Our Approach
Aptar Digital Health offers comprehensive support throughout the treatment journey, from solutions design to deployment and operations, aligned with services to maximize value and impact.
- Patient Insights
- Solution Design
- Solution Development
- Regulatory Approval
- Market Access
- Implementation
- Operations
PATIENT INSIGHTS
Market benchmarking & intelligence, stakeholder research.
By working synergistically 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, payers, caregivers, and more.
These services can take many shapes along the product development lifecycle, starting with cross-functional workshops to identify patient and key stakeholders’ needs, as well as desired outcomes and benefits. Through our findings, we can challenge the competitive landscape and standard of care of the targeted indications and geographies. Through additional stakeholder research, support for commercial scale up, and brand optimization services, we can advance the impact of this market benchmarking once your product hits the market.
Solution Design
Designing the right solutions for patients
UX and Human Factors studies
We design our solutions in close collaboration with patients and healthcare professionals, implementing the best practices in usability and human factors engineering. We are driven by a better understanding of the patient journey at every stage to develop solutions that patients feel empowered and confident to use. We implement the industry’s best practices to offer an optimal user experience, accessible, easy to use and adapted to each culture. Our design teams work hard to deliver user-friendly solutions for every kind of users, across ages, languages and social determinants of health.
Leveraging the voice of the patient, Aptar Digital Health educates and supports its partners in the design and execution of meaningful user experiences. Formative and summative studies determine, evaluate, and compare usability and patient preferences, providing output that is pivotal to driving adoption of future solutions and market success.
Digital interventions and Decision Support
We leverage the best available science and evidence to design digital interventions and decision-support modules to ensure alignment with standards of care.
Through robust and proven processes and proprietary design tools adapted to Software-as-a-Medical Device, we collaborate with medical experts to design digital solutions and algorithms adapted to each disease state and therapy. Our goal is to help deliver personalized education and real-time recommendations aligned with clinical best practices and validated guidelines. We work closely with key opinion leaders (such as members of our international Clinical Advisory Board) to implement decision-support functions that align with routine clinical practice.
Solution Development
Developing and validating digital solutions
State-of-the-art Development Process
We develop your digital solutions based on our software and connected hardware platforms offering off-the-shelf modules addressing common needs for companion apps, digital therapeutics and disease management solutions out-of-the box.
Our platforms accelerate and de-risk the development of digital solutions. It also facilitates custom developments to deliver unique features adapted to patients treated with specific conditions and drugs. Through an agile process, our expert teams of engineers, clinicians, risk managers, cybersecurity experts, designers and human factors specialists work hand-in hand to develop solutions in accordance with standards and guidelines applicable to connected devices and Software-as-Medical-Devices.
Verification and Validation
We verify and validate our solutions through robust processes, based on international standards for hardware and Software-as-a-Medical Device. Each product we build follows strict requirements for performance and safety. Once the product is developed, our Verification & Validation team conduct thorough test campaigns to confirm that it meets its specifications. Its final validation is subject to extensive risk management and human factors analyses. Finally, when necessary, rigorous clinical studies such as randomized controlled trials are conducted to demonstrate the safety, efficacy, acceptance and technical performance of our solutions.
regulatory approval
Securing market authorizations
Robust Quality Systems and Strategies
Some of the solutions we build are regulated as medical devices. Based on our successful track record of 15+ regulatory approvals for SaMDs and connected devices, we design and implement regulatory strategies to secure approval from relevant authorities. Our platforms and quality management system have supported approvals in the US, EU and Canada. Through the MDSAP-certification, we can support our partners in additional geographies such as Japan, Australia, Brazil and more.
The road to successful regulatory approval of regulated digital solutions starts on day 1, through appropriate planning and documentation of all activities required to develop connected devices and SaMDs. Our tools, processes and methods have proven their ability to secure market authorizations such as 510(k) clearances and CE marks.
Legal Manufacturer
Aptar Digital Health can also assume the responsibilities of legal manufacturer for the solutions co-developped with pharma partners and can lead regulatory activities such as pre-submission meetings, submissions and maintenance of the regulatory dossiers throughout the life cycle of the solutions once commercialized.
Market access
Unlocking the value of digital health
We guide our partners in developing the best strategies to put our product in the hands of patients and healthcare professionals. Our market access effort combines expertise from Medical, Regulatory, Data Analytics and in-country specialist teams to ensure that the right patient gets access to the right treatment at the right time and price.
Depending on the demonstrated impact of each digital solution, the targeted markets and the available access frameworks, we co-develop strategies with our pharma partners that maximize the value creation either through standalone reimbursement or other value drivers positively impacting the corresponding drug products.
Learn more about our Market Access services.
Implementation
Implementing solutions in the real-world
The journey from final validation to go-live is much more complex than a single action. It is a process through which sub-committees and related projects come together to wrap up the final product. The term “implementation” embodies this robust, fluid process and well represents the breadth of services offered by Aptar Digital Health.
Clinical Integration
Our solutions are designed with patients, for patients. When these solutions are intended to be prescribed by HCPs, our implementation process places the care team at the heart of our strategy. Health providers and care teams are looking for single-point experience, with one unique portal or dashboard for their entire population of patients. We meet providers and care teams where they work today, directly in the electronic health records (EHR) – our solutions are compatible with many industries leading EMR/EHR and clinical information systems.
Training and onboarding
Our patient services offer the possibility to set up a personalized enrollment process adapted to each patient and treatment. These services can be integrated with existing or new Patients Support Programs and will help in the enrollment of patients using a digital health solution. Additionally, we develop clear and understandable Instructions For Use and technical documentation (demo video, tutorial, user manual, FAQ) to facilitate adoption and minimize risk of non-compliance.
We also provide support, training and onboarding session with care team to ensure they feel comfortable with the new digital solutions and ensure a fluid integration of the new solution in routine clinical practice.
operations
Operating digital solutions once launched
As patients and healthcare professionals use our digital solutions in the real-world, we work in the background to ensure an optimal user experience. For our partners, it means that we offer a comprehensive suite of services for in-market solutions covering secure hosting, device vigilance, customer support, software maintenance, data management and analytics.
Our work doesn’t stop with the validation and approval of the digital solutions. We support our partners across the life cycle of the solution we develop. Once the product is in market, we take care of technical operations such as hosting in our secure cloud infrastructure, app publishing on stores and technical support. As legal manufacturer of the majority of the solutions we develop with pharma partners, we are in charge of device vigilance and contribute to pharmacovigilance activities. We also ensure that any data processing is performed in accordance with applicable data privacy regulations.
Maintenance
Finally, we provide maintenance services to ensure that the hardware and software product we develop are compatible with new phone models, browsers and operating systems as they become available on the market. And through post-market surveillance and post-market clinical follow-up, we monitor changes in clinical evidence and best practices to adapt our solutions accordingly.
Contact Us
Aptar Digital Health is dedicated to improving patient experiences as your global partner. Contact us to explore how our robust digital solutions can help you accelerate your healthcare initiatives with confidence.
