Review
Chemistry, Analytical
Mohammadreza Omidali, Ali Mardanshahi, Mariella Sarestoeniemi, Zuomin Zhao, Teemu Myllyla
Summary: This paper provides a comprehensive overview of recent advancements in acousto-optic (AO)-based techniques in the field of medical applications, focusing on improvement in resolution, detection speed, and imaging depth. It covers theoretical modeling strategies, numerical simulation methods, and recent medical applications. The paper compares different techniques in terms of complexity, achieved depth in tissue, and resolution, as well as different numerical simulation methods. The challenges faced by AO techniques, particularly in realistic in vivo imaging, are also discussed, along with prospects of AO-based medical diagnosis methods.
Article
Medicine, General & Internal
Michael Bretthauer, Sara Gerke, Cesare Hassan, Omer F. Ahmad, Yuichi Mori
Summary: The European Union has implemented stricter regulations for medical devices through the Medical Device Regulation (MDR), which includes increased requirements for clinical trials and surveillance throughout the device's life cycle. New expert panels have been established to assess devices for certification, and the role of previous notified bodies has been expanded. All existing medical devices must be recertified under the MDR, with a deadline extension to 2027 or 2028. Meeting these new requirements may be uncertain for most manufacturers and the MDR is expected to have significant consequences for various stakeholders.
ANNALS OF INTERNAL MEDICINE
(2023)
Article
Education, Scientific Disciplines
Lauren M. Maloney, Mathew Hakimi, Thomas Hays, Joseph Adachi, Annie Chau, Brecken S. Esper, Vasilios Koulouris, Preston Kung, Karl R. Meier, Ryan S. Schum, Sha Sha, Ada Wong, Ariel Wu, Wei Yin, Christopher R. Page
Summary: Medical schools should provide students with more opportunities to learn the conceptual framework of medical device innovation, which will support the development of innovation skills such as clinical needs finding, concept generation, iterative prototyping, and intellectual property management.
Article
Business
Steffan James, Zheng Liu, Victoria Stephens, Gareth R. T. White
Summary: The COVID-19 pandemic has caused significant disruption to the healthcare sector, leading to an acceleration of medical innovations. This study aims to understand the nature of micro-relations within medical innovations during the COVID-19 crisis and examines the performance of medical innovation in response to the crisis.
TECHNOLOGICAL FORECASTING AND SOCIAL CHANGE
(2022)
Article
Engineering, Biomedical
Koji Nakao, Mitsuo Umezu, Kiyotaka Iwasaki
Summary: The Stanford Biodesign program has achieved significant outcomes in Japan by developing leadership talent and fostering entrepreneurship in medical technology innovation. Despite the challenges of low entrepreneurial awareness and new business entry rates in Japan, the program has demonstrated the need for improvement in business-related programs and team learning.
JOURNAL OF ARTIFICIAL ORGANS
(2022)
Editorial Material
Biotechnology & Applied Microbiology
Sainiteesh Maddineni, Wasan Kumar
Summary: The dominant paradigm in academic medicine is to develop new technologies and apply them to clinically relevant problems, but there is a need for greater emphasis on identifying important clinical problems before seeking solutions.
NATURE BIOTECHNOLOGY
(2023)
Article
Public, Environmental & Occupational Health
Feng Hu, Liping Qiu, Haiyan Zhou
Summary: This article analyzes international trade data of global medical device products, examines the impact of product distance on the feasibility of medical device products, and evaluates the innovation potential and opportunities for Asian countries' medical device products.
FRONTIERS IN PUBLIC HEALTH
(2022)
Article
Health Care Sciences & Services
Heejung Kim, Harry Jeong, Kwangsoo Shin
Summary: In order to avoid regulation becoming a hindrance to healthcare technological innovation, it is essential for regulation to adapt as new healthcare technologies emerge. This study developed a new method from a multi-layer perspective, analyzing papers, patents, and clinical research, and drawing regulatory implications based on it. By applying this method to intraocular lens (IOLs) for cataract treatment, the study identified four major healthcare technologies and two recent healthcare technologies, while also discussing current regulations' evaluation of these technologies. The findings provide insights into healthcare technological advances and the direction of regulatory evolution, contributing to the development of theoretical methods for co-evolution with regulations based on healthcare technology innovation.
