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Glossary 2017-09-29T16:32:38+00:00

Understand the terms associated with product development.

Activity Centered Design (ACD)
Methodology to interaction design that explores the activities a user would perform with a given piece of technology. The designers use objective research to get insights of the users.

Additive Manufacturing (3D printing)
A type of rapid prototyping also known as 3D printing, is a process of making three dimensional solid objects from a digital file by laying down successive layers of material (e.g. plastic or metal). Virtual models created via computer aided design (CAD) are transformed into thin, virtual, horizontal cross-sections with specialized software, and then built in layers in a machine until the real model is complete.

Types of additive manufacturing:
• Selective Laser Sintering (SLS)
• Direct Metal Laser Sintering (DMLS)
• Fused Deposition Modeling (FDM)
• Stereolithography (SLA)
• Laminated Object Manufacturing (LOM)
• Electron Beam Melting (EBM)
• Powder Bed and Inkjet Head 3D Printing
• Plaster-Based 3D Printing (PP)
Anodization
An electrolytic passivation process used to increase the thickness of the natural oxide layer on the surface of metal parts, such as aluminum and titanium. Anodizing upsurges corrosion resistance and wear resistance.

Anthropometry
The measurement of the human individual. Anthropometry plays a key role in industrial design and ergonomics where statistical data about the distribution of body dimensions in the population are used to optimize products.

Applied Mechanics
This bridges the gap between physical theory and its application to technology. It is used in many fields of engineering, especially mechanical engineering. It examines the response of bodies (solids and fluids) or systems of bodies to external forces. Some examples of mechanical systems include the flow of a liquid under pressure, the fracture of a solid from an applied force, or the vibration of an ear in response to sound.

Autoclave Sterilization
An autoclave is a device used to sterilize medical equipment and supplies by subjecting them to high pressure saturated steam. Most reusable medical devices are autoclave sterilized prior to each use.

Bill of Materials (BOM)
A list of the raw materials, sub-assemblies, intermediate assemblies, sub-components, components, parts, vendors, and the quantities of each needed to manufacture a product. A bill of materials links component pieces to a major assembly and each assembly or sub-assembly into its component parts.

Biocompatibility
Related to the behavior of biomaterials with respect to how they interact with the human body and eventually how those interactions determine the clinical success of a medical device.

Biomechanics
The study of the structure and function of biological systems such as humans, animals, plants, organs, and cells by means of the methods of mechanics. Biomechanics is closely related to engineering, as it often utilizes traditional engineering sciences to analyze biological systems.

Biomechatronics
An applied interdisciplinary science that aims to integrate mechanical elements, electronics and parts of biological organisms. This integrates mechanical parts with a human being, either in the form of removable devices such as an exoskeleton, or permanent implants. Such an entity is often identified in science fiction as a cyborg. The result is that the devices help replace the human motor control that was lost or impaired by trauma, disease or birth defects.

Biomedical Engineering
The application of engineering principles and design concepts to medicine and biology. This field seeks to close the gap between engineering and medicine. It combines the design and problem-solving skills of engineering with medical and biological sciences to improve healthcare diagnosis, monitoring and therapy.

Biomimicry (Biomimetics)
The examination of Nature: its models, systems, processes, and elements to emulate or take inspiration from in order to solve human problems. The emerging field of biomimetics has given rises to modern technologies created from biologically inspired engineering in both the macro scale and nanoscale levels.

Biotribology
The study of Contact Mechanics & Tribology within biological systems, especially human joints such as hips and knees. Biotribology plays a vital role to improve the design and produce successful biomaterials for medical and clinical purposes. If the performance of tibial component needs to be analyzed, the principles of biotribology are used to determine the wear performance of the implant and lubrication effects of synovial fluid.

Blow Molding
Also known as Blow Molding or Blow Forming, is a manufacturing process by which hollow plastic parts are formed. In general, there are three main types of blow molding: extrusion blow molding, injection blow molding, and stretch blow molding. The blow molding process begins with melting down the plastic and forming it into a preform. The preform is molded, then air pressure pushes the plastic out to match the mold. Once the plastic has cooled and hardened the mold opens and the part is ejected.

Bottom-Up Design
During the design and development of new products, designers and engineers rely on both a bottom-up and top-down approach. The bottom-up approach is being utilized when off-the-shelf or existing components are selected and integrated into the product. An example would include selecting a fastener, such as a bolt, and designing the receiving components such that the fastener will fit properly.

Broaching
A machining process that uses a toothed tool, called a broach, to remove material. There are two main types of broaching: linear and rotary. Linear broaching, the more common process, the broach is run linearly against a surface to affect the cut. In rotary broaching, the broach is rotated and pressed into the workpiece to cut an axis symmetric shape.

C-K Design Theory
Also known as Concept-Knowledge Theory, it’s both a design theory and a theory of reasoning in design. It defines design reasoning as a logic of expansion processes, i.e. a logic that organizes the generation of unknown objects. The theory builds on several traditions of design theory, including systematic design, axiomatic design, creativity theories, general design theories, and artificial intelligence-based design models.

CE Mark
The CE marking, an abbreviation of French: Conformité Européenne, meaning “European Conformity.” It has been legally called this since 1993 is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer ensures that the product conforms with the essential safety and functional requirements of the applicable EC directives.

Centrifugal Casting
Also known as Spin Casting or Centrifugal Rubber Mold Casting (CRMC), it consists of producing metal or liquid thermoset plastic castings by causing the material to solidify in rotating molds. Formed under pressures many times that of gravity combined with directional solidification, two unique characteristics of the centrifugal casting process, metal parts exhibit a denser, closer grained structure with vastly improved physical properties compared to conventional gravity or static casting methods.

Chemical Vapor Deposition (CVD)
A chemical process used to produce high-purity, high-performance materials and coatings. On medical devices, these coatings can greatly increase the mechanical properties of the surfaces they’re applied to, specifically to decrease the coefficient of friction, increase durability, and galling resistance.

Class I Medical Device
Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.
. Class I devices are subject to “General Controls” as are Class II and Class III devices. General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices.

Class II Medical Device
These devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to “special controls”. A few Class II devices are exempt from the premarket notification, but many require the 510(k) process which uses a pre-existing similar device in the market called a “predicate device” for comparison. Special controls may include special labeling requirements, mandatory performance standards and post market surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.
43% of medical devices fall under this category.

Class III Medical Device
Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices which currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.

Clinical Trials
Clinical trials are a set of procedures in medical device development that are conducted to allow safety and efficacy data to be collected for health interventions. These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment.

Competitive Advantage
Defined as the strategic advantage a product has over its competing products within its industry. Achieving competitive advantage strengthens and positions a product better within the marketplace. Superior products allow a business to stay ahead of current or potential competition and ensure market leadership.

Composite Material
Often shortened to composites, are engineered or naturally occurring materials made from two or more constituent materials with significantly different physical or chemical properties which remain separate and distinct within the finished structure.

Computational Fluid Dynamics (CFD)
Usually abbreviated as CFD, is a branch of fluid mechanics that uses numerical methods and algorithms to solve and analyze problems that involve fluid flows. Computers are used to perform the calculations required to simulate the interaction of liquids and gases with surfaces defined by boundary conditions.

Computer Aided Analysis (CAA)
Like Computer Aided Engineering (CAE), but not as broad. It only includes engineering analysis tools, such as Finite Element Analysis (FEA/FEM) and Computational Fluid Dynamics (CFD).

Computer Aided Design (CAD)
Also known as computer-aided design and drafting (CADD), is the use of computer systems to assist in the creation, modification, analysis, or optimization of a design. Computer-aided drafting describes the process of creating a technical drawing with the use of computer software. CAD software is used to increase the productivity of the designer, improve the quality of design, improve communications through documentation, and to create a database for manufacturing.

Computer Aided Engineering (CAE)
The broad usage of computer software to aid in engineering tasks. CAE tools are being used, for example, to analyze the robustness and performance of components and assemblies. The term encompasses simulation, validation, and optimization of products and manufacturing tools. CAE systems can be major providers of information to help support design teams in decision making. It includes Computer-Aided Design (CAD), Finite Element Analysis (FEA/FEM), Computational Fluid Dynamics (CFD), Computer-Aided Analysis (CAA), Computer-Aided Manufacturing (CAM), and Material Requirements Planning (MRP).

Computer Aided Industrial Design (CAID)
A subset of Computer-Aided Design (CAD) that includes software that directly helps in product development. It helps the designer to focus on the technical part of the design methodology rather than sketching and modeling. Within CAID programs designers have the freedom of creativity, but typically follow a simple design methodology:
1. Creating sketches, using a stylus
2. Generating curves directly from the sketch
3. Generating surfaces directly from the curves
Computer Aided Manufacturing (CAM)
The use of a computer to assist in all operations of a manufacturing plant, including planning, management, transportation and storage. Its primary purpose is to create a faster production process and components and tooling with more precise dimensions and material consistency, which in some cases, uses only the required amount of raw material (thus minimizing waste), while simultaneously reducing energy consumption. CAM is a subsequent computer-aided process after computer-aided design (CAD) and sometimes computer-aided engineering (CAE), as the model generated in CAD and verified in CAE can be input into CAM software, which then controls the machine tool.

Computer Aided Process Planning (CAPP)
The use of computer technology to aid in the process planning of a part or product, in manufacturing. CAPP is the link between CAD and CAM in that it provides for the planning of the process to be used in producing a designed part. Process planning is concerned with determining the sequence of individual manufacturing operations needed to produce a given part or product.

Computer Aided Quality Assurance (CAQ)
The engineering application of computers and computer controlled machines for the definition and inspection of the quality of products. This includes: Measuring equipment management, Goods inward inspection, Vendor rating, Attribute chart, Statistical process control (SPC), and Documentation.

Computer Integrated Manufacturing (CIM)
The manufacturing approach of using computers to control the entire production process. This integration allows individual processes to exchange information with each other and initiate actions. Through the integration of computers, manufacturing can be faster and less error-prone, although the main advantage is the ability to create automated manufacturing processes.

Computer Numerical Control (CNC)
In these automated machine tools, end-to-end component design is highly automated using computer-aided design (CAD) and computer-aided manufacturing (CAM) programs. The programs produce a computer file that is interpreted to extract the commands needed to operate a machine via a postprocessor, and then loaded into the CNC machines for production.

