How the FDA aims to speed review of medical devices

Curated on Posted on by Stefaan Verhulst

Kathleen Hickey at GCN: “The Food and Drug Administration is piloting a new system to speed up the premarket review process for new medical devices.

One of the main bottlenecks in the medical device review process is finding the right expert reviewer. Currently the FDA relies on “the usual suspects” – a core group of reviewers from the FDA Office of Device Evaluation (ODE), according to a GovLab report on the pilot program. However, this pool of experts is limited and may not include those with knowledge of the specific technologies in new medical devices. Finding qualified reviewers outside this core group can take as long as nine months.

To combat the issue, the Department of Health and Human Services is creating a network database of experts — HHS Profiles — based on a customized version of theHarvard Profiles Research Networking Software, a National Institutes of Health-funded open source tool for finding researchers with specific areas of expertise.

Potential expert reviewers create profiles in the system describing their skills and experience. The software then imports and analyzes reviewer contact information, publications and other data sources to create and maintain a searchable library of electronic resumes of HHS experts. Representatives of the Office for Device Evaluation can then search the profiles to identify the most qualified individuals to participate in the regulatory review of a given medical device.

The pilot will compare the efficacy of picking expert reviewers from profiles versus the current methods, including determining whether matching individuals based on their published articles and academic degrees is the best method for finding the right reviewer; the time required for the panel to meet and review a device; and safety outcomes – e.g. product recalls and adverse event reports.

The FDA anticipates the new platform will increase the speed and effectiveness of the medical device regulatory review process and expand the pool of reviewers. Currently the premarket approval review process, done exclusively by internal staff, takes an average of 266 days. Reviewing unique devices takes an average of 18 months.

The pilot program is being conducted this year in partnership with GovLab and its MacArthur Foundation Research Network on Opening Governance.  Funding is provided by the General Services Administration from its The Great Pitch investment contest….(More)”

Accelerating Discovery with New Tools and Methods for Next Generation Social Science

Curated on Posted on by Stefaan Verhulst

DARPA: “The explosive growth of global digital connectivity has opened new possibilities for designing and conducting social science research. Once limited by practical constraints to experiments involving just a few dozen participants—often university students or other easily available groups—or to correlational studies of large datasets without any opportunity for determining causation, scientists can now engage thousands of diverse volunteers online and explore an expanded range of important topics and questions. If new tools and methods for harnessing virtual or alternate reality and massively distributed platforms could be developed and objectively validated, many of today’s most important and vexing challenges in social science—such as identifying the primary drivers of social cooperation, instability and resilience—might be made more tractable, with benefits for domains as broad as national security, public health, and economics.

To begin to assess the research opportunities provided by today’s web-connected world and advanced technologies, DARPA today launched its Next Generation Social Science (NGS2) program. The program aims to build and evaluate new methods and tools to advance rigorous, reproducible social science studies at scales necessary to develop and validate causal models of human social behaviors. The program will draw upon and build across a wide array of disciplines—including social sciences like sociology, economics, political science, anthropology, and psychology, as well as information and computer sciences, physics, biology and math.

As an initial focus, NGS2 will challenge researchers to develop and use these new tools and methods to identify causal mechanisms of “collective identity” formation—how a group of individuals becomes a unified whole, and how under certain circumstances that community breaks down into a chaotic mix of disconnected individuals.

“Social science has done a remarkable job of helping us understand ourselves as the highly social creatures we are, but the field has long acknowledged and rued some frustrating research limitations, including technical and logistical limits to experimentally studying large, representative populations and the challenges of replicating key studies to better understand the limits of our knowledge,” said Adam Russell, DARPA program manager. “As a result, it’s been difficult for social scientists to determine what variables matter most in explaining their observations of human social systems and to move from documenting correlation to identifying causation.”

On top of those methodological and analytic limitations, Russell said, the field is inherently challenged because of its subject matter: human beings, with all their complex variability and seeming unpredictability. “Physicists have joked about how much more difficult their field would be if atoms or electrons had personalities, but that’s exactly the situation faced by social scientists,” he said.

By developing and applying new methods and models to larger, more diverse, and more representative groups of individuals—such as through web-based global gaming and alternate reality platforms—NGS2 seeks to validate new tools that may empower social science in the same way that sophisticated telescopes and microscopes have helped advance astronomy and biology….(More)”

Don’t know where to go when the volcano blows? Crowdsource it.

