Robotic surgery is at the forefront of modern medical
technology.Innovations in this space are often quickly
patented and otherwise isolated to the patent holder. An
example of this is the case of Intuitive Surgical’s da
Vinci®system in the areas of minimally invasive surgery, single
site surgery, natural orifice transluminal endoscopic surgery
(NOTES) and non-minimally invasive robotic systems(Brodie,
2018).As soon as the patent expired, competitors were able to
build and expand on the initial works of the da Vinci system.
In general, the go to market process for medical devices is
rigorous and very cost prohibitive.This is due to the large pre-
market costs, like clinical testing.To start, the initial innovation
itself is a struggle to develop.Once that stage is complete and
a new tangible device or new technique is developed, next is
patenting (Rish, n.d.).Risk studies and many different types of
clinical and regulatory testing must be done (Rish, n.d.).If, at
this point the product passes through, because of the patent,
the product can enjoy a monopoly on it’s market share (Rish,
n.d.).The trade off in all of this is the improvement to patient
outcomes because of these innovations.
The second medical innovation that would also need to go
through the rigorous regulatory and go to market process is the
area of prosthetics.3D printing has made building simple
custom prosthetics much easier over the last ten years.The
next phase of evolution is connection prosthetics to the brain
(The Future of Bionic Limbs, 2021)
Second Topic:
I think the theme of the prompt for the second topic
speaks to diagnostic testing.Diagnostic testing can be a sticky
wicket holding back cost containment attempts.Over testing
can easily cause exponential cost increases for the
patient.Diagnostic test can be invasive and does carry it’s own
medical risk (Abram, 2021).Diagnostics are necessary for
identifying and treating disease but should be utilized in a
purposeful, targeted fashion (Abram, 2021).A huge concern
when discussing the topic of diagnostic testing is informed
consent.
Every patient has the right of informed consent,
regarding their healthcare.Applied to diagnostic testing, this
means patients have a right to know how invasive and what the
effects of the test are, along with the goal of the gaining the test
result (Shi, 2019).Grappling with the issues of what the patient
can hope to gain from a certain procedure versus an alternative
is also a very important stage of informed consent.Balancing
whether a difficult procedure is worth the information gained in
the outcome is a critical function of informed consent between
providers and patients.
Informed consent has a role in the insurance world.For
example, in 1998 the Women’s Health and Cancer Rights Act
was passed (U.S. Centers for Medicare & Medicaid Services,
n.d.).This legislation mandates:
“The Women's Health and Cancer Rights Act of 1998
(WHCRA) is a federal law that provides protections to
patients who choose to have breast reconstruction in
connection with a mastectomy.
(
If WHCRA applies to you and you are receiving benefits in
connection with a mastectomy and you elect breast
reconstruction, coverage must be provided for:
(
·(((((((All stages of reconstruction of the breast on which the
mastectomy has been performed;
·(((((((Surgery and reconstruction of the other breast to
produce a symmetrical appearance; and
·(((((((Prostheses and treatment of physical complications of
all stages of the mastectomy, including lymphedema
(U.S. Centers for Medicare & Medicaid Services, n.d.).”
(
(
This protects mastectomy patients from having to pay out of
pocket for breast reconstruction.Prior to this law, insurers
routinely class all breast reconstruction as elective and not
payable under their plans.The WHCRA stops that behavior and
requires insurance companies to inform their members of their
rights in this regard during enrollment.Circling back to the
theme of efficacy – without reconstruction patients were having
less efficacious outcomes overall post-mastectomy (U.S. Centers
for Medicare & Medicaid Services, n.d.).
References:
Brodie, A. (2018, September 1).NCBI - The future of robotic
surgery. Ncbi.Nlm.Nih.Gov. Retrieved May 26, 2022, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6216754/
Rish, T. (n.d.).Complete Guide to Bringing a Medical Device to
Market. Green Guru. Retrieved May 26, 2022,
fromhttps://www.greenlight.guru/blog/bringing-medical-device-
to-market
Shi, L. & Singh, D. A. (2019). Essentials of the U.S. Health Care
System (5th ed.). Jones & Bartlett Learning.Burlington, MA.
The future of bionic limbs. (2021, March 2). Research Features.
Retrieved May 26, 2022, from
https://researchfeatures.com/future-bionic-limbs/
Abram, E. S., MD. (2021, October 19).Rational Use of Screening
and Diagnostic Tests: Overview, Pretest and Posttest Probability,
Definitions and Calculations. MedScape. Retrieved May 26,
2022, from https://emedicine.medscape.com/article/773832-
overview?reg=1
U.S. Centers for Medicare & Medicaid Services. (n.d.). Women’s
Health and Cancer Rights Act (WHCRA) | CMS.CMS.GOV
.
Retrieved May 25, 2022,
fromhttps://www.cms.gov/CCIIO/Programs-and-Initiatives/Other-
Insurance-Protections/whcra_factsheet