Concurrent Engineering
A work methodology based on the parallelization of tasks (i.e. performing tasks concurrently). It refers to an approach used in product development in which functions of design engineering, manufacturing engineering and other functions are integrated to reduce the elapsed time required to bring a new product to the market. The overall goal is the concurrent nature of these processes significantly increases productivity and product quality, aspects that are important in today’s fast-paced market.

Contextual Design (CD)
A user-centered design process that incorporates ethnographic methods for gathering data relevant to the product via field studies, rationalizing workflows, and designing human-computer interfaces. In practice, this means that researchers aggregate data from customers in the field and applying these findings into a final product. Contextual Design be an alternative to engineering and feature driven models of creating new systems.

Contextual Research
Design research methodology employed to allow one to gain a greater understanding of end users and their needs. Typically, interviews are conducted at the user’s workplace. The researcher begins by watching the user during their normal activities and discusses those activities with the user.

Conventional Machining
A form of subtractive manufacturing, in which a collection of material-working processes utilizing power-driven machine tools, such as saws, lathes, milling machines, and drill presses, are used with a sharp cutting tool to physically remove material to achieve a desired geometry. Machining is a part of the manufacture of many metal products, but it can also be used on materials such as wood, plastic, ceramic, and composites.

Cooperative Design
Designers and users have equal importance. Starting from the exploration of the local and contextual environment of tools and resources that are usually considered as design knowledge, it suggests a possible cross-field between the field of design knowledge management and the knowledge production practices that characterize the cooperation within networks.

Coordinate Measuring Machine (CMM)
A 3D device for measuring the physical geometrical characteristics of an object. This machine may be manually controlled by an operator or it may be computer controlled. Measurements are defined by a probe attached to the third moving axis of this machine.

Copyright
A legal concept, enacted by most governments, giving the creator of an original work exclusive rights to it, usually for a limited time. Generally, it is “the right to copy”, but also gives the copyright holder the right to be credited for the work, to determine who may adapt the work to other forms, who may perform the work, who may financially benefit from it, and other related rights. It is an intellectual property form (like the patent, the trademark, and the trade secret) applicable to any expressible form of an idea or information that is substantive and discrete. Typically, the duration of copyright is the whole life of the creator plus fifty to a hundred years from the creator’s death, or a finite period for anonymous or corporate creations.

Cost of Goods (COG)
The total cost to manufacture (or sell) a product. This usually includes the cost of raw materials, machinery setup fees, non-recurring engineering costs (NRE), tooling, testing, packaging, shipping, etc.

Cradle-to-Cradle Design
A biomimetic approach to the design of systems. A holistic economic, industrial and social framework that seeks to create systems that are not just efficient but essentially waste free. The model in its broadest sense is not limited to industrial design and manufacturing; it can be applied to many various aspects of human civilization such as urban environments, buildings, economics and social systems.

Cross-Functional Team
A group of people with different functional expertise working toward a common goal. It may include people from finance, marketing, operations, engineering, industrial design, and manufacturing departments. Typically, it includes employees from all levels of an organization.

Design for Assembly (DFA)
A process by which products are designed with ease of assembly in mind. If a product contains fewer parts it will take less time to assemble, thereby reducing assembly costs. In addition, if the parts are provided with features which make it easier to grasp, move, orient and insert them, this will also reduce assembly time and assembly costs.

Design for Manufacturing (DFM)
The general engineering art of designing products in such a way that are easy to manufacture. The basic idea exists in almost all engineering disciplines, but details differ widely depending on the manufacturing technology. This design practice not only focuses on the design aspect of a part but also on the producibility.

Design History File
A compilation of documentation that describes the design history of a finished medical device. The regulation requires medical devices manufacturers of Class II and Class III devices to implement design controls. These design controls consist of a development and control plan used to manage the development of a new product, and a design history file where these activities are documented. The design history file, or DHF, is part of regulation Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.

Design Thinking
The methods and processes for investigating ill-defined problems, acquiring information, analyzing knowledge, and positing solutions in the design and planning fields. As a style of thinking, it is generally considered the ability to combine empathy for the context of a problem, creativity in the generation of insights and solutions, and rationality to analyze and fit solutions to the context.

Die Casting
A metal casting process that is characterized by forcing molten metal under high pressure into a mold cavity. The mold cavity is created using two hardened tool steel dies which have been machined into shape and work similarly to an injection mold during the process. Most die castings are made from non-ferrous metals, specifically zinc, copper, aluminum, magnesium, lead, pewter and tin based alloys.

Diffusion of Innovations
A theory that seeks to explain how, why, and at what rate innovative ideas and technology spread through cultures. Diffusion is the process by which an innovation is communicated through certain channels over time among the members of a social system.

Direct Metal Laser Sintering (DMLS)
An additive metal fabrication technology sometimes also referred to by the terms selective laser sintering (SLS) or selective laser melting (SLM). The process involves use of a 3D CAD model whereby a .stl file is created and sent to the machine’s software. A technician works with this 3D model to properly orient the geometry for part building and adds supports structure as appropriate. Once this “build file” has been completed, it is “sliced” into the layer thickness the machine will build in and downloaded to the DMLS machine allowing the build to begin. Inside the build chamber area, there is a material dispensing platform and a build platform along with a recoated blade used to move new powder over the build platform. The technology fuses metal powder into a solid part by melting it locally using the focused laser beam.

Drawing
A metalworking process which uses tensile forces to stretch metal. It is broken up into two types: sheet metal drawing and wire, bar, and tube drawing. The specific definition for sheet metal drawing is that it involves plastic deformation over a curved axis. For wire, bar, and tube drawing the starting stock is drawn through a die to reduce its diameter and increase its length. Drawing is usually done at room temperature, thus classified a cold working process, however it may be performed at elevated temperatures to hot work large wires, rods or hollow sections to reduce forces.

Durable Medical Equipment
A term of art used to describe any medical equipment used in the home to aid in a better quality of living. It is a benefit included in most insurances. In some cases, certain Medicare benefits, that is, whether Medicare may pay for the item. The item is defined by Title XIX for Medicaid: (n) The term “durable medical equipment” includes iron lungs, oxygen tents, Nebulizers, CPAP, catheters, hospital beds, and wheelchairs.

Electrical Discharge Machining (EDM)
Sometimes colloquially also referred to as Burning or Die Sinking- a manufacturing process where a desired shape is obtained using electrical discharges (sparks). Material is removed from the workpiece by a series of rapidly recurring current discharges between two electrodes, separated by a dielectric liquid and subject to an electric voltage.

Electrical Engineering
A field of engineering that generally deals with the study and application of electricity, electronics and electromagnetism. Electronics engineering deals with implementation of applications, principles and algorithms developed within many related fields. For example, solid-state physics, radio engineering, telecommunications, control systems, signal processing, systems engineering, computer engineering, instrumentation engineering, electric power control, robotics, and many others.

Electron Beam Melting (EBM)
A type of additive manufacturing for metal parts. It is often classified as a rapid manufacturing method. The technology manufactures parts by melting metal powder layer by layer with an electron beam in a high vacuum. Unlike some metal sintering techniques, the parts are fully dense, void-free, and extremely strong. The EBM machine reads data from a 3D CAD model and lays down successive layers of powdered material. These layers are melted together utilizing a computer controlled electron beam. In this way, it builds up the parts.

Electron Beam Welding (EBW)
A fusion welding process in which a beam of high-velocity electrons is applied to the materials being joined. The workpieces melt as the kinetic energy of the electrons are transformed into heat upon impact, and the filler metal, if used, also melts to form part of the weld. The welding is often done in conditions of a vacuum to prevent dissipation of the electron beam. EBW permits the welding of refractory and dissimilar metals that are typically unsuited for other methods.

Electronic Design Automation (EDA)
A category of software tools for designing electronic systems such as printed circuit boards and integrated circuits. The tools work together in a design flow that chip designers use to design and analyze entire semiconductor chips. Current digital flows are extremely modular. The front ends produce standardized design descriptions that compile into invocations of cells, without regard to the cell technology. Cells implement logic or other electronic functions using an integrated circuit technology.

End-user Development (User Customization)
A research topic within the field human-computer interaction, describing activities or techniques that allow end-users to program computers. People who are not professional developers can use EUD tools to create or modify software artifacts (descriptions of automated behavior) and complex data objects without significant knowledge of a programming language. Lessons learned from EUD solutions can significantly influence the software life cycles for commercial software products, in-house intranet/extranet developments and enterprise application deployments.

Enterprise Resource Planning (ERP)
ERP systems integrate internal and external management information across an entire organization, embracing finance/accounting, manufacturing, sales and service, customer relationship management, etc. ERP systems automate this activity with an integrated computer software application. Their purpose is to facilitate the flow of information between all business functions inside the boundaries of the organization and manage the connections to outside stakeholders.

Ergonomics
Also known as Human Factors, is the study of designing equipment and devices that fit the human body, its movements, and its cognitive abilities. It is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data and methods to design to optimize human well-being and overall system performance.

Extrusion
A process used to create objects of a fixed cross-sectional profile. A material is pushed or drawn through a die of the desired cross-section. The two main advantages of this process over other manufacturing processes are its ability to create very complex cross-sections and work materials that are brittle, because the material only encounters compressive and shear stresses. It also forms finished parts with an excellent surface finish. The extrusion process can be done with the material hot or cold. Commonly extruded engineering materials include metals, polymers, and ceramics.

Failure Analysis
The process of collecting and analyzing data to determine the cause of a failure. It is an important discipline in many branches of the manufacturing industry, where it is a vital tool used in the development of new products and for the improvement of existing products. It relies on collecting failed components for subsequent examination of the cause or causes of failure using a wide array of methods, especially microscopy and spectroscopy.

Fatigue Failure
The progressive and localized structural damage that occurs when a material is subjected to cyclic loading. The nominal maximum stress values are less than the ultimate tensile stress limit, and may be below the yield stress limit of the material. Fatigue occurs when a material is subjected to repeated loading and unloading.

Fatigue Strength
Also known as the Fatigue Limit or Endurance Limit. It is used to describe a property of materials: the range of cyclic stress that can be applied to the material without causing fatigue failure. Ferrous alloys and titanium alloys have a distinct limit, an amplitude below which there appears to be no number of cycles that will cause failure. Other structural metals such as aluminum and copper, do not have a distinct limit and will eventually fail even from small stress amplitudes. In these cases, many cycles (usually 107) is chosen to represent the fatigue life of the material.

