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Today, firms pursuing a pioneering strategy are often engaged in supply chain relationships to benefit from external resources and to improve their innovation. However, this effort can be impeded by power asymmetries in such relationships and especially by the execution of coercive power by their partner firm. Contracts could potentially reduce this risk of opportunistic behavior. Our survey study on 778 small to medium-sized enterprises in the European packaging and medical equipment industries examines how coercive power of the partner and the contractual arrangement between firms moderate the pioneering strategy's innovation outcomes in the short and long run. Our results confirm the negative effect of coercive power on innovation performance in both the short and long term. However, the compensating effect of rather complete contracts differs temporally. Whereas, contract completeness protects against higher dependence at the beginning of the collaboration, their effect diminishes over time. In contrast, rather incomplete contracts enhance the innovation performance in the long term, possibly complemented with trust. [ABSTRACT FROM AUTHOR]

[Display omitted] • Development of multifunctional composites suitable for material extrusion additive manufacturing. • Evaluation of PEG as a reduction agent in in-situ reactive melt mixing. • Silver Nitrate was the additive and medical grade polypropylene the matrix for the development of PP/Ag nanocomposites. • The mechanical properties were slightly improved (∼10 % in the tensile test). • Sufficient antibacterial performance was found especially for the S. aureus bacterium. This research focused on developing medical-grade polypropylene (PP)/silver (Ag) nanocomposites for the production of components through material extrusion (MEX) three-dimensional printing (3DP). The objective was to improve the performance of PP by enhancing its mechanical properties and imparting antibacterial characteristics. An industrially scalable process was utilized to fabricate PP/Ag nanocomposites through the reactive melt mixing technique. Polyethylene glycol (PEG) served as the reduction agent, and silver nitrate (AgNO 3) was incorporated as the additive. During the extrusion of the three-dimensional printing (3DP) filaments, reactive melt mixing occurred, resulting in the production of specimens for various standard tests. The addition of 5.0 wt% AgNO 3 and 2.5 wt% PEG in the PP thermoplastic led to a slight improvement in mechanical performance, with a 9.9 % increase in tensile strength observed. The antibacterial properties of the composites were assessed through agar well diffusion tests against Escherichia coli (E-coli) and Staphylococcus aureus (S. aureus). A more significant biocidal effect was observed for S. aureus compared to E-coli. These composites have the potential to be utilized in industrial applications that require enhanced mechanical properties and durability, as well as important biocidal properties, such as in the medical equipment industry or the defense sector. [ABSTRACT FROM AUTHOR]

Titanium alloy is widely used in high-precision fields such as aerospace industries and medical equipment because of its corrosion resistance and heat resistance. In conventional micro-EDM, the machining of small deep holes of difficult-to-cut materials has always been a problem due to difficult waste debris discharge and low machining efficiency when the machined aperture is small and the aspect ratio is large. Based on the above shortcomings, the high-frequency ultrasonic vibration was introduced into micro-EDM to improve processability. And the optimal ultrasonic system was designed on analytical calculation, finite element simulation, impedance test, and error analysis. The system was applied to SE-WK008 microporous machine for titanium alloy drilling test, and the univariate control experiment based on ultrasonic parameters and electrical parameters (processing voltage, pulse width, pulse interval, and peak current) was carried out. The influence law of each parameter on processing efficiency and electrode wear was summarized and the experimental data was fitted with polynomial curves, and then the multi-objective particle swarm optimization (MOPSO) algorithm was used to find out the optimal parameter array to verify the correctness of the selected processing parameter group. Through experimental analysis, the designed ultrasonic system can be applied to the traditional microporous machine, the highest processing efficiency is increased by 82.7%, and the maximum electrode wear is reduced by 68.7%, which points out the direction for the parameter selection of actual small deep hole machining. [ABSTRACT FROM AUTHOR]

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AIenabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient. The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the safety and efficacy of medical devices, has not effectively addressed AI system safety issues for its clearance processes. If the FDA cannot reasonably reduce the risk of injury for AI-enabled medical devices, injured patients should be able to rely on ex post recovery options, as in products liability cases. However, the Medical Device Amendments Act (MDA) of 1976 introduced an express preemption clause that the U.S. Supreme Court has interpreted to nearly foreclose liability claims, based almost completely on the comprehensiveness of FDA clearance review processes. At its inception, MDA preemption aimed to balance consumer interests in safe medical devices with efficient, consistent regulation to promote innovation and reduce costs. Although preemption remains an important mechanism for balancing injury risks with device availability, the introduction of AI software dramatically changes the risk profile for medical devices. Due to the inherent opacity and changeability of AI algorithms powering AI machines, it is nearly impossible to predict all potential safety hazards a faulty AI system might pose to patients. This Article identifies key preemption issues for AI machines as they affect ex ante and ex post regulatory-tort allocation, including actual FDA review for parallel claims, bifurcation of software and device reviews, and dynamics of the technology itself that may enable plaintiffs to avoid preemption. This Author then recommends an alternative conception of the regulatory-tort allocation for AI machines that will create a more comprehensive and complementary safety and compensatory model. [ABSTRACT FROM AUTHOR]

