WO2023187445A1 - Method and system for collecting data for post-marketing surveillance of medical devices and accessories thereof - Google Patents

Method and system for collecting data for post-marketing surveillance of medical devices and accessories thereof Download PDF

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Publication number
WO2023187445A1
WO2023187445A1 PCT/IB2022/052942 IB2022052942W WO2023187445A1 WO 2023187445 A1 WO2023187445 A1 WO 2023187445A1 IB 2022052942 W IB2022052942 W IB 2022052942W WO 2023187445 A1 WO2023187445 A1 WO 2023187445A1
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WIPO (PCT)
Prior art keywords
user
questions
electronic apparatus
electronic document
activation signal
Prior art date
Application number
PCT/IB2022/052942
Other languages
French (fr)
Inventor
Enrico PERFLER
Original Assignee
1Med Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 1Med Sa filed Critical 1Med Sa
Priority to PCT/IB2022/052942 priority Critical patent/WO2023187445A1/en
Publication of WO2023187445A1 publication Critical patent/WO2023187445A1/en

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q30/00—Commerce
    • G06Q30/01—Customer relationship services
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q30/00—Commerce
    • G06Q30/01—Customer relationship services
    • G06Q30/015—Providing customer assistance, e.g. assisting a customer within a business location or via helpdesk
    • G06Q30/016—After-sales
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q30/00—Commerce
    • G06Q30/02—Marketing; Price estimation or determination; Fundraising
    • G06Q30/0201—Market modelling; Market analysis; Collecting market data
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Definitions

  • the present invention relates to a method for collecting data for post-marketing surveillance of medical devices and accessories thereof.
  • the present invention further relates to a system for collecting data for post-marketing surveillance of medical devices and accessories thereof.
  • real-world data i.e. data collected downstream of the marketing of the devices, for example by asking questions of those who distribute them and/or those who use them.
  • the Applicant has set itself the objective of providing a tool capable of facilitating and speeding up the activities of collecting data and preparing the relevant documentation.
  • the Applicant has found a solution based on an automated questionnaire, which can be activated, for example, through recognition of a QR code or via a web link, and which provides the user with questions with a pre-set structure and with the possibility of close-ended questions. In this manner, the data can be collected rapidly and effectively. Furthermore, the information is homogeneously structured, thanks to the structure of the questionnaire, thus simplifying the generation of documents/reports and enabling further processing, for example of a statistical type, to be performed downstream in an automated manner.
  • the invention relates to a method for collecting data for post-marketing surveillance of medical devices and accessories thereof.
  • the method comprises receiving, from an electronic apparatus, an activation signal, representative of an activation of an operational reference associated with a medical device.
  • the method comprises providing, in response to the activation signal and via a user interface of said electronic apparatus, a series of questions, having a pre-set structure, said questions regarding at least one from among safety, performance, integrity and use of the device.
  • the method comprises receiving, via a user interface of said electronic apparatus, the user's answers to each of said questions.
  • the method comprises automatically generating an electronic document, containing a reference to said device and the answers provided by the user.
  • the method comprises storing said electronic document in a dedicated memory area or sending said electronic document to a pre-established recipient.
  • the invention relates to a system for collecting data for post-marketing surveillance of medical devices and accessories thereof.
  • the system comprises a processing unit.
  • the processing unit is configured to receive, from an electronic apparatus, an activation signal, representative of an activation of an operational reference associated with a medical device.
  • the processing unit is configured, in response to the reception of said activation signal, to provide, via a user interface of said electronic apparatus, a series of questions having a pre-set structure, said questions regarding at least one from among safety, performance, integrity and use of the device.
  • the processing unit is configured to receive, via said user interface, the user's answers to each of said questions.
  • the processing unit is configured to automatically generate an electronic document containing a reference to said device and the answers provided by the user.
  • the processing unit is configured to store said electronic document in a dedicated memory area or send said electronic document to a pre-established recipient.
  • the invention can comprise one or more of the preferred features that follow.
  • said operational reference is a QR code and/or a web link.
