Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices, as well as innovation in software-driven devices, may introduce new safety concerns – all the more so when such devices are used in patients’ homes, well outside of traditional health care delivery settings. We review four key mechanisms for the post-market surveillance of medical devices in the United States: (1) Post-market trials and registries; (2) manufacturing plant inspections; (3) adverse event reporting; and (4) recalls. We use comprehensive regulatory data documenting adverse events and recalls to describe trends in the post-market safety of medical devices, based on the presence or absence of software. Overall, devices with software are associated with more reported adverse events (i.e. individual injuries and deaths) and more high-severity recalls, compared to devices without software. However, in subgroup analyses of individual medical specialties, we consistently observe differences in recall probability but do not consistently detect differences in adverse events. These results suggest that adverse events are a noisy signal of post-market safety and not necessarily a reliable predictor of subsequent recalls. As patients and health care providers weigh the benefits of new remote monitoring technologies against potential safety issues, they should not assume that safety concerns will be readily identifiable through existing post-market surveillance mechanisms. Both health care providers and developers of remote patient monitoring technologies should therefore consider how they might proactively ensure that newly introduced remote patient monitoring technologies work safely and as intended.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

How do you read a patent and what subject matter is patentable? What is the purpose of a patent? Who is an inventor on the patent if work is done by many people on the project? What is the process of obtaining a patent in my country and globally? Read this chapter to see how you could lose commercialization rights to your own invention. When exactly does an invention or idea become patentable? Once you own a patent, how can you make money from it? What is the process of licensing and the key terms that should be negotiated in such a license agreement? What is the use of a copyright or a trade secret in biotech? What exactly constitutes patent infringement ? These questions and many others are addressed in this chapter on intellectual property.

The vast world of biotechnology applications to human health is reviewed and the terminology used in the rest of the book is defined here. An overview of the industry, the value chains, the specific types of human health products covered in this text are presented in this chapter. A time-tested way to analyze an industry’s attractiveness for new entrants is presented here using Porter’s five forces model. Technology trends such as mobile health, artificial intelligence, 3D printing, cell and gene therapy, and robotics are presented to the reader in the context of the mission of improving human health. The overall process of development of new products in these various segments of drugs, devices and diagnostics sectors is reviewed here. The reader will leave this chapter with a 30,000-foot view of the industry dynamics and understand the context within which product commercialization is to be done.

Within the operating theatre, perioperative practitioners will use a variety of different pieces of equipment to help them carry out their role and care for patients undergoing anaesthesia and surgery. Whether it is checking an anaesthetic machine, handling surgical instruments, or setting up an analgesic pump in the post-anaesthetic care unit, the management of medical equipment requires more understanding than just simply using it. This chapter explores the procurement, use, and maintenance of medical equipment.

This chapter focus on a description of pathways undertaken to transfer the UNCD film technology from the laboratory into the market, through Original Biomedical Implants (OBI-USA) and OBI-México, founded by O. Auciello and colleagues. Topics discussed in this chapter include: 1) Summary of regulatory pathways in different regions of the worldfor approval of medical devices and prostheses; 2) description of pathway to bring to the market a UNCD-coated microchip (artificial retina) implantable inside the eye to restore partial vision to blind people), 2) description of the process to bring to the market a new generation of long life superior performance UNCD-coated prostheses (artificial hips, knees, dental implants, and more); 3) description of pathway to bring into the market a novel retina reattachment process using combined UNCD-coated magnet outside the eye and injection of super-paramagnetic nanoparticles inside the eye, pushing the retina backon to the inner eye’ layer, when attracted by the magnetic field created by the external magnet.

This concluding chapter takes stock of the ways in which the bioinformation governance landscape would look different if it were to embrace the picture of narrative identity impacts, interests, and responsibilities characterised and defended in this book. It proposes that information subjects’ identity-related interests in whether and how they encounter information about their bodies, biology, and health should be firmly installed amongst and routinely weighed alongside the other ethical concerns – such as protecting health, privacy, confidentiality, and autonomy. This does not mean that identity interests should invariably prevail over other ethical, practical, or legal considerations but that they should be afforded weight commensurate with the centrality of an inhabitable, embodied self-narrative to a full, flourishing, and practically engaged life. Mindful of what has been said about the ways in which identity impacts vary between information types and individual circumstances and thus the need for responsive rather than rigid disclosure policies and practices, this chapter proposes priorities for reform in five contexts in which ethical and legal debates about information access are currently pressing. These contexts are donor conception, including mitochondrial donation; return of individual research findings to participants; navigating confidentiality and consent in healthcare; direct-to-consumer genomics; and personal health-tracking devices.

Over the last decade, the number of connected-to-network medical devices has grown significantly, which is leading to their increased exposure to cyber incidents and attacks. Medical devices’ cybersecurity is of utmost relevance all over the world. The EU legal framework here is heavily characterized by fragmentation and a lack of regulatory guidance. Moreover, legal literature on the topic is scarce, mainly because the regulation of cybersecurity and medical devices is a relatively novel subject. This chapter analyzes the applicable legal framework for cybersecurity of medical devices in the EU and pinpoints the main ethical concerns as well as the relevant regulatory challenges. The chapter introduces the key ethical concerns (i.e., harm to users’ privacy, confidentiality and integrity risks, misuse of personal and health data) and critically assesses the EU legislation regarding medical devices’ cybersecurity (such as the new EU medical devices Regulation, GDPR, NIS Directive, the Cybersecurity Act) respectively applicable to different stakeholders having different obligations. Recommendations on possible ways the stakeholders may approach medical devices’ cybersecurity are drafted with the special attention given to pre/postmarket obligations for manufacturers, the notion of data controllership, requirements applicable to operators of essential services, and the certification schemes relevant for the sector.

The FDA has put guidance in place detailing how it will use RWE while regulating medical devices and published a framework to explain its use of RWE in regulating drugs. Inside the agency, influential officials resist the use of RWE in regulatory decision-making while championing the importance of randomized controlled trials. Outside, a growing body of literature highlights the challenges involved in securing high-quality evidence postapproval. Growing safety concerns about several medical devices — discovered only after real world use — has renewed calls for more rigorous pre and postmarket evaluation

Attempts to modernize and speed up the FDA’s premarketing clearance and classification process for medical devices have included both new device classifications and ways of filing abbreviated applications. The FDA’s “De Novo” classification and Breakthrough Devices program allow applicants to create entirely new medical device types, with special controls and technological characteristics, including specifications on hardware and software. To encourage innovation and competition, the 21st Century Cures Act allows De Novo devices to serve as “predicates” for subsequent follow-on medical devices through the 510(k) application process, if such follow-on devices use the same controls and possess “the same” technological characteristics as the “predicate” device. This lends itself to a potentially anticompetitive strategy mediated by the interaction between IP and the 510(k) application requirements: successful De Novo applicants could use their portfolios to prevent follow-on applicants from making use of similar characteristics – potentially stymying an entire class of follow-on devices in the process. This strategy could threaten a greater diversity of new devices; may encourage an “up” classification of devices; and incentivizes technical characteristics and special controls of De Novo devices where general ones may suffice. This chapter concludes by proposing future evidence-based research in the area.

We incorporate the perspectives of research participants in a clinical trial of DBS for TBI about investigator and sponsor responsibilities with respect to posttrial access to a functioning embedded medical device. We argue that investigators owe a duty of transparency about posttrial access to device maintenance, upgrades, or removal as part of an ongoing informed consent process.