Creating a Space for Innovative Device Development

McMurry-Heath, Michelle; Hamburg, Margaret A.

doi:10.1126/scitranslmed.3005269

Cited by 18 publications

(10 citation statements)

References 3 publications

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“…Based on statistics from the US Department of Commerce, approximately 75% of US medical device manufacturers have fewer than 20 employees . Along with start‐up companies that may financially rely on the success of one medical device, these small companies often have limited capital and resources to apply to research, development, and regulatory issues associated with biomedical discovery and evolving technologies.…”

Section: Collaborative Research and Support Programs (Table Section A)mentioning

confidence: 99%

“…To aid new product development, MDIC created a public–private partnership (currently composed of over 40 members including individual companies, nonprofit organizations, patient groups, FDA, the National Institutes of Health (NIH), and the Centers for Medicare & Medicaid Services)) to foster medical device innovation by supporting collaborative interaction. The objective of the partnership is to address common issues facing industry, particularly in the early‐stage development of new technologies, in a noncompetitive and nonproprietary space . Through MDIC, companies can pool their limited resources and work directly with federal agencies to evaluate scientific topics which may increase patient access to safer and more effective devices.…”

Section: Collaborative Research and Support Programs (Table Section A)mentioning

confidence: 99%

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Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

2015

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Section: Collaborative Research and Support Programs (Table Section A)mentioning

confidence: 99%

Section: Collaborative Research and Support Programs (Table Section A)mentioning

confidence: 99%

Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

2015

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“…3 Of the more than 5,000 device manufacturers in the U.S., about 75% have fewer than 20 employees. Small device companies have become the innovation engines in the U.S. and their survival is of upmost importance to fuel new and innovative treatment options to patients.…”

Section: State Of Medical Device Innovation In the Usmentioning

confidence: 99%

Medical Device Innovation in the United States

Andersson

2016

Spine

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“…Devices also dif er from drug development because historically, their development life cycle and investment periods are shorter, and the sector faces a shorter regulatory time frame. However, the medical device sector is increasingly faced with technically complex applications, including assisting the delivery of drugs and cell-based therapeutic products, and regulatory bodies are beginning to explore their oversight roles (21). In concert, there has been a slow increase in consortia focused on medical devices, which includes diagnostic instruments as well as those that assist in medical interventions (such as surgical tools and robotic technologies) (Fig.…”

Section: Consortia Spur Sciencementioning

confidence: 99%

Consortium Sandbox: Building and Sharing Resources

Lim

2014

Sci. Transl. Med.

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Some common challenges of biomedical product translation-scientif c, regulatory, adoption, and reimbursement-can best be addressed by the broad sharing of resources or tools. But, such aids remain undeveloped because the undertaking requires expertise from multiple research sectors as well as validation across organizations. Biomedical resource development can benef t from directed consortia-a partnership framework that provides neutral and temporary collaborative environments for several, oftentimes competing, organizations and leverages the aggregated intellect and resources of stakeholders so as to create versatile solutions. By analyzing 369 biomedical research consortia, we tracked consortia growth around the world and gained insight into how this partnership model advances biomedical research. Our analyses suggest that research-by-consortium provides benef t to biomedical science, but the model needs further optimization before it can be fully integrated into the biomedical research pipeline. from the European Seventh Framework Programme (FP7), a multination funding program that aims to stimulate and support networked research within this continent. Of the 183 total biomedical research consortia (61%) launched in the European Union between 2007 and 2013, 111 were supported with FP7 funding, which includes those associated with IMI. Using broad categoriesacademia, government, health care organizations, industry, nonprof t foundations, and third-party organizations (table S2)-we assessed the types of organizations responsible for initiating consortia and found that government agencies were responsible for initiating the majority of the 369 consortia cataloged, followed by third-party organizations and industry ( Fig. 2A). Data on trends by year (Fig. 2B) suggested that industry has increased initiation of its own consortia, with two-thirds of industry-initiated consortia launched between 2007 and 2013 supported by IMI.Of all biomedical research consortia launched in Europe, ~58% operated under strategic research plans that were def ned by a government agency. T is level of government involvement is considerable compared with that of North America (24%); in Asia, government agencies initiated six of nine consortia. Scientif c needs were not the only driver of collaboration; 36% of all government-initiated consortia had secondary objectives of economic development, and ~20% of the 369 consortia sought to advance regulatory science through the participation of a regulatory of cial in the consortium's research or on an oversight committee (7).Mechanisms of collaboration. T e m o dels used to structure a consortium ref ect the requirements of their sponsors, complexity of the science being pursued, resources available, type of output expected, and methods for sharing output with the public. Despite these dif erences, we found some common features among the collaboration models used by the 369 consortia studied. T e majority of consortia had clear mission statements outlining the targeted deliverables and timefra...

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Creating a Space for Innovative Device Development

Abstract: FDA announces a partnership—the Medical Device Innovation Consortium—to advance regulatory science in the medical technology arena.

Cited by 18 publications

References 3 publications

Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

Medical Device Innovation in the United States

Consortium Sandbox: Building and Sharing Resources

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