  • said operational reference is a QR code
  • said activation signal is generated by framing and decoding said QR code
  • the operational reference is a web link
  • said activation signal is generated by activating said web link.
  • said web link is activated by clicking or tapping.
  • the method comprises acquiring, by means of said electronic apparatus, data representative of a category to which said user belongs.
  • the method comprises entering an indication of said category in said electronic document.
  • said questions are selected according to the category of user.
  • said category belongs to the following set: non-professional user, professional user, economic operator.
  • processing unit and said user interface are integrated in a single electronic apparatus.
  • processing unit and said user interface are integrated in distinct apparatus.
  • - figure 1 shows a block diagram of a system in accordance with the present invention
  • - figure 2 shows a block diagram of a part of the system in figure 1;
  • figure 3 shows a block diagram of a variant of the part of the system in figure 2;
  • FIG. 4-20 show an example embodiment of data used in the system in figure 1 .
  • 1 denotes in its entirety a system for collecting data for postmarketing surveillance of medical devices and accessories thereof.
  • the system 1 (figure 1) comprises a processing unit 10.
  • the processing unit 10 can be made as or be part of a personal computer, a server, a tablet, a smartphone and, more in general, of an apparatus having a conventional standard configuration, and suitably programmed to perform the operations described and claimed herein.
  • the processing unit is configured to receive, from an electronic apparatus 20, an activation signal AS, representative of an activation of an operational reference X associated with a medical device.
  • the electronic apparatus 20 is preferably made as a mobile device (e.g. smartphone, tablet, schematically represented in figure 2) or as a device more dedicated to operating under static conditions (e.g. personal computer, laptop, etc. schematically shown in figure 3).
  • a mobile device e.g. smartphone, tablet, schematically represented in figure 2
  • static conditions e.g. personal computer, laptop, etc. schematically shown in figure 3
  • the operational reference X can be produced, for example, as a graphic or alphanumeric code (such as a QR code) and/or as a web link.
  • the QR code can be affixed onto the medical device and/or the packaging thereof and/or documentation related to the medical device (e.g. instruction manual or other documentation).
  • the activation signal AS is generated by framing the QR code by means of the electronic apparatus 20; the QR code is decoded and returns, for example, a web link that directs the electronic apparatus 20 to the processing unit 10 and to the content managed by the latter - which will be better described further below.
  • a web link can be directly provided to users it is desired to have participate in the data collection.
  • This link can be provided, for example, by sending an email message and/or by means of a push notification of an application pre-installed in the electronic apparatus 20.
  • the link can be distributed for example by using a mailing list - dedicated in particular to the category of "professional users”, which will be better described further below.
  • the activation signal AS is thus generated by the reading and decoding of the QR code, or else by the user clicking or tapping (depending on whether he/she is using a mouse or a touch-screen technology) on the web link.
  • the processing unit 10 will provide a series of questions Q via a user interface 21 of the electronic apparatus 20.
  • the questions regard at least one from among safety, performance, integrity and use of the device.
  • the user Via the user interface 21, the user has the possibility of providing an answer to each of the questions, so that the answers are received by the processing unit 10 (arrow "A” in figure 1).
  • the processing unit 10 is configured to automatically generate an electronic document ED containing a reference to the medical device that is the subject of the questionnaire and the answers provided by the user.
  • the electronic document ED thus generated is stored in a dedicated memory area and/or sent to a pre- established recipient.
  • the users are divided into multiple categories.
  • three categories can be provided for:
  • Non-professional users i.e. ordinary people who use the device autonomously, for example at home;
  • a sequence of dedicated questions is provided for each category of users; for example, the questions posed to a professional user will at least partly differ from those posed to a commercial operator.
  • the processing unit 10 is configured to acquire, by means of the electronic apparatus 20, the category to which the user participating in the questionnaire belongs.
  • the user can enter the category to which he/she belongs in an initial setting phase, by means of a dedicated dialogue window; this setting phase can coincide with the user's subscription to the service.
