Medical instrument technical achievement transformation assisting method and device and electronic equipment

Abstract

The invention relates to the technical field of computers and internet platforms, in particular to a medical instrument product technical achievement conversion assisting method and device and electronic equipment, and the method comprises the steps that user login information is acquired; when it is determined that a user logs in with a customer account or a service staff account according to the user login information, executing the following operations: displaying a definition interface; and displaying the ready interface. Through deep integration of the structured process, the intelligent approval information engine and the cooperative work platform, the registration failure risk of the medical instrument product is remarkably reduced, the cooperation efficiency is improved, and the system becomes a strategic enabling platform for realizing rapid, safe and compliant technical achievement transformation of the product in a highly supervised and intense competitive medical market of an enterprise.

Description

Technical Field

[0001] This disclosure relates to the field of computer and internet platform technology, specifically to a method, device, and electronic device for assisting in the transformation of medical device technology achievements. Background Technology

[0002] Medical device products include, but are not limited to, treatment, monitoring, and rehabilitation equipment (such as surgical instruments and pacemakers), as well as in vitro diagnostic reagents (IVD) used for in vitro sample testing (such as blood glucose test strips and PCR reagents). Medical device products are a highly regulated industry globally, as they bear the crucial mission of protecting human health and safety. Accurately facilitating the commercialization of medical device technologies to ensure compliance with all registration requirements, procedures, and milestones, significantly reducing registration risks, and accelerating compliant market entry are key to helping companies gain a competitive edge in a highly regulated market. However, the commercialization of medical device technologies currently faces the following challenges: First, medical device products require vastly different registration information at different stages, from conceptual design and R&D testing to clinical trials and post-market surveillance. This information is not only diverse in type (technical documents, performance data, safety reports, process validation, etc.) but also highly dynamic and subject to change. Companies often lack a systematic information management framework that spans the entire product technology transfer process, leading to gaps in the transfer of some technological achievements. This results in omissions or delays in key stages of technology transfer information. Such information gaps can, at best, delay the review process, and at worst, lead to rejection due to incomplete evidence chains or failure to meet stage requirements, jeopardizing significant upfront investments.

[0003] Secondly, the medical device approval information system is characterized by its multi-level (national / regional), multi-dimensional (safety / effectiveness / quality / labeling) and high-frequency updates. If companies rely solely on manual retrieval and paper document management, there are significant limitations: it is difficult to track the dynamic changes of relevant information in real time; it is impossible to efficiently parse massive amounts of text to accurately locate the specific requirements applicable to their own product type, intended use, and target market; and it is more likely to misjudge the compliance path due to information lag. This lag and ambiguity in approval information management directly translates into significant risks of registration failure or market launch delays.

[0004] Furthermore, there are inherent professional gaps and differing goals among a company's R&D, quality, and clinical departments. R&D focuses on technological innovation, quality adheres strictly to compliance, clinical focuses on data generation, and registration requires integrating all information related to the commercialization of technological achievements to meet regulatory requirements. This professional division easily leads to information silos: R&D data is not structured according to registration requirements, clinical reports are not promptly incorporated into quality considerations, and key changes are not communicated synchronously, resulting in a broken information transmission chain. Personnel involved in the commercialization of technological achievements often have to spend a lot of energy tracing, clarifying, and even reorganizing information, causing communication friction, decision-making delays, and even leading to the questioning or rejection of registration documents due to inconsistencies in information.

[0005] The entire process of compliant technology transfer for medical device products involves multiple stages. According to current regulatory requirements, when a product registration application is submitted, if the reviewing agency finds that the technology transfer materials for a particular stage do not meet the requirements, the company must not only return to that stage to re-prepare the application materials, but also re-perform all subsequent inspections and tests from that stage onwards, and re-prepare the materials. This process not only consumes a significant amount of time and resources, but more importantly, it severely delays the product's market launch, exposing companies and investors to the huge risk of losing market share and wasting their initial investment. Summary of the Invention

[0006] To address the problems in related technologies, this disclosure provides an auxiliary method, apparatus, and electronic device for the transformation of medical device technology achievements.

[0007] In a first aspect, this disclosure provides a method for assisting in the transformation of medical device technology achievements, the method comprising: Obtain user login information; When it is determined from the user login information that the user is logged in with a customer account or a service personnel account, perform the following operations: The definition interface is displayed, which includes multiple definition controls, including a stage control, a product name control, and at least one product feature control. The stage control is used to define the achievement transformation stage of the product, the product name control is used to define the product name, and the product feature control is used to define the corresponding features of the product. Based on the user's operation on the defined control, determine the specified product that the user wants to define and the specified stage in the technology transfer of the specified product. Displays an approval information control related to the specified product at the specified stage; The ready interface is displayed, which includes a group of ready process claim items control for the specified product at each stage of achievement transformation. Each process stage corresponds to one or more review and approval claim item control groups and one or more ready process operation claim item control groups. The ready process operation claim item control groups include: fill-in template control, review basis control, teaching control, claim document control, lock control, not ready to start control, and ready control. When a user logs in with a customer account, the system receives the technology transfer application materials uploaded by the user. After the technology transfer application materials are reviewed by the service personnel, the system displays either a not-ready-to-start status or a ready status. In the not-ready-to-start status, the user is allowed to modify or supplement the technology transfer application materials. When a user logs in with a service personnel account, after the user uploads the application materials for technology transfer, in response to the user's operation on the lock control, the application materials for technology transfer are locked and displayed. The system obtains the user's selection of the not-ready-to-start control or the ready control and displays the not-ready-to-start status or the ready status accordingly. Specifically, when the application materials for technology transfer are approved by the service personnel, the service personnel select the ready control; otherwise, they select the not-ready-to-start control.

