Running head: REFLECTION ON INNOVATION IN MENTAL HEALTH CARE

Reflection on Innovation in Mental Health Care

Amy Barley

Pennsylvania College of Health Sciences

Innovation and Technology

IPC 502-OB

Michal Kalfin

April 15, 2019

INNOVATION IN MENTAL HEALTH CARE 2

Abstract

Innovation in healthcare is defined by Omachonu (2010) as “the introduction of a new concept,

idea, service, process, or product aimed at or improving treatment, diagnosis, education,

outreach, prevention, and research, and with the long term goals of improving quality, safety,

outcomes, efficiency, and costs” (p. 5). Throughout the history of healthcare innovation,

implementation of disruptive innovation are those innovations that change the face of healthcare

very quickly each time. The future of healthcare innovation focuses on data-driven healthcare,

meaning that healthcare is becoming more and more personalized which means that more

responsibility and control is being taken from healthcare providers and being given to patients

and their families. Psychiatric healthcare, or mental and behavioral health is not without its

share in the impact of innovation of healthcare. This area of practice has had disruptive

innovations in the pharmaceutical, medical device, biotechnology, and health informatics sectors

of healthcare. Each of these possesses implications related to access, quality, and costs. They

also each are not without legal and ethical concerns.

INNOVATION IN MENTAL HEALTH CARE 3

Reflection on Innovation in Mental Health Care

The purpose of this paper is to reflect on the impact of innovation and technology on

healthcare. Innovation as it applies to healthcare will be defined. The influence of innovation

and technology in the pharmaceutical, medical device, biotechnology, and health informatics

sectors of healthcare as it effects the practice of mental health will be discussed. The ways in

which these types of innovations have changed mental health will be noted. For each of these

sectors, the impact of innovation and technology on cost, access, and quality will be addressed.

The legal and ethical implication of innovation that effect mental health will be discussed.

Finally, any problems that are left to be solved and potential solutions to those problems will be

offered.

Pharmaceutical Innovation in Mental Heath

Many new pharmaceuticals have been introduced into the field of mental health. These

drugs are greatly improving the lives of those who suffer from mental disorders and are usually

the first line of defense when a person becomes psychotic, depressed, or overcome by

debilitating anxiety. One of the most recent pharmaceutical innovations in mental health is

brexanolone, an IV infusion to treat postpartum depression. Brexanolone is a recently FDA-

approved pharmaceutical solution to postpartum depression. For the patient, brexanolone is innovative in

how the patient’s needs are met because it provides relief from postpartum depression much more quickly

than the usual anti-depressants which “can take week to take effect” (Chuck & Dunn, 2019, p.1). 

According to Morgan, Lopert & Greyson (2008), “pharmaceutical innovation requires novelty of

effectiveness” (p. 4) and that “pharmaceutical innovations create value to society by making it possible to

generate improvements in patient health that were previously unattainable” (p. 4).  Brexanolone is novel

in several ways.  It is the first drug developed to treat postpartum depression and it is received in a one-

time dose which takes effect within 12 hours. 

INNOVATION IN MENTAL HEALTH CARE 4

Brexanolone was just approved by the FDA in March of 2019, making it now available to

access for new mothers who are experiencing postpartum depression.  FDA approval of new

drugs and devices is not a quick process.  According to Norman, “for drugs, this process can take

10 to 15 years” (2016, p. 171).  The mission of the FDA is “to provide consumers with assurance

that medical drugs and devices that reach the marketplace have proven safety and efficacy in the

roles for which they have been tested and approved” (Norman, 2016, p. 171).  Brexanolone “is

not believed to have any long-term safety concerns” and that side effects most common are

“drowsiness and dizziness” (Chuck & Dunn, 2019, p. 3).  Brexanolone is not a cheap drug as “it

is expected to cost somewhere between $20,000 and $35,000 for the infusion” and this price

“does not include the price of a stay in whatever facility it is administered in” (Chuck & Dunn,

2019, p.3). 

All pharmaceuticals come with legal and ethical concerns. For mental health, these

revolve around issues getting patients to comply with medication administration. Sometimes

healthcare providers are tempted to conceal the truth about the type of medication so that the

patient will take it. There are also ethical issues involving whether or not a medication benefits a

patient if it alters their personality to the point that they are not themselves any longer.

Brexanolone’s ethical issue may just be that only the very wealthy will be able to afford it.