  • An indication of the category to which the user belongs can be sent to the processing unit 20 simultaneously with the activation signal AS; in one embodiment, this indication can be integrated in the signal AS itself. In general, it is preferable that the indication reaches the processing unit 20 before the questions are presented to the user, so that the questionnaire can be set according to the category to which he/she belongs.
  • the questions are selected (and more in general set) based on the fact that the user belongs to a given category.
  • figures 4-18 show a series of questions, with associated answers, that can be posed to a non-professional user.
  • the questions posed to a non-professional user comprise one or more among:
  • the user interface shows a graphic representation of the state of completion of the questionnaire - i.e. an indication of how many questions are yet to be completed before the end of the questionnaire, possibly combined with an indication of how many questions have already been answered.
  • a bar can be displayed which increases in length proportionally to the number of questions answered; an indication can also be provided of the maximum length of the bar (for example, equal to the width of the screen or of the window in which the questions are shown).
  • a numerical indication of the questions already answered and of the total questions can be displayed.
  • Figure 19 illustrates, by way of example, a possible question that can be posed to a professional user.
  • the question regards the number of patients to whom the user could prescribe the device. It is clearly an example, which can in reality be replaced by other questions or accompanied by other questions similarly dedicated to professional users.
  • Figure 20 shows a possible question that can be posed to an economic operator (e.g. carrier), or also to another category of user. It is asked, in particular, to report whether the packaging of the medical device is damaged in some way, and the option is given of adding a photograph showing the damage.
  • the electronic apparatus 20 is thus configured to acquire a photograph and attach it to the answer. This feature is particularly practical when implemented by means of a smartphone or tablet, which can use its own integrated camera to acquire the photograph; the latter will then be immediately available for inclusion in the answer.
  • Figures 19-20 respectively show, for the sake of simplicity, a single example of a question posed to a professional user and to an economic operator. It is preferably envisaged that a range of questions is posed to each category of users. For the professional user and/or the economic operator the same graphic solutions as described above for the non-professional user can be adopted (e.g. regarding the progress of the questionnaire).
  • the processing unit 10 is provided with an IP recognition algorithm so as to prevent the duplication of data coming from a same user.
  • processing unit 10 and the electronic apparatus 20 have been described and represented separately for the sole purpose of clearly disclosing the features of the present invention.
  • the electronic apparatus 20 allows interaction with the user via its user interface 21 , whilst the processing unit 10 has the task of managing the sending of questions and processing the answers.
  • the electronic document containing the answers and, preferably, the indication of the category to which the user belongs is generated directly by the electronic apparatus 20 and sent to the processing unit 10.
  • processing unit 10 and the electronic apparatus 20 are made as a single device, configured to perform the operations described herein.
  • application used can be configured to operate locally until the final step of sending/storing the report containing the answers.
  • the processing unit 10 is made up of a variety of apparatus (so-called distributed architecture), so as not to require a single apparatus to dialogue with the various electronic apparatus 10 and to process the relevant data.
  • the Applicant observes that the information collected by means of the present invention is useful for determining one or more from among:

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Abstract

A method for collecting data for post-marketing surveillance of medical devices and accessories thereof, said method comprising: receiving, from an electronic apparatus (20), an activation signal (AS), representative of an activation of an operational reference (X) associated with a medical device; in response to the activation signal (AS), providing, via a user interface (21) of said electronic apparatus (20), a series of questions (Q), having a pre-set structure, said questions (Q) regarding at least one from among safety, performance, integrity and use of the device; receiving, via the user interface (21) of said electronic apparatus (20), the user's answers (A) to each of said questions (Q); automatically generating an electronic document (ED) containing a reference to said device and the answers provided by the user; and storing said electronic document (ED) in a dedicated memory area or sending said electronic document (ED) to a pre-established recipient.

Description

Description of an Industrial Invention entitled:
“METHOD AND SYSTEM FOR COLLECTING DATA FOR POST-MARKETING SURVEILLANCE OF MEDICAL DEVICES AND ACCESSORIES THEREOF”
DESCRIPTION
The present invention relates to a method for collecting data for post-marketing surveillance of medical devices and accessories thereof.
