Computer implemented method for designing complex part of in-vitro diagnostic instrument

Abstract

To provide a method and program for designing a complex part of an in-vitro diagnostic instrument, and an in-vitro diagnostic instrument.SOLUTION: A method 110 comprises a step of retrieving at least one target constraint 118, and a step of retrieving at least one set of input parameters 122. The input parameters comprise at least one design target 124 for defining a complex part of an in-vitro diagnostic instrument. The method further comprises a step of determining at least one design solution of the complex part by using at least one iterative algorithm considering the input parameters. In each iteration, the iterative algorithm comprises: determining at least one candidate complex part of the in-vitro diagnostic instrument; comparing the candidate complex part to the target constraint; and rating the candidate complex part according to the comparison. Until a predefined number of iterations is reached and / or until the target constraint is fulfilled within predetermined tolerances, the operation is repeated to determine the design solution of the complex part of the in-vitro diagnostic instrument.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present application relates to a computer implemented method for designing a composite part of an in vitro diagnostic instrument, a method for manufacturing a composite part of an in vitro diagnostic instrument and a composite part of an in vitro diagnostic instrument. The invention further relates to a computer program having program means for performing the method according to the invention, a non-transitory computer readable medium, a computer readable storage medium, a print data set and a computer program for generating a print data set. [Background technology]

[0002] Computer-aided design (CAD) programs and processes are typically used to design and / or build products and parts. However, today's CAD solutions are primarily designed for cubes and turned components whose shapes can be economically produced using traditional manufacturing processes. With the development of additive manufacturing processes, most of the limitations on geometry and / or material composition that are typically set for traditional manufacturing processes do not apply. Instead, additive manufacturing processes have advanced significantly and are well beyond the stage of pure prototype construction. Thus, different design and / or construction methods seem to be required. Many CAD software vendors have therefore responded to this trend by proposing solutions that help to take fuller advantage of additive manufacturing processes such as laser sintering, 3D printing and similar processes. However, the steady development of manufacturing processes requires steady improvement and adaptation of design methods and processes.

[0003] Furthermore, it would be desirable for the design methods and processes to take into account the field of application and the corresponding acting forces and loads. For example, composite parts of in-vitro diagnostic equipment, such as magnetic glass particle (MGP) mixers, may suffer from vibrations acting on them. Not only does the MGP plate shake, but also the entire assembly (and the chassis in which it is embedded), due to imbalances caused by, for example, eccentrics. Due to the reduction in mass when miniaturizing composite parts of in-vitro diagnostic equipment, this problem is further increased and may cause interference with adjacent processes due to vibrations. In addition, fatigue failure of load-bearing components may be an issue.

[0004] US Patent Application Publication No. 2019 / 0283368 describes a thermoplastic elastomer compound comprising a hydrogenated styrenic block copolymer having a polyisoprene soft block, a styrene-isobutylene-styrene block copolymer, a tackifier having a softening point of at least about 80° C. by ASTM 6493, and, optionally, one or more additional thermoplastic elastomers. The compound has a compound tan δ peak temperature (10 Hz) of at least 10° C., a compound tan δ peak height (10 Hz) of at least 0.85 when no thermoplastic polyurethane is present, and a compound tan δ peak height (10 Hz) of at least 0.60 when the additional thermoplastic elastomer is present, and includes a thermoplastic polyurethane. Summary of the Invention

[0005] It is therefore desirable to provide a method and an apparatus that addresses the above mentioned technical problems. In particular, a method, a computer program and an apparatus should be proposed that allow the generation of topology optimized composite parts for in-vitro diagnostic instruments.

[0006] This problem is addressed by a computer implemented method for designing a composite part of an in-vitro diagnostic device, a method for manufacturing a composite part of an in-vitro diagnostic device, a composite part of an in-vitro diagnostic device, a computer program having program means for carrying out the method, a non-transitory computer readable medium, a computer readable storage medium, a print data set and a computer program for producing a print data set having the features of the independent claims. Advantageous embodiments which may be realised alone or in any combination are set out in the dependent claims as well as in the specification as a whole.

[0007] The terms "have", "comprise" or "include" used below, or any grammatical variants thereof, are used non-exclusively. Thus, these terms may refer both to the situation where no further features are present in the entity described in this context, in addition to the features introduced by these terms, and to the situation where one or more additional features are present. As an example, the expressions "A has B", "A comprises B" and "A includes B" may both refer to the situation where, apart from B, no other elements are present in A (i.e., A consists solely and exclusively of B), and to the situation where, apart from B, one or more further elements are present in the entity A, such as element C, elements C and D, or further elements.

[0008] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may be present one or more times are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, regardless of the fact that each feature or element may be present one or more times.

[0009] Furthermore, when used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "particularly", "more particularly" or similar terms are used with any feature without limiting the possibility of substitution. Thus, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The invention may be implemented using alternative features, as the skilled artisan will recognize. Similarly, features introduced by "in one embodiment of the invention" or similar expressions are intended to be optional features, without any limitations on alternative embodiments of the invention, without any limitations on the scope of the invention, and without any limitations on the possibility of combining the feature so introduced with other optional or non-optional features of the invention.

[0010] In a first aspect, a computer-implemented method for designing a composite component of an in-vitro diagnostic instrument is proposed.

[0011] The term "computer-implemented" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but is not limited to, refer to a method involving at least one computer and / or at least one computer network or cloud. The computer and / or computer network and / or cloud may comprise at least one processor configured to perform at least one of the method steps of the method according to the invention. Preferably, each of the method steps is performed by the computer and / or computer network and / or cloud. The method may be performed fully automatically, e.g., without user interaction. The term "automatically" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but is not limited to, refer to a process performed fully by at least one computer and / or computer network and / or cloud and / or machine, e.g., without manual action and / or user interaction.

[0012] The term "in vitro diagnosis" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art, and should not be limited to a special or customized meaning. Specifically, in vitro diagnosis can include performing at least one test on a sample, such as a biological sample obtained from a human or animal body. For example, the test on the sample can include applying at least one reagent to the sample and monitoring a detectable reaction. As an example, to perform in vitro diagnosis, such as at least one test on a sample, an in vitro diagnostic device can be used in a laboratory or other environment for performing scientific or technical research, experiments and / or measurements. For example, an in vitro diagnostic device can be part of a clinical laboratory, a medical laboratory, a forensic laboratory, or a blood bank.

[0013] The term "biological sample" as used herein is a broad term and should be given its ordinary and customary meaning to one of skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to at least one biological material that may contain, but is not limited to, at least one analyte of interest. For example, a biological sample may include a bodily fluid, such as blood, interstitial fluid, urine, saliva, or other types of bodily fluids. For example, a biological sample may be or include an aliquot of a substance, such as a biological compound. For example, a biological sample may be or include at least one biological sample, such as one or more of blood, serum, plasma, urine, saliva. A biological sample may be a liquid sample. For example, a liquid sample may be or include at least one pure liquid containing a biological material, such as a liquid substance and / or a solution containing one or more liquid substances. A liquid sample may be or include a liquid mixture, such as a suspension, emulsion, and / or dispersion of a biological material. The biological sample may be an individual sample, such as at least one sample of tissue.

[0014] The term "in vitro diagnostic device" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to any device configured to perform in vitro diagnosis, such as, but not limited to, the analysis of biological samples. An in vitro diagnostic device may be one or more of a pre-analytical device, an analytical device, or a post-analytical device.

[0015] The term "composite part" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, individual parts that combine and / or accumulate multiple components and / or one or more of their functions. For example, a composite part may accumulate multiple components, e.g., their functions, in a single part. A composite part cannot be disassembled. For example, a composite part may be made integrally, i.e., form a single part, such that non-destructive disassembly into individual components may not be possible. Multiple components whose functions may be combined and / or accumulated in a composite part may be components that typically have rigid interfaces, which may be connected, for example, by one or more of gluing, screwing, riveting, and / or welding.

