Medical Product Development Challenges PDF

16/12/2024, 23:28 Medical Product Development Challenges can you make a short summary from this text? As medical products encompass more...

16/12/2024, 23:28 Medical Product Development Challenges can you make a short summary from this text? As medical products encompass more features and technology, they will grow in complexity and sophistication. The hardware and software for these products will be driven by necessity to become highly synergistic and intricate which will in turn dictate tightly coupled designs. The dilemma is whether to tolerate longer development schedules to achieve the features and technology, or to pursue shorter development schedules. There really is no choice given the competitive situation of the marketplace. Fortunately, there are several possible solutions to this difficulty. One solution that viably achieves shorter development schedules is a reduction of the quantity of requirements that represent the desired feature set to be implemented. By documenting requirements in a simpler way, the development effort can be reduced by lowering the overall product development complexity. This would reduce the overall hardware and software requirements which in turn reduces the overall verification and validation time. The terms verification and validation are sometimes confused and used interchangeably, when in reality they are very different. Verification is the process of evaluating the products of a given phase of development to ensure correctness and consistency with respect to the products and standards provided as input to that phase. Verification ensures that all requirements for the device have been tested and proven to be correct. Verification is performed during the development process and is accomplished on subsystems as well as the system. Validation is the process of evaluating a product to ensure compliance with specified and implied requirements. Validation ensures that the product, as designed, is the device the customer requested and meets all the customer’s needs. Validation is performed at the end of the design cycle and is accomplished on the actual device as manufactured according to all manufacturing specifications and standards. The issue is how to reduce the number of documented requirements without sacrificing feature descriptions. This can be achieved by limiting the number of product https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 1/454 16/12/2024, 23:28 Medical Product Development Challenges requirements, being more judicious about how the specified requirements are defined, or by recognizing that some require- ments are really design specifications. A large part of requirements definition should be geared toward providing a means to delay making decisions about product feature requirements that are not understood until further investigation is carried out. As stated above, verification and validation must test the product to assure that the requirements have been met and that the specified design has been implemented. At worst, every requirement will necessitate at least one test to demonstrate that it has been satisfied. At best, several requirements might be grouped such that at least one test will be required to demonstrate that they all have been satisfied. The goal for the design engineer is to specify the requirements in such a manner as to achieve as few requirements as are absolutely necessary and still allow the desired feature set to be implemented. Several methods for achieving this goal are refinement of requirements, assimilation of requirements, and requirements versus design. As medical products become more complex with advanced features and technologies, the development process faces challenges in balancing longer schedules with competitive pressures for shorter timelines. A key solution is reducing the number of documented requirements, simplifying them, or distinguishing between requirements and design specifications. This can streamline development, reduce hardware and software complexity, and shorten verification and validation efforts. Verification ensures correctness during development, focusing on subsystems and the overall system, while validation confirms the final product meets customer needs and complies with specifications. Efficient requirements management, such as delaying decisions on unclear features and grouping related requirements into fewer tests, can optimize the development process while maintaining the desired feature set. can you make short notes from this text: As medical products encompass more features and technology, they will grow in complexity and https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 2/454 16/12/2024, 23:28 Medical Product Development Challenges sophistication. The hardware and software for these products will be driven by necessity to become highly synergistic and intricate which will in turn dictate tightly coupled designs. The dilemma is whether to tolerate longer development schedules to achieve the features and technology, or to pursue shorter development schedules. There really is no choice given the competitive situation of the marketplace. Fortunately, there are several possible solutions to this difficulty. One solution that viably achieves shorter development schedules is a reduction of the quantity of requirements that represent the desired feature set to be