Firms in emerging markets are rapidly developing frugal innovation capabilities (FICs) in order to harness the growth potential of these markets. Researchers have explored this frugal innovation phenomenon through case studies of such firms. This nascent domain of study has been growing, and the demand for a specialized focus on FICs and their measurement is strong. This paper aims to satisfy the demand by conceptualizing FICs using the theoretical framework of dynamic capability, developing a measurement scale, and empirically validating the scale to measure FICs. Data from the medical device and automobile sectors in India were applied for this purpose. It is proposed that FICs are a composite variable with four dimensions: value for money, acceptable quality, scalability and marketability. The confirmatory factor analysis results validate these dimensions, presenting a gateway to explore FICs and their applications. [ABSTRACT FROM AUTHOR]

In the hopes of more efficiently and quickly reaching their aims, many humanitarian and development organizations (HDOs) - including nongovernmental organizations, such as the International Committee of the Red Cross (ICRC) and Doctors Without Borders (MSF), and international organizations such as the United Nations International Children's Emergency Fund (UNICEF) and theWorldHealthOrganization(WHO) - havefrequently sought partnerships with academia in recent years. These partnerships aim to use academic research and scientific expertise to address problems, through technology, that HDOs encounter "in the field" - generally inlow-incomeorcrisis-affectedsettings. Their reporting cycles are also often annual; thus, any use of resources will have to show results within a short period of time and should align with the HDO's strategic goals (of which technology innovation is rarely a part). Investigating this self-sustainability is essential due diligence for HDO's planning at technology deployment - because technology obsolescence will have significant negative impacts on the HDO's operations further down the line. [Extracted from the article]

The article highlights the recommendations of Germany's Quality Task Force for maintaining hygiene standards when dealing with external persons in the Reprocessing Unit for Medical Devices (RUMED). Topics discussed include health risks facing external persons in the RUMED, hazard assessment as per the Biological Agents Regulation, and mandatory protective measures for external persons.

The article examines the implications of the Medical Device Regulation (MDR) for operators of medical devices in healthcare institutions in the European Union (EU). Topics discussed include important changes introduced by the MDR for medical device operators and manufacturers, implications of changes to the classification system, and the Medical Device Law Implementing Act in Germany.

In sterilization departments, manual washing of medical devices is not regulated by any standard. The control of the preparation of the instruments detergent bath is essentially linked to the quality of the water and detergent distribution system. However, conformity is only presumed. No parametric control is carried out. The use of the conductivity as a control tool of detergent bath is relevant. A standard detergent (Excel D®) and a prionicide (Alka100®) were studied. The correlations found for detergents are excellent (R2>0.9). Conductivity target values for each detergent allow to conclude about the conformity of the detergent bath. A mix-up of the detergents can be detected at an early stage, thanks to the differences in conductivity between the two detergents. Also, this control allows an early detection of a failure of a dosing system. However, routine use requires specific training of the staff [ABSTRACT FROM AUTHOR]

The article offers information related to the implications of Medical Device Regulation (MDR) for the economic operator. It mentions about the changes introduced by MDR for economic operators including medical device identification system changes with the incorporation of a Unique Device Identifier; and need of additional documentation obligations due to new class III devices.

Aim: The aim of the survey was to find out whether the respondents encountered an undesirable event in the use of electrosurgical equipment, as well as preventive measures in relation to electrosurgery set in selected operating theaters and whether generally valid recommendations related to the use of electrosurgical equipment are followed. Methods: For data collection, a qualitative method of semi-structured interview with 6 respondents (head/station nurses of operating theaters) from three medical facilities within one region was chosen, which was supplemented by participating observation in operating theaters. The survey was conducted from July to September 2018. The observation was carried out at random within the operational program. Recording sheet creation was based on recommendations of the Competency & Credentialing Institute focused on safe perioperative care in the field of electrosurgery. Results: It was found that all respondents encountered an undesirable event in the field of electrosurgery and that the monitored workplaces did not have their own guidelines on this issue. The training of staff at this area varied from one healthcare facility to another. More problematic moments were registered in the stage before and during the operation. Among the more significant findings was that they did not verify in advance at the workplace whether flammable anesthetics and alcohol disinfection would be used. In some cases, the staff relied solely on a machine check and did not verify the situation visually. Conclusions: Most of the generally applicable safety precautions specified by the manufacturer or by specialist companies have been followed. The problems identified mostly consisted in performing tasks by an incompetent person or by not following the recommendations of the manufacturer of electrosurgical devices. [ABSTRACT FROM AUTHOR]

