We specialize in developing systems that connect to medical devices. We know the ins and outs of device connectivity protocols, including wired, wireless, cellular and Bluetooth protocols. We know how to optimize speed and reliability, reduce interference and maximize cybersecurity. We understand the tradeoffs of between Bluetooth Low Energy (BLE) and Bluetooth Classic, and their limitations with different mobile operating systems for passive and continuous monitoring and device control. That means we can anticipate many of the issues that can arise with these technologies, so our customers have lower risks and fewer surprises.
We have deep expertise with native and cross platform development on iOS, Android, and Windows platforms, as well as HTML5 / Angular Responsive Web Interfaces. We developed some of the first Class II mobile medical apps with Bluetooth connectivity, and continue to lead in the field of FDA regulated mobile and web applications.
Many of our clients are still building and refining their hardware, even as they begin the companion software development process. We have extensive experience coordinating with leading hardware and firmware partners to create seamless end-to-end development processes that allow parallel hardware and software development. Our processes reduce the risks inherent in rapid parallel development of medical devices and companion software.
One of the biggest sources of delays and cost overruns for medical devices is conflict between the underlying subsystems and interfaces. We address these challenges by emphasizing interface compatiability between systems early in both the hardware and software development processes. We accomplish this by applying interface control processes and a lightweight testing and simulation framework, which enables faster build-test-fix cycles for both hardware and software.
We design and build scalable, secure and extensible architectures on HIPAA-compliant cloud infrastructures such as Amazon AWS, Microsoft Azure and Catalyze.io.
Systems we’ve designed and implemented have been scaled to hundreds of thousands of devices and users.
Interfacing with clinicians and clinical data is often a critical piece to commercializing connected care products. Orthogonal works with leading middleware vendors to integrate the platforms and applications we build with major EMR systems like EPIC, Allscripts, eClinicalWorks and Cerner, as well as other clinical and laboratory information management systems.
We begin every medical software development project with an intense period of data collection and formative assessments called an Inception.
The Inception is a collaborative in-person workshop designed to explore and capture the system’s functionality and intended users. Our subject matter experts in human factors engineering, Agile development and Quality Systems collaborate with project stakeholders to identify and define work flows, user types, functionality, risks and everything else necessary to facilitate the start of a successful and detailed design, development and FDA submission effort.
At Orthogonal, every project begins with an Inception. Contact us to learn more or to schedule an Inception for your medical device software project.