[0008] According to embodiments of this disclosure, the stage control includes at least one of the following options for defining the technology transfer stage of the product: prototype, system prototype, engineering prototype, and registered product; The product feature control includes any one of the following: The production region control is used to define the production region of a product; Regulatory category control, used to define the regulatory category of a product; User category control, used to define the user categories of the product; Property controls are used to define the attribute categories of a product.

[0009] According to embodiments of this disclosure, the production region control includes at least one of the following options for defining the production region of the product: domestic, imported; The regulatory category control includes at least one of the following options for defining the regulatory category of the product: Category I, Category II, Category III; The user category control includes at least one of the following options for defining the user category of the product: consumer use, professional use; The property control includes at least one of the following options for the property category of the application-defined product: medical device, in vitro diagnostic reagent.

[0010] According to embodiments of this disclosure, the multiple product feature controls in the defined interface are organized according to a first preset logic tree; The multiple ready process claim item control groups in the ready interface are determined based on the user's operation on the multiple product feature controls and according to the second preset logic tree. The second preset logic tree is used to describe the logical relationship between the product feature controls and the ready process claim item controls. The display definition interface includes: displaying at least one of the plurality of product feature controls; and determining the subsequent product feature controls to be displayed based on the logic tree according to the user's operation on the displayed product feature controls. The display ready interface includes: determining the ready process claim item control group to be displayed based on the second logic tree according to the user's operation on the product feature control.

[0011] According to embodiments of this disclosure, the approval information control is used to display at least one of the following: guiding principles, product standards, normative documents, and working documents.

[0012] According to embodiments of this disclosure, the filling template control is used to provide users with a filling template for the technology transfer documents of the specified product at the corresponding technology transfer stage; The review basis control is used to provide users with the review basis for the technology transfer application materials of the specified product at the corresponding technology transfer stage; The teaching controls are used to provide users with instructional videos on filling out the application materials for the commercialization of the specified product at the corresponding stage of commercialization. The claim document control is used to provide users with a channel for uploading claim documents for the technology transfer application materials of the specified product at the corresponding technology transfer stage.

[0013] According to embodiments of this disclosure, when it is determined from user login information that a user has logged in with a customer account, service personnel account, or administrator account, the following operations are performed: The milestone interface displays the status information of the specified product at each stage of the transformation of medical device product technology achievements, wherein: The transformation of the technological achievements of the medical device products includes at least one of the following stages: determining the required information, preparing product information, compiling complete application materials, submitting the application to the institution, and document review and recording. The status information includes at least one of the following: service scope, service start time, first reporting time, and completion time; When the status information at any stage indicates that the service for that stage is completed, users are allowed to download or view the relevant technology transfer application materials for that stage.

[0014] Secondly, this disclosure provides an auxiliary device for the transformation of medical device technology achievements, the device comprising: The login information acquisition module is configured to acquire user login information. The display module is configured to perform the following operations when it is determined from the user's login information that the user is logged in with a customer account or a service personnel account: The definition interface is displayed, which includes multiple definition controls, including a stage control, a product name control, and at least one product feature control. The stage control is used to define the achievement transformation stage of the product, the product name control is used to define the product name, and the product feature control is used to define the corresponding features of the product. Based on the user's operation on the defined control, determine the specified product that the user wants to define and the specified stage in the technology transfer of the specified product. Displays an approval information control related to the specified product at the specified stage; The ready interface is displayed, which includes a group of ready process claim items control for the specified product at each stage of achievement transformation. Each process stage corresponds to one or more review and approval claim item control groups and one or more ready process operation claim item control groups. The ready process operation claim item control groups include: fill-in template control, review basis control, teaching control, claim document control, lock control, not ready to start control, and ready control. The upload module is configured to receive the technology transfer application materials uploaded by the user when the user logs in with a customer account, and display the technology transfer application materials as either not ready to start or ready after the service personnel have reviewed them. In the not ready to start state, the user is allowed to modify or supplement the technology transfer application materials. The review module is configured as follows: when a user logs in with a service personnel account, after the user uploads the application materials for technology transfer, in response to the user's operation on the lock control, the application materials for technology transfer are locked and displayed. The module obtains the user's selection of the not-ready-to-start control or the ready control and displays the not-ready-to-start status or the ready status accordingly. Specifically, when the application materials for technology transfer are approved by the service personnel, the service personnel select the ready control; otherwise, they select the not-ready-to-start control.

[0015] According to embodiments of this disclosure, the apparatus further includes: a milestone display module; the milestone display module is configured to: when user login information determines that a user has logged in with a customer account or a service personnel account, perform the following operations: The milestone interface displays the status information of the specified product at each stage of the transformation of medical device product technology achievements, wherein: The transformation of the technological achievements of the medical device products includes at least one of the following stages: determining the required information, preparing product information, compiling complete application materials, submitting the application to the institution, and document review and recording. The status information includes at least one of the following: service scope, service start time, first reporting time, and completion time; When the status information at any stage indicates that the service for that stage is completed, users are allowed to download or view the relevant technology transfer application materials for that stage.

