System and method for identifying events in supply chain processes

Abstract

A method for identifying events during a supply chain process includes preparing a product during the supply chain process, determining the occurrence of an event during product preparation in the supply chain process, and identifying changes to the supply chain process to mitigate the occurrence of the event during subsequent product preparation in the supply chain process. An event causes a change in the product.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Application No. 63 / 490,380, filed on March 15, 2023, which is hereby incorporated by reference in its entirety.

[0002] Aspects of the present disclosure relate to systems and methods for identifying events that occur during supply chain processes such as products. More specifically, embodiments of the present 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.) that a product undergoes at a particular stage of a supply chain process. The product may include a device or apparatus such as a medical device. The supply chain process may include one or more stages such as the manufacture, assembly, testing, sterilization, packaging, and / or distribution of the product.

[0003] The systems and methods of the present disclosure may identify particular stages in a supply chain process, such as one or more periods and / or points in time when an event occurs. The event may indicate an error or malfunction in a supply chain process where the product may be structurally at risk or rendered inoperable. The cause of the event may be due to various characteristics or causes in the supply chain process, such as measurement devices and / or tools used to prepare and / or manage the product during the particular stage in which the event occurs. By identifying the stage of the supply chain process in which the event occurs, the systems and methods of the present disclosure may identify one or more changes to characteristics or causes associated with a particular stage of the supply chain process in order to mitigate future occurrences of the event.

[0004] Introduction Product preparation and / or control in the supply chain process may include the manufacturing, assembly, testing, sterilization, packaging, and / or delivery of products (e.g., medical devices such as syringes for storing fluid substances) in various arrangements, locations, configurations, and / or locations. In some examples, parameters such as load (e.g., force) may be incidentally applied to the product by one or more causes related to the supply chain process, such as manufacturing equipment. Applying parameters may result in unintended changes and / or damage to the product. If the product is a medical device, more specifically a syringe, such changes and / or damage may lead to premature failure and / or improper use of the syringe by the user. In other examples, human error in the handling, control, positioning, and / or transport of a product (e.g., a syringe) at a stage in the supply chain process may similarly require the application of parameters that may affect the structural integrity of the product.

[0005] The occurrence of parameters (e.g., load) applied to a syringe before its use in administering a dose to a user (i.e., an event) can cause health and safety complications for the user (e.g., the patient). For example, a load on a syringe can result in the needle becoming displaced or at least some of the fluid stored in the syringe being inadvertently released, thereby causing the syringe that the user may use to malfunction. [Overview of the Initiative]

[0006] This specification discloses systems and methods for identifying events in the supply chain process of products, in particular medical devices such as syringes for storing fluid substances, where the event causes damage to the product. In one embodiment of the disclosure, a method for identifying an event in the supply chain process includes preparing the product in the supply chain process, determining that the event occurs during the preparation of the product in the supply chain process, determining that the event causes a change in the product and / or damages the product at least partially, and identifying changes in the supply chain process to mitigate the occurrence of the event during subsequent preparation of the product.

[0007] The accompanying drawings incorporated into and constituting portions thereof illustrate various exemplary embodiments and, together with their descriptions, serve to illustrate the principles of the disclosed embodiments. The drawings illustrate different aspects of the disclosure, and where appropriate, reference numbers indicating similar structures, components, materials, and / or elements in different drawings are similarly labeled. It is understood that various combinations of structures, components, and / or elements in various embodiments other than those specifically shown are contemplated and fall within the scope of the disclosure. [Brief explanation of the drawing]

[0008] [Figure 1] An exploded elevation view of an exemplary product, including a medical device, according to an aspect of this disclosure is shown. [Figure 2] A schematic diagram illustrating an exemplary supply chain process for the product shown in Figure 1, according to aspects of this disclosure, is provided. [Figure 3] A flowchart illustrating an exemplary method for identifying the occurrence of an event for the product in Figure 1 during the supply chain process in Figure 2, according to an aspect of this disclosure, is shown. [Figure 4] Figure 2 shows a schematic diagram illustrating an exemplary manufacturing stage of the product according to an aspect of this disclosure. [Modes for carrying out the invention]

[0009] This specification describes and illustrates many embodiments. This disclosure is not limited to any single aspect or embodiment thereof, nor to any combination and / or permutation of such aspects and / or embodiments. Each aspect and / or embodiment of this disclosure may be used alone or in combination with one or more other aspects and / or embodiments of this disclosure. For the sake of brevity, many of these combinations and permutations are not discussed separately in this specification.

[0010] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” or any other variation thereof are intended to mean non-exclusive inclusion. Therefore, a process, method, product, or apparatus containing a list of elements may not contain only those elements, but may also contain other elements not expressly enumerated, or other elements specific to such process, method, product, or apparatus. The term “exemplary” is used to mean “example,” not “ideal.” In particular, embodiments or configurations described herein as “example” or “exemplary” should not be construed as, for example, preferable or advantageous to other embodiments or configurations, but rather are intended to reflect or indicate that the embodiment(s) are “exemplary” and not “ideal.” Furthermore, terms such as “first,” “second,” etc., in this specification do not imply any order, quantity, or importance, but are used to distinguish elements, structures, steps, or processes from one another. Furthermore, the terms “a” and “an” in this specification do not imply a limit on quantity, but rather mean that one or more of the items mentioned exist. Furthermore, terms such as "approximately," "about," and "effectively" used to describe numerical values ​​indicate a variation of + / - 10% unless otherwise specified.

