System and method for identifying events in supply chain process

Abstract

A method for identifying events during a supply chain process, comprising: preparing a product during the supply chain process; determining an occurrence of the event during preparation of the product during the supply chain process; and identifying a modification to the supply chain process to inhibit the occurrence of the event during a subsequent preparation of the product in the supply chain process. The event causes a change in the product.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Application No. 63 / 490,380, filed March 15, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] Various aspects of this disclosure relate to systems and methods for identifying the occurrence of events, such as those involving a product, during a supply chain process. More specifically, embodiments of this disclosure relate to systems and methods for detecting the occurrence of an event and determining one or more measurable parameters (e.g., force, pressure, temperature, light intensity, impedance, etc.) experienced by the product at a specific stage of the supply chain process. The product may include equipment or apparatus, such as a medical device. The supply chain process may include one or more stages, such as the manufacturing, assembly, testing, sterilization, packaging, and / or transportation of the product.

[0004] The systems and methods of this disclosure can identify specific stages during a supply chain process, such as one or more cycles and / or points in time in which events occur. An event can be an indication of an error or failure in the supply chain process, during which a product may become structurally damaged or render unusable. The source of an event can be attributed to various features or sources within the supply chain process, such as instruments and / or tools used to prepare and / or manage the product during the specific stage in which the event occurs. By identifying the stages of the supply chain process in which events occur, the systems and methods of this disclosure can identify modifications to one or more features or sources associated with the specific stage of the supply chain process to mitigate the future occurrence of the event. Background Technology

[0005] The preparation and / or management of a product during the supply chain process may involve the manufacture, assembly, testing, sterilization, packaging, and / or delivery of products in various arrangements, locations, configurations, and / or locations (e.g., medical devices, such as syringes storing fluid substances). In some cases, parameters such as loads (e.g., forces) may be unintentionally applied to the product by one or more sources (such as manufacturing instruments) associated with the supply chain process. Applying this parameter may result in unintended modifications and / or damage to the product. In the case of a medical device, and more particularly a syringe, such modifications and / or damage may lead to premature failure of the syringe and / or inaccurate use of the syringe by the user. In other cases, human error in handling, controlling, positioning, and / or delivering products (e.g., syringes) during stages of the supply chain process may similarly require the application of parameters that may affect the structural integrity of the product.

[0006] Before a dose is administered to a user using a syringe, the occurrence of parameters to be applied to the syringe (e.g., load) (i.e., events) may cause health and safety problems for the user (e.g., the patient). For example, syringe load may result in needle misalignment, accidental release of at least some of the fluid material stored in the syringe, etc., rendering the syringe unusable for the user. Summary of the Invention

[0007] This document discloses systems and methods for identifying events during the supply chain process of a product, and particularly for medical devices such as syringes storing fluid substances, where the events cause damage to the product. In one embodiment of this disclosure, a method for identifying events during the supply chain process includes: preparing the product during the supply chain process; determining, during the supply chain process, the occurrence of an event during the preparation of the product, wherein the event causes changes to the product and / or at least partially damages the product; and identifying modifications to the supply chain process to suppress the occurrence of the event during subsequent preparation of the product. Attached Figure Description

[0008] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the specification, serve to explain the principles of the disclosed embodiments. The drawings illustrate different aspects of this disclosure, and reference numerals illustrating similar structures, components, materials, and / or elements in different figures are similarly labeled where appropriate. It should be understood that various combinations of structures, components, and / or elements in various embodiments other than those specifically shown are to be considered within the scope of this disclosure.

[0009] Figure 1 An exploded front view depicting an exemplary product including a medical device according to aspects of this disclosure.

[0010] Figure 2 Describing aspects according to this disclosure Figure 1 A schematic diagram of an exemplary supply chain process for the product.

[0011] Figure 3 A flowchart depicting an exemplary method according to aspects of this disclosure, for use in Figure 2 Identify the impact during the supply chain process Figure 1 The incident involving the product.

[0012] Figure 4 Describing aspects according to this disclosure Figure 2 A schematic diagram of an exemplary manufacturing stage of the supply chain process.

[0013] This document describes and illustrates numerous embodiments. This disclosure is neither limited to any single aspect or embodiment thereof, nor to any combination and / or arrangement of such aspects and / or embodiments. Each aspect of this disclosure and / or embodiment thereof may be employed individually or in combination with one or more other aspects of this disclosure and / or embodiments thereof. For the sake of brevity, the numerous combinations and arrangements are not discussed separately herein. Detailed Implementation

[0014] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” or any other variation thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but may also include other elements not expressly listed or inherent to the process, method, article, or apparatus. The term “exemplary” means, in a sense, “example” rather than “exemplary.” It is important to note that embodiments or implementations described herein as “exemplary” or “exemplary” should not be construed as preferred or advantageous, for example, relative to other embodiments or implementations; rather, they are intended to reflect or indicate that an embodiment is “exemplary” rather than “exemplary.” Furthermore, the terms “first,” “second,” etc., used herein do not indicate any order, quantity, or importance, but are used to distinguish an element, structure, step, or process from another element, structure, step, or process. Moreover, the terms “a” and “an” herein do not indicate a limitation of quantity but rather the presence of one or more referenced items. Additionally, unless otherwise specified, the terms “about,” “approximately,” “basically,” etc., when used to describe numerical values, indicate a variation of + / - 10% of the value.