Medical device industry encompasses a wide range of technologies and applications, which makes the process validation approach (IQ/OQ/PQ framework) and OQ/PQ implementation method difficult to be defined in the industry's regulation and process validation guidance documents. Based on two-level (component production level and device assembly level) process validation approach, this article proposes 1) a typical section structure & contents for production equipment/system/process validation OQ/PQ protocols, 2) a typical subsection structure & contents for the protocols' most critical section - Test Plan, and 3) the validation approach and OQ Detailed Test Plan for both common equipment and test equipment. [ABSTRACT FROM AUTHOR]

The article offers information on the German Society of Sterile Supply (DGSV e.V.) Congress on medical device reprocessing that was held from October 2 to 4, 2019 at the Esperanto Congress Centre in Fulda, Germany. Several expert who participated in the event includes Marc Thanheiser, Walter Popp, and Madelaine Schenk.

This Medical News article describes the marketing of continuous glucose monitoring devices to individuals without diabetes. [ABSTRACT FROM AUTHOR]

Abstract Corynebacterium glutamicum is a major workhorse in industrial biotechnology. For the past several decades, this soil bacterium has been used to produce the amino acids l -glutamate and l -lysine at a level of 6 million tons per year. Utilizing novel genome editing methods and advanced tools of systems and synthetic biology, the portfolio of C. glutamicum has exploded from classical food and feed products to the chemical industry, cosmetics and healthcare applications. Within the past five years, the number of industrial products has almost doubled to approximately 70 natural and non-natural compounds. This review summarizes the state-of-the-art regarding metabolically engineered cell factories of C. glutamicum , illustrates recent key technological developments and provides examples of the major industrial applications of this important microbe. Highlights • Genome-editing of the microbe allows for multiplexed genomic engineering. • Biosensors display a key innovation to drive strain development and screening. • Metabolically engineered Corynebacterium glutamicum is meanwhile applied to produce more than 70 products. • Novel substrate assimilation routes strongly expand the raw material basis for renewable bio-production. [ABSTRACT FROM AUTHOR]

The article offers information on several medical devices including the Deprox regulated vaporization system from Hygiene Solutions, the SonoTranVR System proprietary ultrasound device from OxSonics, and the DeLee Obstetrical Forceps from Sklar.

New trends in product development aim at integrating the improvement of all activities related to the products’ life-cycle, particularly when considering environmental issues. Within this context, Product-Service System (PSS) appears as a promising model, representing a win-win solution for both companies and customers. In particular, the medical devices industry is a sector where the PSS approach can assume a key role. However, despite the potential benefits deriving from the implementation of PSS solutions, few studies on PSS consider this sector. To accomplish this, the paper proposes a methodology based on the analysis of the market demand and customers’ needs by means of the Quality Function Deployment (QFD) method, and the simulation of life-cycle scenarios through the Screening Life Cycle Modelling (SLCM) method supported by Life Cycle Assessment (LCA) and Life Cycle Costing (LCC) tools. A case study performed in collaboration with a manufacturer of biomedical devices showed the benefits of the proposed methodology in the development of sustainable PSS solutions. Actually, the results demonstrate the validity of such an approach in enhancing customer satisfaction, while reducing environmental concerns and costs. [ABSTRACT FROM AUTHOR]

2016 saw cybersecurity standards appear in both automotive and medical device industries. Both standards are understandably based on processes that already exist in the respective industries. The automotive J3061¹ standard is very much focussed on existing categories for defining the cybersecurity threats, ie, systems, hardware and software. Cybersecurity is very much a multifaceted topic, and by restricting the scope to these 3 subject areas there is the risk that many significant threats could be overlooked, in particular the malicious acts of employees within an organisation. The medical cybersecurity report AAMI TIR 57² takes the approach based on ISO 14971³ the medical device risk management standard, which encourages a more open-minded approach to evaluating cybersecurity threats. Both of these documents, which are discussed in this paper, are short of practical examples or techniques for assessing and mitigating threats; the topic is handled in a more theoretical manner. Key issues such as trojan circuits in microcontrollers are not well represented in either document. Generally, software topics such as authentication and encryption are given good coverage in international standards; however, this not the case when reviewing hardware concerns. Both TIR 57 and J3061 are good starting documents for the topic of cybersecurity, but both could benefit from expansion to cover the wider topics affecting cybersecurity. [ABSTRACT FROM AUTHOR]