[0016] Thirdly, embodiments of this disclosure provide an electronic device, characterized in that it includes the apparatus described in any one of the second aspects; or, it includes a memory and a processor; wherein the memory is used to store one or more computer instructions, wherein the one or more computer instructions are executed by the processor to implement the method described in any one of the first aspects.

[0017] Fourthly, this disclosure provides a computer-readable storage medium having computer instructions stored thereon, which, when executed by a processor, implement the method as described in any one of the first aspects.

[0018] Fifthly, this disclosure provides a computer program product, including a computer program, characterized in that the computer program, when executed by a processor, implements the method described in any one of the first aspects.

[0019] To address the core challenges of medical device product registration, this disclosed technical solution integrates stage definition, precise matching of approval information, and readiness management. It provides intelligent and structured support for the entire process of technology transfer required for registration. The multi-option definition interface allows clients and service personnel to clearly understand the current stage and status of the product's technology transfer, becoming the core logic engine driving all subsequent functions. The approval information control, based on the user-defined specific medical device product type and precise technology transfer stage, automatically extracts applicable regulations and requirements for that stage from a vast, multi-level approval information database (related guidelines, normative documents, and working documents). This completely eliminates the "needle in a haystack" manual retrieval, ensuring that all registration application materials submitted by enterprises at each stage of product technology transfer are compliant and avoiding the risk of large-scale rework due to non-compliant final submissions. The readiness interface generates a structured and standardized list of upload tasks, with each task associated with specific approval information clauses and stage requirements. This completely breaks down information silos, eliminates version confusion and duplicate collection, and greatly saves manpower and time costs. This disclosure, through the deep integration of structured processes, intelligent approval information engines, and collaborative work platforms, upgrades the transformation of technological achievements in medical device products from a "workshop" model that relies on personal experience and passive responses to a modern management system that is data-driven, proactively planned, and highly collaborative. This significantly reduces the risk of medical device product registration failure, improves collaboration efficiency, and becomes a strategic empowerment platform for enterprises to achieve rapid, safe, and compliant product launches in a highly regulated and competitive medical market.

[0020] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this disclosure. Attached Figure Description

[0021] Other features, objects, and advantages of this disclosure will become more apparent from the following detailed description of non-limiting embodiments, taken in conjunction with the accompanying drawings. In the drawings: Figure 1 A flowchart illustrating an auxiliary method for the transformation of medical device technology achievements according to an embodiment of the present disclosure is shown.

[0022] Figure 2 A schematic diagram showing a defined interface according to an embodiment of this disclosure is provided.

[0023] Figure 3 A stage control according to an embodiment of this disclosure is shown.

[0024] Figure 4 A production region control according to an embodiment of this disclosure is shown.

[0025] Figure 5 A regulatory category control is shown according to an embodiment of this disclosure.

[0026] Figure 6 A user category control according to an embodiment of this disclosure is shown.

[0027] Figure 7 An attribute control according to an embodiment of this disclosure is shown.

[0028] Figure 8 Subsequent feature controls according to embodiments of this disclosure are shown.

[0029] Figure 9 An approval information control according to an embodiment of this disclosure is shown.

[0030] Figure 10 A ready interface according to an embodiment of this disclosure is shown.

[0031] Figure 11 A definition interface for selecting a product feature control according to an embodiment of the present disclosure is shown.

[0032] Figure 12 The corresponding embodiments according to this disclosure are shown. Figure 11 Define the prototype stage area in the ready interface of the product feature control selection ready process claim item control group.

[0033] Figure 13 The corresponding embodiments according to this disclosure are shown. Figure 11 Define the area of ​​the system prototype stage in the ready interface for selecting the ready process claim item control group of the interface product feature control selection.

[0034] Figure 14 The corresponding embodiments according to this disclosure are shown. Figure 11 Define the areas for the engineering prototype stage and the registered product stage in the ready interface of the product feature control selection, and the ready process claim item control group.

[0035] Figure 15 A milestone interface is shown according to an embodiment of this disclosure.

[0036] Figure 16 A structural block diagram of an electronic device according to an embodiment of the present disclosure is shown. Detailed Implementation

[0037] In the following, exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings to enable those skilled in the art to readily implement them. Furthermore, for clarity, portions unrelated to the description of exemplary embodiments have been omitted from the drawings.

[0038] In this disclosure, it should be understood that terms such as “comprising” or “having” are intended to indicate the presence of features, figures, steps, behaviors, components, parts or combinations thereof disclosed in this specification, and are not intended to exclude the possibility of the presence or addition of one or more other features, figures, steps, behaviors, components, parts or combinations thereof.

[0039] It should also be noted that, unless otherwise specified, the embodiments and features described in this disclosure can be combined with each other. This disclosure will now be described in detail with reference to the accompanying drawings and embodiments.

