- 21 CFR 820
The regulations in the United States for the Quality System Regulations for Medical Devices. These regulations are maintained by the FDA.
- Business CaseDocument created for ideas/concepts entering the Business Case Stage/Phase. The Business Case is more than just an ROI/NPV, it also includes thorough market, technical, manufacturing, financial, risk, and legal assessments.
- Business Case PhaseThis stage is intended to flesh out the product concept into a winning product definition, and to develop a sound basis for taking the project into the development stage. The major activities during this stage include a cross-functional team working together in building a robust business case.(...)
- Business ModelExplains who your customers are and how you plan to make money by providing your customers with value, as opposed to the Business/Competitive Strategy, which explains how you will beat competitors by being different. The Business Model defines Who, What, Where and How: Who are you serving,(...)
- Concept EvaluationUsing both qualitative and quantitative methods to determine the technical, financial, and marketing feasibility of a product. This could involve ranking multiple concepts to determine which concept is most likely to succeed and should move forward in the new product development process.
- Concept GenerationThe initial phase of concept generation includes the identification of a problem or unmet customer need. Depending on the complexity of the problem, it can be broken into subgroups. The next phase includes trying to solve the problem, and this can be done by a variety of methods including:(...)
- Corrective Action and Preventative ActionA process to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Corrective actions are a response to problems that have already occurred. Preventative(...)
- Critical Quality AttributeThe chemical, physical, etc. properties that can be defined, measured, and continually monitored to ensure the final product outputs remain within acceptable quality limits.
- Customer NeedsExpression of the customer or user problem with high level solution requirements. They are often expressed in qualitative terms which are then translated into product requirements or design inputs.
- Deductive ReasoningDeductive reasoning is based on the logic that if something is true for a class of things, it is also true for all members of that class ii (top-down). The investigator starts with a theory and makes predictions based on the theory. Controlled experiments are used to determine whether the(...)
- Design and Development PlanA document used to describe how the new product will be developed and includes elements such as key activities, responsibilities, timing, interfaces between different groups.
- Design ChangesAny change to the product or manufacturing process design. In Medical Devices, these changes include evolutionary changes such as performance enhancements as well as revolutionary changes such as corrective actions resulting from the analysis of failed product.
- Design ControlsSet of requirements related to medical device product development and product changes. The requirements are based on good engineering product development processes, product maintenance, and project management processes. The application of design controls to any product may be adjusted based(...)
- Design for ManufacturabilityThe process of proactively designing products to (1) optimize all the manufacturing functions: fabrication, assembly, test, procurement, shipping, delivery, service, and repair, and (2) assure the best cost, quality, reliability, regulatory compliance, safety, time-to-market, and customer(...)
- Design FreezeThe point in product development when the design is considered ‘done’ and the design is captured as a baseline. In medical devices, changes to the design after this point are tracked and evaluated for impact to meeting intended use, design inputs, and risk management controls.
- Design History FileA compilation of the records describing the entire history of the medical device design. It begins prior to development, is maintained through the product life, and includes design documents plus product change documents.
- Design InputsThe documented product requirements which are used as the basis for the device design. Design inputs are developed by translating the customer needs and requirements into product requirements.
- Design OutputsThe documented results of the design effort which enables verification against the design inputs. FDA: The total finished design output consists of the device, its packaging and labeling, and the device master record. ISO: The final version will include the product requirements used for(...)
- Design ReviewA documented systematic review of the design. From the FDA’s perspective this should be a system level review and include a review of many key functions within the project based on where the project is in development.
- Design TransferTranslation of device design to production specifications to ensure the product can be reliably and reproducibly manufactured, and which meets the design safety and efficacy.
- Design ValidationDocumented, objective evidence that the design meets the user needs and the intended use.
- Design VerificationDocumented objective evidence that the design meets the design requirements.
- Device Master RecordA compilation of records containing the procedures and specifications (such as BOM, drawings, manufacturing instructions) for a finished device.
- DiffusionDiffusion is defined by Everett Rogers as the process by which an innovation is communicated through certain channels over time among the members of a social system. Some people take longer than others to try out and adopt a new innovation.
- Discovery Stage/PhaseThis is one of the earliest stages in the new product development process. Activities during Discovery include a high level investigation and description of the idea. The description should include an overview of the idea, the problem it will solve, strengths and weaknesses of the idea and(...)
- Fuzzy Front EndThe Fuzzy Front End (FFE) is the messy beginning period of product development, when the product idea is still very vague. It precedes the more formal new product development process and generally consists of three tasks: strategic planning, concept generation and concept evaluation. These(...)
- GatekeepersGatekeepers play an important role in the Stage/Phase Gate process. They are the decision-makers that make important project decisions based on strategically driven criteria. It is best practice to have gatekeepers vary based on the stage of the new product development process. Executive(...)