Finite Element Analysis (FEA)
The practical application of the Finite Element Method (FEM). However, it’s commercial use typically only refers to its application in stress/strain analysis. FEA is employed in an extremely broad range of engineering analysis software, including Multiphysics, chemical kinetics, fluid mechanics, heat transfer, electric and magnetic fields, and molecular dynamics. FEA based Stress/Stain analysis consists of a computer model of a material or design that is stressed and analyzed for specific results. It is used in new product design, and existing product refinement.

Finite Element Method (FEM)
A numerical technique for finding approximate solutions of partial differential equations (PDE) as well as integral equations. The solution approach is based either on eliminating the differential equation completely, or rendering the PDE into an approximating system of ordinary differential equations, which are then numerically integrated using standard techniques. In solving partial differential equations, the primary challenge is to create an equation that approximates the equation to be studied, but is numerically stable, meaning that errors in the input and intermediate calculations do not accumulate and cause the resulting output to be meaningless.

Flexible Manufacturing System (FMS)
A manufacturing system in which there is some amount of flexibility that allows the system to react in the case of changes, whether predicted or unpredicted. This flexibility is generally considered to fall into two categories, which both contain numerous subcategories. The first category, machine flexibility, covers the system’s ability to be changed to produce new product types, and ability to change the order of operations executed on a part. The second category is called routing flexibility, which consists of the ability to use multiple machines to perform the same operation on a part, as well as the system’s ability to absorb large-scale changes, such as in volume, capacity, or capability. Most FMS consist of three main systems. Key advantages of an FMS is its high flexibility in managing manufacturing resources like time and effort in order to manufacture a new product. The best application of an FMS is found in the production of small sets of products like those from a mass production.

Flexible Product Development
The ability to make changes in the product being developed or in how it is developed, even relatively late in development, without being too disruptive. Consequently, the later one can make changes, the more flexible the process is, the less disruptive the change is, the greater the flexibility. Flexibility is important because the development of a new product naturally involves change from what came before it. Change can be expected in what the customer wants and how the customer might use the product, in how competitors might respond, and in the new technologies being applied in the product or in its manufacturing process. The more innovative a new product is, the more likely it is that the development team will have to make changes during development. Flexible development counteracts the tendencies of many contemporary management approaches to plan a project completely at its outset and discourage change thereafter. These include Six Sigma, which aims to drive variation out of a process; lean, which acts to drive out waste; and traditional project management and phased development systems (including the popular Stage-Gate model), which encourage upfront planning and following the plan. Although these methodologies have strengths, their side effect is encouraging rigidity in a process that needs flexibility to be effective, especially for truly innovative products.

Food and Drug Administration (FDA)
An agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of medical devices. The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.

Forging
A manufacturing process involving the shaping of metal using localized compressive forces. Forging is often classified according to the temperature at which it is performed: “cold”, “warm”, or “hot” forging. Forged parts range in weight from less than a kilogram to 580 metric tons. Forged parts usually require further processing to achieve a finished part. There are many kinds of forging processes available, however they can be grouped into three main classes:
1. Drawn out: length increases, cross-section decreases
2. Upset: length decreases, cross-section increases
3, Squeezed in closed compression dies: produces multidirectional flow Common forging processes include: roll forging, swaging, cogging.

Fracture Mechanics
The field of mechanics concerned with the study of the propagation of cracks in materials. It uses methods of analytical solid mechanics to calculate the driving force on a crack and those of experimental solid mechanics to characterize the material’s resistance to fracture. In modern materials science, fracture mechanics is a valuable tool in improving the mechanical performance of materials and components. It applies the physics of stress and strain, the theories of elasticity and plasticity, to the microscopic crystallographic defects found in real materials to predict the macroscopic mechanical failure of bodies.

Freedom to Operate (FTO)
Refers to determining whether an action, such as commercializing a product, can be done without infringing valid intellectual property rights of others. If a patent or patent application is discovered that seems to relate to the action for which you are seeking FTO, you can’t immediately conclude that there isn’t FTO, because for a variety of reasons the matter claimed in the patent could be available to use. If there are valid intellectual property rights of others that would be infringed by the action you want to take, you may be able to obtain freedom to operate with respect to any one of those rights by negotiating for a license with the owner of the IP rights.

Fused Deposition Modeling (FDM)
An additive manufacturing technology commonly used for modeling, prototyping, and production applications. FDM works on an “additive” principle by laying down material in layers. A plastic filament or metal wire is unwound from a coil and supplies material to an extrusion nozzle which can turn the flow on and off. The nozzle is heated to melt the material and can be moved in both horizontal and vertical directions by a numerically controlled mechanism, directly controlled by a computer-aided manufacturing (CAM) software package. The model or part is produced by extruding small beads of thermoplastic material to form layers as the material hardens immediately after extrusion from the nozzle.

Fuzzy Front End
The front-end period of the product development processes where an organization formulates a concept of the product to be developed and decides whether to invest resources in the further development of an idea. It is the phase between first consideration of an opportunity, and when it is judged ready to enter the structured development process. This includes all activities from the search for new opportunities through the formation of an idea to the development of a precise concept.

Geometric Dimensioning and Tolerancing (GD&T)
A system for defining and communicating engineering tolerances. It uses a symbolic language on engineering drawings and computer-generated three-dimensional solid models for explicitly describing nominal geometry and its allowable variation. It tells the manufacturing staff and machines what degree of accuracy and precision is needed on each facet of the part.

Good Manufacturing Practice (GMP)
A production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of these guidelines remain like the ultimate goals of safeguarding the health of the patient as well as producing superior quality medicine, medical devices or active pharmaceutical products.

Heat Treating
A group of industrial and metalworking processes used to alter the physical, and sometimes chemical, properties of a material. The most common application is metallurgical. Heat treatment involves the use of heating or chilling, normally to extreme temperatures, to achieve a desired result such as hardening or softening a material.

House of Quality
A diagram, resembling a house, used for defining the relationship between customer desires and the product capabilities. It is a part of the Quality Function Deployment (QFD) and it utilizes a planning matrix to relate what the customer wants to how a firm (that produces the products) is going to meet those wants. It looks like a House with a “correlation matrix” as its roof, customer wants versus product features as the main body, competitor evaluation as the porch etc. It is based on “the belief that products should be designed to reflect customers’ desires and tastes. It also is reported to increase cross functional integration within organizations using it, especially between marketing, engineering and manufacturing.

Human Computer Interaction (HCI)
Involves the study, planning, and design of the interaction between users and computers. It is often regarded as the intersection of computer science, behavioral sciences, design and several other fields of study. Interaction between users and computers occurs at the user interface, which includes both software and hardware; for example, characters or objects displayed by software on a personal computer’s monitor, input received from users via hardware peripherals such as keyboards and mouse, and other user interactions with large-scale computerized systems such as aircraft and power plants.

Human Factors Engineering (HFE)
Also see “Ergonomics”. HFE is the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. It can be applied to the design of all systems having a human interface, including hardware and software. Its application to system design improves ease of use, system performance and reliability, and user satisfaction, while reducing operational errors, operator stress, training requirements, user fatigue, and product liability. HFE is distinctive in being the only discipline that relates humans to technology. Human factors engineering focuses on how people interact with tasks, computers, and the environment with the consideration that humans have limitations and capabilities.

Hydroforming
Also known as Hydramolding or Hydropening- is a cost-effective way of shaping malleable metals such as aluminum or brass into lightweight, structurally stiff and strong pieces. Hydroforming is a specialized type of die forming that uses a high pressure hydraulic fluid to press room temperature working material into a die.

Ideation
Also known as Idea Generation or Brainstorming, is the creative process of generating, developing, and communicating new ideas, where an idea is understood as a basic element of thought that can be either visual, concrete, or abstract. Ideation is all stages of a thought cycle, from innovation, to development, to actualization.

Implant (Medicine)
A medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone or apatite depending on what is the most functional.

In Vitro Testing
Refers to studies in experimental biology that are conducted using components of an organism that have been isolated from their usual biological context to permit a more detailed or more convenient analysis than can be done with whole organisms. Colloquially, these experiments are commonly referred to as “test tube experiments.

In Vivo Testing
Experimentation using a whole, living organism as opposed to a partial or dead organism, or an in vitro controlled environment. Animal testing and clinical trials are two forms of in vivo research. In vivo testing is often employed over in vitro because it is better suited for observing the overall effects of an experiment on a living subject.

Industrial Design (ID)
A combination of applied art and applied science to improve the aesthetics, ergonomics, and usability of a product, but it may also be used to improve the product’s marketability and production. Some of the processes that are commonly used are user research, sketching, comparative product research, model making, prototyping and testing.

Injection Molding
A manufacturing process for producing parts from both thermoplastic and thermosetting plastic materials. Material is fed into a heated barrel, mixed, and forced into a mold cavity where it cools and hardens to the configuration of the cavity. Injection molding is widely used for manufacturing a variety of parts, from the smallest component to entire body panels of cars.

Inkjet Head 3D Printing
An additive manufacturing technology that can make objects described by digital data. As in many other rapid prototyping processes, the part to be printed is built up from many thin cross sections of the 3D model. The inkjet-based technology works by jetting state of the art photopolymer materials in ultra-thin layers (16µ) onto a build tray layer by layer until the part is completed.

Innovation
The creation of better or more effective products, processes, services, technologies, or ideas that are accepted by markets, governments, and society. Innovation differs from invention in that innovation refers to the use of a new idea or method, whereas invention refers more directly to the creation of the idea or method itself.

Intellectual Property (IP)
A term referring to a distinct type of creations of the mind for which a set of exclusive rights are recognized under the corresponding fields of law. Under intellectual property law, owners are granted certain exclusive rights to a variety of intangible assets, such as musical, literary, and artistic works; discoveries and inventions; and words, phrases, symbols, and designs. Common types of intellectual property rights include copyrights, trademarks, patents, industrial design rights and trade secrets in some jurisdictions.

Interaction Design (IxD)
In design, human-computer interaction, and software development, interaction design (Ix)D, is “about shaping digital things for people’s use”, alternately defined as “the practice of designing interactive digital products, environments, systems, and services.” Like many other design fields interaction design also has an interest in form but its focus is on behavior.

