Manufacturing and qualification techniques

Abstract

To provide an improved method and apparatus for automated production and / or qualification of devices and / or device components.SOLUTION: The apparatus generally comprises an improved manufacturing technique. The apparatus provided is a substantial improvement over automated manufacturing techniques.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 684,047, filed August 16, 2024, which is incorporated herein by reference in its entirety.

[0002] shared application No. 13 / 961,422, filed August 7, 2013, entitled "Method and Device for Simultaneously Documenting and Treating Tension Pneumothorax and / or Hemothorax," U.S. patent application Ser. No. 14 / 581,339, filed December 23, 2014, entitled "Percutaneous Channel System and Method," U.S. patent application Ser. No. 16 / 113,707, filed August 27, 2018, entitled "Percutaneous Access Pathway System," U.S. patent application Ser. No. 16 / 113,707, filed March 15, 2019, entitled "Systems and Methods Relating to Medical Applications of Synthetic Polymer Compounds ... August 27, 2018, entitled "Systems and Methods Relating to Medical Applications of Synthetic Polymer Compounds," U.S. patent application Ser. U.S. patent application Ser. No. 16 / 354,418, entitled "Percutaneous Access Pathway System," filed October 5, 2020; U.S. patent application Ser. No. 16 / 948,885, entitled "Percutaneous Access Pathway System," filed July 28, 2022; U.S. patent application Ser. No. 17 / 876, entitled "Wound Treatment Device," filed July 28, 2022;No. 187, U.S. patent application Ser. No. 18 / 448,455, filed August 11, 2023, entitled "Percutaneous Access Pathway System," U.S. patent application Ser. No. 18 / 485,800, filed October 12, 2023, entitled "Systems and Methods Relating to Medical Applications of Inverse Thermosensitive Polymer Foam Formulations," and U.S. patent application Ser. No. 18 / 926,615, filed October 25, 2024, entitled "Autoinjector Assembly," are incorporated herein by reference in their entireties.

[0003] Government Licensing Rights This invention was made with U.S. Government support under Contract FA864923P0557 for "Fully-Qualified Manufacturing for the Automated, On-Demand, Point-of-Use Production and Qualification of Devices and Device Components," awarded by FA8649 USAF RESEARCH LAB AFRL SBRK. The U.S. Government has certain rights in this invention.

[0004] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of manufacturing, and more particularly to the automated production and / or qualification of devices and / or device components. [Background technology]

[0005] Automated manufacturing technologies have revolutionized the production of a wide range of devices and device components. This includes technologies using additive manufacturing (AM), also known as 3D printing, which includes stereolithography (SLA), selective laser sintering (SLS), fused deposition modeling (FDM), feedstock jetting, binder jetting, selective laser melting (SLM), direct metal laser sintering (DMLS), electron beam melting (EBM), fused filament fabrication (FFF), and related technologies. It also includes technologies using subtractive manufacturing (SM), which includes computer numerical control (CNC) machining, electrical discharge machining (EDM), laser cutting, water jet cutting, and related technologies.

[0006] Automated manufacturing technologies have improved supply chains in various industries, often enabling the production of devices and / or device components in a just-in-time manner and / or at distributed locations closer to the point of use, thereby reducing the logistical burden of transporting and storing finished products. Examples of industries that have explored such production include both the medical field and the aerospace industry. However, while these technologies have improved the ability to manufacture devices and device components in a distributed manner (e.g., using additive manufacturing and / or synthetic manufacturing), there has not been an equal improvement in the ability to qualify these components during production (e.g., ensuring they are usable based on established inspection and / or other manufacturing standards), which has significantly hindered the benefits of such technologies.

[0007] In the military, future multi-domain battlefield scenarios will benefit from simplified, mobile surgical teams in more remote, forward environments. These teams will move away from the cumbersome equipment of the past and require small, lightweight, and portable surgical capabilities for ease of transport and movement. To that end, additive manufacturing has been explored for the production of medical devices and equipment at the point of need. This technology has great potential to shift the focus of the supply chain from bulk transportation and storage of finished products to the flexible production of needed equipment at the point of use.

[0008] Similarly, in the civilian world, there was significant interest in utilizing AM technologies to alleviate certain medical supply shortages during the early days of the COVID-19 pandemic. There were several public, open-source engineering events focused on COVID-19 responses, such as the SOCOM-sponsored DIY Hack-a-Vent Innovation Challenge, as well as other publicly-intended attempts to produce alternatives to traditionally manufactured personal protective equipment (PPE). Despite the willingness to use AM to fill critical gaps in the medical supply chain, fundamental obstacles were encountered that prevented these devices from being used for their intended medical purposes. These AM-printed devices did not undergo the necessary quality and regulatory compliance requirements (e.g., required by the FDA) after production and therefore could not be used by humans for medical purposes.

[0009] While 3D printing hobbyist components is relatively straightforward using current technology, medical devices are regulated by the FDA and require compliance with strict quality and regulatory requirements, including extensive testing and inspection processes after manufacture and before human use, strict processing and output controls under the established Quality System Regulation (QSR), and compliance with Current Good Manufacturing Practices (cGMP). These extensive quality systems are in place to ensure that FDA-regulated devices consistently benefit and do not harm patients. However, these regulations (e.g., ISO 13485, CFR Title 21 Part 820) present implementation hurdles for point-of-use manufacturing of medical devices that have yet to be overcome using current technology. Although researchers now have the ability to 3D print and even sterilize surgical instruments and other medical devices in a distributed manner (such as in a far-forward or hostile environment), the devices produced cannot be used unless they are produced under stringent Good Manufacturing Process (GMP) and Quality Management System (QMS) procedures required by the FDA. The FDA has issued industry guidance on the use of AM in medical device manufacturing in the document "Technical Considerations for Additive Manufacturing Medical Devices Guidance for Industry and Food and Drug Administration Staff," published on December 5, 2017, but this document focuses primarily on use under the traditional paradigm.

[0010] In a traditional medical device supply chain, manufactured lots are received (or produced) within an organization and then inspected, tested, and qualified before human use. This process is typically performed by quality inspectors and / or engineers and includes the creation of quality metrics, risk analysis, and the use and testing of biocompatible materials in accordance with ISO 10993. Therefore, despite the usefulness of AM for overcoming critical medical supply chain shortages, the inherent nature of this on-demand, point-of-use production means that there are no on-site quality inspectors to ensure that the produced devices meet regulatory requirements. Therefore, a significant gap in current capabilities is the ability to manufacture medical devices, such as surgical instruments, at the point-of-use under GMP / QMS and then automatically qualify them for use.

[0011] While there are several examples of medical devices and components being 3D printed for remote use (e.g., in disaster situations, remote locations for global health) described in the media, such devices have not been cleared by the FDA for use. This is because the FDA requires full traceability and testing of medical devices and their components under established and rigorous QSR. For example, early in the COVID-19 pandemic, there was a shortage of ventilators, and there was much interest in using AM to produce necessary disaster supplies. For medical device companies with extensive FDA-required quality systems (e.g., ISO 13486 certification), AM manufacturing of common devices or components (e.g., personal protective equipment, ventilator parts) is relatively straightforward using current technology. However, the difficult part of this challenge is producing fully qualified, FDA-approved (21 CFR Part 820 QSR and cGMP compliant) devices once they leave the printing press without the need for separate manual inspection and subsequent qualification processes.