[0015] The embodiments of this disclosure can be used in any type of product, including fluid-containing products that can be dispensed in a dose-dependent form, such as liquid pharmaceutical substances, liquid placebos, or other liquids (or liquid solutions). As used herein, the term "substance" may mean a formulation comprising one or more active ingredients. In some embodiments, the systems and aspects of this disclosure can be used to manufacture devices and / or apparatuses for use with any therapy that uses the immune system to fight disease, such as immunotherapy including vaccines, allergy treatments, cancer treatments, etc. In particular, the systems and aspects of this disclosure can be used to manufacture devices and / or apparatuses for treating patients with cancer (e.g., immuno-oncology). However, embodiments of this disclosure are also contemplated for application to any other treatment, liquid product, and / or device and / or apparatus for any other context in which one or more substances can be stored. While medical indications are described herein, non-medical devices and / or apparatuses are contemplated for use in conjunction with the systems and methods described herein. It should be understood that embodiments of this disclosure can be used with devices and / or apparatuses that do not contain any liquid substances.

[0016] As used herein, the terms “distal” and “distally” mean a location (or part of the device) relatively close to or in the direction of the drug delivery end of the device, and the terms “proximal” and “proximally” mean a location (or part of the device) relatively close to or in the direction of the device end opposite to the distal end. As used herein, when referring to a part of a product, the term “component” may mean a feature of the product suitable for use in serving any purpose of the product. In examples where the product may include a medical device, a component may include a body, such as a barrel (e.g., a syringe barrel), a tube, a cylinder, or another part of a device capable of storing a fluid substance. In some embodiments, the body may also include a distal end portion having a nozzle, a needle, a needle attachment point, and / or a distal cap.

[0017] This document describes exemplary embodiments of products, such as devices, and in particular medical devices, such as autoinjectors including syringes. In some cases, embodiments or aspects of embodiments disclosed herein can be used with medical devices that include other types of fluid-containing products, such as, but not limited to, vials, cartridges, and / or other suitable devices. In further cases, embodiments or aspects of embodiments disclosed herein can be used with a variety of other suitable products (e.g., devices and / or apparatuses). Such systems and methods can help identify sources of human or automated equipment error in supply chain processes and / or improve the accuracy and efficiency of supply chain processes by recognizing events that occur during one or more stages of the supply chain process (e.g., product manufacturing, assembly, testing, sterilization, packaging, labeling / marking, storage, shipping, sales, and / or delivery processes).

[0018] Now for reference Figure 1 This describes an exemplary product 10. It should be understood that product 10 may include various articles of manufacture, including but not limited to devices, tools, machines, instruments, mechanisms, appliances, accessories, equipment, or other various forms of equipment. By way of example only, product 10 may include a medical device (e.g., an autoinjector) comprising multiple components, such as a first component 12, a second component 14, and a third component 16. The first component 12 may include a cap configured to selectively couple with the third component 16 to enclose one or more contents therein. The second component 14 may include a container configured to store a fluid substance such as a drug (e.g., a pharmaceutical product). In some embodiments, the container of the second component 14 may include, but is not limited to, a syringe, a barrel, a vial, a cartridge, a tube, etc.

[0019] The third component 16 may include a housing, sized, shaped, and / or otherwise configured to at least partially house one or more of the first component 12 and the second component 14. In other words, the third component 16 may define the outer body of the product 10 for storing the inner components of the product 10, such as the first component 12 and the second component 14. Each of the first component 12, the second component 14, and the third component 16 may be formed of a variety of suitable materials, including but not limited to glass, plastic, etc. It should be understood that the product 10 (e.g., an autoinjector) may include additional and / or fewer components than those shown and described herein, including but not limited to needles, plungers, biasing mechanisms, etc. Alternatively, the first component 12, the second component 14, and / or the third component 16 of the product 10 may include a variety of other shapes, sizes, arrangements, or configurations other than those shown and described herein, without departing from the scope of this disclosure. In some embodiments, the product 10 may omit one or more of the first component 12, the second component 14, and the third component 16 entirely.

[0020] Still referencing Figure 1 The sensing device 18 may be coupled to product 10, and in particular to one or more of the first component 12, the second component 14, and / or the third component 16. It should be understood that the sensing device 18 may be selectively coupled to product 10 such that the sensing device 18 is not a component of product 10. In other words, according to various aspects of this disclosure, for the purpose of identifying the occurrence of events during the supply chain process of product 10, the sensing device 18 may be removably attached to product 10 such that the sensing device 18 is not a common feature part of product 10. Furthermore, although only a single sensing device 18 is described, those skilled in the art will understand that any suitable number of sensing devices 18 may be provided within the scope of this disclosure. For example, two, three, four, or any suitable number of sensing devices may be provided according to the scope of this disclosure.

[0021] In this example, the sensing device 18 may be coupled to and / or inserted within the second component 14. In other examples, the sensing device 18 may be positioned on and / or inside the first component 12 and / or the third component 16 in place of the second component 14. It should be understood that including the sensing device 18 in the product 10 enables the product 10 to be a “test” or “experimental” version of the product 10 for implementing the methods described further in detail herein (see reference). Figure 3 In other embodiments, the sensing device 18 may be a common feature of product 10.

[0022] Sensing device 18 may be configured to detect and / or measure one or more parameters indicating the characteristics and / or measurable parameters experienced by product 10. For example, sensing device 18 may include a force sensor configured to detect and / or measure a force load applied to product 10. In another example, sensing device 18 may include an accelerometer configured to detect and / or measure acceleration, agitation, spin, and / or vibration of product 10. By a further example, sensing device 18 may include a gyroscope configured to detect and measure the angular velocity of product 10. In other examples, sensing device 18 may include a temperature probe, a pressure (e.g., piezoelectric) sensor, a fluid sensor, a vaporized hydrogen peroxide (VHP) sensor, a luminance meter (light) sensor, a photodetector, a chemical (biological) sensor / indicator, etc. It should be understood that sensing device 18 may be configured to detect and / or measure a variety of other suitable parameters (e.g., rotation, tilt, compression, etc.) besides those described herein without departing from the scope of this disclosure.