[0011] Embodiments of this disclosure may be used in any type of product, including fluid-containing products such as liquid drug substances, liquid placebos, or other liquids (or liquid solutions) that can be dispensed in dose form. Where used herein, the term “substance” may refer to a formulated substance containing an active ingredient(s). In some embodiments, the systems and embodiments of this disclosure may be used in devices and / or devices manufactured for use in any therapy that uses the immune system to fight disease, such as vaccines, allergy treatments, and immunotherapies, including cancer treatments. In particular, the systems and embodiments of this disclosure may be used in devices and / or devices manufactured for the treatment of cancer patients (e.g., immuno-oncology). However, embodiments of this disclosure may also be applicable to devices and / or devices used in any other situation where any treatment, liquid product, and / or one or more substances can be stored. While medical indications are described herein, non-medical devices and / or devices may be used in conjunction with the systems and methods described herein. It should be understood that embodiments of this disclosure may be used with devices and / or devices that do not contain liquid substances.

[0012] As used herein, the terms “distal” and “distal” refer to 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 “proximal” refer to a location (or part of the device) relatively close to, or in the direction of, the end of the device opposite the distal end. As used herein, when used in reference to a part of a product, the term “component” may refer to a feature of the product that is suitable for performing any purpose of the product. In examples where the product may include a medical device, the component may include a body, e.g., a barrel (such as a syringe barrel), tubing, cylinder, or other part of a device capable of storing a fluid substance. In some embodiments, the body may also include a distal end having a nozzle, needle, needle attachment site, and / or distal cap.

[0013] This specification describes exemplary embodiments of products such as apparatus, and in particular medical devices such as auto-injectors, including syringes. In some examples, embodiments or aspects of embodiments disclosed herein may be used with medical devices including other types of fluid-containing products, such as but not limited to vials, cartridges, and / or other suitable devices. In further examples, embodiments or aspects of embodiments disclosed herein may be used with a variety of other suitable products (e.g., apparatus and / or devices). Such systems and methods may help improve the accuracy and efficiency of supply chain processes by identifying the causes of human or automated machine errors in the supply chain process and / or identifying the occurrence of events in the supply chain process. For example, this may occur during one or more stages of such process (e.g., product manufacturing, assembly, testing, sterilization, packaging, labeling / marking, storage, shipping, sales, and / or distribution processes).

[0014] Figure 1 shows an exemplary product 10. It should be understood that product 10 can include, but is not limited to, a variety of manufactured goods, including devices, tools, machines, instruments, mechanisms, appliances, gadgets, apparatus, or other various equipment. As a mere example, product 10 could include a medical device (e.g., an auto-injector) comprising several 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 combine with the third component 16 to enclose one or more contents. The second component 14 could include a container configured to store a fluid substance, such as a drug (e.g., a pharmaceutical). In some embodiments, the container of the second component 14 could include, but is not limited to, a syringe, barrel, vial, cartridge, tube, etc.

[0015] The third component 16 may include a housing configured to be of a size, shape, and / or otherwise to house at least partially one or more of the first component 12 and the second component 14 inside. In other words, the third component 16 can define the outer body of the product 10 for housing the internal 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 from a variety of suitable materials, including but not limited to glass and plastic. The product 10 (e.g., an automatic syringe) may include, but not limited to, a needle, plunger, and biasing mechanism, and may include additional and / or fewer components than those shown and described herein. Alternatively, the first component 12, the second component 14, and / or the third component 16 of the product 10 may include a variety of shapes, sizes, arrangements, or configurations beyond those shown and described herein without departing from the scope of this disclosure. In some embodiments, one or more of the first component 12, the second component 14, and the third component 16 can be completely omitted from product 10.

[0016] Furthermore, as shown in Figure 1, the detection device 18 may be coupled to product 10, specifically 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 detection device 18 is not a component of product 10, as it can be selectively coupled to product 10. In other words, the detection device 18 is not a typical feature of product 10, as it may be detachably attached to product 10 for the purpose of identifying the occurrence of an event during the supply chain process of product 10, according to aspects of this disclosure. Furthermore, although only a single detection device 18 is shown, those skilled in the art will understand that any suitable number of detection devices 18 may be provided within the scope of this disclosure. For example, two, three, four, or any suitable number of detection devices may be provided according to the scope of this disclosure.

[0017] In this example, the detection device 18 may be coupled to the second component 14 and / or inserted within the second component 14. In other examples, the detection device 18 may be located on and / or inside the first component 12 and / or the third component 16 instead of the second component 14. It should be understood that by including the detection device 18 within product 10, product 10 can be rendered as a “test” or “experimental” version of product 10 for administering the method described in further detail herein (see Figure 3). In other embodiments, the detection device 18 may be a normal feature of product 10.

[0018] The detection device 18 may be configured to detect and / or measure one or more parameters and / or measurable parameters that characterize the product 10. For example, the detection device 18 may include a force sensor configured to detect and / or measure a force load applied to the product 10. In another example, the detection device 18 may include an accelerometer configured to detect and / or measure the acceleration, agitation, rotation, and / or vibration of the product 10. As a further example, the detection device 18 may include a gyroscope configured to detect and measure the angular velocity of the product 10. In other examples, the detection device 18 may include a temperature probe, a pressure (e.g., piezoelectric) sensor, a fluid sensor, an evaporated hydrogen peroxide (VHP) sensor, a photometer (light) sensor, a photodetector, a chemical (biological) sensor / indicator, etc. It should be understood that the detection device 18 may be configured to detect and / or measure a variety of other suitable parameters (e.g., rotation, tilt, compression, etc.) other than those described herein, without departing from the scope of this disclosure.