[0012] Another example is rehabilitation braces, commonly indicated for the management of musculoskeletal injuries (MSKI). Musculoskeletal injuries can affect a wide range of body regions, including bones, joints, cartilage, ligaments, tendons, muscles, and other soft tissues. Braces provide localized rigidity to protect and stabilize a vast array of injury types, while simultaneously allowing at least some movement to prevent long-term loss of stiffness and mobility. The wide variety of body parts, sides, and injuries presents significant challenges in properly storing and customizing braces where and when they are needed. Currently, specific braces are manufactured, selected, transported, and stored based on weight and volume storage limitations, as well as an estimate of how much of each type of brace will be needed. This presents challenges in hospitals, emergency departments, and local medical stores, and is of particular concern in military and deployed settings (e.g., first aid stations with roll-over capacity).

[0013] Existing devices, such as the ActivArmor® and Cortex exoskeleton casts, are produced through additive manufacturing to provide personalized and durable casts, which represent a promising advancement in operational agility for providing splints at the point of use. However, existing methods use hard, inflexible plastics, producing rigid products that completely immobilize the injury site. While certain MSKI injury types warrant the use of hard casts (such as the acute management of certain fractures), these are only suitable for a limited range of MSKI injuries. Thus, the use cases for these existing products are limited. Furthermore, many common injury types, including those most prominent within the U.S. military, require braces that allow at least partial mobility. These include sprains, strains, and many fractures, which benefit from some degree of controlled range of motion during recovery. Thus, there is a significant unmet need for a system that can manufacture flexible, personalized braces on-site and on-demand following MSKI to accelerate recovery, reduce the need for medical evacuation, and facilitate the return of combatants to readiness.

[0014] Another example is in-space component manufacturing, such as that based on ISO 9001 or AS 9100, which is used throughout the aerospace industry. Recent technological advances have extended the lifespan of satellites, necessitating the adoption of new capabilities for use in on-orbit service and related space operational support. Key to these efforts is the ability to repair existing assets and manufacture new components in-space as the need arises. To that end, additive manufacturing (AM) has already begun to revolutionize what is possible in space. Compared to traditional manufacturing methods (e.g., injection molding, milling, decanting), AM is optimized for the on-orbit environment because it can produce a variety of products with complex shapes using small amounts of raw material and in a small space. Furthermore, AM offers greater flexibility, allowing design changes to be immediately incorporated into 3D-printed structures. Indeed, 3D-printed products have the potential to be manufactured with unit-level customization optimized for unique mission requirements, both on-site and on-demand.

[0015] One of the first 3D-printed parts in space was a wrench produced on the International Space Station. This provided proof of concept that an on-orbit manufacturing system could produce designs remotely transmitted from Earth. Analysis revealed that microgravity had no significant engineering effect on the process. Several groups have begun exploring the manufacturing of AM components for satellites, working to embed electronics such as complex antennas into printed parts. However, the ability to produce printed components in space is only the first step. Once a part is produced, it is important to verify that it meets the requirements of its intended application. This, for example, can facilitate and integrate other in-space inspection, assembly, and manufacturing (ISAM) technologies. While component qualification is a standard manufacturing step in any industry, it is particularly rigorous for parts for specialized, high-risk applications (e.g., aerospace). Currently, virtually every part of a spacecraft is physically inspected before it reaches the launch pad, down to the nut, bolt, and individual solder joint. The challenge then arises of how to inspect any components manufactured on-orbit in the absence of a quality inspector or engineer. Thus, a significant gap in current capabilities is the ability to manufacture parts on-orbit and then automatically qualify them for use.

[0016] This specification discloses various additional known methods and apparatus related generally to apparatus and methods related to the manufacturing arts, and more particularly to the automated production and / or qualification of apparatus and / or apparatus components, although all are limited in some aspects.

[0017] Each of the above patents and published patent applications is incorporated herein by reference. Summary of the Invention

[0018] The present disclosure overcomes and substantially alleviates deficiencies in the prior art by providing improved apparatus and methods related generally to the field of manufacturing, and more particularly to the automated production and / or qualification of equipment and / or equipment components. In various aspects, the present disclosure is an improved manufacturing technique that enables semi-automated or automated, on-demand, point-of-use production and / or qualification of equipment and equipment components. The improved manufacturing technique rapidly produces fully qualified parts by integrating automated manufacturing with a series of pre-processing, in-processing, and / or post-processing inspection, evaluation, and / or qualification capabilities. In embodiments, the improved automated manufacturing technique produces parts and automates the subsequent inspection process, delivering a product that is certified and ready for use upon completion of production without the need for further quality inspection or manual intervention.

[0019] In some embodiments, the improved automated manufacturing techniques disclosed herein allow for the remote manufacturing of qualified components without the physical presence of a quality inspector or technician, which is of great benefit to industries that require distributed production of products to strict quality specifications, i.e., medical devices or satellite components.

[0020] In embodiments, after automated production, the system then enables immediate automated inspection and qualification of the produced product for use at a remote location. In embodiments, the improved manufacturing techniques disclosed herein provide improved quality functionality, including part and / or assembly-specific data persistence. This is key to manufacturing parts and assemblies with full manufacturing traceability, meaning that data related to the manufacturing of a specific part and / or assembly can be traced back to that part and / or assembly after the fact. For example, in embodiments, the system automatically stamps and / or labels parts printed using automated manufacturing techniques with a unique identifier code at the time of manufacturing. Data related to the manufacturing of that specific part is then stored and can be traced back to that specific unique identifier code. For example, if the system tracks the ambient temperature in a production environment (e.g., build room, stockroom, outside environment), the system enables the ability to track the exact temperature during the printing of that specific part. In embodiments, other collected data is similarly stored to enable search by specific unique identifier code (i.e., part number). In embodiments, the technology enables data persistence for all relevant data generated during the manufacturing of a part, assembly, and / or lot. In embodiments, this is key to producing parts and assemblies with full manufacturing traceability.

[0021] In embodiments, the improved manufacturing techniques disclosed herein have integrated environmental controls to detect and / or correct changes in their manufacturing environment (e.g., storage chamber and / or build chamber). Environmental management provides benefits by enabling quality production of parts in remote and / or unmonitored environments. By better monitoring and / or correcting these variables (e.g., ambient temperature in the build chamber), the system can more accurately predict manufacturing output (e.g., cooling time of previously printed layers). In embodiments, the environmental sensors and / or regulators include sensors and / or regulators for temperature, humidity, particulates, pressure (e.g., specific equipment sections, external environment, internal pressure, differential pressure), light and / or other radiation exposure, orientation, structural integrity, gas measurements, equipment component location, bioburden, contamination levels, airflow, and / or vibration. In embodiments, the improved manufacturing techniques include environmental sensors integrated into their print chamber, storage area, external case, and / or other areas of the equipment housing. In conjunction with environmental conditioners (e.g., heaters, air conditioners, heat pumps, humidifiers, dehumidifiers, filters, disinfectants), this allows the equipment to track and / or optimize one or more portions of the production environment. For example, a room heater can control the ambient temperature to allow for more consistent extrusion under AM. In embodiments, one or more portions of the production environment are kept at a positive pressure relative to the outside environment to allow the equipment and / or build area to function similarly to an enclosed clean room. In some embodiments, the equipment is separately maintained and / or certified as a clean room (e.g., under ISO standards).