[0040] As mentioned earlier, medical devices, as a highly regulated industry globally, bear the heavy responsibility of safeguarding human health and safety. Their registration process requires precise understanding of the entire process, procedures, and key milestones involved in the commercialization of technological achievements to significantly reduce registration risks and accelerate compliant market entry, thereby giving companies a competitive edge in a stringent regulatory environment. However, the current registration process for medical devices faces three core challenges: Firstly, there are different dynamic information needs at each stage of the transformation of product technology achievements, covering multiple types of key evidence such as technical documents, performance data, and safety reports. Due to the lack of a systematic information management framework, enterprises often omit or delay the characteristic information of each stage. This can lead to delays in review or even rejection due to broken evidence chains or inconsistencies between stages, resulting in significant risks to the initial investment. Secondly, the medical device product registration and approval information system has multi-level (national / regional), multi-dimensional (safety / effectiveness / quality / label) and high-frequency update characteristics. Relying on manual retrieval and paper management makes it difficult to track the dynamics of approval information in real time and accurately analyze massive amounts of text to match product type and target market requirements. Information lag can easily lead to misjudgment of compliance path in the transformation of technological achievements, which directly translates into the risk of registration failure and delay. Third, the professional goals of R&D, quality, clinical, and technology transfer personnel create collaboration barriers. R&D data is not structured to meet registration requirements, clinical reports are not incorporated into the quality system in a timely manner, and key changes are not transmitted synchronously, resulting in information silos and broken transmission chains. This forces technology transfer personnel to spend energy tracing, clarifying, or even reconstructing information, causing communication friction, decision-making delays, and document inconsistency risks, which may ultimately lead to registration obstacles. These systemic dilemmas urgently require innovative solutions to break the deadlock.

[0041] To address the aforementioned issues, this disclosure provides a method, apparatus, and electronic device for assisting in the transformation of medical device technology achievements. Through an intuitive user interface and interactive functions, it systematically integrates previously scattered information, helping users accurately understand and comply with the relevant approval information requirements for medical device registration. Embodiments of this disclosure implement compliance control at each stage of the registration process, ensuring that registration application materials at each stage meet approval standards and tracking progress in real time. By breaking down collaboration barriers between different departments or stages and optimizing resource allocation, it ultimately improves the efficiency of the entire medical device product registration process, while making the entire process more transparent, controllable, safe, and reliable.

[0042] Figure 1 A flowchart illustrating an auxiliary method for the transformation of medical device technology achievements according to embodiments of this disclosure is shown. Figure 1 As shown, the auxiliary method for the transformation of medical device technology achievements includes the following steps S101-S106: In step S101, user login information is obtained; In step S102, when it is determined from the user login information that the user has logged in with a customer account or a service personnel account, the following operations are performed: The definition interface is displayed, which includes multiple definition controls, including a stage control, a product name control, and at least one product feature control. The stage control is used to define the achievement transformation stage of the product, the product name control is used to define the product name, and the product feature control is used to define the corresponding features of the product. In step S103, based on the user's operation on the definition control, the specified product to be defined by the user and the specified stage in the technology transfer of the specified product are determined; In step S104, an approval information control related to the specified product at the specified stage is displayed; In step S105, the ready interface includes ready process claim item control groups for the specified product at each achievement transformation stage. Each process stage corresponds to one or more review and approval claim item control groups and one or more ready process operation claim item control groups. The ready process operation claim item control groups include: fill-in template control, review basis control, teaching control, claim document control, lock control, not ready start control, and ready control. In step S106, when a user logs in with a customer account, the system receives the technology transfer application materials uploaded by the user. After the technology transfer application materials are reviewed by the service personnel, the system displays either a not-ready-to-start status or a ready status. In the not-ready-to-start status, the user is allowed to modify or supplement the technology transfer application materials. When a user logs in with a service personnel account, after the user uploads the application materials for technology transfer, in response to the user's operation on the lock control, the application materials for technology transfer are locked and displayed. The system obtains the user's selection of the not-ready-to-start control or the ready control and displays the not-ready-to-start status or the ready status accordingly. Specifically, when the application materials for technology transfer are approved by the service personnel, the service personnel select the ready control; otherwise, they select the not-ready-to-start control.

[0043] The following is for reference. Figures 2-6 The present disclosure provides a detailed description of the auxiliary method for the transformation of medical device technology achievements according to embodiments of the present disclosure.

[0044] Figure 2 A schematic diagram of a defined interface according to an embodiment of this disclosure is shown.

[0045] like Figure 2 As shown, the definition interface according to an embodiment of this disclosure includes multiple definition controls, including a stage control, a product name control, and at least one product feature control. The stage control is used to define the technology transfer stage of the product, the product name control is used to define the product name, and the product feature control is used to define the corresponding features of the product.

[0046] Figure 3 A stage control according to an embodiment of this disclosure is shown.

[0047] According to embodiments of this disclosure, the stage control includes at least one of the following options for defining the technology transfer stage of the product: prototype, system prototype, production engineering prototype, engineering prototype, and registered product. Figure 3 As shown, when the user clicks the stage control, a drop-down menu is displayed. The drop-down menu contains options such as prototype, system prototype, production engineering prototype, engineering prototype, and registered product. The user can define the technology transfer stage of the product by clicking the corresponding option.

[0048] According to embodiments of this disclosure, the product feature controls include any one of the following: a production region control for defining the production region of the product; a regulatory category control for defining the regulatory category of the product; a user category control for defining the user category of the product; and an attribute control for defining the attribute category of the product. According to embodiments of this disclosure, other product feature controls can also be set as needed.

[0049] Figure 4 A production region control according to an embodiment of this disclosure is shown.

[0050] According to embodiments of this disclosure, the production region control includes at least one of the following options for defining the production region of the product: domestic, imported. Figure 4 As shown, when the user clicks the production region control, a drop-down menu is displayed, which includes options such as domestic and imported. The user can define the production region of the product by clicking the corresponding option.

[0051] Figure 5 A regulatory category control according to an embodiment of this disclosure is shown.

