Can the SBIR and STTR programs advance research goals?

With diminishing grant support for traditional funding in immunology, can the small-business program leverage a research program? The small-business grants programs offered by the US National Institutes of Health and other organizations support high-risk, early-stage technology commercialization at small businesses.

Media, Advertising and Inventing (Anna)rexia.

Too many Australians suffer from poor body image and eating disorders. The Israeli, French and Norwegian Governments have created body image legislation to try to address this: it responds to concerns that the countless images of thin women people see can contribute to poor body image. By contrast, Australia does not have a Body Image Law: it has a voluntary code that the advertising industry generally does not follow. This article argues that Australia should enact a Body Image Law that reflects health evidence that body image needs to be improved. The Body Image Law would require disclaimers on images that were not retouched, create a specialised government body to evaluate images and attract civil penalties for breaching it. The authors believe that this is the first Australian article to suggest an Australian Body Image Law of this kind.

Models of Governance for Innovation in Medicine and Health Research.

Personalised medicine, digital innovations, and neuro-technologies all offer significant potential benefit for human health and welfare, but also raise complex governance challenges. A variety of approaches have been adopted in the governance of innovative medicines and health technologies, including risk assessment, ethics and self-governance. Recently anticipatory or 'upstream' modes of governance have garnered favour. Anticipatory regulation demands a closer relationship between regulators and innovators, to shape the trajectories of the technology. In the EU context, responsible research and innovation has emerged as a key mechanism of governance. This is linked but distinct from a human rights governance which has the advantage of exerting both legal and moral force. What is needed in the healthcare context are governance models which ensure human rights considerations are taken into account from the earliest stages of innovation, to maximise the likelihood that developments are from the outset beneficial and oriented towards protecting ethical values.

USA Vs Europe: Who Is Leading the Diabetes Tech Race?

PURPOSE OF REVIEW: To highlight global advancements in diabetes technology and compare available technologies and device approval processes in the USA and Europe and their impact on safety and innovation. RECENT FINDINGS: The last two decades have seen a rapid growth in diabetes technology driven by the impetus to improve glycemic control, avoid complications of insulin therapy, improve quality of life, and hand more autonomy to individuals with diabetes. Meanwhile, changes to regulatory processes in the USA and Europe aim to facilitate entry of new devices into the marketplace. Major strides have been made in digitization of insulin pens, continuous glucose monitors and their integration with insulin pumps, automated insulin delivery systems, and closed-loop insulin pump systems. The centralized regulatory body in the USA and more decentralized approval bodies in Europe have led to differences in the rate of market availability of diabetes devices. While both US and Europe systems have different advantages and disadvantages in device approval, they continue to struggle with balancing accelerated device access with adequate clinical evidence and monitoring to ensure safety of such devices.

The changing regulatory landscape for biomedical implants and its relationship to withdrawal of some vaginal mesh products.

PURPOSE OF REVIEW: Advancements in biomedical engineering and advanced therapies including tissue engineering products necessitate revisions to the regulation and governance of their production and use to ensure patient safety. In this review, the current regulations and recent improvements on the governance of biomedical devices are reviewed. RECENT FINDINGS: Current regulations on approval of biomedical devices failed to address some important aspects related to the definition of biocompatibility of medical implants. The main issue was that the failure to establish design requirements for a specific application - in this case, the pelvic floor. Another issue was the lack of knowledge on disease mechanisms leading to an inability to define clear targets for surgical treatment. A clear example of this is the recent vaginal mesh scandal. SUMMARY: Surgical innovations are inherently challenging. It is no surprise that the regulatory landscape lags behind advancements in biomedical technologies. Very recent modifications to the available regulations particularly in Europe aim to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures patient safety while supporting innovation.

Invention in Dermatology: A Review

Dermatologists are among the most inventive physicians, trained in the multiple disciplines of medical dermatology, surgical dermatology, and dermatopathology. Many of the advances in dermatology practice have been derived from inventive colleagues who identify opportunities for improvement in practice, develop viable prototypes to address these practice opportunities, and persevere through the hard work of developing new technologies to advance the practice of dermatology. In this article, we will review the basic elements of invention, patents, and the range of outcomes associated with the pursuit of invention. Examples of innovative dermatologic technologies and approaches will be reviewed. Opportunities abound for dermatologists to contribute to the advancement of medical care through invention in our specialty. J Drugs Dermatol. 2019;18(9):904-908.

How Do Policymakers Regulate AI and Accommodate Innovation in Research and Medicine?