[0022] In embodiments, the improved manufacturing techniques disclosed herein include component input analysis capabilities. The output of automated manufacturing techniques is highly dependent on the input components. Additionally, unlike current standard methods, in embodiments, the improved manufacturing techniques include an integrated material inspection process to increase confidence that the produced parts and / or assemblies will meet output requirements. For example, filaments used in 3D printing machines have specific diameter dimensions (e.g., 1.75 mm, 2.85 mm). If the input filament diameter is out of tolerance (e.g., above or below the diameter expected by manufacturing tolerances), the overall dimensions and volume of the AM part are subsequently affected. To ensure the input filament is of an acceptable diameter and meets specifications, in embodiments, the system incorporates an integrated filament measurement sensor. This sensor ensures that the raw filament consistently falls within acceptable tolerances to avoid under- or over-extrusion. In embodiments, the filament measurement tool is a physical diameter measurement device and / or an optical micrometer. In embodiments, this sensor is used for pre-processing inspection to ensure that the filament diameter is consistently within tolerance. In an embodiment, component input analysis capabilities include assessment of mass, temperature, humidity, durometer, diameter, color, chemical composition, and / or shape of the raw material.

[0023] In embodiments, the improved manufacturing techniques disclosed herein include one or more automated manufacturing technologies (e.g., AM, SM) with one or more automated manufacturing operation systems. In embodiments, the automated manufacturing operation system functionality includes self-calibration, as is common in many existing systems to ensure equipment performance. However, unlike standard automated manufacturing techniques, in embodiments, the improved manufacturing techniques also have 100% data persistence due to self-calibration, ensuring that applicable data is preserved for later quality assessment based on component individual part, assembly, and / or lot number. Automated manufacturing technologies are well known in the art and include single-axis to multi-axis systems that further encompass build plate motion systems. For example, in embodiments, the AM subsystem includes an AM printer motion system that is integral to the system's ability to move the printer head and produce parts. In some embodiments, the AM printer head can move both side-to-side and front-to-back, while the build plate can move up and down. With this arrangement, the kinematic capabilities of this mechanical system enable three-dimensional AM printing. In some embodiments, the automated manufacturing operations system includes a multi-head tool changer that can retrieve and utilize system tool heads (e.g., print heads, CNC heads, probing tools).

[0024] In embodiments, the improved manufacturing techniques disclosed herein uniquely integrate existing automated manufacturing technologies with a suite of automated and / or semi-automated inspection and associated quality testing capabilities. This complete integration and approach provides a novel solution to the problem of remotely manufacturing fully qualified components. Thus, in embodiments, the improved manufacturing techniques provide a ready-to-use solution that provides complete end-to-end component production and qualification. In embodiments, the automated and / or semi-automated inspection and associated quality testing capabilities occur pre-processing, during processing, and / or post-processing.

[0025] In embodiments, the improved manufacturing techniques disclosed herein include an automated manufacturing operation system that enables the system to print on multiple materials, including filament types such as PLA, ABS, PETG, nylon (polyamide synthetic resin), TPE, TPU, TPA, wood, HIPS, PVA, PET, metal fiber, PLA carbon fiber, lignin, polycarbonate, copolyester, conductive (e.g., graphite plastic blends), wax, PETT, ASA, PP, acetal, PMMA, acrylic, sandstone, glow-in-dark plastic, cleaning materials, PC-ABS, magnetic (e.g., PLA blends), color changing (e.g., plastic blends), nGen, TPC, PORO-LAY, FPE, aluminum alloys, stainless steel, tool steel, titanium alloys, cobalt-chromium superalloys, nickel superalloys, precious metals, other metals, composites, conductive filaments, support filaments, biodegradable filaments, and / or other commercially available filaments. In these embodiments, this has the ability to utilize high temperature materials for printing (eg, high temperature polymers, polysulfone).

[0026] In embodiments, the improved manufacturing techniques disclosed herein integrate automated manufacturing techniques with semi-automated and / or automated inspection subsystems, which in embodiments include one or more inspection fixtures.

[0027] In an embodiment, an example of an inspection tool is a reflective laser scanner capable of measuring relative and / or absolute distances between scanned surfaces. This inspection tool allows for rapid scanning of identified layers immediately after they are produced (e.g., from an automated manufacturing technology subsystem). In an embodiment, the scanner emits a beam of light that sweeps across the identified object and then reflects back to the scanner, providing the geometric shape of the printed layer. This allows for a non-contact measurement method that records precise positions and distances. In an embodiment, an example of an inspection tool is an optical inspection tool (e.g., a camera) that allows for the capture of photographic data (e.g., high-quality photographs). This inspection tool allows the system to provide a means for visual inspection. In an embodiment, an example of an inspection tool is a probe for physical inspection (e.g., tactile). In an embodiment, an example of an inspection tool is a bioburden sensor (e.g., involving filtration, incubation, and / or enumeration).

[0028] In embodiments, an automated manufacturing motion system (e.g., used for AM and / or SM production) also moves one or more inspection tools. In other embodiments, one or more inspection tools have their own motion system and / or utilize motion from the manufacturing bed. In embodiments, one or more inspection tools are integrated into a multi-tool. Conventional multi-tool capabilities for printing and / or manipulating different material types are common in many automated manufacturing technologies. However, evaluation and testing tools associated with such technologies in current technology are non-existent or very limited. In embodiments, the improved manufacturing techniques disclosed herein utilize a multi-tool system to additionally provide one or more inspection tools in addition to the automated manufacturing technology. In some embodiments, one or more inspection tools are not part of a multi-tool but are otherwise integrated into the device (e.g., a static scanner that functions in conjunction with the movement of the manufacturing bed).

[0029] In embodiments, the improved inspection techniques address a wide range of challenges in AM part inspection due to the wide range of shapes and complex geometries possible, including parts that cannot be fully physically inspected after build completion (e.g., hollow cavities within a part that cannot be reached after production by a probe). In embodiments, the improved manufacturing techniques disclosed herein enable inspection at various points during the build (e.g., physical probe inspection mid-build), thereby enabling evaluation of these types of areas as well as real-time quality test data not currently available on AM presses. In embodiments, the improved manufacturing techniques also include one or more additional machine sensors (e.g., build volume, build plate, and / or nozzle temperature, extrusion pressure to ensure layer consistency, bioburden, sterilization markers). In embodiments, the sensor data for the improved manufacturing techniques includes 100% persistent data logging by part and / or lot number, which is not available with current technology.