[0019] Referring further to Figure 1, the detection device 18 may include a plurality of sensors located on one or more components of product 10, each of which is configured to detect and measure the same or different parameters. For example, the detection device 18 may include a sensor array ranging from about 16 to 32 sensors, which can be coupled to one or more components of product 10. In other embodiments, a single detection device 18 may be configured and operable to detect and measure two or more parameters.

[0020] Product 10 is shown and described herein as a medical device having a specific configuration and arrangement of assembled components, in particular as an auto-injector, but Product 10 may include a variety of other medical devices, medical packages, or non-transient computer-readable media, and it should be understood that the systems and methods described herein are not limited to auto-injectors. For illustrative purposes only, other exemplary medical products may include, for example, suppository applicators and drugs, transdermal drug delivery devices, medical implants, needles, cannulas, medical instruments, blister packs, boxes, etc.

[0021] Referring further to Figure 1, as described in detail herein, the detection device 18 may be capable of measuring parameters (or more) that product 10 receives from one or more sources (e.g., objects, surfaces, etc.) located in the surrounding environment of product 10 during the supply chain process of product 10. These parameters may cause defects or damage corresponding to product 10 and may arise from one or more sources interacting with product 10 during its preparation and / or control in the supply chain process. In some embodiments, the detection device 18 may be capable of communicating with one or more remote systems or computers via various appropriate communication protocols. For example, the detection device 18 may be capable of communicating with remote systems or computers (not shown) via a network that can be implemented as a wireless network (e.g., Wi-Fi), a wired network (e.g., Ethernet), a local network area network (LAN), a wide area network (WAN), Bluetooth, near-field communication (NFC), cellular satellite, or any other type of network (or more) capable of providing communication between the detection device 18 and the remote system.

[0022] A remote system or computer may be configured and operable to perform one or more steps of a method shown and described herein in accordance with the Disclosure, such as Method 200 in the Figure. Although not shown, it should be understood that a remote system may include one or more computer hardware platforms having one or more central processing units ("CPUs") in the form of one or more processors for performing computer-readable instructions according to exemplary embodiments of the Disclosure. One or more computer hardware platforms may also include data storage for various data files to be processed and / or communicated, such as data from the sensing device 18.

[0023] Referring now to FIG. 2, an exemplary supply chain process 100 for product 10 is shown. Supply chain process 100 (hereinafter "process 100") may include one or more steps or sub - processes shown and described herein. The steps of process 100 are merely exemplary, and thus it should be understood that additional and / or fewer steps can be included in process 100 without departing from the scope of the present disclosure. Further, some of the steps of process 100 can be omitted, combined, and / or performed in an order different from that shown and described herein while maintaining consistency with the present disclosure.

[0024] In this example, process 100 can include a plurality of steps such as a first step 110 including receiving raw materials for manufacturing product 10, a second step 120 including manufacturing and / or assembling product 10, a third step 130 including quality control testing (or other forms of testing) of product 10, a fourth step 140 including sterilizing or cleaning product 10, a fifth step 150 including packaging and / or labeling product 10, a sixth step 160 including storing product 10, a seventh step 170 including shipping product 10, an eighth step 180 including selling product 10, and a ninth step including delivering product 10 to an end - user or the like.

[0025] As an example, the first stage 110 may include the process of receiving raw materials from a supplier to manufacture one or more of the first component 12, the second component 14, and the third component 16 of the product 10. The second stage 120 may include the process of manufacturing the first component 12, the second component 14, the third component 16, and / or the detection device 18 and / or the assembled product 10. In an embodiment where the product 10 includes a syringe for storing a fluid substance, the second stage 120 may include the process of filling the syringe with the fluid substance. The third stage 130 may include the process of testing the assembled product 10 from the perspective of quality control, etc., to evaluate the proper assembly and operation of the product 10. It should be understood that the third stage 130 may include testing the product 10 to an extent suitable for the type of the product and / or in accordance with applicable standards and / or protocols related to the type of the product.

[0026] The fourth stage 140 may include the process of sterilizing the product 10 by a sterilization method. In some embodiments, the fourth stage 140 may involve the final sterilization of the product 10 by a sterilization method using a chemical substance (such as vaporized hydrogen peroxide (VHP), ethylene oxide, nitrogen dioxide, etc.) to remove contaminants and other biological factors present on the product 10. For example, the fourth stage 140 may include placing the product 10 in a sterilization chamber configured to execute a sterilization cycle at a predetermined temperature and pressure, and supplying a sterilization chemical product into the sterilization chamber at an adjustable concentration during the cycle. It should be understood that the term "sterilization" refers to achieving an appropriate level of sterility for the product 10. In an example of the product 10 including an auto-injector storing a formulated drug substance, the fourth stage 140 may include sterilization techniques applicable to the commercial distribution and use of medical devices. It should be understood that the fourth stage 140 may include cleaning the product 10 to an extent suitable for the type of the product and / or in accordance with applicable standards and / or protocols related to the type of the product.