[0016] For example, the composite part may be an element of a magnetic glass particle (MPG) mixer of an in-vitro diagnostic instrument. The MPG mixer may comprise at least one support configured to hold the MPG mixer assembly together. The support may be configured to serve as an interface with other parts of the in-vitro diagnostic instrument. The MPG mixer may comprise at least one carrier, also called a shaker plate. The carrier may be configured to receive and hold the MGP cassette to mix the MGP. The MPG mixer may comprise at least one electric motor. The motor may be configured to drive the carrier. The MGP mixer may be configured to mix the sample by shaking in one plane. For example, the mixing process may be performed using two eccentrics. Both eccentrics may each be driven via a belt by a single electric motor. The motors can be controlled independently of each other. The resulting offset may be compensated by a linear guide. The MPG mixer may comprise additional components such as one or more of at least one motor for receiving and / or opening the MGP cassette, at least one RFID reader, at least one printed circuit board, etc. For the MGP cassette, reference is made to EP 2 423 688. For example, the composite part of the in-vitro diagnostic device comprises one or more of the carrier, support or gears of a magnetic glass particle mixer. For example, the composite part may comprise one or more of the functions of the carrier, support or gears of a magnetic glass particle mixer, or may comprise, for example, alone or in combination.

[0017] The term "design" as used herein is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, the procedure of planning and / or specifying an object or process. As an example, the design procedure may include developing and / or defining at least one characteristic of the object or process. The design may include at least one optimization with respect to at least one goal.

[0018] The term "designing a composite part" as used herein is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, the procedure of planning and / or specifying a composite part. For example, designing a composite part may be or may include developing and / or defining at least one characteristic of the composite part, such as, for example, the geometry and / or shape and / or material or material composition. As an example, a design solution of a composite part, such as an element of an MPG mixer of an in-vitro diagnostic device, at least in manufacturable form, such as a 3D model, and / or in one or more technical drawings, may be a result of designing a composite part, such as an output of designing a composite part.

[0019] The method steps may be performed in a given order or in a different order. Further, there may be one or more additional method steps not listed. Further, one, more than one, or even all of the method steps may be performed repeatedly.

[0020] The method comprises: i. deriving at least one goal constraint; ii. extracting at least one set of input parameters, the input parameters including at least one design objective for defining a composite part of the in-vitro diagnostic device and at least one constraint parameter of the composite part of the in-vitro diagnostic device; iii. determining at least one design solution for the composite part by using at least one iterative algorithm taking into account the input parameters, wherein in each iteration, the iterative algorithm: determining at least one candidate composite component of an in vitro diagnostic device; comparing the candidate composite parts to the target constraints; and Evaluating the candidate composite parts responsive to the comparison.

[0021] The method includes repeating step iii until a predetermined number of iterations is reached and / or until the determined candidate composite parts satisfy the target constraints at least within a predetermined tolerance, thereby determining a design solution for the composite part of the in-vitro diagnostic device.

[0022] The term "retrieving" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to a process of a system, specifically a computer system, that generates data and / or retrieves data from any data source, such as, but not limited to, from a data storage, from a network, or from a further computer or computer system or cloud, and / or receives data as user input, for example, via a human-machine interface. Retrieving may specifically be performed by at least one computer interface, for example, a communication interface, through a port, for example, a serial or parallel port. Retrieving may include several sub-steps, such as the sub-step of obtaining one or more items of primary information, for example, by using a processor, and generating secondary information by utilizing the primary information, for example, by applying one or more algorithms to the primary information. Furthermore, retrieving may include taking data from one or more of user input, at least one measurement, at least one calculation, literature, at least one handbook, knowledge, experience, and at least one simulation.

[0023] The retrieval in step i. and / or step ii. may be performed by using at least one communication interface. The term "communication interface" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, an item or element forming a boundary configured to transfer information. The communication interface may be configured to transfer information from a computing device, such as a computer, for example, to transmit or output information to another device. Additionally or alternatively, the communication interface may be configured to transfer information to a computing device, such as a computer, for example, to receive information. The communication interface may provide a means for transferring or exchanging information. The communication interface may provide a data transfer connection, such as Bluetooth, NFC, inductive coupling, etc. By way of example, the communication interface may be or may comprise at least one port comprising one or more of a network or internet port, a USB port, and a disk drive. The communication interface may be at least one web interface.

[0024] A communication interface, e.g., a human-machine interface, may be or may comprise a user interface through which a user can input data. The term "user interface" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may refer to a communication interface configured to interact with an environment, such as for the purpose of exchanging information unidirectionally or bidirectionally, such as for, but not limited to, exchanging one or more of data or commands. For example, the user interface may be a bidirectional interface. The user interface may be configured to share information with a user and receive information by a user. The user interface may include, by way of example, one or more of a graphical user interface, a data interface, such as a wireless and / or wired data interface.

[0025] For example, retrieving the target constraints may include retrieving the target constraints from at least one data storage, which may include at least one table or at least one lookup table that includes the multiple target constraints.

[0026] The term "target constraint" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, features or specifications that are targeted and / or aimed for when designing a composite part. The target constraint may be or include at least one reference feature and / or characteristic, also referred to as a target criterion, that is compared to the features of the composite part. For example, the target constraint includes at least one constraint selected from the group consisting of: geometry constraint; topology constraint; pressure constraint; shear force constraint; mechanical stability constraint; strength constraint such as tensile strength constraint; weight constraint; force distribution constraint; surface property constraint; production machine constraint; production constraint; economic constraint. The target constraint may be a parameter that affects further features and / or behavior of the composite part. For example, the target constraint may be a parameter related to fluid dynamics such as pressure drop, impact on turbulence, or laminar flow conveying that affects the mixing ratio of the cassettes of the MPG-mixer. As an example, the target constraint may include at least one static target such as a constant and / or a timely and unchanging value. Additionally or alternatively, the goal constraint may include at least one dynamic target, such as at least one variation and / or development value, for example according to a predetermined progress and / or development. For example, the dynamic target may be or include at least one feature that changes its value according to a predetermined function, for example a function of time and / or space, and / or a function of further parameters, such as temperature and humidity. Additionally or alternatively, the dynamic target may be or include a constraint that is not available for a predetermined deployment and / or modification function, for example, a maximized stiffness, a minimized material consumption and / or a component weight, etc., that can reduce the improvement, for example, the reduction of stress.

[0027] The term "input parameters" as used herein is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to any special or customized meaning. The term may specifically refer to, but is not limited to, input values ​​for an iterative algorithm and / or data that may be inserted into an iterative algorithm. The iterative algorithm may be configured to generate and / or determine a design solution for a composite part based on the input parameters, e.g., values. The set of input parameters may include multiple input parameters.

[0028] The input parameters include at least one design goal for defining a composite part of an in-vitro diagnostic device. The term "design goal" as used herein is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a starting point of a process of designing a composite part. A design goal may be any primary and / or initial two-dimensional and / or three-dimensional form or shape. A design goal may be or include a three-dimensional base type of a composite part. A design goal may be an initial geometry of a composite part. For example, a design goal may be a predefined base type of a composite part, such as a previously developed structure and / or form. As an example, a design goal may have or include a feature that may be targeted to be present in a composite part, such as a lattice structure. A design goal may be a two-dimensional and / or three-dimensional structure that may be described by using a geometric form such as one or more of at least one rectangular parallelepiped, at least one cube, at least one cylinder, etc. Additionally or alternatively, the design goal may be retrieved as one or more of at least one mathematical equation, at least one vector, and at least one matrix. Additionally or alternatively, the target design may be a predetermined and / or existing geometry, such as the design solution previously determined in step iii.