[0030] In embodiments, the improved manufacturing technology includes an array of one or more automated and / or semi-automated inspection processes and / or methods. In embodiments, this enables full inspection, traceability, and / or reporting upon print completion. For example, in embodiments, each manufactured component is automatically marked for traceability with an individual part and / or lot number (e.g., a unique identifier code). In embodiments, the improved manufacturing technology utilizes an inspection multi-tool and / or associated capabilities (e.g., 3D scanning, physical probing, photogrammetry, structured light, laser triangulation) to evaluate the final product. This allows the software to perform automated analysis and generate a Certificate of Conformance and / or associated report if the final part meets pre-established individual quality inspection parameters. In embodiments, parts that do not meet quality inspections are automatically discarded and / or quarantined, held for manual approval (e.g., remote and / or on-site), and / or not provided to users (i.e., to prevent unqualified components from leaving the equipment). In embodiments, the quality process allows for full traceability and 100% data sustainability, inspecting component level data on everything manufactured, with end-of-line user access. In embodiments, this ensures full end-to-end traceability from raw materials to the final produced part or equipment, which in embodiments is included in a final report identifying whether a component passed inspection.

[0031] In embodiments, the improved manufacturing techniques disclosed herein include one or more main processing computers. In embodiments, the improved manufacturing techniques include one or more microcontrollers (e.g., for controlling the operating system). In embodiments, the improved manufacturing techniques further include one or more single-board computers (e.g., to serve as a Web UI and handle tasks requiring more memory or computing power, such as calculating complex kinematic movements). In embodiments, these components work together to collect data, which is provided to the main processing computer.

[0032] In an embodiment, the software is programmed to collect sensor readings as well as print progress data from the 3D printer. The data collection system can capture all identified parameters (e.g., at a frequency of 1 second intervals).

[0033] In embodiments, the inspection subsystem includes expected representation software tailored to develop an accurate three-dimensional (3D) representation of the expected produced component and / or assembly based on an input computer software model (e.g., a CAD model) based on the selected automated manufacturing technology being used. In traditional automated manufacturing production, there are subtle differences in geometry when comparing the input CAD model to the physical output part and / or assembly created from that model. For example, small AM artifacts (intermediate products), such as layer lines, are common in any production. Using a representation based on an idealized CAD model of the produced part leads as the basis for automated inspection would lead to false-positive inspection issues when the system detects these artifacts that are expected based on the manufacturing method. To overcome this challenge with current technology, in embodiments, the expected representation software disclosed herein converts coordinates within the CAD model into a point cloud (e.g., a digital 3D representation of the physical object) that serves as a 3D "map" of the ideal output of the printer based on known printer functionality. Each layer is modeled to represent an ideal extrusion, including details such as fill patterns (if applicable) used to reinforce the structure. This representation can then be used to compare with the actual output using an inspection tool (e.g., scanning the print layers extruded by the AM system), allowing a determination to be made whether the produced part meets established inspection criteria.

[0034] In embodiments, the improved manufacturing techniques disclosed herein additionally include cybersecurity measures to ensure the system is not compromised, reduced weight and volume for launch, and / or modifications for zero gravity. In embodiments, the improved manufacturing techniques include additional modifications for operational use during fully unmanned missions, including ensuring the system is compatible with robotic extensions to collect, assemble, and / or implement produced and / or approved parts, as needed. In embodiments, the improved manufacturing techniques uniquely integrate with existing methods currently used in FFF AM and / or are diagnostically adapted for other types of manufacturing, meaning they can be used with a wide range of commercially available technologies.

[0035] In embodiments, the improved manufacturing techniques disclosed herein additionally include a user interface to facilitate user interaction with the device. In embodiments, this user interface is one or more of the user interfaces common in the art (e.g., graphical user interface, command line interface, menu-driven, touch interface, human voice, form-based, natural language, tangible user interface, conversational user, menu, natural user interface, window, biometric interface, IEEE 1394 interface, macOS, iOS, Android, Linux, etc.). In embodiments, the user interface is physically connected to the improved manufacturing technology and / or provides a remote connection.

[0036] In embodiments, in addition to the commonly utilized computer-aided design (CAD) files that communicate the physical structure of a part selected for production to an automated manufacturing technology (e.g., AM, SM components), the improved manufacturing technology disclosed herein includes accompanying software data (e.g., included in the same file or separately) that communicates the inspection, test, and / or production requirements for that part to the system. This allows for automated production and qualification of production parts through the same system. In embodiments, the accompanying software consolidates information that is typically separate in engineering files (e.g., tolerances, finish) and / or functional requirements that are found in other specification documents (e.g., durometer, color) into one complete software file or set of files for uploading to the system, enabling automated quality assurance activities.

[0037] In embodiments, the improved manufacturing techniques disclosed herein include a comprehensive, integrated, and semi-automated and / or automated quality monitoring system. In embodiments, this includes 100% continuous data logging of system performance (e.g., temperature, acceleration, speed, encountered forces). In embodiments, this includes equipment build inspection from raw materials, through processing, to final build. In embodiments, periodic inspections throughout the build process (e.g., part geometry) are custom programmable and / or automated based on configuration software, as needed. In embodiments, this extends to the complete installation qualification (IQ), operational qualification (OQ), and / or performance qualification (PQ) processes.

[0038] In some embodiments, the system software can automatically change the frequency and complexity of inspections based on past and current build results. For example, if some parameters are found to be non-critical and consistently achieved by the equipment, the improved manufacturing techniques disclosed herein automatically reduce disruptive quality check processes, thus increasing build speed without reducing quality assurance. If minor variations (such as process creep) are found, the system automatically increases quality inspections to ensure product specifications are met.

[0039] In embodiments, the improved manufacturing techniques disclosed herein provide automated, real-time, and / or in-process corrective and preventative actions (CAPA). For example, in embodiments, the manufacturing techniques inspect critical features layer by layer using various inspection tools. If inspection identifies a nonconformance, the equipment automatically increases inspection rates to ensure consistency. Furthermore, in embodiments, if a nonconformance is detected, the equipment can automatically determine whether there are corrective actions available, such as using subtractive manufacturing to modify dimensions or changing printing parameters to correct the problem on subsequent layers. In embodiments, the improved manufacturing techniques also take the next step to implement automated preventative actions to reduce the chance of repeat issues. If a nonconformance is discovered, the equipment has several methods to ensure the remainder of the process and all overlapping parts are manufactured to specification. Examples include variations in extrusion width, applied layer height, temperature compensation, extrusion pressure variations, and / or increased inspection.

[0040] In embodiments, the improved manufacturing techniques disclosed herein include one or more automated and / or semi-automated post-production inspection tools and / or processes based on preset individual quality inspection parameters. In embodiments, this means that the system can produce and test components and / or assemblies to meet the strict standards and regulations set forth by FDA, cGMP, ISO 13485, and / or AS9100. Furthermore, in embodiments, these inspection processes, techniques, and / or specifications can be preset and / or modified in real time based on production feedback or changes in desired output. In embodiments, the improved manufacturing techniques can function anywhere a signal can be transmitted, including in orbit, in distributed hospitals, or other locations.

[0041] In embodiments, the improved manufacturing techniques disclosed herein include an outer housing. In embodiments, the outer housing provides protection for the internal components. In embodiments, the outer housing provides durability and / or protection against one or more of moisture, physical tampering, dropping, vibration, heat, cold, air pressure, vacuum pressure, contamination, and / or radiation. In embodiments, the outer housing houses all additional electronics and materials necessary for production of the part and / or assembly.