[0023] Still referencing Figure 1 The sensing device 18 may include a plurality of sensors disposed on one or more components of the product 10, each of which is configured to detect and measure the same or different parameters. For example, the sensing device 18 may include a sensor array of approximately 16 to 32 sensors that may be coupled to one or more components of the product 10. In other embodiments, a single sensing device 18 may be configured and operable to detect and measure more than two parameters.

[0024] While product 10 is shown and described herein as a medical device, and in particular an autoinjector having a specific configuration and arrangement of assembled components, it should be understood that product 10 may include a variety of other medical devices, medical packaging, or non-medical devices, such that the systems and methods described herein are not limited to autoinjectors. Other exemplary medical products may include, by way of illustrative example only, suppository applicators and medications, transdermal drug delivery devices, medical implants, needles, cannulas, medical instruments, blister packs, boxes, etc.

[0025] Still referencing Figure 1As described in detail herein, sensing device 18 can be operable to measure parameters experienced by product 10 from one or more sources (e.g., objects, surfaces, etc.) in its surrounding environment during the supply chain process of product 10. These parameters may cause corresponding defects or damage to product 10 and may originate from one or more sources that interact with product 10 during its preparation and / or management in the supply chain process. In some embodiments, sensing device 18 can be operable to communicate with one or more remote systems or computers via various suitable communication protocols. For example, sensing device 18 can be operable to communicate with a remote system or computer (not shown) via a network, which may be implemented as a wireless network (e.g., Wi-Fi), a wired network (e.g., Ethernet), a local area network (LAN), a wide area network (WAN), Bluetooth, near field communication (NFC), cellular satellite, or any other type of network capable of providing communication between sensing device 18 and the remote system.

[0026] A remote system or computer may be configured and operable to perform the methods shown and described herein according to this disclosure (such as... Figure 3 The method 200) includes one or more steps. Although not shown, it should be understood that the remote system may include one or more computer hardware platforms having a central processing unit (“CPU”) in the form of one or more processors for executing computer-readable instructions according to exemplary embodiments of the present disclosure. The one or more computer hardware platforms may also include data storage devices for various data files (such as data from sensing device 18) to be processed and / or communicated.

[0027] Now for reference Figure 2 This document describes an exemplary supply chain process 100 for product 10. Supply chain process 100 (hereinafter “process 100”) may include one or more stages or sub-processes as shown and described herein. It should be understood that the stages of process 100 are merely illustrative and therefore may include additional and / or fewer stages without departing from the scope of this disclosure. Furthermore, some stages of process 100 may be omitted, combined, and / or performed in a different order than shown and described herein, while remaining consistent with this disclosure.

[0028] In the example, process 100 may include multiple stages, such as a first stage 110, involving receiving source materials for producing product 10; a second stage 120, involving the manufacture and / or assembly of product 10; a third stage 130, involving quality control testing (or other forms of testing) of product 10; a fourth stage 140, involving sterilization or cleaning of product 10; a fifth stage 150, involving packaging and / or labeling of product 10; a sixth stage 160, involving storage of product 10; a seventh stage 170, involving shipment of product 10; an eighth stage 180, involving sales of product 10; and a ninth stage 190, involving delivery of product 10, such as delivery to an end user.

[0029] For example, the first stage 110 may include a process in which a supplier receives source materials for one or more of the first component 12, second component 14, and third component 16 to produce product 10. The second stage 120 may include a process of manufacturing the first component 12, second component 14, third component 16 and / or sensing device 18 and / or assembling product 10. In embodiments where product 10 includes a syringe containing a fluid substance, the second stage 120 may involve a process of filling the syringe with the fluid substance. The third stage 130 may include processes such as testing the assembled product 10 from a quality control standpoint to evaluate the proper assembly and operation of product 10. It should be understood that the third stage 130 may involve testing product 10 to a degree suitable for use with and / or in accordance with applicable standards and / or protocols associated with the product type.

[0030] Phase 4 140 may include a process of sterilizing product 10 via a sterilization method. In some embodiments, Phase 4 140 may involve final sterilizing product 10 using a sterilization method employing chemicals (e.g., vaporized hydrogen peroxide (VHP), ethylene oxide, nitrogen dioxide, etc.) to remove contaminants and other biological agents present on product 10. For example, Phase 4 140 may include positioning product 10 in a sterilization chamber configured to operate a sterilization cycle at predetermined temperature and pressure, and supplying sterilizing chemicals to the sterilization chamber at an adjustable concentration during the cycle. It should be understood that the term “sterilization” means achieving a degree of sterility suitable for use with product 10. In the example of product 10, which includes an autoinjector storing a prepared pharmaceutical substance, Phase 4 140 may include suitable sterilization techniques for commercial distribution and use in medical devices. It should be understood that Phase 4 140 may involve cleaning product 10 to a degree suitable for use and / or in accordance with applicable standards and / or protocols associated with the product type.

[0031] Still referencing Figure 2Phase 5, 150 may include processes for packaging product 10. For example, product 10 may be packaged in a protective container, such as a blister pack, configured to contain product 10. Additionally and / or alternatively, phase 5, 150 may include processes for labeling / marking product 10 or packaging product 10. Phase 6, 160 may include processes such as storing product 10 upon completion of the aforementioned manufacturing, testing, sterilization, and packaging processes. Product 10 may be stored isolated or with multiple other products, such as in containers suitable for shipping the product to retailers for sale. In phase 7, 170, product 10 may be shipped to one or more locations for sale through distributors. Product 10 may be shipped via various suitable means of transport (e.g., air, land, sea, etc.), and upon arrival at its destination, product 10 may be sold to the end user (e.g., a consumer) in phase 8, 180, and subsequently delivered to the end user in phase 9, 190.

