Best Practices Associated with Medical Device Regulatory Strategy Success: A Case Study

In the evolving medical device industry, understanding how to achieve effective regulatory strategies is crucial. This study explored the foundations of regulatory strategy success in the United States, using qualitative insights from regulatory affairs professionals and industry investors. It identified operational, leadership, product design, and external factors essential for developing and implementing successful regulatory strategies. Key findings highlighted the importance of financial planning, agile regualtory process management, strategic knowledge integration, and proactive engagement with regulatory authorities. The study also pointed to the role of business ecosystems in supporting regulatory outcomes, suggesting a strategic planning approach that aligns product design with quality and business goals. This research contributed to the academic and practical discussion on regulatory strategy in the medical device sector, providing insights for stakeholders from entrepreneurs to investors. It shed light on the complexity of regulatory pathways in the United States and its influence on market access, encouraging further research on the impact of technological advancements and global regulatory changes on strategy effectiveness

Sensory Computing and Object Processing Entity: Assistive Robotics for Healthcare

Team SCOPE has created an assistive robot for healthcare delivery. The robot is mobile, responds to spoken commands, and possesses Artificial Intelligence (AI). It extracts meanings about the patient’s health from conversations and visual interactions. It summarizes these observations into reports that could be merged with the patient’s Electronic Health Records (EHRs). This process aids healthcare professionals in delivering better care by augmenting attendance, increasing accuracy of patient information collection, aiding in diagnosis, streamlining data collection, and automating the process of ingesting and incorporating this information into EHR systems. SCOPE’s solution uses cloud-based AI services along with local processing. Using VEX Robotics parts and an Arduino microcontroller, SCOPE created a mobile platform for the robot. The robotic platform implements basic motions and obstacle avoidance. These separate systems are integrated using a Java master program, Node-Red, and IBM Watson cloud services. The resulting AI can be expanded for different applications within healthcare delivery

Development of a mapping system engineering approaches to classic product development processes of technical products: A work project of project management in product development

Project Work presented as the partial requirement for obtaining a Master's degree in Information Management, specialization in Information Systems and Technologies ManagementThe automotive industry faces the challenge of meeting customer requirements while ensuring technological advancements, fast and cost-effective development, and high-quality production. Information systems play a crucial role in efficiently designing internal processes and meeting customer demands. Personalized solutions are increasingly adopted to cater to individual preferences while maintaining up-to-date technology. Information systems are utilized to record and manage customer requirements, optimize production processes, control inventories, and facilitate effective communication between departments. Product data management (PDM) solutions are widely employed, with 77% of automotive companies implementing them. PDM encompasses the storage and management of data relevant to product development, supporting the entire product lifecycle. As product complexity grows, efficient management of product data becomes essential, along with the optimization of business processes to shorten development time and parallelize tasks. CAx coordination, involving computer-aided design (CAD), manufacturing (CAM), and engineering (CAE), ensures smooth communication and coordination across the product development process. PDM systems act as intermediaries between CAx coordination and enterprise resource planning systems, facilitating seamless integration of design and manufacturing processes. Leading providers of enterprise resource planning and CAD systems offer software solutions for product lifecycle management and PDM, enabling centralized and accessible product information, streamlining development and management processes

Revolutionizing Pharma: Unveiling the AI and LLM Trends in the Pharmaceutical Industry

This document offers a critical overview of the emerging trends and significant advancements in artificial intelligence (AI) within the pharmaceutical industry. Detailing its application across key operational areas, including research and development, animal testing, clinical trials, hospital clinical stages, production, regulatory affairs, quality control and other supporting areas, the paper categorically examines AI's role in each sector. Special emphasis is placed on cutting-edge AI technologies like machine learning algorithms and their contributions to various aspects of pharmaceutical operations. Through this comprehensive analysis, the paper highlights the transformative potential of AI in reshaping the pharmaceutical industry's future

Complexity, transparency and time pressure: practical insights into science communication in times of crisis

A global crisis such as the COVID-19 pandemic that started in early 2020 poses significant challenges for how research is conducted and communicated. We present four case studies from the perspective of an interdisciplinary research institution that switched to “corona-mode” during the first two months of the crisis, focussing all its capacities on COVID-19-related issues, communicating to the public directly and via media, as well as actively advising the national government. The case studies highlight the challenges posed by the increased time pressure, high demand for transparency, and communication of complexity and uncertainty. The article gives insights into how these challenges were addressed in our research institution and how science communication in general can be managed during a crisis

Project Half Double Current Results of Phase 1 and Phase 2, December 2017

The Half Double mission: Project Half Double has a clear mission. We want to succeed in finding a project methodology that can increase the success rate of our projects while increasing the development speed of new products and services. We are convinced that by doing so we can strengthen Denmark’s competitiveness and play an important role in the battle for jobs and future welfare. The overall goal is to deliver “Projects in half the time with double the impact” where projects in half the time should be understood as half the time to impact (benefit realization, effect is achieved) and not as half the time for project execution. The Half Double project journey: It all began in May 2013 when we asked ourselves: How do we create a new and radical project paradigm that can create successful projects? Today the movement includes hundreds of passionate project people, and it grows larger by the day. The formal part of Project Half Double was initiated in June 2015. It is a two-phase project: phase 1 took place from June 2015 to June 2016 with seven pilot projects, and phase 2 is in progress from July 2016 to July 2018 with 10 pilot projects.The Half Double consortium: Implement Consulting Group is the project leader establishing and managing the collaboration with the pilot project companies in terms of methodology. Aarhus University and the Technical University of Denmark will evaluate the impact of the pilot projects and legitimize the methodology in academia.The Danish Industry Foundation, an independent philanthropic foundation, is contributing to the project financially with DKK 13.8 million.About this report: This report focuses on phase 2 pilot projects documenting their development and further consolidates results from the phase 1 pilot projects. This is the third report about Project Half Double (Svejvig et al. 2016, Svejvig et al. 2017). This report’s target group inludes practitioners in Danish industry and society in general. The editorial team from Aarhus University prepared the report from October 2017 to December 2017, which means that data about pilot projects from December 2017 is not included