In Support of Medical Sumerians
- coronary revascularization
- medical economics
- percutaneous coronary intervention
- resource utilization
- technology transfer ◼ biotechnology
The United States and the developed world are facing massive increases in healthcare cost at time when the global economy and that of many individual nations is floundering. On the other hand, medical research and development (R&D) has improved human health more in the last century than in previously recorded history. Consider that an American born today will have an average life expectancy >30 years longer than someone born in 1900. In this context, it is useful to consider the future of innovation and technology development in science and medicine. Understanding the genesis and consequences of paradigm-shifting technology in medicine is important to inform how we promote the development of life-saving, cost-effective new therapies and diagnostics. Making the correct decisions about incentives and investment in science and technology has profound implications for the public and economic health of nations involved in this endeavor.
Article see p 743
The work by Xu et al1 using the coronary artery stents as a test case provide a number of interesting insights regarding the ontology of medical device/therapeutics development. In an examination of US patents from 1984 (first patent issued for coronary stents) and 1994 (first approval), the authors report a steadily increasing number of patent filings and a change in the origin of the applications. In the early years, patents from private companies and individual inventors predominated. As the technology evolved, publicly traded companies filed an increasing number of patents in this field. Overall, in the preapproval era of stent development, private entities and individual inventors accounted for >62% of the patents filed, consistent with early stage intellectual property development by medical scientist-innovators working independently. The analysis suggests that the most impactful investment in transformative medical technology should be aimed at innovator or investigator directed research. The trajectory of technology development may take one of several paths after this catalytic investment at early stages including traditional mechanisms such as academic collaborations, start-up companies, and new technology accelerator programs such as those developed by the American Heart Association, Leducq Foundation, and the National Institute of Health.
The origins of medical device development revealed by examining patents relevant to coronary stents is more generally applicable to other biomedical technologies. The history of technology development is replete with similar case histories such as those cited by the authors, eg, balloon catheters and bone densitometers, but there are many other transformative therapies with a similar history, eg, the internal cardioverter-defibrillator. In fact, this paradigm is likely the rule and not the exception, particularly for core or foundational technologies; what is more, the impact of independent and academic/university on technology development is probably underestimated given the expense and logistics of patent filing. Moreover, the environment of the academic setting and small private company incubator serves to train and generate the inventors and innovators.
This work does not undermine the importance of research and development in publicly-traded companies in the process of technology development. There are well-described examples of fundamental research done in the industry setting that has resulted in paradigm shifts in medicine either directly or indirectly. Blue Sky Research in Bell Labs produced the transistor in 1947, which transformed the world, including medicine and a myriad of discoveries in pharmaceutical, and biotech companies have catalyzed the development of modern therapeutics. Even in the setting of publicly-funded breakthroughs, the importance of public–private partnerships in product development and commercialization is difficult to understate. For example, it is both unlikely and unreasonable to ask for-profit, publicly-traded industry to invest in early-stage development at a time when there is a substantial uncertainty about economic return. The processes of the initial development and subsequent refinement/commercialization of technology are complementary and distinct, the latter requiring the former and having a greater capacity to support movement of technology through the later, more expensive, stages of the developmental continuum, where the economic return is more assured.
Another, more general, implication of this work is the importance of investment in the biomedical research sector in the promotion of public health and economic vitality. The noteworthy effects of investment in biomedical R&D include product development as described in this article and the ensuing job growth2 as well as decline in morbidity and mortality rates,3 with the promise of lower expenditures on health care and increased tax revenue. The patent trail for coronary stents reveals the important and complementary roles of government and private-sector investment in biomedical research and is consistent with an independent analysis by the National Bureau of Economic Research, which demonstrated parallel increases in R&D investment by the National Institute of Health and industry (private and public).4
Of the many roles investment in research can play in society, support of education and training and a focus on the early stages of the developmental pipeline are vital to the development of novel medical technologies. The authors appropriately conclude that policies and incentives need to be aligned to promote this type of investment.
The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.
- © 2012 American Heart Association, Inc.
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- Avorn J,
- Kesselheim AS
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