Article
Surgery
Janene H. Fuerch, Paul Wang, Ryan Van Wert, Lyn Denend
Summary: Established in 2014, the Stanford Biodesign Faculty Fellows program aims to train medical and engineering faculty in a repeatable innovation process for health technology translation while accommodating their busy clinical schedules. Through an eight-month training program, participants are equipped with necessary skills and knowledge to advance technologies towards patient care. Survey results from three years of program participants show that the fellowship effectively improves awareness and experience with skill sets required for health technology innovation and entrepreneurship.
SURGICAL INNOVATION
(2021)
Review
Chemistry, Multidisciplinary
Ehsaneh Daghigh Ahmadi, Saudah Hafeji, Zohaib Khurshid, Eisha Imran, Muhammad Sohail Zafar, Morvarid Saeinasab, Farshid Sefat
Summary: This review paper focuses on the application of photonics in dentistry, including surgical applications, dental biomaterials, diagnosis, and treatments. Biophotonics is regarded as the application of photonics in medicine, while photonics is a technology for creating and connecting packets of light energy. The paper extensively discusses the main elements of photonics in dentistry.
APPLIED SCIENCES-BASEL
(2022)
Review
Chemistry, Analytical
Yasmin Mustapha Kamil, Muhammad Hafiz Abu Bakar, Nurul Hida Zainuddin, Mohd Hanif Yaacob, Mohd Adzir Mahdi
Summary: Biosensors play a crucial role in diagnostic and medicinal applications for monitoring, managing illness, and public health. Microfiber-based biosensors have the ability to sensitively measure the presence and behavior of biological molecules. The flexibility of microfiber in supporting different sensing layer designs and integration with nanomaterials enhances specificity.
Review
Chemistry, Multidisciplinary
Hui Li, Xin Wang, Tymish Y. Ohulchanskyy, Guanying Chen
Summary: Light in the near-infrared (NIR) spectral region is increasingly used in bioapplications due to its deeper penetration in biological tissues. Lanthanide-doped luminescent nanoparticles with excitation and/or emission in the NIR range are gaining attention for noninvasive biological applications, offering unique optical properties such as large Stokes shift, sharp luminescence emissions, long lifetimes, and photostability. Advanced strategies for enhancing the luminescence brightness of these nanoparticles have been introduced, along with a review of their superior biophotonic applications in high-resolution imaging, single-nanoparticle-level detection, and tissue-penetrating diagnostics and therapeutics.
ADVANCED MATERIALS
(2021)
Article
Business
Guilherme Sales Smania, Glauco Henrique de Sousa Mendes, Fabiane Leticia Lizarelli, Camila Favoretto
Summary: This study validates a model of relationships between critical factors such as service strategy, culture-climate, leadership, customer involvement, technology strategy and service innovation (SI), and investigates the impact of SI on a company's performance with the moderating role of digitalization. The results suggest positive associations between service strategy towards culture-climate, leadership, customer involvement, and technology strategy, but only customer involvement and technology strategy positively influence SI, affecting financial and non-financial performance. Digitalization does not strengthen the influence of four antecedents in SI.
JOURNAL OF BUSINESS & INDUSTRIAL MARKETING
(2022)
Review
Engineering, Biomedical
Chaymaa Hachimi Alaoui, Ahmed Fatimi
Summary: This patent review provides a comprehensive overview of innovations, inventions, and patents related to hydrogel coatings, which can be a valuable reference for researchers in the fields of coatings and interfaces, biofabrication, tissue engineering, biomaterials, and biomedical engineering. It specifically focuses on the patentability of hydrogel applications, such as coating medical devices to improve their clinical performance. A total of 2937 patent documents were found, with the year 2012 having the highest number of patent documents (177). The majority of patents and inventions are related to biomaterials for coating prostheses, characterized by their function or physical properties, such as macromolecular materials, hydrogels, and biologically active materials. The paper also highlights the research on medicinal formulations with unique physical forms, based on clusters of knowledge and expert driving factors. Finally, a selection of relevant patent applications, granted patents, and commercial products based on patented technologies are presented to illustrate the innovation trends in hydrogel-based coatings.
