Sven JungmannDec 26, 20211 minReal World Evidence (RWE) versus Real World Data (RWD)Real-World Evidence (RWE) Real-world evidence (RWE) is a type of clinical evidence (i.e., gathered from observation and treatment of...
Sven JungmannDec 26, 20211 minCost-effectiveThe general definition of cost-effective concerns whether a product, process, solution, etc., saves or makes money when compared to the...
Sven JungmannDec 26, 20211 minClinical harmClinical harm is unintended physical injury as a result of an adverse effect of medical care. This includes not only undesired reactions...
Sven JungmannDec 26, 20211 minClinical BenefitSimilar to a word like “value,” clinical benefit can take on different meanings based on each stakeholders’ perspective. For the patient,...
Sven JungmannDec 26, 20211 minValueDefining value is not so easy because it can take on several meanings based on different perspectives within the healthcare ecosystem....
Sven JungmannDec 26, 20211 minUncertaintyUncertainty is defined as the “subjective perception of ignorance,” or simply put, “we know that we don’t know.” It is a constant in...
Sven JungmannDec 26, 20211 minClinical evidenceClinical evidence is a critical component of technical documentation for a product or device. It is generated by the clinical evaluation...
Sven JungmannDec 26, 20211 minClinical evaluationClinical evaluation is a process undertaken by the manufacturer with both initial and ongoing/routine actions to substantiate the safety,...
Sven JungmannDec 26, 20211 minClinical dataClinical data is information regarding the performance, effectiveness, and/or safety of a medical product or device. This data is...
Sven JungmannDec 26, 20211 minIntended use / intended purposeIntended use or intended purpose refers to what a manufacturer intends their product to do or accomplish. In other words, what was the...
Sven JungmannDec 26, 20212 minOutcome-Action PairingOutcome-Action Pairing (OAP) is a term heard quite frequently when discussing AI solutions, so let’s break it down: Outcome = An output...
Sven JungmannDec 26, 20211 minDisease burdenDisease burden quantifies the impact of a specific health condition by measuring the gap between the current health of a population and...
Sven JungmannDec 26, 20211 minClinical study designClinical study design is the creation and development of medical experiments or trials for research involving humans. This also includes...
Sven JungmannDec 26, 20211 minClinical Decision-MakingClinical Decision-Making has been described as the “contextual, continuous and evolving process where data is gathered, interpreted and...
Sven JungmannDec 26, 20211 minClinical TrialA clinical trial is a research procedure to investigate potential outcomes and effects of medical products, devices, and lifestyle...
Sven JungmannDec 26, 20211 minIn Vitro Diagnostic (IVD) medical deviceFirst off, let’s define, “in vitro.” This term refers to where a process takes place: in a culture dish; a test tube (e.g., in-vitro...
Sven JungmannDec 26, 20211 minSaMD ChangesSaMD Changes, simply put, mean any modifications made throughout its lifecycle. This includes any modifications made during the...
Sven JungmannDec 26, 20211 minSaMD ManufacturerThe SaMD manufacturer is the person or entity (company or corporation) legally responsible for the design and/or manufacturing of a SaMD....
Sven JungmannDec 26, 20211 minSoftware as a Medical Device“Software as a Medical Device,” or SaMD, refers to a software product that is intended for medical purposes but is independent from...
Sven JungmannDec 26, 20211 minMedical DeviceA medical device is defined as any “instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,...