- GatesDistinct period of time where a cross-functional management team reviews all key deliverables presented by the product development team. The project will encounter a decision point where it can be given a Go (Green), Stop (Red), Recycle (Yellow), Hold (Blue).
- Health EconomicsA field of study which evaluates the investment in health against the outcomes or benefits for either the individual or society. Investments in health may include costs for testing, diagnosis, and treatment. Outcomes or benefits may include faster recovery, longer life, herd immunity, or more(...)
- Human FactorsOften called ergonomics, it is the science of the interactions between humans and other elements of a system, with the goal of making that interaction easy, safe, and effective.
- Idea Solicitation ProgramTool created that outlines and explains various programs & techniques for generating new product ideas internally and externally, and for ultimately keeping the new product development pipeline full.
- IEC 61160Standard covering design reviews.
- Incremental Product ChangeUsually offers a modest enhancement in features or functionality. It commonly extends a product line or fills a minor gap in the existing product line.
- Independent ReviewerIndividual(s) included in a design review, who is not directly responsible for the design being reviewed, and has sufficient knowledge or experience to evaluate the design objectively.
- Indications for UseDescribes the disease or condition under which the medical device will be used and under what conditions.
- Inductive ReasoningInductive reasoning makes broad generalizations from specific observations (bottom-up). The investigator collects observations, finds patterns in the data, makes tentative hypotheses and finally presents a theory or rationale that explains the patterns. Theories generated through inductive(...)
- InnovationAn innovation creates value for the customer in a new and unique way. As Peter Drucker said, a product that is different, but does not create new value for the customer, is merely a novelty. A novelty may temporarily capture a customer’s interest because it is different, but it will quickly be(...)
- Instructions for UsePart of medical device labeling which provides the directions on how to use the product and may be physical or electronic. Examples include: label, package insert, and user manual.
- Intended UseGeneral information on what the medical device does, who the product is intended for, and how it would be used.
- ISO 13485Standard which covers the Quality Management System for Medical Devices. It is based on ISO 9001, but contains elements specific to Medical Devices.
- ISO 14971Standard covering user and patient risk management for medical devices.
- Key Customer DriversThe attributes, features or other issues that a customer considers in determining which, if any, product to purchase. Understanding key customer drivers is important in developing products, determining pricing and positioning, and selecting distribution channels.
- Lead UsersReferred to as early a dopters of new methods, products and technologies. They provide significant opportunities for introduction of breakthrough products since they are in the forefront of new concepts when compared to the general public.
- Market ResearchMarket Research is a systematic, objective collection and analysis of data related to a market, customer base, industry, competition, etc. In new product development, market research serves many purposes, such as identifying new product opportunities, understanding customer needs, evaluating(...)
- Matrix OrganizationA matrix structure organizes people and resources simultaneously, by function and product. Employees with similar skills are grouped together for product work. For example, all engineers may be in one engineering department and report to an Engineering Manager, but these same engineers may be(...)
- Medical DeviceProducts which are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The device consists of the actual device and all its packaging and(...)
- Mini-Business Case StageStage developed to evaluate low risk projects that include simple revisions or cost saving projects.
- Multi-Divisional MatrixRefers to an organization structure that supports functions that are in separate divisions within an organization. Typically used by an organization/conglomerate whose products are very different between divisions. This structure is advantageous for organizations that have divisions that serve(...)
- Network StructureA network structure is a cluster of different organizations whose actions are coordinated by contracts and agreements rather than through a formal hierarchy. This is analogous to an organization that outsources their major functional areas (e.g. IT, Supply Chain, Manufacturing).
- Notified BodyIn Medical Devices and in the European Union, is an organization that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture. For example, a Notified Body(...)
- Opportunity IdentificationIs an activity that is executed in the early stages of the new product development process a.k.a. the Fuzzy Front End (FFE). Prior to the identification of the opportunity, an opportunity/market scan can be performed to determine the best opportunities. Once the opportunity is identified(...)
- PD Body of KnowledgeA tool created by Strategy 2 Market to facilitate the execution and implementation of the new product development process. It includes detailed explanations of each stage of the process including important activities and responsibilities associated with every step within the NPD process",,,,BOK"
- Phase Gate Lite PhaseAn alternative phase-gate stage developed to review low risks projects including: Product Revision and Cost Improvement product types.
- Phase Gate New Product Development ProcessThis is a new product development process in which a set of activities and required deliverables are defined for sequential stages/phases. Phases are separated by decision points, or Gates, in which deliverables from the prior phase are evaluated and a decision is made on whether to advance to(...)
- PhasesSeparate periods of time where specific tasks are undertaken by the project team and key deliverables are developed to present during the gate meetings.
- PlatformA collection of the common elements, especially the underlying defining technology, implemented across a range of products. In general, a platform is the lowest common denominator of relevant technology in a set of products or a product line.
