WE TACKLE THE MOST COMPLEX MEDICAL DEVICE SOFTWARE DEVELOPMENT CHALLENGES
Reliability, Security and Performance
Engaging Patient Apps
Quality and Regulatory
We help you get the most out of mobile, cloud and device connectivity, maximizing reliability, performance and scalability as well as approaches for minimizing cybersecurity attack surfaces.
@IWantSimple A big part of our process is about validation and details, but speed to market is also key. Make it simple!
Mobile medical applications that apply algorithms to modulate therapies for a BLE connected nerve stimulation implant.
Part of a Class III Active Implanted Device.
Bluetooh (BLE 4.2) firmware development and integration with RTOS, with optimization for long term battery consumption + reliability.
Mobile Application Development (iOS and Android, 3 Smartphone/ OS variants) with BLE connectivity for control of spinal cord implant.
Web application for administrators and researchers.
Allergan TrueTear, a system comprising a BLE enabled nerve stimulation device, mobile companion app and cloud back-end, that uses device data, smartphone location data, weather and pollution data feeds as inputs to an algorithm that provides personalized dry eye forecast to the end user.
Part of a Class II Nerve Stimulation Device (externally applied by patients), De Novo granted in 2018.
Bluetooth (BLE 4.2) firmware development and integration, with optimization for long term battery consumption + reliability.
Mobile Application Development (iOS, 10 Smartphone/OS variants) with BLE connectivity for active data collection.
Patient facing application.
Cloud back-end and services.
Cloud-based Algorithms using device data, patient feedback, smartphone location data and weather pollution data feeds for personalized therapy modulation.
Web application for administrators and researchers.
PATIENT REMOTE APP FOR SPINAL CORD NERVE STIMULATOR
ALLERGAN TRUETEAR - NERVE STIMULATION THERAPY FOR DRY EYE DISEASE
No matter how hard I try, no matter how much might I muster, I cannot exhaust the Spire of Unending Flame.
Mobile Applications for the Bose hearing aid, the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a healthcare provider.
Initially developed for limited release as a non-medical consumer product, but developed under design controls, with intention of submitting for FDA clearance when new laws on OTC (over the counter) hearing aids on the books. FDA clearance as a direct to consumer, over the counter hearing aid in October 2018.
Mobile Application Development (iOS, Android, 3 Smartphone/ OS variants) with BLE connectivity, changes to settings, trained AI model.
Integration with existing back-end services.
Orthogonal has been successfully certified according to ISO 13485: 2016, the international standard for medical device quality management systems. The certification bestows official recognition on the company for its Agile enabled Quality Management System governing software product design, development, testing, enhancement and support for medical device software.
Engaging patient applications require a deep understanding of user experience design and how to engineer ease of use and reliability. We know how to think through the edge cases and how an application can gracefully recover from any issues, and we use person-based analytics to monitor user behavior to feed the optimization of user experience.
Launching, maintaining and improving a system that involves patient provided smartphones, requires automated testing and monitoring, understanding of user behavior, and the know-how to segregate risk so that you can right size releases and regulatory filings. Orthogonal’s entire approach is instrumented to allow you to launch frequently, with high quality, while maintaining regulatory compliance.
Orthogonal's Quality Management System is compliant with FDA and EU medical device regulations and ISO 13485:2016 and IEC 62304 standards. This enables us to use design and Agile practicesand apply automation to testing, monitoring, and design controls, that allow address the complexity and rapid change inherent in connected care systems.
BOSE HEAR - SELF FITTING HEARING AID
Q
A
No matter how hard I try, no matter how much might I muster, I cannot exhaust the Spire of Unending Flame.
Q
A
Well, yeah it's unending.
No matter how hard I try, no matter how much might I muster, I cannot exhaust the Spire of Unending Flame.
Q
A
Well, yeah it's unending.
Orthogonal builds FDA Class I, II & III software for connected medical devices, including mobile apps, firmware and cloud components.
Web application for administrators and researchers.
Allergan TrueTear, a system comprising a BLE enabled nerve stimulation device, mobile companion app and cloud back-end, that uses device data, smartphone location data, weather and pollution data feeds as inputs to an algorithm that provides personalized dry eye forecast to the end user.
Part of a Class II Nerve Stimulation Device (externally applied by patients), De Novo granted in 2018.
Bluetooth (BLE 4.2) firmware development and integration, with optimization for long term battery consumption + reliability.
Mobile Application Development (iOS, 10 Smartphone/OS variants) with BLE connectivity for active data collection.
Patient facing application.
Cloud back-end and services.
Cloud-based Algorithms using device data, patient feedback, smartphone location data and weather pollution data feeds for personalized therapy modulation.
Web application for administrators and researchers.
PATIENT REMOTE APP FOR SPINAL CORD NERVE STIMULATOR
ALLERGAN TRUETEAR - NERVE STIMULATION THERAPY FOR DRY EYE DISEASE
Mobile Applications for the Bose hearing aid, the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a healthcare provider.