[0042] In embodiments, the improved manufacturing techniques disclosed herein enable automated, on-demand, point-of-use production of human-usable surgical instruments for use by surgical teams in austere environments. The improved manufacturing techniques produce fully qualified, human-usable surgical instruments (e.g., scalpel handles, Kelly forceps, retractors), enhancing surgical capabilities and contributing to improved mobility. It also reduces the storage burden of such instruments in both military and civilian settings.

[0043] In embodiments, the improved manufacturing techniques disclosed herein rapidly produce fully qualified surgical instruments by integrating a series of automated inspection and associated quality testing capabilities into additive manufacturing (AM). For medical devices, all aspects of design, development, and manufacturing must be performed under GMP and QMS processes in accordance with FDA requirements, which have previously prevented the rapid 3D printing of medical devices requiring human intervention. The improved manufacturing techniques overcome this challenge with a series of pre-, in-, and / or post-processing inspection, evaluation, and / or qualification capabilities. In embodiments, the improved manufacturing techniques can produce parts under GMP / QMS and automate the subsequent inspection process, delivering a certified, ready-to-use product at the completion of production without the need for further quality inspection or manual intervention.

[0044] In embodiments, to manufacture fully qualified, human-usable surgical instruments and / or other medical devices, a user first selects the specific item needed from a portfolio of possible devices using a manufacturing equipment interface. In embodiments, the stand-alone manufacturing equipment resembles a standard 3D printing machine and uses Fused Filament Fabrication (FFF) and Computer Aided Design (CAD) files to manufacture the selected surgical instrument. In embodiments, the improved manufacturing techniques disclosed herein have additional capabilities. For example, unlike standard 3D printing machines, in embodiments, the improved manufacturing techniques have 100% data persistence, ensuring all data is stored and / or transmitted for later quality assessment based on the device's individual part and / or lot number (e.g., unique identifier code). This is key to producing parts and devices with full manufacturing traceability. In embodiments, the improved manufacturing techniques have integrated probes for physical inspection, optical inspection, and / or laser scanning inspection (e.g., to evaluate the construct during and / or after manufacturing). In embodiments, the improved manufacturing techniques include an array of additional automated post-manufacturing inspection tools and / or processes to allow for full inspection, traceability, and / or reporting upon printing completion.

[0045] In embodiments, an advantage of the improved manufacturing techniques disclosed herein is the ability to produce parts using biocompatible materials. In embodiments, an advantage of the improved manufacturing techniques is the ability to produce parts using materials that can be subsequently sterilized (e.g., autoclave, chemicals, gases, ionizing radiation, dry heat, liquid chemicals, perforating acids, filtration, microwaves, glass beads, vaporized hydrogen peroxide, and / or other sterilization methods).

[0046] For example, in embodiments, parts are printed from PPSU (polyphenylsulfone), a high-performance, high-temperature polymer. PPSU has been evaluated for biocompatibility in accordance with ISO standards 10993-1, 10993-4, 10993-5, and 10993-18, meeting regulatory requirements for skin and tissue contact for up to 24 hours, and indirect blood contact, where applicable. Additionally, PPSU is extremely stiff and possesses good mechanical properties for replicating metal parts.

[0047] In embodiments, the improved manufacturing techniques disclosed herein manufacture parts via print-in-place models, allowing entire mechanical assemblies to be 3D printed in a single piece without the need for secondary assembly. In embodiments, this means that improved manufacturing techniques medical devices (e.g., surgical instruments printed with PPSU) are ready for use once sterilized, separate from the build plate. In embodiments, sterilization is integrated with and / or occurs as a semi-automated and / or automated step within the improved manufacturing techniques. In embodiments, sterilization is via ethylene oxide, chlorine dioxide, nitrogen dioxide, hydrogen peroxide vapor, peracetic acid vapor, e-beam, x-ray, gamma ray, autoclave / steam, dry heat, supercritical carbon dioxide, and / or nitric acid.

[0048] In embodiments, the improved manufacturing techniques disclosed herein have the capability to perform partial and / or full assembly of devices post-part production. Automated assembly capabilities are well known in the art and, in embodiments, are either partially or fully integrated into the improved manufacturing techniques. Examples of this automated assembly capability include robots, assembly mechanisms, fixed automation, robotic assembly, welding, conveyors, dial indexers, flexible automation, machinery, adhesive supply, carousel assembly systems, CNC milling, CNC motion control, collaborative robotics, control systems, dial assembly, flexible manufacturing systems, full automation, Internet of Things, dilute automation, material handling, quality control, semi-automation, vision systems, and / or sterilization. For example, in embodiments, produced parts are placed via the automated assembly capability into bags equipped with a sterilizing agent (e.g., chlorine dioxide). The bags are automatically labeled by the improved manufacturing techniques, and the produced product is contained within a labeled, FDA-compliant storage bag for sterilization.

[0049] In embodiments, the improved manufacturing techniques disclosed herein may be distributed to hospitals and / or other sites for decentralized production of medical devices (e.g., surgical instruments). In embodiments, users may select from a library of FDA-regulated devices to enable automated, on-demand manufacturing for immediate use.

[0050] In embodiments, the improved manufacturing techniques disclosed herein enable on-demand, decentralized production of braces, splints, and / or casts to accelerate recovery from musculoskeletal injuries. In embodiments, the improved manufacturing techniques produce braces, splints, and / or casts personalized to an individual patient (e.g., patient dimensions, anthropometry), injury site (e.g., ACL, lateral ankle, proximal ankle inter-joint, etc.), side (i.e., left or right), and / or type (e.g., Grade I-III sprain, etc.) that facilitates healing from the musculoskeletal injury. In embodiments, the improved manufacturing techniques reduce the burden of administering and / or storing braces, splints, and / or casts.

[0051] In embodiments, to manufacture a brace, splint, and / or cast, a provider first inputs patient-specific data into an improved manufacturing technology manufacturing device. In embodiments, the stand-alone manufacturing device has a small operational footprint and / or can be distributed according to anticipated need (e.g., in one or more first aid stations, private urgent care, emergency departments, and orthopedic clinics). In embodiments, the provider inputs the actual or estimated dimensions of the patient's affected body part (e.g., ankle) into the system using standard anthropometric measurements and / or an integrated scanner. In embodiments, the dimensions can be specific (e.g., circumference measurement) and / or more general (e.g., small, medium, large). In embodiments, the specific injury type (e.g., lateral Grade II sprain) is also input.

[0052] In embodiments, the remainder of the production of the brace, splint, and / or cast is fully automated. The improved manufacturing techniques disclosed herein automatically convert input information into a personalized, optimized, patient-specific brace. In embodiments, the individualized brace is then robotically produced directly by the system.

