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.). b Risk studies and many different types of clinical
and regulatory testing must be done (Rish, n.d.). b If, at this point the product
passes through, because of the patent, the product can enjoy a monopoly on its
market share (Rish, n.d.). b The trade off in all of this is the improvement to
patient outcomes because of these innovations. b
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:
b b 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. b 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.
b b Every patient has the right of informed consent, regarding their
healthcare. b 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. b
b b 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:
· b All stages of reconstruction of the breast on which the mastectomy
has been performed;
· b Surgery and reconstruction of the other breast to produce a
symmetrical appearance; and
· b 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, from https://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, from