implemented. By documenting requirements in a simpler way, the development effort can be reduced by lowering the overall product development complexity. This would reduce the overall hardware and software requirements which in turn reduces the overall verification and validation time. The terms verification and validation are sometimes confused and used interchangeably, when in reality they are very different. Verification is the process of evaluating the products of a given phase of development to ensure correctness and consistency with respect to the products and standards provided as input to that phase. Verification ensures that all requirements for the device have been tested and proven to be correct. Verification is performed during the development process and is accomplished on subsystems as well as the system. Validation is the process of evaluating a product to ensure compliance with specified and implied requirements. Validation ensures that the product, as designed, is the device the customer requested and meets all the customer’s needs. Validation is performed at the end of the design cycle and is accomplished on the actual device as manufactured according to all manufacturing specifications and standards. The issue is how to reduce the number of documented requirements without sacrificing feature descriptions. This can be achieved by limiting the number of product requirements, being more judicious about how the specified requirements are defined, or by recognizing that some require- ments are really design specifications. A large part of requirements definition should be geared toward providing a means to delay making decisions about product feature requirements https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 3/454 16/12/2024, 23:28 Medical Product Development Challenges that are not understood until further investigation is carried out. As stated above, verification and validation must test the product to assure that the requirements have been met and that the specified design has been implemented. At worst, every requirement will necessitate at least one test to demonstrate that it has been satisfied. At best, several requirements might be grouped such that at least one test will be required to demonstrate that they all have been satisfied. The goal for the design engineer is to specify the requirements in such a manner as to achieve as few requirements as are absolutely necessary and still allow the desired feature set to be implemented. Several methods for achieving this goal are refinement of requirements, assimilation of requirements, and requirements versus design. Notes on Medical Product Development: Increasing Complexity: Medical products are becoming more complex due to advanced features and technologies. Hardware and software must work synergistically, leading to tightly coupled designs. Development Dilemma: Longer schedules for advanced features vs. shorter schedules to remain competitive. Solution: Reduce and simplify documented requirements. Simplifying Requirements: Reducing the number of requirements lowers product development complexity. Simpler requirements reduce hardware/software needs and verification/validation time. Verification vs. Validation: Verification: Ensures correctness and consistency during development. Tests subsystems and the system to confirm all requirements are met. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 4/454 16/12/2024, 23:28 Medical Product Development Challenges Validation: Confirms the product meets customer needs and specifications. Performed on the final product post-manufacturing. Managing Requirements: Limit the number of product requirements without losing essential features. Define requirements carefully and distinguish them from design specifications. Delay decisions on unclear feature requirements until further investigation. Efficient Testing: Every requirement needs at least one test to confirm satisfaction. Group related requirements to minimize the number of tests. Goals for Design Engineers: Define only essential requirements to implement desired features. Methods: Refine and assimilate requirements, and distinguish between requirements and design. can you make short notes from this text: As an example, suppose a mythical device has the requirement ‘‘the output of the analog to digital converter (ADC) must be accurate to within plus or minus 5%.’’ Although conceptually this appears to be a straight forward requirement, to the software engineer performing the testing to demonstrate satisfaction of this requirement, it is not as simple as it looks. As stated, this requirement will necessitate at least three independent tests and most likely five tests. One test will have to establish that the ADC is outputting the specified nominal value. The second and third tests will be needed to confirm that the output is within the
5% range. Being a good software engineer, the 5% limit is not as arbitrary as it may seem due to the round-off error of the percent calculation with the ADC output units. Consequently, the fourth and fifth test will be made to ascertain the sensitivity of the round-off calculation. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 5/454 16/12/2024, 23:28 Medical Product Development Challenges A better way to specify this requirement is to state ‘‘the output of the ADC must be between X and Y,’’ where X and Y values correspond to the original requirement of
