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

Abstract

The invention discloses a computer-implemented method for designing a complex part (112) of an in vitro diagnostic instrument (114). Further disclosed are a method for manufacturing a complex part (112) of an in vitro diagnostic instrument (114), a complex part (112) of an in vitro diagnostic instrument (114), a computer program having a program tool for executing a method for designing a complex part (112) of an in vitro diagnostic instrument (114), a non-transitory computer-readable medium, a computer-readable storage medium, and a method for manufacturing a complex part (112) of an in vitro diagnostic instrument (114). A print data set and a computer program for generating a print data set.

Description

Technical Field

[0001] The present application relates to a computer-implemented method for designing a complex part of an in vitro diagnostic instrument, a method for manufacturing a complex part of an in vitro diagnostic instrument, and a complex part of an in vitro diagnostic instrument. The invention further relates to a computer program with program means for executing 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 producing a print data set. Background Art

[0002] In order to design and / or construct products and parts, computer-aided design (CAD) programs and processes are usually used. However, today's CAD solutions are mainly designed for cubic and rotational parts, the shapes of which can be economically produced using traditional manufacturing processes. With the development of additive manufacturing processes, most of the restrictions on geometry and / or material composition that are usually set for traditional manufacturing processes no longer apply. On the contrary, additive manufacturing processes have made great progress and have long surpassed the stage of pure prototype construction. Therefore, different ways of designing and / or constructing seem to be necessary. Therefore, many CAD software suppliers have responded to this trend and provided solutions that help to make more full use of additive manufacturing processes (such as laser sintering, 3D printing and similar processes). However, the steady development of manufacturing processes requires continuous improvement and adaptation of design methods and processes.

[0003] Furthermore, it is desirable that the design methods and processes take into account the application area and the corresponding forces and loads. For example, complex parts of in vitro diagnostic instruments such as magnetic glass particle (MGP) mixers may be affected by vibrations acting on them. For example, due to the imbalance caused by the eccentric mechanism, not only the MGP plate may shake, but also the entire assembly (and the chassis embedded in it). This problem is further exacerbated by the reduction in mass when complex parts of in vitro diagnostic instruments are miniaturized and may interfere with adjacent processes due to vibrations. In addition, fatigue fracture of load-bearing components may also be a problem.

[0004] US2019 / 0283368 A1 describes a thermoplastic elastomer compound comprising a hydrogenated styrene 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 according to ASTM 6493, and optionally, one or more additional thermoplastic elastomers. If no thermoplastic polyurethane is present, the compound has a compound loss tangent peak temperature (at 10 Hz) of at least 10°C, a compound loss tangent peak height (at 10 Hz) of at least 0.85, and if an additional thermoplastic elastomer is present and includes a thermoplastic polyurethane, the compound loss tangent peak height is at least 0.60.

[0005] Issues to be resolved

[0006] Therefore, it is desirable to provide methods and devices that solve the technical challenges mentioned above. In particular, a method, a computer program and a device should be proposed, which allow generating topologically optimized complex parts of in vitro diagnostic instruments. Summary of the invention

[0007] This problem is solved by the following with the features of the independent claims: a computer-implemented method for designing a complex part of an in vitro diagnostic instrument, a method for manufacturing a complex part of an in vitro diagnostic instrument, a complex part of an in vitro diagnostic instrument, a computer program with program means for executing 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 producing a print data set. In the dependent claims and throughout the description, advantageous embodiments are listed which can be realized individually or in any combination.

[0008] As used below, the terms "having", "comprising" or "including" or any grammatical variations thereof are used in a non-exclusive manner. Thus, these terms may refer to the absence of other features in the entity described in this context in addition to the features introduced by these terms, or the presence of one or more other features. As an example, the expressions "A has B", "A includes B" and "A contains B" may refer to the absence of other elements in A in addition to B (i.e., the presence of A solely and exclusively consisting of B); or to the presence of one or more other elements in entity A in addition to B (such as element C, element C and element D, or even other elements).

[0009] Further, 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 once or more than once are usually used only once when introducing the corresponding feature or element. In the following, in most cases, when referring to the corresponding feature or element, the expression "at least one" or "one or more" is not repeated even though the corresponding feature or element may be present only once or more than once.

[0010] Further, as used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features without limiting the possibilities of alternatives. Therefore, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As the skilled person will recognize, the present invention may be carried out through the use of alternative features. Similarly, the features introduced by "in one embodiment of the present invention" or similar expressions are intended to be optional features without any limitation on alternative embodiments of the present invention, without any limitation on the scope of the present invention, and without any limitation on the possibility of combining the features introduced in this manner with other optional or non-optional features of the present invention.

[0011] In a first aspect, a computer-implemented method for designing a complex portion of an in vitro diagnostic instrument is presented.

[0012] As used herein, the term "computer-implemented" is a broad term and should be given its ordinary and customary meaning to a person of ordinary skill in the art, and should not be limited to a special or customary meaning. The term may specifically refer to, but is not limited 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 include at least one processor configured to perform at least one of the method steps of the method according to the present invention. Preferably, each of the method steps is performed by a computer and / or computer network and / or cloud. The method may be performed completely automatically (e.g., without user interaction). As used herein, the term "automatically" is a broad term and is given its ordinary and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, a process performed entirely with the aid of at least one computer and / or computer network and / or cloud and / or machine, such as without manual operation and / or interaction with a user.

[0013] As used herein, the term "in vitro diagnostic" is a broad term and is given a common and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. For example, in vitro diagnostics can include performing at least one test on a sample, such as a biological sample obtained from a human or animal body. For example, testing the sample can include applying at least one reagent to the sample and monitoring a detectable reaction. As an example, in order to perform an in vitro diagnosis, such as the at least one test on the sample, an in vitro diagnostic instrument can be used, such as performing scientific or technical research, experiments and / or measurements in a laboratory or other environment. For example, the in vitro diagnostic instrument can be part of a clinical laboratory, a medical laboratory, a forensic laboratory, or a blood bank.

[0014] As used herein, the term "biological sample" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, at least one biological material that may potentially include at least one analyte of interest. For example, a biological sample may include a body fluid, such as blood, interstitial fluid, urine, saliva, or other types of body fluids. For example, according to some embodiments, a biological sample may be or may include an aliquot of a substance such as a biological compound. For example, a biological sample may be or may include at least one biological specimen, such as one or more of the following: blood; serum; plasma; urine; saliva. A biological sample may be a liquid sample. For example, a liquid sample may be or may include at least one pure liquid, such as a liquid substance and / or a solution containing one or more liquid substances, which contains a biological substance. A liquid sample may be or may include a liquid mixture, such as a suspension, emulsion, and / or dispersion of a biological substance. A biological sample may be a solid sample, for example, at least one tissue sample.

[0015] As used herein, the term "in vitro diagnostic instrument" is a broad term and is given the ordinary and customary meaning to those of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any device configured to perform in vitro diagnosis, such as analyzing a biological sample. An in vitro diagnostic instrument may be one or more of the following: a pre-analytical instrument, an analytical instrument, or a post-analytical instrument.