[0027] Referring further to Figure 2, the fifth stage 150 may include the process of packaging the product 10. For example, the product 10 may be packaged in a protective container configured to contain the product 10, such as blister packaging. Additionally and / or alternatively, the fifth stage 150 may include the process of labeling / marking the product 10 or the packaging of the product 10. The sixth stage 160 may include the process of storing the product 10, such as after the completion of the aforementioned manufacturing, inspection, sterilization, and packaging processes for the product 10. The product 10 may be stored isolated or together with several other products in a container suitable for transporting the product to a retailer for sale. In the seventh stage 170, the product 10 may be shipped by a sales agent to one or more locations for sale. The product 10 may be shipped via various suitable means of transport (e.g., air, ground, sea, etc.), and once it reaches its destination, the product 10 may be sold to an end user (e.g., a consumer) in the eighth stage 180, and then delivered to the end user in the ninth stage 190.

[0028] It should be understood that during each of the multiple stages of process 100, product 10 may interact with various and / or numerous objects, surfaces, or personnel. It should be understood that the term “interact” may include any physical, chemical, or other contact or exposure (direct or indirect) with product 10. For example, one or more of the multiple components of product 10 (see Figure 1) may be physically handled, controlled, positioned, and / or manipulated during one or more of the multiple stages of process 100 so as to be in a different configuration and / or arrangement relative to each other or to the surrounding environment. In further examples, components of product 10 may be exposed to various elements without physical contact during the multiple stages of process 100, such as light (or lack thereof), heat (or lack thereof), and fluids (e.g., air, water, gas).

[0029] One or more of the steps of process 100 may include product 10 (and in particular one or more of the first component 12, the second component 14, or the third component 16) interacting with an object responsible for performing operations related to the manufacture, quality control, testing, sterilization, packaging, storage, shipping, sale, and / or delivery of product 10. The object may include, but is not limited to, one or more surfaces, tools, assemblies, machines, equipment, measuring devices, systems, etc. In some embodiments, the object may be remotely controlled by automated operation, such as by a computer. In other embodiments, the object may be manually controlled and operated by personnel of process 100.

[0030] For example, product 10 may interact with one or more personnel (e.g., humans) during one or more of the stages of process 100, such as personnel responsible for performing operations related to the manufacture, quality control testing, sterilization, packaging, storage, shipping, sales, or delivery of product 10. It should be understood that various other elements, factors, or influences may be present in process 100 and may be involved in one or more of the manufacture, quality control testing, sterilization, packaging, storage, shipping, sales, and delivery of product 10. In other words, product 10 may have additional and / or alternative interactions during process 100 that are not described herein, without departing from the scope of this disclosure.

[0031] In any case, the interaction between product 10 and an object, person, or other factor may cause the occurrence of an event in which product 10 may be subjected to or encounter a parameter (e.g., force, pressure, temperature, light intensity, impedance, etc.) at a particular stage of process 100. In other words, during one or more of the stages of process 100, the interaction between product 10 and its surrounding environment may include an event in which a change (and / or creation) of a parameter occurs in at least one of the components of product 10. The parameter is sufficient to cause potential damage (e.g., structural, mechanical, chemical, etc.) to product 10. As described herein, the sensing device 18 may be configured to detect and / or measure the change and / or creation of a parameter to product 10 when an event occurs at a particular stage of process 100.

[0032] Figure 3 shows a flowchart of an exemplary method 200 for identifying the occurrence of an event to a product during a supply chain process, as described herein. It should be understood that the steps of method 200 are described herein in the context of computer executable instructions that may be performed or implemented by one or more remote systems or remote computing systems, such as computers, communicating with a detection device 18.

[0033] In step 202, the preparation and / or control of a product, such as product 10, can be carried out at the current stage of a supply chain process, such as process 100. In other words, product 10 may be prepared and / or controlled according to operations related to any one of the multiple stages of process 100 shown and described in step 202 (see Figure 2).

[0034] As a mere example, 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, the manufacturing environment 20 of the second stage 120 is shown, as can be seen in Figure 4, and the environment 20 may include a number of pieces of equipment arranged along various locations on the assembly line 30. For example, the environment 20 may include a first manufacturing piece 22 located adjacent to a first location 32 on the assembly line 30, a second manufacturing piece 24 located adjacent to a second location 34 on the assembly line 30, a third manufacturing piece 26 located adjacent to a third location 36 on the assembly line 30, and a fourth manufacturing piece 28 located adjacent to a fourth location 38 on the assembly line 30. While this specification shows and describes a specific number and arrangement of apparatus for the second stage 120, it should be understood that the manufacturing environment 20 is merely illustrative and may include additional and / or fewer apparatus (or other types of apparatus) in the second stage 120 of process 100 and other suitable configurations without departing from the scope of this disclosure.

[0035] In this example, each piece of equipment within the manufacturing environment 20 may be configured and operable to perform one or more operations at each location on the assembly line 30 for manufacturing the product 10. During the second stage 120, the 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 equipment 22, the second manufacturing equipment 24, the third manufacturing equipment 26, and the fourth manufacturing equipment 28) and / or surfaces (e.g., parts of the assembly line 30 along the first position 32, the second position 34, the third position 36, and the fourth position 38). It should be understood that, although not illustrated, the manufacturing environment 20 may include various other elements or factors (e.g., light, temperature, fluids, etc.) that may interact with the product 10 during the manufacturing process of the second stage 120.

