We take your digital health product – from early concept and design – to development, validation and subsequent successful launch, operation and maintenance, in full compliance with regulatory requirements.

Insights & Design

Business Development

We apply data to drive business decisions – beyond the pill.

The business case of our customer is at the core of all projects. What are we trying to achieve? Will the product make treatments better, our customer more competitive, the patients more loyal? How do we measure success? How do we collect data, how is it analyzed and by whom? Are there clearly defined measurable goals and how do we further develop the product if it becomes successful?

Research

Every great concept is built on a solid foundation of insights.

Who is your target user? What are their pains? Do you understand them? Are we improving medication compliance, reducing drop-outs, educating patients, empowering doctors, connecting devices, connecting people, building healthy habits? Have you investigated if a digital solution is even what they need? Everything starts with systematic end-user research. To succeed, we need to understand the problem we are trying to address.

Design Thinking

Our preferred approach to developing successful digital health projects are anchored in design thinking principles.

Design Thinking revolves around empathy for the end-user while answering business-critical questions through design, prototyping, and testing with real users. We set a competent team of consultants and together we work in short design sprints, thus arriving at effective product decisions and aligning all stakeholders much faster than traditional approaches.

Product Design

We are passionate about changing people’s lives through great user experiences.

Strict regulations has historically been a limiting factor for delivering innovative user experiences when developing medical software. Our designers work in collaboration with regulatory experts and change the status quo by putting human needs and well-being at the core of everything we do. At Dawn, we have a structured approach to human-centered design that enables us to create outstanding products.

Planning & Development

Regulatory Affairs

Our regulatory experts make sure that your digital product complies with applicable regulatory requirements.

Depending on the functionality and intended use of your digital product, it may be subject to medical device or GxP regulations. This puts strict requirements to how the product is developed, documented, and approved. Our regulatory specialists can help assess if your product is regulated in markets worldwide and ensure compliance from concept to launch.

Software Development

Our engineering team is specialized in agile development of digital solutions with strict regulatory requirements.

We develop digital products using cutting-edge technologies and employ an agile development methodology. Our agile methodology ensures a continuous learning and exploration and priorities towards the requirements that delivers the most value and impact. We plan critical project milestones where the product components are traced, tested and qualified by our certified MedTech developers and Quality specialists.

Quality Assurance

Quality Assurance is at the core of our processes and our products are carefully planned and scrutinized from concept to launch.

Using our ISO 13485:2016 certified Quality Management System we develop, operate and maintain Software as a Medical Device and GxP critical software solutions. We can demonstrate the ability to consistently provide high-quality products and services that meet customer requirements and ensures regulatory compliance in the development of digital health products. Our team can qualify and develop software in accordance with IEC 82304, IEC 62304, ISO 14971 and GAMP 5.

Launch

Product Release

A well-planned release of a digital health product is crucial for ensuring that our clients get their expected return on investment.

We help you prioritize launch markets and adapt your global organization to support your digital products. We provide the necessary documentation for approval of labeling material and submission to ethical committees and help you produce compelling, localized presentations in mobile app stores.

User Acqusition

To ensure our clients get the expected return on their digital product investments, a user acquisition strategy is crucial.

We help you navigate legal and regulatory requirements and identify the right channels for promoting your products. Online and real-time advertising, recommendations from healthcare providers, social media, and data-driven marketing are all tools that can be leveraged to ensure your products find your patients and providers.

Post-launch

Operations & Maintenance

We continuously monitor our customers’ digital products for updates to applications, operating systems, and critical third-party libraries.

Our Operations Team continuously and proactively monitors our applications for incidents or changes that can impact the validated state, security or user experience of your digital products - all in accordance with our ISO 13485:2016 certified Quality Management System.

Hosting & Monitoring

At Dawn, safeguarding the confidentiality and integrity of personal data is the highest priority.

Through our Microsoft Partnership, we operate GDPR & HIPAA compliant cloud hosting environments. For digital products that must comply with regulatory requirements, we offer SaMD- and GxP-ready Cloud solutions using our qualified Microsoft Azure platform that seamlessly integrates with our mobile- and web-based applications.

Product Optimization

When the products launch in the market, you always end up with new insights from your end users.

Our product strategists help you understand and prioritize both behavioural insights from analytics and qualitative feedback from the end users. With a clear understanding of the product performance, we help you define the ongoing product strategy and new features, to ensure the product creates the intended value.

Decommissioning

We ensure a controlled decommission of the digital health product and related data at the end of life.

Secure and complete decommisioning is increasingly becoming a concern of regulators and inspectors. In agreement with our customers, we ensure a controlled decommissioning of data and applications, including delisting of medical devices with regualatory authorities.

Interested in working with us?

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