[0052] According to embodiments of this disclosure, the regulatory category control includes at least one of the following options for defining the regulatory category of a product: Category I, Category II, or Category III. Figure 5 As shown, when a user clicks the regulatory category control, a drop-down menu is displayed, which includes options such as Category I, Category II, and Category III. Users can define the regulatory category of a product by clicking the corresponding option.

[0053] Figure 6 A user category control according to an embodiment of this disclosure is shown.

[0054] According to embodiments of this disclosure, the user category control includes at least one of the following options for defining user categories of the product: consumer use, professional use. Figure 6 As shown, when a user clicks the user category control, a drop-down menu is displayed, which includes options such as consumer use and professional use. Users can define the user category of the product by clicking the corresponding option.

[0055] Figure 7 A property control according to an embodiment of the present disclosure is shown.

[0056] According to embodiments of this disclosure, the attribute category control includes at least one of the following options for defining the attribute category of a product: medical device, in vitro diagnostic reagent. Figure 7 As shown, when a user clicks the attribute category control, a drop-down menu is displayed, including options such as medical devices and in vitro diagnostic reagents. The user can define the product's attribute category by clicking the corresponding option. According to an embodiment of this disclosure, the multiple product feature controls in the definition interface are organized according to a first preset logic tree; the display of the definition interface includes: displaying at least one of the multiple product feature controls; and determining the subsequent product feature controls to be displayed based on the logic tree according to the user's operation on the displayed product feature controls.

[0057] Figure 8 Subsequent feature controls according to embodiments of this disclosure are shown.

[0058] Defining a medical device product is a highly complex and detailed process, as different medical device products may use different product feature controls or have different options within those controls. The definition process according to embodiments of this disclosure is a progressively refined process based on user interactions with product feature controls, similar to exploring a logic tree layer by layer from the root node to the leaf nodes. Therefore, embodiments of this disclosure analyze and correlate the feature controls and their options for various medical device products to construct a first logic tree. When a user defines a product through the definition interface, the tree displays corresponding subsequent feature controls based on the user's interactions with the previously displayed feature controls. For example, in... Figure 8 In the context of this system, when a user selects the "Medical Device" option within the feature controls, the next feature control, "Implantable in Human Body," is displayed. Conversely, if the user selects the "Implantable" option within "Implantable in Human Body," the next feature control, "Sterilized and Provided," is displayed. By organizing the feature tools through a first logic tree, users are no longer required to go through tedious approval information searches to learn how to define a product. This allows users unfamiliar with the definition rules for medical device products to quickly and accurately define their own products, improving user efficiency and reducing the probability of errors.

[0059] In this disclosure, after conducting in-depth research on the entire process of medical device products from conceptual design to registration completion, the inventors have divided the product technology transfer process into the following five stages according to the product development and compliance review process: principle prototype, system prototype, production engineering prototype, engineering prototype, and registered product.

[0060] The above five stages fully cover the entire process of medical device products from principle design to registration completion. Each stage corresponds to specific information and data required for the transformation of technological achievements. At the same time, a rigorous logic tree is established based on definition controls to accurately define medical device products, effectively solving the problem of "incomplete stage information". Furthermore, based on the definition information in the definition interface, corresponding ready interfaces are provided to ensure the integrity and timeliness of the evidence chain for the transformation of technological achievements, avoiding the risk of rejection due to information lag or lack.

[0061] Figure 9 An approval information control according to an embodiment of this disclosure is shown.

[0062] According to embodiments of this disclosure, the approval information control is used to display at least one of the following: guiding principles, normative documents, and working documents.

[0063] Given that in actual compliance operations, companies must first comply with the "Regulations on the Supervision and Administration of Medical Devices," then apply according to the "Registration Management Measures" (departmental regulations), and finally improve their materials with reference to the guiding principles, and considering that technical guiding principles and review points directly affect the research and development direction (such as clinical trial design), this disclosure defines product information on the interface, intelligently matches and classifies approval information in multiple dimensions, enabling users to accurately match document levels and needs, significantly improving compliance efficiency, and accurately matching and continuously providing compliance warnings, transforming the uncertainty of approval information into a controllable factor.

[0064] Figure 10 A ready interface according to an embodiment of this disclosure is shown.

[0065] According to embodiments of this disclosure, the ready interface includes ready process claim item control groups for the specified product at each achievement transformation stage, wherein each process stage corresponds to one or more review and approval claim item control groups and one or more ready process operation claim item control groups, the ready process operation claim item control groups include: fill-in template control, review basis control, teaching control, claim document control, lock control, not ready to start control, and ready control; Figure 11 A definition interface for selecting a product feature control according to an embodiment of the present disclosure is shown.

[0066] Figure 12 The corresponding embodiments according to this disclosure are shown. Figure 11 Define the prototype stage area in the ready interface of the product feature control selection ready process claim item control group.

[0067] Figure 13 The corresponding embodiments according to this disclosure are shown. Figure 11 Define the area of ​​the system prototype stage in the ready interface for selecting the ready process claim item control group of the interface product feature control selection.

[0068] Figure 14 The corresponding embodiments according to this disclosure are shown. Figure 11 Define the areas for the engineering prototype stage and the registered product stage in the ready interface of the product feature control selection, and the ready process claim item control group.