5%. This is a better requirement statement because it simplifies the testing that occurs. In this case, only two tests are required to demonstrate satisfaction of this requirement. Test one is for the X value and test two is for the Y value. The requirement statements are equivalent but the latter is more effective because it has reduced the test set size, resulting in less testing time and consequently a potential for the product to reach the market earlier. Notes on Simplifying Requirements: Original Requirement: "The output of the ADC must be accurate to within ±5%." Appears straightforward but requires at least 3 to 5 tests: 1. Verify ADC outputs the nominal value. 2. Confirm output is within the +5% range. 3. Confirm output is within the -5% range. 4-5. Address round-off error sensitivity of ±5% calculation. Improved Requirement: "The output of the ADC must be between X and Y," where X and Y correspond to ±5%. Simplifies testing to only 2 tests: 1. Verify output meets lower bound (X). 2. Verify output meets upper bound (Y). Benefits of Simplified Requirement: Reduces the number of required tests. Saves testing time. Speeds up product development and market readiness. can you make short notes from this test: Consider the situation where several requirements can be condensed into a single equivalent require- ment. In https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 6/454 16/12/2024, 23:28 Medical Product Development Challenges this instance, the total test set can be reduced through careful analysis and an insightful design. Suppose that the user interface of a product is required to display several fields of information that indicate various parameters, states, and values. It is also required that the user be able to interactively edit the fields, and that key system critical fields must flash or blink so that the user knows that a system critical field is being edited. Further assume that the software requirements document specifies that ‘‘all displayed fields can be edited. The rate field shall flash while being edited. The exposure time shall flash while being edited. The volume delivered field shall flash while being edited.’’ These statements are viable and suitable for the requirements specification but they may not be optimum from an implementation and test point of view. There are three possible implementation strategies for these requirements. First, a ‘‘monolithic’’ editor routine can be designed and imple- mented that handles all aspects of the field editing, including the flash function. Second, a generic field editor can be designed which is passed a parameter that indicates whether or not the field should flash during field editing. Third, an editor executive could be designed such that it selects either a nonflashing or flashing field editor routine depending on whether the field was critical or not. Conceptually, based on these requirements statements, the validation team would ensure that (1) only the correct fields can be displayed, (2) the displayed fields can be edited, (3) critical fields blink when edited, and (4) each explicitly named field blinks. The first ‘‘monolithic’’ design option potentially presents the severest test case load and should be avoided. Since it is monolithic in structure and performs all editing functions, all validation tests must be performed within a single routine to determine whether the requirements are met. The validation testing would consist of the four test scenarios presented above. The second design option represents an improvement over the first design. Because the flash=no flash flag is passed as a parameter into the routine, the testing internally to the routine is reduced because part of the testing burden has been shifted to the interface between the calling and called routines. This is easier to test because the flash=no flash discrimination is made at a higher level. It is an inherent part of the calling https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 7/454 16/12/2024, 23:28 Medical Product Development Challenges sequence of the routine and therefore can be visually verified without formal tests. The validation testing would consist of test situations one, two, and four as presented above. The third design option represents the optimum from a test standpoint because the majority of the validation testing can be accomplished with visual inspections. This is possible because the flash=no flash discrimination is also implemented at a higher level and the result of the differenti- ation is a flashing field or a nonflashing field. The validation testing would consist of test situations two and four as presented above. Based on the design options, the requirements could be rewritten to simplify testing even further. Assume that the third design option in fact requires less testing time and is easier to test. The requirement statements can then be written to facilitate this situation even more. The following requirements statements are equivalent to those above and in fact tend to drive the design in the direction of the third design option. ‘‘All displayed fields can be edited. All critical items being edited shall flash to inform the user that editing is in progress.’’ In this instance, the third design can be augmented by creating a list or look-up table of the fields required to be edited and a flag can be associated with each that indicates whether the field should flash or not. This approach allows a completely visual inspection to replace the testing because the field is either in the edit list or it is not, and if it is, then it either flashes or it does not. Testing within the routine is still required, but it is now associated with debug testing during development and not with formal validation testing after implementation. Notes on Condensing Requirements and Optimizing Testing: Original Scenario: Requirements specify that: 1. All displayed fields can be edited. 2. Critical fields (e.g., rate, exposure time, volume) must flash when edited. Validation must ensure: 1. Correct fields are displayed. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 8/454 16/12/2024, 23:28 Medical Product Development Challenges 2. Fields can be edited. 3. Critical fields flash during editing. 4. Each named field flashes when edited. Design Options: 1. Monolithic Editor: Single routine handles all functions (editing, flashing). Requires testing all validation scenarios (1, 2, 3, 4) within one routine. High testing complexity—should be avoided. 2. Generic Field Editor: Uses a "flash/no flash" parameter passed into the routine. Shifts some testing to the interface between routines. Validation tests: 1, 2, 4. 3. Editor Executive (Optimal): Separate flashing and non-flashing editors selected based on field criticality. Most validation achieved through visual inspection. Validation tests: 2, 4. Optimizing Requirements: Simplify requirements to encourage the third design: "All displayed fields can be edited. All critical items being edited shall flash to inform the user that editing is in progress." Use a look-up table to associate fields with a "flash" flag: Fields either flash or not, depending on their criticality. Reduces formal validation testing; focus shifts to debug testing during development. Benefits: Reduced test scenarios. Easier and quicker validation through visual inspections. Faster product development and testing process. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 9/454 16/12/2024, 23:28 Medical Product Development Challenges what is assimilation of requirements? Assimilation of Requirements refers to the process of combining multiple related requirements into a single, more comprehensive requirement to simplify the design, development, and testing process. This approach helps reduce the complexity of managing individual requirements and can streamline validation and verification efforts. Key Aspects of Requirement Assimilation: 1. Combining Related Requirements: Identify similar or overlapping requirements. Merge them into a unified requirement that captures the essence of the individual ones. 2. Reducing Redundancy: Eliminate duplicate or unnecessary requirements. Focus on the core functionality or feature set. 3. Simplifying Testing: A single, well-defined requirement reduces the number of tests needed. Ensures that testing efforts are more focused and efficient. 4. Improving Clarity: A consolidated requirement is easier to understand and interpret. Reduces ambiguity for designers, developers, and testers. Example: Before Assimilation: "The system must display the current temperature." "The system must display the current humidity." "The system must display the current pressure." After Assimilation: "The system must display current environmental conditions, including temperature, humidity, and pressure." https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 10/454 16/12/2024, 23:28 Medical Product Development Challenges By assimilating the requirements, testing is simplified to validating a single display function, rather than validating each parameter individually. This reduces development complexity and speeds up the overall process. can you make short notes from this text: There is agreement that there is a lot of overlap between requirements and design, yet the division between these two is not a hard line. Design can itself be considered a requirement. Many individuals, however, do not appreciate that the distinction between them can be used to simplify testing and consequently shorten overall software development times. Requirements and their specification concentrate on the functions that are needed by the system or product and the users. Requirements need to be discussed in terms of what has to be done, and not how it is to be done. The requirement ‘‘hardcopy strip chart analysis shall be available’’ is a functional requirement. The requirement ‘‘hardcopy strip chart analysis shall be from a pull down menu’’ has design requirements mixed with the functional requirements. Consequently, there may be times when requirements specifications will contain information that can be construed as design. When devel- oping a requirements specification, resist placing the ‘‘how to’’ design requirements in the system requirements specification and concentrate on the underlying ‘‘what’’ requirements. As more ‘‘how’’ requirements creep into the requirements specification, more testing must occur on principally two levels. First, there is more detail to test for and second, but strategically more important, there is more validation than verification that needs to be done. Since verification is qualitative in nature and ascertains that the process and design were met, low- key activities have been transferred from the visual and inspection methods into validation testing which is