International Organization for Standardization (ISO)
Widely known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. ISO’s main products are international standards. ISO also publishes technical reports, technical specifications, publicly available specifications, technical corrigenda, and guides.

Inventorship
In patent law, an inventor is the person, or persons, who contribute to the claims of a patentable invention. Under U.S. case law, an inventor is the one with “intellectual domination” over the inventive process, and not merely one who assists in its reduction to practice. Since inventorship relates to the claims in a patent application, knowing who an inventor is under the patent law is sometimes difficult.

Investment Casting
An industrial process, also known as Lost-Wax Casting, one of the oldest known metal-forming techniques. Lost Foam Casting is a modern form of investment casting that eliminates certain steps in the process. The process is generally used for small castings, but has been used to produce complete aircraft door frames, steel castings of up to 300 kg (660 lbs) and aluminum castings of up to 30 kg (66 lbs). It is generally more expensive per unit than die casting or sand casting, but has lower equipment costs. It can produce complicated shapes that would be difficult or impossible with die casting, yet like that process, it requires little surface finishing and only minor machining.

ISO 13485
Medical Devices – Quality Management Systems – Requirements for regulatory purposes. This is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001.

ISO 9001
ISO 9001:2008 (Quality management systems – Requirements) is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards: ISO 9000:2005 Quality management systems – Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization – A quality management approach.

Iterative Design
A design methodology based on a cyclic process of prototyping, testing, analyzing, and refining a product or process. In interaction with the designed system is used as a form of research for informing and evolving a project, as successive versions, or iterations of a design are implemented. The iterative design process may be applied throughout the new product development process. However, changes are easiest and less expensive to implement in the earliest stages of development. The first step in the iterative design process is to develop a prototype. The prototype should be evaluated by a focus group or a group not associated with the product to deliver non-biased opinions.

Kinematics
The branch of classical mechanics that describes the motion of points, bodies (objects) and systems of bodies without consideration of the forces that cause it. The study of kinematics is often referred to as the geometry of motion. Kinematic analysis is the process of measuring the kinematic quantities used to describe motion. In engineering, for instance, kinematic analysis may be used to find the range of movement for a given mechanism, and, working in reverse, kinematic synthesis designs a mechanism for a desired range of motion.

Knowledge-Based Engineering (KBE)
A discipline with roots in computer-aided design (CAD) and knowledge-based systems that can act as a support tool for a design engineer generally within the context of product design. KBE can be defined as engineering based on electronic knowledge models. These models can be imported in and/or stored in specific engineering applications that enable engineers to specify requirements or create designs based on the knowledge in such models. There are various methods available for the development of knowledge models. The development of KBE applications concerns the requirements to identify, capture, structure, formalize and finally implement knowledge.

Laminated Object Manufacturing (LOM)
A rapid prototyping system where layers of adhesive-coated paper, plastic, or metal laminates are successively glued together and cut to shape with a knife or laser cutter. Dimensional accuracy is slightly less than that of Stereolithography and Selective laser sintering. With LOM no milling step is necessary and it presents a much lower cost solution due to readily available raw material. The process is performed as follows: 1. Sheet is adhered to a substrate with a heated roller. 2. Laser traces desired dimensions of prototype. 3. Laser cross hatches non-part area to facilitate waste removal. 4. Platform with completed layer moves down out of the way. 5. Fresh sheet of material is rolled into position. 6. Platform moves up into position to receive next layer. 7. The process is repeated.

Laser Beam Welding (LBW)
A welding technique used to join multiple pieces of metal using a laser. The beam provides a concentrated heat source, allowing for narrow, deep welds and high welding rates. The process is frequently used in high volume applications, such as in the automotive industry. Like electron beam welding (EBW), laser beam welding has high power density (on the order of 1 MW/cm2) resulting in small heat-affected zones and high heating and cooling rates. LBW is a versatile process, capable of welding carbon steels, HSLA steels, stainless steel, aluminum, and titanium.

Laser Scanning
In modern engineering, with respect to geometric inspection and reverse engineering, the term `laser scanning’ is used to describe the controlled steering of laser beams followed by a distance measurement at every pointing direction. This method, often called 3D object scanning or 3D laser scanning, is used to rapidly capture shapes of objects. 3D object scanning enhances the design process, speeds up and reduces data collection errors, saves time and money, and thus makes it an attractive alternative to traditional inspection, measurement, and data collection techniques.

Lateral Thinking
Solving problems through an indirect and creative approach, using reasoning that is not immediately obvious and involving ideas that may not be obtainable by using only traditional step-by-step logic. Lateral thinking is different from our normal perceptions regarding creativity and innovation, and it is even different from pure vertical logic and pure horizontal imagination: Purely horizontal thinking is known as daydreaming. Fantasy. Mysticism. The purely horizontal thinker has a thousand ideas but puts none of them into action.

Lead User
A market research tool that may be used by companies and / or individuals seeking to develop breakthrough products. In contrast to the traditional market research techniques that collect information from the users at the center of the target market, the Lead User method takes a different approach. It collects information about both needs and solutions from the leading edges of the target market and from analogue markets, markets facing similar problems in a more extreme form. A lead user addresses needs that will be general in a marketplace, or a service that currently experience needs still unknown to the public and who also benefit greatly if they obtain a solution to these needs.

Linear Dimensioning and Tolerancing
Almost all engineering drawings communicate geometry, dimensions and tolerances. Linear Dimensioning is the simplest dimensioning system as it just specifies distances between points- width or length. Since the advent of well-developed interchangeable manufacture, these distances have been accompanied by tolerances of the plus-or-minus or min-and-max-limit types. Coordinate dimensioning was the sole best option until the development of geometric dimensioning and tolerancing (GD&T), which departs from the limitations of linear and coordinate dimensioning to allow the most logical tolerancing of both geometry and dimensions of the form.

Manufacturing Engineering
A discipline of engineering dealing with different manufacturing practices and the research and development of processes, machines, tools and equipment. This field also deals with the integration of different facilities and systems for producing quality products by applying the principles of physics and the results of manufacturing systems studies. Manufacturing engineering discipline has very strong overlaps with mechanical engineering, industrial engineering, electrical engineering, electronic engineering, computer science, materials management, and operations management. Manufacturing engineers’ success or failure directly impacts the advancement of technology and the spread of innovation.

Manufacturing Process Management (MPM)
A collection of technologies and methods used to define how products are to be manufactured. MPM differs from ERP/MRP which is used to plan the ordering of materials and other resources, set manufacturing schedules, and compile cost data. A cornerstone of MPM is the central repository for the integration of all these tools and activities aids in the exploration of alternative production line scenarios; making assembly lines more efficient with the aim of reduced lead time to product launch, shorter product times and reduced work in progress (WIP) inventories as well as allowing rapid response to product or product changes.

Manufacturing Process Planning (MPP)
The task in the manufacturing process planning domain is to find a plan to manufacture a set of parts. This domain contains a variety of machines, such as lathes, punches, spray painting, welding, etc. The operator specification defines features of each part that are described by a set of predicates, such as temperature, painted, has-hole, etc. These features are changed by the operators. The measure of plan cost is the schedule length, the time to manufacture all parts. In this domain, all the machining operations are assumed to take unit time. The machines and the objects are modeled as resources to enforce that only one part can be placed on a machine at a time and that a machine can only operate on a single part at a time.

Market Intelligence
Occasionally called business intelligence, is a branch of market research, involving collation and analysis of available and relevant information and data on specific markets. Market intelligence typically involves collation of data from various sources such as company accounts, official statistics, data from trade bodies, interviews with business contacts, and research on consumer attitudes. Whereas market research is often considered a consumer-orientated discipline, market intelligence tends to offer a broader view of markets including business and sector data – such as market-sizing, -segmentation, and -share data.

Market Penetration
Market penetration occurs when a company enters/penetrates a market in which current products already exist. The best way to achieve this is by gaining competitors’ customers and part of their market share. Other ways include attracting non-users of your product or convincing current clients to use more of your product/service. Penetration is a measure of brand or category popularity. It is defined as the number of people who buy a specific brand or a category of goods at least once in each period, divided by the size of the relevant market population.

Market Research
Commonly interchanged with Marketing Research, is any organized effort to gather information about markets or customers. Market research, includes social and opinion research, and is the systematic gathering and interpretation of information about individuals or organizations using statistical and analytical methods and techniques of the applied social sciences to gain insight or support decision making. It is a very important component of product development and business strategy. Market research is a key factor to get advantage over competitors when developing a new product, as it can expose weaknesses in their products’ design that can be capitalized on.

Material Requirements Planning (MRP)
A production planning and inventory control system used to manage manufacturing processes. Most MRP systems are software-based, while it is possible to conduct MRP by hand as well. An MRP system is intended to simultaneously meet three objectives:
1. Ensure materials are available for production and products are available for delivery to customers.
2. Maintain the lowest possible material and product levels in store
3. Plan manufacturing activities, delivery schedules and purchasing activities.

Materials Selection
When designing new products, the main goal of material selection is to minimize cost while meeting product performance goals. Systematic selection of the best material for a given application begins with properties and costs of candidate materials. Systematic selection for applications requiring multiple criteria is more complex. For example, a rod which should be stiff and light requires a material with high Young’s modulus and low density. If the rod will be pulled in tension, the specific modulus, should be considered. For medical applications where x-rays will be taken, any materials that might adversely obscure the x-ray path must be radiolucent, such as most carbon-fiber composites and plastics are.

Mechanical Engineering
A discipline of engineering that applies the principles of physics and materials science for analysis, design, manufacturing, and maintenance of mechanical systems. It is the branch of engineering that involves the production and usage of heat and mechanical power for the design, production, and operation of machines and tools. It is one of the oldest and broadest engineering disciplines. The engineering field requires an understanding of core concepts including mechanics, kinematics, thermodynamics, materials science, and structural analysis.

Mechanics
The branch of physics concerned with the behavior of physical bodies when subjected to forces or displacements, and the subsequent effects of the bodies on their environment. The discipline has its roots in several ancient civilizations. Sub-disciplines of mechanics utilized for medical device product design and development include: Solid mechanics, elasticity, Fracture mechanics, Statics, Fluid mechanics, Continuum mechanics, Hydraulics, Fluid statics, Applied mechanics (Engineering mechanics), Biomechanics, and Biophysics.