In most trendsetting industries like the aerospace, automotive and medical industry functionally critical parts are of highest importance. Due to strict legal requirements regarding the securing of the functionality of high-risk parts, both production costs and quality costs contribute significantly to the manufacturing costs. Thus, both types of costs have to be taken into consideration during the stage of technology planning. Due to the high variety of potential interactions between individual component properties as well as between component properties and manufacturing processes, the analysis of the influence of the manufacturing history on an efficient design of inspection processes and inspection strategies is extremely complex. Furthermore, the effects of inspection strategies and quality costs on the planning of manufacturing process sequences cannot be modeled to date. As a consequence, manufacturing and inspection processes are designed separately and thus a high cost reduction potential remains untapped. In this paper, a new approach for an integrative technology and inspection planning is presented and applied to a case study in medical industry. At first, existing approaches with regard to technology and inspection planning are reviewed. After a definition of relevant terms, the case study is introduced. Following, an approach for an integrative technology and inspection planning is presented and applied to the case study. In the presented approach, the complex causalities between technology planning, manufacturing history, and inspection planning are considered to enable a cost-effective production process and inspection sequence design. [ABSTRACT FROM AUTHOR]

Abstract: The AB5000 Circulatory Support System is paracorporeal pulsatile ventricular assist device. The AB Portable Driver is a portable console for this system. We experienced two cases with accelerated hemolysis while receiving support by the AB Portable Driver. The purpose of this study was to clarify the mechanical differences associated with the hemolysis between the AB5000 console and the AB Portable Driver. The mock circulatory system modeled by an AB5000 ventricle and a blood sampling bag of vinyl chloride was run with an AB5000 console or AB Portable Driver. The peak drive‐line pressure, the mean arterial cannula pressure and the pumping rate of the VAD were recorded. The AB5000 console generated a peak drive‐line pressure of 280–300 mm Hg in LVAD mode and 210–220 mm Hg in RVAD mode, approximately 100 mm Hg lower than officially documented. In contrast, the AB Portable Driver generated pressures of 310–330 mm Hg in LVAD mode and 230–250 mm Hg in RVAD mode, 65–95 mm Hg higher than officially documented. The AB Portable Driver console generates higher drive‐line pressures than the AB5000 console, possibly explaining the accelerated hemolysis. [ABSTRACT FROM AUTHOR]

Background: Financial ties between physicians and the pharmaceutical and medical device industry are common, but little is known about how patient trust is affected by these ties.Objective: The purpose of this study was to evaluate how viewing online public disclosure of industry payments affects patients' trust ratings for physicians, the medical profession, and the pharmaceutical and medical device industry.Design: This was a randomized experimental evaluation.Participants: There were 278 English-speaking participants over age 18 who had seen a healthcare provider in the previous 12 months who took part in the study.Interventions: Participants searched for physicians on an online disclosure database, viewed payments from industry to the physicians, and assigned trust ratings. Participants were randomized to view physicians who received no payment ($0), low payment ($250-300), or high payment (>$13,000) from industry, or to a control arm in which they did not view the disclosure website. They also were asked to search for and then rate trust in their own physician.Main Measures: Primary outcomes were trust in individual physician, medical profession, and industry. These scales measure trust as a composite of honesty, fidelity, competence, and global trust.Key Results: Compared to physicians who received no payments, physicians who received payments over $13,000 received lower ratings for honesty [mean (SD): 3.36 (0.86) vs. 2.75 (0.95), p < 0.001] and fidelity [3.19 (0.65) vs. 2.89 (0.68), p = 0.01]. Among the 7.9% of participants who found their own physician on the website, ratings for honesty and fidelity decreased as the industry payment to the physician increased (honesty: Spearman's ρ = -0.52, p = 0.02; fidelity: Spearman's ρ = -0.55, p = 0.01). Viewing the disclosure website did not affect trust ratings for the medical profession or industry.Conclusions: Disclosure of industry payments to physicians affected perceptions of individual physician honesty and fidelity, but not perceptions of competence. Disclosure did not affect trust ratings for the medical profession or the pharmaceutical and medical device industry. ClinicalTrials.gov identifier: NCT02179632 ( https://clinicaltrials.gov/ct2/show/NCT02179632 ). [ABSTRACT FROM AUTHOR]