[0029] Design objectives for defining a composite part of an in-vitro diagnostic device may include at least one set of forming geometry parameters defining a forming geometry of the composite part and / or at least one starting digital model of the composite part.

[0030] The term "shape geometry parameters" as used herein is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to any parameter that defines the shape of the mold geometry, such as, but not limited to, a digital description of a digital model, e.g., a preliminary and / or seed shape. The shape may be an outer boundary or an outer surface of the mold geometry, e.g., an envelope. The set of mold geometry parameters that defines the mold geometry of a composite part may include a number of mold parameters and / or starting values ​​of the mold geometry parameters. The mold geometry parameters may include at least one parameter selected from the group consisting of at least one parameter selected from the group consisting of length, width, height, at least one parameter that defines a pattern structure of the composite part, at least one parameter that characterizes a carrier, support, or type of composite part, such as gears, lattice structures, and other structures of the composite part.

[0031] Retrieving the set of shaping geometry parameters may include receiving the set of shaping geometry parameters from at least one data storage. The data storage may include at least one table or at least one lookup table that includes a plurality of different starting geometries and associated shaping geometry parameters.

[0032] The term "digital model" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a digital representation, e.g., a two-dimensional or three-dimensional representation, of any surface of an object. The starting digital model may be a predetermined and / or existing digital model, such as an initial digital model and / or a design solution previously determined in step iii. The starting digital model may be or include a computer-generated digital model, e.g., by using at least one algorithm dedicated to the generation of a digital model and / or by scanning an object and transforming the scanned data into a digital model. For example, the method may include determining the starting digital model by using a set of forming geometry parameters in at least one computer-aided design tool. As an example, the set of forming geometry parameters may be used to set a starting digital model, e.g., an initial digital representation of a design goal, e.g., in at least one computer-aided design tool. For example, the starting digital model may be based on, e.g., a DXF file or the like retrieved in step ii as part of at least one set of input parameters.

[0033] The input parameters include at least one constraint parameter of the composite part of the in-vitro diagnostic device. The term "constraint parameter" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, at least one boundary condition for the design solution. For example, the at least one constraint parameter of the composite part may include at least one of product characteristics, available construction space, potential materials, potential manufacturing processes, or cost targets. The input parameters may include multiple constraint parameters.

[0034] The term "composite part design solution" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, at least one result or outcome of an iterative algorithm. The design solution may include a set of parameters that define one or more of the geometry, shape, material, or structure of the composite part. The design solution may refer to the outcome of a computer-implemented method for designing a composite part of an in-vitro diagnostic device. As an example, the design solution, for example, in the method, may exist in the form of a virtual model, such as a two-dimensional and / or three-dimensional model. For example, the design solution may be provided in a computer-readable format, such as a data format readable by a processor, for example, in the form of a 3D file, by a processor involved in implementing the method.

[0035] Determining at least one design solution in step iii may be performed by using at least one processor. The term "processor" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not limited to, refer to any logic circuitry configured to perform basic operations of a computer or system, and / or may generally refer to a device configured to perform calculations or logical operations. In particular, the processor may be configured to process basic instructions that drive a computer or system. As an example, the processor may comprise at least one arithmetic logic unit (ALU), at least one floating point unit (FPU), such as a numeric coprocessor or numeric coprocessor, a number of registers, in particular registers configured to supply operands to the ALU and store the results of the operations, and memories, such as L1 and L2 cache memories. In particular, the processor may be a multi-core processor. In particular, the processor may be or include a central processing unit (CPU). In particular, the processor may be or include at least one graphics processing unit (GPU). Additionally or alternatively, the processor may be or include a microprocessor, and thus in particular the elements of the processor may be included in a single integrated circuit (IC) chip. Additionally or alternatively, the processor may be or comprise one or more chips, such as one or more application specific integrated circuits (ASICs) and / or one or more field programmable gate arrays (FPGAs) and / or one or more tensor processing units (TPUs) and / or at least one digital signal processor (DSP), and / or at least one system on a chip (SoC), and / or a neuromorphic processing unit (NPU), and / or a dedicated machine learning optimization chip, etc. The processor may be at least partially cloud-based.

[0036] The term "iterative algorithm" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, an algorithm that includes at least one iteration. Each iteration may include the named sub-steps: determining at least one candidate composite part of an in-vitro diagnostic device, comparing the candidate composite part with a goal constraint, and evaluating the candidate composite part according to the comparison. The iterative algorithm may include multiple loops. In the initial loop, the input parameters retrieved in step ii may be used as a starting point.

[0037] The iterative algorithm may be designed to take into account one or more of at least one invariant region, such as due to a predefined interface to other components; acting forces; kinematics; predefined fixed points; manufacturing method; materials; tool accessibility during production and / or assembly; stackability; or nesting of individual components, for example for efficient logistics. The iterative algorithm may be designed to take into account factors used in manufacturing methods such as one or more of 2-axis CNC, 5-axis CNC, CNC lathes, casting tools with and without slides, etc. This may allow further optimization of the process, for example to allow upscaling of costs and / or quantities.

[0038] For example, the iterative algorithm may include at least one iteration of the named steps, e.g., multiple iterations that may be performed in subsequent loops. The loops may be performed consecutively, e.g., one after the other, and the outcome of the previous loop may be used as an input parameter for the next loop. For example, a multiplier may be used to, e.g., reinforce the variance in the solution landscape. This may make it possible to prevent local minima or maxima. The resulting "noise" of the resolution accuracy may be affected. For example, sometimes a larger variation, e.g., the concept phase, is desired, but sometimes an accurate, well-defined solution is desired. Thus, the iterative algorithm may be based on "classical" iteration, where a single solution is generated at each iteration, and the sequence of solutions of successive iterations approaches the optimal solution.

[0039] The iterative algorithm may include topology optimization. For example, topology optimization may include iteratively determining the geometry of the composite part. Topology optimization may use input parameters, e.g., design objectives and constraint parameters. Topology optimization may include defining a build space as a basis for topology optimization, considering forces and loads acting to determine an optimal geometry. Topology optimization may include performing at least one finite element method (FEM) analysis and at least one material reduction operation in an iterative or alternative manner. The iterative algorithm may consider one or more of the following during the iteration: demolding direction (for casting), build direction (additive process), accessibility by tools (chip removal process). The FEM analysis and material reduction operation may be performed until a predetermined number of iterations is reached and / or until the determined candidate composite part meets the goal constraints at least within a predetermined tolerance. The iterative algorithm may consider multiple goal constraints. The goal constraints may be interdependent. The goal constraints may have priorities. The priorities may be considered using different weightings. For example, it is more important to be demoldable than to achieve a mass specification.

[0040] The term "candidate composite part" as used herein is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a preliminary result of a simulation of a composite part taking into account input parameters. A candidate composite part may be a virtual prototype of a composite part.

[0041] As used herein, the term "simulation of a composite part" is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to a process of applying at least one simulation tool, such as an algorithm and / or a neural network, to input parameters with the purpose of determining a design solution for the composite part, but is not limited thereto. In subsequent iterations, the value of at least one parameter of the set of parameters may vary depending, for example, on the outcome of the comparison of the candidate composite part to the target constraints. The parameters and / or the values ​​of the parameters may be changed by following one or more of a preset and / or predetermined pattern, a preset and / or predetermined algorithm, a preset and / or predetermined mathematical rule set, a preset and / or predetermined method, or a preset and / or predetermined protocol, and / or may be changed randomly. The adaptation of the forming geometry parameters may include at least one material reduction operation.

