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Article Reference: ‘Journal of Diabetes Science and Technology’ by SAGE

Heinemann, L. (2021) ‘Expenditure for the Development of a Medical Device: Much Higher Than Commonly Assumed’, Journal of Diabetes Science and Technology, 15(1), pp. 3–5. doi: 10.1177/1932296820986016.

P.1. ‘the development of a new medical device has (highly) complex requirements; the path from an idea to a finished product that a patient with diabetes (PwD) can use in everyday life is rocky and often ends nowhere.’ medical devices cannot be made that easily or quickly. Have to find new alternatives to living with the device or a change in the status quo

P.2. ‘PwD are usually not engineers; they should be able to operate such systems safely under quite different and often not optimal environmental conditions, etc. We often forget that the “simple” operation of a smartphone requires extremely complex and sophisticated technology in the background for implementation.’ We often relate technology to smart phones, that are easy to use and very much user-friendly but we often forget that these devices are made extremely sophisticatedly and are very complex. 

P.2. ‘Just because you hold the best/most beautiful/most innovative product in your hands after all the effort and years of intensive work, this does not guarantee success in the market. No diabetologist who is unfamiliar with a new product is willing to use it just like that.’

P.2. ‘complex the requirements are in our modern health care systems that are connected with the development of medical devices.’


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