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The majority of the world's medical care facilities and research labs have limited access to optimal tools because of the exorbitant prices of proprietary equipment. This results in both reduced acute public health and slows the rate of medical science hampering future public health. The tremendous success of free and open source software in driving innovation and lowering costs has spread to the world of hardware. Free and open-source hardware (FOSH) provides the “code” for hardware including the bill of materials, schematics, instructions, computer aided designs (CAD), and other information needed to recreate a physical artifact. FOSH has already led to improved product innovation and reduced costs in a wide range of fields and can go far beyond simply sharing data in the medical community. By combining digital manufacturing such as 3-D printing with open-source microcontrollers, hundreds of high-quality low-cost medical and scientific tools have already been developed. Scientists and medical equipment engineers can design, share and build on one another's work to develop better and less costly medical devices. Such latterly scaled replication saves 90-99% of traditional costs. This article summarizes medical research policy to encourage maximizing the return on investment of public funding for medical equipment development by: 1) identifying, funding and disseminating FOSH design of the most costly medical equipment, 2) funding validation studies of this equipment, and 3) enacting purchasing policy preferences for FOSH. Past results indicate that these policies will directly save millions of dollars of public funding for health care, while supporting rapid innovation in medical equipment design.
2020 •
Distributed digital manufacturing offers a solution to medical supply and technology shortages during pandemics. To prepare for the next pandemic, this study reviews the state-of-the-art for open hardware designs needed in a COVID-19-like pandemic. It evaluates the readiness of the top twenty technologies requested by the Government of India. The results show that the majority of the actual medical products have had some open source development, however, only 15% of the supporting technologies that make the open source device possible are freely available. The results show there is still considerable work needed to provide open source paths for the development of all the medical hardware needed during pandemics. Five core areas of future work are discussed that include: i) technical development of a wide-range of open source solutions for all medical supplies and devices, ii) policies that protect the productivity of laboratories, makerspaces and fabrication facilities during a pandemic, as well as iii) streamlining the regulatory process, iv) developing Good-Samaritan laws to protect makers and designers of open medical hardware, as well as to compel those with knowledge that will save lives to share it, and v) requiring all citizen-funded research to be released with free and open source licenses.
The articles in this issue look at how the development and use of free and open source hardware (FOSH or simply “open hardware”) are changing the face of science, engineering, business, and law. Free and open source software (FOSS) has proven very successful and now dominates the development of software on a global scale. It is available in source code (open source) and can be used, studied, copied, modified, and redistributed either without restriction or with restrictions only to ensure that further recipients have the same open source rights. Similarly, FOSH provides the “code” for hardware—including the bill of materials, schematics, instructions, computer-aided designs, and other information needed to recreate a physical artifact. Use of FOSH can improve product innovation in a wide range of fields. In this issue authors from a variety of disciplines and work environments discuss how this open model of innovation will drive the future of engineering. First, Alicia Gibb, founder and executive director of the Open Source Hardware Association (OSHWA) and director of the ATLAS1 Blow Things Up (BTU) Lab at the University of Colorado Boulder, argues that hardware is the next step to open sourcing everything. She touches on intellectual property (IP) issues, cites the benefits of open source hardware, introduces and explains the role of OSHWA, and hints at the future of open hardware. The open source paradigm is already making deep inroads in the hardware space in 3D printing. With the development of the open source RepRap project (a 3D printer that can print itself) the cost of 3D printers has dropped to a point where nearly anyone can afford one for rapid prototyping and small batch manufacturing. Ben Malouf and Harris Kenny of Aleph Objects describe their company’s approach to the use of open hardware in every aspect of their business to create the popular Lulzbot 3D printer. Their primary product is open—and consistently wins one of the top spots in Make: Magazine’s annual 3D printer shootout, ahead of proprietary 3D printers from much larger companies with far greater resources. Lulzbot printers, and those of many other manufacturers, are rapidly increasing in sales as the number of free and open source 3D printable designs erupts on the Web, making distributed manufacturing a reality. In this context, law professor Lucas Osborn at the Campbell University School of Law takes us on a deep dive into how IP law will need to change in this new 3D printing era. After summarizing the basics of IP law and explaining why it was created, he discusses how it could both benefit and hinder 3D printing technology. His arguments will challenge readers independent of their views on patent law. For those with conventional IP leanings, he shows how IP law can hinder innovation. For those born in the Internet age, where sharing is second nature and little thought is given to licenses as long as the code is posted on Github, he offers some important lessons. He ends with a challenge for engineers to make more of an effort in helping form IP