[0036] Returning to and referring to Figure 3, step 204 determines whether the occurrence of an event is detected at the current stage of process 100, for example, by the detection device 18. As described in detail above, an event may be defined by an interaction (e.g., physical or chemical) between product 10 and the surrounding environment at the current stage of process 100, such as an object, person, or other factor. The occurrence of an event may allow the detection device 18 to detect a change (and / or creation of a parameter) applied to product 10. In other words, the occurrence of an event may allow the detection device 18 to detect a change in the properties of product 10. The parameter may be of a degree or magnitude sufficient to cause a change in the product and / or cause at least partial damage to product 10, such as causing a defect or (structural) damage to one or more components of product 10.

[0037] In response to determining in step 204 that no event occurred during the current phase of process 100, method 200 may proceed to step 206, in which product 10 continues to the next phase of process 100. In this example, since the current phase of process 100 has been executed and completed without any event occurring, method 200 may return to step 202, during which time the continued preparation and / or control of product 10 may be performed according to the corresponding operation of the next phase of process 100. Alternatively, in response to determining in step 204 that an event detected by the sensing device 18 occurred during the current phase of process 100, in step 208, data associated with the event may be transmitted from product 10 (particularly via the sensing device 18) to one or more remote systems or computers (e.g., processors).

[0038] The transmitted data may include, but is not limited to, sensor data indicating the parameter(s) detected by the detection device 18, and may include multiple pieces of information. In some embodiments, the sensor data may include the corresponding period during the current stage of process 100 in which the parameter(s) were detected. In other embodiments, the sensor data may include the corresponding identification of the component of product 10 (e.g., a first component 12, a second component 14, a third component 16) in which the parameter(s) were received. For illustrative purposes only, as shown in Figure 4, the event may include a physical manipulation (e.g., gripping) of product 10 by a fourth manufacturing tool 28 while product 10 is positioned adjacent to a fourth position 38 on the assembly line 30 in the manufacturing environment 20. When gripping product 10, the detection device 18 may detect the load (i.e., parameter) applied to the second component 14 (see Figure 1) by the fourth manufacturing tool 28.

[0039] Referring to Figure 3, in step 210, the source or cause of the event may be determined based on sensor data detected and transmitted by the detection device 18. In this example, the source or cause of the event (e.g., physical manipulation of product 10) may be determined to be the fourth manufacturing apparatus 28 located adjacent to the fourth position 38 along the assembly line 30. In step 212, the relative value or degree of a parameter (e.g., load) applied to product 10 may be determined based on sensor data detected and transmitted by the detection device 18. In the example shown in Figure 4, the value of the parameter applied to product 10 by the fourth manufacturing apparatus 28 may be approximately 2 Newtons (N). In other examples, the value of the parameter may be greater than 2N, less than 2N, or measured in various other appropriate units of measurement.

[0040] It should be noted 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, and as a result, the sensor data transmitted in step 208 may include data indicating one or more events and / or parameters detected during the current phase. In this example, method 200 may include, for one or more events and / or parameters detected during the current phase of process 100, a separate determination of the cause of each event (step 210) and a value or degree of each parameter (step 212).

[0041] In step 214, the parameter(s) determined in step 212 may be compared to a threshold. In some embodiments, the threshold may be predetermined and stored in one or more remote systems, etc. In other embodiments, the threshold may be user-defined and received by one or more remote systems, etc. The threshold can define the maximum (acceptable) value or degree of the parameter determined in step 212 without requiring any modification of process 100 to suppress further occurrence of the event detected in step 204. Alternatively, the threshold can define the maximum value or degree of the parameter without requiring any modification of process 100 to minimize further application of the parameter to product 10 during the occurrence of subsequent events. In this example, even though the event continues to occur during further process 100, the parameter that product 10 receives from that event may be minimized. A value or degree of the parameter exceeding the threshold may indicate a rejection parameter sufficient to cause some kind of change to the product, and / or at least partial damage to product 10, such as a structural change to the product, a change in the function of the product, a change in the sterility level of the product, or a change in the level of fluid stored in the product.

[0042] For example, a threshold could define the maximum value or degree of a parameter corresponding to the condition under which damage or defect(s) (e.g., physical, functional, aesthetic, operational, etc.) does not occur, even though an event has occurred in step 204. In this example, a parameter determined to exceed the threshold may indicate a product that has suffered (or is likely to suffer) some form of damage or defect, while a parameter that does not exceed the threshold may indicate a product that has not suffered (or is not likely to suffer) any damage or defect.

[0043] 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 resulting change or defect (e.g., a defect or damage) in product 10, and such minimum value or degree is approximately below (or equal to) a 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, degraded, non-sterile, and / or inoperable for its intended use, and the value or degree of the determined parameter is greater than (or equal to) a threshold.

[0044] In an example where product 10 may include a medical device such as a syringe or auto-injector having one or more of a needle, a plunger, and / or a barrel that stores a fluid substance internally, parameters applied to the medical device, if exceeding a threshold, could cause inadvertent movement of the component. For example, applying parameters that exceed a threshold could result in the needle being deflected, rendering the medical device unusable by a user (e.g., a patient), the plunger moving and prematurely releasing the stored fluid substance, or the barrel being damaged and leaking the stored fluid substance. In a further example, applying parameters that exceed a threshold could result in the barrel being exposed to excessive vibration, shock, light, and / or heat, thereby physically and / or chemically altering the properties of the fluid substance stored inside.