[0032] It should be understood that Product 10 may interact with various and / or numerous objects, surfaces, or people during each of the multiple stages of Process 100. It should be understood that the term "interaction" may include any physical, chemical, or other contact or exposure (direct or indirect) with Product 10. For example, during one or more of the multiple stages of Process 100, one or more of the multiple components of Product 10 may interact with... Figure 1 Physically manipulate, control, position, and / or manipulate to different configurations and / or arrangements relative to each other or the surrounding environment. Further, for example, during multiple stages of process 100, components of product 10 may be exposed to various elements without physical contact, such as light (or lack thereof), heat (or lack thereof), fluids (e.g., air, water, gas), etc.

[0033] One or more stages of process 100 may involve the interaction of product 10 (and particularly one or more of first component 12, second component 14, or third component 16) with an object responsible for performing operations associated with the manufacturing, quality control testing, sterilization, packaging, storage, shipment, sale, and / or delivery of product 10. The object may include, but is not limited to, one or more surfaces, tools, components, machinery, equipment, instrumentation systems, etc. In some embodiments, the object may be controlled remotely via automated operation, such as via a computer. In other embodiments, the object may be manually controlled and operated by personnel within process 100.

[0034] For example, product 10 may interact with one or more persons (e.g., humans) during one or more of the multiple stages of process 100, such as persons responsible for performing operations associated with the manufacture, quality control testing, sterilization, packaging, storage, shipment, sale, or transportation of product 10. It should be understood that various other elements, factors, or influences may be present in process 100 and involve one or more of the following: the manufacture, quality control testing, sterilization, packaging, storage, shipment, sale, and transportation of product 10. That is, without departing from the scope of this disclosure, product 10 may have additional and / or alternative interactions with its surrounding environment during process 100 that differ from those described herein.

[0035] In any case, the interaction between product 10 and an object, person, or other factor can cause an event to occur during which product 10 may experience or encounter parameters (e.g., force, pressure, temperature, light intensity, impedance, etc.) at a specific stage of process 100. In other words, during one or more stages of process 100, the interaction between product 10 and its surrounding environment can involve an event in which at least one component of product 10 undergoes a change (and / or creation) in parameters sufficient to cause potential damage to product 10 (e.g., structural, mechanical, chemical, etc.). As described herein, sensing device 18 may be configured to detect and / or measure the change and / or creation of parameters on product 10 when an event occurs at a specific stage of process 100.

[0036] Figure 3 A flowchart depicts an exemplary method 200 for identifying the occurrence of an event during a supply chain process leading to a product, according to this disclosure. It should be understood that the steps of method 200 are described herein in the context of computer-executable instructions that can be executed or implemented by a remote computing system, such as one or more remote systems or computers communicating with sensing device 18.

[0037] At step 202, the preparation and / or management of a product, such as product 10, can be carried out in the current stage of the supply chain process, such as process 100. In other words, it can be carried out according to any of the multiple stages of process 100 shown and described above in step 202. Figure 2 The associated operations are used to prepare and / or manage the product 10.

[0038] By way of example only, the current stage of process 100 in step 202 may include the manufacturing process of product 10 in the second stage 120 described above. For illustrative purposes, as Figure 4As seen herein, a manufacturing environment 20 for the second stage 120 is described, wherein environment 20 may include multiple pieces of equipment positioned at various locations along assembly line 30. For example, environment 20 may include a first manufacturing instrument 22 positioned at a first location 32 adjacent to assembly line 30, a second manufacturing instrument 24 positioned at a second location 34 adjacent to assembly line 30, a third manufacturing instrument 26 positioned at a third location 36 adjacent to assembly line 30, and a fourth manufacturing instrument 28 positioned at a fourth location 38 adjacent to assembly line 30. Although a specific number and arrangement of equipment has been shown and described herein with respect to the second stage 120, it should be understood that manufacturing environment 20 is merely illustrative, and therefore additional and / or fewer instruments (or other types of equipment) may be included in the second stage 120 of process 100 and other suitable configurations without departing from the scope of this disclosure.

[0039] In this example, each instrument in manufacturing environment 20 may be configured and operable to perform one or more operations for manufacturing product 10 at a corresponding location on assembly line 30. During the second phase 120, product 10 (and in particular one or more of the first component 12, the second component 14, and the third component 16) may interact with various objects (e.g., the first manufacturing instrument 22, the second manufacturing instrument 24, the third manufacturing instrument 26, and the fourth manufacturing instrument 28) and / or surfaces (e.g., a portion of assembly line 30 along the first location 32, the second location 34, the third location 36, and the fourth location 38). Although not shown, it should be understood that manufacturing environment 20 may include various other elements or factors (e.g., light, temperature, fluid, etc.) that may interact with product 10 during the manufacturing process of the second phase 120.

[0040] Return to reference Figure 3 In step 204, it is determined whether an event has occurred, such as as detected by sensing device 18, at the current stage of process 100. As described in detail above, an event can be defined at the current stage of process 100 by the interaction (e.g., physical or chemical) between product 10 and its surrounding environment, such as with objects, people, or other factors. The occurrence of an event may cause a change in parameters (and / or creations) applied to product 10 detected by sensing device 18. That is, the occurrence of an event may cause a change in the characteristics of product 10 detected by sensing device 18. The parameters may reach a range or extent sufficient to cause a change in product 10 and / or at least partially damage the product, such as by causing a defect or (structural) damage to one or more parts of product 10.

