Formal review
WP1: Medical need and product specification can not be edited if:
- The project is under review;
- It passed the review;
Reviews:
- Status:
- Rejected
- Created at:
- 06/02/2018 15:16:18 +00:00
- Concluded at:
- 09/12/2018 10:43:31 +00:00
- Concluding comment:
- Thanks for your work. Some improvements are necessary before the opening of WP2. 1) Product requirements should refer just to usability and safety, while it seems that you have already a design before having a conceptual design 2) on "existing solution", please make a list (with links to scientific paper, if possible) of current methods for screening breast cancer and the go deeper with the analysis of the device for "self examination" 3) on the "device classification", please reflect on the questionnaire, because the question "Is it intended for diagnosis and monitoring?" "You answered: Yes", makes your device for diagnosis, while you claim that it is just for self assessment.
- Status:
- Rejected
- Created at:
- 09/14/2018 08:23:40 +00:00
- Concluded at:
- 09/17/2018 13:25:48 +00:00
- Concluding comment:
- Some specific comments: 1) in the overview section: the sentence "This practice is not carried by women because they are not confident on their own ability to detect lump." is too strong. Rephrase "Although safe, this practice is not commonly carried by women because they are not confident in their own ability to detect a lump." 2) in the overview section: the sentence "The first target of the patients are women who have high familiar or genetic" has to be changed in "Women, with high familiar or genetic onset, are the first target patient population, which have to undergo to several breast diagnostic exams" 3) clinical needs: please include the sentence "For further information, please visit the following websites" before the links at the end of the section 4) existing solutions: please provide also a clickable link to the reference "Nover, Jagtap, Anjum, Yegingil, Shih and Brooks, “Modern Breast Cancer Detection: A Technological Review,” International Journal of Biomedical Imaging, no. 902326, 2009" 5) existing solutions: change the sentence "The wearable solutions to support the early detection are available even if they use other detecting techniques compared to the simulation movements of breast self-palpation (https://www.higia.tech/en/eva)." in "Wearable solutions to support the BSE are instead based on thermal imaging, based on the assumption of the different metabolic activity, and thus heat production, of tumor respect to healthy tissue 6) intended users: please correct "The device is intended to be used by all women, including pregnant ones, because it is safe, easy and does not use any radiation. Moreover, it can be used at home. The target patients are women who have high familiar or genetic onset because they have to do many breast diagnostic exams. 7) product requirement: you are starting from the assumption you have the final device in your hands, without considering other possible conceptual design. This is not correct, at least in this first section. Plase change the following sentences accordingly: - "Functional requirements: the device should be wearable in contact with the skin. Do not use radiation, it must be simple and safe. To simulate palpation, an inflator system should impose an external pressure on the breast, to mimic the movement of the hand. Sensors should be able to detect the stiffness difference between nodule and breast tissue." --> Functional requirements: the device should be wearable in contact with the skin, and it must not use electromagnetic radiation. It must be simple and safe. - Usability requirements: The device can be used by all women, because is wearable, self and safe. It should be intuitive to use with a graphical interface. --> Usability requirements: The device has to be intuitive, to be used by all women, also without a medical background. It has to be wearable, for increasing the patient's comfort - Safety requirements: The device should has not particular risks. The power supply should be used for the circuit for sensor readings. The inflation system could be annoying for women with a particular sensitivity, even though the pressure applied is very low, like hand. --> Safety requirements: The device should has not particular risks as it is intedend for Self Examination device and not for diagnosis. Because it should mimic the breast palpation, the stress to be applied on the body will be low or moderate - Interaction requirements: A intuitive graphical interface (mobile o pc) show the results of analysis. (which is the difference with the usability?, you can delete this item) 8) Device classification : I'm agree it should be class I (similar to an electronic thermometer)
- Status:
- AcceptedButWorkpackageReopened
- Created at:
- 09/18/2018 09:59:13 +00:00
- Concluded at:
- 09/18/2018 21:54:02 +00:00
- Concluding comment:
- The revision of the WP1 is compliant with the indications.
- Status:
- Accepted
- Created at:
- 09/09/2019 13:45:33 +00:00
- Concluded at:
- 09/18/2019 08:50:41 +00:00
- Concluding comment:
- Thank you for your work. The revisions of the WPs are compliant with the indications.