more rigorous and requires formal proof of requirements fulfillment. The distinction of design versus requirements is difficult, but a careful discrimination of what goes where is of profound benefit. As a rule of thumb, if it looks like a description of ‘‘what’’ needs to be implemented, then it belongs in the requirements specification. If it looks like a ‘‘how to’’ description, if a feature can be implemented in two or more ways and https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 11/454 16/12/2024, 23:28 Medical Product Development Challenges one way is preferred over another, or if it is indeterminate as to whether it is requirements or design, then it belongs in the design specification. There is another distinct advantage to moving as many ‘‘how’’ requirements to design as possible. The use of computer-aided software engineering (CASE) tools has greatly automated the generation of code from design. If a feature or function can be delayed until the design phase, it can then be implemented in an automated fashion. This simplifies the verification of the design because the automation tool has been previously verified and validated so that the demonstration that the design was implemented is simple. Notes on Requirements vs. Design: Overlap Between Requirements and Design: The distinction is not clear-cut, but separating them simplifies testing and development. Requirements specify what needs to be done, while design specifies how it will be done. Examples: Functional Requirement: "Hardcopy strip chart analysis shall be available." Mixed Requirement: "Hardcopy strip chart analysis shall be from a pull- down menu." Avoid Mixing "What" and "How": Keep "how to" details out of the requirements specification. Focus on functional needs in the requirements and implementation methods in the design. Impact of Mixing Design into Requirements: Increases testing at two levels: 1. More detailed verification. 2. More rigorous validation, requiring formal proof of fulfillment. Guidelines for Separation: "What" goes into requirements specifications. "How" or indeterminate details belong in the design specification. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 12/454 16/12/2024, 23:28 Medical Product Development Challenges Benefits of Separation: Simplifies validation and verification. Enables use of CASE (Computer-Aided Software Engineering) tools: Automates design implementation. Reduces manual validation effort, as CASE tools are pre-validated. can you fix this sentence: I am social, work well both independently and in a team, and love tackling demanding challenges, both from an engineering and computer science point of view. I am sociable, work effectively both independently and as part of a team, and enjoy tackling demanding challenges from both engineering and computer science perspectives. can i another word for computer science? Sure! Here's a revised version using an alternative term: "I am sociable, work effectively both independently and as part of a team, and enjoy tackling demanding challenges from both engineering and computational perspectives." but dont you think that has more to do with math than computer science? You're correct that "computational" often leans more toward mathematics or algorithmic theory. If you'd like a term that aligns more closely with computer science, you could use: Software development Information technology Programming https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 13/454 16/12/2024, 23:28 Medical Product Development Challenges Technology Here’s the revised sentence using "technology": "I am sociable, work effectively both independently and as part of a team, and enjoy tackling demanding challenges from both engineering and technology perspectives." Or using "software development": "I am sociable, work effectively both independently and as part of a team, and enjoy tackling demanding challenges from both engineering and software development perspectives." Thinking outside the box to help people live their best lives is my passion. can you make this sentence sound less cliche? I am passionate about finding innovative solutions that empower people to improve their quality of life. can you fix this text: I, Katrín Ósk Kristinsdóttir, am applying for the position of Student Assistant in Engineering and Business Support at Novo Nordisk. As a leading healthcare company, Novo Nordisk is known for its innovative and life-saving treatments and products, which greatly aligns with my values and interests. I am currently pursuing a Master’s degree in Biomedical Engineering with a focus on biomechanics, biosensors, robotics and signal processing. I hold dual Bachelor’s degrees in Biomedical Engineering and Computer Science, both completed concurrently in four years with great GPAs. I have passion and drive for what I study and I put all of my effort into every task that I take on. Here’s a revised version of your text for improved flow and professionalism: https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 14/454 16/12/2024, 23:28 Medical Product Development Challenges My name is Katrín Ósk Kristinsdóttir, and I am excited to apply for the position of Student Assistant in Engineering and Business Support at Novo Nordisk. As a leading healthcare company, Novo Nordisk's innovative and life-saving treatments resonate deeply with my values and interests. I am currently pursuing a Master’s degree