics and treatment) the budget to medical devices side is slightly on upper side. Mode of Action: The medical devices differ from drugs in several forms. The most important being the mode of its action on the living being. Unlike biochemical target bound pharmacodynamics actions of drugs as medical agents, devices which are classified as non-biochemical in nature of action, function mainly in but not limited to physical modes such as electrical, mechanical, Energy based functions (Including radiation, electromagnetic, magnetic, photoelectric etc.), replacement and correction basis (Including tissue grafts, biotechnological grafts, shunts, plates, implants, error correction) etc. what does this mean to us as a medical or paramedical person? It means medical devices are several times more widespread than drugs. Secondly, action of drugs and hence their adverse reactions are precisely predictable but actions of devices may vary from person to person, device to device and from one location to other. Action of Drug in tissue: Most of the drugs are administered in the mod through several routes such as oral intravenous etc. and a few are locally or topically applied and in almost all cases they affect the patient. In case of device there the device many be implanted (like a stent or a pacemaker) removable inserted (Contact lenses or IUCD), placed with or for support (prosthetic foot, neck support belt or spectacle) or it may not even touch the body(x -ray, scanning device. The device may effect on the patient for therapeutic reasons (stent, pacemaker, lenses), affect the assessor for diagnosis or procedural or protection reasons (stethoscope, microscope), affect patient for non-therapeutic reasons (walking sticks, fixing splints for unconscious patient), affecting doctor and patient both (Surgical instruments) affecting none of the assessors but someone else (Condom) etc. End-user process: The end user of the drugs is the same as the person who is consuming it. In short, the purpose is served when the medicine is reaches to the consumer. Even if the medicine is injected by a doctor, its direct effect is on the patient. But in medical devices, in about 50% cases the end-user is not the person who receives the effect or purpose of medical device. For example the purpose of an injection syringe with its needle is to inject or withdraw some material from patient’s body. And in this case, end user may be a doctor, or nurse, or someone else or even patient himself. Authenticity and check parameters: In a Drug testing authenticity is easier in several ways and literature can be referred for standard action. Absorption, distribution, metabolism and elimination (what we collectively call pharmacokinetics), its record of bio-availability, its tissue and blood concentrations in animal models, and its pharmacodynamics are almost confirmed. Its dosage, toxicity, overdosing etc. are well confirmed. More so-over healthy human beings can also be tested before it is given for therapeutic reasons. Contrarily, medical devices have very limited scope of test on healthy human-beings. More critical the device is, less its data of safety is available. Animal studies in healthy and disease models are main source of information apart from bio-compatibility and tissue adaptation tests. Overall biological evaluation is quite limited. Hence main dependency lies on its mechanical and physical tests and for biological evaluation of especially implantable and long contact devices, have to satisfy on limited data. Even for shelf life, expiry, stability of the composition, periodical and confirmed tests for drugs are available, in medical devices even these tests are quite primitive. Challenges in Medical device for a country’s regulation and healthcare system Widespread of definition of medical devices A medical device can be from a small chip to a large machine of size of a room in itself. For example the smallest devices in routine use are a needle used for injection and a large device we often watch is an x-ray machine. A Band-Aid tape, a tooth brush, a spectacle or contact lenses, crutches, walking sticks cotton used for dressing or even contraceptive devices like condom all are medical devices. Constantly progressing medical technology and thus further adding to definition Regulating medical devices – challenge Balancing among many aspects Difficult to get all in one expertise to evaluate all medical devices in one go No uniformity in Standardization of performance, adverse events, device related preclinical and clinical trial outcomes Loop-holes in regulation and victimization of patients as subjects in clinical trials Poor reporting mandate for reporting adverse events of medical devices Challenges and solutions in Insurance of Medical devices: underwriting – an iceberg phenomenon claim assessments impact healthcare insurance premium Increasing medical device cost effectively: In-house production Recycling and threats of infections Disposal and crap management Low administrative and non-production costs Challenges in Clinical trials of medical devices: Designing is the biggest challenge in Medical device clinical trials area. Finding perfect control is the another biggest issue Investigator or end user impact Evaluation, interpretation and understanding and presentation of the data Control on medical devices an effective tool in controlling healthcare system and costs. Cost control on maximum prizes Encouraging in-land manufacture – at least of the replaced principles Strengthening clinical trials and classification regulations Rule of 80-20 applied to the medical device industry in developing country like India Looking towards global velocity of medical devices in development in healthcare facility, and high share of Africa (Chart II) in it feasibility of these countries being only passive supporters is limited. Increasing “market” for healthcare facility attracts giant global players into competition. Hence, contemporary developments in medical management systems requires highly active indulgence of the governance, along with WHO’s effort of prevention patient’s rights in many contexts. As per the Schedule of Listed Electronic Products Hazardous Substances Act, No 15 of 1973 Regulation No R. 1302, 14 June 1991, many dangerous goods are already indicated by regulation, even if there are no clear regulatory directives for all kind of medical devices yet. As medical devices is a very wide area and in tertiary healthcare there is very wide use of medical devices, I am trying to limit myself to clinical research in Medical devices.