[0042] As used herein, the term "comparing a candidate composite part to a target constraint" is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, comparing at least one physical and / or mechanical property and / or characteristic of a candidate composite part to a target constraint.

[0043] For example, comparing may include analyzing the candidate composite part by simulating the use of the composite part by applying at least one numerical simulation to the candidate composite part, thereby determining at least one physical and / or mechanical property of the candidate composite part of the in vitro diagnostic device. As used herein, the term "simulating the use of the composite part" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to simulating the behavior of the composite part under at least one test condition, such as, but not limited to, a condition as defined by at least one force, deformation, stress, temperature, or one or more of loads.

[0044] The physical and / or mechanical properties may include at least one property selected from the group consisting of weight; material; tensile properties; pressure properties; shear properties; stiffness; relative stiffness; damping properties; hardness; energy dissipation; properties under compression; properties under deformation; inertia; thermal conductivity, elasticity, fatigue strength, rust resistance, suitability for manufacturing processes, such as suitability related to machining, casting, bending, etc.

[0045] Analyzing the candidate composite part may include discretizing the candidate composite part into a mesh including a finite number of mesh elements. The analysis may include using at least one Finite Element Method (FEM) simulation, also referred to as FEM analysis. The FEM simulation may be configured to determine, e.g., visualize, the behavior of the candidate composite part under one or more of conditions or loads, such as defined by at least one of forces, deformations, stresses, and temperatures. The FEM simulation may be configured to identify failures, such as weak points. The FEM simulation may be configured to determine the behavior of the candidate composite part statically or the evolution over time. The FEM simulation may be based on one or more of voxels, point clouds, B-Rep, SDF, and the like.

[0046] Comparing the candidate composite part to the target constraints may include comparing the determined physical and / or mechanical properties to the target constraints and adapting at least one of the molded geometry parameters in response to the comparison. The method includes repeating step iii until a predetermined number of iterations is reached and / or until the determined candidate composite part satisfies the target constraints at least within a predetermined tolerance. The method repeats step iii with the adapted molded geometry parameters until the determined physical and / or mechanical properties satisfy the target constraints at least within a predetermined tolerance, thereby determining a design solution for the composite part of the in-vitro diagnostic device having an adapted set of molded geometry parameters in which the target constraints are satisfied at least within a predetermined tolerance. For example, the predetermined number of iterations may depend on the initial situation and may be, for example, 2 to 80. For example, the method may include stopping after, for example, 60 iterations. The method may include manual corrections that may be used as a new starting geometry. The term "satisfy" as used herein is a broad term and should be given its ordinary and customary meaning to one of skill in the art and should not be limited to any special or customized meaning. The term may specifically refer to the achievement of any goal, such as, but not limited to, following at least one predetermined or preset criterion. Thus, the term "meeting at least within a predetermined tolerance" may specifically refer to any state of reaching a predetermined goal, such as, but not limited to, following at least one predetermined or preset criterion, where the predetermined tolerance may be applied when determining achievement. The term "meeting a target constraint at least within a predetermined tolerance" may refer to the fact that a target constraint that is capable of deviation within a predetermined tolerance is fully met. Specifically, the target constraint may be considered to be met as long as the determined physical and / or mechanical properties of the candidate composite part and the target constraint differ from each other by 50% or less, preferably 20% or less, more preferably 10% or less. For example, the termination criterion of the simulation may be the achievement of the target constraint. Additionally or alternatively, at least one time limit may be used, for example, the simulation is terminated after 24 hours.This may make it possible to control costs, for example, if calculations are performed in the cloud or a local PC is used and capacity is exceeded for too long.

[0047] Additionally or alternatively, an iterative algorithm, for example, determining the candidate composite parts and comparing the candidate composite parts, may be implemented using at least one genetic algorithm. An iterative algorithm using a genetic algorithm may include generating a set of solutions at each iteration. At each iteration, a solution from the previous population may be randomly selected. These selected solutions may be used as parents to produce children of the next generation of the population. An optimal solution may be reached after successive iterations. For example, one of the interdependent parameters may be selected, and its weight may be minimized or maximized, for example, to a local and / or global optimum (maximum or minimum of the function). For optimization, see, for example, en.wikipedia.org / wiki / Mathematical_optimization.

[0048] The term "evaluating a candidate composite part responsive to a comparison" as used herein is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, classifying the candidate composite part as a design solution suitable for prototyping or as an intermediate solution for the next iteration, and / or assigning at least one score indicating compatibility with the target constraints, such as 1 (poor compatibility) to 10 (perfect compatibility).

[0049] The method may include outputting the design solution obtained after repeating step iii for a predetermined number of iterations and / or where the target constraints are satisfied at least within a predetermined tolerance. The term "outputting" as used herein is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a process of making information available to another system, data storage, person or entity. By way of example, the outputting may be performed via one or more interfaces, such as a computer interface, a web interface, or a human-machine interface. The outputting may be performed in one or more of a computer-readable format, a visual format, or an audible format, by way of example. Outputting the design solution may include outputting at least one information regarding one or more of: height distribution; wall thickness distribution; at least one length; pattern structure; general geometry and / or shape; material; manufacturing process; topology; volume; surface; mass; foam structure having open or closed cells; lattice structure, e.g., the shape and / or position and / or distribution and / or extension of at least one cutout and / or hole and / or web.

[0050] The method may further include prototyping the composite part of the in-vitro diagnostic device obtained after repeating step iii for a predetermined number of iterations and / or where the target constraints are satisfied at least within a predetermined tolerance. The term "prototyping" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, the process of manufacturing a full-scale functional model or form of any element or object, or the process of generating a virtual prototype. For example, a CAD model may be built into a higher assembly as an unfinished model. Cost calculations can be performed on the resulting geometry, simulated by FEM, packings, etc. can be evaluated. These findings can then be returned to the optimization process. The prototype may be a model of the composite part and may be used to test and / or validate at least one feature or specification of the composite part. The prototype may be manufactured prior to a large-scale production process or mass production process. The prototype may be produced or manufactured as part of the development phase of the composite part, for example. Thus, prototyping of the composite part may be performed, particularly prior to commencing a large-scale production process or manufacturing of the composite part. The method may include validating the prototyped composite part by comparing at least one characteristic of the prototyped composite part with at least one characteristic of the simulated composite part, and / or evaluating the prototyped composite part by using at least one characteristic of the prototyped composite part in comparison to the at least one target constraint, e.g., when there are two or more target constraints for the at least one target constraint.

[0051] In a further aspect of the invention, a method for manufacturing a composite part of an in-vitro diagnostic device is disclosed. The method for manufacturing a composite part of an in-vitro diagnostic device is also called a manufacturing method. The manufacturing method comprises designing a composite part of an in-vitro diagnostic device by using the method for designing a composite part disclosed herein. Therefore, for possible definitions of the terms and possible embodiments, reference is made to the disclosure of the method for designing a composite part as disclosed above or in more detail below.

[0052] The manufacturing method further comprises manufacturing the composite part of the in-vitro diagnostic device based on the designed composite part, i.e. based on the design solution, by using at least one manufacturing process selected from the group consisting of milling, such as computer numerically controlled milling; casting; molding; powder bed fusion, binder jetting; additive manufacturing, such as material jetting, 3D printing; and cutting, such as laser cutting and / or water jet cutting.

[0053] The manufacturing method may include, for example, producing the composite part by one or more conventional ablative manufacturing processes, such as milling, e.g., by computer numerical control milling, or cutting, such as laser cutting and / or water jet cutting, where the components, i.e., composite parts, can be created from solid materials and / or blocks by removing material layer by layer from the solid materials and / or blocks. Additionally or alternatively, the manufacturing method may include producing the composite part by one or more conventional molding processes, such as casting and / or molding, where a reusable and / or lost mold may be used to cast the components, i.e., composite parts. Still additionally or alternatively, the manufacturing method may include producing the composite part by one or more recently developed additive manufacturing processes, such as by powder bed fusion, binder jetting, material jetting, 3D printing, etc., where the components, i.e., composite parts, can be created by adding material layer by layer.

