Connected medical devices are no longer an aspiration, they are the reality. They empower physicians, patients, and payers, improving the system across the continuum of care. Together, Insight and Orthogonal develop best-in-class devices and companion software for digital health from definition to delivery.
Our unified workflow ensures a complete understanding of your hardware and software needs from concept to launch.
Our phased service offerings are as follows:
Before principal design-development begins, we help you understand your connected care system and frame the requirements for a successful production effort.
Design Strategy:
We integrate contextual understanding with prioritization of user and clinical stakeholder needs in order to identify design opportunities and technical possibilities for innovative device and companion software offerings, including novel devices, modified platforms, mobile applications, cloud based data management and data analytics.
Inception:
You have the data, now we assist you in assembling the strategy. The inception is a collaborative in-person workshop designed to explore and capture the system’s functionality and intended users in preparation for principal design and development under quality controls.
During design-development, our collaborative team ensures your device and companion solution is effective for your users, technically efficient and properly configured for regulatory submission.
Usability Testing and Human Factors:
Our Human Factors engineers design user experiments involving surveys, interactive prototypes and behavioral analysis to isolate needs, behaviors and risks and convert those insights into executable instructions for the development team and documentation for the regulatory submission.
Advanced Hardware Development:
Characterization of requirements, proof of technical viability, and roadmapping technologies are utilized to enable integrated digital health offerings including architecture, platform and security considerations for device and software.
Device User Experience Design:
We create optimal device experiences that satisfy user needs and create differentiation through an iterative design, test and build process conducted in harmony with companion software development.
Device Design for Commercialization:
We perform detailed design and development to satisfy functional specifications under design controls through delivery to client development teams and manufacturing entities.
Lean UX Design:
User-centered design thinking drives everything we do, from risk verification to development requirements. By seamlessly integrating design work with the software requirements definition, architecture, prototyping, and user testing effort, our design team can move rapidly from comps to finished pixel-perfect assets.
Agile and Test-Driven Development:
Our developers use Agile, Test-Driven software development processes that are designed to discover problems early and prioritize the elimination of hazards and risk for cloud, mobile and embedded software systems.
Quality Management:
Make sure your companion system is compliant and stays that way. Our quality management system is compliant with FDA and EU medical device regulations as well as ISO 13485 and IEC 62304 standards.
Commercially scaling and maintaining medical devices and software is a significant challenge for medical companion systems. We can help with:
Commercialization Support:
We provide device and software verification and ongoing product lifecycle management including regulatory agency filing support.
Tiered Software Release Support:
We provide support throughout the product’s life cycle. 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.
