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  • articleNo Access

    FAILURE MODES IN MEDICAL DEVICE SOFTWARE: AN ANALYSIS OF 15 YEARS OF RECALL DATA

    Most complex systems today contain software, and systems failures activated by software faults can provide lessons for software development practices and software quality assurance. This paper presents an analysis of software-related failures of medical devices that caused no death or injury but led to recalls by the manufacturers. The analysis categorizes the failures by their symptoms and faults, and discusses methods of preventing and detecting faults in each category. The nature of the faults provides lessons about the value of generally accepted quality practices for prevention and detection methods applied prior to system release. It also provides some insight into the need for formal requirements specification and for improved testing of complex hardware-software systems.

  • articleNo Access

    INSIDE INDUSTRY

      A*STAR and GE Healthcare to improve healthcare outcomes through next generation innovations.

      Phylogica enters into research and licensing agreement with Genentech.

      FUJIFILM Completes Acquisition of Kalon Biotherapeutics.

      Bina Technologies acquired by Roche.

      ONO and Gilead enter exclusive license agreement to develop BTK inhibitor for the treatment of B-cell malignancies and other diseases.

      Uroplasty and Vision-Sciences to merge, creating medical device company.

      Amgen joins with LabCentral to support life-sciences and biotech startups in Cambridge.

      Temasek Life Sciences Laboratory appoints Prof Yu Hao as Executive Director.

      SomaGenics receives $2,275,000 in NIH funding to develop its RNAi Therapeutics and microRNA Technologies.

    • articleNo Access

      FEATURES

        Tapping on ASEAN'S Healthcare Opportunities through Singapore by Dr Derrick Tan

        ASEAN – The New Playing Field for Global Medical Device Companies by Ms Cecelia Zhou

        The Burden of Great Potential: the ASEAN Economic Community & Biopharmaceuticals by Dr Ross Horsburgh

        Impact of the ASEAN Economic Community on the Region's Healthcare Market by Dr. Umapathy Panyala

      • articleNo Access

        EYE ON CHINA

          ‘Made in China 2025’ Momentum Propelling the Medical Device Industry Forward.

          China to Build New Comprehensive National Labs.

          NSFC - UNEP Project Launched to Boost Food and Water Security in Zambezi Basin.

          New Tech Turns Potato Effluent into Fertilizer.

          How Does Ruminal Protein and Feed Intake Effect on Endogenous Nitrogen and Amino Acids Flow in Goats?

          China Plans More Gravitational Wave Research.

          TUFM Links Mitochondrial Dysfunction to EMT in Lung Cancer.

          How Organic Matter Decomposition Responds to Labile C and N Inputs.

          Transgenic Monkeys Overexpressing Human MECP2 Gene Exhibit Autism-Like Behaviors and Germline Transmission.

          Hearts of Cows Used in Ancient Cosmetics.

          Genetic Lineage Tracing Analyses Reveal Endocardial Origin of Cardiac Fat.

          Hong Kong News – Flu Remains the Most Prevalent Fatal Viruses in Hong Kong.

        • articleNo Access

          BIOBOARD

            SINGAPORE – Singapore eHealth Innovations Summit Announces the First EMRAM Stage 7 Hospital in Singapore and Emphasized Technology as Transformative Agent in Specialty Functions.

            TAIWAN – Health2Sync Strategically Partners with Taiwan's Ministry of Health and Welfare in Asia's First Government Supported Online Diabetes Care Program.

            UNITED STATES – Scientists Identify Protein Involved in Restoring Effectiveness of Common Treatment for Breast Cancer.

            UNITED STATES – Scientists Reveal How Signals from Pathogenic Bacteria Reach Danger Sensors of Cells.

            UNITED STATES – Scientists Find New Path in Brain to Ease Depression.

            UNITED STATES – Tips for Living a Heart Healthy Lifestyle.

            CANADA – Review Suggests Eating Oats Can Lower Cholesterol as Measured by a Variety of Markers.

            SOUTH KOREA – CSA Group Opens Highly Advanced Electro - Medical Laboratory in Seoul.

            AUSTRALIA – Cynata’s Technology Significant Efficacy in Preclinical Asthma Study.

            INDIA – Essilor Launches ‘Love to See Change’ Campaign to Educate People about Need to Preserve Visual Health.

          • articleNo Access

            COLUMNS

              Biomedical Engineering Industry Alliance (BME IA): Working in Favour of the Industry's Stakeholders

              Counter-Acting Chemotherapy's Side Effects

              (Writer's Thought) Treating Patients, Not Diseases

            • articleNo Access

              EYE ON CHINA

                Mab-Venture Biopharma & Thermo Fisher Establish Asia Pacific’s First “SmartFactory” for Antibody Drugs.

                Venus Medtech’s TAVR Device Is Approved By CFDA, Creating A New Era of Interventional Cardiology in China.

                Key Diabetes Receptor Structure Determined by International Collaboration.

                China Sets Up National Lab Developing Brain-Like AI Technology.

                Chinese Scientists Realize On-site Drug Detection.