[0054] The manufacturing process may be selected, for example, by taking into account the design solution of the composite part of the in vitro diagnostic device as determined in the method for designing the composite part of the in vitro diagnostic device as disclosed herein. As an example, the manufacturing process may be selected by taking into account the feasibility of manufacturing the design solution of the design method disclosed herein. For example, the manufacturing process may be selected according to the ability of the design solution to be produced using the process. Thus, the design solution determined in the design method may be, for example, automatically evaluated according to predetermined and / or pre-set criteria, and a manufacturing process capable of manufacturing and / or producing the composite part may be selected and / or evaluated according to the evaluation of the design solution. The criteria used in the evaluation of the ability of the design solution to be manufactured and / or produced by the manufacturing process may be, for example, one or more of size, required tolerances, e.g., surface tolerances, and the presence or absence of undercuts. Further criteria may also be possible, such as one or more materials used for the composite part.

[0055] As an example, at least one material for manufacturing a composite part of an in-vitro diagnostic device may be selected by considering the design solution. The material may be or may include at least one material selected from the group consisting of: metallic materials; e.g., steel and / or its alloys; casting materials; non-ferrous metallic materials, e.g., one or more of aluminum, titanium and / or their alloys; inherent lattice-structured materials, e.g., lattice-structured metallic materials, materials with lattice-structured features, materials that can be arranged in lattice structures; plastic materials; compound materials; wood. In particular, the composite part may be or may include a lattice-structured rigid material, such as a metamaterial, and flexible features, e.g., a flexible system, may be interpreted and / or constructed by designing the topological properties of the material, so that flexibility that may not exist in the basic rigid material is created.

[0056] In a further aspect of the invention, a composite part of an in-vitro diagnostic device is disclosed. The composite part can be obtained by using the method for manufacturing a composite part disclosed herein. For possible definitions of the terms and possible embodiments, reference is therefore made to the disclosure of the method, e.g. manufacturing method, for manufacturing a composite part of an in-vitro diagnostic device as disclosed above or as disclosed in more detail below.

[0057] The composite part may include at least one lattice structure. For example, the composite part may include a regular patterned structure or an irregular patterned structure. As an example, the composite part may be or include at least one portion and / or part having a lattice structure, e.g., having an inherent lattice structure, having lattice structure characteristics such as deformable and / or elastic characteristics, and / or arranged in a lattice structure, such as a regular or irregular patterned structure.

[0058] In a further aspect of the invention, a computer program is disclosed comprising instructions which, when said program is executed by a processor, for example by a processor of a computer or a computer network, cause the processor to perform at least step iii of the method for designing a composite part as disclosed herein. For possible definitions of the terms and possible embodiments, reference is therefore made to the disclosure of the method for designing a composite part, for example the description of step iii of said method as disclosed above or as disclosed in more detail below. In particular, the computer program may be configured to cause the processor to perform the determination of at least one design solution for the composite part by using at least one iterative algorithm as disclosed herein.

[0059] In a further aspect of the invention, a computer readable storage medium is disclosed comprising instructions which, when executed by a processor, for example by a processor of a computer or a computer network, cause the processor to perform at least step iii of the method for designing a composite part as disclosed herein. Again for possible definitions of terms and possible embodiments, reference is therefore made to the disclosure of the method for designing a composite part, for example the description of step iii of the method as disclosed above or as disclosed in more detail below. In particular, the computer readable storage medium may be configured to cause the processor to perform the determination of at least one design solution for the composite part by using at least one iterative algorithm as disclosed herein.

[0060] In a further aspect of the invention, a non-transitory computer readable medium is disclosed, comprising instructions which, when executed by one or more processors of, for example, a computer or a computer network, cause the one or more processors to perform at least step iii of the method for designing a composite part as disclosed herein. Accordingly, again for possible definitions of terms and possible embodiments, reference is made to the disclosure of the method for designing a composite part, e.g. the description of step iii of the method as disclosed above or as disclosed in more detail below.

[0061] In a further aspect of the invention, a computer-readable data carrier, in particular a non-transitory storage medium, is disclosed that includes instructions that, when executed by an apparatus for additive manufacturing, in particular a 3D printing apparatus, cause the apparatus for additive manufacturing to produce a composite part as disclosed herein. For possible definitions of terms and possible embodiments, therefore, reference is made to the disclosure of the composite part as disclosed above or in more detail below.

[0062] The term "apparatus for additive manufacturing", also referred to as "additive manufacturing apparatus" as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not exclusively, refer to a manufacturing module and / or a manufacturing system configured to generate three-dimensional objects, e.g. parts and / or components, from one or more liquid and / or solid materials by layer-by-layer assembly under computer control. The additive manufacturing apparatus may comprise an interface, e.g. for data transmission, e.g. an STL interface, for reading information and / or instructions stored, e.g., on a computer-readable data carrier.

[0063] The term "computer-readable data carrier", also referred to as "data carrier", as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to a non-transitory storage medium, such as, but not limited to, at least one non-transitory data storage device and / or hardware data storage medium on which computer-executable instructions are stored. As an example, the instructions may be stored in the data storage medium as a data structure that, after being loaded into the working memory and / or main memory of the additive manufacturing device, causes the additive manufacturing device to produce a composite part according to the present invention. The computer-readable data carrier may be or comprise a storage medium readable by the additive manufacturing device, such as a random access memory (RAM) and / or a read-only memory (ROM). As an example, the computer-readable storage medium may include printing information, for example a printing data set as further outlined below.

[0064] For example, the instructions on the data carrier may be in the form of a 3D file, such as in STL format, DXF format, VRML format, OBJ format, 3DS format, OFF format, AMF format, 3MF format or a similar file format readable by the additive manufacturing device. Alternatively or additionally, the instructions may be present on the data carrier as a layer file, e.g. in a layer file format, e.g. as a CLI file, as an SLC file or a similar file format, containing information about a number of cutting contours for the layer-by-layer fabrication of the holder in the additive manufacturing device.

[0065] In a further aspect of the present invention, a printing data set is disclosed that comprises information that, when provided to an apparatus for additive manufacturing, in particular a 3D printing apparatus, enables the apparatus for additive manufacturing to produce a composite part as disclosed herein. For possible definitions of terms and possible embodiments, therefore, reference is made to the disclosure of the composite part as disclosed above or in more detail below.

[0066] The term "printing data set" as used herein is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to data including information for producing a three-dimensional object in an additive manufacturing device, such as, but not limited to, an instruction manual. As an example, the printing data set may include instructions on how to control the print head of the additive manufacturing device and / or the amount of material to apply per layer. For example, the printing data set may be in G-code format. For example, the printing data set may be adapted to a particular additive manufacturing device, for example of a particular type and / or manufacturer.

[0067] In a further aspect of the invention, the computer program comprises instructions which, when the program is executed by the computer or computer network, cause the computer or computer network to produce the printing data set as disclosed herein. For possible definitions of the terms and possible embodiments, reference is therefore made to the disclosure of the printing data set as disclosed above or in more detail below.

[0068] As an example, the instructions of the computer program, e.g., instructions present or stored in the computer program, may include a digital representation of a composite part, in particular a composite part according to the present invention as described herein, i.e. according to one of the embodiments described above or according to one of the embodiments described in more detail below. For example, the digital representation of the composite part may include a 3D model of the composite part, such as a design solution. For example, the computer program may be configured to create and / or generate a printing data set from a digital representation of a holder.