The present invention further relates to a system for collecting data for post-marketing surveillance of medical devices and accessories thereof.
As is well known, products belonging to the medical sector require specific certifications in order to be placed on the market.
In order to obtain and maintain such certifications it is necessary to present, together with other documents, so-called real-world data, i.e. data collected downstream of the marketing of the devices, for example by asking questions of those who distribute them and/or those who use them.
In this context, the Applicant has observed that collecting such data is often very challenging and entails a particularly large effort in terms of the time and financial resources to be committed.
The Applicant has set itself the objective of providing a tool capable of facilitating and speeding up the activities of collecting data and preparing the relevant documentation.
The Applicant has found a solution based on an automated questionnaire, which can be activated, for example, through recognition of a QR code or via a web link, and which provides the user with questions with a pre-set structure and with the possibility of close-ended questions. In this manner, the data can be collected rapidly and effectively. Furthermore, the information is homogeneously structured, thanks to the structure of the questionnaire, thus simplifying the generation of documents/reports and enabling further processing, for example of a statistical type, to be performed downstream in an automated manner.
In accordance with a first aspect, the invention relates to a method for collecting data for post-marketing surveillance of medical devices and accessories thereof.
Preferably, the method comprises receiving, from an electronic apparatus, an activation signal, representative of an activation of an operational reference associated with a medical device.
Preferably, the method comprises providing, in response to the activation signal and via a user interface of said electronic apparatus, a series of questions, having a pre-set structure, said questions regarding at least one from among safety, performance, integrity and use of the device.
Preferably, the method comprises receiving, via a user interface of said electronic apparatus, the user's answers to each of said questions.
Preferably, the method comprises automatically generating an electronic document, containing a reference to said device and the answers provided by the user.
Preferably, the method comprises storing said electronic document in a dedicated memory area or sending said electronic document to a pre-established recipient.
In accordance with a second aspect, the invention relates to a system for collecting data for post-marketing surveillance of medical devices and accessories thereof.
Preferably, the system comprises a processing unit.
Preferably, the processing unit is configured to receive, from an electronic apparatus, an activation signal, representative of an activation of an operational reference associated with a medical device.
Preferably, the processing unit is configured, in response to the reception of said activation signal, to provide, via a user interface of said electronic apparatus, a series of questions having a pre-set structure, said questions regarding at least one from among safety, performance, integrity and use of the device.
Preferably, the processing unit is configured to receive, via said user interface, the user's answers to each of said questions.
Preferably, the processing unit is configured to automatically generate an electronic document containing a reference to said device and the answers provided by the user.
Preferably, the processing unit is configured to store said electronic document in a dedicated memory area or send said electronic document to a pre-established recipient.
In one or more of the aforesaid aspects, the invention can comprise one or more of the preferred features that follow.
Preferably, said operational reference is a QR code and/or a web link.
Preferably, said operational reference is a QR code, and said activation signal is generated by framing and decoding said QR code.
Preferably, the operational reference is a web link, and said activation signal is generated by activating said web link.
Preferably, said web link is activated by clicking or tapping.
Preferably, the method comprises acquiring, by means of said electronic apparatus, data representative of a category to which said user belongs.
Preferably, the method comprises entering an indication of said category in said electronic document.
Preferably, said questions are selected according to the category of user.
Preferably, said category belongs to the following set: non-professional user, professional user, economic operator.
Preferably, said processing unit and said user interface are integrated in a single electronic apparatus.
Preferably, said processing unit and said user interface are integrated in distinct apparatus.
Additional features and advantages will become more apparent from the detailed description of a preferred but not exclusive embodiment of the invention. The description is provided here below with reference to the accompanying figures, which likewise have a purely illustrative and hence non-limiting purpose, in which:
- figure 1 shows a block diagram of a system in accordance with the present invention; - figure 2 shows a block diagram of a part of the system in figure 1;
- figure 3 shows a block diagram of a variant of the part of the system in figure 2;
- figures 4-20 show an example embodiment of data used in the system in figure 1 .
