- 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 Case
- Business Case Phase This 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 Model Explains 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 Evaluation Using 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 Generation The 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 Action A 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 Attribute The chemical, physical, etc. properties that can be defined, measured, and continually monitored to ensure the final product outputs remain within acceptable quality limits.
- Customer Needs Expression 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 Reasoning Deductive 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 Plan A 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 Changes Any 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 Controls
- Design for Manufacturability The 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 Freeze The 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 File A 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 Inputs
- Design Outputs The 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 Review A 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 Transfer Translation 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 Validation Documented, objective evidence that the design meets the user needs and the intended use.
- Design Verification Documented objective evidence that the design meets the design requirements.
- Device Master Record A compilation of records containing the procedures and specifications (such as BOM, drawings, manufacturing instructions) for a finished device.
- Discovery Stage/Phase This 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 End
- Gates Distinct 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 Economics A 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 Factors Often 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 Program Tool 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 61160 Standard covering design reviews.
- Incremental Product Change Usually 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 Reviewer Individual(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 Use Describes the disease or condition under which the medical device will be used and under what conditions.
- Inductive Reasoning Inductive 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(...)
- Innovation An 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 Use Part 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 Use General information on what the medical device does, who the product is intended for, and how it would be used.
- ISO 13485 Standard which covers the Quality Management System for Medical Devices. It is based on ISO 9001, but contains elements specific to Medical Devices.
- ISO 14971 Standard covering user and patient risk management for medical devices.
- Key Customer Drivers The 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 Users Referred 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 Research
- Matrix Organization A 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 Device Products 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 Stage Stage developed to evaluate low risk projects that include simple revisions or cost saving projects.
- Multi-Divisional Matrix Refers 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 Structure A 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 Body In 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 Identification Is 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 Knowledge A 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 Phase An alternative phase-gate stage developed to review low risks projects including: Product Revision and Cost Improvement product types.
- Phase Gate New Product Development Process
- Phases Separate periods of time where specific tasks are undertaken by the project team and key deliverables are developed to present during the gate meetings.
- Platform A 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 Management Portfolio 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 Teams The 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(...)
- Prescreen This 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.
- Pretotype An 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 Structure An 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 Management A 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 Repositioning Products 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 Strategy Defines 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,(...)
- Prototype An 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 Deployment Is a matrix tool that assists a cross-functional team in translating customer needs into technical requirements.
- Quality Management System Collection of processes and procedures to ensure that finished medical devices and/or services will be safe and effective for their intended use.
- Quality Manual A 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 Plan A 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.
- RACI Method 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 File Summary of risks related user and patient safety, which is usually developed per ISO 14971.
- Root Cause The underlying factor(s) which lead to a specific problem. Removal of the factor(s) will prevent the problem from recurring.
- Scoping Document Document 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 Stage Activities 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 Canvas
- Technology Strategy Defines 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 Team A 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 Matrix Tool used to link customer requirements to design inputs/ product requirements to design outputs and documentation proving the requirements have been satisfied.
- Use Case A 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 & Validation Generally used for testing a design or process to ensure it meets requirements.
- Voice of the Customer VOC 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 Space White space is that unexplored and undiscovered domain of opportunity for new products and new markets.