law that will benefit innovation. If these lessons on IP and open hardware replication with 3D printers are turned to experimental research in science and engineering, there is an important opportunity to radically reduce the costs of experimental research while improving it. In the next article I argue that by harnessing a scalable open source method, federal funding is spent just once for the development of scientific equipment and then a return on this investment (ROI) is realized by digital replication of scientific devices for only the costs of materials. With numerous examples I show that the ROI climbs into the thousands of percent while accelerating any research that the open paradigm touches. To harness this opportunity, I propose four straightforward and negative-net-cost policies to support FOSH development and improve access to scientific tools in the United States. The policies will directly save millions in research and STEM education expenditures, while providing researchers and students access to better equipment, which will promote advances in technology and concomitant benefits for the American economy. Thinking about the future and the changes needed to support this development in STEM education, AnnMarie Thomas and Deb Besser of the St. Thomas School of Engineering consider how engineers and engineering educators can use maker methods to introduce students to engineering and build their technological literacy. They show that the maker movement is closely tied to open hardware and sharing as well as the traits of successful engineers. Makerspaces and fabrication (fab) labs (what Gibb calls hackerspaces) are physical hubs of the maker culture. Although these trends are clearly important for the United States, this cultural change and open hardware ethos can have dramatic impacts in the developing world. Matthew Rogge, Melissa Menke, and William Hoyle of TechforTrade explain the potential for open source and 3D printing to produce many needed items in low-resource settings, where lack of infrastructure makes local production impractical and high tariffs, unreliable supply chains, and economic instability make importation costly. Saving 90 percent on medical or scientific tools is nice in my lab, for instance, but it literally saves lives in a developing world context. The issue concludes with an op-ed by Tom Callaway, a senior software engineer at Red Hat, Inc., an open source software company with revenue over $2 billion last year (up 15 percent year over year). What makes this business accomplishment so impressive is that all of the company’s software products are available for free. Although old ways of thinking demand that companies secure a monopoly and certainly not give away “intellectual property” for free, Red Hat’s success comes from offering its customers support, collaboration, control, and a high-quality product. Tom argues that the proven open source software mentality is porting to hardware, opening up incredible opportunities for humanity. He concludes, “open source and open innovation work…. They also empower society and make it possible to push the limits of what is possible. When the barriers to collaboration are lifted, people can accomplish incredible things.” As all of the articles show, open source tools in the hands of this and future generations of engineers will be incredible indeed.
There is an opportunity to radically reduce the costs of experimental research while improving it by supporting the development of free and open source hardware (FOSH) for science and engineering. By harnessing a scalable open source method, federal funding is spent just once for the development of scientific equipment and then a return on this investment is realized by direct digital replication of scientific devices for only the costs of materials. FOSH for science and engineering has been growing at a rapid pace and already supports many fields. Scaled peer production and digital replica-tion reduce traditional costs by 90–99 percent, making scientific equipment much more accessible not only for research but also for preparation of the next generation of scientists and engineers as research-grade tools are available for science, technology, engineering, and math (STEM) education. I propose four straightforward and negative-net-cost policies to support FOSH development and improve access to scientific tools in the United States. The policies will directly save millions in research and STEM education expenditures, while providing researchers and students access to better equipment, which will promote advances in technology and concomitant benefits for the US economy. Free and open source hardware can reduce research and education costs, increase access, and enhance scientific and technological progress.
As a growing number of companies reject intellectual property (IP) monopoly-based business models to embrace libre product development of free and open source hardware and software, there is an urgent need to refurbish the instruments of university-corporate research partnerships. These partnerships generally use a proprietary standard research agreement (PSRA), which for historical reasons contains significant IP monopoly language and restrictions for both the company and the university. Such standard research agreements thus create an artificial barrier to innovation as both companies using a libre model and universities they wish to collaborate with must invest significantly to restructure the contracts. To solve this problem, this article provides a new Sponsored Libre Research Agreement (SLRA). The differences between the agreements are detailed. The advantages of using an SLRA are provided for any type of company and include: (1) minimizing research investments on reporting requirements; (2) reducing delays related to confidentiality and publication embargos; and (3) reducing both transaction and legal costs as well as research time losses associated with IP. Moving to libre agreements both speeds up and reduces costs for setting up collaborative research. Under the SLRA, university researchers can spend more time innovating for the same investment.