[0069] According to embodiments of this disclosure, the multiple ready process claim item control groups in the ready interface are determined based on the user's operation on the multiple product feature controls, according to a second preset logic tree, which is used to describe the logical relationship between the product feature controls and the ready process claim item controls. The display ready interface includes: determining the ready process claim item control group to be displayed based on the second logic tree according to the user's operation on the product feature control.

[0070] According to embodiments of this disclosure, the filling template control is used to provide users with a filling template for the technology transfer documents of the specified product at the corresponding technology transfer stage; The review basis control is used to provide users with the review basis for the technology transfer application materials of the specified product at the corresponding technology transfer stage; The teaching controls are used to provide users with instructional videos on filling out the application materials for the commercialization of the specified product at the corresponding stage of commercialization. The claim document control is used to provide users with a channel for uploading claim documents for the technology transfer application materials of the specified product at the corresponding technology transfer stage.

[0071] This disclosure, through a ready-to-use interface, based on relevant approval information requirements and a list of stage information, allows for the selection of product feature controls on the defined interface. It then determines and generates a structured and standardized list of claim items according to a second preset logic tree. Each task is clearly associated with specific approval information clauses and stage requirements. Furthermore, instructional controls provide users with video tutorials on filling out technology transfer application materials for the specified product at the corresponding technology transfer stage. R&D, quality, clinical, and technology transfer personnel can work based on the same application material template, completely breaking down information silos, eliminating version confusion and duplicate collection, and promoting a shift in technology transfer work towards a proactive planning, efficient collaboration, and forward-looking risk management model.

[0072] According to an embodiment of this disclosure, when a user logs in with a customer account, the system receives the technology transfer application materials uploaded by the user. After the technology transfer application materials are reviewed by the service personnel, the system displays either a not-ready-to-start state or a ready state. In the not-ready-to-start state, the user is allowed to modify or supplement the technology transfer application materials. When a user logs in with a service personnel account, after the user uploads the application materials for technology transfer, in response to the user's operation on the lock control, the application materials for technology transfer are locked and displayed. The system obtains the user's selection of the not-ready-to-start control or the ready control and displays the not-ready-to-start status or the ready status accordingly. Specifically, when the application materials for technology transfer are approved by the service personnel, the service personnel select the ready control; otherwise, they select the not-ready-to-start control.

[0073] Specifically, users logged in with a customer account can download and fill out document templates and claim document templates after entering the ready interface, and upload the completed technology transfer application materials (including technology achievement documents, claim documents, or other relevant materials). Users logged in with a service personnel account can lock, display, and review the uploaded technology transfer application materials. After approval, clicking the ready control will display the ready status on the ready interface of the user logged in with the customer account, indicating that the technology transfer application materials at this stage meet the registration requirements. Otherwise, if the review fails, the user logged in with the service personnel account will click the not ready start control, and the not ready start status will be displayed on the ready interface of the user logged in with the customer account, indicating that the technology transfer application materials at this stage do not meet the requirements and need further modification.

[0074] This approach ensures that users complete all required technology transfer materials at every stage of the medical device product compliance technology transfer process, avoiding situations where users discover that materials from a particular stage do not meet the requirements only when submitting the technology transfer application to the reviewing agency, leading to a complete rework of that stage and subsequent stages.

[0075] Furthermore, according to embodiments of this disclosure, only after the application materials for technology transfer in the previous stage have been approved and are in a ready state is the user, logged in with a customer account, allowed to submit the application materials for technology transfer in the next stage. Since failure to meet the requirements of the application materials for technology transfer in any stage will render the application materials for technology transfer in the subsequent stages unusable, this mandatory requirement ensures that users prepare the application materials for technology transfer strictly in accordance with the requirements step by step, avoiding situations where "futile efforts" are made.

[0076] According to embodiments of this disclosure, when it is determined from user login information that a user has logged in with a customer account, service personnel account, or administrator account, the following operations are performed: The milestone interface displays the status information of the specified product at each stage of the transformation of medical device product technology achievements, wherein: The transformation of the technological achievements of the medical device products includes at least one of the following stages: determining the required information, preparing product information, compiling complete application materials, submitting the application to the institution, and document review and recording. The status information includes at least one of the following: service scope, service start time, first reporting time, and completion time; When the status information at any stage indicates that the service for that stage is completed, users are allowed to download or view the relevant technology transfer application materials for that stage.

[0077] Figure 15A milestone interface according to an embodiment of this disclosure is shown.

[0078] Through the milestone interface, clients, service personnel, and administrators (such as investors) can share information on the progress of technology transfer. The milestone interface, with its structured, visual, and highly controllable design, enhances efficiency and risk management in the technology transfer process. Its core value lies in breaking down the complex and lengthy process into clear and controllable key stages, displaying the service scope, start and end times, and key milestones of each stage in real time, achieving transparent tracking throughout the entire process. When any stage is marked as completed, the system automatically unlocks access to view and download the relevant data for that stage, ensuring that document delivery is strictly linked to the process progress and preventing data errors or version confusion. Administrators can intuitively identify bottlenecks (such as a stage that has been incomplete for an extended period) and quickly allocate resources to intervene, preventing delays in implementation.