[0053] In embodiments, the improved manufacturing techniques disclosed herein utilize a method for high-strength, bonded, direct-to-garment additive manufacturing, where fused elements are 3D printed directly onto a pliant textile material. In embodiments, the improved manufacturing techniques utilize a nonwoven fabric with the same raw materials used for additive manufacturing, so the original printed material is the same as a coating on the nonwoven fabric. This allows the heat from the extrusion to permanently fuse the components together, producing a single unit and resulting in a strong product. For example, in embodiments, the improved manufacturing techniques utilize a thin layer of thermoplastic polyurethane (TPU), a flexible and versatile polymer, first applied to a selected nonwoven fabric with a special weave that is strong, durable, lightweight, and resilient. In embodiments, the TPU is also used as a filament for 3D printing, so the printed raw material is the same as a coating on the nonwoven fabric. The TPU is then 3D printed directly onto the coated nonwoven fabric, and the heat from the extrusion permanently fuses the components together. In contrast, other methods for 3D printing on nonwovens involve taking a loosely woven mesh nonwoven and extruding the 3D printed filament through (rather than onto) the nonwoven. These other methods are less reproducible and result in weaker products, reflecting the differences between stitching versus welding.

[0054] In embodiments, the improved manufacturing techniques disclosed herein enable the automated production of complex additively manufactured structures on a flexible woven fabric, enabling a myriad of possible brace, splint, and / or cast configurations. In embodiments, the improved manufacturing techniques use an integrated laser cutter to cut each specific brace, splint, and / or cast from a uniform feeder woven fabric. In embodiments, this allows for customization of the brace to a specific patient and their anatomy, with a myriad of possible shapes and sizes. In embodiments, this complete end-to-end manufacturing process is fully automated without requiring manual intervention by the provider. In embodiments, the improved manufacturing techniques integrate automated additive manufacturing (AM) and laser cutting functionality with serial scanning, inspection, and / or qualification capabilities to produce individualized braces, splints, and / or casts tailored to individual bodies and injury types.

[0055] In embodiments, the improved manufacturing techniques disclosed herein enable distributed production and qualification of components in the space environment. In embodiments, this includes components for in-space servicing, assembly, and manufacturing (ISAM). In various embodiments, this includes parts and / or assemblies for on-orbit servicing, maneuvering, debris removal, and / or related space virtual support. Satellites and related space components require production with stringent testing requirements. In embodiments, the improved manufacturing techniques support the process of producing space infrastructure. Use cases for on-orbit manufactured parts include: post-launch designed and / or manufactured in-space to enable servicing from another spacecraft (e.g., by modifying or adding standard interfaces), manufacturing ports and / or defensive mechanisms to prevent enemy use of interfaces, replacement and / or repair of damaged surfaces or components, manufacturing replacement parts to support rendezvous proximity operations (RPO), and / or servicing on-orbit objects by part manufacturing and / or onboard another spacecraft.

[0056] Methods and apparatus relating to manufacturing techniques have been shown and described herein. While particular embodiments of the present disclosure have been described, the present disclosure is not intended to be limited thereto, as the disclosure is intended to encompass the breadth of the art and the specification is intended to be read in the same manner.

[0057] Although the improved manufacturing techniques disclosed herein have been described with a certain degree of particularity, it will be apparent that many changes may be made in the details of construction and the arrangement of components without departing from the spirit and scope of the present disclosure. It will be understood that the present disclosure is not limited to the embodiments set forth herein for illustrative purposes, and that elements of particular embodiments may be combined with elements of other embodiments. Additional objects, advantages, and novel features of the present disclosure will be set forth in the following description, or will become apparent to those skilled in the art upon review of the following detailed description and drawings. It will be understood that not all of the described features need be incorporated into a given system or method. [Brief explanation of the drawings]

[0058] [Figure 1] FIG. 1 is a flow chart illustrating a method for an improved manufacturing technique according to one embodiment of the present disclosure. [Figure 2] FIG. 2 is a flow chart illustrating a method for an improved manufacturing technique according to one embodiment of the present disclosure. [Figure 3] FIG. 3 is a schematic diagram of an improved manufacturing technique (IMT) according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0059] Referring to the drawings, FIG. 1 generally illustrates one embodiment of portions of the present disclosure. This embodiment may be adapted to suit standard automated manufacturing technology workflows known in the art (and not described herein). In this embodiment, an improved manufacturing technology (IMT) 100 is initially initiated in step 101 (e.g., by an end user at a distributed location external to the manufacturer who is responsible for product quality). In embodiments, feedstock may be added to the IMT in step 102 before and / or after step 101. In embodiments, the IMT 100 has similar functionality to a standard paper printing press, such as a graphical interface, insertion of feedstock (e.g., filament), etc.

[0060] Next, the IMT 100 performs a system check in step 103. In an embodiment, the system check verifies one or more of a power check, a sensor check, an environmental sensor check, a temperature check, a filament diameter check, an empty production bed check, an operating system check, a probe check, a level check, a pressure check, a bioburden check, a connectivity check, a storage room check, a manufacturing bed check, etc. If the system check 103 fails, the user can attempt to troubleshoot the problem in step 104 and then repeat the system check 103.

[0061] If system check 103 passes, in embodiments, the user may select a desired product in step 110 (e.g., from a product list on a graphical user interface). In embodiments, the desired product includes device components and / or a complete device. The system then generates a unique identifier code (UIC) (e.g., a unique device identifier under FDA guidance) for the produced product in step 111. In embodiments, the UIC is labeled and / or permanently placed (e.g., engraved and / or embossed) on each individually manufactured product during the manufacturing product process. For example, in one embodiment, the UIC is embossed in a special area designed for product tracking through the use of additive manufacturing, which automatically adds the UIC to the product in addition to the standard product geometry outlined by its CAD file.

[0062] The manufactured product processing 112 occurs as described elsewhere herein. In an embodiment, the manufactured product processing 112 includes the use of one or more automated manufacturing techniques, and the processing occurs within a production subsystem (e.g., an automated manufacturing operating system, a production bed with multi-tool capabilities).

[0063] Before, during, and / or after manufactured product processing 112, pre-processing testing in step 113, in-processing testing in step 114, and / or post-processing testing in step 115 are performed. These processes are performed as described elsewhere herein. In embodiments, these testing steps include the use of one or more automated inspection techniques (e.g., laser scanners, physical probing, photogrammetry, structured light, laser triangulation, temperature sensors, pressure sensors).

[0064] The quality data generated from each individual product build is then compared to product-specific quality parameters previously determined by manufacturing in step 120. For example, in an embodiment, this comparison includes comparing laser scan data to pre-set geometric data with approved tolerances. Another example includes comparing environmental sensor data to approved ranges (e.g., manufacturing bed temperature).

[0065] If the produced product fails the comparison in step 120, the product is quarantined in step 122. In an embodiment, step 122 involves physically isolating the failed product so that it is physically unavailable to the end user. In an embodiment, this involves placing such product in a "trash" area by IMT 100. In other embodiments, the failed product may still be available to the user, but a warning (electronic or otherwise) notifies the user that the product has been quarantined (i.e., should not be used).

[0066] If the produced product passes comparison 120, the product is sent to the user in step 121. In embodiments, the product is one or more of: made available to the user for use (e.g., made available for removal from the manufacturing environment); physically dispensed from the IMT 100 (e.g., as in a vending machine); or dispensed within an outer cover (e.g., dispensed in packaging such as a bag or box). In embodiments, the packaging can facilitate subsequent sterilization. Examples of packaging include autoclavable, double-bagged, gas-permeable barriers (e.g., ethylene oxide, chlorine, chloramine, etc.), bagged with a chemical disinfectant (e.g., chlorine dioxide), equipped with sterilization sensor(s) (e.g., autoclave indicator tape), and / or capable of receiving ionizing radiation. In embodiments, product sterilization is directly integrated with the IMT 100, resulting in an facilitated, semi-automated, and / or fully automated portion of the process. In embodiments, additional materials are dispensed to the end user during step 121. Examples include automatic printing of Instructions for Use (IFU) and / or device-specific labeling (eg, on supplied packaging).