Curated on Posted on by Stefaan Verhulst

Anne Frances Johnson in ThrivingEarthExchange: “In the shadow of a rumbling volcano, Quito, Ecuador solicits just-in-time advice from the world’s disaster experts…

Cotopaxi’s last large-scale eruption was in 1877, and the volcano’s level of activity suggests another one is inevitable. In addition to spewing lava, a major eruption would melt Cotopaxi’s glaciers and send a large flow of material barreling down the mountain, posing an immediate risk to people and potentially causing rivers to overflow their banks. Some 120,000 people living in the valley beneath the volcano would have a mere 12 minutes to escape the lava’s path, and more than 325,000 other area residents would have only slightly more time to evacuate. An eruption could also create significant long-term challenges across a broad area, including dangerous air quality and disruptions to infrastructure, food systems and water supplies.

As danger looms, a city gets coaching from the crowd

Aware that the city was underprepared for a significant eruption, The Governance Lab, a program of the New York University Tandon School of Engineering, volunteered its time and expertise to help local officials accelerate preparation efforts. The GovLab, which helps governments and other institutions work collaboratively to solve problems, teamed up with Linq, the city’s innovation agency.

“We were very aware that this was a time-sensitive matter—we needed experts, and we needed them fast,” explained Dinorah Cantú-Pedraza, a human rights lawyer and Research Fellow at The GovLab who collaborated on the project. “So that’s why we decided to create online sessions focused on how innovations can solve specific problems facing the city.”…

GovLab’s “fail-fast, learn-by-doing” approach is crucial to its projects’ success in remaining responsive to the problems at hand. “That was a central element in how we worked with our partners and improved the approach as we went forward,” said Cantú-Pedraza.

To help translate the Cotopaxi crowdsourcing model for other circumstances, GovLab is working to build a network of innovators and experts that can be tapped on short notice to address problems as they emerge around the world. Although we can hope for the best in Quito and elsewhere, the reality is that we must plan for the worst…(More)

Revolutionizing Innovation: Users, Communities, and Open Innovation

Curated on Posted on by Stefaan Verhulst

Book edited by Dietmar Harhoff and Karim R. Lakhani: “The last two decades have witnessed an extraordinary growth of new models of managing and organizing the innovation process that emphasizes users over producers. Large parts of the knowledge economy now routinely rely on users, communities, and open innovation approaches to solve important technological and organizational problems. This view of innovation, pioneered by the economist Eric von Hippel, counters the dominant paradigm, which cast the profit-seeking incentives of firms as the main driver of technical change. In a series of influential writings, von Hippel and colleagues found empirical evidence that flatly contradicted the producer-centered model of innovation. Since then, the study of user-driven innovation has continued and expanded, with further empirical exploration of a distributed model of innovation that includes communities and platforms in a variety of contexts and with the development of theory to explain the economic underpinnings of this still emerging paradigm. This volume provides a comprehensive and multidisciplinary view of the field of user and open innovation, reflecting advances in the field over the last several decades.

The contributors—including many colleagues of Eric von Hippel—offer both theoretical and empirical perspectives from such diverse fields as economics, the history of science and technology, law, management, and policy. The empirical contexts for their studies range from household goods to financial services. After discussing the fundamentals of user innovation, the contributors cover communities and innovation; legal aspects of user and community innovation; new roles for user innovators; user interactions with firms; and user innovation in practice, describing experiments, toolkits, and crowdsourcing, and crowdfunding…(More)”

The New ABCs of Research: Achieving Breakthrough Collaborations

Curated on Posted on by Stefaan Verhulst

Book by Ben Shneiderman: “The problems we face in the 21st century require innovative thinking from all of us. Be it students, academics, business researchers of government policy makers. Hopes for improving our healthcare, food supply, community safety and environmental sustainability depend on the pervasive application of research solutions.

The research heroes who take on the immense problems of our time face bigger than ever challenges, but if they adopt potent guiding principles and effective research lifecycle strategies, they can produce the advances that will enhance the lives of many people. These inspirational research leaders will break free from traditional thinking, disciplinary boundaries, and narrow aspirations. They will be bold innovators and engaged collaborators, who are ready to lead, yet open to new ideas, self-confident, yet empathetic to others.

