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Since hydrogel therapies have been introduced into clinic treatment procedures, the biomedical industry has to face the technology transfer and the scale-up of the processes. This will be key in the roadmap of the new technology implementation. Transfer technology and scale-up are already known for some applications but other applications, such as 3D printing, are still challenging. Decellularized tissues offer a lot of advantages when compared to other natural gels, for example they display enhanced biological properties, due to their ability to preserve natural molecules. For this reason, even though their use as a source for bioinks represents a challenge for the scale-up process, it is very important to consider the advantages that originate with overcoming this challenge. Therefore, many aspects that influence the scaling of the industrial process should be considered, like the addition of drugs or cells to the hydrogel, also, the gelling process is important to determine the chemical and physical parameters that must be controlled in order to guarantee a successful process. Legal aspects are also crucial when carrying out the scale-up of the process since they determine the industrial implementation success from the regulatory point of view. In this context, the new law Regulation (EU) 2017/745 on biomedical devices will be considered. This review summarizes the different aspects, including the legal ones, that should be considered when scaling up hydrogels of natural origin, in order to balance these different aspects and to optimize the costs in terms of raw materials and engine.

Wearable medical devices (WMDs) will advance point-of-care diagnostics and therapeutics. This article analyses the market and patents for wearable devices. Activity monitors have the largest market share, and the intellectual property landscape is dominated by electronics corporations. However, the majority of these patents have not been realized in commercial products.

Knee replacement surgery is one of the most commonly done and cost-effective musculoskeletal surgical procedures. The numbers of cases done continue to grow worldwide, with substantial variation in utilisation rates across regions and countries. The main indication for surgery remains painful knee osteoarthritis with reduced function and quality of life. The threshold for intervention is not well defined, and is influenced by many factors including patient and surgeon preference. Most patients have a very good clinical outcome after knee replacement, but multiple studies have reported that 20% or more of patients do not. So despite excellent long-term survivorship, more work is required to enhance this procedure and development is rightly focused on increasing the proportion of patients who have successful pain relief after surgery. Changing implant design has historically been a target for improving outcome, but there is greater recognition that improvements can be achieved by better implantation methods, avoiding complications, and improving perioperative care for patients, such as enhanced recovery programmes. New technologies are likely to advance future knee replacement care further, but their introduction must be regulated and monitored with greater rigour to ensure patient safety.

Elizabeth Holmes, the company's founder and former CEO, once the world's youngest self-made female billionaire, was last week found guilty of four of 11 charges of fraud related to her actions at the now defunct blood testing company. Conscientious scientists at Theranos who voiced concerns—and there were several—were marginalised, fired, and made to sign non-disclosure agreements under the threat of litigation, supposedly in the name of protecting trade secrets. For the Lancet Commission on diagnostics: transforming access to diagnostics see https://www.thelancet.com/commissions/diagnostics For more on automated assays see Articles Lancet Infect Dis 2021; published online Oct 7. https://doi.org/10.1016/S1473-3099(21)00452-7 For more on metabolomics see Clin Cancer Res 2022; published online Jan 4. https://doi.org/10.1158/1078-0432.CCR-21-2855 For more on investment in health care technology see https://www.economist.com/business/how-health-care-is-turning-into-a-consumer-product/21807114 Kimberly White/Getty Images

Digital health technologies have the potential to help address some of the challenges in the clinical development of drugs for central nervous system disorders. This article discusses strategies for the development of such tools in the context of the European regulatory environment.Digital health technologies have the potential to help address some of the challenges in the clinical development of drugs for central nervous system disorders. This article discusses strategies for the development of such tools in the context of the European regulatory environment.

Soon after, the Centers for Medicare & Medicaid Services found that the Theranos laboratory violated federal rules, and the US Food and Drug Administration reclassified the nanotainers—devices that store the droplets of blood—as higher-risk medical devices subject to additional safety requirements. In 2017, Theranos agreed to pay more than 76 000 Arizona customers $4·6 million to settle claims by the Arizona Attorney General that the company's “advertisements misrepresented the method, accuracy, and reliability of its blood testing and that the company was out of compliance with federal regulations contained in the Clinical Laboratory Improvement Amendments of 1988”. In September, 2021, a three-judge panel of the US Court Of Appeals for the Ninth Circuit allowed a class action lawsuit to proceed against Holmes, Balwani, and Walgreens filed by patients in California and Arizona who received Theranos blood tests. [...]with interest rates so low, the only real way to make

Background Home-based health technologies for paediatric palliative care have great potential to improve care for children, caregivers, healthcare professionals, and health systems. However, no systematic reviews have directly addressed the intersections among the ethical, legal, and social aspects of these technologies for paediatric palliative care. The objective of this systematic review was to identify and analyse the ethical, legal, and social aspects of health technologies for home-based paediatric palliative care. Methods We have conducted a systematic review, inspired by the framework suggested by McCullough. We registered the review protocol in PROSPERO (CRD42024496034) and conducted a systematic search in six databases (ASSIA, Cinahl, Embase, Medline, PsycInfo, and Web of Science) on 27 November 2023 to identify relevant studies. Pairs of authors independently assessed the eligibility of the studies and extracted data. The eligible studies employed a range of different methods from randomised controlled trials to usability studies. We then synthesised the data according to the ethical, legal and social aspects of the technologies. Results Overall, our search resulted in 9,545 reports, which were screened after deduplication. The quality of the reports was assessed according to being published in peer reviewed journals. Fifteen reports were included, which showed that the main ethical issues are harm reduction, improved services, agency and autonomy, trust and empowerment. The main legal aspects are privacy equal access to care, participation in decisions and standardisation. The main social issues are cost reduction, transformation of family relations and novel modes of communication. Health technologies have the potential to alleviate burdens and improve the quality of care for children in paediatric palliative care and their families, but they also create novel burdens through constant reporting requirements and the vulnerability of some health technologies to technological malfunction. Nevertheless, they can increase family inclusion and children’s autonomy and participation, thus empowering children, particularly through co-development of solutions. Furthermore, studies have indicated that health technologies themselves may have positive effects on children’s health. The legal aspects of health technologies pertain to privacy and control over one’s health information and equitable access to care and participation in care, while social issues can potentially reduce costs for health systems but also involve novel costs. Conclusion The reviewed studies concerning the co-development of health technologies reported increased benefits in terms of health, agency, well-being, and strengthened children’s rights in home-based paediatric palliative care. However, the social dimensions of such technologies can lead to both public savings and reconfiguration of family constellations. We recommend that future researchers consider privacy, the formal dimensions of apps and smartphones, and their impacts on families. PROSPERO reference CRD42024496034.

Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and outcomes. As the regulatory contours of these technologies are being defined, there is a notable lack of literature on the key stakeholders such as the organizations and interest groups that have a significant input in shaping the regulatory framework. This article explores the perspectives and contributions of these stakeholders in shaping the regulatory paradigm of AI-enabled medical technologies. The formation of an AI regulatory framework requires the convergence of ethical, regulatory, technical, societal, and practical considerations. These multiple perspectives contribute to the various dimensions of an evolving regulatory paradigm. From the global governance guidelines set by the World Health Organization (WHO) to national regulations, the article sheds light not just on these multiple perspectives but also on their interconnectedness in shaping the regulatory landscape of AI.