[0079] This disclosure provides a medical device technology transfer auxiliary device, the device comprising: The login information acquisition module is configured to acquire user login information. The display module is configured to perform the following operations when it is determined from the user's login information that the user is logged in with a customer account or a service personnel account: The definition interface is displayed, which includes multiple definition controls, including a stage control, a product name control, and at least one product feature control. The stage control is used to define the achievement transformation stage of the product, the product name control is used to define the product name, and the product feature control is used to define the corresponding features of the product. Based on the user's operation on the defined control, determine the specified product that the user wants to define and the specified stage in the technology transfer of the specified product. Displays an approval information control related to the specified product at the specified stage; The ready interface is displayed, which includes a group of ready process claim items control for the specified product at each stage of achievement transformation. Each process stage corresponds to one or more review and approval claim item control groups and one or more ready process operation claim item control groups. The ready process operation claim item control groups include: fill-in template control, review basis control, teaching control, claim document control, lock control, not ready to start control, and ready control. The upload module is configured to receive the technology transfer application materials uploaded by the user when the user logs in with a customer account, and display the technology transfer application materials as either not ready to start or ready after the service personnel have reviewed them. In the not ready to start state, the user is allowed to modify or supplement the technology transfer application materials. The review module is configured as follows: when a user logs in with a service personnel account, after the user uploads the application materials for technology transfer, in response to the user's operation on the lock control, the application materials for technology transfer are locked and displayed. The module obtains the user's selection of the not-ready-to-start control or the ready control and displays the not-ready-to-start status or the ready status accordingly. Specifically, when the application materials for technology transfer are approved by the service personnel, the service personnel select the ready control; otherwise, they select the not-ready-to-start control.

[0080] According to embodiments of this disclosure, the apparatus further includes: a milestone display module; the milestone display module is configured to: when user login information determines that a user has logged in with a customer account or a service personnel account, perform the following operations: The milestone interface displays the status information of the specified product at each stage of the transformation of medical device product technology achievements, wherein: The transformation of the technological achievements of the medical device products includes at least one of the following stages: determining the required information, preparing product information, compiling complete application materials, submitting the application to the institution, and document review and recording. The status information includes at least one of the following: service scope, service start time, first reporting time, and completion time; When the status information at any stage indicates that the service for that stage is completed, users are allowed to download or view the relevant technology transfer application materials for that stage.

[0081] This disclosure provides an electronic device, characterized in that it includes the apparatus described in any one of the second aspects; or, it includes a memory and a processor; wherein the memory is used to store one or more computer instructions, wherein the one or more computer instructions are executed by the processor to implement the method according to the embodiments of this disclosure.

[0082] Figure 16 A structural block diagram of an electronic device according to an embodiment of the present disclosure is shown. Figure 16 As shown, the electronic device includes a memory and a processor; wherein the memory is used to store one or more computer instructions, wherein the one or more computer instructions are executed by the processor to implement the method described in any of the above method embodiments.

[0083] This disclosure provides a computer-readable storage medium storing computer instructions that, when executed by a processor, implement the method described according to this disclosure.

[0084] This disclosure provides a computer program product, including a computer program, characterized in that the computer program, when executed by a processor, implements the method described in this disclosure.

[0085] The above description is merely a preferred embodiment of this disclosure and an explanation of the technical principles employed. Those skilled in the art should understand that the scope of the invention involved in this disclosure is not limited to technical solutions formed by specific combinations of the above-described technical features, but should also cover other technical solutions formed by arbitrary combinations of the above-described technical features or their equivalents without departing from the inventive concept. For example, technical solutions formed by substituting the above-described features with (but not limited to) technical features disclosed in this disclosure that have similar functions.

Claims

1. A method for assisting in the transformation of technological achievements in medical device products, characterized in that, The method includes: Obtain user login information; When it is determined from the user login information that the user is logged in with a customer account or a service personnel account, perform the following operations: The definition interface is displayed, which includes multiple definition controls, including a stage control, a product name control, and at least one product feature control. The stage control is used to define the achievement transformation stage of the product, the product name control is used to define the product name, and the product feature control is used to define the corresponding features of the product. Based on the user's operation on the defined control, determine the specified product that the user wants to define and the specified stage in the technology transfer of the specified product. Displays an approval information control related to the specified product at the specified stage; The ready interface is displayed, which includes a group of ready process claim items control for the specified product at each stage of achievement transformation. Each process stage corresponds to one or more review and approval claim item control groups and one or more ready process operation claim item control groups. The ready process operation claim item control groups include: fill-in template control, review basis control, teaching control, claim document control, lock control, not ready to start control, and ready control. When a user logs in with a customer account, the system receives the technology transfer application materials uploaded by the user. After the technology transfer application materials are reviewed by the service personnel, the system displays either a not-ready-to-start status or a ready status. In the not-ready-to-start status, the user is allowed to modify or supplement the technology transfer application materials. When a user logs in with a service personnel account, after the user uploads the application materials for technology transfer, in response to the user's operation on the lock control, the application materials for technology transfer are locked and displayed. The system obtains the user's selection of the not-ready-to-start control or the ready control and displays the not-ready-to-start status or the ready status accordingly. Specifically, when the application materials for technology transfer are approved by the service personnel, the service personnel select the ready control; otherwise, they select the not-ready-to-start control.

2. The auxiliary method for the transformation of medical device product technology achievements according to claim 1, characterized in that: The stage control includes at least one of the following options for defining the technology transfer stage of the product: prototype, system prototype, engineering prototype, registered product; The product feature control includes any one of the following: The production region control is used to define the production region of a product; Regulatory category control, used to define the regulatory category of a product; User category control, used to define the user categories of the product; Property controls are used to define the attribute categories of a product.

