Connected Medical Devices
and Companion Software

A Holistic Pathway for Success

Software is playing an increasingly prominent role in medical device development. While it is possible to continue to address device and software development as separate tracks, it is no longer optimal. User requirements specific to software may change device requirements, and vice-versa. Innovative companies should look at this process holistically.

Our unified workflow ensures a complete understanding of your hardware and software needs from concept to launch.

Connected Medical Devices

We have deep expertise in serving complex healthcare applications where a combination of device complexity, connectivity requirements and data management/analytics are inextricably linked, including:

Clinical Medical Devices

Optimizing the delivery of care through the development of new care models that leverage health data to improve operational efficiencies across all clinical workflows that empower healthcare professionals

Drug Delivery Systems

Holistic patient- and healthcare- driven chronic disease state management applied to delivery systems, training/onboarding and longitudinal adherence to improve outcomes and patient engagement

Consumer Managed Health

Combining consumer experiences with clinical benefits to deliver to users the means to manage virtually every aspect of their health through new brand-driven offerings


Bringing diagnostics and analytics to the point of care to decentralize and speed clinical decision-making and direct treatment plans in real time

I/O Product Development Workflow

Medical Connected Devices Collaboration

Our combined services are devised to address key challenges and and market trends affecting our clients digital health design and development strategy.

Our phased service offerings are as follows:

Definition Phase:

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.

Development and Design Controls Phase:

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.

Product Lifecycle Management:

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.

Insight and Orthogonal are collaborating to develop best-in-class devices and companion software for digital health from definition to delivery.

This collaboration:

  • Ensures that digital health offerings are holistically designed to enable seamless user experiences and device/companion software optimization throughout the product life cycle management
  • Brings together global leaders in device development and companion software—two unique disciplines that are typically utilized independently and asynchronously
  • Operationally aligns development processes implementing ISO 13485 certification and IEC 62304 standards and enables design controls driven device development
  • Incorporates best-in-class development methodologies for device and companion software including Agile and systems engineering
  • Reduces development risk and speeds time to market
  • Ultimately results in the launch of safe, effective and differentiated devices and companion software

About Insight and Orthogonal

Orthogonal Capabilities Overview

Orthogonal specializes in designing and building connected care systems that integrate medical devices, sensors and diagnostics with mobile applications, cloud computing and clinical systems. Our clients include medical device startups developing breakthrough therapies, diagnostics and monitoring solutions using wearable sensors and implanted devices, as well as industry leaders looking to extend their devices with systems and services, measurably improve health and economic outcomes, and position them to prosper in a value-based care environment. We offer full life-cycle product design and development services using an Agile development process that accelerates product introduction and minimizes risk.

Insight Product Development

Insight delivers innovative design development for medical devices, drug delivery, and consumer health. Leveraging more than 25 years in product development, we help clients, from startups to the Fortune 500 uncover valuable opportunities, innovate the technologies and experiences that enable them, and drive their development through commercialization. The primary outcomes we provide are Design Strategy, Advanced Development for technology refinement and scaling, and Design through Commercialization for device market launch.