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Abstract
From software as a medical device to medicinal products: The intended use of a healthtech product serves as strategic pivotal point from conception to reimbursement strategies: Understanding its importance defines advertising claims and ensures that the product meets the needs of patients.
Objective
Know and understand different definitions: medical need / public health assessment/; personalized medicine, pharmacogenomics/ customized device. Understand the importance of medical and stakeholder needs assessments in medicine / medtech / in- vitro diagnostics / software as medical device / artificial intelligence and among different stakeholders. Understand the relationship between indication / intended use / intended purpose and development, including risk assessment. Define the intended use / intended purpose for a healthtech product and derive user groups, patient groups, indications and contra-indications. Understand and derive an overview of the different stakeholders of a healthtech product and their different interests. Design and Development Plan, Clinical Development Plan: Plan development correctly. Overview of different development models, starting with requirements engineering, the classical waterfall model and V-model up to agile methods for software as medical device or AI concepts. ISO 14971: Understanding and applying principles of risk man-agement. IEC 62366: Understanding and applying the principles of usability engineering. Artificial Intelligence: Know the challenges of artificial intelligence in healthtech products, define an AI policy and develop a verification process.
Content
The intended use is the “linchpin” in the development, approval and reimbursement of medicinal products or medical devices: Whether software as a medical device, artificial intelligence in medical devices, but also in pharmaceuticals or biotechnology, the intended use is the first and last touchstone - alpha and omega - of all healthtech concepts. - Intended use, user and patient groups I/III: How the intended use of a healthtech product influences its development, safety, performance, marketing strategy and reimbursement possibilities. - Intended use, user and patient groups II/III: How the intended use of a healthtech product determines the patient population and thus defines indications and contraindications. - Intended use, user and patient groups III/III: How the intended use of a healthtech product determines the requirements for different user groups. - Software as a medical device or drug: What is the market missing - what does the patient want? Derive product re-quirements by understanding market requirements and pa-tient needs. (development planning). - Software as a medical device or drug: Who is interested in the product, who benefits from it, who works with it? Derive concepts for usability and risk management by understand-ing the different user groups and their interests (verification and validation). - Software as a medical device: artificial intelligence, digital biomarkers, new biotech concepts: development and market-ing in compliance with regulations by applying "existing" standards to future technologies (regulatory compliance / legal compliance).
General Information
- Language
- English
- Levels
- WBZ , NDS
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise | Intended Use / Indication | No time listed | 55 h semesterly |