[0016] As used herein, the term "complex part" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a combination and / or stacking of multiple components and / or separate parts of one or more of their functions. For example, a complex part may stack the multiple components, such as integrating their functions into a single part. The complex part cannot be disassembled. For example, a complex part may be made in one piece, i.e., forming a single part, making it impossible to disassemble it into separate components non-destructively. The multiple components whose functions may be combined and / or stacked within the complex part may be components that typically have rigid interfaces, for example, which may be connected by one or more of gluing, threading, riveting and / or welding.

[0017] For example, the complex part can be an element of a magnetic glass particle (MPG) mixer of an in vitro diagnostic instrument. The MPG mixer may include at least one support configured to hold the MPG mixer assembly together. The support may be configured to be used as an interface with other parts of the in vitro diagnostic instrument. The MPG mixer may include at least one carrier, also referred to as a shaking plate. The carrier may be configured to receive and hold an MGP box and configured to mix the MGP. The MPG mixer may include 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 a plane. For example, two eccentric mechanisms may be used to perform the mixing process. The two eccentric mechanisms may be driven via belts, each belt being driven by a single electric motor. The motors may be controlled independently of each other. The resulting offset may be compensated by a linear guide. The MPG mixer may include additional components, such as one or more of at least one motor for driving reception and / or opening of an MGP box, at least one RFID reader, at least one printed circuit board, etc. Regarding the MGP box, please refer to EP 2 423 688 A1. For example, a complex part of an in vitro diagnostic instrument includes one or more of a carrier, a support or a gear of a magnetic glass particle mixer. For example, a complex part may be or may include, for example, alone or in combination, one or more of the functions of a carrier, a support or a gear of a magnetic glass particle mixer.

[0018] As used herein, the term "design" is a broad term and is given a meaning that is ordinary and customary to one of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a procedure for planning and / or specifying an object or process. As an example, a procedure for designing may include developing and / or defining at least one characteristic of an object or process. The design may include at least one optimization for at least one objective.

[0019] As used herein, the term "designing a complex part" is a broad term and is given a meaning that is ordinary and customary to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a procedure for planning and / or specifying a complex part. For example, the design of a complex part may be or may include developing and / or defining at least one characteristic of the complex part, such as geometry and / or shape and / or material or material composition. As an example, a complex part (e.g., an element of an MPG mixer for an in vitro diagnostic instrument), such as a design solution for the complex part (at least in a manufacturable form), such as a 3D model and / or in one or more technical drawings, may be a result of designing the complex part, such as a design output of the complex part.

[0020] The method steps may be performed in a given order or may be performed in a different order. Further, there may be one or more additional method steps not listed. Further, one, more than one or even all method steps may be performed repeatedly.

[0021] The method includes

[0022] i. Retrieve at least one target constraint;

[0023] ii. retrieving at least one set of input parameters, wherein the input parameters include at least one design goal for defining a complex portion of an in vitro diagnostic instrument and at least one constraint parameter of the complex portion of the in vitro diagnostic instrument,

[0024] iii. determining at least one design solution for the complex part by using at least one iterative algorithm taking into account input parameters, wherein in each iteration, the iterative algorithm includes

[0025] Identify at least one candidate complex part of an in vitro diagnostic device,

[0026] comparing the candidate complex part to the target constraint, and

[0027] The candidate complex parts are ranked based on the comparison.

[0028] The method comprises repeating step iii until a predefined number of iterations is reached and / or until the determined candidate complex part satisfies the target constraint at least within a predefined tolerance, thereby determining a design solution for the complex part of the in vitro diagnostic instrument.

[0029] As used herein, the term "retrieval" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a process in which a system (specifically a computer system) generates data and / or obtains data and / or retrieves data (e.g., via a man-machine interface as user input) from any data source (such as from a data storage device, from a network or from another computer or computer system or cloud). Retrieval may specifically be performed through at least one computer interface (e.g., a communication interface), such as via a port (e.g., a serial or parallel port). Retrieval may include several sub-steps, such as the following sub-steps: obtaining one or more primary information and generating auxiliary information by utilizing the primary information, such as by, for example, applying one or more algorithms to the primary information using a processor. In addition, retrieval may include obtaining data from one or more of user input, at least one measurement, at least one calculation, literature, at least one manual, knowledge, experience, and at least one simulation.

[0030] The retrieval in step i. and / or step ii. can be performed by using at least one communication interface. As used herein, the term "communication interface" is a broad term and will be given the common and customary meaning for ordinary technicians in the field, and is not limited to a special or customized meaning. The term can specifically refer to, but is not limited to, an item or element that forms a boundary, which is configured to transmit information. The communication interface can be configured to transmit information from a computing device (such as a computer), such as to send or output information to, for example, another device. Additionally or alternatively, the communication interface can be configured to transmit information to a computing device (such as a computer), such as to receive information. The communication interface can provide a way to transmit or exchange information. The communication interface can provide a data transmission connection, such as Bluetooth, NFC, inductive coupling, etc. As an example, the communication interface can be or may include at least one port, which includes one or more of a network or Internet port, a USB port, and a disk drive. The communication interface can be at least one Web interface.

[0031] A communication interface, such as a human-machine interface, may be or may include a user interface via which a user inputs data. As used herein, the term "user interface" is a broad term and should be given the ordinary and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may refer to, but is not limited to, a communication interface configured for interacting with its environment, such as for the purpose of exchanging information unidirectionally or bidirectionally, such as for exchanging one or more data or commands. For example, a user interface may be a bidirectional interface. A user interface may be configured to share information with a user and receive information by a user. As an example, a user interface may include one or more of the following: a graphical user interface; a data interface, such as a wireless and / or wired data interface.

[0032] For example, the retrieval of the target constraint may include retrieving the target constraint from at least one data storage device. The data storage device may include at least one table or at least one lookup table containing a plurality of target constraints.

[0033] As used herein, the term "target constraint" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, features or specifications targeted and / or aligned when designing a complex part. A target constraint, also referred to as a target criterion, may be or may include at least one reference feature and / or characteristic to which a feature of a complex part is compared. For example, the target constraint includes at least one constraint selected from the group consisting of: geometric constraints; topological 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 machine constraints; production constraints; and economic constraints. The target constraint may be a parameter that affects another feature and / or behavior of a complex part. For example, the target constraint may be a parameter related to fluid dynamics, such as a pressure drop, affecting turbulence or transport laminar flow, which affects the mixing ratio of the box of an MPG mixer. As an example, a target constraint may include at least one static target, such as a constant and / or time-invariant value. Additionally or alternatively, the target constraint may include at least one dynamic target, such as at least one changing and / or evolving value, for example according to a predefined schedule and / or evolution. For example, a dynamic target may be or may include at least one feature that changes its value according to a predefined function (e.g., a function of time and / or space and / or a function of another parameter such as temperature and humidity). Additionally or alternatively, a dynamic target may be or may include a constraint for which no predefined evolving and / or changing function is available, such as improving, for example, reducing stress reduction, maximizing stiffness, minimizing material consumption and / or component weight.

[0034] As used herein, the term "input parameter" is a broad term and is given a meaning that is ordinary and customary to one of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, input values ​​of an iterative algorithm and / or data that may be populated into an iterative algorithm. An iterative algorithm may be configured to generate and / or determine a design solution for a complex part based on input parameters (e.g., values). The set of input parameters may include a plurality of input parameters.

