Our unified workflow ensures a complete understanding of your hardware and software needs from concept to launch.
- Provides deep expertise in serving complex integrated healthcare applications such as Clinical Medical Devices, Drug Delivery Systems, Consumer Managed Health and Diagnostics
- Ensures that digital health offerings are holistically designed to enable seamless user experiences and device/companion software optimization throughout the product life cycle management, reducing risk and time to market
- Operationally aligns development processes implementing ISO 13485 certification and IEC 62304 standards and enables design controls driven device development
- Brings together global leaders in device development and companion software—two unique disciplines that are typically utilized independently and asynchronously
- 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
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:
Before principal design-development begins, we help you understand your connected care system and frame the requirements for a successful production effort.
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.
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.
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:
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.