We investigated accounts of how individuals in public and private organisations operating in the medical device industry use different forms of capital (social e.g. networks and cultural e.g. knowledge) to solve design based problems. We define capital as resources embedded in social networks, knowledge or economic wealth [Bourdieu 1986. “Forms of Capital.” InHandbook of Theory and Research for the Sociology of Education, edited by J. Richardson, 241–258. New York: Greenwood]. Data were collected from interviews and written diaries from individuals involved in the design process of medical devices using interpretative analysis. Inferences made from our analyses suggested that individuals working in organisations who successfully solve problems may do so by using both social and cultural capital and so may be more likely to engage in innovative activity than others. These exploratory findings suggest workers in large organisations may have the capability to use a greater level of in-house social and cultural capital, whereas those in smaller organisations may be more reliant on high levels of social capital in order to ‘tap into’ cultural capital beyond organisational boundaries. [ABSTRACT FROM PUBLISHER]

The simultaneous measurement of the lung transfer factor for carbon monoxide (DLCO) and nitric oxide (DLNO) is now available as a powerful method for studying the alveolar-capillary gas exchange. However, application of the DLNO-CO technique in daily settings is still limited by some technical drawbacks. This paper provides a manufacturer’s overview of the measuring principles, technical challenges and current available solutions for implementing the DLNO-CO measurement in to a marketed device. This includes the recent developments in technology for NO sensors, latest findings on NO uptake and new statistical methods. [ABSTRACT FROM AUTHOR]

Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single Market for sale and clinical use. The impending introduction of a revised Medical Device Regulatory Framework in the EU will require an assessment of how stakeholders in the MedTech sector will be affected. Understanding the impact will be essential for maintaining compliance in the changing regulatory environment as well as for promoting commercial competitiveness and facilitating early access to innovative medical device technologies. In Ireland, a national initiative has been launched to centralise expertise on the regulatory requirements for medical devices in the EU and to analyse how the new medical device regulations will affect requirements for medical device clinical investigations and commercialisation of medical device technologies. [ABSTRACT FROM AUTHOR]

The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of the MDR to the still-valid Active Implantable Medical Device Directive (AIMD) and Medical Device Directive (MDD). Some changes will have a great impact on the way that devices are marketed, but many others are unpredictable and may disrupt the medical device market. Until manufacturers and authorities adapt to the changes, the transition years will pose difficulties for all stakeholders. [ABSTRACT FROM AUTHOR]

Product robustness refers to the consistency of performance of all of the units produced. It is often the case that process manufactured products are not designed concurrently, so by the end of the product design phase the Process Manufacturing Concept (PMC) has yet to be decided. Allocating process capable tolerances to the product during the design phase is therefore not possible. The robustness of the concept (how capable it is to achieve the product specification), only becomes clear at this late stage and thus after testing and iteration. In this article, a method for calculating the unit-to-unit robustness of an early-stage for a PMC is proposed. The method uses variability and adjustability information from the manufacturing concept in combination with sensitivity information from products' design to predict its functional performance variation. A Technology maturation factor for addressing varied process capability confidence was applied. A four-step process of Define, Connect, Map and Quantify was proposed for calculating PMC robustness and was tested for a wound-care product. The results show that the method was applicable and enabled PMC selection based on quantified robustness. The case also demonstrates that higher robustness is possible even at higher parameter variability with suitable measurements and adjustability. [ABSTRACT FROM AUTHOR]

A characterisation of the medical device development landscape in South Africa would be beneficial for future policy developments that encourage locally developed devices to address local healthcare needs. The landscape was explored through a bibliometric analysis (2000–2013) of relevant scientific papers using co-authorship as an indicator of collaboration. Collaborating institutions thus found were divided into four sectors: academia (A); healthcare (H); industry (I); and science and support (S). A collaboration network was drawn to show the links between the institutions and analysed using network analysis metrics. Centrality measures identified seven dominant local institutions from three sectors. Group densities were used to quantify the extent of collaboration: the A sector collaborated the most extensively both within and between sectors; local collaborations were more prevalent than international collaborations. Translational collaborations (AHI, HIS or AHIS) are considered to be pivotal in fostering medical device innovation that is both relevant and likely to be commercialised. Few such collaborations were found, suggesting room for increased collaboration of these types in South Africa. Significance: • Results could inform the development of strategies and policies to promote certain types of medical device development. • Further studies could identify drivers and barriers to successful medical device development in South Africa. [ABSTRACT FROM AUTHOR]