[0045] In some embodiments, at least one threshold may be defined and / or predetermined for multiple parameters (e.g., force, pressure, temperature, light intensity, fluid level, impedance, etc.) that the product 10 may experience in process 100. Thus, applicable thresholds corresponding to the type of parameter (from the multiple parameters) determined in step 212 can be identified and compared in step 214. It should be understood that the threshold may include a value or degree corresponding to the unit of measurement of the relevant parameter.

[0046] Continuing to refer to Figure 3, it may be determined in step 216 whether the parameter value or degree exceeds a threshold. In response to determining in step 216 that the parameter does not exceed a threshold, method 200 may proceed to step 206, in which product 10 may continue to the next stage of process 100. In this example, since the parameter was not of a value or degree sufficient to cause resulting damage or defects in product 10, method 200 may return to step 202, in the meantime, to prepare and / or control product 10 according to the corresponding operation of the next stage of process 100. Alternatively, in response to determining in step 216 that the parameter exceeds a threshold, one or more proposed modifications to the current stage of process 100 may be identified in step 218 by one or more remote systems, etc.

[0047] One or more proposed changes identified in step 218 may be aimed at resolving 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 changes to the location, position, operation, and / or various other characteristics of the source of an event, for the purpose of suppressing further occurrence of the event (detected in step 204) and / or minimizing the value or degree of any parameter (determined in step 212) that product 10 may receive further during the current stage of process 100. Referring to the example shown in Figure 4, the remote system(s) may be configured to identify changes to one or more characteristics of the fourth manufacturing apparatus 28 that was determined in step 210 to be the cause of the event.

[0048] In another example, one or more remote systems may be configured and operable to identify potential changes to objects other than the event cause that could directly and / or indirectly affect the occurrence of the event. Referring to the example shown in Figure 4, the remote system(s) may be configured to identify changes to one or more of the first manufacturing apparatus 22, the second manufacturing apparatus 24, the third manufacturing apparatus 26, the assembly line 30, and / or one or more of the other surfaces, tools, assemblies, machines, equipment, measuring devices, and systems.

[0049] As described in detail above, one or more objects responsible for performing operations related to the current stage of process 100 (e.g., manufacturing, quality control testing, sterilization, packaging, storage, shipping, sales, and / or delivery) may be controlled by automated operations (e.g., by a computer). In this example, the potential change(s) identified in step 218 may include adjustments to the automated control of the object, such as modifying computer executable instructions and / or programmable computer code that can operate to automate the operation of the object. In embodiments where the object may be operated manually by personnel in process 100, the potential change(s) identified in step 218 may be communicated to users and / or personnel for implementation.

[0050] Continuing to refer to Figure 3, Method 200 may include step 220, in which any changes identified in step 218 for the current stage of process 100 may be communicated to the user for approval or rejection, etc. (e.g., via user input through one or more remote systems). In other embodiments, one or more remote systems may be configured and operational to automatically implement one or more changes in step 220. Once the changes for the current stage of process 100 have been communicated and / or implemented in step 220, Method 200 returns to step 202, during which time product 10 may be prepared and / or managed according to the corresponding operation of the next stage of process 100.

[0051] It should be understood that the general description of this disclosure provides a brief general description of suitable computing environments in which this disclosure may be implemented. In one embodiment, any of the disclosed systems and / or methods may be run or implemented by a computing system (e.g., one or more remote systems) that is identical to or similar to the computing system described herein. Although not required, aspects of this disclosure are described in the context of computer executable instructions, such as routines, executed by data processing devices, e.g., computer hardware platforms, wireless devices, and / or personal computers. Those skilled in the art will understand that aspects of this disclosure may be implemented in other communications, data processing, or computer system configurations. In fact, the terms “computer,” “processor,” “remote system,” etc., are generally used interchangeably herein and refer to any of the above-mentioned devices and systems, as well as any data processor.

[0052] Aspects of this disclosure may be embodied in a dedicated computer and / or data processor that is programmed, configured, and / or configured specifically to execute one or more of the computer executable instructions described in detail herein. While certain aspects of this disclosure, such as the steps of Method 200, are described as being executed on a single device or system only, this disclosure may also be implemented in a distributed environment in which functions or modules linked over a communication network are shared among different processing devices. Similarly, techniques presented herein as involving multiple devices may be implemented on a single device. In a distributed computing environment, program modules may be located on both local and remote memory storage devices.

[0053] Aspects of the Disclosure may be stored and / or distributed on non-temporary computer-readable media. Alternatively, computer implementation instructions, data structures, screen displays, and other data according to aspects of the Disclosure may be distributed over the Internet and / or other networks (including wireless networks). Programmatic aspects of the Technology may be considered “products” or “manufactured articles” in the form of executable code and / or associated data, typically mounted or embodied on a certain type of machine-readable media. “Storage” type media include any or all of a computer, or tangible memory such as a processor, or its associated modules, which may at any time provide non-temporary storage for software programming. Terms such as computer “readable media” as used herein refer to any medium involved in giving instructions to a processor and causing it to execute, unless not limited to non-temporary tangible “storage” media.

[0054] While several embodiments are presented herein, multiple variations of such embodiments and combinations of elements from one or more embodiments are possible and are intended to be within the scope of this disclosure. Furthermore, those skilled in the art will understand that the underlying concepts of this disclosure can be readily used as a basis for designing other structures, methods, and systems to accomplish some of the purposes of this disclosure.

[0055] Embodiments of this disclosure may include the following features: Clause 1. A method for identifying an event during a supply chain process includes preparing a product during the supply chain process, identifying the occurrence of the event causing a change in the product during the preparation of the product during the supply chain process, and identifying a change in the supply chain process to suppress the occurrence of the event during subsequent preparation of the product during the supply chain process.