[0069] In a further aspect of the present invention, an in-vitro diagnostic device is disclosed herein. The in-vitro diagnostic device comprises a composite part, in particular a composite part as described herein according to the present invention, i.e. according to one of the above-mentioned embodiments or according to one of the embodiments described in more detail below. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the composite part as disclosed above or as disclosed in more detail below. The composite part comprised in the in-vitro diagnostic device is one or more of the following: a carrier of a magnetic glass particle mixer, a support of a magnetic glass particle mixer, and a gear of a magnetic glass particle mixer. Alternatively, the composite part comprised in the in-vitro diagnostic device comprises at least one function of one or more of the following: a carrier of a magnetic glass particle mixer, a support of a magnetic glass particle mixer, and a gear of a magnetic glass particle mixer.

[0070] The method and apparatus according to the invention may offer numerous advantages over known methods and apparatus. By way of example, the proposed method and apparatus may enable rapid design and / or time-saving production of composite parts, thus ensuring rapid availability of components and allowing revisions during the product lifecycle. Furthermore, the proposed method and apparatus may make it possible to streamline the development process. Furthermore, the proposed method and apparatus may make it possible to simplify production, assembly, warehousing, documentation, service and quality assurance compared to known methods and apparatus. The method may be combined with predictive maintenance, which allows to eliminate weak spots in the next revision. The method may be used for several Industry 4.0 applications. The method may be combined with swarm intelligence techniques.

[0071] In summary, without excluding further embodiments, the following embodiments may be envisaged:

[0072] Embodiment 1: A computer-implemented method for designing a composite component of an in-vitro diagnostic device, the method comprising: i. deriving at least one goal constraint; ii. extracting at least one set of input parameters, the input parameters including at least one design objective for defining a composite part of the in-vitro diagnostic device and at least one constraint parameter of the composite part of the in-vitro diagnostic device; iii. determining at least one design solution for the composite part by using at least one iterative algorithm taking into account the input parameters, wherein in each iteration, the iterative algorithm: determining at least one candidate composite component of an in vitro diagnostic device; comparing the candidate composite parts to the target constraints; and evaluating the candidate composite parts responsive to the comparison; The method includes repeating step iii until a predetermined number of iterations is reached and / or until the determined candidate composite parts satisfy the target constraints at least within a predetermined tolerance, thereby determining a design solution for the composite part of the in-vitro diagnostic device.

[0073] Embodiment 2: The method of the preceding embodiment, wherein the composite part of the in-vitro diagnostic device comprises one or more of a carrier, a support, or a gear of a magnetic glass particle mixer.

[0074] Embodiment 3: A method as described in any one of the preceding embodiments, wherein the target constraints include at least one constraint selected from the group consisting of: geometry constraints; topology constraints; pressure constraints; shear force constraints; mechanical stability constraints; strength constraints such as tensile strength constraints; weight constraints; force distribution constraints; surface property constraints; production machinery constraints; production constraints; and economic constraints.

[0075] Embodiment 4: A method as in any one of the preceding embodiments, wherein retrieving includes retrieving the target constraints from at least one data storage, the data storage including at least one table or at least one lookup table including a plurality of target constraints.

[0076] Embodiment 5: A method as described in any one of the preceding embodiments, wherein the design objectives for defining a composite part of an in-vitro diagnostic device include at least one set of molding geometry parameters defining a molding geometry of the composite part and / or at least one starting digital model of the composite part.

[0077] Embodiment 6: The method of the preceding embodiment, wherein the set of forming geometry parameters defining the forming geometry of the composite part includes a number of forming parameters and / or starting values ​​for the forming geometry parameters.

[0078] Embodiment 7: A method according to any one of the two preceding embodiments, wherein the molding geometry parameters include at least one parameter selected from the group consisting of length, width, height, at least one parameter defining a pattern structure of the composite part, at least one parameter characterizing a type of composite part, lattice, and structure of the composite part.

[0079] Embodiment 8: A method as described in any one of the three preceding embodiments, wherein the method includes determining a starting digital model by using a set of molding geometry parameters within at least one computer-aided design tool.

[0080] Embodiment 9: A method according to any one of the four preceding embodiments, wherein retrieving the set of shaping geometry parameters includes receiving the set of shaping geometry parameters from at least one data storage, the data storage including at least one table or at least one lookup table including a plurality of different starting geometries and associated shaping geometry parameters.

[0081] Embodiment 10: The method of any one of the preceding embodiments, wherein at least one constraint parameter of the composite part includes at least one of product characteristics, available build space, potential materials, potential manufacturing processes, or cost targets.

[0082] Embodiment 11: The method of any one of the preceding embodiments, wherein the iterative algorithm includes analyzing the candidate composite parts by applying at least one numerical simulation to the candidate composite parts, thereby simulating the use of the composite parts, thereby determining at least one physical and / or mechanical property of the candidate composite parts of the in vitro diagnostic device.

[0083] Embodiment 12: The method of the preceding embodiment, wherein the physical and / or mechanical properties include at least one property selected from the group consisting of weight; material; tensile properties; pressure properties; shear properties; stiffness; relative stiffness; damping properties; hardness; energy dissipation; properties under compression; properties under deformation; and inertia.

[0084] Embodiment 13: A method according to any one of the two preceding embodiments, wherein analyzing the candidate composite part includes discretizing the candidate composite part into a mesh including a finite number of mesh elements.

[0085] Embodiment 14: The method of any one of the three preceding embodiments, wherein the analyzing includes using at least one finite element method (FEM) simulation.

[0086] Embodiment 15: A method according to any one of the four preceding embodiments, wherein comparing the candidate composite part with the target constraints comprises comparing the determined physical and / or mechanical properties with the target constraints and adapting at least one molding geometry parameter in response to the comparison, and the method comprises repeating step iii with the adapted molding geometry parameters until the determined physical and / or mechanical properties satisfy the target constraints at least within a predetermined tolerance, thereby determining a design solution for the composite part of the in-vitro diagnostic device having an adapted set of molding geometry parameters in which the target constraints are satisfied at least within a predetermined tolerance.

[0087] Embodiment 16: The method of any preceding embodiment, wherein adapting the forming geometry parameters includes at least one material reduction operation.

[0088] Embodiment 17: The method of any one of the preceding embodiments, wherein the iterative algorithm includes at least one genetic algorithm.

[0089] Embodiment 18: A method as described in any one of the preceding embodiments, wherein the iterative algorithm is designed to take into account one or more of: at least one invariant region due to predetermined interfaces to other components, etc.; acting forces; kinematics; predetermined fixed points; manufacturing method; materials; accessibility to tools during production and / or assembly; stackability; or nesting of individual components.

[0090] Embodiment 19: A method as described in any one of the preceding embodiments, wherein the method includes outputting a design solution obtained after repeating step iii for a predetermined number of iterations and / or in which the target constraints are satisfied at least within a predetermined tolerance.

[0091] Embodiment 20: The method of the preceding embodiment, wherein outputting the design solution includes outputting at least one information regarding one or more of: height distribution; wall thickness distribution; at least one length; pattern structure; general geometry and / or shape; material; manufacturing process; topology; volume; surface; mass; foam structure having open or closed cells; lattice structure, e.g., the shape and / or position and / or distribution and / or extension of at least one cutout and / or hole and / or web.

[0092] Embodiment 21: The method of any one of the preceding embodiments, wherein the method further comprises prototyping a composite part of an in-vitro diagnostic device obtained after repeating step iii for a predetermined number of iterations and / or for which the target constraints are satisfied at least within a predetermined tolerance.

