Standards-their impact upon the economics of instrumentation development

The potential impact of the medical device amendments bill pending before Congress is analyzed in terms of its possible effects on 27 specific biomedical instrumentation and equipment markets. Characteristics, business opportunities, and growth potentials are evaluated for three tiers of device manufacturers, resulting in the development of several scenarios. The "most likely" scenario, according to the author, will result in strong growth for biomedical equipment and device markets but an uneven effect upon market participants.