The term medical technology refers to the application of scientific knowledge and skills in the form of devices, medicine, vaccines, procedures, and systems made to solve a health problem and improve patients’ quality of life (Ten Haken et al., 2018). The technological developments observed in the 21st century have led to tremendous changes in healthcare (Thimbleby, 2013). What could be thought of as science fiction a couple of decades prior is, now, everyday medical practice. From the use of robots (Hockstein et al., 2007) to tailoring therapy to each patient’s needs (Mathur and Sutton, 2017), modern medicine could be considered an advanced technological profession (Mesko, 2018). This notion is further reinforced by the introduction of modern engineering, information technology, wireless communications and Software as a Medical Device in everyday medical practices.
CalenDarer's quality assurance process includes the utilization of Software as a Medical Device, demonstrating the use of the regulatory parameters of the computer software source code INSIDE and OUTSIDE of the Medical Device Hardware to design, develop and deploy Digital Therapeutic medical device innovations that correct rare medical conditions. This quality assurance process to illustrate the type of fine tuning processes involved in ensuring ethical design is presented in the hereafter.
*The clinical data pertaining to the use of technological processes to design, develop and deploy digital therapeutic medical device innovations that correct medical conditions, via the use of software, serve to highlight the intense testing and verification of the computer software system to ensure the Beta-Testing process is not only utilized to work out flaws, but to utilize those corrective design and development processes for the purpose of designing, developing and deploying medical device innovations from the regulatory parameters of the computer software source code,
Via the use of Software as a Medical Device (SaaMD), process management is translated to Artificial Intelligence as a Medical device for managing the use of the regulatory parameters of the computer software towards designing, developing and deploying Digital Therapies that treat medical conditions.
Treating problems tied to head injuries is complex. This is, in part, because it is not possible to directly examine the brain of a living person and because every brain injury is unique. Advanced brain imaging to detect concussions is not available in standard clinical settings, so clinicians rarely have clear roadmaps for rehabilitation.
Via the translation of Natural Language Code to Computer Language Code to Image Artificial Intelligence, Prescriptions for Cybernetic Digital Therapeutics are applied via psychological means to engage the autonomic nervous system in order to deliver the 21st Century Cure to the patient via the central nervous system.
Blockchain Molecular Bond (comparison)
Gabapentin
PHARMACEUTICAL
The physiologic effect of gabapentin is by means of Decreased Central Nervous System Disorganized Electrical Activity.
- 21 U.S. Code Chapter 9 -
CalenDarer DTx
MEDICAL DEVICE
The physiologic effect of CalenDarer DTx is by means of Removal of Central Nervous System Disorganized Electrical Activity.
- 28 USC § 3002 (15)(a)(b)(c) -.
Complex Regional Pain Syndrome
Diagnostic
The Cost to Diagnose Complex Regional Pain Syndrome
$
Treatment
The cost to treat Complex RegionalPain Syndrome
$
Rehabilitation
The cost to rehabilitate from Complex Regional Pain Syndrome
$
Cost Analysis
Clinical trials are carefully designed research studies that evaluate safety, efficacy and effectiveness of new treatments or interventions via the utilization of the translational Research Clause of The 21st Century Cures Act. The process involves screening for eligibility, providing informed consent, actively participating in the study sometimes for prolonged periods and undergoing monitoring by experienced healthcare professionals.
Via the utilization of Cybernetic Technology, Artificial Intelligence, Blockchain Technology and Software Technology, purposeful modulation of the nervous system's activity can be achieved without invasive (e.g. microelectrodes) or non-invasive means (e.g. transcranial magnetic stimulation or transcranial electric stimulation, tES, such as tDCS or transcranial alternating current stimulation, tACS) to offer a solution for difficult to treat medical conditions such as pain stemming from Complex Regional Pain Syndrome and Post Concussion Syndrome.
With multiple Digital Medicines in the pipeline for mental health conditions and Congress reviewing "The Access to Prescription Digital Therapeutics Act", the move is swift to quickly identify, design and build Prescriptions for the Cybernetic Digital Therapeutic that offer consistent patient solutions.
*Please download and review the Costs Analysis for CRPS, a medical condition that is cured by one of CalenDarer's novel Cybernetic Medical Device Innovations.
CalenDarer's mission in healthcare involves training licenced psychologist to adminster cybernetic digital therapeutic medical device innovations that remove pain stemming from neurological disorder or injury. In this case, the psychologist gets added to the referral network of the diagnostic process for solving diffilcult to solve medical conditions.