Efficacy of human resource development program for young industry personnel who will be involved in future medical device development

Background: Training next-generation personnel from small/medium enterprises (SMEs) is an urgent issue in promoting medical device research and development (R&D). Since 2014 we have engaged in governmentally funded human resource development program for medical/non-medical SMEs, and have assessed its effectiveness by analyzing self-evaluation of achievement level (SEAL) data obtained before and after the training course. Methods: Human resource development experts interviewed 34 key opinion leaders with deep knowledge of medical device R&D from industry, government, and academia. The skills required for R&D personnel were written down, and a set of skills was created by making a greatest common measure in the list of common elements among them. Using that skill sets, skill evaluations were conducted on trainees at “Osaka University Training Course,” twice before participation and after completion of the entire program using SEAL assessment. Results: There were 97 men and 25 women, with one-third in the’30 s. Among them, 61 participants (50%) were from R&D divisions, and 32 (26%) were from business/sales divisions. 94 (77%) were from medical SMEs, and 28 (23%) were from non-medical SMEs (new entry). After completing the training course, significant growth was observed in every item of both Soft and Hard skill sets. Especially in new entry SME members, a striking improvement was observed in practical medical knowledge to enhance communication with medical doctors (p < 0.0001). Conclusion: Our training course, though 7-day-short in total, showed that both Soft and Hard skills could be improved in young medical/non-medical SME members. Further assessment is needed to establish the necessary skill sets for our future partners from industries, to foster the creation of innovative medical devices through med-tech collaboration.The version of record of this article, first published in Surgical Endoscopy, is available online at Publisher’s website: https://doi.org/10.1007/s00464-023-10474-

Development of the ARICA-2 Satellite Using Spresense as an Onboard Computer

Gamma-ray bursts (GRBs) are transient astronomical phenomena that emit enormous amounts of energy in electromagnetic waves, mainly in the gamma-ray range, for several seconds to tens of seconds. GRB observations are challenging because of the difficulty in predicting the location and time of occurrence and its extremely short duration. Therefore, it is necessary to notify about the discovery in space and to conduct follow-up observations by researchers. The AGU Remote Innovative CubeSat Alert system-2 (ARICA-2) has been developed to demonstrate a new alert system using commercial satellite network services. ARICA-2 uses SONY’s Spresense as its onboard computer (OBC). We manufactured the special board to attach two Spresenses as a redundancy of the OBC system. We will present the system development of ARICA-2 using Spresense

Power System Development of the AGU Remote Innovative CubeSat Alert System -2 – ARICA-2

We present the power system development of the 2U CubeSat, AGU Remote Innovative CubeSat Alert system -2(ARICA-2). The main goal of the ARICA-2 project is to demonstrate the real-time alert system of transient astronomical sources using commercial satellite network devices. 1U CubeSat ARICA was launched in November 2021. However, we have not been able to send and receive the data at this point. Therefore, we started developing 2U CubeSat ARICA-2, which is an improved version of ARICA, in April 2022. One of the possible causes of the communication problem of ARICA is the power system, such as a negative power budget or a failure in the installation of the inhibit switches. ARICA-2 is upsized from 1U to 2U to ensure a sufficient power generation and is equipped with improved inhibit switches. The calculation of power consumption and simulation of power supply on orbit have been finished. We confirmed the performance of our Electric Power System (EPS) and the health of the installed batteries. We are currently in the EM development phase with the goal of launching in Japanese fiscal year 2024

Overview and Status of AGU Remote Innovative Cubesat Alert System-2 on 2023

We present the overview of the 2U CubeSat, AGU Remote Innovative Cubesat Alert system - 2 (ARICA-2). ARICA-2 was selected as a feasibility study phase of the JAXA-Small Satellite Rush Program (JAXA-SMASH) and the JAXA Innovative Satellite Technology Demonstration-4 project in 2022. The main goal of ARICA-2 is to demonstrate the real-time alert system of transient astronomical sources, such as gamma-ray bursts, using commercial satellite network services. The first 1U CubeSat ARICA, which had the same mission goal as ARICA-2, was successfully launched in 2021 by the JAXA’s Epsilon rocket No.5. However, communication with ARICA has yet to be established due to severe hardware issues. Therefore, ARICA-2 is the re-challenging mission of ARICA. ARICA-2 has several different features compared to ARICA. First, a transceiver using amateur radio frequency is added to the commercial satellite network devices to communicate directly from the ground. Second, ARICA-2 uses Sony’s low-power board Spresense as an onboard computer. Third, the attitude control system using magnetorquer is installed to establish better communication with the commercial network satellites. Fourth, the size of a gamma-ray detector is 70 mm x 70 mm x 10 mm, which is larger by a factor of 200 in volume compared to ARICA, to enhance the detection rate of gamma-ray bursts. We plan to develop the engineering model (EM) in 2023 and perform thermal vacuum and vibration tests on the EM. We report the current status and a prospect of ARICA-2

Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort

The version of record of this article, first published in Esophagus, is available online at Publisher’s website: https://doi.org/10.1007/s10388-024-01056-w.Background: Real-world clinical outcomes of and prognostic factors for nivolumab treatment for esophageal squamous-cell carcinoma (ESCC) remain unclear. This study aimed to evaluate real-world outcomes of nivolumab monotherapy in association with relevant clinical parameters in recurrent/unresectable advanced ESCC patients. Methods: This population-based multicenter cohort study included a total of 282 patients from 15 institutions with recurrent/unresectable advanced ESCC who received nivolumab as a second-line or later therapy between 2014 and 2022. Data, including the best overall response, progression-free survival (PFS), and overall survival (OS), were retrospectively collected from these patients. Results: Objective response and disease control rates were 17.0% and 47.9%, respectively. The clinical response to nivolumab treatment significantly correlated with development of overall immune-related adverse events (P <.0001), including rash (P <.0001), hypothyroidism (P =.03), and interstitial pneumonia (P =.004). Organ-specific best response rates were 20.6% in lymph nodes, 17.4% in lungs, 15.4% in pleural dissemination, and 13.6% in primary lesions. In terms of patient survival, the median OS and PFS was 10.9 and 2.4 months, respectively. Univariate analysis of OS revealed that performance status (PS; P <.0001), number of metastatic organs (P =.019), C-reactive protein-to-albumin ratio (CAR; P <.0001), neutrophil–lymphocyte ratio (P =.001), and PMI (P =.024) were significant. Multivariate analysis further identified CAR [hazard ratio (HR) = 1.61, 95% confidence interval (CI) 1.15–2.25, P =.0053)] in addition to PS (HR = 1.65, 95% CI 1.23–2.22, P =.0008) as independent prognostic parameters. Conclusions: CAR and PS before nivolumab treatment are useful in predicting long-term survival in recurrent/unresectable advanced ESCC patients with second-line or later nivolumab treatment

An international Delphi consensus for surgical quality assessment of lymphadenectomy and anastomosis in minimally invasive total gastrectomy for gastric cancer

BACKGROUND: Minimally invasive total gastrectomy (MITG) is a mainstay for curative treatment of patients with gastric cancer. To define and standardize optimal surgical techniques and further improve clinical outcomes through the enhanced MITG surgical quality, there must be consensus on the key technical steps of lymphadenectomy and anastomosis creation, which is currently lacking. This study aimed to determine an expert consensus from an international panel regarding the technical aspects of the performance of MITG for oncological indications using the Delphi method. METHODS: A 100-point scoping survey was created based on the deconstruction of MITG into its key technical steps through local and international expert opinion and literature evidence. An international expert panel comprising upper gastrointestinal and general surgeons participated in multiple rounds of a Delphi consensus. The panelists voted on the issues concerning importance, difficulty, or agreement using an online questionnaire. A priori consensus standard was set at > 80% for agreement to a statement. Internal consistency and reliability were evaluated using Cronbach's α. RESULTS: Thirty expert upper gastrointestinal and general surgeons participated in three online Delphi rounds, generating a final consensus of 41 statements regarding MITG for gastric cancer. The consensus was gained from 22, 12, and 7 questions from Delphi rounds 1, 2, and 3, which were rephrased into the 41 statetments respectively. For lymphadenectomy and aspects of anastomosis creation, Cronbach's α for round 1 was 0.896 and 0.886, and for round 2 was 0.848 and 0.779, regarding difficulty or importance. CONCLUSIONS: The Delphi consensus defined 41 steps as crucial for performing a high-quality MITG for oncological indications based on the standards of an international panel. The results of this consensus provide a platform for creating and validating surgical quality assessment tools designed to improve clinical outcomes and standardize surgical quality in MITG

An international Delphi consensus for surgical quality assessment of lymphadenectomy and anastomosis in minimally invasive total gastrectomy for gastric cancer

Minimally invasive total gastrectomy (MITG) is a mainstay for curative treatment of patients with gastric cancer. To define and standardize optimal surgical techniques and further improve clinical outcomes through the enhanced MITG surgical quality, there must be consensus on the key technical steps of lymphadenectomy and anastomosis creation, which is currently lacking. This study aimed to determine an expert consensus from an international panel regarding the technical aspects of the performance of MITG for oncological indications using the Delphi method. A 100-point scoping survey was created based on the deconstruction of MITG into its key technical steps through local and international expert opinion and literature evidence. An international expert panel comprising upper gastrointestinal and general surgeons participated in multiple rounds of a Delphi consensus. The panelists voted on the issues concerning importance, difficulty, or agreement using an online questionnaire. A priori consensus standard was set at > 80% for agreement to a statement. Internal consistency and reliability were evaluated using Cronbach's α. Thirty expert upper gastrointestinal and general surgeons participated in three online Delphi rounds, generating a final consensus of 41 statements regarding MITG for gastric cancer. The consensus was gained from 22, 12, and 7 questions from Delphi rounds 1, 2, and 3, which were rephrased into the 41 statetments respectively. For lymphadenectomy and aspects of anastomosis creation, Cronbach's α for round 1 was 0.896 and 0.886, and for round 2 was 0.848 and 0.779, regarding difficulty or importance. The Delphi consensus defined 41 steps as crucial for performing a high-quality MITG for oncological indications based on the standards of an international panel. The results of this consensus provide a platform for creating and validating surgical quality assessment tools designed to improve clinical outcomes and standardize surgical quality in MITG. The online version contains supplementary material available at 10.1007/s00464-023-10614-9