                Scientists Map Single-Copy HIV-1 Provirus Loci in Human Chromosomes in Live Host Cells.

                Gene Variant Explains Differences in Blood Fatty Acid Levels.

                Scientists Illustrate How Host Cell Responds to Zika Virus Infection.

                Hong Kong News – Uni-Bio Science Launches Best-in-Class Oral Anti-Diabetic Drug Mitiglinide Branded “博康泰®”(Bokangtai).

              • articleNo Access

                BIOBOARD

                  JAPAN – Asia Pacific Medical Technology Association (APACMed) announces partnership with Japan Federation of Medical Devices Associations (JFMDA).

                  UNITED STATES – Gene Mutation May Speed Up Memory Loss in Alzheimer’s Disease.

                  UNITED STATES – Know the Facts About Skin Cancer.

                  UNITED STATES – Another Reason to Exercise: Burning Bone Fat – a Key to Better Bone Health.

                  AUSTRALIA & NEW ZEALAND – LCT Collaborates with Auckland University Centre for Brain Research to Extend Product Pipeline.

                  TAIWAN – Peptide Nasal Spray to Delay Onset of Alzheimer’s disease.

                  TAIWAN – TLC178 Designated by US FDA as Drug for Rare Pediatric Disease in the Treatment of Rhabdomyosarcoma.

                • articleNo Access

                  EYE ON CHINA

                    China approves norovirus vaccine for clinical trial.

                    Public hospitals in China receive increasing government funds.

                    Tax incentives for top talents in the Greater Bay Area.

                    National Health Commission of China calls for production of generic drugs.

                    AI offers breakthrough in cancer diagnosis.

                    Drug-free theranostic agent for cancer treatment.

                    E-healthcare innovation competition finishes in Shanghai.

                    Bioindustry Convention held in Guangzhou.

                    China’s State Council publishes new regulations on the management of human genetic resources.

                    Chinese institutions ranked high in Nature Index.

                    US$120 million joint venture in China to develop innovative cell therapies for cancer.

                    Digital mental health strategy in China.

                  • articleNo Access

                    Columns

                      The following topics are under this section:

                      • Game Changers – Medical Device company leverages on artificial intelligence for robotic surgery
                      • Epidemiology of Factors associated with Low Muscle Mass in Elderly
                      • Low Glycaemic Index Foods for Healthier Diets
                      • Disruptive Technologies in the Tobacco Industry

                    • articleNo Access

                      Ni–NTA-COATED NANOWIRE MATERIALS FOR PROTEIN ENRICHMENT AND THE APPLICATION IN A MEDICAL DEVICE USED FOR BLOOD GLUCOSE DEGRADATION

                      Nano30 May 2013

                      A general and reliable method has been developed to functionalize either the iron oxide or the silicon nanowires (NWs) with nickel–nitriloacetic acid (Ni–NTA) complex, which was manufactured to manipulate His-tagged proteins and enzymes. The Ni–NTA-functionalized sea-urchin-shaped α-Fe2O3 NWs exhibit the superior protein purification efficiency and excellent stability in the form of dry powder. Application of this new nanotechnology in biomedical research field has been explored. A glucose degradation bio-matrix was made via the Ni–NTA-modified silicon NW-chips, which were conjugated with an enzyme essential to glycolysis. The glucose level in a simulated blood solution was found to be reduced from 14.4 mM to 9 mM after incubating the hexokinase I-functionalized silicon NW-chips for 12 h. These results suggest a possible way to build up a medical device using enzymes functionalized NW-chips for the removal of excess blood glucose.

                    • articleNo Access

                      First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws

                      TECHNOLOGY01 Sep 2019

                      Obtaining venous access for blood sampling or intravenous (IV) fluid delivery is an essential first step in patient care. However, success rates rely heavily on clinician experience and patient physiology. Difficulties in obtaining venous access result in missed sticks and injury to patients, and typically require alternative access pathways and additional personnel that lengthen procedure times, thereby creating unnecessary costs to healthcare facilities. Here, we present the first-in-human assessment of an automated robotic venipuncture device designed to safely perform blood draws on peripheral forearm veins. The device combines ultrasound imaging and miniaturized robotics to identify suitable vessels for cannulation and robotically guide an attached needle toward the lumen center. The device demonstrated results comparable to or exceeding that of clinical standards, with a success rate of 87% on all participants (n=31), a 97% success rate on nondifficult venous access participants (n=25), and an average procedure time of 93±30s (n=31). In the future, this device can be extended to other areas of vascular access such as IV catheterization, central venous access, dialysis, and arterial line placement.

                    • chapterNo Access

                      Medical Applications of Adaptive Polymers

                        This chapter summarises different medical applications and the unique medical performance of adaptive polymer materials that use several different types of adaptive polymers. The content emphasises the progress and frontiers of adaptive polymeric products for medical applications, including design requirements and specific examples of tissue engineering, diagnosis, medical treatments and medical devices. These adaptive polymers include polymer gels, and shape memory, active, molecular imprinted and modified polymers, as well as other polymers with adaptive properties.