With reference to the accompanying figures, 1 denotes in its entirety a system for collecting data for postmarketing surveillance of medical devices and accessories thereof.
In the present description and in the subsequent claims, medical device means, as per Regulation (EU) 2017/745:
"any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The system 1 (figure 1) comprises a processing unit 10.
The processing unit 10 can be made as or be part of a personal computer, a server, a tablet, a smartphone and, more in general, of an apparatus having a conventional standard configuration, and suitably programmed to perform the operations described and claimed herein.
The processing unit is configured to receive, from an electronic apparatus 20, an activation signal AS, representative of an activation of an operational reference X associated with a medical device.
The electronic apparatus 20 is preferably made as a mobile device (e.g. smartphone, tablet, schematically represented in figure 2) or as a device more dedicated to operating under static conditions (e.g. personal computer, laptop, etc. schematically shown in figure 3).
From a practical standpoint, the operational reference X can be produced, for example, as a graphic or alphanumeric code (such as a QR code) and/or as a web link.
The QR code can be affixed onto the medical device and/or the packaging thereof and/or documentation related to the medical device (e.g. instruction manual or other documentation).
In this example embodiment, the activation signal AS is generated by framing the QR code by means of the electronic apparatus 20; the QR code is decoded and returns, for example, a web link that directs the electronic apparatus 20 to the processing unit 10 and to the content managed by the latter - which will be better described further below.
In addition or alternatively, a web link can be directly provided to users it is desired to have participate in the data collection.
This link can be provided, for example, by sending an email message and/or by means of a push notification of an application pre-installed in the electronic apparatus 20.
In one embodiment, the link can be distributed for example by using a mailing list - dedicated in particular to the category of "professional users”, which will be better described further below.
The activation signal AS is thus generated by the reading and decoding of the QR code, or else by the user clicking or tapping (depending on whether he/she is using a mouse or a touch-screen technology) on the web link.
In response to the reception of the activation signal AS, the processing unit 10 will provide a series of questions Q via a user interface 21 of the electronic apparatus 20.
These questions have a pre-set structure; at least some questions are close-ended, for example of the multiple-choice type.
The questions regard at least one from among safety, performance, integrity and use of the device.
Via the user interface 21, the user has the possibility of providing an answer to each of the questions, so that the answers are received by the processing unit 10 (arrow "A” in figure 1).
The processing unit 10 is configured to automatically generate an electronic document ED containing a reference to the medical device that is the subject of the questionnaire and the answers provided by the user.
The electronic document ED thus generated is stored in a dedicated memory area and/or sent to a pre- established recipient.
Preferably, the users are divided into multiple categories. For example, three categories can be provided for:
- Non-professional users, i.e. ordinary people who use the device autonomously, for example at home;
- Professional users, for example medical personnel;
- Commercial operators, for example those who handle the logistics of the device (transport, storage, delivery, etc.).
Preferably, a sequence of dedicated questions is provided for each category of users; for example, the questions posed to a professional user will at least partly differ from those posed to a commercial operator.
The processing unit 10 is configured to acquire, by means of the electronic apparatus 20, the category to which the user participating in the questionnaire belongs.
For example, the user can enter the category to which he/she belongs in an initial setting phase, by means of a dedicated dialogue window; this setting phase can coincide with the user's subscription to the service.
An indication of the category to which the user belongs can be sent to the processing unit 20 simultaneously with the activation signal AS; in one embodiment, this indication can be integrated in the signal AS itself. In general, it is preferable that the indication reaches the processing unit 20 before the questions are presented to the user, so that the questionnaire can be set according to the category to which he/she belongs.
In fact, as mentioned, in a preferred embodiment the questions are selected (and more in general set) based on the fact that the user belongs to a given category.
By way of example, figures 4-18 show a series of questions, with associated answers, that can be posed to a non-professional user.