Background: A majority of academic medical centers (AMCs) have now adopted conflict of interest policies (COI) to address relationships with pharmaceutical and device industries that can increase the risk of bias in patient care, education and research. However, AMCs may have little information on the impact of their policies. This paper provides a new method, which is a free, publicly-available survey, to fill this information gap and improve COI programs at AMCs. Methods & findings: The survey, piloted in three AMCs and designed in collaboration with national conflicts of interest policy experts, covers a range of universal compliance-related concerns, which allows institutions to tailor questions to align with their own policies and culture. The survey was low-burden, and provided important data for these AMCs to evaluate their policies. A descriptive analysis of the pooled pilot site data (n = 1578) was performed, which found that a majority of respondents did not have financial ties with industry and a majority was satisfied with specific COI policies at their institutions. The analysis also showed that the survey is sensitive to differences that AMCs will find meaningful. For instance, individuals with industry ties were significantly more likely than individuals without ties to think that COI policies unnecessarily hindered interactions with industry (p = .004), were ineffective at reducing harm to patients (p < .001), and were ineffective in reducing bias in medical education (p>.001). Conclusion: The survey is now free and publicly available for use by any institution. AMCs can use the results to update and refine policies, and to provide ongoing education regarding existing policies. [ABSTRACT FROM AUTHOR]

The medical device industry has grown rapidly and incessantly over the past century. The sophistication and complexity of the designed instrumentation is nowadays rising and, with it, has also increased the need to develop some better, more effective and efficient maintenance processes, as part of the safety and performance requirements. This paper presents the results of performance tests conducted on 50 mechanical ventilators and 50 infant incubators used in various public healthcare institutions. Testing was conducted in accordance to safety and performance requirements stated in relevant international standards, directives and legal metrology policies. Testing of output parameters for mechanical ventilators was performed in 4 measuring points while testing of output parameters for infant incubators was performed in 7 measuring points for each infant incubator. As performance criteria, relative error of output parameters for mechanical ventilators and absolute error of output parameters for infant incubators was calculated. The ranges of permissible error, for both groups of devices, are regulated by the Rules on Metrological and Technical Requirements published in the Official Gazette of Bosnia and Herzegovina No. 75/14, which are defined based on international recommendations, standards and guidelines. All ventilators and incubators were tested by etalons calibrated in an ISO 17025 accredited laboratory, which provides compliance to international standards for all measured parameters.The results show that 30% of the tested medical devices are not operating properly and should be serviced, recalibrated and/or removed from daily application. [ABSTRACT FROM AUTHOR]

A clear understanding of the fatigue properties of Ti–6Al–4V manufactured with electron beam melting (EBM) is needed to ensure performance in critical applications in the medical device and aerospace industries. In this work, the effects of residual stress and internal defects (pores and voids) on fatigue properties of EBM Ti–6Al–4V material in as-built, stress-relieved, and hot isostatic pressed (HIPed) conditions were evaluated. Conventional techniques were used to measure the chemical composition and quantify microstructures, and neutron scattering was utilized to measure residual stresses. Post-processing did not alter chemical composition. Compared to the as-built condition, microstructure was unchanged for stress-relieved material and coarser for HIPed material. No significant residual stresses were measured for any of the three conditions. This indicates build platform and layer preheating lead to sufficient process temperatures to achieve full stress relief in-situ. The fatigue strengths at 10 7 cycles measured for the as-built and stress-relieved conditions were statistically similar and were measured to be 200–250 MPa. A significantly higher fatigue strength at 10 7 cycles of 550–600 MPa was measured for the HIPed condition. The increase in fatigue endurance limit was attributed to a reduction in internal porosity and void content. [ABSTRACT FROM AUTHOR]

To meet new regulations, alternative plasticizers to di(2-ethylhexyl) phthalate (DEHP) are now commonly used in the manufacturing of medical devices. These are: acetyl tri-n-butyl citrate (ATBC), bis (2-ethylhexyl)adipate (DEHA), dioctyl terephtalate (DEHT), di-isononylphtalate (DINP), diisononylcyclohexane-1.2-dicarboxylate (DINCH) and trioctyltrimellilate (TOTM). An HPLC-UV analysis was previously developed to characterize four of them. However, two compounds were systematically co-eluated: DEHP with DEHA and DEHT with DINP. The first derivative of UV spectra and photodiode array detection allow the quantification of DEHA and DINP. Moreover, for each plasticizer, maximum wavelength absorbance was chosen to be as specific as possible. Quantification ranged from 0.3 to 750 µg/mL according to the plasticizer. The assays were validated by analysis of variance. Our method was validated by determining the following parameters: specificity, linearity, limits of detection and quantification. The relative biases were inferior to 5% for ATBC, DEHP, DEHA and DINCH and inferior to 10% for DEHT, DINP and TOTM. Plasticizers were extracted with tetrahydrofuran and methanol. The developed method was then used to determine the composition of plasticizers in several medical devices used in clinical service. The major plasticizers were quantified from 19% to 40% w/w, traces of DEHT were found in six medical devices and DEHP in five. [ABSTRACT FROM AUTHOR]

The author discusses the need for clinicians to collaborate with manufacturers in prototyping and development of anaesthetic devices. He references findings of a study to assess the performance of adjustable pressure valves (APL) and the manufacturer's claim that the assessment technique is flawed. The author advises clinicians to be proactive in setting standards for equipment manufacturers.