[0035] The input parameters include at least one design goal for defining a complex part of an in vitro diagnostic instrument. As used herein, the term "design goal" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, the starting point of the process of designing a complex part. The design goal may be any primary and / or initial two-dimensional and / or three-dimensional form or shape. The design goal may be or may include a three-dimensional basic type of a complex part. The design goal may be the initial geometry of a complex part. For example, the design goal may be a predefined basic type of a complex part, such as a previously developed structure and / or form. As an example, the design goal may have or may include a feature that may be specified to be present in a complex part, such as a lattice structure. The design goal may be a two-dimensional and / or three-dimensional structure, which may be described in geometric form, such as one or more of at least one cuboid, 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 predefined and / or pre-existing geometry, such as a design solution previously determined in step iii.

[0036] The design goals for defining a complex part of an in vitro diagnostic instrument may include at least one set of forming geometry parameters defining a forming geometry of the complex part and / or at least one starting digital model of the complex part.

[0037] As used herein, the term "forming geometry parameter" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, any parameter that defines the forming geometry, such as a digital description of a digital model, such as a preliminary shape and / or a seed shape. The shape may be an outer boundary or outer surface of the forming geometry, such as an envelope. The set of forming geometry parameters that define the forming geometry of the complex part may include a plurality of forming parameters and / or starting values ​​of the forming geometry parameters. The forming geometry parameters may include at least one parameter selected from the group consisting of: length, width, height, at least one parameter that defines the pattern structure of the complex part, at least one parameter that characterizes the type of the complex part (such as a carrier, a support or a gear), other structures such as the lattice structure of the complex part.

[0038] Retrieving the set of forming geometric parameters may include receiving the set of forming geometric parameters from at least one data storage device. The data storage device may include at least one table or at least one lookup table including a plurality of different starting geometries and associated forming geometric parameters.

[0039] As used herein, the term "digital model" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a digital representation, such as a two-dimensional or three-dimensional representation of any surface of an object. The starting digital model may be an initial digital model and / or a predefined and / or pre-existing digital model, such as a design solution previously determined in step iii. The starting digital model may be or may include a computer-generated digital model, such as by using at least one algorithm dedicated to generating a digital model and / or by scanning the object and converting the scanned data into a digital model. For example, the method may include determining the starting digital model by using the set of forming geometric parameters within at least one computer-aided design tool. As an example, the set of forming geometric parameters may be used, such as within the at least one computer-aided design tool, to set a starting digital model, such as an initial digital representation of the design target. For example, the starting digital model may be based on a DXF file retrieved in step ii., etc., such as part of the at least one set of input parameters.

[0040] The input parameters include at least one constraint parameter of a complex part of the in vitro diagnostic instrument. As used herein, the term "constraint parameter" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, at least one boundary condition of a design solution. For example, the at least one constraint parameter of the complex part may include at least one of a product characteristic, available build space, potential materials, potential manufacturing processes, or a cost target. The input parameters may include multiple constraint parameters.

[0041] As used herein, the term "design solution for a complex part" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not 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. A design solution may include a set of parameters that define one or more of the geometry, shape, material, or structure of a complex part. A design solution may refer to the outcome of a computer-implemented method for designing a complex part of an in vitro diagnostic instrument. As an example, a design solution, such as in the method, may exist in the form of a virtual model, such as a two-dimensional and / or three-dimensional model. For example, a design solution may be provided, such as by a processor involved in executing the method, in a computer-readable format, such as in a data format readable by the processor, for example, in the form of a 3D file.

[0042] Determining at least one design solution in step iii. can be performed by using at least one processor. As used herein, the term "processor" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, any logic circuit system configured to perform basic operations of a computer or system; and / or, in general, a device configured to perform calculations or logical operations. In particular, the processor may be configured to process basic instructions that drive the computer or system. As an example, the processor may include at least one arithmetic logic unit (ALU), at least one floating point unit (FPU) (such as a math coprocessor or a numerical coprocessor), a plurality of registers (specifically registers configured to provide operands to the ALU and store operation results) and a memory (such as L1 and L2 cache memories). In particular, the processor may be a multi-core processor. In particular, the processor may be or may include a central processing unit (CPU). In particular, the processor may be or may include at least one graphics processing unit (GPU). Additionally or alternatively, the processor may be or may include a microprocessor, whereby, in particular, elements of the processor may be contained in a single integrated circuit (IC) chip. Additionally or alternatively, the processor may be or may include 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 processor unit (NPU) and / or one or more chips, such as dedicated machine learning optimized chips, etc. The processor may be at least partially cloud-based.

[0043] As used herein, the term "iterative algorithm" is a broad term and is given the ordinary and customary meaning to ordinary technicians in the field, and is not limited to a special or customized meaning. The term can specifically refer to, but is not limited to, an algorithm that includes at least one iteration. Each iteration can include specified substeps, namely, determining at least one candidate complex part of the in vitro diagnostic instrument, comparing the candidate complex part with the target constraints, and rating the candidate complex part based on the comparison. The iterative algorithm can include multiple loops. In the initial loop, the input parameters retrieved in step ii can be used as a starting point.

[0044] Iterative algorithms may be designed to take into account one or more of: at least one unchangeable area, such as due to predefined interfaces with other components; forces; kinematics; predefined fixed points; manufacturing methods; materials; accessibility of tools during production and / or assembly; stackability; or nesting of individual components, for example to achieve efficient logistics. Iterative algorithms may be designed to take into account one or more of the elements used in the manufacturing method, such as two-axis CNC, five-axis CNC, CNC lathes, casting tools with and without slides, etc. This may allow further optimization of the process, for example to allow cost and / or production scale-up.

[0045] For example, an iterative algorithm may comprise at least one repetition of a specified step, such as a number of repetitions that may be performed in subsequent loops. Loops may be performed continuously, such as one after another, wherein the outcome of the previous loop may be used as an input parameter for the next loop. For example, multipliers may be used, for example to enhance the dispersion in the solution landscape. This may allow preventing local minima or maxima. The resulting "noise" of the solution accuracy may be affected. For example, sometimes greater variations are required, such as the conceptual phase, while sometimes a precise and clear solution is required. Thus, an iterative algorithm may be based on a "classical" iteration, wherein a single solution is generated in each iteration and the sequence of solutions of consecutive iterations approaches the optimal solution.

[0046] The iterative algorithm may include topology optimization. For example, the topology optimization may include iteratively determining the geometry of the complex part. The topology optimization may use input parameters, such as design goals and constraint parameters. The topology optimization may include defining a construction space as a basis for the topology optimization, taking into account forces and loads to determine the optimal geometry. The topology optimization may include iteratively and alternately performing at least one finite element method (FEM) analysis and at least one material reduction operation. The iterative algorithm may consider one or more of the demoulding direction (for casting), the building direction (additive process), and the accessibility of the tool (chip removal process) during the iteration. The FEM analysis and the material reduction operation may be performed until a predefined number of iterations is reached and / or until the determined candidate complex part satisfies the target constraint at least within a predefined tolerance. The iterative algorithm may consider multiple target constraints. The target constraints may be interdependent. The target constraints may have a priority order. Different weights may be used to consider the priorities. For example, demoulding is more important than achieving quality specifications.

[0047] As used herein, the term "candidate complex part" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a preliminary result of simulating a complex part taking into account input parameters. The candidate complex part may be a virtual prototype of the complex part.