[0041] In response to the determination in step 204 that no event has occurred during the current stage of process 100, method 200 may proceed to step 206, whereby product 10 continues to the next stage of process 100. In this case, given that the current stage of process 100 has been performed and completed without an event, method 200 may return to step 202, during which the continued preparation and / or management of product 10 may be performed according to the corresponding operations for the next stage of process 100. Alternatively, in response to the determination in step 204 that an event has indeed occurred during the current stage of process 100, as detected by sensing device 18, data associated with this event may be transmitted by product 10 (and specifically via sensing device 18) to one or more remote systems or computers (e.g., processors) in step 208.

[0042] The transmitted data may include a variety of information, such as, but not limited to, sensor data indicating the parameters detected by sensing device 18. In some embodiments, the sensor data may include a corresponding time period during the current stage of the parameter detection process 100. In other embodiments, the sensor data may include corresponding identification of the components of product 10 receiving the parameters (e.g., first component 12, second component 14, third component 16). This is only an illustrative example; see references below. Figure 4 This event may include physical manipulation (e.g., grasping) of the product 10 via a fourth manufacturing instrument 28 when the product 10 is positioned at a fourth location 38 adjacent to the assembly line 30 in the manufacturing environment 20. While grasping the product 10, the sensing device 18 may detect the force applied to the second component 14 via the fourth manufacturing instrument 28 (see image). Figure 1 The load (i.e., parameters) of ).

[0043] refer to Figure 3 In step 210, the origin or cause of the event can be determined, for example, based on sensor data detected and transmitted by sensing device 18. In an example, the origin or cause of the event (e.g., physical manipulation of product 10) could be determined as the positioning of a fourth manufacturing instrument 28 adjacent to a fourth location 38 along assembly line 30. In step 212, the relative value or extent of a parameter (e.g., load) applied to product 10 can be determined, for example, based on sensor data detected and transmitted by sensing device 18. Figure 4 In the illustrative example, the parameter value applied to product 10 by the fourth manufacturing instrument 28 may be approximately 2 Newtons (N). In other examples, the value of the parameter may be greater than or less than 2N, or may be measured by various other suitable units of measurement.

[0044] It should be understood that in step 204, multiple events may be detected during the current phase of process 100, and / or multiple parameters may be applied to product 10 during a single event, such that the sensor data transmitted at step 208 may include data indicating one or more events and / or parameters detected during the current phase. In this case, method 200 may include separately determining the source of each event (in step 210) and the value or extent of each parameter (in step 212) for each of the one or more events and / or parameters detected during the current phase of process 100.

[0045] In step 214, the parameter determined in step 212 may be compared with a threshold. In some embodiments, this threshold may be predetermined and stored in, for example, one or more remote systems. In other embodiments, the threshold may be user-defined and received via, for example, one or more remote systems, such as through user input. The threshold may define the maximum (acceptable) value or extent of the parameter determined in step 212 without modifying process 100 for the purpose of suppressing further occurrence of the event detected in step 204. Alternatively, the threshold may define the maximum value or extent of the parameter without modifying process 100 for the purpose of minimizing further application of the parameter to product 10 during subsequent occurrence of the event. In this case, although the event continues to occur during further process 100, the parameter experienced by product 10 during this event can be minimized. The value or extent of the parameter exceeding this threshold may indicate a rejection parameter sufficient to cause product change and / or at least partially damage product 10 in some form, such as changes in product structure, changes in product function, changes in the sterility level of the product, changes in the level of liquid stored in the product, etc.

[0046] For example, a threshold can define the maximum value or extent of a parameter corresponding to the condition that product 10 does not suffer damage or defects (e.g., physical, functional, aesthetic, operational, etc.), even though this event occurs in step 204. In this case, a parameter determined to exceed this threshold may indicate that the product has experienced (or has an increased likelihood of experiencing) some form of damage or defect, while a parameter not exceeding this threshold may indicate that the product has not experienced (or has no increased likelihood of experiencing) damage or defects.

[0047] In other words, the value or degree of the parameter determined in step 212 may be less than the minimum value or degree required to cause a change or damage (e.g., defect or damage) to product 10, such that the minimum value or degree is approximately less than (or equal to) this threshold. Alternatively, the parameter determined in step 212 may be sufficient to cause a change or to make product 10 at least partially damaged, defective, damaged, unsterilized, and / or unusable for its intended purpose, such that the value or degree of the determined parameter is greater than (or equal to) this threshold.

[0048] In an example where product 10 may include a medical device, such as a syringe or autoinjector having one or more of a needle, plunger, and / or a cylinder in which a fluid substance is stored, applying parameters to the medical device beyond a threshold can cause unintentional movement of the components. For example, applying parameters beyond this threshold could involve deflecting the needle and rendering the medical device unusable by a user (e.g., a patient), moving the plunger and causing premature release of the stored fluid substance, or damaging the cylinder and causing leakage of the stored fluid substance. As a further example, applying parameters beyond this threshold could involve exposing the cylinder to excessive vibration, shock, light, and / or heat, thereby physically and / or chemically altering the properties of the fluid substance stored therein.

[0049] In some implementations, at least one threshold may be defined and / or predetermined for multiple parameters (e.g., force, pressure, temperature, light intensity, liquid level, impedance, etc.) that the product 10 may experience in process 100. Accordingly, an applicable threshold corresponding to the parameter type (from multiple parameters) determined in step 212 may be identified and compared in step 214. It should be understood that this threshold may include a value or degree corresponding to a unit of measurement of the associated parameter.