Initially developed for limited release as a non-medical consumer product, but developed under design controls, with intention of submitting for FDA clearance when new laws on OTC (over the counter) hearing aids on the books. FDA clearance as a direct to consumer, over the counter hearing aid in October 2018.
Mobile Application Development (iOS, Android, 3 Smartphone/ OS variants) with BLE connectivity, changes to settings, trained AI model.
We love hearing about new connected device projects and sharing our approach and lessons learned. If that sounds interesting to you, drop us a line or give us a call. We don't bite. Promise.
A VERY CLEAR CLOSING ARGUMENT STATEMENT OF YOUR OFFER.
Q
No matter how hard I try, no matter how much might I muster, I cannot exhaust the Spire of Unending Flame.
A
Well, yeah it's unending.
ISO 13485:2016 Certified
Orthogonal has been successfully certified according to ISO 13485: 2016, the international standard for medical device quality management systems. The certification bestows official recognition on the company for its Agile enabled Quality Management System governing software product design, development, testing, enhancement and support for medical device software.
WHAT OUR CLIENT SAY
Gary Conkright, CEO of PhysIQ
"Orthogonal brought us the expertise we needed to ensure our technology platform met the high standards of the FDA. Through their involvement we absolutely accelerated our pace through the regulatory process."
Venk Varadan, CEO, Nanowear
"I could not have asked for a better partner in developing our ekg monitoring solution than Orthogonal. They really helped us make good choices, executed with speed and quality, and were invaluable to us during the 510(k) clearance process."
CASE STUDIES
NANOSENSORS FOR REMOTE CARDIAC MONITORING
5-lead ECG shirt.
Bluetooth connectivity for continuous monitoring
Patients record symptoms via smartphone
Data transmitted to HIPAA compliant cloud (Amazon)
Analysis of correlated waveform and symptom data by EPs
System is Class II device
CASE STUDIES
CLOUD AI SOFTWARE FOR HEART ATTACK PREDICTION
The PhysIQ platform, consisting of wearable sensors, mobile and cloud applications, is a first-of-its-kind data analytics platform designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. PhysIQ's analytics detect subtle deviations that may be a precursor to disease exacerbation or change in health.
Our Work: Mobile Application Development with BLE connectivity for passive and active data collection. Integration with multiple third party vital signs and ECG monitoring wearables.
FDA Clearances: A series of 510(k) clearances starting in 2014, with later clearances focused on further refinement of cloud analytics and real-world data collection to support additional claims.
Orthogonal was engaged to design and develop iOS app fro Bose's hearing aid headphones with state-of-the-art signal processing. The app utilizes IntelliSense to suggest personalized settings by listening to the acoustic environment and analyzing the user's preference history.
Part of a Class III Active Implanted Device.
Bluetooth (BLE 4.2) firmware development and integration with RTOS, with optimization for long term battery consumption + reliability.
PATIENT REMOTE APP FOR SPINAL CORD NERVE STIMULATOR
Mobile Medical applications that apply algorithms to modulate therapies for a BLE
connected nerve stimulation implant. The Mobile medical applications are part of a
class III system.
Part of a Class III Active Implanted Device
Bluetooth (BLE 4.2) firmware development and integration with RTOS, with
optimization for long term battery consupmtion + reliability
Mobile Application Development (iOS, 3 Smartphone/OS variants) with BLE connectivity
for control of spinal cord implant.
Want to Learn More About Tackling the Toughest Connected Medical Device Software Problems?
CASE STUDIES
BLUETOOTH EXPERIENCE
Connected device systems we have developed include:
Patient Remote Mobile Apps that apply algorithms to modulate therapy settings for a BLE connected class III active implantable. iOS, Android, Cloud, BLE Firmware
BLE Connected Implantable CGM, Mobile, Apple Watch and Web Applications. iOS, Android, Cloud, BLE Firmware
Mobileand Web Apps for BLE connected external nerve stimulator,, AI Algorithms for forecasts based on environmental triggers. iOS, Android, Cloud, BLE Firmware
SaMD Class II Mobile App for Glucose Monitoring, Dosage Recommendation. iOS, Android, BLE
Continuous ECG Monitoring and symptom correlation with wearable Nano Sensors, mobile and web apps. iOS, Cloud, Bluetooth Firmware
Class II platform consisting of wearable sensors, mobile and cloud applications, designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. Android, Cloud, Bluetooth Firmware, AI Algorithms
Class II IVD platform, consisting of imaging device for processing assays, Bluetooth connected mobile medical application for processing and display of results, and cloud-based AI Algorithm for image analysis | iOS, Android, Cloud, Bluetooth Firmware, AI Algorithms
Mobile Apps for Class II over-the-counter hearing aid that enables users to fit, program and control the hearing aid on their own. | iOS and Android