[0056] Clause 2. The method of Clause 1, further comprising determining the cause in the supply chain process that causes the occurrence of the event, the determination of which includes identifying the change, which includes identifying adjustments to the operation of the cause.

[0057] Clause 3. The method of Clause 2, wherein, prior to identifying the modification, the method includes ensuring that a parameter causing damage to the product is applied to the product during the event due to the cause.

[0058] Clause 4. The method according to Clause 3, wherein the product includes a detection device configured to detect the parameters applied to the product during the occurrence of the event. Clause 5. The method according to Clause 4, wherein, before identifying the change, the method includes transmitting the parameter to a remote processor communicatively coupled to the sensing device, the remote processor being configured to determine the value of the parameter.

[0059] Clause 6. The method according to Clause 5, wherein, before identifying the change, the method includes comparing the value of the parameter to a threshold, identifying the change in response that the value of the parameter exceeds the threshold, and refraining from identifying the change in response that the value of the parameter does not exceed the threshold.

[0060] Clause 7. The method according to Clause 3, wherein the parameters include temperature, pressure, force, speed, light intensity, fluid level, impedance, compression, incline, or rotation experienced by the product during the event.

[0061] Clause 8. The method according to Clause 4, wherein the detection device includes an accelerometer, a gyro sensor, a temperature probe, a pressure sensor, a fluid level sensor, an evaporated hydrogen peroxide (VHP) sensor, a photometer (light) sensor, a photodetector, and a chemical (biological) sensor.

[0062] Clause 9. The method of Clause 2, wherein the Product includes devices, tools, machines, fixtures, mechanisms, appliances, gadgets, or apparatus, and the Cause includes surfaces, tools, assemblies, machines, equipment, measuring devices, or systems responsible for performing operations in the supply chain process for preparing the Product.

[0063] Clause 10. The method of Clause 9, wherein the product includes a medical device, and the cause includes an automated measuring device for manufacturing the medical device, thereby identifying the changes in the supply chain process, which includes adjustments to computer executable instructions defining the operation of the automated measuring device.

[0064] Clause 11. The medical device is the method described in Clause 10, including an auto-injector or syringe. Clause 12. The method described in Clause 9, which includes preparing the product during the supply chain process, including one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling, or delivering the product.

[0065] Clause 13. The method according to Clause 2, wherein the event is a first event occurring during a first stage of the supply chain process for preparing the product, and the cause causing the event to occur is a first cause in the supply chain process for preparing the product in the first stage.

[0066] Clause 14. The method of Clause 13, further comprising determining that a second event occurs during the preparation of the product during a second stage of the supply chain process, wherein the second stage is different from the first stage of the supply chain process, and determining a second cause in the supply chain process that causes the occurrence of the second event, wherein the second cause is different from the first cause.

[0067] Clause 15. The method of Clause 14, further comprising identifying a second change to the supply chain process in order to suppress the occurrence of the second event during the subsequent preparation of the product in the supply chain process.

[0068] Clause 16. The method according to Clause 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 level of fluid stored in the product. Clause 17. A method for suppressing the occurrence of an event during a supply chain process, comprising: preparing a product during the supply chain process; determining the occurrence of the event causing a change in the product during the preparation of the product during the supply chain process; and determining a change in the supply chain process to suppress the occurrence of the event during the subsequent preparation of the product.

[0069] Clause 18. The method according to Clause 17, wherein, before determining the change, the method includes determining that a cause responsible for preparing the product in the supply chain process is causing the event, determining a parameter applied to the product by the cause during the event, comparing the value of the parameter to a threshold, determining the change in response that the value of the parameter exceeds the threshold, and refraining from determining the change in response that the value of the parameter does not exceed the threshold.

[0070] Clause 19. The method according to Clause 18, wherein the Product includes devices, tools, machines, fixtures, mechanisms, appliances, gadgets, or apparatus, and the Cause includes surfaces, tools, assemblies, machines, equipment, measuring devices, or systems responsible for performing operations in the supply chain process for preparing the Product, and the Parameters include temperature, pressure, force, speed, light intensity, fluid level, impedance, compression, tilt, or rotation experienced by the Product during the event.

[0071] Clause 20. Preparing the product during the supply chain process is the method described in Clause 17, which includes one or more of the following: manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling, or delivering the product.

[0072] Clause 21. The method according to Clause 17, wherein the change to the product includes a structural change, a change in the sterility level, or a change in the level of the fluid stored in the product. Clause 22. A method for identifying an event that causes a change to a product during a supply chain process, the method comprising: preparing the product during the supply chain process; determining that the product is subjected to the change caused by the event by determining that the event occurs when the product is being prepared in the supply chain process; and identifying a change to the supply chain process that prevents the occurrence of the change to the product during preparation by suppressing the occurrence of the event in the supply chain process.

[0073] Clause 23. The method according to Clause 22, wherein, before identifying the change, the method includes determining the event and the parameters to apply to the product based on the cause that causes the change in the product; comparing the parameters with a threshold; identifying the change when the parameter value exceeds the threshold; and refraining from identifying the change when the parameter does not exceed the threshold.

[0074] Clause 24. The method of Clause 22, wherein preparing the product during the supply chain process includes one or more of the manufacturing, assembly, testing, sterilization, packaging, labeling or marking, storage, shipment, sale, or delivery of the product, and the cause includes surfaces, tools, assemblies, machines, equipment, measuring devices, or systems that perform operations in the supply chain process for preparing the product.

