Contents

• Funding
• Potential Projects
• Finding Collaborators 
• Dr. Bernard Weigl: Grantee Perspectives
• History

Finding Collaborators 

You can find potential NIH- and NIBIB-funded collaborators in the U.S. on the NIH RePORTER website. On the right side of the NIH RePORTER search page, about a third of the way down, you will see the words Agency/Institute/Center; click the Select box to the right. When the pop-up window appears, click on the square box next to the Natl Inst of Biomedical Imaging and Bioengineering, then click on the Select box below. This will take you back to the original window where you will click on the Submit Query button (toward the middle of the page) which will evoke the search and generate a list of grantees and projects. To streamline your search, enter keywords specific to your project interests in the Term Search box to the left of the search page, such as point of care, diagnostic devices, cancer screening, etc. Results will provide the Principal Investigator's name, university or institution affiliation, title and abstract of the grant, etc.

Other potential collaborators can be found on the Participant List from the Workshop on Low-cost Diagnostic and Therapeutic Medical Technologies, which was held in June 2009 (Full Workshop Report), as well as through the Linked In blog hosted by NIBIB's Liaison for International Activities, Dr. John Haller. Another good resource is the Indo-US Science and Technology Forum web site. 

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Dr. Bernard Weigl: Grantee Perspectives on the Indo-U.S. Collaboration Initiative

Global management of health care demands fresh, innovative thinking to alleviate disparities on an international scale. In an effort to confront these new challenges, NIBIB has initiated a unique grant opportunity that aims to facilitate international collaborations focused on development of low-cost medical technologies between researchers in the U.S. and India.

Dr. Bernhard Weigl, recipient of one of the U.S.-Indo Collaborative Program on Low-cost Medical Devices Administrative Supplement funds, is Director of the Center for Point of Care Diagnostics for Global Health (GHDx Center) at PATH in Seattle, Washington (ULR HERE). Weigl’s supplement is associated with the NIBIB Center grant, and fits nicely into NIBIB’s mission for Point-of-Care technology. He says, “With five PATH offices in India, I already had connections in India, and this gave me ready-made possibilities for collaboration projects.”

So, what’s involved? “I had to identify a collaborator, then figure out specifics of a project. I wanted to work in the area of diabetes because it was an area that the GHDx Center wanted to expand into. My attendance in the NIBIB-sponsored Workshop on Low-cost Diagnostic and Therapeutic Medical Technologies in Hyderabad, India, in 2008, led me to a potential research partner, Dr. Mohan. He is one of the top five diabetes researchers in India, and his participation at the workshop alone demonstrated his interest in international collaboration.” 

Weigl admits that he and Mohan were somewhat apprehensive in the beginning. “There was quite a bit of coordination required. Dr. Mohan got approval for his grant through the Indian Department of Biotechnology (DBT), and then I needed to get approval for my part of the project, but we appreciated the fact that the process moved forward in a fairly ‘unbureaucratic’ way, and that ultimately made the application effort a success.”

Weigl cautions collaborators to coordinate protocol development. He says, “We realized in retrospect that research procedures must be completely in sync. IRB requirements are different in the two countries, so using exactly the same protocol that will fit both IRB requirements will save applicants time. We developed a second round of protocols that were sent to Dr. Mohan for his approval, and then we will submit them to our IRB again; we anticipate approval in May 2011. It has been especially helpful to have PATH offices in India because a person in the New Delhi office has assisted with some of the protocol issues that would otherwise be quite difficult to coordinate because of time zone and cultural differences. Also, we’re used to the NIH process and forms, but when you’re working with another system, it can be entirely different. It would be nice to have an international system, but there is no movement toward that at this time.”

He adds, “We also need agreement to the revised protocol of two diabetes screening test companies manufacturing because we will be evaluating their devices per the new protocols. For R&D projects, manufacturing is very important, and partners should be consulted in the earliest phases of the project. If you are able to find manufacturing partners in India, that goes a long way, because then you have a commercialization outlet, and you can make it cost effective based on materials that they already have and know how to use in the manufacturing process.”

The ability to obtain alternative financing might also determine the feasibility of a project. Weigl adds, “Micro credit can also be part of the process of the roll out of the product. It’s very commonly used, especially in Asia. For example, they might give aspiring entrepreneurs small loans to set up a primary care facility to distribute products and provide care.”

Economic and geographic constraints are critical considerations in U.S.-Indo collaborations. “You should start with a specific target product profile for a particular device that fits a particular need, but this ‘need’ is fundamentally different in India than the U.S. Here in the U.S., if you suspect someone has diabetes, you can ordinarily ask them to come back for a repeat visit for a fasting glucose tolerance test. But health care is not as accessible for a lot of people in India, so you need to have a device that can be used without a lot of user training, and without clinical follow up. In India, you may be very challenged to follow up with a second or third visit because many people don’t have the money or ability to travel long distances or take time off from work. What you need is a device that could immediately, on the first visit, at the point of care, tell you that someone has diabetes, and it has to be affordable within their personal economy. What the average American spends on diabetes care is absolutely unsustainable in India because many people make only about $2 a day.”

Weigl anticipates that the Indian government will supplement initial screening at a dollar or two per patient, but sustainability after diagnosis is just as critical. He is hoping that negotiations with insulin makers who offer special programs will result in a deal to make insulin available to certain patients in India at a very low cost that could be afforded even by poor people. He remarks, “That’s really cool, and it’s a fraction of what it would cost in the U.S. You also need to add $3 to $5 for testing strips, which gets you about 15 strips. The patient couldn’t do the normal testing regimen like most diabetics in the U.S., but they could measure every other day and establish a control program. In addition, diagnosis should be a tool for behavior and diet change.”

Developing a Target Product Profile, in Weigl’s opinion, is critical for anyone who wants to do develop medical technology devices. “You have to describe what you want to sell. It’s not a business plan, because that’s something that is a document telling how you would get there, but this describes the actual device. What would that device have to do? You look at the technical side of what it could do and the features it would have, and you identify what people would actually want or need in that device. Ask various experts for input and ideas.”

For more information on Target Product Profile, see: http://www.imshealth.com/imshealth/Global/Content/Document/Target_Product_Profile.pdf

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History

In October 2007, NIBIB and the Department of Biotechnology (DBT) of the Ministry of Science and Technology in India entered into a bilateral agreement to develop low-cost health care technologies for the medically underserved. The following year, the Workshop on Low-cost Diagnostic and Therapeutic Medical Technologies hosted scientists, engineers, and clinicians from India and North America who helped to identifiy and prioritize areas of opportunity for improvements in health care in low-resource settings. Based on Workshop recommendations, NIBIB and the DBT developed joint funding initiatives that fund collaborative, multidisciplinary research projects between participants in the U.S. and India which aim to provide effective, low-cost solutions to significantly improve health care in underserved communities in the U.S. and India, and help remedy health disparities around the world.

For more information, contact:

In the U.S.:
Vinay M. Pai, Ph.D.
Program Director
Biomedical Imaging Informatics
Extramural Program, NIBIB
Phone: 301-451-4781
Email: paiv@mail.nih.gov

In India:
Dr. T.S. Rao
Department of Biotechnology
Ministry of Science and Technology, India
Email: tsrao@dbt.nic.in

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