The article presents information on the compensation received by the CT colonography industry and all its employees. Details related to it include an insight into the background of this medical process, the efforts having been made post 2009 to implement it predominantly in medical technology, and the advancements seen in this field.

Background: Airway exchange catheters (AEC) and fiberoptic bronchoscopes (FOB) for tracheal intubation are selected so that there is only a minimal gap between their outer and inner diameter of endotracheal tube (ETT) to minimize the risk of impingement during airway instrumentation. This study aimed to test the ease of passage of FOBs and AECs through paediatric ETT of different sizes and from different manufacturers when using current recommendations for dimensional equipment compatibility taken from text books and manufacturers information.Methods: Twelve different brands of cuffed and uncuffed ETT sized ID 2.5 to 5.0 mm were evaluated in an in vitro set-up. Ease of device passage as well as the locations of an impaired passage within the ETT were assessed. Redundant samples were used for same sized ETT and all measurements were triple-checked in randomized order.Results: In total, 51 paired samples of uncuffed as well as cuffed paediatric ETT were tested. There were substantial differences in the ease of ETT passage concordantly for FOBs and AECs among different manufacturers, but also among the product lines from the same manufacturer for a given ID size. Restriction to passage most frequently was found near the endotracheal tube tip or as a gradually increasing resistance along the ETT shaft.Conclusions: Current recommendations for dimensional equipment compatibility AECs and FOBs with ETTs do not appear to be completely accurate for all ETT brands available. We recommend that specific equipment combinations always must be tested carefully together before attempting to use them in a patient. [ABSTRACT FROM AUTHOR]

We have previously reported that fluorine-incorporated amorphous carbon (a-C:H:F) coating dramatically reduced the number and activation of adherent platelets in contact with human blood. In order to convert a-C:H:F coating into a commercial reality, it is necessary to estimate its life span and the sustainability of antithrombogenic properties using accelerated aging tests under various temperature conditions. The purpose of this study was to investigate the effect of different temperature conditions using accelerated aging tests on the antithrombogenic properties of a-C:H:F. The a-C:H:F film was deposited on silicon substrates from a mixture of acetylene and octafluoropropane using the inductively coupled plasma enhanced chemical vapor deposition method. The a-C:H:F coated substrates were then stored at room temperature, 55 °C, 70 °C and 90 °C, respectively. The surface chemical compositions of a-C:H:F film were examined using X-ray photoelectron spectroscopy (XPS). The antithrombogenic properties were evaluated through incubation with platelet-rich plasma isolated from human whole blood, and the properties of adhesion between film and metallic stents were evaluated by examining before-and-after balloon expansion. The XPS analysis showed that the relative amount of fluorine atoms slightly decreased and the amount of oxygen increased over time on the surface of a-C:H:F samples. Furthermore, the change in chemical composition was the most prominent in the samples stored at 90 °C. However, no significant difference in the number of adherent platelets were observed among a-C:H:F coated sample surfaces after accelerated aging tests, suggesting that changes in chemical composition due to elapsed time and temperature changes do not significantly affect the antithrombogenic properties. Furthermore, the stability of the adhesive properties on a-C:H:F coated stents was revealed, because there were no cracks or instances of delamination on any a-C:H:F coated stent surfaces after expansion. This work demonstrated that excellent antithrombogenic properties of a-C:H:F were maintained over time at each temperature, and thus a-C:H:F film could be utilized as a coating material for medical device commercialization. Prime novelty statement We report that the antithrombogenic and adhesive properties of fluorine-incorporated amorphous carbon (a-C:H:F) are stable even after accelerated aging tests, and thus a-C:H:F film could be utilized as a coating material for medical device commercialization. [ABSTRACT FROM AUTHOR]