Preferably, the questions posed to a non-professional user comprise one or more among:
- A question regarding the possibility that the device is being used for the first time;
- A question regarding how the user came to know of the device;
- A question regarding the indications/reasons why the user is using the device;
- A question regarding after how applications I how many uses the user got relief from the discomfort the device is intended to confront;
- A question regarding the frequency of use of the device by the user;
- A question regarding the number of consecutive days the device is used by the user;
- A question regarding how the device is kept by the user;
- A question regarding how long the device is kept by user after opening the package;
- A question regarding possible side effects caused by the device;
- A question regarding a level of severity of said side effects;
- A question regarding a quantification of the benefit obtained by using the device;
- A question regarding a quantification of the ease of use of the device by the user;
- A question regarding a quantification of the clarity of the instructions for use;
- A question regarding a quantification of the clarity of the indications received from the doctor who prescribed use of the device;
- A question regarding a quantification of the clarity of the information provided by the device manufacturer/distributor/supplier, for example by means of a website.
Preferably, the user interface shows a graphic representation of the state of completion of the questionnaire - i.e. an indication of how many questions are yet to be completed before the end of the questionnaire, possibly combined with an indication of how many questions have already been answered. For example, a bar can be displayed which increases in length proportionally to the number of questions answered; an indication can also be provided of the maximum length of the bar (for example, equal to the width of the screen or of the window in which the questions are shown). In addition or alternatively, a numerical indication of the questions already answered and of the total questions can be displayed.
Both the bar and the numerical indication of the total questions (15) and the questions already answered are shown in the example provided in figures 4-18,.
It should be noted that, on the basis of the same concept, different graphic representations can be provided, which are in any case suitable for conveying the same information regarding the state of progress of the questionnaire.
Figure 19 illustrates, by way of example, a possible question that can be posed to a professional user. The question regards the number of patients to whom the user could prescribe the device. It is clearly an example, which can in reality be replaced by other questions or accompanied by other questions similarly dedicated to professional users.
Figure 20, on the other hand, shows a possible question that can be posed to an economic operator (e.g. carrier), or also to another category of user. It is asked, in particular, to report whether the packaging of the medical device is damaged in some way, and the option is given of adding a photograph showing the damage. The electronic apparatus 20 is thus configured to acquire a photograph and attach it to the answer. This feature is particularly practical when implemented by means of a smartphone or tablet, which can use its own integrated camera to acquire the photograph; the latter will then be immediately available for inclusion in the answer.
Figures 19-20 respectively show, for the sake of simplicity, a single example of a question posed to a professional user and to an economic operator. It is preferably envisaged that a range of questions is posed to each category of users. For the professional user and/or the economic operator the same graphic solutions as described above for the non-professional user can be adopted (e.g. regarding the progress of the questionnaire).
It is important to observe that both the questions and the answers shown in figures 4-20 are wholly exemplificative and aimed simply at illustrating a possible embodiment of a questionnaire dedicated to a nonprofessional or professional user or an economic operator.
Advantageously, the processing unit 10 is provided with an IP recognition algorithm so as to prevent the duplication of data coming from a same user.
It should be noted that the processing unit 10 and the electronic apparatus 20 have been described and represented separately for the sole purpose of clearly disclosing the features of the present invention.
In fact, in a preferred solution, they are two physically distinct apparatus connected by means of a remote connection; the electronic apparatus 20 allows interaction with the user via its user interface 21 , whilst the processing unit 10 has the task of managing the sending of questions and processing the answers.
In a variant embodiment, the electronic document containing the answers and, preferably, the indication of the category to which the user belongs, is generated directly by the electronic apparatus 20 and sent to the processing unit 10.
In a further variant, the processing unit 10 and the electronic apparatus 20 are made as a single device, configured to perform the operations described herein. In particular, the application used can be configured to operate locally until the final step of sending/storing the report containing the answers.
In more complex embodiments it is envisaged that the processing unit 10 is made up of a variety of apparatus (so-called distributed architecture), so as not to require a single apparatus to dialogue with the various electronic apparatus 10 and to process the relevant data.
