Scalpel please, nurse… oh, wait!
Imagine that during your travels you break your leg and are sent to the local hospital. There is a team of qualified clinicians and they recommend an operation – but are unable to operate because of a lack of equipment.
An unmet global need for surgical care has always existed, but only recently have we understood the severity of this problem. Diseases and injuries treatable by surgery are common worldwide, yet 30% of the world’s population receives only 3.5% of all surgical procedures. Proper equipment is just as vital to surgery as a trained surgeon, but the majority of surgical equipment used in the Majority World is old, donated and, within 6 months of being donated, no longer functional.
In the United States, it takes roughly 3 to 7 years for a new medical device to go from the bench to the bedside or, in this case, the operating room. Most of these new innovations have to go through a stringent Premarket Approval (PMA) process to determine efficacy and safety. There are ways to ‘fast track’ the PMA. If a medical device contains only minor differences from a previously approved product, the device can downgrade into a class with a less-stringent approval process. This means less time and money are spent proving safety and efficacy and there is more time for the manufacturer to make money. Interestingly, devices in Europe need to be CE (European Conformity) approved but, fortunately, can go through this approval process 2 to 3 years faster than the US approval process. How does this relate to global health and surgery?
It is estimated that the global market for surgical equipment will grow from $8.43 billion (2012) to more than $11.28 billion (2019) with a compounded annual growth rate (CAGR) of 4.2%, with the fastest growth in Asia and the Pacific, at a CAGR of 16.1%. Surgeons and anaesthetists around the world need instruments to care for their patients. This is especially true in low- to middle-income countries, due to the volume and type of cases. There have been some innovative products from the high-resource world, such as Lifebox and One Breath. Other innovations originate in low-resource environments, for example the Jaipur foot, a significantly cheaper version of a prosthetic limb.
Pioneers in surgery, such as Dr TE Udwadia in India, have even invented (or re-engineered) laparoscopic surgical techniques because of the lack of adequate equipment. Just as impressive is the work done by Dr Benjamin Warf, who started CURE Uganda, a global leader in minimally invasive neurosurgery. Currently, multiple neurosurgeons around the world are training at CURE Uganda and the research has changed the way neurosurgery is practised in the developing world.
It is time for major manufacturers of medical devices in rich countries to use their power of innovation to address the needs of patients globally. Manufacturers should realize the potential market for their tools and make efforts to redesign existing technology to bring down the costs for those with little money. A barrier to this is Food and Drug Administration (FDA) and CE approval, but this can be mitigated by fast tracking an existing technology to adapt it for use in poorer countries with fewer resources. I believe everyone deserves access to surgical care. More importantly, everyone deserves to benefit from the ingenuity of the manufacturers of surgical equipment, and from the strict standards of FDA- and CE-approved devices.
As in Dr Udwadia’s case, desperation breeds ingenuity. If we can entice rich manufacturers to build appropriate technology, our colleagues in the under-resourced regions of the world will have powerful allies in the struggle to provide safe surgical care for their patients.
Maziar M Nourian is a 1st-year medical student at the University of Utah School of Medicine and he is interested in advancing global surgery and anaesthesia efforts.
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