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

We have deep expertise in serving complex healthcare applications where a combination of device complexity, user experience and connectivity 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

Connected Medical Devices

Our services are devised to address key challenges 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.

  • 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 standards

Developing best-in-class devices and companion software user experience for digital health from definition to delivery.

  • Ensuring that digital health offerings are holistically designed to enable seamless user experiences and device/companion software optimization throughout the product life cycle management
  • Operationally aligns development processes implementing ISO 13485 certification 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

Learn more about our Design Strategy, Advanced R&D, or Design for Commercialization approach.