Showing 8 ideas for tag "technology"

Goal 1: Promote Human Health

Developing tools/algorithms for objective evaluation of sleep health

What are the best tools/algorithms for robust and objective evaluations of sleep health biomarkers?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Sleep deficiency is pervasive in today’s society and associated with an array of threats to health and public safety. The availability of a biomarker(s) for sleep health would turn-the-curve on developing practical and feasible ways to identify individuals at risk for sleep deficiency and prevent/manage associated risks to health and public safety on a large-scale.

Feasibility and challenges of addressing this CQ or CC

Sleep and circadian regulation is coupled to an array of behavioral, physiological and molecular/genetic processes to leverage in the development of biomarkers for sleep health.
Untreated sleep disorders and sleep deficiency pose a significant burden on health and public safety. There is currently no biomarker, or point-of-care technology available to objectively measure an individual’s level of sleep deficiency or susceptibility, a significant barrier to prevention and management.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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124 net votes
162 up votes
38 down votes
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Goal 3: Advance Translational Research

Incentivizing Earlier Investment in NHLBI-Funded Technologies

How might NHLBI assist its awardees to attract private sector funding or partnerships earlier in the product development process to help bridge the gap between academic discoveries and product commercialization?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Attracting private sector support earlier in the development pipeline would help fill an important funding gap between academic discoveries and product commercialization, enabling products to reach patients more quickly, and improving the return on NHLBI’s investments in basic research.

Feasibility and challenges of addressing this CQ or CC

Some existing initiatives such as the SBIR Phase IIB Bridge and Small Market Awards encourage non-federal investors to invest earlier in NHLBI-funded technologies. In addition, the NCAI is designed to support critical feasibility studies and business case development to de-risk earlier investment by the private sector. These efforts are showing early signs of success, but impact only a small proportion of NHLBI-funded basic research discoveries.
Estimates for the cost of developing a new drug or device range from the hundreds of millions to billions of dollars and 10-15 years to get from the lab to the patient. The NHLBI cannot fully support that development, so private sector support is critical for biomedical technologies to be commercialized. Overall private capital investment in the life sciences is increasing, but it is not being targeted at heart, lung, blood, and sleep technologies or at the seed stage of development. Venture capital investment in heart, lung, blood, and sleep technologies has declined or remained stagnant since 2008 (http://graphics.wsj.com/venture-capital-and-the-human-body/) and seed stage investment from the private sector for early stage high-risk projects is in short supply (PWC Moneytree: https://www.pwcmoneytree.com/HistoricTrends/CustomQueryHistoricTrend).

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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15 net votes
23 up votes
8 down votes
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Goal 2: Reduce Human Disease

Novel technologies to save minutes and lives

There is a need to develop hand-held portable imaging or other technologies that can help paramedics to collect and transmit data when patients are undergoing cardiovascular events.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

Save time and lives for patients destined to Emergency

Feasibility and challenges of addressing this CQ or CC

The component technologies are developed enough to integrate them in the next 5-10 years
Time spent waiting for an ambulance, driving to a hospital and enduring diagnostic tests before medical intervention can quickly add up, especially with patients undergoing cardiovascular events. In the era of internet, smartphones, and portable imaging and handheld technologies, saving valuable time during which paramedics can be assisting the emergency physicians in diagnosing heart attacks and help to identify and start the needed intervention at once when the patient arrive at the hospital.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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6 net votes
13 up votes
7 down votes
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Goal 3: Advance Translational Research

Behavioral Interventions Through Modern Technology

What are the effects of behavioral interventions delivered with modern technology and using modern media techniques on changing the habits of adults between age 40 and 60?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Feasibility and challenges of addressing this CQ or CC

Recruit two hundred thousand adults between the ages of 40 and 60 as a laboratory for behavioral interventions delivered with modern technology and using modern media techniques – use the seven habits or similar – provide resources so that the population is representative, encourage the baseline collection of serum samples. Model this on some of the patient center networks funded by PCORI in 2013. Partner with AHA, PCORI, CDC.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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10 net votes
21 up votes
11 down votes
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Goal 2: Reduce Human Disease

US-based Clinical Development of Innovative Medical Devices

Though innovative medical devices are often conceived of and developed in the US, US consumers are frequently the last to benefit. Innovators frequently go to market first in Europe and are now moving toward emerging countries, delaying the medical benefits available to the US population. Can the NHLBI and FDA’s CDRH, working together as sister agencies, develop strategies such as funding opportunities or collaborative... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Addressing this CC may empower the development of new regulatory paradigms within CDRH, enable the streamlined development of several NHLBI medical devices in the US, lead to a minimized delay in US availability for truly innovative technologies, and grow the pool of US clinicians experienced in working with device developers at the earliest stages of human/device interaction.

Feasibility and challenges of addressing this CQ or CC

In the past 18 months
• NHLBI and CDRH have executed a structured working relationship, within the NIH Centers for Accelerated Innovations, where CDRH provides high-level feedback to early stage NHLBI medical device developers.
• CDRH has developed two new programs –one to enable US conduct of early feasibility studies/first-in-human (EFS/FIH) studies and a second to provide expanded access to senior agency reviewers for innovators developing high risk technologies.
Additionally, CDRH is focused on exploring and evaluating additional pilot programs to expand first-in-human trials within the US. NHLBI’s portfolio of awardees includes a number of medical device development projects that could qualify for the EFS/FIH program. Development of new collaboration or funding opportunities focused on this segment of device developers could attract additional innovators to the NHLBI family and encourage the US-based clinical development of their innovative technologies. The relationship that has been built between NHLBI and CDRH, in conjunction with CDRH’s more open approach to working with innovators, makes this the perfect time to expand NHLBI/CDRH innovator support beyond the NCAI program and into the overall NHLBI portfolio.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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4 net votes
19 up votes
15 down votes
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Goal 4: Develop Workforce and Resources

