How do we build successful connected care products? By making complex systems simple and elegant. Our process is designed from the ground up to address complexity, uncertainty and change.


Human Factors Engineering and Design

We believe a relentless focus on designing intuitive software for users is the key to capturing medical device market share and mitigating risk. Our research-driven human factors evaluations are the key to understanding how people will interact with all of the elements of a connected medical device. This focus ensures that the connected care systems we design and build are intuitive and easy to use for users of all types while also reducing risk.

User Experience Engineering

At Orthogonal, we are not a run-of-the-mill medical software design and development agency; we are user-centered and product forward. At the beginning of every project, we establish a quantitative baseline of the intended users and their behaviors through behavior research before creating and designing user flows, prototype interfaces and system and architecture recommendations. We work seamlessly with our client’s internal project stakeholders to integrate user research into the development decision making process.

User Interface Design

We take user interface design seriously. And our in-house design team is made up of some of the best in the industry. By seamlessly integrating design work with the software requirements definition, architecture, prototyping, and user testing effort, Orthogonal’s design team can move rapidly from comps to finished pixel perfect assets. Orthogonal’s lean design methodology delivers enviable results. Our human factors engineers offer tangible insight that is then translated into development solutions.

Usability Testing

You’ve worked hard to build a medical device you believe will help patients and clinicians. You believe that you have identified how they will use and interact with the device. But why rely only on assumptions? At Orthogonal, we test and validate user’s expectations as they interact with the device. We continually test medical devices in simulated and real environments using real end users throughout the iterative design and development effort to uncover potential risks and identify mitigations.

Our human factors engineers design user experiments involving surveys, interactive prototypes and behavioral analysis to isolate user tendencies and behaviors and convert those insights into executable instructions for the development team. The human factors process produces documentation detailing architecture, interface, design, risk and controls. Without fail, our human factors research and experiments always provide clients with new insights about the market, about target consumers and helps them build a better medical device.


User-centered design thinking drives everything we do, from risk verification to development requirements. We ensure features are effective for your users, technically efficient and, above all, compliant.

Agile Software Development


Orthogonal developers use Agile and Lean software development processes that are designed to discover problems early and prioritize the elimination of hazards and risk.

Using iterative development cycles, we get feedback early and often, allowing clients to make time-sensitive and cost-effective adjustments based on timely data. This allows us to deal with uncertainty and mitigate risk. This streamlined development process accelerates our client’s medical device commercialization efforts.

Software Verification

Our verification process, verification-driven design extends test-driven development (TDD) and behavior-driven design (BDD) so that verification protocols and their results are developed concurrently with the software within the iterative framework. This approach provides a single interpretation of requirements and minimizes surprises and delays during formal verification. In other words, it helps you avoid “verification hell”.

Testing Automation

Testing automation is the key to achieving and maintaining velocity over time. Orthogonal employs state-of-the-art requirements management and testing tools to automate traceability, verification and validation. We build testing frameworks for system testing, including testing of hardware, firmware and software. All of these frameworks operate to dramatically decrease the development, manufacturing and maintenance time both initially, and during subsequent upgrades.

Quality Management

When you build medical device software, quality management is essential. Orthogonal’s quality management system is compliant with FDA and EU medical device regulations and ISO 13485 and IEC 62304 standards, and enables the design and agile practices to address the complexity and rapid change inherent in connected care systems.

Support and Maintenance

Maintaining medical device software is a significant challenge for many med device manufacturers. As such, we provide support throughout the product’s life cycle. Continuous developments in mobile and web operating systems, Bluetooth protocols and regulatory standards require a standard device and companion software verification process. Our emphasis on testing automation during the development process allows our customers to keep up with changes in technology and platforms and to quickly deliver verified software updates.

Risk Assessment and Mitigation



Actively managing risks and hazards is integral to Orthogonal’s development processes. Mitigating risk and anticipating harm has been integrated into our Agile design and development process. The design and development of all companion medical software begins with data collection and inputs from human factors engineers, client stakeholders and potential users in experiments designed and led by our internal human factors engineering team.

We implement security, technical and quality controls across every department and at every stage of development. Ultimately, we increase patient safety, minimize liability, and position our clients for a straightforward FDA submission process, all while providing market-leading medical device companion software.

Percutaneous Tibial Nerve Stimulation

Medical Device Companion Software for Treating Urinary Urgency

Orthopedic Range of Motion Analysis

Real time analysis using wearable sensors

Diabetes Management System

Bluetooth-Connected Glucometer and Mobile Medical Apps


From Inception to Launch

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.