Our approach

Aptar Digital Health, in collaboration with Noble, an Aptar Pharma company, utilizes market and patient insights to create best-in-class experiences for patients, healthcare providers, payers, caregivers, and others.

Our services span the product development lifecycle, beginning with cross-functional workshops to identify needs, desired outcomes, and benefits for patients and stakeholders. We challenge the competitive landscape and standard of care in targeted indications and regions. Our further research, commercial scale-up support, and brand optimization services enhance market impact upon product launch.

In close collaboration with patients and healthcare professionals, we design solutions that emphasize usability, human factors engineering, and a deep understanding of the patient journey. Our goal is to create empowering, user-friendly solutions that are accessible, easy to use, and culturally adaptable. We consider users of all ages, languages, and social determinants of health. By incorporating patient feedback, Aptar Digital Health guides partners in designing and executing impactful user experiences. Formative and summative studies assess usability and patient preferences, informing 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 that align with standards of care. Our robust, proven processes and proprietary design tools, tailored to Software-as-a-Medical Device, facilitate collaboration with medical experts in designing digital solutions and algorithms for each disease state and therapy. Our objective is to provide personalized education and real-time recommendations in line with clinical best practices and validated guidelines. By partnering with key opinion leaders, such as members of our international Clinical Advisory Board, we ensure that decision-support functions align with routine clinical practice.

We develop digital solutions using our software and connected hardware platforms, which offer ready-made modules for companion apps, digital therapeutics, and disease management solutions.

Our platforms accelerate and de-risk development while enabling customizations for specific conditions and treatments. Through an agile process, our interdisciplinary team of engineers, clinicians, risk managers, cybersecurity experts, design and human factors specialists collaborates to develop solutions that adhere to the standards and guidelines for connected devices and Software-as-Medical-Devices.

Verification and Validation:

Our solutions undergo a robust verification and validation process, based on international standards for hardware and Software-as-a-Medical Device. Each product follows strict performance and safety requirements. Upon completion, our Verification & Validation team conducts comprehensive tests to confirm that the product meets its specifications. Final validation involves in-depth risk management and human factors analyses. When necessary, rigorous clinical studies, such as randomized controlled trials, demonstrate the safety, efficacy, acceptance, and technical performance of our solutions.

Some of the solutions we build are regulated as medical devices and we have a successful track record of 15+ regulatory approvals for SaMDs and connected devices. We design and implement strategies to secure approval from relevant authorities, with experience in the US, EU, and Canada. Our MDSAP-certification supports partners in additional geographies, including Japan, Australia, and Brazil. The path to regulatory approval begins with proper planning and documentation of all activities required for connected devices and SaMDs, utilizing proven tools and processes.

Legal Manufacturer

Aptar Digital Health can assume the responsibilities of legal manufacturer for the solutions co-developed 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.

We guide our partners in developing the best strategies for delivering our products to patients and healthcare professionals. Our market access approach combines expertise from Medical, Regulatory, Data Analytics, and in-country specialists, ensuring timely access to appropriate treatments at the right price. Depending on the solution’s impact, targeted markets, and available access frameworks, we co-develop strategies with pharma partners to maximize value creation through standalone reimbursement or other value drivers positively affecting corresponding drug products.

Learn more about our Market Access services

Implementation, from final validation to go-live, is a robust and fluid process that encompasses various sub-committees and projects. Aptar Digital Health offers an extensive array of services for this process.

Clinical Integration:

Our patient-centered solutions involve healthcare providers in the implementation strategy. We ensure seamless experiences by integrating our solutions with leading EMR/EHR systems and clinical information systems.

Training and Onboarding:

Our patient services enable personalized enrollment processes adaptable to each patient and treatment. These services can be integrated into existing or new Patient Support Programs. We develop clear Instructions For Use and technical documentation (demo videos, tutorials, user manuals, FAQs) to facilitate adoption and minimize non-compliance risks.

Furthermore, we offer support, training, and onboarding sessions for care teams, ensuring their comfort with digital solutions and promoting smooth integration into routine clinical practice.

Aptar Digital Health ensures an optimal user experience as patients and healthcare professionals use our solutions. We offer a comprehensive suite of services for in-market solutions, including secure hosting, device vigilance, customer support, software maintenance, data management and analytics.

Beyond validation and approval, we support partners throughout the solution life cycle. We handle technical operations such as secure cloud infrastructure hosting, app publishing, and technical support. As the legal manufacturer for most solutions, we manage device vigilance and contribute to pharmacovigilance activities, while ensuring data processing complies with privacy regulations.

Maintenance

We provide maintenance services to ensure compatibility with new phone models, browsers, and operating systems. Through post-market surveillance and clinical follow-up, we monitor changes in clinical evidence and best practices, adapting our solutions as needed.