Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　- Harmonization By Doing for Children.

BACKGROUND: The Harmonization By Doing (HBD) program was established in 2003 as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on streamlining processes of global medical device development for cardiovascular medical devices. While HBD has traditionally focused on development of devices intended to treat conditions prevalent in adults, in 2016, HBD established the "HBD-for-Children" program, which focuses on the development of pediatric devices as the development of medical devices for pediatric use lags behind that of medical devices for adults in both countries.Methods and Results:Activities of the program have included: (1) conducting a survey with industry to better understand the challenges that constrain the development of pediatric medical devices; (2) categorizing pediatric medical devices into five categories based on global availability and exploring concrete solutions for the early application and regulatory approval in both geographies; and (3) facilitating global clinical trials of pediatric medical devices in both countries. CONCLUSIONS: The establishment of the HBD-for-Children program is significant because it represents a global initiative for the introduction of pediatric medical devices for patients in a timely manner. Through the program, academia, industry and regulatory agencies can work together to facilitate innovative pediatric device development from a multi-stakeholder perspective. This activity could also encourage industry partners to pursue the development of pediatric medical devices.

Technical and scale efficiency in public and private Irish nursing homes - a bootstrap DEA approach.

This article provides methodological and empirical insights into the estimation of technical efficiency in the nursing home sector. Focusing on long-stay care and using primary data, we examine technical and scale efficiency in 39 public and 73 private Irish nursing homes by applying an input-oriented data envelopment analysis (DEA). We employ robust bootstrap methods to validate our nonparametric DEA scores and to integrate the effects of potential determinants in estimating the efficiencies. Both the homogenous and two-stage double bootstrap procedures are used to obtain confidence intervals for the bias-corrected DEA scores. Importantly, the application of the double bootstrap approach affords true DEA technical efficiency scores after adjusting for the effects of ownership, size, case-mix, and other determinants such as location, and quality. Based on our DEA results for variable returns to scale technology, the average technical efficiency score is 62 %, and the mean scale efficiency is 88 %, with nearly all units operating on the increasing returns to scale part of the production frontier. Moreover, based on the double bootstrap results, Irish nursing homes are less technically efficient, and more scale efficient than the conventional DEA estimates suggest. Regarding the efficiency determinants, in terms of ownership, we find that private facilities are less efficient than the public units. Furthermore, the size of the nursing home has a positive effect, and this reinforces our finding that Irish homes produce at increasing returns to scale. Also, notably, we find that a tendency towards quality improvements can lead to poorer technical efficiency performance.