- Portfolio ManagementPortfolio Management is a decision-making process where a business’ list of current and proposed new product development projects is continually reviewed and revised. The review usually covers criteria such as strategic alignment, risk, reward and resource availability.
- Portfolio Management TeamsThe number of portfolio management teams within an organization can vary based on the size. In mid-to-large size companies, two portfolio management teams are common. The first team consists of a “core multi-functional portfolio team” that meets monthly. This team is responsible for scoring(...)
- PrescreenThis occurs usually prior to the Discovery Stage/Phase. It is a very gentle screen to determine whether an internal or external idea deserves additional resources prior to moving to the Discovery Stage/Phase.
- PretotypeAn extremely simplified, mocked, or virtual version of a product to test the initial appeal and actual usage of a potential new product by simulating its core experience with the smallest possible investment of time and money.
- Product Division StructureAn organizational structure in which centralized support functions service the needs of a number of different product lines. Typically used by organizations whose products are broadly similar and aimed at the same market, such as a food company that produces frozen foods (e.g. pizza,(...)
- Product Portfolio ManagementA product portfolio ideally contains projects that represent different product types and levels of risk. You want to balance and maximize the value of the portfolio during the portfolio management process. The portfolio process also provides an avenue to ensure appropriate resource allocation(...)
- Product RepositioningProducts that are unchanged in quality or feature set that are marketed with a different set of benefits. An example includes repositioning aspirin as a safeguard during a heart attack as well as a temporary pain reliever.
- Product StrategyDefines the future vision and goals for each category, product line and product, as well as a plan for reaching those goals. Generally a product strategy document will address the nature of the product(s), the target markets/segments, the technologies/platforms to be leveraged or developed,(...)
- PrototypeAn early sample, model, or release of a product built to test a concept or process or to act as a thing to be replicated or learned from.
- Quality Functional DeploymentIs a matrix tool that assists a cross-functional team in translating customer needs into technical requirements.
- Quality Management SystemCollection of processes and procedures to ensure that finished medical devices and/or services will be safe and effective for their intended use.
- Quality ManualA document which defines the scope of the quality system, an outline of the document structure for quality system documents, documented procedures or reference to them, a description of the interactions between the processes of the quality management system.
- Quality PlanA document which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. Each manufacturer establishes how the requirements for quality will be met.
- RACIMethod used to indicate the roles and responsibilities of people or groups on work activities. The acronym stands for Responsible, Accountable, Consulted, and Informed.
- Risk Management FileSummary of risks related user and patient safety, which is usually developed per ISO 14971.
- RoadmapsRoadmapping is a tool that can be used for planning and depicting your new product and technology acquisition strategies. The output of a product-technology roadmapping exercise is a roadmap that displays market and business needs over time, along with the products, technologies and other(...)
- Root CauseThe underlying factor(s) which lead to a specific problem. Removal of the factor(s) will prevent the problem from recurring.
- Scoping DocumentDocument created to capture a preliminary market, technical, manufacturing, financial, risk, and legal assessment. This document is presented to the gatekeepers during the Scoping Gate.
- Scoping StageActivities during Scoping include conducting secondary research on the proposed idea. It is quick preliminary assessment that helps determine whether the project is worth pursuing in the next stage/phase. It is too early in the Scoping Stage/Phase to determine any financial metrics like NPV or ROI.
- Strategy CanvasThe Strategy Canvas is a tool for mapping out white space in strategies. It was popularized by W. Chan Kim and Renee Maubogne in their book Blue Ocean Strategy. This tool visually displays the strategies of firms in a market space, making it possible for the user to identify radically(...)
- Technology StrategyDefines the set of technologies required by the firm to support the product strategy, the method of acquisition and timing. Technologies can be acquired by various means, including internal development, licensing, joint venture and/or business acquisition.
- Tiger TeamA divisional structure in which specialists from the support functions are combined into dedicated product development teams, this structure is also referred to as a Tiger Team. It is typically used by an organization whose products are very technologically complex or whose(...)
- Traceability MatrixTool used to link customer requirements to design inputs/ product requirements to design outputs and documentation proving the requirements have been satisfied.
- Use CaseA written description of how users will perform tasks using the product. It outlines, from a user’s point of view, a system’s behavior as it responds to the interaction. Each use case is represented as a sequence of simple steps, beginning with a user’s goal and ending when that goal is fulfilled.
- Verification & ValidationGenerally used for testing a design or process to ensure it meets requirements.
- Voice of the CustomerVOC is a process for gathering and prioritizing needs from customers. It uses indirect questioning to lead interviewees through a series of situations in which they have experienced and found solutions to the set of problems being investigated. The result is a structured hierarchy of needs,(...)
- White SpaceWhite space is that unexplored and undiscovered domain of opportunity for new products and new markets.