Medical Device Software Development
Providing custom medical software design and development services, Full
Spectrum Software has developed medical devices for a wide range of
applications. These FDA controlled products have been developed using our ISO
13485 certified processes and using our clients’ quality management systems.
Projects we have built include Class III invasive medical devices.
Full Spectrum has provided software development for medical software
systems and patient monitoring systems including clinical monitoring systems,
in-home patient monitors and remote telemetry monitoring adjuncts.
Full Spectrum's portfolio of medical devices include clinical laboratory
instruments, radiation therapy systems, 2D and 3D CT, X-Ray and other imaging
and image guided medical devices that support DICOM.
HL7 software integration, integration with Google Health, Microsoft
HealthVault and other PACS, Hospital Information Systems are included in many of
the medical software systems we have created including patient management and
scheduling systems built by Full Spectrum.
Full Spectrum's capabilities include graphical user interface design and
implementation for medical devices. As well as process control and automation,
Full Spectrum provides medical device GUI development. We'll often work with our
clients' graphic design firms to build highly aesthetic user interfaces with
proper human factors analysis and documentation required for proper medical
software design compliance.
Below you will find descriptions of some of the domains with which we have
worked. This is not a complete listing but should give some idea of the
technologies and visualizations with which we have worked.
Neuorodiagnostics
Full Spectrum Software has been involved in developing a wide range of neurodiagnostic instruments. One example is a product that allows neurophysicists to develop and approve algorithms for the detection and analysis of encephalographic signal to determine a patient's level of sedation. This product included the development of large-scale back-end databases, all aspects of data manipulation for data visualization and reporting and was developed in a cross-platform environment including both Windows and Linux.
Virology
Full Spectrum Software has been involved in gene sequencing and assay development for the identification of specific gene sequences which identify HPV (Human Papilloma Virus). Software development efforts have included mechanical control of pick and place, microfluidics, image processing, back-end storage and UI development.
CT Scan
The company has developed various components of CT systems including image processing, remote systems diagnostics and injection systems for the delivery of contrast agents. These projects encompassed all aspects of development including software design, SQA, mechanical control, remote service interfaces and database development.
MRI
Full Spectrum Software has developed software for MRI systems for the targeting of radiation therapy and deep brain stimulation.
PET
Designed and developed a fluid delivery system for the injection of radioactive material (FDG) for detection of tumors in the human body. Development efforts involved all aspects of software design, development and QA of touch-screen-UI, communications, remote diagnostics, optimization and full SQA including software V&V and accelerated reliability testing.
Radiation Therapy
Designed and developed highly sophisticated Quality Assurance test plans and protocols and simulation tools to test the system for V&V as well as simulation in support of software development. These are very wide scale systems that depend on complex messaging such as DDS. This is a Class III medical device.
Hypothermic Treatment
Designed and developed refrigeration/cooling systems for the treatment of infants who experienced hypoxic events or cerebral trauma. Efforts included software design, control software, development of UI-touch screen, full SQA including test plans, test protocols and software V&V.
Deep Brain Stimulation
Designed and developed all of the software for the product including data visualization, high speed data acquisition, interfaces to the hardware which included insertable electrode bundles that are attached to the human skull, recording, playback, signal conversion and signal filtering for the targeting of therapeutic electrodes for the treatment of Parkinson's disease, depression and Epileptic seizures. This is a Class III medical device.
Orthopedic - ROM (Range of Motion)
Software development and SQA efforts included acquisition and recording of motion to detect deficits in range of motion in areas such as the neck and elbow and a patient's ability to exercise a full range of motion. Software included full prototyping of the system, GUI, file UI, device communications and diagnostic measurements against orthopedic standards for range of motion as well as reporting systems.
PSG (Polysomnography)
Full Spectrum Software design and developed the data acquisition systems, GUI prototyping, final GUI, motion sensing and sleep analysis for adult and pediatric patients and the reporting system, which is a key element of a PSG system.
Epilepsy Monitoring
The company has developed multiple systems in this area. Software development efforts included data acquisition of both AC and DC data streams, data storage, synchronization of audio and video data to detect a facial twitch or facial changes to determine when the onset of a seizure occurs, data storage, GUI development and HIS integration utilizing HL-7.
Pediatric Neurodiagnostics
Software engineering encompassed all aspects of software design and SQA, including development of cerebral monitors to allow a physician to determine if an infant is exhibiting improved neurological function over time. Efforts included GUI design and implementation, function signal processing, data management and storage, administrative functioning and remote (web services) support.
Patient/Physiological Monitoring
Full Spectrum has designed and developed multiple systems that monitor blood oximetry, blood pressure, heart rate, movement monitoring utilizing motion sensors, video and audio synchronization for patient monitoring and evoked potential which involves applying a stimulus to a patient and determining if there is a neurological response.
Pediatric Screening
Full Spectrum Software has designed and developed auditory diagnostics tools and post pediatric screening monitoring systems to follow up and to track whether an infant is receiving the required care and treatment prescribed by the pediatrician (required by some state laws). The screening systems are primarily web services with front end diagnostic tools that report into back-end databases.
Auditory/Hearing Diagnostics
Extensive software development work in hearing diagnostic instruments including systems that analyzes a combination of evoked potential, transiently evoked auto acoustic emissions, distortion product auto acoustic emissions and auditory brain stem response. These systems provide a very precise measurement of potential hearing deficits that a child or adult might have. They are particularly important for children to insure that a hearing deficit can be treated appropriately so that normal speech development is not impeded.
Remote Cerebral Monitoring
Designed and developed this capability for several systems. While most cerebral monitoring systems function at the patient's bedside, these systems allow a neurologist to be called in to monitor a patient's cerebral function or seizure at the point of necessity. The software technology involved includes web services, data acquisition, parallel processing and data synchronization.
Cardiovascular Imaging
Designed and developed injectors for contrast agents for venal and arterial imaging. These systems are Class III devices requiring extensive SQA. Software design and development included mechanical control and system monitoring. SQA efforts included all FDA required SQA documentation, full software V&V and accelerated reliability testing.
Dental Imaging
Designed and developed a variety of portable X-Ray based systems which involved building drivers, developing camera controls, developing imaging applications for image manipulation, clarification and improvement and developing applications for image storage and retrieval. Full Spectrum has also developed highly customized systems for companies that produce personalized dental implant products.
Myoelectric Prosthesis
Designed and developed a new architecture and researched new technologies to allow patients to "train" the prosthesis using their own nervous system and to achieve many more degrees of articulation than previously thought possible. Full SQA efforts including software V&V.
Oncology: Cytology
Designed and developed several systems utilizing highly specific dyes/stains to identify certain types of structures within normal and tumor cells using high-end microscopy, sophisticated image acquisition with tunable filters to allow visualization of various regions of the sample that were stained with different dyes enabling physicians to identify certain abnormal cell behavior.
Oncology: Melanoma Detection
Full Spectrum designed and developed embedded and application-level software utilizing UV light source for image acquisition and analysis for the detection of melanomas. Full SQA efforts and documentation.
Sedation Monitoring
Architected and developed software for two different devices used for sedation monitoring in an OR setting. Software engineering included neurological signal detection and analysis, detection and identification of "signals of interest" during long-term recordings, development of back-end databases and full SQA. This device is a Class III medical device.
Patient Scheduling System
Full Spectrum designed and developed a highly sophisticated patient scheduling system that calculated all of the logistics of room availability, physician availability, equipment availability, maintenance and many other variables to optimize patient care and workflow. The software included back-end data storage and HL-7 interfaces to HIS systems.