[0048] As used herein, the term "simulating a complex part" is a broad term and is given the ordinary and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a process of applying at least one simulation tool (such as an algorithm and / or a neural network) to input parameters in order to determine a design solution for a complex part. In subsequent iterations, the value of at least one parameter in a set of parameters may vary, for example, depending on the results of a comparison of a candidate complex part with a target constraint. Parameters and / or parameter values ​​may vary by following one or more of a preset and / or predetermined pattern, a preset and / or predetermined algorithm, a preset and / or predetermined set of mathematical rules, a preset and / or predetermined method, or a preset and / or predetermined protocol, and / or may vary randomly. Adjustment of the forming geometry parameters may include at least one material reduction operation.

[0049] As used herein, the term "comparing a candidate complex part to a target constraint" is a broad term and is given the ordinary and customary meaning to one of ordinary skill in the art and is not 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 feature of a candidate complex part to a target constraint.

[0050] For example, the comparison may include analyzing the candidate complex part by applying at least one numerical simulation to the candidate complex part to simulate the use of the complex part, thereby determining at least one physical and / or mechanical property of the candidate complex part for the in vitro diagnostic instrument. As used herein, the term "simulating the use of a complex part" is a broad term and is given the ordinary and customary meaning to one of ordinary skill in the art, and is not limited to a special or customized meaning. The term specifically may refer to, but is not limited to, simulating the behavior of a complex part under at least one test condition, such as under one or more of at least one force, deformation, stress, condition such as defined by temperature, or load.

[0051] The physical and / or mechanical properties may include at least one property selected from the group consisting of: weight; material; tension properties; pressure properties; shear properties; rigidity; 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.

[0052] The analysis of the candidate complex part may include discretizing the candidate complex 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, for example, determine and visualize the behavior of the candidate complex part under one or more of at least one force, deformation, stress, conditions such as defined by temperature, or loads. The FEM simulation may be configured to identify faults such as weak points. The FEM simulation may be configured to statically determine the behavior of the candidate complex part or its development over time. The FEM simulation may be based on one or more of voxels, point clouds, B-Reps, SDFs, etc.

[0053] Comparing the candidate complex part with the target constraint may include comparing the determined physical and / or mechanical properties with the target constraint and adjusting at least one of the forming geometric parameters according to the comparison. The method includes repeating step iii until a predefined number of iterations is reached and / or until the determined candidate complex part satisfies the target constraint at least within a predefined tolerance. The method may include repeating step iii. with the adjusted forming geometric parameters until the determined physical and / or mechanical properties satisfy the target constraint at least within a predefined tolerance, thereby determining a design solution for the complex part of the in vitro diagnostic instrument with a set of adjusted forming geometric parameters, for which the target constraint is satisfied at least within a predefined tolerance range. For example, the predefined number of iterations may depend on the initial situation, for example, may be between 2 and 80. For example, the method may include terminating after, for example, 60 iterations. The method may include manual correction, which may be used as a new starting geometry. As used herein, the term "satisfy" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, achieving any goal, such as complying with at least one predefined or preset standard. Therefore, the term "at least satisfied within a predefined tolerance" may specifically refer to, but is not limited to, any state of reaching a predefined goal by complying with the at least one predefined or preset standard, wherein the predefined tolerance may be applied when determining the achievement. The term "at least satisfying the target constraint within a predefined tolerance" may refer to the fact that the target constraint is fully satisfied, wherein deviations are possible within the predefined tolerance. In particular, the target constraint may be considered to be satisfied as long as the determined physical and / or mechanical properties of the candidate complex part differ from the target constraint by no more than 50%, preferably no more than 20%, and more preferably no more than 10%. 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, such as the simulation terminating after 24 hours. This may control costs if, for example, the calculation is performed in the cloud, or local PC capacity is used for a long time.

[0054] Additionally or alternatively, an iterative algorithm, such as at least one genetic algorithm, can be used to perform the determination of candidate complex parts and the comparison of candidate complex parts. An iterative algorithm using a genetic algorithm can include generating a solution population in each iteration. In each iteration, a solution can be randomly selected from a previous population. These selected solutions can be used as parents to produce offspring for the next generation population. After continuous iterations, an optimal solution can be obtained. For example, one of the interdependent parameters can be selected and its weight can be minimized or maximized, for example to achieve a local and / or global optimum (maximum or minimum value of a function). Regarding optimization, reference is made to, for example, en.wikipedia.org / wiki / Mathematical_optimization.

[0055] As used herein, the term "rating candidate complex parts according to comparison" is a broad term and is given the ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, classifying the candidate complex parts, for example, as a suitable design solution for prototyping or as an intermediate solution for the next iteration, and / or assigning at least one score indicating compliance with a target constraint, for example, from 1 (no compliance) to 10 (complete compliance).

[0056] The method may include outputting a design solution obtained after repeating the predefined number of iterations of step iii and / or for which the target constraint is satisfied at least within a predefined tolerance. As used herein, the term "output" is a broad term and should be given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a process of making information available for use by another system, data storage, individual, or entity. As an example, the output may be performed via one or more interfaces, such as a computer interface, a network interface, or a human-machine interface. As an example, the output may be performed in one or more of a computer-readable format, a visual format, or an audible format. The output design solution may include outputting at least one information about one or more of the following: height distribution; wall thickness distribution; at least one length; pattern structure; general geometry and / or shape; material; manufacturing process; topology; volume; surface; quality; foam structure with open or closed cells; lattice structure, such as the form and / or position and / or distribution and / or extension of at least one cut and / or hole and / or mesh.

[0057] The method may further include prototyping a complex part of an in vitro diagnostic instrument obtained after repeating the predefined number of iterations of step iii and / or for which the target constraints are met at least within a predefined tolerance. As used herein, the term "prototyping" is a broad term and will be given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, the process of manufacturing a full-size and functional model or form of any element or object or generating a virtual prototype. For example, a CAD model may be built into a higher-level component as an unfinished model. Through FEM simulation, cost calculations may be evaluated, which may be performed using the obtained geometry, fillers, etc. Then, these findings may flow back into the optimization process. A prototype may be a model of a complex part and may be used to test and / or verify at least one feature or specification of a complex part. A prototype may be manufactured before a large-scale production process or a batch production process. For example, a prototype may be produced or manufactured as part of a development phase of a complex part. Therefore, the prototyping of a complex part may be specifically performed before starting a large-scale production process or manufacturing of a complex part. The method may include validating the prototype complex part by comparing at least one characteristic of the prototype complex part to at least one characteristic of the simulated complex part and / or rating the prototype complex part by comparing at least one characteristic of the prototype complex part to the at least one target constraint (e.g., to at least one of the target constraints if there is more than one target constraint).

[0058] In another aspect of the present invention, a method for manufacturing a complex part of an in vitro diagnostic instrument is disclosed. The method for manufacturing a complex part of an in vitro diagnostic instrument is also referred to as a manufacturing method. The manufacturing method comprises designing a complex part of an in vitro diagnostic instrument by using a method for designing a complex part as disclosed herein. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the method for designing a complex part as disclosed above or as disclosed in further detail below.

[0059] The manufacturing method further includes manufacturing the complex part of the in vitro diagnostic instrument based on the designed complex 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 numerical control 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.

