Course code BM 1220-13
Education period 3
Coordinator Dr. ir. G.J.M. Tuijthof
A prototype of a new instrument has a long way before entering the market. Apart from assessing its commercial value, a medical instrument or device needs to be produced in accordance with regulatory guidelines even before clinical evaluation can take place. In the course Quality Assurance in Design, students analyze designs of medical instruments (prototypes and/or technical drawings) based on the Medical Device Directive and several ISO standards. The analysis contains aspects on the possible use and misuse of the instrument, a risk analysis, and existing evidence from literature on the added value of the device. Using ISO 13485 standard for medical devices, a roadmap is proposed by the students that contains explicit steps for a medical instrument, which should lead to a successful clinical evaluation. In this roadmap items such as material selection, production, cleanliness, sterilization, certification risk management and proper technical documentation will be addressed. Finally, a proposal for clinical investigation is formulated including a study goal, power analysis and ethical aspects when dealing with patients.
At the end of the course the student must be able to:
Justify the importance of the Medical Device Directive and the need for medical devices to comply to this directive
Describe the required adjustments for a medical instrument prototype to comply with regulatory guidelines
Perform literature search, sort and prioritize the information and determine its quality and reliability
Cite references in a proper manner
Demonstrate critical thinking in discussing the benefits relative to the risks of a medical device
Perform a qualitative risk analysis for a medical instrument prototype and indicate possible measures to reduce the risks
Perform analyses with uncertainty by identifying missing/unreliable information and formulate and apply a plan to address this
Demonstrate creative thinking in designing engineering solutions to solve a problem
Implement key items to set up a clinical validation protocol of the medical device (statistical power analysis and ethical issues)
At the start of the course, lectures familiarize the students with the regulatory guidelines based on examples. Students will select a test case from the prototypes that have been developed within the department. The students work in groups, where they set up a road map for CE marking and clinical evaluation of the prototype guided by assignments that address the most important regulatory aspects (Medical Device Directive and ISO standards). Close collaboration is required as all topics are related and a redesign of parts of the prototype is obliged to conform to the ISO standards. In the remainder contact hours students are expected to present and discuss their progress. The course is finalized with a presentation of the roadmap based on their assignments.
All relevant information is provided through Blackboard. The students need to find missing information via a literature search.