in Biomedical Engineering, specializing in biomechanics, biosensors, robotics, and signal processing. In addition, I hold dual Bachelor’s degrees in Biomedical Engineering and Computer Science, which I completed concurrently in four years with excellent GPAs. I am passionate about my field of study and approach every task with dedication and a commitment to excellence. This version maintains a professional tone, eliminates redundancies, and emphasizes your qualifications and enthusiasm for the role. can you fix this text: At the KarriereDagene event, I had an engaging conversation with one of your employees. I shared my experiences and interest in working in this field, especially with Novo Nordisk. They did a great job increasing my enthusiasm working for your company, showing me the departments and the company's drives. At the KarriereDagene event, I had the pleasure of speaking with one of your employees about my experiences and my interest in working in this field, particularly at Novo Nordisk. Our conversation further heightened my enthusiasm for joining your company as they provided valuable insights into the departments and shared the company's vision and ambitions. what word describes more than happy? A word that describes being more than happy is "elated". Other options include: Overjoyed Thrilled Ecstatic https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 15/454 16/12/2024, 23:28 Medical Product Development Challenges Euphoric Delighted Exuberant Each conveys a heightened sense of happiness, so you can choose one that best fits the tone or context of your message. can you make short notes: FDA is authorized, under section 520(f) of the act, to promulgate regulations detailing compliance with current GMPs. GMPs include the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of a device. The GMP regulations were established as manufacturing safeguards to ensure the production of a safe and effective device and include all of the essential elements of a quality assurance program. Because manufacturers cannot test every device, the GMPs were established as a minimum standard of manufacturing to ensure that each device produced would be safe. If a product is not manufactured according to GMPs, even if it is later shown not to be a health risk, it is in violation of the act and subject to FDA enforcement action. The general objectives of the GMPs, not specific manufacturing methods, are found in Part 820 of the Code of Federal Regulations. The GMPs apply to the manufacture of every medical device. The newest GMP regulations were released in 1996 and gave the FDA the authority to examine the design area of the product development cycle for the first time. The regulation also parallels very closely the ISO 9000 set of standards. 2/2 Notes on FDA and GMPs: FDA Authorization: Authorized under Section 520(f) of the act to issue regulations on compliance with Good Manufacturing Practices (GMPs). Purpose of GMPs: https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 16/454 16/12/2024, 23:28 Medical Product Development Challenges Cover methods, facilities, and controls for manufacturing, packing, storage, and installation of devices. Ensure safe and effective device production as part of a quality assurance program. Key Points: Manufacturers can't test every device, so GMPs act as minimum manufacturing standards. Non-compliance with GMPs violates the act, even if the product poses no health risk. Regulations: Found in Part 820 of the Code of Federal Regulations. Apply to the manufacture of all medical devices. Updates: Latest GMP regulations released in 1996. First to include design aspects of product development. Align closely with ISO 9000 standards. can you make short notes from this text: Each product program must establish and maintain a plan(s) that describes or references the design and development activities and defines responsibility for implementation. It identifies and describes the interfaces with different groups or activities that provide, or result in, input to the design and development process. The design and development plan is reviewed, updated, and approved as the design and development of a product evolves. The design and development plan describes how the different design control requirements are to be met. It includes all major activities, design deliverables, responsibilities, resources, and associated timelines for the development of a product. The program team creates the design and development plan and reviews, updates, and approves the plan as design and development evolves. The design and development plan resides in the DHF and any changes made to the plan also reside in the DHF. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 17/454 16/12/2024, 23:28 Medical Product Development Challenges Notes on Design and Development Plan: Purpose: Establishes and maintains a structured plan for design and development activities. Defines responsibilities for implementation. Key Components: Identifies interfaces with groups or activities contributing to the design process. Includes major activities, design deliverables, responsibilities, resources, and timelines. Updates and Reviews: Reviewed, updated, and approved as the product design evolves. Compliance: Describes how design control requirements will be met. Resides in the Design History File (DHF). Changes to the plan are also documented in the DHF. Responsibility: Created, reviewed, and updated by the program team. can you make short notes from this text: The following elements are addressed, if applicable, in the design and development plan. The applicability of these elements is determined by the program team and justification is provided for elements deemed not applicable. 