[0067] Finally, in an embodiment, data generated during the production of a particular product is maintained by the UIC in step 123. In an embodiment, this data is maintained locally and / or transmitted remotely to a remote manufacturer responsible for quality monitoring.

[0068] 2 generally illustrates one embodiment of portions of the present disclosure. In an embodiment, this embodiment may be adapted to suit within a quality manufacturing workflow (e.g., ISO 13485, cGMP, ISO 9001, and / or AS9100) well known in the art (not described herein). In this embodiment, a central manufacturing responsible for quality assurance first designs the product and defines its requirements in step 200. In an embodiment, this process follows a standard workflow for device and / or component design and development well known in the art.

[0069] Next, the initial geometric coordinates are uploaded to the IMT in step 201. In an embodiment, this step includes uploading CAD files and / or their processed derivatives (e.g., stl files) to the IMT, for example, for automated manufacturing.

[0070] The IMT then facilitates manufacturing products with varying input metrics to assess the desired manufacturing range, step 202. In an embodiment, this step involves varying key parameters, for example, to produce multiple iterations of a single product for subsequent testing. For example, the temperature within the IMT 100 may be intentionally varied by degrees (i.e., hotter and colder). In another example, multiple iterations of a single product may be produced, which will naturally result in variations in certain dimensions.

[0071] Next, in step 203, quality assurance (QA) testing is performed by the manufacturer on the produced product iterations. In embodiments, this is done via an established testing protocol, which may vary from product to product based on the product requirements defined in step 200. For example, a product may have a certain strength it must maintain for a particular use defined by the requirements. This testing step 203 utilizes existing testing methods known in the art to determine whether iterations produced from the selected product meet the requirements (e.g., by applying a selected force to a selected area and measuring damage). Examples of testing include benchtop testing, simulation testing, live animal testing (e.g., biocompatibility, safety, efficacy), and actual use testing (e.g., clinical trials, live rocket launch tests).

[0072] The data from step 203 is then utilized to define product-specific quality parameters in step 204. In an embodiment, for example, the aforementioned tests may provide a range of quality parameters that result in the production of individual product iterations that pass all required test parameters. These quality parameters that the IMT 100 is capable of measuring can then be selected as final quality specifications and used in place of other tests (e.g., benchtop force tests that the system cannot perform) for ongoing manufacturing quality monitoring. For example, if the tests indicate that all iterations of a particular product produced within a certain range of quality parameters will result in a product that passes the required tests, the IMT 100 will pass or fail the produced product based on those quality parameters.

[0073] The product specifications (CAD and quality) defined in the previous step are then configured and uploaded to the end-user facing IMT device in step 205. In an embodiment, the approved product can then be selected by the end user for manufacturing according to the process described in connection with FIG.

[0074] 3 is a schematic diagram of an improved manufacturing technology (IMT) system according to one embodiment of the present disclosure. The manufacturing system 300 may include a software / controller system 302 configured to operate software to control system functions. The software / controller system 302 may include one or more central processing units 304 and a data storage device 306. The software / controller system 302 may also operate a semi-automated and / or automated quality monitoring system 308 as described herein. Expected rendering software 310 may also be operated by the software / controller system 302 as described above.

[0075] System 300 may also include a storage room 312 and a build room 314. Storage room 312 stores input materials 316 used in manufacturing the parts and may include input material inspection functionality 318, as described herein. Build room 314 may define a production environment 320 in which the parts are manufactured. A production subsystem 322 associated with build room 314 may operate automated manufacturing technology 324 that manufactures the parts, and an inspection subsystem 326 may include one or more inspection tools 328 and provide component input analysis functionality 330, as described herein. An environmental control system 332 may include one or more environmental sensors 334 and / or environmental regulators 336 to monitor and / or control the production environment 320 within build room 314.

[0076] System 300 may also have many additional features and / or capabilities. For example, system 300 may have a remote connection feature 338 for establishing communication and / or data transfer with remote devices using appropriate electronics. An outer housing 340 may enclose and protect the physical components of system 300, as described above. A user interface 342 may be provided on outer housing 340 for control purposes. Additionally or alternatively, user interface 342 may be remotely operated to control system 300 via remote connection feature 338. A disposal and / or isolation room 344 may be provided for parts that fail certain qualification checks described herein. One or more products 346, such as parts, assemblies, or components, may also be present in system 300 once such products 346 are manufactured. System 300 may also have manufacturing traceability capabilities 348, as described herein.

[0077] In one embodiment, a manufacturing system utilizes one or more automated manufacturing technologies to enable remote manufacturing of qualified components. The system may include at least one build chamber defining a production environment therein. At least one environmental sensor and / or regulator may be configured to provide integrated environmental control capable of detecting changes in the production environment within the build chamber and / or modifying the production environment within the build chamber. The production subsystem may include at least one automated manufacturing technology configured to manufacture products within the production environment. The inspection subsystem may include at least one inspection tool, the inspection subsystem configured to inspect manufactured products for compliance with one or more standards. The at least one processor may be configured to verify compliance of the manufactured products with the one or more standards.

[0078] In some embodiments, the at least one processor is configured to qualify the components in the physical absence of a quality inspector or technician.

[0079] In some embodiments, the at least one processor is configured to automatically qualify the produced components according to certain quality standards and / or regulations.

[0080] In an embodiment, the inspection subsystem is configured to analyze one or more input components of at least one automated manufacturing technology.

[0081] In an embodiment, one or more input components may be analyzed by the inspection subsystem to determine the mass, temperature, humidity, durometer, diameter, color, chemical composition, and / or shape of the input components.

[0082] In an embodiment, the at least one processor is configured to provide a unique identifier code for the manufactured product.

[0083] In an embodiment, the at least one processor is further configured to store data about the product from raw materials to manufactured product to enable traceability of the manufactured product based on the unique identifier code.

[0084] In embodiments, the at least one environmental sensor and / or regulator is configured to sense and / or correct one or more of temperature, humidity, particulates, pressure, light and / or other radiation exposure, orientation, structural integrity, gas measurements, device component location, bioburden, contamination levels, airflow, and vibration.

[0085] In an embodiment, the inspection subsystem comprises one or more of a reflective laser scanner, an optical inspection tool, a probe for physical inspection, and a bioburden sensor.

[0086] In an embodiment, the at least one processor is configured to automatically discard and / or quarantine a manufactured part, hold it for manual approval, and / or not provide it to a user if the manufactured part does not comply with one or more criteria.

[0087] In an embodiment, the at least one processor is configured to operate expected representation software to develop a three-dimensional representation of the expected product based on the input computer software model.

[0088] In an embodiment, the inspection subsystem is configured to compare the manufactured product with a three-dimensional representation of the expected product.