[0075] Clause 25. The method according to Clause 22, wherein the change to the product includes a structural change, a change in the sterility level, or a change in the level of the fluid stored in the product. Other embodiments of this disclosure will be apparent to those skilled in the art from considerations herein and the practice of the invention disclosed herein. This specification and the examples are intended to be exemplary, and the true scope and spirit of the invention are set forth by the following claims.

Claims

1. A method for identifying events in a supply chain process, The preparation of the product during the aforementioned supply chain process, Determining the occurrence of the event that causes a change in the product during the preparation of the product in the supply chain process, A method further comprising identifying changes to the supply chain process in order to suppress the occurrence of the event during the subsequent preparation of the product in the supply chain process.

2. The method according to claim 1, further comprising determining the cause in the supply chain process that causes the occurrence of the event, wherein identifying the change includes identifying adjustments to the operation of the cause.

3. Before identifying the change, the method The method according to claim 2, comprising determining that the parameter is applied to the product during the event due to the cause and that the parameter causes damage to the product.

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

5. Before identifying the change, the method The method according to claim 4, comprising transmitting the parameter to a remote processor that is communicably coupled to the detection device, wherein the remote processor is configured to determine the value of the parameter.

6. Before identifying the change, the method The aforementioned value of the parameter is compared with a threshold, The method according to claim 5, comprising identifying the change in response to the value of the parameter exceeding the threshold, and refraining from identifying the change in response to the value of the parameter not exceeding the threshold.

7. The method according to claim 3, wherein the parameters include temperature, pressure, force, speed, light intensity, fluid level, impedance, compression, incline, or rotation experienced by the product during the event.

8. The method according to claim 4, wherein the detection device includes an accelerometer, a gyro sensor, a temperature probe, a pressure sensor, a fluid level sensor, an evaporated hydrogen peroxide (VHP) sensor, a photometer (light) sensor, a photodetector, and a chemical (biological) sensor.

9. The aforementioned products include devices, tools, machines, instruments, mechanisms, appliances, gadgets, or apparatus. The method according to claim 2, wherein the cause includes a surface, tool, assembly, machine, equipment, measuring device, or system responsible for performing operations in the supply chain process for preparing the product.

10. The method of claim 9, wherein the product includes a medical device, and the cause includes an automated measuring device for manufacturing the medical device, and thereby identifying the change to the supply chain process includes adjusting computer executable instructions that define the operation of the automated measuring device.

11. The method according to claim 10, wherein the medical device includes an automatic syringe or a syringe.

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

13. The method according to 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 cause causing the event to occur is a first cause in the supply chain process for preparing the product in the first stage.

14. Determining the occurrence of a second event during the preparation of the product in the second stage of the supply chain process, wherein the second stage is different from the first stage of the supply chain process, and determining that the second stage is different from the first stage of the supply chain process. The method of claim 13, further comprising determining a second cause in the supply chain process that causes the occurrence of the second event, wherein the second cause is different from the first cause.

15. The method according to claim 14, further comprising identifying a second change to the supply chain process in order to suppress the occurrence of the second event during the subsequent preparation of the product in the supply chain process.

16. The method according to 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 level of fluid stored in the product.

17. A method for suppressing the occurrence of events in a supply chain process, The preparation of the product during the aforementioned supply chain process, Determining the occurrence of the event that causes a change in the product during the preparation of the product in the supply chain process, A method comprising suppressing the occurrence of the change in the product by determining a change in the supply chain process to suppress the occurrence of the event in the supply chain process during the subsequent preparation of the product.

18. Before determining the change, the method Determining that the cause responsible for preparing the product in the supply chain process is causing the occurrence of the event, During the occurrence of the aforementioned event, the parameters applied to the product by the aforementioned cause are determined, The value of the aforementioned parameter is compared with a threshold, The method according to claim 17, comprising determining the change in response to the value of the parameter exceeding the threshold, and refraining from determining the change in response to the value of the parameter not exceeding the threshold.

19. The aforementioned products include devices, tools, machines, instruments, mechanisms, appliances, gadgets, or apparatus. The aforementioned causes include surfaces, tools, assemblies, machines, equipment, measuring devices, or systems responsible for performing operations in the supply chain process for preparing the product, The method according to claim 18, wherein the parameters include temperature, pressure, force, velocity, light intensity, fluid level, impedance, compression, vibration, shock, tilt, or rotation experienced by the product during the event.

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

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

22. A method for identifying events that cause product changes during the supply chain process, Preparing the product during the aforementioned supply chain process, When the aforementioned event occurs while the product is being prepared in the supply chain process, it is determined that the product undergoes the aforementioned change during the supply chain process. A method comprising identifying a change to the supply chain process that suppresses the change in the product by suppressing the occurrence of the event during the supply chain process.

23. Before identifying the change, the method Determining the cause of the event and the parameters applied to the product by the cause that causes the change in the product, Comparing the aforementioned parameters with a threshold, The method according to claim 22, comprising identifying the change when the parameter exceeds the threshold, and refraining from identifying the change when the parameter does not exceed the threshold.

24. 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 delivering the product. The method according to claim 23, wherein the cause includes a surface, tool, assembly, machine, equipment, measuring device, or system responsible for performing operations in the supply chain process for preparing the product.

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

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