Sponsorship, Collaborative Effort, and Regional Innovation

A long-held view of innovation is that producers are motivated to innovate by the expectation of profits. These profits will disappear if anyone can simply copy producers’ innovations, and, therefore, producers must be granted subsidies or intellectual property rights that give them exclusive control over their innovations for some period of time. However, the producers’ model is only one mode of innovation; there are several alternatives to this model, as exemplified by single-user firms, individuals, and open collaborative innovation. Each of these three forms represents a different way to organise human effort and investments aimed at generating valuable new innovations [23, 24]. Approaching the respective industry member supplying the device for sponsorship or subsidy for patients who are unable to afford it seem like an impasse. If it is a multinational organisation (e.g. Nuvasive for MAGEC rods, Medtronic for SHILLA screws), it can easily afford to serve such patients and use it as a marketing tool to enhance their mission in advancement and availability of quality healthcare throughout the world. Another way to demonstrate value for the industry member is to begin a prospective study involving these patients, giving the industry member access to long-term clinical data in exchange for sponsoring such patients. In resource-limited settings such as India, public sector employees, private sector employees with health insurance, and upper middle class (out-of-pocket expense) constitutes 30% of all the patients who undergo MAGEC rod distraction-based surgery. The other 70% of patients undergoing traditional rod distraction-based surgery are people who cannot afford MAGEC and/or have congenital scoliosis, which is not covered by most medical policies. There lies an acceptance of traditional growth rod surgery among the people who have no means to afford surgeries or rely on medical loans, nongovernmental organisations, welfare funding, etc. This reflects the misunderstanding that MAGEC is a premium (i.e. unnecessary) product, and because traditional growth rods have been used in the past, underprivileged patients do not deserve any better. It is unknown why SHILLA (using domino-rod interface) or APC etc. have not be used instead of traditional growth rods in this majority of underprivileged patients. One may argue that there could be long-term complications with use of SHILLA leading to one or two revision surgeries, however repeated surgeries (5-15) with traditional growth rods is a bigger source of morbidity for patients with EOS.

There exists a gap between advancement in growth rod technology and affordability of such in developing countries. An ideal solution would be to provide the advanced technology at a lower cost, through government subsidies and affordable healthcare insurance. However, in the absence of such a programme or subsidies, a pragmatic approach should at least include provision of a bridging technology. A regional or locally developed source of such devices would avoid this problem because the development of such devices will, by design, consider the economy of the region. An opportunity exists to either innovate a distinct technology with the freedom to operate commercially or reproduce and build upon an existing technology when the parent industry or inventors does not deem it worthy of protection in a given economic system. By law, a disclosed technology is public knowledge when not protected as per the countries’ patent regulations within a given time frame. Efforts should also be directed toward collaborative work with the industry member to develop a bridging technology. Many external grants exist from large industry members, such as Medtronic, who support individual research conducted by surgeons.

When fostering innovation, surgeons should be careful of companies (nonpractising entities) that find ways to make money on patentinfringement lawsuits. These are entities who buy cheap patents from bankrupt companies, universities, and researchers affiliated to these institutions through superficially appealing agreements; however, they never actually produce anything. Instead, they find companies or individuals who appear to have infringed upon a patent they own and exploit them. They exploit the patent-infringers by demanding licensing fees and then threaten them with lawsuits if they will not comply [25].

Reducing Regulatory Hurdles

Exacting regulatory processes fosters microinnovation (mini-innovation) to such a great extent that patients are exposed to passive forms of medical abuse. The model regulatory environment that exists today in developed nations, and is gradually being adopted in developing nations, penalises technological advancement in the form of delay and capital investment. Although it is necessary to guard public interest by governing bodies, such a stringent method also harms the public by reducing the rate of access to newer medical treatments and technologies [26, 27]. The regulation should be limited to a framework necessary to carry innovation with precision and safety without stifling the rate at which it is undertaken. Unlike a systematic drug development process, most spinal medical instrumentation achieves its objective via a mechanical mode of action. Most material and the wear particulates from these materials do pose a biological response, however, the focus of device development and the improvement cycle should be on reducing it rather than on drawing a hard line of acceptance and rejection. Nevertheless, this climate in developed nations could drive industry members to conduct clinical trials of their latest medical technology in countries with limited resources where there are fewer regulatory hurdles. The utmost safety and affordability may not coexist in countries with limited resources and thus remain open to new technologies in pursuit of better clinical data, which may provide a backdoor entrance to long-term clinical trials without the question of affordability. Just as Europe is well-known for conducting clinical trials of new technology, the cost of which are fully funded by the industry seeking long-term data, countries with limited resources could also encourage this with proper patient consent and the existence of credible preliminary data.

 
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