Articles on Law, Science, and Engineering

CONCLUSIONS[index]

There is a crisis in the design of legally risky machines: machines that are both indeterminate and dangerous. These machines cannot be safely used by untrained or otherwise incompetent users. Yet the medical community has little incentive to restrict the use of these machines to skilled users. Such restrictions would reduce the autonomy of physicians and would shift liability from the manufacturer to the incompetent physician user.

Medical device manufactures must develop strategies to assure that legally risky devices are restricted to competent users. These may range from the controlled leasing of equipment to federal legislation. Unless engineers are allowed to design machines for sophisticated users, innovation will suffer and legal costs will destroy the competitiveness of the U.S. medical device manufactures.

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