JOURNAL OF BIOMATERIALS SCIENCE-POLYMER EDITION
(2023)
Review
Health Care Sciences & Services
Jiakan Yu, Jiajie Zhang, Shintaro Sengoku
Summary: This study reviews the landscape of software as a medical device (SaMD) and aims to clarify the innovation process, typology, and driving mechanisms in the SaMD industry. The findings indicate that the current SaMD industry is concentrated in medical image processing and radiological analysis, with incumbents focusing on incremental innovation and startups producing disruptive innovation. Hardware medical devices serve as complementary assets for SaMD, and the interaction between SaMD and these assets varies based on intended use. Data accessibility plays a key role in building disruptive innovation.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Article
Biochemical Research Methods
Jiayue Li, Ewelina Pijewska, Qi Fang, Maciej Szkulmowski, Brendan F. Kennedy
Summary: In this study, the two most prevalent strain estimation methods used in compression optical coherence elastography (OCE) were analyzed and compared. A new phase unwrapping algorithm was proposed and combined with one of the methods, which resulted in improved accuracy and contrast in strain imaging.
BIOMEDICAL OPTICS EXPRESS
(2022)
Article
Optics
Alireza Mowla, Jiayue Li, Matt S. Hepburn, Samuel Maher, Lixin Chin, George C. Yeoh, Yu Suk Choi, Brendan F. Kennedy
Summary: This study presents a subcellular mechano-microscopy technique based on optical coherence microscopy, which enables more accurate mapping of cellular elasticity in three dimensions with higher resolution and contrast. This technique has important implications in cellular mechanics research and biomedical applications.
Article
Biochemical Research Methods
Ken Y. Foo, Kyle Newman, Qi Fang, Peijun Gong, Hina M. Ismail, Devina D. Lakhiani, Renate Zilkens, Benjamin F. Dessauvagie, Bruce Latham, Christobel M. Saunders, Lixin Chin, Brendan F. Kennedy
Summary: In this study, a convolutional neural network (CNN) was used for multi-class breast tissue classification using multi-channel optical coherence tomography (OCT) and attenuation images. The researchers introduced a novel loss function based on the Matthews correlation coefficient (MCC) to better correlate with performance metrics. The results showed that adding attenuation images to OCT images significantly improved the performance of breast tissue classification.
BIOMEDICAL OPTICS EXPRESS
(2022)
Article
Oncology
Peijun Gong, Synn Lynn Chin, Wes M. Allen, Helen Ballal, James D. Anstie, Lixin Chin, Hina M. Ismail, Renate Zilkens, Devina D. Lakhiani, Matthew McCarthy, Qi Fang, Daniel Firth, Kyle Newman, Caleb Thomas, Jiayue Li, Rowan W. Sanderson, Ken Y. Foo, Chris Yeomans, Benjamin F. Dessauvagie, Bruce Latham, Christobel M. Saunders, Brendan F. Kennedy
Summary: This study investigated the application of a handheld QME probe to directly detect residual cancer in the breast cavity during breast-conserving surgery. The results showed that QME detected increased stiffness in four cancer cases, while 19 out of 21 benign cases exhibited low stiffness.