Medical Device Innovation in Mental Health

There is not an impressive amount of medical device innovations in mental health. The

trend for mental health veers away from devices and procedures such as surgeries, or electro-

convulsion therapy. Interventions such as mechanical restraints or other ways to restrict the

movement of patients have faded away with new research that indicates these types of
INNOVATION IN MENTAL HEALTH CARE 5

interventions would cause more harm than benefit. There are some innovations, like the Fisher-

Wallace Stimulator, that claim to improve depression and anxiety through brain stimulation.

Many people are averse to taking medication for their depression, anxiety, and or insomnia. The

Fisher Wallace Stimulator is a recently FDA-cleared device that is a non-pharmacological

solution to depression, anxiety, and insomnia. Its innovation is that unlike oral medications, the

Fisher Wallace Stimulator uses cranial electrotherapy stimulation to produce neurochemicals

such as serotonin.  For the patient, the Fisher Wallace Stimulator is innovative in that it “treats

insomnia but is not a sedative - instead, the device modulates the brain to produce a restful state

that accelerates sleep onset and restores longer periods of sleep” (Fisher Wallace, 2019).  The

Fisher Wallace Stimulator is innovative for the healthcare provider as it can be used as an

alternative to medication or used in conjunction with medications to treat depression, anxiety,

insomnia. Norman describes the process that a new medical device must go through in order to

get cleared by the FDA: “the device enters a cycle of testing and redesign that typically takes 2-3

years and costs between $10 million and $20 million” (2019, p. 278). 

“Whereas pharmaceutical drugs must be FDA-approved to enter the market, medical

devices must be FDA-cleared. The Fisher Wallace Stimulator is FDA-cleared to treat depression,

anxiety, insomnia and chronic pain” (Fisher Wallace, 2019). This clearance means that providers

and patients will trust the safety and effectiveness of the device. According to Norman (2016),

“after a device goes to market, federal regulations require hospitals, health professionals, and

other users of medical devices to report patient incidents involving the device, both to the

manufacturer and to the FDA if the incident results in serious patient injury, death, or other

patient-adverse experiences” (p. 285).  The quality of a device includes safety issues surrounding

its use.  This product would have to be utilized at home or in an outpatient setting rather than in a
INNOVATION IN MENTAL HEALTH CARE 6

mental health facility, psychiatric hospital, or other acute care situation where patients are

activity suicidal.  The Fisher Wallace Stimulator can be purchased online for $599 and with

those with Medicare or Medicaid, it is available for $499, if recommended by a physician (Fisher

Wallace, 2019).  If Medicare and Medicaid were to offer more in its coverage, patients would be

interested in trying it. 

Legal and ethical concerns about medical devices used in mental healthcare have to do

with the rights of a patient to the same freedoms of those without mental health issues. Devices

used to restrain patients are no longer acceptable practice. Beyond those, there are not a lot of

devices used other than things that may help a patient to relax such as headphones or a white

noise machine. The Fisher Wallace Stimulator does not seem to pose any threats ethically or

legally.

Biotechnology Innovation in Mental Health

Biotechnology innovations are beginning to make a greater impact in mental health than

ever before. With the new developments in DNA testing, patients are receiving better treatment

than in the past. The GeneSight test in an example of how biotechnology is impacting mental

healthcare. People who suffer from mental health disorders spend a tremendous amount of time

trying to figure out the medications that work best for them.

The GeneSight Test is a DNA test that can narrow down the best options for medications

for people with mental health disorders. Its innovation is that unlike the trial and error approach

which can take months to identify what medication works best, the GeneSight Test determines

what medications work best in just 36 hours. According to Evens and Kaitin, for the future of

biotechnology, “a key initiative will be the continued development of ‘personalized medicine,’ or

pharmacogenomics, in which the genetics of the individual patient will indicate the likely
INNOVATION IN MENTAL HEALTH CARE 7

response of the disease to the biologic treatment This will allow prescribers to tailor individual

treatment regiments to include medicines that have a likelihood of offering a positive therapeutic

outcome, while avoiding those treatments that might result in serious adverse events” (2015, pp

217-218).  At the time this article was written, GeneSight was part of the future and today that

future is here.  In regard to access, Gene Sight Testing is very accessible.  Primary care providers

collect a specimen by swabbing the inside of the cheeks and send it away to a lab for testing. 

The test results are available in 36 hours and providers can immediately make decisions about

which anti-depressants or anti-psychotics will work best. According to one clinical study,

“Patients were 2x as likely to respond to medications guided by the GeneSight Psychotropic test”

(Assurex Health, 2018) and “Patients taking medications guided by the GeneSight Psychotropic

test saw a 70% greater improvement in depressive symptoms” (Assurex Health, 2018).  The Gene

Sight test is very expensive as it is new but there is financial assistance available to those who are

eligible.