Mechatronics
The combination of Mechanical Engineering, Electronic Engineering, Computer Engineering, Software Engineering, Controls Engineering, and Systems Design Engineering to design and manufacture useful products. Mechatronics is a multidisciplinary field of engineering, it rejects splitting engineering into separate disciplines. Originally, mechatronics just included the combination between mechanics and electronics, hence the word is only a portmanteau of mechanics and electronics; however, as technical systems has become more and more complex the word has been “updated” during recent years to include more technical areas. A mechatronics engineer unites the principles of mechanics, electronics, and computing to generate a simpler, more economical and reliable system.

Medical Device
An instrument, apparatus, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through chemical action within or on the body. Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, thermal, physico-chemical or chemical means. Medical devices include a wide range of products varying in complexity and application.

Medical Device Directive
Intended to harmonize the laws relating to medical devices within the European Union. The MD Directive is a ‘New Approach’ Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers’ products meeting ‘harmonized standards’ have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and many changes were made. Compliance with the revised directive became mandatory on March 21, 2010.

Metal Casting
Involves pouring liquid metal into a mold, which contains a hollow cavity of the desired shape, and then allowing it to cool and solidify. The solidified part is also known as a casting, which is ejected or broken out of the mold to complete the process. Casting is most often used for making complex shapes that would be difficult or uneconomical to make by other methods. The casting process is subdivided into two main categories: expendable and non-expendable casting. It is further broken down by the mold material, such as sand or metal, and pouring method, such as gravity, vacuum, or low pressure.
Metal Injection Molding (MIM)
A metalworking process where finely-powdered metal is mixed with a measured amount of binder material to comprise a ‘feedstock’ capable of being handled by plastic processing equipment through a process known as injection mold forming. The variety of metals capable of implementation within MIM feedstock are referred to as powder metallurgy, and these contain the same alloying constituents found in industry standards for common and exotic metal applications. Subsequent conditioning operations are performed on the molded shape, where the binder material is removed and the metal particles are coalesced into the desired state for the metal alloy.

Metal Spinning
Also known as spin forming or spinning, is a metalworking process by which a disc or tube of metal is rotated at high speed and formed into an axially symmetric part. Commercial applications include rocket nose cones, cookware, gas cylinders, brass instrument bells, and public waste receptacles. Virtually any ductile metal may be formed, from aluminum or stainless steel, to high-strength, high-temperature alloys.
Microelectromechanical Systems (MEMS)
Also written as micro-electro-mechanical, MicroElectroMechanical or microelectronic and microelectromechanical systems, is the technology of very small devices; it merges at the nano-scale into nanoelectromechanical systems (NEMS) and nanotechnology. MEMS are made up of components between 1 to 100 micrometres in size (i.e. 0.001 to 0.1 mm), and MEMS devices generally range in size from 20 micrometres (20 millionths of a metre) to a millimetre (i.e. 0.02 to 1.0 mm). They usually consist of a central unit that processes data (the microprocessor) and several components that interact with the outside such as microsensors.
Milling
Milling is a manufacturing method where material is incrementally removed from the work piece. Milling machines are often classed in two basic forms, horizontal and vertical, which refers to the orientation of the main spindle. Both types range in size from small, bench-mounted devices to room-sized machines. Unlike a drill press, which holds the workpiece stationary as the drill moves axially to penetrate the material, milling machines also move the workpiece radially against the rotating milling cutter, which cuts on its sides as well as its tip. Milling machines may be manually operated, mechanically automated, or digitally automated via computer numerical control.

Non-Obviousness
Refers to the patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive to be patented. One of the main requirements of patentability is that the invention being patented is not obvious, meaning that a “person having ordinary skill in the art” would not know how to solve the problem at which the invention is directed by using the same mechanism. Furthermore, the combination of previously known elements can be considered obvious.

Novelty
An invention is not novel, and therefore not patentable, if the claimed subject matter was disclosed by another party before the date of filing, or before the date of priority if a priority is claimed, of the patent application. The standard method for researching the novelty of an invention is to perform a prior art search. A prior art search is generally performed with a view to proving that the invention is “not new” or old. No search can possibly cover every single publication or use on earth, and therefore cannot prove that an invention is “new”. It is impossible to guarantee the novelty of an invention, even once a patent has been granted, since some obscure little-known publication may have disclosed the invention as claimed.

Orthopedics (Orthopaedics)
The study of the human musculoskeletal system. The Greek word ‘ortho’ means straight or correct and ‘pedics’ comes from the Greek ‘pais’ meaning children. Orthopedic doctors (also called Orthopedists or Orthopeds) specialize in diagnosis and treatment of problems of the musculoskeletal system. The musculoskeletal system includes: bones, joints, ligaments, tendons, muscles, and nerves. It is a main branch of surgery. A number of professions offer non-surgical treatment options for many orthopedic problems, such as: physiotherapy, chiropractic, occupational therapy, podiatry, and kinesiology. Conditions requiring medication or surgical intervention are managed by orthopedic surgeons and podiatric surgeons.

Overmolding
Overmolding adds a soft-touch exterior of products that enhances grip or “feel” and provides a stylish appearance that’s attractive to consumers. Over-molding also reduces shock and vibration, dampens sound, provides electrical insulation, and improves chemical/UV resistance-which increases product longevity. Depending on the particular product, over-molding can be a single-shot or multi-shot operation. Thermoplastic elastomers (TPEs) or liquid silicones are typically utilized for overmolding depending on the application.
Participatory Design (PD)
Formerly known as ‘Cooperative Design’ – is an approach to design attempting to actively involve all stakeholders in the design process to help ensure the product designed meets their needs and is usable. In participatory design participants are invited to cooperate with designers, researchers and developers during an innovation process. Potentially, they participate during several stages of an innovation process: they participate during the initial exploration and problem definition both to help define the problem and to focus ideas for solution, and during development, they help evaluate proposed solutions.

Passivation
In physical chemistry and engineering, is a material becoming “passive” in relation to being less affected by environmental factors such as air or water. It means a shielding outer layer of corrosion which can be demonstrated with a micro-coating or found occurring spontaneously in nature. Passivation is useful in strengthening, and preserving the appearance of, metallic. As a technique, passivating is using a light coat of material such as metal oxide to create a shell against corrosion. Stainless steels are corrosion-resistant by nature, which might suggest that passivating them would be unnecessary. However, stainless steels are not completely impervious to rusting.

Patent
A form of intellectual property that consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period in exchange for the public disclosure of an invention. The procedure for granting patents, the requirements placed on the patentee, and the extent of the exclusive rights vary widely between countries according to national laws and international agreements. Typically, however, a patent application must include one or more claims defining the invention which must meet the relevant patentability requirements such as novelty and non-obviousness.

Patent Infringement
The commission of a prohibited act with respect to a patented invention without permission from the patent holder. Permission may typically be granted in the form of a license. The scope of the patented invention or the extent of protection is defined in the claims of the granted patent. In other words, the terms of the claims inform the public of what is not allowed without the permission of the patent holder. Patents are territorial, and infringement is only possible in a country where a patent is in force.

Patent Licensing
The owner of a patent may freely license or assign the patent rights to another person or entity. Patent licensing agreements are contracts in which the patent owner (the licensor) agrees to forgo their right to sue the licensee for infringement of the licensor’s patent rights, usually in return for a royalty or other compensation. The ability to assign ownership rights increases the liquidity of a patent as property.

Patentability
Within the context of a national or multilateral body of law, an invention is patentable if it meets the relevant legal conditions to be granted a patent. By extension, patentability also refers to the substantive conditions that must be met for a patent to be held valid. Patent laws usually require that, for an invention to be patentable, it must be:
1. Patentable subject matter
2. Novel
3. Non-obvious
4. Useful

Physical Vapor Deposition (PVD)
PVD is a type of vacuum deposition and is a general term used to describe any of a variety of methods to deposit thin films by the condensation of a vaporized form of the desired film material onto various workpiece surfaces (e.g., onto medical devices). The coating method involves purely physical processes such as elevated temperature vacuum evaporation with subsequent condensation, or plasma sputter bombardment rather than involving a chemical reaction at the surface to be coated as in Chemical Vapor Deposition (CVD).

Pilot Production Run
In mass production industries where complicated products are being developed, Pilot production runs offer the opportunity to make small changes prior to full-scale manufacturing. Pilot runs can be anywhere from 10 to 10,000 pieces, depending on the product to bridge the gap between prototype to full-production. The information gained during pilot runs can increase the likelihood for the product to be successful in the marketplace and can minimize the cost of potentially expensive warranty repairs or even recalls.

Plaster Based 3D Printing (PP)
A type of powder bed based 3D printing is an additive manufacturing technology that can make objects described by digital data. As in many other rapid prototyping processes, the part to be printed is built up from many thin cross sections of the 3D model. An inkjet-like printing head moves across a bed of powder (plaster), selectively depositing a liquid binding material in the shape of the section. A fresh layer of powder is spread across the top of the model, and the process is repeated. When the model is complete, unbound powder is automatically removed.

Pre-Clinical Trials
A laboratory test of a new drug or new invasive medical device on animal subjects (see “In Vivo Testing”); conducted to gather evidence justifying a clinical trial.

Precision Forging
Also known as Impression-die forging, closed-die forging, and net-forging. Metal is placed in a die resembling a mold, which is attached to the anvil. Usually the hammer die is shaped as well. The hammer is then dropped on the workpiece, causing the metal to flow and fill the die cavities. The hammer is generally in contact with the workpiece on the scale of milliseconds. Depending on the size and complexity of the part the hammer may be dropped multiple times in quick succession.

Premarket Approval (PMA)
The U.S. Food and Drug Administration (FDA) process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices and is significantly different from the Premarket Notification process known as 510(k). Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, under section 515 of the FD&C Act, these devices must obtain marketing clearance.

Premarket Notification (510k)
Each entity who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the exemptions. Before marketing a device, each submitter must receive an order from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order “clears” the device for commercial distribution.

Prior Art
In most systems of patent law, Prio Art constitutes all information that has been made available to the public in any form before a given date that might be relevant to a patent’s claims of originality. If an invention has been described in prior art, a patent on that invention is not valid. Information kept secret, for instance, as a trade secret, is not usually prior art, if employees and others with access to the information are under a non-disclosure obligation. To anticipate a claim, prior art is generally expected to provide a description sufficient to inform an average worker in the field of some subject matter falling within the scope of the claim. Prior art must be available in some way to the public, and in many countries, the information needs to be recorded in a fixed form somehow.