6.2.1.1 Program Goals High-level goals and objectives of the product are described, i.e., what is to be developed and other considerations that communicate the size, scope, and complexity of the product development project. 6.2.1.2 Design and Development Elements Design and development elements refer to different categories of activities performed in the design of a medical device from design inputs through design transfer to manufacturing and service. The design and https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 18/454 16/12/2024, 23:28 Medical Product Development Challenges development plan describes the different elements including their scope and planned approach to fulfill the requirements of each element. Timeline for the activities associated with the different elements is incorporated in the design and development schedule. Required design and development elements include the following:. Design input: Identify the design inputs that will be used during design and development. Identify the activities for translating user needs and product requirements into technical design inputs.. Design activities: Identify the design activities anticipated to develop the product including those performed by suppliers and contractors. Include anticipated design iterations and contingencies. Design activities shall include, if applicable:. Development of new technologies. Reuse of existing technologies. Definition of system, subsystem, and module architectures. Design characterization and definition of design parameters. Component selection and supplier quality. Development and testing of subsystem prototypes and modules. System integration and testing. Design for reliability and risk analyses. Software design and development (including configuration management). Activities to develop other design outputs. Technical assessments. Regulatory strategy and submissions. Design outputs: Identify the design output elements that will be developed and the activities for developing them.. Formal design reviews: Identify the timing, intended content, and the reviewers for the formal design review(s) that will be conducted during the product program. Each product program should have at least one formal design review. Formal design review(s) should be conducted to review, at a minimum, the following:. Completed design inputs. Completed design outputs. Completed design validation. Design verification: Identify and provide an overview of the verification activities, for developing objective https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 19/454 16/12/2024, 23:28 Medical Product Development Challenges evidence that design input requirements have been met, including activities for the development of verification plans, test methods, testing, reporting, and reviewing results.. Design validation: Identify and provide an overview of the validation activities for developing objective evidence that the device design meets product requirements, including activities for the development of validation plans, test methods, testing, reporting, and reviewing results.. Design transfer: Identify the activities for translating the device design to production and service specifications and for transferring it to the manufacturing and service operations. Identify the requirements to be considered in selecting a manufacturing site or identify the manufacturing site, if known.. Design change control: Identify the mechanism(s) and responsibilities for reviewing and approving design changes.. Design history file: Identify the location of the product program DHF contents to allow ease of access. Reference other DHFs (and their locations) that may be leveraged for the product being developed. Identify key milestones at which all the documents in the DHF shall be brought up to date and be revision controlled, as appropriate.. Risk management: Summarize the methods and activities that will be used to address potential product and process hazards to customers through risk management. 6.2.1.3 Organizational and Key Interfaces Identify the key individuals=functions responsible for performing the design and development tasks, including cross-functional program team members and external resources, such as suppliers, contractors, or partners. At a minimum, define the roles for R&D, marketing, manufacturing, quality, reliability, regulatory, and service. 6.2.1.4 Deliverables and Responsibilities Identify the design control deliverables for the product program and indicate the personnel responsible for completing them. The deliverables to be addressed are dependent on the size, scope, and complexity of the product program and must be defined by the program team leader and program team. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 20/454 16/12/2024, 23:28 Medical Product Development Challenges 6.2.1.5 Design and Development Schedule Based on the size, scope, and complexity of the product program; design and development elements; and list of deliverables prepare a design and development schedule. The schedule is specified at the level of detail necessary for carrying out major activities, completing program deliverables, and addressing design control requirements. Identify these activities, deliverables, the responsible individual=function, resources required, and the associated due dates. Indicate which activities are concurrent, sequential, and dependent on other activities. Identify the major milestones and formal design reviews. 