Synthetic biology is described as a new field of biotechnology that models itself on engineering sciences. However, this view of synthetic biology as an engineering field has received criticism, and both biologists and philosophers have argued for a more nuanced and heterogeneous understanding of the field. This paper elaborates the heterogeneity of synthetic biology by clarifying the role of design and the variability of design methodologies in synthetic biology. I focus on two prominent design methodologies: rational design and directed evolution. Rational design resembles the design methodology of traditional engineering sciences. However, it is often replaced and complemented by the more biologically-inspired method of directed evolution, which models itself on natural evolution. These two approaches take philosophically different stances to the design of biological systems. Rational design aims to make biological systems more machine-like, whereas directed evolution utilizes variation and emergent features of living systems. I provide an analysis of the methodological basis of these design approaches, and highlight important methodological differences between them. By analyzing the respective benefits and limitations of these approaches, I argue against the engineering-dominated conception of synthetic biology and its "methodological monism", where the rational design approach is taken as the default design methodology. Alternative design methodologies, like directed evolution, should be considered as complementary, not competitive, to rational design.
Background: Mechanical ventilation is an essential therapy to support critically ill respiratory failure patients. Current standards of care consist of generalised approaches, such as the use of positive end expiratory pressure to inspired oxygen fraction (PEEP-FiO2) tables, which fail to account for the inter- and intra-patient variability between and within patients. The benefits of higher or lower tidal volume, PEEP, and other settings are highly debated and no consensus has been reached. Moreover, clinicians implicitly account for patient-specific factors such as disease condition and progression as they manually titrate ventilator settings. Hence, care is highly variable and potentially often non-optimal. These conditions create a situation that could benefit greatly from an engineered approach. The overall goal is a review of ventilation that is accessible to both clinicians and engineers, to bridge the divide between the two fields and enable collaboration to improve patient care and outcomes. This review does not take the form of a typical systematic review. Instead, it defines the standard terminology and introduces key clinical and biomedical measurements before introducing the key clinical studies and their influence in clinical practice which in turn flows into the needs and requirements around how biomedical engineering research can play a role in improving care. Given the significant clinical research to date and its impact on this complex area of care, this review thus provides a tutorial introduction around the review of the state of the art relevant to a biomedical engineering perspective. Discussion: This review presents the significant clinical aspects and variables of ventilation management, the potential risks associated with suboptimal ventilation management, and a review of the major recent attempts to improve ventilation in the context of these variables. The unique aspect of this review is a focus on these key elements relevant to engineering new approaches. In particular, the need for ventilation strategies which consider, and directly account for, the significant differences in patient condition, disease etiology, and progression within patients is demonstrated with the subsequent requirement for optimal ventilation strategies to titrate for patient- and time-specific conditions. Conclusion: Engineered, protective lung strategies that can directly account for and manage inter- and intra-patient variability thus offer great potential to improve both individual care, as well as cohort clinical outcomes.
Equipment Design, Equipment Safety, Equipment and Supplies, Humans, Biomedical Engineering, Computer Security, Medical Device Legislation, and Software
We propose a reference architecture aimed at supporting the safety and security of medical devices. The ISOSCELES (Intrinsically Secure, Open, and Safe Cyber-Physically Enabled, Life-Critical Essential Services) architecture is justified by a collection of design principles that leverage recent advances in software component isolation based on hypervisor and other separation technologies. The instantiation of the architecture for particular medical devices is supported by a development process based on Architecture Analysis and Design Language. The architecture models support safety and security analysis as part of a broader risk management framework. The models also can be used to derive skeletons of the device software and to configure the platform's separation policies and an extensive set of services. We are developing prototypes of the architecture and example medical device instantiations on low-cost boards that can be used in product solutions. The prototype and supporting development and assurance artifacts are being released under an open-source license.
Journal Of Medical Engineering & Technology [J Med Eng Technol] 2018 Aug; Vol. 42 (6), pp. 435-442. Date of Electronic Publication: 2019 Jan 21.
Attitude, Endoscopy, Humans, Perception, Surveys and Questionnaires, Biomedical Engineering, Gastroenterologists psychology, Interdisciplinary Communication, and Interdisciplinary Research
The role of technology in healthcare is rapidly evolving. However, it can be argued that gastroenterology has not kept pace with other medical fields due to the multifaceted needs of this speciality and other issues. Innovation in healthcare technology increasingly requires interdisciplinary collaboration between engineers and clinicians. Nevertheless, working in such an interdisciplinary environment can be challenging due to factors such as working culture, communication and difference in priorities. We surveyed the views of clinicians specialising in gastroenterology and engineers on interdisciplinary health research. The 21 respondents expressed a range of opinions on the perceived benefits and challenges of interdisciplinary collaboration. Though engineers and clinicians recognised its advantages, they expressed a need for further improvement. However, engineers and clinicians differed in how best this could be achieved. The results of this survey are discussed with reference to the literature on interdisciplinary collaboration.