Pro-Innovation Bias
In diffusion of innovation theory, a pro-innovation bias reflects a personal bias toward an innovation that someone is trying to implement or diffuse among a population. The bias refers to the fact that the innovation’s “champion” has such strong bias in favor of the innovation, that he/she may not see its limitations or weaknesses and continues to promote it nonetheless. An example may be an inventor who creates a new product and wants to take it to market for financial gain. While the invention may be interesting and have promise, if the inventor is experiencing pro-innovation bias, he/she may not heed market data that postulates that the invention will or may not sell.

Product Data Management (PDM)
The business function often within product lifecycle management that is responsible for the management and publication of product data. In software engineering, this is known as version control. Product data management (PDM) is the use of software or other tools to track and control data related to a product. The data tracked usually involves the technical specifications of the product, specifications for manufacture and development, and the types of materials that will be required to produce goods. The use of product data management allows a company to track the various costs associated with the creation and launch of a product. Product data management is part of product life cycle management, and is primarily used by engineers. Within PDM the focus is on managing and tracking the creation, change and archive of all information related to a product.

Product Development
In business and engineering, Product Development, also referred to as New Product Development (NPD), is the term used to describe the complete process of bringing a new product to market. A product is a set of benefits offered for exchange and can be tangible or intangible such as a service or experience. There are two parallel paths involved in the Product Development process: one involves the idea generation, product design and detail engineering; the other involves market research and marketing analysis. Companies typically see Product Development as the first stage in generating and commercializing new products within the overall strategic process of product life cycle management used to maintain or grow their market share.

Product Lifecycle Management (PLM)
The process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal. PLM integrates people, data, processes and business systems and provides a product information backbone for companies and their extended enterprise. PLM systems help organizations in coping with the increasing complexity and engineering challenges of developing new products for the global competitive markets. PLM describes the engineering aspect of a product, from managing descriptions and properties of a product through its development and useful life.

Project Management
The discipline of planning, organizing, securing, managing, leading, and controlling resources to achieve specific goals. A project is a temporary endeavor with a defined beginning and end (usually time-constrained, and often constrained by funding or deliverables), undertaken to meet unique goals and objectives, typically to bring about beneficial change or added value. The temporary nature of projects stands in contrast with business as usual (or operations), which are repetitive, permanent, or semi-permanent functional activities to produce products or services. In practice, the management of these two systems is often quite different, and as such requires the development of distinct technical skills and management strategies. The primary challenge of project management is to achieve all of the project goals and objectives while honoring the preconceived constraints. Typical constraints are scope, time, and budget. The secondary, and more ambitious, challenge is to optimize the allocation of necessary inputs and integrate them to meet pre-defined objectives.

Prototype
An early sample or model built to test a concept or process or to act as a thing to be replicated or learned from. It is a term used in a variety of contexts, including semantics, design, electronics, and software programming. A prototype is designed to test and trial a new design to enhance precision by system analysts and users. Prototyping serves to provide specifications for a real, working system rather than a theoretical one. There is no general agreement on what constitutes a “prototype” and the word is often used interchangeably with the word “model” which can cause confusion. In general, “prototypes” fall into five basic categories: Proof-of-Principle Prototypes, Form Study Prototypes, User Experience Prototypes, Visual Prototypes, and Functional Prototypes.

Provisional Patent Application (PPA)
A legal document filed in the United States Patent and Trademark Office (USPTO), that establishes an early filing date, but which does not mature into an issued patent unless the applicant files a regular non-provisional patent application within one year. There is no such thing as a “provisional patent”. A provisional application should include a specification and drawings, but does not require formal patent claims, inventors’ oaths or declarations, or any information disclosure statement (IDS). Furthermore, because no examination of the patentability of the application in view of the prior art is performed, except in the rare case of an interference. A provisional application can establish an early effective filing date in one or more continuing patent applications later claiming the priority date of an invention disclosed in earlier provisional applications by one or more of the same inventors.

Quality Function Deployment (QFD)
A method to transform user demands into design quality, to deploy the functions forming quality, and to deploy methods for achieving the design quality into subsystems and component parts, and ultimately to specific elements of the manufacturing process. QFD is designed to help planners focus on characteristics of a new or existing product or service from the viewpoints of market segments, company, or technology-development needs. QFD helps transform customer needs into engineering characteristics for a product or service, prioritizing each product or service characteristic while simultaneously setting development targets for product or service.

Quality Management System (QMS)
A quality management system (QMS) can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management. Quality System requirements for medical device manufacturers have been internationally recognized to assure product safety and efficacy and customer satisfaction since at least 1983, and were instituted as requirements in a final rule. According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations. As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.

Radiolucence
Also known as Radiolucency, indicates greater transparency or “transradiancy” to X-ray photons. Materials that inhibit the passage of electromagnetic radiation are called radiodense, while those that allow radiation to pass more freely are referred to as radiolucent. For some Medical devices, it’s preferable to design them to be radiolucent. The latter is the case with operating tables where x-rays will be used during the surgery to internally visualize the patient’s structures in real-time while undergoing a surgical procedure.

Rapid Prototyping
A group of techniques used to quickly fabricate a scale model of a physical part or assembly using three-dimensional computer aided design (CAD) data. Construction of the part or assembly is typically done using 3D printing technology.

Rate of Adoption
The relative speed with which members of a social system adopt an innovation. It is usually measured by the length of time required for a certain percentage of the members of a social system to adopt an innovation. The rates of adoption for innovations are determined by an individual’s adopter category. In general, individuals who first adopt an innovation require a shorter adoption period than late adopters. Within the rate of adoption there is a point at which an innovation reaches critical mass. This is a point in time within the adoption curve that enough individuals have adopted an innovation in order that the continued adoption of the innovation is self-sustaining.

Regenerative Design
Sometimes referred to as cradle-to-cradle design, is a process-oriented systems theory based approach to design. The term “regenerative” describes processes that restore, renew or revitalize their own sources of energy and materials, creating sustainable systems that integrate the needs of society with the integrity of nature. The basis is derived from systems ecology with a closed loop input-output model or a model in which the output is greater than or equal to the input with all outputs viable and all inputs accounted for. Regenerative design is the biomimicry of ecosystems that provide for all human systems to function as a closed viable ecological economics system for all industry.

Relevance Paradox
An attempt to gather information relevant to a decision, which fail because the elimination of information perceived as distracting or unnecessary and thus detrimental to making an optimal decision, also excludes information that is crucial. In many cases in which action or decision is required, it is obvious what information relevant to the matter at hand may be lacking: a military attack may not have maps so reconnaissance is undertaken, an engineering project may not have ground condition details, and these will be ascertained, a public health program will require a survey.

Reverse Engineering
The process of discovering the technological principles of a device, object, or system through analysis of its structure, function, and operation. It often involves taking a mechanical device, electronic component, software program, or biological, chemical, or organic matter apart and analyzing its workings in detail. It’s used in maintenance, or to try to make a new device or program that does the same thing without using or simply duplicating the original. As computer-aided design (CAD) has become more popular, reverse engineering has become a viable method to create a 3D virtual model of an existing physical part for use in 3D CAD, CAM, CAE or other software.

Risk Analysis
Risk analysis is the science of risks and their probability and evaluation. Probabilistic risk assessment is one analysis strategy usually employed in science and engineering. Risk analysis should be performed as part of the risk management process for each project. The data of which would be based on risk discussion workshops to identify potential issues and risks ahead of time before these were to pose cost and/ or schedule negative impacts.

Rogers’ 5 Factors
Defines several intrinsic characteristics of innovations that influence an individual’s decision to adopt or reject an innovation.
1. Relative Advantage: How improved an innovation is over the previous generation.
2. Compatibility: The level of compatibility that an innovation must be assimilated into an individual’s life.
3. Complexity or Simplicity: If the innovation is perceived as complicated or difficult to use, an individual is unlikely to adopt it.
4. Trialability: How easily an innovation may be experimented. If a user can test an innovation, the individual will be more likely to adopt it.
5. Observability: The extent that an innovation is visible to others. An innovation that is more visible will drive communication among the individual’s peers and personal networks and will in turn create more positive or negative reactions.

Rolling
In metalworking, Rolling is a metal forming process in which metal stock is passed through a pair of rolls. Rolling is classified according to the temperature of the metal rolled. If the temperature of the metal is above its recrystallization temperature, then the process is termed as hot rolling. If the temperature of the metal is below its recrystallization temperature, the process is termed as cold rolling.

Rotational Molding
Also known as rotomolding, rotocasting, and spin casting- produces hollow forms with a constant wall thickness. Polymer powder is tumbled around inside the mold to produce virtually stress-free parts. A heated hollow mold is filled with a charge or shot weight of material, it is then slowly rotated, causing the softened material to disperse and stick to the walls of the mold. To maintain even thickness throughout the part, the mold continues to rotate always during the heating phase and to avoid sagging or deformation also during the cooling phase.

RTV Molding
Often called urethane casting- the RTV molding process has been used to create models for prototyping and reverse engineering. RTV molding can be utilized to fill the void between prototype and production manufacturing. RTV molding is an effective and inexpensive way to crate multiple copies of a master prototype part, known as a pattern. Patterns are often created via rapid prototypes (such as FDM, SLA, and 3D Printing). The resulting copies are cast using polyurethane, silicone or wax. Silicone molds can reproduce remarkable detail, and because of the flexibility of silicone, draft angles, inserts, and undercuts are not as critical as in other molding processes. After the RTV mold is created from the master pattern, liquid silicone is poured around the pattern to produce a core and cavity of a mold. The pattern is then removed, leaving a negative cavity into which polyurethane is cast.

Sand Casting
Also known as sand molded casting- a metal casting process characterized by using sand as the mold material. It is relatively economical and sufficiently refractory even for steel foundry use. A suitable bonding agent is mixed or occurs with the sand. The mixture is moistened with water to develop strength and plasticity of the clay and to make the aggregate suitable for molding.

Selective Laser Sintering (SLS)
An additive manufacturing technique that uses a high-power laser to fuse small particles of plastic, metal (Direct Metal Laser Sintering, DMLS), ceramic, or glass powders into a mass that has a desired 3-dimensional shape. The laser selectively fuses powdered material by scanning cross-sections generated from a 3D digital description of the part (for example from a CAD file or scan data) on the surface of a powder bed. After each cross-section is scanned, the powder bed is lowered by one-layer thickness, a new layer of material is applied on top, and the process is repeated until the part is completed.