[0060] The manufacturing method may, for example, include manufacturing the complex part by one or more traditional ablative manufacturing processes, such as by milling, for example by computer numerical control milling; or cutting, such as laser cutting and / or water jet cutting, wherein the component (i.e., the complex part) can be formed from a solid material and / or block by removing material layer by layer from the solid and / or block. Additionally or alternatively, the manufacturing method may include manufacturing the complex part by one or more traditional molding processes, such as by casting and / or molding, wherein reusable and / or lost foam can be used to cast the component (i.e., the complex part). Further additionally or alternatively, the manufacturing method may include manufacturing the complex part by one or more recently developed additive manufacturing processes, such as by powder bed fusion, binder jetting, material jetting, 3D printing, etc., wherein the component (i.e., the complex part) can be formed by adding material layer by layer.

[0061] For example, a manufacturing process can be selected by considering a design solution, such as a design solution for a complex part of an in vitro diagnostic instrument as determined in a method for designing a complex part of an in vitro diagnostic instrument as disclosed herein. As an example, a manufacturing process can be selected by considering the manufacturing feasibility of a design solution of a design method as disclosed herein. For example, a manufacturing process can be selected based on the ability of the design solution to be produced using the process. Therefore, the design solution determined in the design method can be evaluated, for example, automatically, according to predetermined and / or preset standards, and the manufacturing process capable of manufacturing and / or producing the complex part can be selected and / or rated based on the evaluation of the design solution. The criteria for evaluating the ability of the design solution to be manufactured and / or produced by the manufacturing process can be, for example, one or more of the following: size, required tolerance (e.g., surface tolerance), and whether there is an undercut. Additional criteria are also possible, such as one or more materials for the complex part.

[0062] As an example, at least one material for manufacturing a complex part of an in vitro diagnostic instrument can be selected by considering a design solution. The material can be or can include at least one material selected from the group consisting of: a metal material; for example, steel and / or its alloys; a casting material; a non-ferrous metal material, such as aluminum, titanium and / or one or more alloys thereof; an intrinsic lattice structure material, such as a lattice structure metal material, a material having lattice structure characteristics, a material that can be arranged into a lattice structure; a plastic material; a composite material; wood. Specifically, the complex part can be or can include a lattice structure rigid material, such as a metamaterial, in which flexible features, such as a flexible system, can be explained and / or constructed by designing the topological properties of the material, so as to produce flexibility that may not exist in the basic rigid material.

[0063] In another aspect of the invention, a complex part of an in vitro diagnostic instrument is disclosed. The complex part can be obtained by using the method for manufacturing a complex part as disclosed herein. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the method for manufacturing a complex part of an in vitro diagnostic instrument (e.g., a manufacturing method) as disclosed above or as disclosed in further detail below.

[0064] The complex portion may include at least one lattice structure. For example, the complex portion may include a regular pattern structure or an irregular pattern structure. As an example, the complex portion may be or may include at least one segment and / or portion having a lattice structure (such as having an intrinsic lattice structure), having lattice structure characteristics (such as deformable and / or elastic characteristics), and / or arranged in a lattice structure, such as arranged in a regular or irregular pattern structure.

[0065] In another aspect of the invention, a computer program is disclosed, the computer program comprising instructions, which, when the program is executed by a processor (e.g., a processor of a computer or a computer network), comprise instructions for causing the processor to perform at least step iii of the method for designing a complex part as disclosed herein. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the method for designing a complex part as disclosed above or as disclosed in further detail below, for example, to the description related to step iii. of the method. In particular, the computer program can be configured to cause the processor to perform the determination of the at least one design solution for the complex part by using the at least one iterative algorithm as disclosed herein.

[0066] In another aspect of the present invention, a computer-readable storage medium is disclosed, which includes instructions, which, when executed by a processor (e.g., a processor of a computer or a computer network), include instructions that cause the processor to perform at least step iii of the method for designing a complex part as disclosed herein. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the method for designing a complex part as disclosed above or as disclosed in further detail below, for example, reference is made to the description related to step iii. of the method. In particular, the computer-readable storage medium can be configured to cause the processor to perform the determination of the at least one design solution for the complex part by using the at least one iterative algorithm as disclosed herein.

[0067] In another aspect of the invention, a non-transitory computer-readable medium is disclosed, the non-transitory computer-readable medium comprising instructions, which, when executed by one or more processors (e.g., processors of a computer or a computer network), cause the one or more processors to perform at least step iii of the method for designing a complex part as disclosed herein. Thus also, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the method for designing a complex part as disclosed above or as disclosed in further detail below, for example, to the description related to step iii. of the method.

[0068] In another aspect of the invention, a computer-readable data carrier, in particular a non-transitory storage medium, is disclosed, the computer-readable data carrier 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 complex part as disclosed herein. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of complex parts as disclosed above or as disclosed in further detail below.

[0069] As used herein, the term "apparatus for additive manufacturing" (also referred to as "additive manufacturing apparatus") is a broad term and is given the ordinary and customary meaning to a person of ordinary skill in the art and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, a manufacturing module and / or a manufacturing system that is configured to generate a three-dimensional object, such as a part and / or component, from one or more liquid and / or solid materials by layer-by-layer assembly under computer control. The additive manufacturing apparatus may include an interface, such as an STL interface, for example for data transmission, such as reading information and / or instructions stored on a computer-readable data carrier.

[0070] As used herein, the term "computer-readable data carrier" (also referred to as "data carrier") is a broad term and is given the ordinary and customary meaning to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, at least one non-transitory data storage device and / or non-transitory storage medium, such as a hardware data storage medium on which computer-executable instructions are stored. As an example, the instructions may be stored as a data structure on a data storage medium, which, after being loaded into the working and / or main memory of an additive manufacturing device, enables the latter to produce a complex part according to the present invention. The computer-readable data carrier may be or may include a storage medium readable by an 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 print information, such as a print data set as further outlined below.

[0071] For example, the instructions on the data carrier may be in the form of a 3-D file, such as an STL format, a DXF format, a VRML format, an OBJ format, a 3DS format, an OFF format, an AMF format, a 3MF format, or a similar file format readable by an additive manufacturing device. Alternatively or additionally, the instructions may be present on the data carrier as a layer file, for example in a layer file format, such as a CLI file, as an SLC file, or in a similar file format comprising information about a plurality of cutting contours for manufacturing the stent layer by layer in an additive manufacturing device.

[0072] In another aspect of the invention, a printing data set is disclosed, which 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 complex part as disclosed herein. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the complex part as disclosed above or as disclosed in further detail below.

[0073] As used herein, the term "print data set" is a broad term and is given a meaning that is ordinary and customary to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, data that includes information for producing a three-dimensional object in an additive manufacturing device, such as an instruction manual. As an example, a print data set may include instructions on how to control a print head of an additive manufacturing device and / or how much material to apply per layer. For example, the print data set may be in G-code format. For example, a print data set may be suitable for a specific additive manufacturing device, such as a device of a specific type and / or a specific manufacturer.

[0074] In another aspect of the invention, a computer program comprises instructions which, when executed by a computer or a computer network, cause the computer or computer network to produce a print data set as disclosed herein. Therefore, for possible definitions of terms and possible embodiments, reference is made to the disclosure of the print data set as disclosed above or as disclosed in further detail below.