[0089] In an embodiment, the system further comprises an outer housing that houses at least one build chamber, at least one environmental sensor and / or regulator, the production subsystem, and the inspection subsystem.

[0090] In an embodiment, the system further comprises a user interface disposed on the outer housing to facilitate user interaction with the system.

[0091] In one embodiment, a method for manufacturing a product can include receiving instructions to manufacture a product, detecting and correcting at least one environmental factor in a production environment, and manufacturing the product in the production environment using at least one automated manufacturing technique based on the received instructions. The manufactured product can be automatically inspected for conformance with one or more standards, and based on the inspection, the manufactured product can be automatically verified for conformance with the one or more standards.

[0092] In an embodiment, the automatic inspection and automatic verification of manufactured products is performed in the absence of a quality inspector or technician physically present.

[0093] In embodiments, one or more input components of at least one automated manufacturing technology may be inspected, including determining one or more of the mass, temperature, humidity, durometer, diameter, color, chemical composition, and / or shape of the input component.

[0094] In an embodiment, manufactured products may be provided with a unique identifier code.

[0095] In an embodiment, product data can be stored from raw materials to manufactured products to enable traceability of manufactured products based on the unique identifier code.

[0096] In embodiments, if a manufactured part does not conform to one or more criteria, the manufactured part may be automatically discarded and / or quarantined, held for manual approval, and / or not provided to a user.

[0097] Various embodiments of systems, devices, and methods have been described herein. These embodiments are provided by way of example only and are not intended to limit the scope of the present disclosure. Furthermore, it should be understood that various features of the described embodiments can be combined in various ways to create many additional embodiments. Furthermore, while various materials, dimensions, shapes, configurations, locations, etc. have been described for use with the disclosed embodiments, others than those disclosed may be utilized without departing from the scope of the present disclosure.

[0098] Those skilled in the relevant art will recognize that the subject matter herein may include fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not intended to be an exhaustive listing of ways in which various features of the subject matter herein can be combined. Thus, the embodiments are not mutually exclusive combinations of features; rather, various aspects may comprise combinations of different individual features selected from different individual embodiments, as would be understood by one skilled in the art. Furthermore, elements described with respect to one embodiment may be implemented in other embodiments, even if not described in that embodiment, unless otherwise specified.

[0099] Although a dependent claim may refer to a specific combination with one or more other claims, other embodiments may also include combinations of the subject matter of the dependent claims with each other or with one or more features of other dependent or independent claims, and such combinations are suggested herein unless it is stated that a particular combination is not intended.

[0100] Any incorporation by reference of the above documents is limited so that no subject matter contrary to the express disclosure of this specification is incorporated. Any incorporation by reference of the above documents is further limited so that no claims contained in such documents are incorporated herein by reference. Any incorporation by reference of the above documents is even more limited so that no definitions provided therein are incorporated by reference unless expressly included herein.

[0101] For purposes of claim interpretation, the provisions of 35 U.S.C. 112(f) are expressly intended not to be invoked unless the specific words "for" or "step for" appear in a claim.

Claims

1. 1. A manufacturing system utilizing one or more automated manufacturing technologies to enable remote manufacturing of qualified components, comprising: The manufacturing system includes: at least one build chamber defining a production environment therein; at least one environmental sensor and / or regulator configured to provide integrated environmental controls capable of detecting changes in the production environment within the build room and / or modifying the production environment within the build room; a production subsystem including at least one automated manufacturing technology configured to manufacture products within the production environment; an inspection subsystem having at least one inspection fixture configured to inspect manufactured products for compliance with one or more standards; and at least one processor configured to verify whether the manufactured product complies with the one or more standards.

2. The manufacturing system of claim 1 , wherein the at least one processor is configured to qualify components in the physical absence of a quality inspector or technician.

3. The manufacturing system of claim 1 or 2, wherein the at least one processor is configured to automatically qualify the produced components to meet specific quality standards and / or regulations.

4. The manufacturing system of claim 1 or 2, wherein the inspection subsystem is configured to analyze one or more input components of the at least one automated manufacturing technology.

5. 5. The manufacturing system of claim 4, wherein the one or more input components can be analyzed by the inspection subsystem to determine a mass, a temperature, a humidity, a durometer, a diameter, a color, a chemical composition, and / or a shape of the input component.

6. The manufacturing system of claim 1 or 2, wherein the at least one processor is configured to provide a unique identifier code to the manufactured product.

7. 7. The manufacturing system of claim 6, wherein the at least one processor is further configured to store data about the manufactured product from raw materials to the manufactured product to enable traceability of the manufactured product based on the unique identifier code.

8. 3. The manufacturing system of claim 1 or 2, wherein the at least one environmental sensor and / or regulator is configured to sense and / or correct one or more of temperature, humidity, particulates, pressure, light and / or other radiation exposure, orientation, structural integrity, gas measurements, equipment component location, bioburden, contamination levels, airflow, and vibration.

9. 3. The manufacturing system of claim 1, wherein the inspection subsystem comprises one or more of a reflective laser scanner, an optical inspection tool, a probe for physical inspection, and a bioburden sensor.

10. 3. The manufacturing system of claim 1 or 2, wherein the at least one processor is configured to automatically discard and / or quarantine a manufactured part, hold it for manual approval, and / or not provide it to a user if the manufactured part does not meet the one or more criteria.

11. 3. The manufacturing system of claim 1 or 2, wherein the at least one processor is configured to operate expected representation software to develop a three-dimensional representation of an expected product based on an input computer software model.

12. The manufacturing system of claim 11 , wherein the inspection subsystem is configured to compare the manufactured product with the three-dimensional representation of the expected product.

13. The manufacturing system of claim 1 or 2, further comprising an outer housing that houses the at least one build chamber, at least one environmental sensor and / or regulator, a production subsystem, and an inspection subsystem.

14. The manufacturing system of claim 13 , further comprising a user interface disposed on the outer housing to facilitate user interaction with the manufacturing system.

15. In the manufacturing process of the product, The manufacturing method includes: receiving instructions to manufacture the product; Detecting and correcting at least one environmental factor within a production environment; manufacturing a product in the production environment using at least one automated manufacturing technique based on the received instructions; automatically inspecting manufactured products for conformance with one or more standards; and automatically verifying whether the manufactured product complies with the one or more standards based on the inspection.

16. 16. The method of claim 15, wherein the automatically inspecting and automatically verifying the manufactured product is performed in the absence of a quality inspector or technician physically present.

17. 17. The manufacturing method of claim 15 or 16, wherein the method further comprises inspecting one or more input components of the at least one automated manufacturing technology, including determining one or more of a mass, a temperature, a humidity, a durometer, a diameter, a color, a chemical composition, and / or a shape of the input components.

18. 17. The method of claim 15 or 16, wherein the method further comprises providing a unique identifier code for the manufactured product.

19. 20. The manufacturing method of claim 18, wherein the method further comprises storing data of the manufactured product from raw materials to the manufactured product to enable traceability of the manufactured product based on the unique identifier code.

20. 17. The manufacturing method of claim 15 or 16, wherein the method comprises automatically discarding and / or quarantining the manufactured part, holding it for manual approval, and / or not providing it to a user if the manufactured part does not comply with the one or more criteria.

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