With the maturation of digital manufacturing technologies like 3-D printing, a new paradigm is emerging of distributed manufacturing in both scientific equipment and consumer goods. Hardware released under free licenses is known as free and open source hardware (FOSH). The availability of these FOSH designs has a large value to those with access to digital manufacturing methods and particularly for scientists with needs for highly-customized low-volume production products. It is challenging to use traditional funding models to support the necessary investment of resources in FOSH development because of the difficulty in quantifying the value of the result. In order to overcome that challenge and harvest the current opportunity in both low-cost scientific equipment and consumer products, this article evaluates the following methods to quantify the value of FOSH design including: 1) downloaded substitution valuation; 2) avoided reproduction valuation and 3) market savings valuation along with additional benefits related to market expansion, scientific innovation acceleration, educational enhancement and medical care improvement. The strengths and weaknesses of these methods are analyzed and the results show that the methods are relatively straight-forward to institute, based on reliable freely-available data, and that they minimize assumptions. A case study of a syringe pump with numerous scientific and medical applications is presented. The results found millions of dollars of economic value from a relatively simple scientific device being released under open-licenses representing orders of magnitude increase in value from conventional proprietary development. The inescapable conclusion of this study is that FOSH development should be funded by organizations interested in maximizing return on public investments particularly in technologies associated with science, medicine and education.
The availability of free and open source hardware designs that can be replicated with low-cost 3-D printers provide large values to scientists that need highly-customized low-volume production scientific equipment. Digital manufacturing technologies have only recently become widespread and the return on investment (ROI) was not clear, so funding for open hardware development was historically sparse. This paper clarifies a method for determining an ROI for FOSH scientific hardware development. By using open source hardware design that can be manufactured digitally the relatively minor development costs result in enormous ROIs for the scientific community. A case study is presented of an syringe pump released under open-licenses, which results in ROIs for funders ranging from 100s to 1,000s of percent after only a few months. It is clear that policies encouraging free and open source scientific hardware development should be made by organizations interested in maximizing return on public investments for science.
Distributed digital manufacturing of free and open-source scientific hardware (FOSH) used for scientific experiments has been shown to in general reduce the costs of scientific hardware by 90–99%. In part due to these cost savings, the manufacturing of scientific equipment is beginning to move away from a central paradigm of purchasing proprietary equipment to one in which scientists themselves download open-source designs, fabricate components with digital manufacturing technology, and then assemble the equipment themselves. This trend introduces a need for new formal design procedures that designers can follow when targeting this scientific audience. This study provides five steps in the procedure, encompassing six design principles for the development of free and open-source hardware for scientific applications. A case study is provided for an open-source slide dryer that can be easily fabricated for under $20, which is more than 300 times less than some commercial alternatives. The bespoke design is parametric and easily adjusted for many applications. By designing using open-source principles and the proposed procedures, the outcome will be customizable, under control of the researcher, less expensive than commercial options, more maintainable, and will have many applications that benefit the user since the design documentation is open and freely accessible.
Ph.D. scientists and engineers are highly qualified personnel (HQP) that improve U.S. economic efficiency and generate new products including weapons of interest to the intelligence community. HQP represent a small fraction of the population, which make them favorable targets to compromise. This study analyzes how to defend against a novel approach of covert infiltration that uses administrative techniques to neutralize HQP without recruiting them directly. The approach follows five hierarchical strategies to replace the innovation cycle with administrative time expenditures. This approach is critically analyzed to further national security goals by providing intelligence service guidelines for defensive measures needed against this new weapon.
This Article provocatively asserts that lawmakers should weaken patents significantly—by between 25% and 50%. The primary impetus for this conclusion is the underappreciated effects of new and emerging technologies, including three-dimensional printing, synthetic biology, and cloud computing. These and other technologies are rapidly decreasing the costs of each stage of the innovation cycle: from basic research, through inventing and prototyping, to marketing and distribution. The primary economic theories supporting patent law hold that inventors and innovators need patents to recoup the costs associated with research, inventing, and commercializing. Because new technologies have begun—and will continue—to dramatically decrease these costs, the case for weakening patents is ripe for analysis.
Nitrate, the most oxidized form of nitrogen, is regulated to protect people and animals from harmful levels as there is a large over abundance due to anthropogenic factors. Widespread field testing for nitrate could begin to address the nitrate pollution problem, however, the Cadmium Reduction Method, the leading certified method to detect and quantify nitrate, demands the use of a toxic heavy metal. An alternative, the recently proposed Environmental Protection Agency Nitrate Reductase Nitrate-Nitrogen Analysis Method, eliminates this problem but requires an expensive proprietary spectrophotometer. The development of an inexpensive portable, handheld photometer will greatly expedite field nitrate analysis to combat pollution. To accomplish this goal, a methodology for the design, development, and technical validation of an improved open-source water testing platform capable of performing Nitrate Reductase Nitrate-Nitrogen Analysis Method. This approach is evaluated for its potential to i) eliminate the need for toxic chemicals in water testing for nitrate and nitrite, ii) reduce the cost of equipment to perform this method for measurement for water quality, and iii) make the method easier to carryout in the field. The device is able to perform as well as commercial proprietary systems for less than 15% of the cost for materials. This allows for greater access to the technology and the new, safer nitrate testing technique.

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