Article
Biochemical Research Methods
Erin M. Lloyd, Matt S. Hepburn, Jiayue Li, Alireza Mowla, Yongsung Hwang, Yu Suk Choi, Miranda D. Grounds, Brendan F. Kennedy
Summary: The mechanical properties of skeletal muscle tissue at an intermediate scale can provide insights into diseases such as muscular dystrophies. In this study, the micro-scale elasticity of murine skeletal muscle was characterized using quantitative micro-elastography (QME). By encapsulating the muscles in transparent hydrogels with flat surfaces, high-quality QME images were obtained. The results showed a significant decrease in elasticity in dysferlin-deficient quadriceps compared to wild-type quadriceps, indicating the impact of dysferlinopathy on muscle function.
BIOMEDICAL OPTICS EXPRESS
(2022)
Article
Biochemical Research Methods
Alireza Mowla, Rose Belford, Julia Kohn-Gaone, Nathan Main, Janina E. E. Tirnitz-Parker, George C. Yeoh, Brendan F. Kennedy
Summary: Hepatocellular carcinoma, arising from cirrhosis, is a lethal cancer worldwide. The increased elasticity of the microenvironment due to chronic liver injury is a potential hepatocarcinogen, but its role is still not fully understood. This study proposes quantitative micro-elastography (QME) as a technique to map the micro-scale elasticity of liver tissue and correlate it with cellular scale cancerous mechanisms. Results of QME on mouse livers indicate a significant increase in elasticity caused by chronic liver injury, which correlates with pathological features such as fibrosis, hepatocyte damage, and immune cell infiltration, as shown in micro-elastograms.
BIOMEDICAL OPTICS EXPRESS
(2022)
Article
Multidisciplinary Sciences
Anastasia Nilasaroya, Alan Matthew Kop, Ryan Christopher Collier, Brendan Kennedy, Lachlan James Kelsey, Faz Pollard, Jennifer Fong Ha, David Anthony Morrison
Summary: A face shield is a secondary PPE for healthcare workers, providing short-term barrier protection against infectious droplet particles. The spike in demand for PPE during the COVID-19 pandemic led to shortages and risks for healthcare workers. This article describes the establishment of local face shield manufacturing in Western Australia to ensure an adequate supply of PPE. The face shields underwent rigorous testing and obtained a TGA license for medical use.
Article
Optics
Peijun Gong, Ken Y. Foo, Devina D. Lakhiani, Renate Zilkens, Hina M. Ismail, Chris Yeomans, Benjamin F. Dessauvagie, Bruce Latham, Christobel M. Saunders, Brendan F. Kennedy
Summary: To aid in the accurate removal of cancer cells during breast-conserving surgery, researchers have developed a handheld optical coherence tomography (OCT) probe and attenuation imaging method, which allows real-time imaging of the surgical cavity. Through experimental validation, this method has been shown to provide accurate and repeatable imaging, and offers an additional tissue contrast mechanism to assist in the identification and removal of cancer cells during breast-conserving surgery.
OPTICS AND LASER TECHNOLOGY
(2023)
Article
Optics
Qi Fang, Seokhyun Choi, Aiden Taba, Devina D. Lakhiani, Kyle Newman, Renate Zilkens, Rowan W. Sanderson, Benjamin F. Dessauvagie, Christobel M. Saunders, Brendan F. Kennedy
Summary: Optical palpation is a new emerging technique that uses an optical imaging system to generate images of mechanical contrast in tissue. A camera-based optical palpation system, called stereoscopic optical palpation (SOP), is proposed in this paper to directly map the strain of a compliant layer placed on top of the tissue. With SOP, a strain sensitivity of 4.2 m is achieved, which is a 24-fold improvement over previous camera-based optical palpation techniques. SOP has the potential for rapid and reliable imaging, and could be used for tumor margin assessment in breast-conserving surgery.
OPTICS AND LASERS IN ENGINEERING
(2023)
Article
Biochemical Research Methods
Qi Fang, Felipe A. Castro-Urrea, Felix Haederle, Rowan W. Sanderson, Dilusha Silva, Wallace A. Cowling, Brendan F. Kennedy
Summary: This study demonstrates the efficacy of OCT for accurate measurement of stem wall thickness of live field pea, and the differences in stem wall thickness and stem width between different cultivars.