[0093] Embodiment 22: The method of any preceding embodiment, wherein the method includes validating the prototyped composite part by comparing at least one characteristic of the prototyped composite part with at least one characteristic of a simulated composite part, and / or evaluating the prototyped composite part by using at least one characteristic of the prototyped composite part in comparison to at least one target constraint.

[0094] Embodiment 23: A method for manufacturing a composite part of an in-vitro diagnostic instrument, the method comprising designing a composite part of an in-vitro diagnostic instrument by using a method for designing a composite part as described in any one of the preceding embodiments, the method further comprising manufacturing the designed composite part, i.e. the composite part of the in-vitro diagnostic instrument based on the design solution, by using at least one manufacturing process selected from the group consisting of milling, computer numerically controlled milling; casting; molding; additive manufacturing such as powder bed fusion, binder jetting, material jetting, 3D printing; cutting such as laser cutting and / or water jet cutting.

[0095] Embodiment 24: The method according to the preceding embodiment, wherein the manufacturing process is selected by taking into account the design solution, e.g., taking into account the manufacturing feasibility of the design solution.

[0096] Embodiment 25: The method according to any one of the two preceding embodiments, wherein at least one material for manufacturing a composite part of an in-vitro diagnostic device is selected by considering the design solution, and the material is at least one material selected from the group consisting of metallic materials; e.g., steel and / or its alloys; casting materials; non-ferrous metallic materials, e.g., one or more of aluminum, titanium and / or their alloys; inherent lattice-structured materials, e.g., lattice-structured metallic materials, materials having lattice structure characteristics, materials that can be arranged in a lattice structure; plastic materials; compound materials; and wood.

[0097] Embodiment 26: A composite part of an in-vitro diagnostic device, the composite part being obtainable by using a method for manufacturing a composite part according to any one of the preceding embodiments referring to a method for manufacturing a composite part.

[0098] Embodiment 27: The composite part of any preceding embodiment, wherein the composite part includes at least one lattice structure, such as a regular or irregular patterned structure.

[0099] Embodiment 28: A computer program comprising instructions that, when executed by a processor, cause the processor to perform at least step iii of a method for designing a composite part according to any one of the preceding embodiments referring to a method for designing a composite part.

[0100] Embodiment 29: A computer-readable storage medium comprising instructions that, when executed by a processor, cause the processor to perform at least step iii of a method for designing a composite part according to any one of the preceding embodiments referring to a method for designing a composite part.

[0101] Embodiment 30: A non-transitory computer-readable medium comprising instructions that, when executed by one or more processors, cause the one or more processors to perform at least step iii of a method for designing a composite part according to any one of the preceding embodiments referring to a method for designing a composite part.

[0102] Embodiment 31: A computer-readable data carrier, in particular a non-transitory storage medium, comprising instructions which, when executed by an apparatus for additive manufacturing, in particular a 3D printing apparatus, cause the apparatus for additive manufacturing to produce a composite part according to any one of the preceding embodiments referring to a composite part of an in-vitro diagnostic device.

[0103] Embodiment 32: A printing dataset comprising information that, when provided to an apparatus for additive manufacturing, in particular a 3D printing apparatus, enables the apparatus for additive manufacturing to produce a composite part according to any one of the preceding embodiments referring to a composite part of an in-vitro diagnostic device.

[0104] Embodiment 33: A computer program comprising instructions which, when the program is executed by a computer or a computer network, cause the computer or the computer network to produce a print data set according to the preceding embodiments.

[0105] Embodiment 34: An in-vitro diagnostic device configured to perform at least one test on a sample, the in-vitro diagnostic device comprising at least one composite part according to any one of the preceding embodiments referring to a composite part, the composite part being or including at least one function of one or more of a carrier of a magnetic glass particle mixer, a support of a magnetic glass particle mixer, and a gear of a magnetic glass particle mixer.

[0106] Further optional features and embodiments are disclosed in more detail in the following description of the embodiments, preferably in conjunction with the dependent claims. In it, each optional feature can be realized separately and in any possible combination, as understood by a person skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated diagrammatically in the figures, in which the same reference numbers in these figures refer to the same or functionally equivalent elements. [Brief description of the drawings]

[0107] [Figure 1] FIG. 1 shows a schematic flow chart of a method for designing a composite part of an in-vitro diagnostic device. [Diagram 2] FIG. 1 shows a flow chart of a schematic overview of a method for manufacturing a composite part of an in-vitro diagnostic device, including a flow chart of a method for designing the composite part of an in-vitro diagnostic device. [Diagram 3] 2 and 3 show a top view and a bottom view of one embodiment of a composite part. [Figure 4] 2 and 3 show a top view and a bottom view of one embodiment of a composite part. [Diagram 5]1A-1D show different embodiments of composite parts in perspective views; [Figure 6] 1A-1D are top views of different embodiments of composite components in an in-vitro diagnostic device. [Figure 7] 1A-1D are top views of different embodiments of composite components in an in-vitro diagnostic device. [Figure 8] 1A-1D are top views of different embodiments of composite components in an in-vitro diagnostic device. [Figure 9] 1A-1D are top views of different embodiments of composite components in an in-vitro diagnostic device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0108] 1 shows a schematic flow chart of a method 110 for designing a composite component 112 of an in-vitro diagnostic device 114. By way of example, different embodiments of the composite component 112 are shown in Figures 3-5, and different embodiments of the composite component 112 in an in-vitro diagnostic device 116 are shown in Figures 6-9.

[0109] The method 110 includes the following steps: i. deriving at least one target constraint 118 (denoted by reference numeral 116); ii. deriving at least one set of input parameters 122 (denoted by reference numeral 120), the input parameters 122 including at least one design goal 124 for defining the composite part 112 of the in-vitro diagnostic device 114 and at least one constraint parameter of the composite part 112 of the in-vitro diagnostic device 114; iii. determining at least one design solution 128 for the composite part 112 by using at least one iterative algorithm taking into account the input parameters 122 (denoted by reference numeral 126), wherein in each iteration, the iterative algorithm: As a first sub-step (indicated by reference numeral 130), determining at least one candidate composite part 132 for the in-vitro diagnostic device 114; As a second substep (indicated by reference numeral 134), comparing the candidate composite parts 132 with the target constraints 118; A third substep (designated 136) includes evaluating the candidate composite parts 132 according to the comparison.

[0110] The method 110 includes repeating step iii 126 until a predetermined number of iterations is reached and / or until the determined candidate composite part 132 satisfies the target constraints 118 within at least a predetermined tolerance, thereby determining a design solution 128 for the composite part 112 of the in-vitro diagnostic device 114.

[0111] The method 110 may further include a step 138 of prototyping the composite part 112 of the in-vitro diagnostic device 114 obtained after repeating step iii 126 for a predetermined number of iterations and / or in which the target constraints 118 are satisfied at least within a predetermined tolerance. As an example, the prototyping step 138 includes generating a prototyped composite part 140.

[0112] Further, method 110 may include a step of validating 142 the prototyped composite part 140 by comparing at least one characteristic of the prototyped composite part 140 with at least one characteristic of a simulated composite part, and / or evaluating the prototyped composite part 140 by using the at least one characteristic of the prototyped composite part 140 against at least one target constraint 118.

[0113] An embodiment of the method 110 further including a prototyping step 138 and a validation step 142 is shown in FIG. 2, which shows a schematic flow chart of a method 144 for manufacturing a composite part 112 of an in-vitro diagnostic device 114 including the method 110. The manufacturing method 144 further includes a step 146 of manufacturing the composite part 112 of the in-vitro diagnostic device 114 based on the design solution 128 of the composite part 112 by using at least one manufacturing process selected from the group consisting of milling, computer numerical control milling casting; molding; additive manufacturing, such as powder bed fusion, binder jetting, material jetting, 3D printing, and cutting, such as laser cutting and / or water jet cutting. Powder bed fusion may be exemplarily shown as a manufacturing process of the manufacturing step 146 shown in FIG. 2.