[0075] As an example, the instructions of a computer program, such as instructions present or stored in the computer program, may include a digital representation of a complex part, in particular a complex part according to the present invention and 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 complex part may include a 3D model of the complex part, such as a design solution. For example, the computer program may be arranged to generate and / or produce a printing data set from the digital representation of the bracket.

[0076] In another aspect of the present invention, an in vitro diagnostic instrument is disclosed. The in vitro diagnostic instrument comprises a complex part, in particular a complex part according to the present invention and as described herein, i.e. according to one of the above-described 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 complex part as disclosed above or as disclosed in further detail below. The complex part comprised by the in vitro diagnostic instrument is 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. Alternatively, the complex part comprised by the in vitro diagnostic instrument 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.

[0077] The method and apparatus according to the invention may provide a number of advantages compared to known methods and apparatus. As an example, the proposed method and apparatus may allow rapid design and / or less time-consuming production of complex parts and may thus ensure rapid availability of components and may enable revisions during the product life cycle. Furthermore, the proposed method and apparatus may allow a simplification of the development process. Furthermore, the proposed method and apparatus may allow a simplification of production, assembly, warehousing, documentation, maintenance and quality assurance compared to known methods and apparatus. The method may be combined with predictive maintenance. This may allow weaknesses to be eliminated in the next revision. The method may be used in a variety of Industry 4.0 applications. The method may be combined with swarm intelligence techniques.

[0078] To summarize and without excluding other possible embodiments, the following embodiments may be envisaged:

[0079] Embodiment 1: A computer-implemented method for designing a complex portion of an in vitro diagnostic instrument, wherein the method comprises

[0080] i. Retrieve at least one target constraint;

[0081] ii. retrieving at least one set of input parameters, wherein the input parameters include at least one design goal for defining a complex portion of an in vitro diagnostic instrument and at least one constraint parameter of the complex portion of the in vitro diagnostic instrument,

[0082] iii. determining at least one design solution for the complex part by using at least one iterative algorithm taking into account input parameters, wherein in each iteration, the iterative algorithm includes

[0083] Identify at least one candidate complex part of an in vitro diagnostic device,

[0084] comparing the candidate complex part to the target constraint, and

[0085] Ranking candidate complex parts based on the comparison,

[0086] The method comprises repeating step iii until a predefined number of iterations is reached and / or until the determined candidate complex part satisfies the target constraint at least within a predefined tolerance, thereby determining a design solution for the complex part of the in vitro diagnostic instrument.

[0087] Embodiment 2: The method according to the preceding embodiment, wherein the complex portion of the in vitro diagnostic instrument comprises one or more of a carrier, a support or a gear of the magnetic glass particle mixer.

[0088] Embodiment 3: A method according to any of the preceding embodiments, wherein the target constraint includes at least one constraint selected from the group consisting of: geometric constraints; topological 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 machine constraints; production constraints; and economic constraints.

[0089] Embodiment 4: A method according to any of the preceding embodiments, wherein the retrieving comprises retrieving the target constraint from at least one data storage device, wherein the data storage device comprises at least one table or at least one lookup table containing a plurality of target constraints.

[0090] Embodiment 5: A method according to any of the preceding embodiments, wherein the design objectives for defining a complex part of an in vitro diagnostic instrument include at least one set of forming geometry parameters defining the forming geometry of the complex part and / or at least one starting digital model of the complex part.

[0091] Embodiment 6: The method according to the preceding embodiment, wherein the set of forming geometric parameters defining the forming geometry of the complex part comprises a plurality of forming parameters and / or starting values ​​of the forming geometric parameters.

[0092] Embodiment 7: A method according to any one of the two preceding embodiments, wherein the forming geometric parameters include at least one parameter selected from the group consisting of: length, width, height, at least one parameter defining the pattern structure of the complex part, at least one parameter characterizing the type of the complex part, and the lattice structure of the complex part.

[0093] Embodiment 8: The method according to any one of the three preceding embodiments, wherein the method comprises determining a starting digital model by using the set of forming geometry parameters in at least one computer-aided design tool.

[0094] Embodiment 9: A method according to any one of the four preceding embodiments, wherein retrieving the set of forming geometric parameters comprises receiving the set of forming geometric parameters from at least one data storage device, wherein the data storage device comprises at least one table or at least one lookup table comprising a plurality of different starting geometries and related forming geometric parameters.

[0095] Embodiment 10: The method according to any one of the preceding embodiments, wherein the at least one constraint parameter of the complex part comprises at least one of product characteristics, available build space, potential materials, potential manufacturing processes, or cost targets.

[0096] Embodiment 11: A method according to any of the preceding embodiments, wherein the iterative algorithm comprises analyzing the candidate complex part by applying at least one numerical simulation to the candidate complex part to simulate the use of the complex part, thereby determining at least one physical and / or mechanical property of the candidate complex part of the in vitro diagnostic instrument.

[0097] Embodiment 12: A method according to the preceding embodiments, wherein the physical and / or mechanical properties include at least one property selected from the group consisting of: weight; material; tension properties; pressure properties; shear properties; rigidity; relative stiffness; damping properties; hardness; energy dissipation; properties under compression; properties under deformation; and inertia.

[0098] Embodiment 13: The method according to any one of the two preceding embodiments, wherein the analyzing of the candidate complex parts comprises discretizing the candidate complex parts into a grid including a finite number of grid elements.

[0099] Embodiment 14: The method according to any one of the three preceding embodiments, wherein the analysis comprises using at least one finite element method (FEM) simulation.

[0100] Embodiment 15: A method according to any one of the four aforementioned embodiments, wherein comparing the candidate complex part with the target constraints includes comparing the determined physical and / or mechanical properties with the target constraints and adjusting at least one of the forming geometric parameters based on the comparison, wherein the method includes repeating step iii with the adjusted forming geometric parameters until the determined physical and / or mechanical properties satisfy the target constraints at least within a predefined tolerance, thereby determining a design solution for the complex part of the in vitro diagnostic instrument with a set of adjusted forming geometric parameters, for which the target constraints are satisfied at least within a predefined tolerance.

[0101] Embodiment 16: The method according to the preceding embodiment, wherein the adjustment of the forming geometry parameters comprises at least one material reduction operation.

[0102] Embodiment 17: A method according to any one of the preceding embodiments, wherein the iterative algorithm comprises at least one genetic algorithm.

[0103] Embodiment 18: A method according to any of the preceding embodiments, wherein the iterative algorithm is designed to take into account one or more of the following: at least one unchangeable area, such as due to predefined interfaces with other components; forces; kinematics; predefined fixed points; manufacturing methods; materials; accessibility of tools during production and / or assembly; stackability; or nesting of individual components

[0104] Embodiment 19: A method according to any one of the preceding embodiments, wherein the method comprises outputting a design solution obtained after repeating step iii for a predefined number of iterations and / or satisfying the target constraint at least within a predefined tolerance.

[0105] Embodiment 20: A method according to the preceding embodiments, wherein the output design solution includes at least one information about one or more of the following: 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 with open or closed cells; lattice structure, such as the form and / or position and / or distribution and / or extension of at least one cut and / or hole and / or mesh.

