Engineering the Brain: Ethical Issues and the Introduction of Neural Devices.

Neural devices now under development stand to interact with and alter the human brain in ways that may challenge standard notions of identity, normality, authority, responsibility, privacy and justice.

Education and training in regulatory science for medical device development.

Regulatory science can be defined as the science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information. In addition to engineering researches that create novel medical devices, scientific methods for evaluating efficacy, safety and quality of medical devices are necessary to enable rational and scientific evaluation of the device in device approval process. Engineers and medical doctors involving research and development of novel medical devices are required to have basic knowledge on medical device safety standard, medical device regulation, and relevant methodologies. In Japan, several graduate schools in Japan have started educational programs on regulatory sciences in collaboration of Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2012, program for researches for development of evaluation guidelines for novel medical device products started where personnel exchanges between academic researches institutes and PMDA. Example of these programs will be introduced in the presentation and its impact on improvement of medical device research and development process will be discussed.

Realities of biomedical product liability suits and the role of junk science: from breast implants to TASER weapons.

In the summer of 2006, manufacturers of a simple respirator mask costing US$1 told the U.S. Congress that Americans would find a shortage of these masks if there was another flu pandemic. The reason for this was that suing the makers of these dust masks became a major business for trial lawyers. By 2006, there had been more than 326,000 lawsuits filed. It has been reported in many cases that the law firms worked with cooperative physicians and contracted with X-ray labs to screen individuals for lung problems. If an individual had an abnormal lung X-ray and claimed that they had used a certain brand of respirator and the manufacturer was still in business and had economic resourcesa lawsuit was filed. Some manufacturers went out of business while others simply stopped making the masks.

Engineering therapies in the CNS: what works and what can be translated.

Engineering is the art of taking what we know and using it to solve problems. As engineers, we build tool chests of approaches; we attempt to learn as much as possible about the problem at hand, and then we design, build, and test our approaches to see how they impact the system. The challenge of applying this approach to the central nervous system (CNS) is that we often do not know the details of what is needed from the biological side. New therapeutic options for treating the CNS range from new biomaterials to make scaffolds, to novel drug-delivery techniques, to functional electrical stimulation. However, the reality is that translating these new therapies and making them widely available to patients requires collaborations between scientists, engineers, clinicians, and patients to have the greatest chance of success. Here we discuss a variety of new treatment strategies and explore the pragmatic challenges involved with engineering therapies in the CNS.

Liability issues with assistive technology projects [senior design].

There are many people with disabilities whose needs are not met by existing medical products and whose problems are not being addressed by medical device companies. They often need a custom device to address their specific set of disabilities. Capstone biomedical engineering design teams are well qualified to develop devices that meet the needs of individual clients with disabilities.

Perspectives in patent law: overview, careers, and controversies.

This paper is directed to scientists and engineers who wish to learn more about careers in patent law. It presents an overview of the patent process along with a description of the various roles of individuals and institutions involved. Finally, the paper briefly discusses a few of the more controversial issues in the patent law field today.

Biomedical engineering and society: policy and ethics.

Biomedical engineering impacts health care and contributes to fundamental knowledge in medicine and biology. Policy, such as through regulation and research funding, has the potential to dramatically affect biomedical engineering research and commercialization. New developments, in turn, may affect society in new ways. The intersection of biomedical engineering and society and related policy issues must be discussed between scientists and engineers, policy-makers and the public. As a student, there are many ways to become engaged in the issues surrounding science and technology policy. At the University of Washington in Seattle, the Forum on Science Ethics and Policy (FOSEP, www.fosep.org) was started by graduate students and post-doctoral fellows interested in improving the dialogue between scientists, policymakers and the public and has received support from upper-level administration. This is just one example of how students can start thinking about science policy and ethics early in their careers.

[On meeting sanitary legal requirements in technical regulation of medical equipment safety].

The article covered observance of sanitary legal requirements in special technical regulations "On requirements to medical equipment and medical products safety". The authors discussed problems of applied terminology, classification of medical products, occupational risk, control over observance of safety requirements on all stages of medical products circulation--design, production, usage.

Biomedical engineers and participation in judicial executions: capital punishment as a technical problem.

This paper discusses the topic of judicial execution from the perspective of the intersection of the technological issues and the professional ethics issues. Although physicians are generally ethically forbidden from any involvement in the judicial execution process, this does not appear to be the case for engineering professionals. This creates an interesting but controversial opportunity for the engineering community (especially biomedical engineers) to improve the humaneness and reliability of the judicial execution process.