[0114] As an example, a manufacturing process may be selected by considering the design solution 128, e.g., taking into account the manufacturing feasibility of the design solution 128. Additionally, at least one material for manufacturing the composite part 112 of the in-vitro diagnostic device 114 may also be selected by considering the design solution 128.

[0115] Different embodiments of the composite part 112 as shown in Figures 3-9 were determined by using the method 110 for designing the composite part 112 of the in-vitro diagnostic device 114. The composite part 112 may include at least one lattice structure 148. As an example, the composite part 112 may include at least one portion and / or part having the lattice structure 148. For example, the composite part 112 may include at least one portion arranged in the lattice structure 148, as can be seen in the composite part shown in Figures 3 and 4. Additionally or alternatively, the composite part may include a regular lattice structure and / or pattern, as can be seen in the composite part 112 shown in Figures 6 and 7. Additionally or alternatively, the composite part 112 may have an intrinsic lattice structure, such as by including at least one intrinsic lattice structure material, as can be seen in the composite part 112 shown in Figures 8 and 9. [Explanation of symbols]

[0116] 110 Methods for designing composite components of in vitro diagnostic devices 112 Composite Parts 114 In-vitro diagnostic devices 116 Process i. 118 Goal Constraints 120 Process ii. 122 Input parameters 124 Design Goals 126 Process iii. 128 Design solution 130 First substep of step iii 132 candidate composite parts 134 Second sub-step of step iii 136 Third sub-step of step iii 138 Prototyping Process 140 Prototyped Composite Parts 142 Verification Process 144 Manufacturing method 146 Manufacturing process 148 Lattice structure

Claims

1. 1. A computer-implemented method for designing a composite part (112) of an in-vitro diagnostic device (114), the method comprising: i. deriving at least one goal constraint (118); ii. deriving at least one set of input parameters (122), said input parameters (122) including at least one design goal (124) for defining said composite part (112) of said in-vitro diagnostic device (114) and at least one constraint parameter of said composite part (112) of said in-vitro diagnostic device (114); determining at least one design solution (128) for said composite part (112) by using at least one iterative algorithm that takes into account said input parameters (122), wherein in each iteration, said iterative algorithm: determining at least one candidate composite part (132) for said in-vitro diagnostic device (114); comparing the candidate composite part (132) with the target constraints (118); and evaluating the candidate composite parts (132) in response to the comparison; The method includes repeating step iii until a predetermined number of iterations is reached and / or until the determined candidate composite part (132) satisfies the target constraints (118) at least within a predetermined tolerance, thereby determining the design solution (128) for the composite part (112) of the in-vitro diagnostic device (114).

2. 10. The method of claim 9, wherein the composite part (112) of the in-vitro diagnostic instrument (114) comprises one or more of a carrier, a support, or a gear of a magnetic glass particle mixer.

3. 10. The method of any one of the preceding claims, wherein the target constraints (118) include at least one constraint selected from the group consisting of: geometry constraints; topology constraints; pressure constraints; shear force constraints; mechanical stability constraints; strength constraints; weight constraints; force distribution constraints; surface property constraints; production machinery constraints; production constraints; and economic constraints.

4. 10. The method of claim 1, wherein the design goals (124) for defining the composite part (112) of the in-vitro diagnostic device (114) include at least one set of molding geometry parameters defining a molding geometry of the composite part (112) and / or at least one starting digital model of the composite part (112), and the set of molding geometry parameters defining a molding geometry of the composite part (112) includes a number of molding parameters and / or starting values ​​of molding geometry parameters.

5. 10. The method of any one of the preceding claims, wherein the at least one constraint parameter of the composite part (112) includes at least one of product characteristics, available build space, potential materials, potential manufacturing processes, or cost targets.

6. 10. The method of any one of the preceding claims, wherein the iterative algorithm comprises analyzing the candidate composite parts (132) by simulating the use of the composite parts (112) by applying at least one numerical simulation to the candidate composite parts (132), thereby determining at least one physical and / or mechanical property of the candidate composite parts (132) in the in-vitro diagnostic device (114).

7. 10. The method of claim 9, wherein the analyzing the candidate composite part (132) comprises one or both of discretizing the candidate composite part (132) into a mesh including a finite number of mesh elements and using at least one finite element method (FEM) simulation.

8. 2. The method of claim 1, wherein comparing the candidate composite part (132) with the target constraints (118) comprises comparing the determined physical and / or mechanical properties with the target constraints (118) and adapting at least one molding geometry parameter in response to the comparison, the method comprising repeating step iii with the adapted molding geometry parameters until the determined physical and / or mechanical properties satisfy the target constraints (118) at least within a predetermined tolerance, thereby determining the design solution (128) for the composite part (112) of the in-vitro diagnostic device (114) having an adapted set of molding geometry parameters in which the target constraints (118) are satisfied at least within a predetermined tolerance.

9. 10. The method of any one of the preceding claims, wherein the iterative algorithm comprises at least one genetic algorithm.

10. 10. The method of any one of the preceding claims, wherein the iterative algorithm is designed to take into account one or more of the following: at least one invariant region due to predefined interfaces to other components or the like; acting forces; kinematics; predefined fixed points; manufacturing methods; materials; accessibility to tools during production and / or assembly; stackability; or nesting of individual components.

11. 10. The method of any one of the preceding claims, wherein the method comprises outputting the design solution (128) obtained after repeating step iii for the predetermined number of iterations and / or in which the target constraints (118) are satisfied at least within a predetermined tolerance.

12. 10. The method of any one of the preceding claims, wherein the method further comprises prototyping the composite part (140) of the in-vitro diagnostic device (114) obtained after repeating step iii for the predetermined number of iterations and / or in which the target constraints (118) are satisfied at least within a predetermined tolerance.

13. 11. The method of claim 10, wherein the method includes validating the prototype composite part (140) by comparing at least one characteristic of the prototype composite part (140) with at least one characteristic of a simulated composite part and / or evaluating the prototype composite part (140) by using at least one characteristic of the prototype composite part (140) against the at least one target constraint (118).

14. 11. A method for manufacturing a composite part (112) of an in-vitro diagnostic instrument (114), the method comprising: designing the composite part (112) of the in-vitro diagnostic instrument (114) by using a method for designing a composite part (112) according to any one of the preceding claims, the method further comprising manufacturing the composite part (112) of the in-vitro diagnostic instrument (114) based on the designed composite part (112) by using at least one manufacturing process selected from the group consisting of milling, computer numerically controlled milling; casting; molding; additive manufacturing, such as powder bed fusion, binder jetting, material jetting, 3D printing, and cutting, such as laser cutting and / or water jet cutting.

15. A composite part (112) of an in-vitro diagnostic device (114), said composite part (112) being obtainable by using a method for manufacturing a composite part (112) according to any one of the preceding claims referring to a method for manufacturing a composite part (112).

16. 13. A computer program comprising instructions which, when executed by a processor, cause the processor to carry out at least step iii of a method for designing a composite part (112) according to any one of the preceding claims referring to a method for designing a composite part (112).

17. A printing dataset comprising information that, when provided to an apparatus for additive manufacturing, enables the apparatus for additive manufacturing to produce a composite part (112) according to any one of the preceding claims referring to a composite part (112) of an in-vitro diagnostic device (114).

18. 16. An in-vitro diagnostic instrument (114) comprising a composite component (112) according to claim 15, wherein the composite component is, or comprises at least one function of, one or more of a carrier for a magnetic glass particle mixer, a support for a magnetic glass particle mixer, and a gear for a magnetic glass particle mixer.

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