Mechanical ventilation innovations: the manufacturer's perspective.
Manufacturers develop products that fit the corporate vision and maximize their return on investment. The expense and time required by the FDA regulatory approval process have a negative impact on product innovation. I propose the following approach: Reduce the amount of documentation required for a PMA or 510(k). Reduce approval times through cooperative interaction among manufacturers, clinicians, and the FDA throughout the product-development process. Allow independent agencies to provide product approvals. Efficacy assessment guidelines should be a function of the level of risk and the claims made for the marked device.
DeVries
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Bird Products Corp., Palm Springs, CA 92262, USA.
D003257:Consumer Product Safety; D003362:Cost-Benefit Analysis; D004059:Diffusion of Innovation; D017598:Efficiency, Organizational; D007221:Industry; D009937:Organizational Objectives; D012121:Respiration, Artificial / Q000639:trends; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration; D012122:Ventilators, Mechanical / Q000639:trends*