In this book, Ben Shneiderman recognizes the unbounded nature of human creativity, the multiplicative power of teamwork, and the catalytic effects of innovation. He reports on the growing number of initiatives to promote more integrated approaches to research so as to promote the expansion of these efforts. It is meant as a guide to students and junior researchers, as well as a manifesto for senior researchers and policy makers, challenging widely-held beliefs about how applied innovations evolve and how basic breakthroughs are made, and to help plotting the course towards tomorrow’s great advancements….(More)”

Guidance for Developing a Local Digital Response Network

Curated on Posted on by Stefaan Verhulst

Guide by Jenny Phillips and Andrej Verity: “…Beyond the obvious desire to create the guidance document, we had three objectives when drafting:

  1. Cover the core aspect. Six pages of concrete questions, answers and suggestions are designed to help ensure that start-up activities are well informed.
  2. Keep it as simple and light as possible. We wanted something that an individual could quickly consume, yet find a valuable resource.
  3. Feed into larger projects. By creating something concrete, we hope that it would feed into larger initiatives like Heather Leason and Willow Brugh’s effort to build out a Digital Responders Handbook.

So, are you a passionate individual who wants to help harness local digitally-enabled volunteers or groups in response to emergencies? Would you like to become a central figure and coordinate these groups so that any response is more than the sum of all its parts? If this describes your desire and you answered the questions positively, then this guidance is for you! Create a local Digital Response Network. And, welcome to the world of digital humanitarian response…(More)”

Evaluating Digital Citizen Engagement

Curated on Posted on by Stefaan Verhulst

Worldbank/DEET: “With growing demand for transparency, accountability and citizen participation in policy making and service provision, engagement between citizens and government, as well as with donors and the private sector that deliver government services, is increasingly important.1 Within this, the rapid proliferation of digital tools is opening up a new era of Digital Citizen Engagement (DCE). Initiatives such as online participatory budgeting, SMS voting and the use of handheld digital devices for beneficiary feedback are growing in use. Increased use of technology brings both opportunities and challenges to citizen engagement processes, including opportunities for collecting, analyzing and evaluating data about these processes.

This guide offers a means of assessing the extent to which digital tools have contributed to citizen engagement2 and to help understand the impacts—positive or negative, intended or unintended—that the introduction of technology has had on the engagement processes. It addresses specific questions: Does adding digital technology to the citizen engagement process really provide quicker, cheaper, easier ways for citizens to engage with the state or other service providers? Can digital technologies lower interaction costs for governments and deliver improved, more targeted development outcomes? What risks come with this new technology—have certain citizens been excluded (intentionally or unintentionally) from the engagement process? Has the way in which people engage and communicate altered, for better or for worse? Has the technology affected the previously existing groups and institutions that were intermediating engagement processes before the technology was introduced? The guide is designed to help people understand when the use of DCE is appropriate and under what circumstances, how to use it more effectively and what to expect from its use. It introduces the key issues relating to Digital Citizen Engagement and offers advice and guidance on how to evaluate it— including methods, indicators, challenges and course corrections that apply to the digital aspect of citizen engagement….(More)”

How Google Optimized Healthy Office Snacks

Curated on Posted on by Stefaan Verhulst

Zoe Chance, Ravi Dhar, Michelle Hatzis and Michiel Bakker at Harvard Business Review: “Employers need simple, low-cost ways of helping employees make healthy choices. The effects of poor health and obesity cost U.S. companies $225 billion every year, according to the Centers for Disease Control, and this number is quickly rising. Although some employer-sponsored wellness programs have yielded high returns — Johnson & Johnson reported a 170% return on wellness spending in the 2000s — the employee wellness industry as a whole has struggled to prove its value.

 

Wellness initiatives often fail because they rely on outdated methods of engagement, placing too much emphasis on providing information. Extensive evidence from behavioral economics has shown that information rarely succeeds in changing behavior or building new habits for fitness and food choices. Telling people why and how to improve their health fails to elicit behavior changes because behavior often diverges from intentions. This is particularly true for food choices because our self-control is taxed by any type of depletion, including hunger. And the necessity of making food decisions many times a day means we can’t devote much processing power to each choice, so our eating behaviors tend to be habit- and instinct-driven. With a clearer understanding of the influences on choice — context and impulsivity, for instance — companies can design environments that reinforce employees’ healthy choices, limit potential lapses, and save on health care costs.