3. The auxiliary method for the transformation of medical device technology achievements according to claim 2, characterized in that: The production region control includes at least one of the following options for defining the production region of the product: domestic, imported; The regulatory category control includes at least one of the following options for defining the regulatory category of the product: Category I, Category II, Category III; The user category control includes at least one of the following options for defining the user category of the product: consumer use, professional use; The property control includes at least one of the following options for the property category of the application-defined product: medical device, in vitro diagnostic reagent.

4. The auxiliary method for the transformation of medical device technology achievements according to claim 1, characterized in that: The multiple product feature controls in the defined interface are organized according to a first preset logic tree; The multiple ready process claim item control groups in the ready interface are determined based on the user's operation on the multiple product feature controls and according to the second preset logic tree. The second preset logic tree is used to describe the logical relationship between the product feature controls and the ready process claim item controls. The display definition interface includes: displaying at least one of the plurality of product feature controls; and determining the subsequent product feature controls to be displayed based on the logic tree according to the user's operation on the displayed product feature controls. The display ready interface includes: determining the ready process claim item control group to be displayed based on the second logic tree according to the user's operation on the product feature control.

5. The auxiliary method for the transformation of medical device technology achievements according to claim 1, characterized in that: The approval information control is used to display at least one of the following: guiding principles, product standards, normative documents, and working documents.

6. The auxiliary method for the transformation of medical device technology achievements according to claim 1, characterized in that: The filling template control is used to provide users with a filling template for the technology transfer documents of the specified product at the corresponding technology transfer stage; The review basis control is used to provide users with the review basis for the technology transfer application materials of the specified product at the corresponding technology transfer stage; The teaching controls are used to provide users with instructional videos on filling out the application materials for the commercialization of the specified product at the corresponding stage of commercialization. The claim document control is used to provide users with a channel for uploading claim documents for the technology transfer application materials of the specified product at the corresponding technology transfer stage.

7. The auxiliary method for the transformation of medical device technology achievements according to claim 1, characterized in that, Also includes: When it is determined from the user login information that a user has logged in with a customer account, service personnel account, or administrator account, perform the following operations: The milestone interface displays the status information of the specified product at each stage of the transformation of medical device product technology achievements, wherein: The transformation of the technological achievements of the medical device products includes at least one of the following stages: determining the required information, preparing product information, compiling complete application materials, submitting the application to the institution, and document review and recording. The status information includes at least one of the following: service scope, service start time, first reporting time, and completion time; When the status information at any stage indicates that the service for that stage is completed, users are allowed to download or view the relevant technology transfer application materials for that stage.

8. A medical device technology transfer auxiliary device, characterized in that, The device includes: The login information acquisition module is configured to acquire user login information. The display module is configured to perform the following operations when it is determined from the user's login information that the user is logged in with a customer account or a service personnel account: The definition interface is displayed, which includes multiple definition controls, including a stage control, a product name control, and at least one product feature control. The stage control is used to define the achievement transformation stage of the product, the product name control is used to define the product name, and the product feature control is used to define the corresponding features of the product. Based on the user's operation on the defined control, determine the specified product that the user wants to define and the specified stage in the technology transfer of the specified product. Displays an approval information control related to the specified product at the specified stage; The ready interface is displayed, which includes a group of ready process claim items control for the specified product at each stage of achievement transformation. Each process stage corresponds to one or more review and approval claim item control groups and one or more ready process operation claim item control groups. The ready process operation claim item control groups include: fill-in template control, review basis control, teaching control, claim document control, lock control, not ready to start control, and ready control. The upload module is configured to receive the technology transfer application materials uploaded by the user when the user logs in with a customer account, and display the technology transfer application materials as either not ready to start or ready after the service personnel have reviewed them. In the not ready to start state, the user is allowed to modify or supplement the technology transfer application materials. The review module is configured as follows: when a user logs in with a service personnel account, after the user uploads the application materials for technology transfer, in response to the user's operation on the lock control, the application materials for technology transfer are locked and displayed. The module obtains the user's selection of the not-ready-to-start control or the ready control and displays the not-ready-to-start status or the ready status accordingly. Specifically, when the application materials for technology transfer are approved by the service personnel, the service personnel select the ready control; otherwise, they select the not-ready-to-start control.

9. The apparatus according to claim 8, characterized in that, The device further includes a milestone display module; the milestone display module is configured to perform the following operations when user login information determines that the user is logged in with a customer account or a service personnel account: The milestone interface displays the status information of the specified product at each stage of the transformation of medical device product technology achievements, wherein: The transformation of the technological achievements of the medical device products includes at least one of the following stages: determining the required information, preparing product information, compiling complete application materials, submitting the application to the institution, and document review and recording. The status information includes at least one of the following: service scope, service start time, first reporting time, and completion time; When the status information at any stage indicates that the service for that stage is completed, users are allowed to download or view the relevant technology transfer application materials for that stage.

10. An electronic device, characterized in that, The apparatus comprises any one of claims 8 to 9; or, it comprises a memory and a processor; wherein the memory is used to store one or more computer instructions, wherein the one or more computer instructions are executed by the processor to implement the method of any one of claims 1 to 7.

11. A computer-readable storage medium storing computer instructions thereon, characterized in that, When the computer instructions are executed by the processor, they implement the method of any one of claims 1 to 7.

12. A computer program product, comprising a computer program, characterized in that, When the computer program is executed by a processor, it implements the method of any one of claims 1 to 7.

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