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 and User Experience

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.


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”.

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.

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.

Agile and Lean Processes

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.


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.


Ongoing software maintenance is as important as the launch. DevOps integration, and attentive patch and new feature releases are the lifeblood effective product lifecycle management. In collaboration with your IT operations team, we provide continuous development support for mobile and web-based systems, device and systems interoperability and API interactivity to help you maintain a stable classified system.


Risk Assessment and Mitigation

After completion of a development release, where contracted, Orthogonal will provide support management—ongoing problem and change management review and engineering support for the Production application codebase and environment. Orthogonal operates in the Tier 3 support level with review-level interaction at the lower tiers, as necessary.

Support management services are organized into Support streams. The streams are tiered packages of system maintenance activities covered under contract. Each corresponds with an Orthogonal staffing module and minimum production period required to fulfill it.

Want to find out more?

We love hearing about new connected device projects, and we love 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.