Funding challenges

The third form of second-round investment, and the most appealing to most biomedical startups, is Phase II SBIR grants and state economic funding. The next section will highlight the benefits of state and government funding for device development. 

Biomedical device development is a fast-paced industry with large competitors that release new devices every few years. It is unlikely a small startup company can keep pace, even with strong patent protection and a novel product. 

Becker T A and Kipke D R (2002), Flow properties of liquid calcium alginate polymer when injected through medical microcatheters for endovascular embolization , J Biomed Mater Res, 61, 533—540. 

Becker T A, CoUins V E and Kipke D R (2001a), Method for forming an endovascular occlusion , US Patent 6592566. 

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Throughout the workshop presentations and discussions, several participants made suggestions for future research needs and pointed out the funding challenges involved. Participants also identified ways to improve education and training in the area of bioinspired chemistry for energy. This chapter highlights those key points. 

R. Keshavaraj and R. W. Tock, Compendium of Results—Chrysler Challenge Fund Project, Chrysler Technology Center (December 1994). 

Situations in which proposed trials must await approval and funding before development of the electronic-based data collection and management system can begin present a real challenge to developers in terms of being able to complete the system before the initiation of data collection. Development of a basic system that is easily adaptable will aid in decreasing the time needed for development. 

Kowolenko, M., Tracy, L. and Lawrence, D.A., Early effects of lead on bone marrow cell responsiveness in mice challenged with L. monocytogenes, Fund. Appl. Toxicol. 17, 75, 1991. 

Spreafico, F. (1988). Immunotoxicology in 1987 Problems and challenges. Fund. Clin. Pharmacol. 2 353-367. 

The FDA s next step will entail the creation of a Critical Path Challenge list, a series of projects with discrete deliverables, on the basis of what has been submitted to us in the docket and our internal knowledge about the kind of work that needs to be done. The FDA will be able to initiate a few of these, limited by the amount of available resources. We hope that identification and explanation of the projects that are not being done will spur additional efforts to get these projects funded and up and running. 

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