[0050] Still referencing Figure 3 In step 216, it can be determined whether the value or degree of the parameter exceeds a threshold. In response to determining in step 216 that the parameter does not exceed the threshold, method 200 can transition to step 206, where product 10 can continue to the next stage of process 100. In this case, assuming the value or degree of the parameter is insufficient to cause the resulting damage or defect to product 10, method 200 can return to step 202, during which product 10 can be prepared and / or managed according to the corresponding operation of the next stage of process 100. Alternatively, in response to determining in step 216 that the parameter does exceed the threshold, one or more proposed modifications to the current stage of process 100, such as via one or more remote systems, can be identified in step 218.

[0051] One or more of the proposed modifications identified in step 218 may address human or automated equipment errors involved in process 100 at the current stage. For example, one or more remote systems may be configured and operable to identify potential modifications to the location, place, operation, and / or various other characteristics of the origin of an event, to suppress further occurrence of the event (detected in step 204) and / or minimize the value or extent of parameters experienced by other products 10 during the current stage of process 100 (determined in step 212). Reference Figure 4 As an illustrative example, the remote system may be configured to identify modifications to one or more characteristics of the fourth manufacturing instrument 28, which are determined to be the source of the event in step 210.

[0052] In another example, one or more remote systems may be configured and operable to identify potential modifications to objects other than the event source that could directly and / or indirectly affect the occurrence of the event. (Reference) Figure 4 As an illustrative example, the remote system may be configured to recognize modifications to one or more of the first manufacturing instrument 22, the second manufacturing instrument 24, the third manufacturing instrument 26, the assembly line 30, and / or one or more other surfaces, tools, components, machinery, equipment, instruments, systems, etc.

[0053] As described in detail above, one or more objects responsible for performing operations associated with the current stage of process 100 (e.g., manufacturing, quality control testing, sterilization, packaging, storage, shipping, sales, and / or delivery) can be controlled by automated operation (e.g., by a computer). In this case, the potential modifications identified in step 218 may include adjustments to the automated control of the objects, such as by modifying computer-executable instructions and / or programmable computer program code operable to automate the operation of the objects. In embodiments where the objects can be manually operated by personnel of process 100, the potential modifications identified in step 218 may be communicated to users and / or personnel for implementation.

[0054] Still referencing Figure 3 Method 200 may include step 220, in which modifications identified in step 218 for the current stage of process 100 may be communicated to the user, such as for approval or rejection (e.g., via user input from one or more remote systems). In other embodiments, one or more remote systems may be configured and operable to automatically implement one or more modifications in step 220. When modifications for the current stage of process 100 are communicated and / or implemented in step 220, method 200 may return to step 202, during which product 10 may be prepared and / or managed according to the corresponding actions for the next stage of process 100.

[0055] It should be understood that the general discussion of this disclosure provides a brief, general description of a suitable computing environment in which this disclosure may be implemented. In one embodiment, any of the disclosed systems and / or methods may be performed or implemented by a computing system (e.g., one or more remote systems) consistent with or similar to those explained in this disclosure. Although not essential, aspects of this disclosure are described in the context of computer-executable instructions, such as subroutines executed by data processing apparatus, such as computer hardware platforms, wireless devices, and / or personal computers. Those skilled in the art will appreciate that aspects of this disclosure may be practiced with other communication, data processing, or computer system configurations. In practice, the terms “computer,” “processor,” “remote system,” etc., are generally used interchangeably herein and refer to any of the aforementioned apparatuses and systems as well as any data processor.

[0056] Various aspects of this disclosure may be embodied in a dedicated computer and / or data processor, which is specifically programmed, configured, and / or constructed to perform one or more computer-executable instructions as detailed herein. While aspects of this disclosure, such as certain steps of method 200, are described as being performed specifically on a single device or system, this disclosure can also be practiced in a distributed environment where functionality or modules are shared among different processing devices linked via a communication network. Similarly, techniques presented herein involving multiple devices can be implemented in a single device. In a distributed computing environment, program modules may reside in both local and / or remote memory storage devices.

[0057] Various aspects of this disclosure may be stored and / or distributed on a non-transient computer-readable medium. Alternatively, computer-implemented instructions, data structures, screen displays, and other data according to various aspects of this disclosure may be distributed on the Internet and / or other networks (including wireless networks). The program aspects of this technology can be considered as manufactured “products” or “articles of art” typically in the form of executable code and / or associated data carried or embodied in a type of machine-readable medium. “Storage” type media includes any or all tangible memory or associated modules of a computer, processor, etc., which can provide non-transient storage for software programming at any time. As used herein, unless limited to non-transient, tangible “storage” media, the term such as computer “readable medium” means any medium involved in providing instructions to a processor for execution.

[0058] While some embodiments are presented herein, numerous variations of such embodiments and combinations of elements from one or more embodiments are possible and contemplated within the scope of this disclosure. Furthermore, those skilled in the art will appreciate that the concepts upon which this disclosure is based can be readily used as the basis for designing other apparatuses, methods, and systems for carrying out some of the purposes of this disclosure.

[0059] The embodiments of this disclosure may include the following features:

[0060] Project 1. A method for identifying events during a supply chain process, comprising: preparing a product during the supply chain process; determining the occurrence of an event during the preparation of the product during the supply chain process, wherein the event causes a change in the product; and identifying modifications to the supply chain process to suppress the occurrence of the event during subsequent preparation of the product in the supply chain process.