Preparing a Diverse Biomedical Technology Development Workforce

How do we best develop a scientific workforce that is fluent in product development and commercialization issues? How can NHLBI best expand the training opportunities for early career scientists to prepare them for entry into the dynamic biomedical workforce landscape? There is a need for scientifically-trained experts from diverse backgrounds who also understand business needs relevant to biomedical technology development,... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

A well-trained biomedical technology development workforce would enhance the quantity and quality of research translated from the lab to the market focused on heart, lung, blood, sleep indications. A better understanding of the product development pathway would improve efficiency and resource usage, and accelerate the time for products to reach the market. Structured training would better prepare academic scientists for industry collaboration and provide an industry-ready scientific workforce. Ensuring these training opportunities are inclusive of scientists from different backgrounds would increase the diversity of the biomedical technology development workforce.

Feasibility and challenges of addressing this CQ or CC

Industry is a large employer of research trainees, and trainees are becoming increasingly vocal about their interest in opportunities to be trained in areas beyond the academic lab that would prepare them for roles in industry. NHLBI can leverage recently launched educational opportunities, including the BEST (Broadening Experiences in Scientific Training), NCAI (NIH Centers for Accelerated Innovations), REACH (Research Evaluation And Commercialization Hubs), and CTSA (Clinical and Translational Science Awards) programs.
Transitioning scientific discoveries to inventions and products to benefit public health requires knowledge and education beyond what is traditionally learned during medical, graduate, and post-doctoral training.

Challenges to addressing this CQ include:

• Need for educators and mentors with relevant industry experience and expertise.

• This would be a culture shift in academic institutions, though the new NIH programs described above has already started to influence this shift.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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19 up votes
19 down votes
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Goal 3: Advance Translational Research

Building a bridge - new approaches to dissemination

There is a need to fundamentally rethink the approach to translation and dissemination of clinical trial results. The current approach relegates dissemination as a side effect to the end of a trial and does not require sufficient funds be set aside to conduct adequate outreach. As a result, it takes up to 17 years for the results of trials to be adopted and used in everyday practice. It is time for a new model which re-prioritizes... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

The benefits of clinical research on the quality of health are compromised by the slow and ineffective process by which they find their way into clinical practice. Decades of theorizing on the dissemination of scientific knowledge has resulted in overreliance on outmoded theoretical approaches to dissemination. Much of the work to date has the appearance of “victim blaming” (e.g., the characteristics of “slow adopters” are identified and many physicians are thought to evidence “clinical inertia”). Much less attention is focused on: a) the outmoded and ineffective process of dissemination itself, disregarding the important (even critical) role of the digital age and social media; b) the ever changing organizational contexts in which dissemination is supposed to occur (not considering the important role of the consumer or patient in dissemination); and c) the demonstrated efficiency of the private sector in disseminating information to organizations, providers and patients (commonly known as direct to consumer advertising). Delays in dissemination result in delays in receipt of new therapies, effective new approaches, safe and more cost effective treatments and contributes to social injustices which perpetuate health disparities.

Feasibility and challenges of addressing this CQ or CC

Many federally funded clinical trials are completed with fastidious attention to scientific quality a key challenge is the relegation of dissemination to an afterthought, often unfunded and neglected. The feasibility of improving dissemination has been repeatedly demonstrated by the private sector driven by a need to complete trials rapidly for immediate dissemination and adoption (time to market). The challenge is to re-prioritize dissemination to be part of the entire clinical trial process (proposal to study close), and to create a separate funding requirement within PAs and RFPs to ensure that there is both a requirement and resources dedicated to dissemination. Conducting a consensus conference between the federal and private sectors to learn the best practices to improve dissemination while maintaining research quality is essential.

Name of idea submitter and other team members who worked on this idea Lisa Marceau. Team Member: John McKinlay

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2 net votes
4 up votes
2 down votes
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Goal 1: Promote Human Health

Adult Cardiomyocytes in Culture

So much basic cardiovascular discovery relies on cell culture models. While cardiac cell lines exist (e.g. HL-1, H9c2), these often poorly model aspects of cardiomyocyte function in-situ (e.g. contractile function, metabolism). In contrast, primary cardiomyocytes isolated from adult animals (especially mice!) are not readily amenable to culture conditions. Even if cells can be kept alive, they are often refractory to... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

Addressing this challenge would provide tools for basic researchers to answer many key questions about basic cardiomyocyte function. Removing the "voodoo" element from these methodologies would be an enabling technology. In the neuron field, companies such as "brain bits" will ship tissue with specific protocols, to enable unskilled technicians to culture highly pure neuron subtypes in a matter of hours. Such methods have led to standardized methods in the field, which is good for reproducibility.

Feasibility and challenges of addressing this CQ or CC

There have been several attempts at keeping adult myocytes alive in culture, using technologies such as electrical pacing, and inclusion of inhibitors in culture media. Likewise some AAV variants are known to transfect hearts in-vivo. However, no uniform widely-accepted methods are used between many different labs. Every lab has their own "trick" to get cells to behave. Many investigators can make a few cells on a dish survive, which is sufficient for single cell work (e.g. microscopy), but getting an entire culture of adult myocytes to survive beyond 24-48 hrs (the minimal time frame needed for genetic manipulations such as siRNA) would open up more common detection and assay measurements. Myocytes from larger animals (e.g. rabbits) are more stable and longer-lived in culture, but such methods do not appear to work for mouse CMs, which therefore precludes application of knockouts and other useful mouse resources.

Name of idea submitter and other team members who worked on this idea Paul Brookes

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-25 net votes
12 up votes
37 down votes
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