Our products are designed for patients by expert teams that combine UX and IU designers, software and hardware engineers, cybersecurity and risk management specialists and medical experts.
We work closely with patients and healthcare professionals to get a deep understanding of our users’ profiles needs and expectations and identify the environment of use. We also consider all the existing knowledge regarding treatment and device usage in similar contexts. Working closely with Noble, an Aptar Pharma company, Aptar Digital Health leverages market and patient insights to develop and launch best-in-class experiences for patients, healthcare providers and caregivers.
We bring our concepts to life by creating prototypes and mock-ups for end-users, following usability guidelines such as IEC 62366. Formative and summative studies determine, evaluate, and compare usability and patient preferences, providing outputs that are critical to driving adoption of future solutions and market success, and meet regulatory requirements. We perform iterative evaluations throughout the design of the device and refine solutions with our end-users until we reach their satisfaction and device ease of use.
Every day, our User Interface (UI) and User Experience (UX) designers work with our development teams to design new features, develop clear content and define graphic guidelines that can ensure usability and accessibility. When the product is ready, we validate its effectiveness and safety with patients and healthcare providers by organizing human factors studies.
With over 40 solutions built and versatile platforms, Aptar Digital Health team has developed a unique expertise in developing Medical Devices and Software-as-a-Medical Device.
Our design and development process implement industry standard such as IEC 62304 – medical device software – software life cycle processes. We combine agility with regulatory compliance; our ISO-certified processes aim at delivering state-of-the-art products and solutions while following the Agile Manifesto.
Your dedicated Aptar Digital Health project manager ensures that the project fully meets your cost, time and quality expectations throughout design, development, validation, and delivery milestones. Your project manager coordinates all activities involved in medical device manufacturing (such as human factors engineering, product risk management or clinical evaluation), in connection with our subject matter-experts.
Our methods are based on ISO 14971 for risk management in medical devices and has been proven across multiple projects of moderate to high safety risks (e.g., class C per IEC 62304). Our engineering approach is based on a systematic analysis of design elements and allows to:
Digital health solutions must fit within a broader healthcare IT ecosystem to facilitate adoption and usage by end-users. This means integrating with external medical devices (e.g., drug delivery systems, sensors and digital biomarkers), third-party software (e.g., ERPs, CRMs, SFAs) and EHRs/EMRs. We design and implement strategies to connect our digital solutions with this diverse ecosystem while maintaining compliance with applicable design controls and data privacy regulations.