[0061] Project 2. The method of Project 1 further includes: identifying the source of the event in the supply chain process, wherein identifying the modification includes identifying adjustments to the operation of the source.

[0062] Item 3. The method as described in Item 2, wherein, prior to identifying this modification, the method includes: determining a parameter applied to the product during the event by a source, which causes damage to the product.

[0063] Item 4. The method as described in Item 3, wherein the product includes a sensing device configured to detect parameters applied to the product during the occurrence of an event.

[0064] Item 5. The method as described in Item 4, wherein, prior to identifying this modification, the method includes: transmitting parameters to a remote processor communicatively coupled to the sensing device, wherein the remote processor is configured to determine the value of the parameters.

[0065] Item 6. The method as described in Item 5, wherein before identifying the modification, the method includes: comparing the value of the parameter with a threshold; and identifying the modification in response to the value of the parameter exceeding the threshold, and abandoning the identification of the modification in response to the value of the parameter not exceeding the threshold.

[0066] Item 7. The method as described in Item 3, wherein the parameters include temperature, pressure, force, speed, light intensity, liquid level, impedance, compression, tilting, or rotation experienced by the product during the event.

[0067] Item 8. The method as described in Item 4, wherein the sensing device includes an accelerometer, a gyroscope sensor, a temperature probe, a pressure sensor, a liquid level sensor, a vaporized hydrogen peroxide (VHP) sensor, a luminance meter (light) sensor, a photodetector, or a chemical (biological) sensor.

[0068] Item 9. The method as described in Item 2, wherein: the product includes apparatus, tools, machines, instruments, mechanisms, appliances, gadgets or equipment; and the source includes surfaces, tools, components, machinery, equipment, instruments or systems responsible for performing operations in the supply chain process to produce the product.

[0069] Item 10. The method of Item 9, wherein the product includes a medical device and the source includes automated instruments for manufacturing the medical device, such that identifying modifications to the supply chain process includes adjustments to computer-executable instructions defining the operation of the automated instruments.

[0070] Item 11. The method as described in Item 10, wherein the medical device includes an autoinjector or a syringe.

[0071] Item 12. The method of Item 9, wherein the preparation of a product during the supply chain process includes one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling or conveying the product.

[0072] Item 13. The method of Item 2, wherein the event is a first event occurring during a first stage of the supply chain process for preparing the product, and the source causing the event is a first source in the supply chain process for preparing the product in the first stage.

[0073] Item 14. The method of Item 13 further comprises: determining, during a second phase of the supply chain process, the occurrence of a second event during the preparation of the product, wherein the second phase differs from the first phase of the supply chain process; and determining a second source in the supply chain process that causes the occurrence of the second event, wherein the second source differs from the first source.

[0074] Item 15. The method of Item 14 further comprises: identifying a second modification to the supply chain process to suppress the occurrence of a second event during subsequent preparation of the product in the supply chain process.

[0075] Item 16. The method as described in Item 1, wherein the change includes a change in the structure of the product, a change in the sterility level of the product, or a change in the liquid level of the liquid stored in the product.

[0076] Item 17. A method for reducing the occurrence of events during a supply chain process, comprising: preparing a product during the supply chain process; determining the occurrence of an event during the preparation of the product in the supply chain process, wherein the event causes a change to the product; and determining a modification to the supply chain process that reduces the occurrence of events in the supply chain process during subsequent preparation of the product, thereby reducing the occurrence of changes to the product.

[0077] Item 18. The method of Item 17, wherein prior to determining the modification, the method comprises: determining that a source responsible for preparing the product in the supply chain process is causing the event to occur; determining a parameter applied to the product by the source during the occurrence of the event; comparing a value of the parameter to a threshold; and determining the modification in response to the value of the parameter exceeding the threshold, and abandoning the determination of the modification in response to the value of the parameter not exceeding the threshold.

[0078] Item 19. The method of Item 18, wherein the product includes apparatus, tools, machines, instruments, mechanisms, appliances, gadgets or equipment; wherein the source includes surfaces, tools, components, machinery, equipment, instruments or systems responsible for performing operations in the supply chain process to produce the product; and wherein parameters include temperature, pressure, force, speed, light intensity, liquid level, impedance, compression, tilt or rotation experienced by the product during an event.

[0079] Item 20. The method of Item 17, wherein the preparation of a product during the supply chain process includes one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling or conveying the product.

[0080] Item 21. The method as described in Item 17, wherein changes to the product include structural changes, changes in sterility levels, or changes in the level of liquids stored in the product.

[0081] Item 22. A method for identifying events that cause product changes during a supply chain process, comprising: preparing a product during the supply chain process; identifying events that occur when the product is prepared in the supply chain process, causing the product to undergo changes due to the events; and identifying modifications to the supply chain process that suppress changes to the product during preparation by reducing the occurrence of events in the supply chain process.

[0082] Item 23. The method as described in Item 22, wherein before identifying the modification, the method includes: determining the source of the event and a parameter applied to the product by the source that causes a change to the product; comparing the parameter to a threshold; and identifying the modification when the parameter exceeds the threshold, and abandoning the identification of the modification when the parameter does not exceed the threshold.

[0083] Item 24. The method of Item 22, wherein the preparation of a product during the supply chain process includes one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling or conveying the product; and wherein the source includes surfaces, tools, components, machinery, equipment, instruments or systems used in the supply chain process for the preparation of the product.

[0084] Item 25. The method as described in Item 22, wherein changes to the product include structural changes, changes in sterility levels, or changes in the level of liquids stored in the product.