There has been an increase in the potential use of wireless devices in healthcare domain for a variety of reasons. The most commonly used device is the cellular phone, which emits strong electromagnetic energy affecting thereby the functionality of the vital medical equipment such as ventilators, ECG monitors, cardiac monitors, and defibrillators. This prompted the healthcare concerns to restrict the use of these phones in the proximity of critical and non-critical care medical equipment. Due to the developments made in the design of medical equipment to comply with the EMC standards, the restriction had been slowly laid off. Still, the researchers are concerned about the electromagnetic interference with medical devices by cellular phones in the healthcare domain and recommend for conducting continuous research to study their interaction with medical equipment. This paper overviews the certain investigations carried out in the recent years to study the electromagnetic interference between medical devices and 2G/3G/4G LTE cellular phones. During the initial development of cellular phones, the 2G cellular phones had caused more interference that affects the function and operation of some medical devices. The possibility of interference from 3G cellular phones with medical devices was considerably lower than the 2G phones, but still exists. Furthermore, almost all of the 4G phones have little to no interference with the medical devices. Currently, with the development of the medical devices industry, the current medical devices are designed to operate safely under any conditions of usage. Finally, a careful analysis would require statistics on the frequency of adverse events across the healthcare system, which apparently do not exist. [ABSTRACT FROM AUTHOR]

Objective: To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry. Methods: We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country. Results: Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians’ disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies. Conclusion: The awareness of participants was low for physicians’ receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness, less concern and more acceptance of surgeon-device industry interactions relative to physician-pharmaceutical industry interactions. We discuss the implications of the findings at the patient, provider, organizational, and systems level. [ABSTRACT FROM AUTHOR]

This section presents a message from the Chairman of Committee of the State Duma of the Russian Federation for science and scientific technologies, Academician of the Russian Academy of sciences. He talks about the underestimation of the contribution of the basic science to the development of innovative medical technologies and the problem of the pathology of osteoarticular apparatus. The program of Moscow International Forum of Bones and Joints Disorders on April 18-21, 2016 is also presented.

The spectrum of medical writing activities across the pharmaceutical and device industries is vast. We conducted a limited survey of medical writers pre dominantly working in industry or for agencies to learn of their personal and professional exper iences. Our results showed that writers entering the medical communic ations world came from diverse backgrounds and had a variety of reasons for choosing this career path. Most had a scientific background and were highly qualified. Though at times stressful and involving long hours, medical writing was generally a satisfy ing and well-rewarded career choice. Several individual responses suggested a lack of appreciation and poor cooperation on the part of some clients and/or authors. Quality of life differed little between pharmaceutical and device employees. While many skills are transferable, those wishing to change focus from pharma ceuticals to medical devices or vice versa may face challenges. Respondents offered a range of advice for new recruits. [ABSTRACT FROM AUTHOR]

The medical device industry is growing increasingly concerned about environmental impact of products. Whilst there are many tools aiming to support environmentally conscious design, they are typically complex to use, demand substantial data collection and are not tailored to the specific needs of the medical device sector. This paper reports on the development of a Maturity Grid to address this gap. This novel design tool was developed iteratively through application in five case studies. The tool captures principles of eco-design for medical devices in a simple form, designed to be used by a team. This intervention tool provides designers and product marketers with insights on how to improve the design of their medical devices and specifically allows consideration of the complex trade-offs between decisions that influence different life-cycle stages. Through the tool, actionable insight is created that supports decisions to be made within the realm of design engineers and beyond. The tool highlights areas which are influenced by design decisions taken, some of which are perceived to be outside of the direct control of designers. [ABSTRACT FROM AUTHOR]

The financial relationships between the pharmaceutical and device industries and healthcare practitioners appear frequently in the spotlight because of their potential to create bias and influence prescribing choices. Public disclosure of these transactions may help patients make informed choices about their healthcare practitioners and may help reduce healthcare costs. The US Sun - shine Act, a Federal law that requires disclosure of transactions between industry and healthcare practitioners, was passed in 2010. Similar disclosure laws and codes now exist globally. Unfortunately, none of the current requirements are clear about the reportability of industry support for medical writing and editorial services. Regardless, medical writers should be aware of these requirements, which can help them as they forge relationships with authors. [ABSTRACT FROM AUTHOR]

This exploratory study seeks to explore the current state of design for the environment (DfE) in the development of medical devices; an historically risk averse industry that lags behind others in terms of addressing environmental considerations. A cross-sectional survey of 34 medical device designers, primarily in the UK and USA, was conducted in order to fulfil this objective. Findings indicate that there is significant motivation to enhance DfE practice, but that there are multiple barriers to this. Major barriers identified are a perception of the high cost of DfE, the industry's current reliance on a single-use business model for many current products and a lack of education about DfE topics on all sides. Designers felt that the most significant opportunities to implement DfE are in situations where they are able to exert direct control, mainly in the early stages of the design process. Issues noted include raw material choice and packaging decisions. The nature of single use business models is also critical, pointing towards the needs for a systemic rather than product focus. For this to be achieved, financial rewards must be evident to firms and the changing regulatory landscape might also make a more significant impact. [ABSTRACT FROM AUTHOR]