TY - JOUR
T1 - Impact of Health Care Reform on Technology and Innovation
AU - Kesavan, Preethi
AU - Dy, Christopher J.
N1 - Funding Information:
NIH NIAMS grant K23AR073928 .
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/5
Y1 - 2020/5
N2 - The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.
AB - The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.
KW - Comparative effectiveness research
KW - Device regulation
KW - Frugal innovation
KW - Medical device industry
KW - Medical device innovation
KW - Postmarket surveillance
KW - Premarket approval
UR - http://www.scopus.com/inward/record.url?scp=85083329792&partnerID=8YFLogxK
U2 - 10.1016/j.hcl.2020.01.008
DO - 10.1016/j.hcl.2020.01.008
M3 - Review article
C2 - 32307056
AN - SCOPUS:85083329792
SN - 0749-0712
VL - 36
SP - 255
EP - 262
JO - Hand clinics
JF - Hand clinics
IS - 2
ER -