[0106] Embodiment 21: A method according to any of the preceding embodiments, wherein the method further comprises prototyping a complex part of the in vitro diagnostic instrument obtained after repeating step iii for a predefined number of iterations and / or for which the target constraints are met at least within a predefined tolerance.

[0107] Embodiment 22: A method according to the aforementioned embodiment, wherein the method includes verifying the prototype complex part by comparing at least one characteristic of the prototype complex part with at least one characteristic of the simulated complex part and / or rating the prototype complex part by comparing at least one characteristic of the prototype complex part with the at least one target constraint.

[0108] Embodiment 23: A method for manufacturing a complex part of an in vitro diagnostic instrument, wherein the method comprises designing a complex part of an in vitro diagnostic instrument by using the method for designing a complex part according to any one of the preceding embodiments, wherein the method further comprises manufacturing the complex part of the in vitro diagnostic instrument based on the designed complex part, i.e., the design solution, 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; cutting, such as laser cutting and / or water jet cutting.

[0109] Embodiment 24: A method according to the preceding embodiment, wherein the manufacturing process is selected by considering the design solution, for example, considering the manufacturing feasibility of the design solution.

[0110] Embodiment 25: A method according to any one of the two preceding embodiments, wherein at least one material for manufacturing a complex part of an in vitro diagnostic instrument is selected by taking into account a design solution, wherein the material is at least one material selected from the group consisting of: metal materials; for example, steel and / or its alloys; casting materials; non-ferrous metal materials, such as aluminum, titanium and / or one or more alloys thereof; inherent lattice structure materials, such as lattice structure metal materials, materials having lattice structure characteristics, materials that can be arranged into a lattice structure; plastic materials; composite materials; wood.

[0111] Embodiment 26: A complex part of an in vitro diagnostic instrument, wherein the complex part can be obtained by using the method for manufacturing a complex part according to any one of the methods for manufacturing a complex part mentioned in the preceding embodiments.

[0112] Embodiment 27: A complex part according to the preceding embodiment, wherein the complex part comprises at least one lattice structure, such as a regular or irregular pattern structure.

[0113] Embodiment 28: A computer program comprising instructions, which, when executed by a processor, causes the processor to perform at least step iii. of the method for designing a complex part according to any one of the methods for designing a complex part mentioned in the preceding embodiments.

[0114] Embodiment 29: A computer-readable storage medium comprising instructions which, when executed by a processor, cause the processor to perform at least step iii. of the method for designing a complex part according to any one of the methods for designing a complex part mentioned in the foregoing embodiments.

[0115] Embodiment 30: A non-transitory computer-readable medium comprising instructions which, when executed by one or more processors, cause the one or more processors to perform at least step iii. of the method for designing a complex part according to any one of the methods for designing a complex part mentioned in the preceding embodiments.

[0116] Embodiment 31: A computer-readable data carrier, specifically a non-transitory storage medium, comprising instructions which, when executed by a device for additive manufacturing, specifically a 3D printing device, enable the device for additive manufacturing to produce a complex part according to any one of the complex parts of an in vitro diagnostic instrument mentioned in the preceding embodiments.

[0117] Embodiment 32: A printing data set comprising information which, when provided to an apparatus for additive manufacturing, specifically a 3D printing apparatus, enables the apparatus for additive manufacturing to produce a complex part according to any one of the complex parts of an in vitro diagnostic instrument mentioned in the preceding embodiments.

[0118] Embodiment 33: A computer program comprising instructions which, when executed by a computer or a computer network, cause the computer or computer network to produce a print data set according to the preceding embodiments.

[0119] Embodiment 34: An in vitro diagnostic instrument configured to perform at least one test on a sample, wherein the in vitro diagnostic instrument includes at least one complex part according to any of the complex parts mentioned in the preceding embodiments, wherein the complex part is or includes 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0120] Other optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Wherein, as will be appreciated by those skilled in the art, each optional feature can be implemented in a separate manner and in any arbitrarily feasible combination. The scope of the present invention is not limited by the preferred embodiments. Embodiments are schematically depicted in the accompanying drawings. Wherein, the same reference numerals in these drawings refer to the same or functionally equivalent elements.

[0121] In the attached picture:

[0122] Figure 1 A flow chart showing a schematic overview of a method for designing a complex part of an in vitro diagnostic instrument;

[0123] Figure 2 A flow chart showing a schematic overview of a method for manufacturing a complex part of an in vitro diagnostic instrument, comprising a flow chart of a method for designing a complex part of an in vitro diagnostic instrument;

[0124] Figure 3 and Figure 4 Take the top plan view ( Figure 2 ) and bottom plan ( Figure 3 ) shows an embodiment of a complex part;

[0125] Figure 5 showing different embodiments of complex parts in perspective view; and

[0126] Figures 6 to 9 Top plan views of various embodiments of complex portions of an in vitro diagnostic instrument are shown. DETAILED DESCRIPTION

[0127] exist Figure 1 In FIG. 1 , a flow chart schematically outlining a method 110 for designing a complex part 112 of an in vitro diagnostic instrument 114 is shown. As an example, Figures 3 to 5 Various embodiments of the complex portion 112 are shown, wherein Figures 6 to 9 Various embodiments of a complex portion 112 in an in vitro diagnostic instrument 116 are shown.

[0128] The method 110 comprises the following steps:

[0129] i. (indicated by reference numeral 116) retrieving at least one target constraint 118;

[0130] ii. (indicated by reference numeral 120) retrieving at least one set of input parameters 122, wherein the input parameters 122 include at least one design goal 124 for defining the complex portion 112 of the in vitro diagnostic instrument 114 and at least one constraint parameter of the complex portion 112 of the in vitro diagnostic instrument 114,

[0131] iii. (indicated by reference numeral 126) determining at least one design solution 128 of the complex part 112 by using at least one iterative algorithm taking into account the input parameters 122, wherein in each iteration, the iterative algorithm includes

[0132] As a first sub-step (indicated by reference numeral 130), at least one candidate complex part 132 of the in vitro diagnostic instrument 114 is determined,

[0133] As a second sub-step (indicated by reference numeral 134), the candidate complex part 132 is compared with the target constraint 118, and

[0134] As a third sub-step (indicated by reference numeral 136), the candidate complex portions 132 are ranked according to the comparison.

[0135] The method 110 includes repeating step iii 126 until a predefined number of iterations is reached and / or until the determined candidate complex part 132 satisfies the target constraint 118 at least within a predefined tolerance, thereby determining a design solution 128 for the complex part 112 of the in vitro diagnostic instrument 114 .

[0136] The method 110 may further comprise a step 138 of prototyping a complex part 112 of the in vitro diagnostic instrument 114 obtained after repeating step iii 126 for a predefined number of iterations and / or for which the target constraints 118 are satisfied at least within a predefined tolerance. As an example, the prototyping step 138 comprises generating a prototype complex part 140.

[0137] Furthermore, the method 110 may include step 142 of validating the prototype complex part 140 by comparing at least one characteristic of the prototype complex part 140 with at least one characteristic of the simulated complex part and / or rating the prototype complex part 140 by comparing at least one characteristic of the prototype complex part 140 with the at least one target constraint 118 .