Humans, Problem Solving, Smartphone, Students, Universities, Wisconsin, Biomedical Engineering organization administration, Biomedical Engineering trends, and Equipment Design trends
In the 1950s and 1960s, there was a popular television show called To Tell the Truth, on which three contestants claimed to be a person with an unusual occupation or distinction. Two of them were impostors, and the other was telling the truth. Four panelists asked the contestants questions to determine who was being truthful. After each panelist chose the contestant he or she thought was telling the truth, the host would ask "Will the real _____ please stand up?" To create drama, each contestant would rise at different times and then sit, leaving the contestant with the unusual occupation or distinction standing.
The emergence of antimicrobial resistance threatens current clinical practice across a range of infection types. Delafloxacin, a non-zwitterionic fluoroquinolone recently approved by the US FDA for the treatment of acute bacterial skin and skin structure infections, has been developed to address some of these challenges. Uniquely delafloxacin has increased intracellular penetration and enhanced antibacterial activity under acidic conditions, an environment seen in many infection sites including abscesses. Delafloxacin is active against a wide range of Gram-positive and -negative species including methicillin-resistant Staphylococcus aureus and many fluoroquinolone-resistant strains. Additionally, according to preclinical and clinical trial data, well-known adverse events related to fluoroquinolone class do not appear to occur with this new molecule. Delafloxacin has been studied in acute bacterial skin and skin structure infections with >1400 patients exposed to both intravenous and oral formulation for up to 14 days and has shown noninteriority to vancomycin with or without aztreonam. For its interesting microbiological and pharmacokinetic/pharmacodynamics characteristics and for its safety profile, delafloxacin represents a very promising option for the treatment of infections caused by multidrug-resistant pathogens.
Pure hexagonal (β-phase) NaYF4-based hydrophobic upconverting nanoparticles (UCNPs) were surface-modified with O-phospho-l-threonine (OPLT), alendronic acid, and PEG-phosphate ligands to generate water-dispersible UCNPs. Fourier-transform infrared (FTIR) spectroscopy was used to establish the presence of the ligands on the UCNP surface. These UCNPs exhibit great colloidal stability and a near-neutral surface at physiological pH, as confirmed by dynamic light scattering (DLS) and zeta potential (ζ) measurements, respectively. The particles also display excellent long-term stability, with no major adverse effect on the size of UCNPs when kept at pH 7.4. Upon exposure to human serum, PEG-phosphate- and alendronate-coated UCNPs showed no formation of biomolecular corona, as confirmed by SDS-PAGE analysis. The photophysical properties of water-dispersible UCNPs were investigated using steady-state as well as time-resolved luminescence spectroscopy, under excitation at ca. 800 nm. The results clearly show that the UCNPs demonstrate bright upconversion (UC) luminescence. Furthermore, the presence of reactive groups on the NPs, such as free amine groups in alendronate-coated UCNPs, enables further functionalisation of UCNPs with, for example, small molecules, peptides, proteins, and antibodies. Overall these protein corona resistant UCNPs show great biocompatibility and are worthy of further investigation as potential new biomaging probes.
Female, Humans, Robotics, Biomedical Engineering, Nanomedicine, and Reproductive Health
Although women and men share many similar health challenges throughout their lifetimes, women are not necessarily healthier. Some conditions that only women experience-such as pregnancy, ovarian cancer, or the abnormal growth of the uterus called endometriosis- can become great health risks. HIV, AIDS, and sexually transmitted infections (STIs) are also serious medical and social issues for women worldwide. And because a woman's reproductive system is complex and delicate-which makes it particularly vulnerable to dysfunction or disease-finding ways to treat conditions that take root in the reproductive tract often prove challenging.
Humans, Artificial Intelligence, Biomedical Engineering, and Delivery of Health Care
As scholars have predicted and researchers have now shown, we are entering an age of global artificial intelligence (AI) convergence. Health care is just one area in which AI is gaining a foothold, as evidenced by two parallel conferences held in March 2018 in Las Vegas, Nevada. The first of these was the annual meeting of the Hospital Information and Management Systems Society, attended by nearly 45,000 participants; the second was a more focused, engineering-oriented conference on biomedical health informatics and biosensor networks, attended by about 450. Straddling those two meetings, IEEE Pulse held its second IEEE Pulse on Stage event, focusing (not surprisingly) on the use of AI in health care (Figure 1).
Cancer Vaccines, Drug Industry, Humans, Biomedical Engineering, Immunotherapy, Neoplasms prevention control, and Neoplasms therapy
More than a century ago, the American surgeon William Coley noticed a correlation between cancer remissions and postoperative infections: some patients who had battled an infection also experienced a regression of their cancer. Because of these observations, Coley hypothesized that a patient's immune response to a bacterial infection could be leveraged to treat cancer. To test his hypothesis, Coley injected live bacteria into an inoperable tumor of one of his patients. The patient's tumor regressed, and Coley went on to experiment with direct injections of live, and later heat-killed, bacteria into more than a thousand patients over the next 40-plus years. Coley's toxins never achieved widespread clinical success due to concerns over reproducibility, although a strain of mycobacterium, bacillus Calmette-Guerin, is still routinely administered to treat early-stage bladder cancers.