[0085] Other embodiments of the invention disclosed herein will be apparent to those skilled in the art upon consideration of the specification and practice thereof. The specification and examples are intended to be illustrative only, so that the true scope and spirit of the invention are indicated by the appended claims.

Claims

1. A method for identifying events during a supply chain process, comprising: The product is prepared during the supply chain process; During the supply chain process, the occurrence of the event during the preparation of the product is determined, wherein the event causes a change in the product; and Identify modifications to the supply chain process to suppress the occurrence of the event during subsequent preparation of the product within the supply chain process.

2. The method of claim 1, further comprising: Determine the source of the occurrence of the event in the supply chain process, wherein identifying the modification includes identifying adjustments to the operation of the source.

3. The method of claim 2, wherein before identifying the modification, the method comprises: The parameters applied to the product during the event by the source were identified, and the parameters caused damage to the product.

4. The method of claim 3, wherein the product includes a sensing device configured to detect the parameter applied to the product during the occurrence of the event.

5. The method of claim 4, wherein before identifying the modification, the method comprises: The parameter is transmitted to a remote processor communicatively coupled to the sensing device, wherein the remote processor is configured to determine the value of the parameter.

6. The method of claim 5, wherein before identifying the modification, the method comprises: The value of the parameter is compared with a threshold; and The modification is identified in response to the value of the parameter exceeding the threshold, and the identification of the modification is abandoned in response to the value of the parameter not exceeding the threshold.

7. The method of claim 3, wherein the parameters include temperature, pressure, force, speed, light intensity, liquid level, impedance, compression, tilting, or rotation experienced by the product during the event.

8. The method of claim 4, wherein the sensing device comprises an accelerometer, a gyroscope sensor, a temperature probe, a pressure sensor, a liquid level sensor, a vaporized hydrogen peroxide (VHP) sensor, a luminance meter (light) sensor, a photodetector, or a chemical (biological) sensor.

9. The method of claim 2, wherein: The products include devices, tools, machines, instruments, mechanisms, implements, small tools, or equipment; and The sources include surfaces, tools, components, machinery, equipment, instruments, or systems used to perform operations in the supply chain process to prepare the product.

10. The method of claim 9, wherein the product includes a medical device, and the source includes automated instruments for manufacturing the medical device, such that identifying the modification to the supply chain process includes adjustments to computer-executable instructions defining the operation of the automated instruments.

11. The method of claim 10, wherein the medical device comprises an autoinjector or a syringe.

12. The method of claim 9, wherein preparing the product during the supply chain process includes one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling or transporting the product.

13. The method of claim 2, wherein the event is a first event occurring during a first stage of the supply chain process for preparing the product, and the source causing the event is a first source in the supply chain process for preparing the product in the first stage.

14. The method of claim 13, further comprising: Determine the occurrence of a second event during the preparation of the product during the second phase of the supply chain process, wherein the second phase differs from the first phase of the supply chain process; and Identify a second source in the supply chain process that causes the occurrence of the second event, wherein the second source is different from the first source.

15. The method of claim 14, further comprising: Identify a second modification to the supply chain process to suppress the occurrence of the second event during subsequent preparation of the product in the supply chain process.

16. The method of claim 1, wherein the change includes a structural change to the product, a change in the sterility level of the product, or a change in the liquid level of the liquid stored in the product.

17. A method for reducing the occurrence of events during supply chain processes, comprising: The product is prepared during the supply chain process; Determine the occurrence of the event during the preparation of the product in the supply chain process, wherein the event causes a change to the product; and Modifications to the supply chain process are identified that reduce the occurrence of the events in the supply chain process during the subsequent preparation of the product, thereby reducing the occurrence of changes to the product.

18. The method of claim 17, wherein before determining the modification, the method comprises: It was determined that the source responsible for producing the product in the supply chain process was causing the event to occur. Determine the parameters applied to the product through the source during the occurrence of the event; The value of the parameter is compared with the threshold. as well as The modification is determined in response to the value of the parameter exceeding the threshold, and the determination of the modification is abandoned in response to the value of the parameter not exceeding the threshold.

19. The method of claim 18, wherein the product comprises an apparatus, tool, machine, instrument, mechanism, appliance, gadget, or device; The sources mentioned include surfaces, tools, components, machinery, equipment, instruments, or systems used in the operations performed in the supply chain process to produce the product; and The parameters mentioned include temperature, pressure, force, speed, light intensity, liquid level, impedance, compression, vibration, impact, tilt, or rotation experienced by the product during the event.

20. The method of claim 17, wherein preparing the product during the supply chain process includes one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling or transporting the product.

21. The method of claim 17, wherein the change to the product includes a structural change, a change in sterility level, or a change in the liquid level of the liquid stored in the product.

22. A method for identifying events that cause product changes during a supply chain process, comprising: The product is prepared during the supply chain process; Identify events that occur when the product is prepared in the supply chain process, causing the product to undergo changes during the supply chain process; as well as Modifications to the supply chain process are identified, which suppress changes to the product by inhibiting the occurrence of the events during the supply chain process.

23. The method of claim 22, wherein before identifying the modification, the method comprises: Determine the source of the event and the parameters that, when applied to the product through the source, cause the change in the product; Compare the parameter with a threshold; and The modification is identified when the parameter exceeds the threshold, and the identification of the modification is abandoned when the parameter does not exceed the threshold.

24. The method of claim 23, wherein preparing the product during the supply chain process comprises one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling or conveying the product; and The sources mentioned include surfaces, tools, components, machinery, equipment, instruments, or systems used in the supply chain process to prepare the product.

25. The method of claim 22, wherein the change to the product includes a structural change, a change in sterility level, or a change in the liquid level of the liquid stored in the product.

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