In this Medical News article, JAMA Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, and Alondra Nelson, PhD, the Harold F. Linder Professor at the Institute for Advanced Study, discuss effective AI regulation frameworks to accommodate innovation.

Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent.

Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution's hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

The American Democratic Deficit in Assisted Reproductive Technology Innovation.

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely those who work within the U.S. Food and Drug Administration, the public is unable to participate in the decision-making process. This lack of a public discourse undermines the goals of the administrative state, which include democratic participation, transparency, and accountability. The United Kingdom, on the other hand, has had a markedly divergent experience with assisted reproductive technology innovation. Instead of ignoring the various ethical, social, and legal issues surrounding assisted reproductive technology innovation, the United Kingdom engaged in a five-strand public consultation on the topic of mitochondrial transfer, a form of assisted reproductive technology that uses genetic modification in order to prevent disease transmission. This article argues that after a multi-decade standstill in terms of the public discourse related to ethical issues associated with assisted reproductive technology and germline modification, it is time for the United States to institute a more democratic inquiry into the scientific, ethical, and social implications of new forms of assisted reproductive technology and ultimately, forthcoming medical innovations that involve genetic modification.

Introducing new technology safely into urological practice.

PURPOSE: Surgical innovation is necessary to ensure continued improvement in patient care. However, several challenges unique to the surgical craft are encountered during the development and validation of such new technology. This article highlights some of these challenges and gives an overview of existing solutions. METHODS: A Pubmed review was performed about the "introduction of new technology" to identify challenges. Cross-referencing was used to explore the possible solutions per challenge. RESULTS: Several characteristics of the surgical craft itself limit our ability to establish randomised controlled trials and hence provide clear categorical evidence. Existing certification bodies for new technology often use unstructured regulations and allow fast-track bypassing systems. Consequently the IDEAL framework (innovation, development, exploration, assessment, long-term follow-up) proposes an objective scientific approach whilst defining stakeholder responsibilities. The selection of which new modality to implement is heavily influenced by third parties unrelated to the best patient outcomes and thus professional organisations can aid in this decision-making. Appropriate training of surgeons and their teams until proficiency is achieved is essential prior to credentialling. Finally long-term surveillance of outcomes in the form of registries is an increasing responsibility of the urological community to maintain our role in directing the adoption or rejection of these innovations. CONCLUSION: Urological innovation is a dynamic and challenging process. Increasing efforts are identified within the urological community to render the process more reliable and transparent.

Everything in moderation, even hype: learning from vaccine controversies to strike a balance with CRISPR.

The ease and applicability of CRISPR/Cas9--a new and precise gene editing and reproductive technology--have garnered hype and heightened concern about its potential 'unprecedented and horrific consequences' and have led many scientific leaders to call for a moratorium on its research and use. CRISPR appears distinctly more controversial than previous technological innovations (genetic or otherwise), with a greater reach and speed of human treatment and enhancement; however, we have seen similarly inflated hopes and fears in response to other medical innovations for well over a century. One intervention that has both historically and recently incited alarm--vaccines--serves as a pertinent example of what could go wrong if a technology's reach is shortened due to inflated fears. By comparing the vaccine controversy and the CRISPR debate, we can help separate the hype from the realistic potential of these technologies. How our society grapples with such innovations will determine the extent to which their impact on our individual and collective health will be beneficial. We must recognise the need for a tempered approach to CRISPR conversation leading to regulation and ethical application. Although CRISPR's reach will continue expanding with ongoing research, thus requiring continuous evaluation, the lessons we have learned from the vaccine controversy demonstrate that our approach must not be to shut down regulation and application now, but to thoughtfully conjoin productive debate and action so that therapeutic gene editing can alleviate suffering as soon as possible without precipitating social outcomes we would belatedly deplore.

Holding the Project Accountable: Research Governance, Ethics, and Democracy.

This paper seeks to address research governance by highlighting the notion of public accountability as a complementary tool for the establishment of an ethical resonance space for emerging technologies. Public accountability can render development and design process of emerging technologies transparent through practices of holding those in charge of research accountable for their actions, thereby fostering ethical engagement with their potential negative consequences or side-effects. Through practices such as parliamentary questions, audits, and open letters emerging technologies could be effectively rendered transparent and opened up to broader levels of scrutiny and debate, thereby contributing to a greater adherence of emerging technologies to ethics and moral consensus. Fundamental democratic practices could thus not only lead to better informed choices in design and development processes, but also contribute to more morally substantive outcomes.