Untangle yourself and make all those puzzle pieces fit into place, let regulatory become your best friend and save time and money.
Get your data ready to improve patient care, do turnkey research, tap into artificial intelligence and streamline your processes.
Use your data to create added value for your customers, improve supplies prediction or create new types of technological markers and diagnostic tools.
Make digitalization and data a core priority and transform your knowledge and processes for even greater reach and better healthcare.
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Johannes is both a medical doctor and a computer scientist, and a TÜV Süd certified Specialist Medical Software for medical device regulatory. Driven by a passion to help others make the best possible use of their data and to transform healthcare with it, Johannes has been providing consulting and hands-on software development services for more than a decade, specializing in projects that merge his cross-disciplinary qualifications. Over the last 15 years, he has been working, researching, and teaching in the areas of biomedical and clinical data, data and information systems, big data analytics and data science at Humboldt-Universität zu Berlin, the University of Pennsylvania, Charité – Universitätsmedizin Berlin – and now at starlinger+ digital health architects. His mission is to ensure that medical innovation isn’t hindered by “translation errors” between disciplines, but is instead accelerated by a blueprint that is technically sound and regulatory-ready from day one.
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Data is at the heart of many modern applications in health and healthcare. We help you develop a plan for the exact steps to transform this data into value and make it usable in data-driven applications, including data analytics, machine learning and artificial intelligence.
Key to data utility are the algorithms and machine learning models created from the data, and the software systems that bring the data to life. We help you design tailor-made system architectures for turning your data into a complete software application that plays well with your existing IT infrastructure.
Creating software as a medical device comes with a plethora of regulatory requirements which should be considered from the very first moment on. Merging regulatory, healthcare and IT knowledge, we provide you with practical, multi-perspective guidance on creating an MDR compliant digital health product.
Turning vision into innovation sometimes is just a matter of identifying a need and knowing the possibilities. Overseeing the full path from healthcare through technical implementation to market, we help you take the next step and design the future generation of health applications.
Whether you're looking for advice how to process your data for a specific type of application or analysis, you want to learn how to do a usability evaluation of your ready made software product, or you're looking for someone to guide you through the full process of creating a medical software product from idea to market, we've got you covered. Whatever your knowledge need in digital health data, systems, regulatory, and innovation may be, get in touch to see how we can help you.
Regulatory aspects of bringing software as a medical device to market can be daunting at first. An understanding of the roadmap and the necessary processes to be implemented is crucial for successful conformity evaluation. On the other hand, these very processes can often serve as a cookbook for creating quality software your customers will love. We provide consulting and coaching to help you 'embrace regulatory' - whether you're new to medical device regulatory and need a first primer on what to expect, you're looking for advice on a particular subject related to regulatory compliance, or you want guidance for setting up your documentation.
When creating digital health solutions, an important first step is often to thoroughly identify and analyze the requirements of the different stakeholders involved. Our rare understanding of both health and IT domains allows us to not only seamlessly translate requirements from med to tech, but to also integrate different perspectives in a structured analysis report ready to be used for system design.
If data is at the heart of modern health care applications, the data model is this heart's anatomy. It provides structure and semantics to the data. With an eye for existing standards such as SNOMED, LOINC, and FHIR and a love for interoperability, we help you create solid data models as the very foundation of your data-driven health application. Together with the data model, we help you stratify your data and make sure that it tells you what you think it should. We identify which analytics and AI applications the data can be used for, and how it might need to be transformed in order to derive the greatest value from it.
Translating a health or healthcare need into an actual system with data storage, processing and machine learning components, user interfaces, and possibly cloud based service interoperability can be challenging - and finding the best system architecture to balance performance and regulatory viability even more so. A cleverly designed system architecture can actively reduce regulatory overhead and cost. We help you find the best cut for your system and, if needed, help you design the complete system architecture right away.
Looking for a focused overview presentation of the various aspects of digital health solutions to update your knowledge? Or rather for a tailor fit hands-on training workshop including an analysis of your own individual application? With experience from teaching top-rated university classes and trainings, and giving countless presentations on a variety of levels of technical depth, you'll be surprised by the new perspective you might gain when seeing things through a broader lens - or through a magnifying glass with a clear focus on health data and systems and their very specific characteristics.
