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Related Concept Videos

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Related Experiment Videos

Regulatory and other public policy issues.

W A Hyman1, V M Brannigan, J J McDermott

  • 1Texas AandM Univ., College Station, TX.

IEEE Engineering in Medicine and Biology Magazine : the Quarterly Magazine of the Engineering in Medicine & Biology Society
|January 1, 1989
PubMed
Summary

Future biomedical engineering and medical device development are shaped by public policy. Key influences include regulatory agencies like the FDA, reimbursement policies, and litigation, impacting innovation and ethical considerations.

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Area of Science:

  • Biomedical Engineering
  • Health Policy
  • Medical Device Technology

Background:

  • The development and application of medical devices are significantly influenced by regulatory and public policy.
  • Federal agencies such as the Food and Drug Administration (FDA) and Health Care Financing Administration (HCFA) play crucial roles.
  • Other entities like OSHA, EPA, and Department of Commerce impact industry profitability and innovation.

Purpose of the Study:

  • To discuss regulatory and public policy issues affecting future biomedical engineering and medical device development.
  • To examine the impact of the regulatory environment on medical software applications.
  • To explore humanistic and ethical challenges posed by technological advancements in healthcare.

Main Methods:

  • Review of regulatory frameworks and public policy impacts on medical devices.
  • Analysis of the influence of government agencies (FDA, HCFA, OSHA, EPA) on the medical technology industry.
  • Consideration of civil litigation and external influences on medical device innovation.

Main Results:

  • Regulatory bodies (FDA, HCFA) and public policies significantly shape medical device development and market entry.
  • The regulatory environment, including litigation, affects the integration of technologies like computer software into medical products.
  • Ten key future technologies and ten external influences on the medical device industry were identified.

Conclusions:

  • Public policy and regulatory landscapes are critical determinants of the future trajectory of biomedical engineering and medical device innovation.
  • Addressing humanistic and ethical concerns is paramount alongside technological advancement.
  • Understanding these external influences is vital for the continued growth and responsible development of the medical device industry.