FDA Regulation Impact on Early Stage Medical Device Innovation in Academia

The commercialization of medical products at the university level is a multilayered and challenging process. One barrier to commercialization is the difficulty of meeting Food and Drug Administration (FDA) regulatory requirements. Regulations and standards are undoubtedly necessary to maintain the highest product safety levels, but it creates many obstacles. This paper will analyze how researchers involved with early-stage medical device innovation in a university setting deal with FDA compliance issues and the implications of this engagement for innovation. I conducted an exploratory case study of ten medical product development projects at the Rochester Institute of Technology (RIT). Overall, I found that FDA approval pathways were challenging for project participants to navigate without proper resources; approximately half of the projects indicated a lack of confidence in their knowledge of and/or progress towards meeting FDA requirements based on the resources available. I offer several suggestions regarding how RIT and other universities can reduce barriers to innovation caused by FDA regulation through actions, both internal and external to the university

Competing by Saving Lives: How Pharmaceutical and Medical Device Companies Create Shared Value in Global Health

This report looks at how pharmaceutical and medical device companies can create shared value in global health by addressing unmet health needs in low- and middle-income countries. Companies have already begun to reap business value and are securing competitive advantages in the markets of tomorrow

London Creative and Digital Fusion

date-added: 2015-03-24 04:16:59 +0000 date-modified: 2015-03-24 04:16:59 +0000date-added: 2015-03-24 04:16:59 +0000 date-modified: 2015-03-24 04:16:59 +0000The London Creative and Digital Fusion programme of interactive, tailored and in-depth support was designed to support the UK capital’s creative and digital companies to collaborate, innovate and grow. London is a globally recognised hub for technology, design and creative genius. While many cities around the world can claim to be hubs for technology entrepreneurship, London’s distinctive potential lies in the successful fusion of world-leading technology with world-leading design and creativity. As innovation thrives at the edge, where better to innovate than across the boundaries of these two clusters and cultures? This booklet tells the story of Fusion’s innovation journey, its partners and its unique business support. Most importantly of all it tells stories of companies that, having worked with London Fusion, have innovated and grown. We hope that it will inspire others to follow and build on our beginnings.European Regional Development Fund 2007-13

Using Serious Games to Motivate Children with Cystic Fibrosis to Engage with Mucus Clearance Physiotherapy

Positive expiratory pressure (PEP) therapy is an effective method for removing mucus build-up in the lungs of sufferers of chronic lung diseases such as cystic fibrosis (CF). However, the compliance by young children and adolescents to undertake such physiotherapy can lead to confrontation and stressful situations within families, and can impact on the health of the individual. We have developed game software which is controlled through breathing into a PEP mask or mouthpiece using an air pressure sensor to interface with the PC. By combining games with mucus clearing devices, it could provide a powerful means of encouraging children, teenagers and adults to engage more frequently, and effectively, with vital mucus clearance physiotherapy. This paper presents promising initial results and describes further usability testing plans

Creative communities:shaping process through performance and play

This paper studies the use of play as a method to unlock creativity and innovation within a community of practice (a group of individuals who share a common interest and who see value in interaction to enhance their understanding). An analysis of communities of practice and the value of play informs evaluation of two case studies exploring the development of communities of practice, one within the discipline of videogames and one which bridges performing arts and videogames. The case studies provide qualitative data from which the potential of play, as a method to inspire creativity and support the development of a potential community of practice, is recognised. Establishing trust, disruption of process through play and reflection are key steps proposed in a ‘context provider’s framework’ for individuals or organisations to utilise in the design of activities to support creative process and innovation within a potential community of practice

Planning for the mobile library: a strategy for managing innovation and transformation at the University of Glasgow Library

Modern mobile devices have powerful features that are transforming access to information. Lippincott argues that as mobile devices such as smartphones become ‘key information devices’ for our users, libraries will want to have a significant presence in offering content and services that are suitable for this medium. This article outlines the process of development and implementation of a mobile strategy at the University of Glasgow Library. What began as an investigation into a mobile interface to the library catalogue evolved into a comprehensive strategic review of how we deliver services now and in the future in this rapidly changing mobile environment

Sociology of low expectations: Recalibration as innovation work in biomedicine

"This article is distributed under the terms of the Creative Commons Attribution 3.0 License (http://www.creativecommons.org/licenses/by/3.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm). "Social scientists have drawn attention to the role of hype and optimistic visions of the future in providing momentum to biomedical innovation projects by encouraging innovation alliances. In this article, we show how less optimistic, uncertain, and modest visions of the future can also provide innovation projects with momentum. Scholars have highlighted the need for clinicians to carefully manage the expectations of their prospective patients. Using the example of a pioneering clinical team providing deep brain stimulation to children and young people with movement disorders, we show how clinicians confront this requirement by drawing on their professional knowledge and clinical expertise to construct visions of the future with their prospective patients; visions which are personalized, modest, and tainted with uncertainty. We refer to this vision-constructing work as recalibration, and we argue that recalibration enables clinicians to manage the tension between the highly optimistic and hyped visions of the future that surround novel biomedical interventions, and the exigencies of delivering those interventions in a clinical setting. Drawing on work from science and technology studies, we suggest that recalibration enrolls patients in an innovation alliance by creating a shared understanding of how the “effectiveness” of an innovation shall be judged.This project was funded by the Wellcome Trust (Wellcome Trust Biomedical Strategic Award 086034)

Human-Robot Collaboration as a new paradigm in circular economy for WEEE management

E-waste is a priority waste stream as identified by the European Commission due to fast technological changes and eagerness of consumers to acquire new products. The value chain of the Waste on Electric and Electronic Equipment (WEEE) has to face several challenges: the EU directives requesting collection targets for 2019–2022, the costs of disassembly processes which is highly dependent on the applied technology and type of discarded device, and the sale of the obtained components and/or raw materials, with market prices varying according to uncontrolled variables at world level. This paper presents a human-robot collaboration for a recycling process where tasks are opportunistically assigned to either a human-being or a robot depending on the condition of the discarded electronic device. This solution presents some important advantages; i.e. tedious and dangerous tasks are assigned to robots whereas more value-added tasks are allocated to humans, thus preserving jobs and increasing job satisfaction. Furthermore, first results from a prototype show greater productivity and profitable projected investment