Shear Stress (τ)
Defined as the component of stress coplanar with a material cross section. Shear stress arises from the force vector component parallel to the cross section. Normal stress, on the other hand, arises from the force vector component perpendicular or antiparallel to the material cross section on which it acts. Engineering quantities of shear stress are expressed in pounds-force per square inch (psi) or kilo pounds-force per square inch (ksi). Any real fluids moving along solid boundary will incur a shear stress on that boundary.

Shell Molding
Also known as shell-mold casting- an expendable mold casting process that uses a resin covered sand to form the mold. As compared to sand casting, this process has better dimensional accuracy, a higher productivity rate, and lower labor requirements. It is used for small to medium parts that require high precision.
Examples include gear housings, cylinder heads and connecting rods. It is also used to make high-precision molding cores. Common materials include cast iron, aluminum and copper alloys. Aluminum and magnesium products average about 13.5 kg (30 lb) as a normal limit, but it is possible to cast items in the 45-90 kg (100-200 lb) range. Typical tolerances are 0.005 in/in because the sand compound is designed to barely shrink and a metal pattern is used. The process, in general, produces very consistent castings from one casting to the next.

Social Design
Social design in term of design, it refers to design in its traditional sense, meaning the shaping of products and services. A system of design that encompasses all the areas of design, towards an open system with multiple, self-adjusting and complementary actors that aim for a vision of a loosely defined common set of goals.

Stage Gate Model
Also referred to as a phase-gate process, is a project management technique in which an initiative or project (e.g., new product development, process improvement, business change) is divided into stages (or phases) separated by gates. At each gate, the continuation of the process is decided by (typically) a manager or a steering committee. The decision is based on the information available at the time, including the business case, risk analysis, and availability of necessary resources (e.g., money, people with correct competencies). The stage-gate model may also be known as stage-limited commitment or creeping commitment. There are a number of advantages to using the stage-gate model for product development, which typically result from its ability to identify problems and assess progress before the project’s conclusion. Poor projects can be quickly rejected by disciplined use of the model. When using the stage-gate model on a large project, the model can help reduce complexity of what could be a large and limiting innovation process into a straightforward rule-based approach. One problem with the stage-gate process is the potential for structural organization to interfere with creativity, as overly structured processes may cause creativity to be reduced in importance.

Stamping
Stamping includes a variety of sheet-metal forming manufacturing processes, such as punching using a machine press or stamping press, blanking, embossing, bending, flanging, and coining. This could be a single stage operation where every stroke of the press produces the desired form on the sheet metal part, or could occur through a series of stages, such as with progressive stamping.

Stereolithography (SLA)
Also known as optical fabrication, photo-solidification, solid free-form fabrication and solid imaging- an additive manufacturing 3D printing technology used for producing models, prototypes, patterns, and production parts. The process which employs a vat of liquid ultraviolet curable photopolymer “resin” and an ultraviolet laser to build parts’ layers one at a time. For each layer, the laser beam traces a cross-section of the part pattern on the surface of the liquid resin. Exposure to the ultraviolet laser light cures and solidifies the pattern traced on the resin and joins it to the layer below. After the pattern has been traced, the SLA’s elevator platform descends by a distance equal to the thickness of a single layer, typically 0.05 mm to 0.15 mm (0.002″ to 0.006″). Then, a resin-filled blade sweeps across the cross section of the part, re-coating it with fresh material. On this new liquid surface, the subsequent layer pattern is traced, joining the previous layer. After being built, parts are immersed in a chemical bath to be cleaned of excess resin and are subsequently cured in an ultraviolet oven.

Strain (ε)
Engineering Strain is expressed as the ratio of total deformation to the initial dimension of the material body in which the forces are being applied. The engineering normal strain is expressed as the change in length ΔL per unit of the original length L of the line element or fibers. The normal strain is positive if the material fibers are stretched or negative if they are compressed. Strain has no units, since it is a ratio of length to length.

Stress (σ)
A measure of the average force per unit area of a surface within a deformable body on which internal forces act, specifically the intensity of the internal forces acting between particles of a deformable body across imaginary internal surfaces. For the simple case of an axially loaded body (e.g. a bar subjected to tension or compression by a force passing through its center) the stress can be obtained by dividing the total normal force by the bar’s cross-sectional area. In the case of a prismatic bar axially loaded, the stress is represented by a scalar called engineering stress or nominal stress that represents an average stress over the area, meaning that the stress in the cross-section is uniformly distributed. Engineering quantities of stress are expressed in pounds-force per square inch (psi) or kilo pounds-force per square inch (ksi).

Stress Analysis
An engineering (e.g. mechanical engineering) discipline that determines the stress in materials and structures subjected to static or dynamic forces or loads. A stress analysis is required for the study and design of structures (e.g. mechanical parts, and structural frames) under prescribed or expected loads. Stress analysis may be applied as a design step to structures that do not yet exist. The aim of the analysis is usually to determine whether the element or collection of elements, usually referred to as a structure, behaves as desired under the prescribed loading. For example, this might be achieved when the determined stress from the applied force(s) is less than the tensile yield strength or below the fatigue strength of the material. Analysis may be performed through analytic mathematical modelling or computational simulation, through experimental testing techniques, or a combination of methods.

Superforming
hot metal forming process that uses similar principles to thermoforming plastics, where a sheet of material is heated and forced onto a male or female superform using air pressure. There are five main Superforming processes: Cavity, Bubble, Back Pressure, Diaphragm and Vacuum Furnace each suitable for specific applications. The process is useful for producing complex surfaces. Superform components can be formed in a range of alloys (including Aluminium, Magnesium and Titanium), each depending on the end application and the forming process required to fulfil the component’s design requirements.

Surgical Protocol
Also known as a Surgical Technique- is an operative manual for specific surgical procedures made available to surgeons and related medical professionals by medical device development firms and manufacturers. These documents provide information regarding indications, instruments, step-wise procedure, potential complications, and other information relevant to a surgical procedure. Surgical protocols are typically made available for surgical implants, such as total hip and knee replacements.

SWOT Analysis
A strategic planning method used to evaluate. Setting the objective should be done after the SWOT analysis has been performed. This would allow achievable goals or objectives to be set for the organization. Strengths: characteristics of the business, or project team that give it an advantage over other Weaknesses (or Limitations): are characteristics that place the team at a disadvantage relative to other Opportunities: external chances to improve performance (e.g. make greater profits) in the environment Threats: external elements in the environment that could cause trouble for the business or project.

Target Market
A group of customers that the business has decided to aim its marketing efforts and ultimately its merchandise towards. A well-defined target market is the first element to a marketing strategy. Once these distinct customers have been defined, a marketing mix strategy of product, distribution, promotion and price can be built by the business to satisfy the target market.

Technical Drawing
Also known as drafting- the act and discipline of composing plans that visually communicate how something functions or must be constructed. Drafting is the visual language of industry and engineering. People who communicate with technical drawings may use technical standards that define practical symbols, perspectives, units of measurement, notation systems, visual styles, or layout conventions. These enable a drafter to communicate more concisely by using a commonly-understood convention.

Technical Monograph
A document, typically made available to surgeons and related medical professionals by medical device development firms and manufacturers, that describes how a medical device can cure specific indicated medical conditions. An example would be describing how a spinal total disc replacement system can alleviate the negative effects of degenerative disc disease. The information in a Technical Monograph can also include design rational, test procedures and related results, and competitive comparisons.

Theory of Constraints (TOC)
Adopts the common idiom “A chain is no stronger than its weakest link” as a new management paradigm. This means that processes, organizations, etc., are vulnerable because the weakest person or part can always damage or break them or at least adversely affect the outcome. The analytic approach with TOC comes from the contention that any manageable system is limited in achieving more of its goals by a very small number of constraints, and that there is always at least one constraint. Hence the TOC process seeks to identify the constraint and restructure the rest of the organization around it, using five focusing steps:
1. Identify the system’s constraint(s) (that which prevents the organization from obtaining more of the goal in a unit of time)
2. Decide how to exploit the system’s constraint(s) (how to get the most out of the constraint)
3. Subordinate everything else to above decision (align the entire system or organization to support the decision made above)
4. Elevate the system’s constraint(s) (make other major changes needed to break the constraint)
5. Warning!!!! If in the previous steps a constraint has been broken, go back to step 1, but do not allow inertia to cause a system’s constraint.

Time to Market (TTM)
The length of time it takes from a product being conceived until its being available for sale. TTM is important in industries where products are outmoded quickly. A common assumption is that TTM matters most for first-of-a-kind products, but the leader often has the luxury of time, while the clock is clearly running for the followers. A tacit assumption of many is that TTM and product quality are opposing attributes of a development process. TTM may be improved (shortened) by skipping steps of the development process, thus compromising product quality. There are no standards for measuring TTM, and measured values can vary greatly.

Top-Down Design
Also known as stepwise design, is essentially the breaking down of a system to gain insight into its compositional sub-systems. In a top-down approach an overview of the system is formulated, specifying but not detailing any first-level subsystems. Each subsystem is then refined in yet greater detail, sometimes in many additional subsystem levels, until the entire specification is reduced to base elements. During the design and development of new products, designers and engineers rely on both a bottom-up and top-down approach. The top-down approach is being utilized when certain requirements (geometry, materials, function, etc.) for the product are driving the design. An example would include designing a custom fastener, such as a bolt, that meets the geometric space requirements for the receiving components such that the fastener will fit properly and be of sufficient strength. In a bottom-up approach, the receiving components would be designed around the specifications of an existing bolt.

Total Quality Management (TQM)
An integrative philosophy of management for continuously improving the quality of products and processes. TQM functions on the premise that the quality of products and processes is the responsibility of everyone who is involved with the creation or consumption of the products or services offered by an organization. In other words, TQM capitalizes on the involvement of management, workforce, suppliers, and even customers, to meet or exceed customer expectations. Considering the practices of TQM as discussed in six empirical studies, Cua, McKone, and Schroeder identified the nine common TQM practices as cross-functional product design, process management, supplier quality management, customer involvement, information and feedback, committed leadership, strategic planning, cross-functional training, and employee involvement.