As with all areas of healthcare, the legal and ethical concerns related to biotechnology

usually pertain to the processes used to research and learn biology and harvest from it

innovations that advance healthcare without harming subjects. In addition, how the new science

gleaned from such research is used also becomes an ethical issue. The same science that is used

to benefit patients can also be used to develop and create choices in how bodies work and what

kind of babies are born.

Health Informatics Innovation in Mental Health

Health informatics innovations in mental health care have impacted the practice greatly in

the way that providers communicate and share information about patients in order to provide the

best treatment possible. The electronic health record is an innovation that has provided almost

instant communication and shared information for providers. Mental health facilities or units are
INNOVATION IN MENTAL HEALTH CARE 8

usually the last to receive funding for new technology because mental health does not, on the

surface, appear to be a critical area where the lives of patients are not in any immediate danger of

being lost. This is not true, of course, and the more that information about a patient can be

shared in a timely manner, the greater the chance that an actively suicidal patient’s life will not

be lost to suicide.

The electronic health record is being used in mental health to share the current status of a

patient’s suicidality, the psychiatric precautions on which a patient is being placed, the level of

observation that a patient needs, and the location and safety of each patient at any time of the

day. The electronic health record is easily accessible as there are numerous software packages

available to facilities. Certainly the immediate and easily accessibility of shared information on a

patient will improve the quality of care that a patient receives. The cost of software is worth it in

order to save lives. Additional costs would include the time it takes to train staff to use the

electronic health record and the cost to maintain the hardware and to fix issues with the software.

This usually involves hiring a full time IT person.

Protection of the privacy of patient information is the primary legal and ethical concern

related to health informatics, including the electronic health record. Not only can software be

hacked into by outsiders but systems must be placed to track the paths used by employees to

ensure that information is not carelessly shared among healthcare workers, compromising

patients’ right to privacy.

Problems and Solutions

The main problem still yet to be solved when it comes to innovation in mental health care

is cost. The majority of mental health patients are individuals who are homeless or at the very

most have very little support. There are many instances where patients cannot afford the
INNOVATION IN MENTAL HEALTH CARE 9

medication that helps them or they do not have the means to transportation for them to fill

prescriptions. These are the same individuals that go off their medications, most of the time due

to lack of funds or transportation, and find themselves involuntarily committed to a psychiatric

facility where they receive treatment that is mostly medication stabilization. These readmissions

to hospitals are extremely expensive. Innovations such as long acting injectable anti-psychotics

have helped so that patients only need to receive their medication once a month but these are

even more costly. Possible solutions like Abilify MyCite are being developed but their

effectiveness is not yet known. Possibilities for solutions for this problem are wide open for

innovative and technological advance.

Conclusion

Psychiatric, mental, and behavioral healthcare is slowly catching up to other fields of

medicine as innovators attempt to tackle the needs for advancement in this area. Advances have

been made in the sectors of pharmaceuticals, medical devices, biotechnology, and health

informatics. Examples of each of these can be evaluated for their impact on access, quality, and

cost of mental health care. None of them are without legal and ethical concerns. Fortunately

there are agencies that spend time assuring the safety of innovations so that patients and

providers can trust their use and explore these improvements in treatment, diagnosis, education,

outreach, prevention, and research.

INNOVATION IN MENTAL HEALTH CARE 10

References

Assurex Health (2018). GeneSight Pamphlet.

Chuck, Elizabeth & Dunn, Lauren. (March 19, 2019) FDA approves first drug for

postpartum depression. NBC News. (1-3). Retrieved from

https://www.nbcnews.com/health/womens-health/fda-approves-first-drug-

postpartum-depression- n984521?cid=sm_npd_nn_fb_ma&sfns=mo.

Evens, Ronald and Kaitin, Kenneth. (2015). The evolution of biotechnology and its impact on

healthcare. Health Affairs. 34(2). 210-219.

Fisher Wallace. (2019). The Fisher Wallace Stimulator. Retrieved from

 https://www.fisherwallace.com/.

Morgan, S., Lopert, R., & Greyson, D. (2008). Toward a definition of pharmaceutical

innovation. Open Medicine. 2(1). 4-7.

Myriad Neuroscience (2019).  GeneSight. Retrieved from genesight.com.

Norman, G.A. (2016). Drugs, devices, and the FDA: Part 1. JACC: Basic to Translational

Science. 1(3). 170-179.

Omachonu, V. & Einspruch, N. (2010). Innovation in healthcare delivery systems: A conceptual

INNOVATION IN MENTAL HEALTH CARE 11

framework. The Innovation Journal: The Public Sector Innovation Journal, 15(1). 1-20.