[0138] Figure 2 An embodiment of the method 110 further comprising a prototyping step 138 and a validation step 142 is shown in , wherein a flow chart of a schematic overview of a method 144 (which includes the method 110) for manufacturing a complex part 112 of an in vitro diagnostic instrument 114 is shown. The manufacturing method 144 further comprises a step 146 of manufacturing the complex part 112 of the in vitro diagnostic instrument 114 based on the design solution 128 of the complex 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; cutting, such as laser cutting and / or water jet cutting. Powder bed fusion can be exemplarily shown as Figure 2 The manufacturing process in manufacturing step 146 is shown in FIG.

[0139] As an example, a manufacturing process may be selected by considering design solution 128, for example, considering the manufacturing feasibility of design solution 128. In addition, at least one material for manufacturing complex portion 112 of in vitro diagnostic instrument 114 may also be selected by considering design solution 128.

[0140] like Figures 3 to 9 The various embodiments of the complex portion 112 shown in the drawings are determined by using the method 110 for designing a complex portion 112 of an in vitro diagnostic instrument 114. The complex portion 112 may include at least one lattice structure 148. As an example, the complex portion 112 may include at least one segment and / or portion having a lattice structure 148. For example, the complex portion 112 may include at least one segment arranged into a lattice structure 148, as in Figure 3 and Figure 4 Additionally or alternatively, the complex portion may include a regular lattice structure and / or pattern, such as in Figure 6 and Figure 7 Additionally or alternatively, the complex portion 112 may have an inherent lattice structure, such as by including at least one inherent lattice structure material, such as in Figure 8 and Fig. 9 This can be seen in the complex portion 112 shown in FIG.

[0141] Reference numerals list

[0142] 110 Methods for designing complex parts of in vitro diagnostic instruments

[0143] 112 Complex Part

[0144] 114 In vitro diagnostic devices

[0145] 116Step i.

[0146] 118 Target Constraints

[0147] 120Step ii.

[0148] 122 Input Parameters

[0149] 124 Design Goals

[0150] 126Stepiii.

[0151] 128 Design Solutions

[0152] 130 First sub-step of step iii. 132 Candidate complex part

[0153] 134 Second sub-step of step iii. 136 Third sub-step of step iii. 138 Prototyping step 140 Prototype complex part

[0154] 142 Verification Step 144 Manufacturing Method

[0155] 146 Manufacturing Step 148 Lattice Structure

Claims

1. A computer-implemented method for designing a complex part (112) of an in vitro diagnostic instrument (114), wherein the method comprises i. Retrieve at least one target constraint (118); ii. retrieving at least one set of input parameters (122), wherein the input parameters (122) include at least one design goal (124) for defining the complex portion (112) of the in vitro diagnostic instrument (114) and at least one constraint parameter of the complex portion (112) of the in vitro diagnostic instrument (114), iii. determining at least one design solution (128) of the complex part (112) by using at least one iterative algorithm taking into account the input parameters (122), wherein in each iteration, the iterative algorithm includes determining at least one candidate complex portion (132) of the in vitro diagnostic instrument (114), comparing the candidate complex portion (132) to the target constraint (118), and ranking the candidate complex portions (132) based on the comparison, The method comprises repeating step iii until a predefined number of iterations is reached and / or until the determined candidate complex part (132) satisfies the target constraint (118) at least within a predefined tolerance, thereby determining the design solution (128) of the complex part (112) of the in vitro diagnostic instrument (114).

2. The method of the preceding claim, wherein the complex portion (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. A method according to any of the preceding claims, wherein the target constraint (118) comprises at least one constraint selected from the group consisting of: a geometric constraint; a topological constraint; a pressure constraint; a shear force constraint; a mechanical stability constraint; a strength constraint; a weight constraint; a force distribution constraint; a surface property constraint; a production machine constraint; a production constraint; and Economic constraints.

4. A method according to any of the preceding claims, wherein the design goal (124) for defining the complex part (112) of the in vitro diagnostic instrument (114) includes at least one set of forming geometric parameters defining the forming geometry of the complex part (112) and / or at least one starting digital model of the complex part (112), wherein the set of forming geometric parameters defining the forming geometry of the complex part (112) includes a plurality of forming parameters and / or starting values ​​of forming geometric parameters.

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

6. A method according to any of the preceding claims, wherein the iterative algorithm includes analyzing the candidate complex part (132) by simulating the use of the complex part (112) by applying at least one numerical simulation to the candidate complex part (132), thereby determining at least one physical and / or mechanical property of the candidate complex part (132) of the in vitro diagnostic instrument (114).

7. The method of the preceding claim, wherein analyzing the candidate complex portion (132) comprises one or both of discretizing the candidate complex portion (132) into a mesh comprising a finite number of mesh elements and using at least one finite element method (FEM) simulation.

8. A method according to any one of the two preceding claims, wherein the comparison of the candidate complex part (132) with the target constraint (118) comprises comparing determined physical and / or mechanical properties with the target constraint (118) and adapting at least one of the forming geometric parameters based on the comparison, wherein the method comprises repeating step iii. with the adapted forming geometric parameters until the determined physical and / or mechanical properties satisfy the target constraint (118) at least within a predefined tolerance, thereby determining the design solution (128) of the complex part (112) of the in vitro diagnostic instrument (114) with a set of adapted forming geometric parameters, for which the target constraint (118) is satisfied at least within a predefined tolerance.

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

10. A method according to any of the preceding claims, wherein the iterative algorithm is designed to take into account one or more of the following: at least one unchangeable area such as due to predefined interfaces with other components; forces; kinematics; predefined fixed points; manufacturing method; materials; accessibility of tools during production and / or assembly; stackability; or nesting of individual components.

11. A method according to any one of the preceding claims, wherein the method comprises outputting the design solution (128) obtained after repeating step iii for a predefined number of iterations and / or for which the target constraint (118) is satisfied at least within a predefined tolerance.

12. A method according to any of the preceding claims, wherein the method further comprises prototyping a complex part (140) of the in vitro diagnostic instrument (114) obtained after repeating the predefined number of iterations of step iii and / or for which the target constraint (118) is satisfied at least within a predefined tolerance.

13. A method according to the preceding claim, wherein the method comprises validating the prototyped complex part (140) by comparing at least one property of the prototyped complex part (140) with at least one property of a simulated complex part and / or rating the prototyped complex part (140) by comparing at least one property of the prototyped complex part (140) with at least one target constraint (118).

14. A method for manufacturing a complex part (112) of an in vitro diagnostic instrument (114), wherein the method comprises designing the complex part (112) of the in vitro diagnostic instrument (114) by using the method for designing a complex part (112) according to any one of the preceding claims, wherein the method further comprises manufacturing the complex part (112) of the in vitro diagnostic instrument (114) based on the designed complex 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; cutting, such as laser cutting and / or water jet cutting.

15. A complex part (112) of an in vitro diagnostic instrument (114), wherein the complex part (112) is obtainable by using a method for manufacturing a complex part (112) according to any of the preceding claims relating to a method for manufacturing a complex part (112).

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

17. A printing data set comprising information which, when provided to an apparatus for additive manufacturing, enables the apparatus for additive manufacturing to produce a complex part (112) according to any of the preceding claims relating to a complex part (112) of an in vitro diagnostic instrument (114).

18. An in vitro diagnostic instrument (114) comprising a complex part (112) according to claim 15, wherein the complex part is or includes 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.

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