Jointly, the Google Food Team and the Yale Center for Customer Insights have been studying how behavioral economics can improve employee health choices. We’ve run multiple field experiments to understand how small “tweaks” can nudge behavior toward desirable outcomes and yield outsized benefits. To guide these interventions, we distilled scattered findings from behavioral science into a simple framework, the four Ps of behavior change:

  • Process
  • Persuasion
  • Possibilities
  • Person

The framework helped us structure a portfolio of strategies for making healthy choices easier and more enticing and making unhealthy choices harder and less tempting. Below, we present a brief example of each point of intervention….(More)”

Missing Maps

Curated on Posted on by Stefaan Verhulst

About Missing Maps: “Objectives:

  1. To map the most vulnerable places in the developing world, in order that international and local NGOs and individuals can use the maps and data to better respond to crises affecting the areas.
  2. To support OpenStreetMap, specifically the Humanitarian OpenStreetMap Team (HOT), in developing technologies, skills, workflows, and communities.
Ethics
  1. Using OpenStreetMap ensures that all data gathered under the project banner will be free, open, and available for use under OpenStreetMap’s open license.
  2. All ‘in country’ activities, i.e. local mapping and data collection, will be carried out in collaboration with local people and in a respectful manner at all times.
  3. When working locally, people come before the data. Meaning if the goal is to map a city there needs to be a plan in place to ensure access to technology and training for those living in that community to continue using the maps after project completion.
  4. Members of Missing Maps actively contribute to Missing Map’s objectives, the OpenStreetMap repository and benefitting communities, both local and international.
  5. Missing Maps activities emphasize building, and leaving behind, local capacity and access. We are cautious about rapid data collection without significant local participation, and always make efforts to ensure local access.
  6. Missing Maps activities are designed to be accessible and open for participation for individuals who want to contribute towards the project objectives.
Membership

Membership of the Missing Maps Project is open to any NGO, educational establishment or civil society group willing to contribute to the goals, and abide by the ethics, stated above. Approval of membership is the responsibility of the current member organisations….(More)”

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How tech is forcing firms to be better global citizens

Curated on Posted on by Stefaan Verhulst

Catherine Lawson at the BBC: “…technology is forcing companies to up their game and interact with communities more directly and effectively….

Platforms such as Kritical Mass have certainly given a fillip to the idea of crowd-supported philanthropy, attracting individuals and corporate sponsors to its projects, whether that’s saving vultures in Kenya or bringing solar power to rural communities in west Africa.

Sponsors can offer funding, volunteers, expertise or marketing. So rather than imposing corporate ideas of “do-gooding” on communities in a patronising manner, firms can simply respond to demand.

HelpfulPeeps has pushed its volunteering platform into more than 40 countries worldwide, connecting people who want to share their time, knowledge and skills with each other for free.

In the UK, online platform Neighbourly connects community projects and charities with companies and people willing to volunteer their resources. For example, Starbucks has pledged 2,500 days of volunteering and has so far backed 70 community projects….

Judging by the strong public appetite for supporting good causes and campaigning against injustice on sites such as Change.org, Avaaz.org, JustGiving andGoFundMe, his assessment appears to be correct.

And LinkedIn says millions of members have signalled on their profiles that they want to serve on a non-profit board or use their skills to volunteer….

Tech companies in particular are offering expertise and skills to good causes as way of making a tangible difference.

For example, in January, Microsoft announced that through its new organisation,Microsoft Philanthropies, it will donate $1bn-worth (£700m) of cloud computing resources to serve non-profits and university researchers over the next three years…

And data analytics specialist Applied Predictive Technologies (APT) has offered its data-crunching skills to help the Capital Area Food Bank charity distribute food more efficiently to hungry people around the Washington DC area.

APT used data to develop a “hunger heat map” to help CAFB target resources and plan for future demand better.

In another project, APT helped The Cara Program – a Chicago-based charity providing training and job placements to people affected by homelessness or poverty – evaluate what made its students more employable….

And Launch, an open platform jointly founded by Nasa, Nike, the US Agency for International Development, and the US Department of State aims to provide support for start-ups and “inspire innovation”.

In the age of internet transparency, it seems corporates no longer have anywhere to hide – a spot of CSR whitewashing is not going to cut it anymore….(More)”.