Trademark
Also known as a Trade Mark, Servicemark, or Service Mark, is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or services from those of other entities. A trademark may be designated by the following symbols:
• ™ for an unregistered trade mark, that is, a mark used to promote or brand goods
• SM for an unregistered service mark, that is, a mark used to promote or brand services
• ® for a registered trademark

A trademark is typically a name, word, phrase, logo, symbol, design, image, or a combination of these elements. There is also a range of non-conventional trademarks comprising marks which do not fall into these standard categories, such as those based on color, smell, or sound. The owner of a registered trademark may commence legal proceedings for trademark infringement to prevent unauthorized use of that trademark. However, registration is not required. The owner of a common law trademark may also file suit, but an unregistered mark may be protectable only within the geographical area within which it has been used or in geographical areas into which it may be reasonably expected to expand.

Transformation Design
A human-centered, interdisciplinary process that seeks to create desirable and sustainable changes in behavior and form often for socially progressive ends. It is a multi-stage, iterative process applied to big, complex issues. Its practitioners examine problems holistically rather than reductively to understand relationships as well as components to better frame the challenge. They then prototype small-scale systems – composed of objects, services, interactions and experiences, that support people and organizations in achievement of a desired change. Successful prototypes are then scaled.

Tungsten Inert Gas Welding (TIG or GTAW)
Also known as Gas Tungsten Arc Welding (GTAW) – An arc welding process that uses a non-consumable tungsten electrode to produce the weld. The weld area is protected from atmospheric contamination by a shielding gas and a filler metal is normally used, though some welds, known as autogenous welds, do not require it. A constant-current welding power supply produces energy which is conducted across the arc through a column of highly ionized gas and metal vapors known as a plasma. GTAW is most commonly used to weld thin sections of stainless steel and non-ferrous metals such as aluminum, magnesium, and copper alloys.

Turning
The process whereby a single point cutting tool is parallel to the surface. It can be done manually or by using a computer controlled and automated lathe. When turning, a piece of material (wood, metal, plastic, or stone) is rotated and a cutting tool is traversed along 2 axes of motion to produce precise diameters and depths. Turning can be either on the outside of the cylinder or on the inside (also known as boring) to produce tubular components to various geometries. The turning processes are typically carried out on a lathe, considered to be the oldest machine tools.

Ultimate Tensile Strength (UTS)
Often shortened to Tensile Strength (TS) or Ultimate Strength- the maximum stress that a material can withstand while being stretched or pulled before necking, which is when the specimen’s cross-section starts to significantly contract. Tensile strength is the opposite of compressive strength and the values can be quite different. The UTS is usually found by performing a tensile test and recording the stress versus strain; the highest point of the stress-strain curve is the UTS. It is an intensive property; therefore, its value does not depend on the size of the test specimen. However, it is dependent on other factors, such as the preparation of the specimen, the presence or otherwise of surface defects, and the temperature of the test environment and material. Tensile strengths are rarely used in the design of ductile members, but they are important in brittle members.

Universal Design
Refers to broad-spectrum ideas meant to produce products that are inherently usable for both people without disabilities and people with disabilities. The term “universal design” was coined by the architect Ronald L. Mace to describe the concept of designing all products and the built environment to be aesthetic and usable to the greatest extent possible by everyone, regardless of their age, ability, or status in life. Universal design is also being applied to the design of technology, instruction, services, and other products and environments.

Usage Centered Design
An approach to user interface design based on a focus on user intentions and usage patterns. It analyzes users in terms of the roles they play in relation to systems and employs abstract use cases for task analysis. It derives visual and interaction design from abstract prototypes based on the understanding of user roles and task cases. Usage-centered design is largely based on formal, abstract models such as models of interaction between user roles, UML workflow models and task case and role profiles. Usage-centered design proponents argue for abstract modelling while many designers use realistic personas, scenarios and high-fidelity prototypes. The techniques have been applied with success in complex software projects, some of which have been reported in case studies.

User Centered Design (UCD)
A design philosophy and a process in which the needs, wants, and limitations of end users of a product are given extensive attention at each stage of the design process. User-centered design can be characterized as a multi-stage problem solving process that not only requires designers to analyze and foresee how users are likely to use a product, but also to test the validity of their assumptions with regards to user behavior in real world tests with actual users.

User Experience
A person’s perceptions and responses resulting from the use and or anticipated use of a product, system or service. Data analysis and research tools are used to understand existing interactions with customers across touchpoints, and anticipate shifts in customer expectations.

User Innovation
Refers to innovation by intermediate users or consumer users, rather than by suppliers. Relies on the premise that many products and services are developed or at least refined, by users, at the site of implementation and use. These ideas are then moved back into the supply network. This is because products are developed to meet the widest possible need; when individual users face problems that most consumers do not, they have no choice but to develop their own modifications to existing products, or entirely new products, to solve their issues. Often, user innovators will share their ideas with manufacturers in hopes of having them produce the product, a process called free revealing. The lead user method that can be used to systematically learn about user innovation to apply it in new product development. User innovation has many degrees: innovation of use, innovation in services, innovation in configuration of technologies, and finally the innovation of novel technologies themselves. While most user innovation is concentrated in use and configuration of existing products and technologies, and is a normal part of long term innovation, modern technologies that are easier for end-users to change and innovate with, and new channels of communication are making it much easier for user innovation to occur and have an impact.

User Interface Design
Also known as User Interface Engineering, is the design of products with the focus on the user’s experience and interaction. The goal of user interface design is to make the user’s interaction as simple and efficient as possible, in terms of accomplishing user goals-what is often called user-centered design. Good user interface design facilitates finishing the task at hand without drawing unnecessary attention to itself. Graphic design may be utilized to support its usability. The design process must balance technical functionality and visual elements to create a system that is not only operational but also usable and adaptable to changing user needs.

Vacuum Forming
Commonly known as vacuum forming, is a simplified version of thermoforming, whereby a sheet of plastic is heated to a forming temperature, stretched onto or into a single-surface mold, and held against the mold by applying a vacuum between the mold surface and the sheet. The vacuum forming process can be used to make most product packaging, speaker casings, and even car dashboards. Vacuum forming is usually, but not always, restricted to forming plastic parts that are rather shallow in depth.

Value Engineering (VE)
A systematic method to improve the “value” of goods or products and services by using an examination of function. Value, as defined, is the ratio of function to cost. Value can be increased by either improving the function or reducing the cost. It is a primary tenet of value engineering that basic functions be preserved and not be reduced because of pursuing value improvements. Value engineering is sometimes taught within the project management or industrial engineering body of knowledge as a technique in which the value of a system’s outputs is optimized by crafting a mix of performance and cost.

Value Proposition
A value proposition is a promise of value to be delivered and a belief from the customer of value that will be experienced. A value proposition can apply to an entire organization, or parts thereof, or customer accounts, or products or services. Creating a value proposition is a part of business strategy. Developing a value proposition is based on a review and analysis of the benefits, costs and value that an organization can deliver to its customers, prospective customers, and other constituent groups within and outside the organization.

Virtual Engineering
Defined as integrating geometric models and related engineering tools such as analysis, simulation, optimization, and decision-making tools, etc., within a computer-generated environment that facilitates multidisciplinary collaborative product development. A virtual engineering environment provides a user-centered, first-person perspective that enables users to interact with an engineered system naturally and provides users with a wide range of accessible tools. This requires an engineering model that includes the geometry, physics, and any quantitative or qualitative data from the real system. The user should be able to walk through the operating system and observe how it works and how it responds to changes in design, operation, or any other engineering modification.

Virtual Prototyping
A technique in the process of product development that involves using computer-aided design (CAD) and computer-aided engineering (CAE) software to validate a design before committing to making a physical prototype. This is done by creating computer generated geometrical shapes (parts) and either combining them into an “assembly” and testing different mechanical motions, fit and function or just aesthetic appeal. The assembly or individual parts could be opened in CAE software to simulate the behavior of the product in the real world. The product design and development process used to rely primarily on engineers’ experience and judgment in producing an initial concept design. A physical prototype was then constructed and tested to evaluate its performance. Without any way to evaluate its performance in advance, the initial prototype was highly unlikely to meet expectations. Engineers usually had to re-design the initial concept multiple times to address weaknesses that were revealed in physical testing.

Voice of the Customer (VoC) Research
A term used to describe the in-depth process of capturing a customer’s expectations, preferences and aversions. Specifically, the Voice of the Customer is a market research technique that produces a detailed set of consumers’ wants and needs, organized into a hierarchical structure, and then prioritized in terms of relative importance and satisfaction with current alternatives. Voice of the Customer studies typically consist of both qualitative and quantitative research steps. They are generally conducted at the start of any new product, process, or service design initiative to better understand the customer’s wants and needs, and as the key input for new product definition.

Water Jet Cutting
A manufacturing method capable of slicing into metal or other materials (such as granite) using a jet of water at high velocity and pressure, or a mixture of water and an abrasive substance. An important benefit of the water jet cutter is the ability to cut material without interfering with the material’s inherent structure as there is no “heat-affected zone” or HAZ. Minimizing the effects of heat allows metals to be cut without harming or changing intrinsic properties. Water jet cutters are also capable of producing rather intricate cuts in material.

Welding
A fabrication or sculptural process that joins materials, usually metals or thermoplastics, by causing coalescence. This is often done by melting the workpieces and adding a filler material to form a pool of molten material (the weld pool) that cools to become a strong joint, with pressure sometimes used in conjunction with heat, or by itself, to produce the weld. This is in contrast with soldering and brazing, which involve melting a lower-melting-point material between the workpieces to form a bond between them, without melting the workpieces. Many different energy sources can be used for welding, including a gas flame, an electric arc, a laser, an electron beam, friction, and ultrasound. While often an industrial process, welding may be performed in many different environments, including open air, under water and in outer space.

Wet Lab
Also known as a Cadaver Lab, is used commonly utilized during surgical implant development, testing, and surgeon training. Wet-labs allow for evaluating new surgical implants and instruments in the most accurate and realistic environment and is often utilized prior to clinical testing and new commercial product releases.

Yield Strength (YS)
Also known as the yield point or elastic limit of a material – engineering and materials science as the stress at which a material begins to deform plastically. Prior to the yield point the material will deform elastically and will return to its original shape when the applied stress is removed. Once the yield point is passed, some fraction of the deformation will be permanent and non-reversible.

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