The Applicant observes that the information collected by means of the present invention is useful for determining one or more from among:
A confirmation of the product's safety;
A confirmation of the product's functionality (performance);
A confirmation of a satisfactory risk/benefit ratio compared to the prior art; Possible unforeseen side effects;
Possible improper uses of the medical device;
Possible further critical issues in the post-marketing phase.
The Applicant further observes that the invention is particularly useful for collecting data for post-marketing surveillance in accordance with Art. 83(3) of Regulation (EU) 2017/745 - the so-called Medical Device Regulation - MDR.

Claims

1 . A method for collecting data for post-marketing surveillance of medical devices and accessories thereof, said method comprising: receiving, from an electronic apparatus (20), an activation signal (AS), representative of an activation of an operational reference (X) associated with a medical device; in response to the activation signal (AS), providing, via a user interface (21) of said electronic apparatus (20), a series of questions (Q) having a pre-set structure, said questions (Q) regarding at least one from among safety, performance, integrity and use of the device; receiving, via the user interface (21) of said electronic apparatus (20), the user's answers (A) to each of said questions (Q); automatically generating an electronic document (ED) containing a reference to said device and the answers provided by the user; storing said electronic document (ED) in a dedicated memory area or sending said electronic document (ED) to a pre-established recipient.
2. The method according to claim 1, wherein said operational reference (X) is a QR code and/or a web link.
3. The method according to claim 2, wherein said operational reference (X) is a QR code, said activation signal (AS) being generated by framing and decoding said QR code.
4. The method according to claim 2, wherein the operational reference (X) is a web link, said activation signal (AS) being generated by activating said web link, preferably by clicking or tapping.
5. The method according to any one of the preceding claims, comprising: acquiring, by means of said electronic apparatus (20), data representative of a category to which said user belongs; entering an indication of that category into said electronic document (ED).
6. The method according to claim 5, wherein said questions (Q) are selected according to the category of user.
7. The method according to claim 5 or 6, wherein said category belongs to the following set: nonprofessional user, professional user, economic operator.
8. A system for collecting data for post-marketing surveillance of medical devices and accessories thereof, said system comprising a processing unit configured (10) to: receive, from an electronic apparatus (20), an activation signal (AS), representative of an activation of an operational reference (X) associated with a medical device; in response to the reception of said activation signal (AS), to provide, via a user interface (21) of said electronic apparatus (20), a series of questions (Q), having a pre-set structure, said questions (Q) regarding at least one from among safety, performance, integrity and use of the device; receive, via said user interface (21), the user's answers (A) to each of said questions (Q); automatically generate an electronic document (ED) containing a reference to said device and the answers provided by the user; store said electronic document (ED) in a dedicated memory area or send said electronic document to a pre-established recipient.
9. The system according to claim 8, wherein said processing unit (10) and said electronic apparatus (20) are integrated in a single device.
10. The system according to claim 8, wherein said processing unit (10) and said electronic apparatus (20) are distinct devices.
PCT/IB2022/052942 2022-03-30 2022-03-30 Method and system for collecting data for post-marketing surveillance of medical devices and accessories thereof WO2023187445A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060129458A1 (en) * 2000-10-12 2006-06-15 Maggio Frank S Method and system for interacting with on-demand video content
US20160132216A1 (en) * 2014-11-07 2016-05-12 Pixrating Ltd. Business-to-business solution for picture-, animation- and video-based customer experience rating, voting and providing feedback or opinion based on mobile application or web browser
US20160283676A1 (en) * 2013-10-07 2016-09-29 Ckn Group, Inc. Systems and methods for interactive digital data collection

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060129458A1 (en) * 2000-10-12 2006-06-15 Maggio Frank S Method and system for interacting with on-demand video content
US20160283676A1 (en) * 2013-10-07 2016-09-29 Ckn Group, Inc. Systems and methods for interactive digital data collection
US20160132216A1 (en) * 2014-11-07 2016-05-12 Pixrating Ltd. Business-to-business solution for picture-, animation- and video-based customer experience rating, voting and providing feedback or opinion based on mobile application or web browser

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