Article
Biochemical Research Methods
Kai L. Metzner, Qi Fang, Rowan W. Sanderson, Alireza Mowla, Brendan F. Kennedy
Summary: This study systematically analyzes the impact of friction in quantitative micro-elastography (QME) and demonstrates that it is influenced by various experimental factors. Significant errors in elasticity estimation were observed in the absence of appropriate lubrication. The study also shows that friction can significantly reduce mechanical contrast in QME.
BIOMEDICAL OPTICS EXPRESS
(2023)
Article
Engineering, Biomedical
Danielle Vahala, Sebastian E. Amos, Marta Sacchi, Bram G. Soliman, Matt S. Hepburn, Alireza Mowla, Jiayue Li, Ji Hoon Jeong, Chrissie Astell, Yongsung Hwang, Brendan F. Kennedy, Khoon S. Lim, Yu Suk Choi
Summary: This study investigates the spatiotemporal shifts in biomechanical properties in tumor tissues and reveals an inverse relationship between spheroid volume and stiffness. The expression of proteins is also found to be correlated with spheroid volume. These findings highlight the importance of volume expansion as a key regulator in 3D mechanosensation of MCF7 breast cancer spheroids.
ADVANCED HEALTHCARE MATERIALS
(2023)
Article
Cell Biology
Francois Xavier Rwandamuriye, Cameron W. Evans, Ben Wylie, Marck Norret, Breana Vitali, Diwei Ho, Dat Nguyen, Ellise A. Roper, Tao Wang, Matt S. Hepburn, Rowan W. Sanderson, Maren Pfirrmann, Vanessa S. Fear, Catherine A. Forbes, Ken Wyatt, Anne L. Ryan, Terrance G. Johns, Marianne B. Phillips, Rupert Hodder, Connull Leslie, Brendan F. Kennedy, Rachael M. Zemek, Killugudi Swaminathan Iyer, Willem Joost Lesterhuis
Summary: Recurrences often occur after surgical removal of primary tumors and adjuvant therapies have limited efficacy. This study developed a surgically optimized biodegradable hydrogel for sustained release of poly(I:C) during surgery, which significantly reduced tumor recurrence in multiple mouse models. Mechanistically, poly(I:C) reshaped the tumor/wound microenvironment by inducing a temporary interferon alpha (IFNa) response, attracting inflammatory monocytes and depleting regulatory T cells. The study also demonstrated that a pre-existing IFN signature predicted the response to the poly(I:C) hydrogel, making tumors more sensitive to immune checkpoint therapy. Veterinary trial in dogs confirmed the safety, immunogenicity, and surgical feasibility of the optimized hydrogel. This surgically optimized poly(I:C)-loaded hydrogel provides a safe and effective approach to prevent cancer recurrence.
CELL REPORTS MEDICINE
(2023)
Article
Materials Science, Multidisciplinary
Evelyn Collier, Brooke Maitland, Rowan W. Sanderson, Behzad Shiroud Heidari, Christopher Lamb, Matt S. Hepburn, Paul D. Dalton, Qi Fang, Elena M. De-Juan-Pardo, Brendan F. Kennedy
Summary: This study describes an in situ method using optical coherence tomography (OCT) to characterize the 3D microstructure of melt electrowritten (MEW) scaffolds. A custom algorithm is used to perform calculations on OCT data, showing close correspondence with scanning electron microscopy (SEM). The 3D capabilities of OCT enable nondestructive characterization of scaffolds with depth-varying microstructures. Integration of the OCT scanner within an MEW printer allows for in situ evaluation and optimization of scaffold microstructure.
ADVANCED PHOTONICS RESEARCH
(2022)
Meeting Abstract
Clinical Neurology
E. Lloyd, M. Hepburn, J. Li, A. Mowla, Y. Choi, Y. Hwang, C. Jackaman, B. Kennedy, M. Grounds
NEUROMUSCULAR DISORDERS
(2022)