6.2.1.6 Approve Design and Development Plan The plan is completed and approved by the program team before the commencement of detailed design. 6.2.1.7 Incorporate Updates to Design and Development Plan Changes to the design and development plan are reviewed and approved at key milestones as determined by the program team. The design and development plan identifies the number and timing of plan reviews by the program team. The plan is revision controlled. Notes on Design and Development Plan Elements: 6.2.1.1 Program Goals: High-level goals and objectives. Describes the product, size, scope, and complexity. 6.2.1.2 Design and Development Elements: Design Input: Translate user needs into technical design inputs. Design Activities: Includes design iterations, new/used technologies, architectures, prototypes, integration, risk analysis, and regulatory strategy. Design Outputs: Identify and plan development of outputs. Formal Design Reviews: https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 21/454 16/12/2024, 23:28 Medical Product Development Challenges Minimum one review; evaluates design inputs, outputs, validation, and verification. Design Verification: Ensure design meets input requirements via plans, methods, tests, and reports. Design Validation: Confirm the design meets product requirements with plans, testing, and reports. Design Transfer: Translate the design to production and service specifications. Design Change Control: Define responsibilities and mechanisms for reviewing design changes. Design History File (DHF): Identify DHF contents, key milestones, and revision control. Risk Management: Summarize methods to address product and process hazards. 6.2.1.3 Organizational and Key Interfaces: Define roles of internal/external stakeholders (e.g., R&D, marketing, manufacturing, quality, and suppliers). 6.2.1.4 Deliverables and Responsibilities: List design control deliverables and assign responsible personnel. 6.2.1.5 Design and Development Schedule: Detail timelines, activities, deliverables, and milestones. Specify dependencies, concurrency, and responsible individuals/functions. 6.2.1.6 Approve Design and Development Plan: Approval required before starting detailed design. 6.2.1.7 Incorporate Updates to Plan: Regular updates reviewed/approved at key milestones. Revision-controlled plan tracks reviews and updates. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 22/454 16/12/2024, 23:28 Medical Product Development Challenges can you make short notes from this text Product requirements are translated into the SRS that specifies what the design must do to an engineering level of detail. Inputs from results of risk management are included. The SRS includes the following types of requirements:. Functional requirements: These requirements specify what the device does, focusing on the operational capabilities of the device and processing of inputs and the resultant outputs.. Physical and performance requirements: These requirements specify how much or how well the design must perform, addressing issues such as speed, strength, size, weight, response times, accuracy, precision, limits of operation, device safety, and reliability.. Interface requirements: These requirements specify characteristics that are critical to compatibility with external systems (including user and patient interface).. System architecture: These requirements specify relationships among logical functions, physical systems=subsystems, and interfaces.. Software requirements (if applicable): These requirements specify product functionality to be implemented through software and the functional, performance, interface, and safety requirements for the software subsystem(s). Where appropriate, the SRS should include additional design details in areas such as specification limits and tolerance, risk management, toxicity and biocompatibility, electromagnetic compatibility (EMC), human factors, software, chemical characteristics, reliability, regulatory requirements, manufacturing processes, service design requirements, and testing. If the design logically decom- poses into subsystems, the SRS may be used to generate subsystem level requirements. Traceability of the SRS to product requirements and design outputs is maintained. Requirements that are essential to the quality, safety, and proper function are identified. Incomplete, ambiguous, or conflicting requirements are identified and resolved using the following mechanism:. Program team reviews design inputs to identify and resolve incomplete, ambiguous, or conflicting requirements. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 23/454 16/12/2024, 23:28 Medical Product Development Challenges. Any remaining incomplete, ambiguous, or conflicting requirements are addressed in a formal design review. The SRS is reviewed, approved, and documented in the DHF. Notes on Software Requirements Specification (SRS): Purpose: Translates product requirements into detailed engineering-level design requirements. Includes inputs from risk management results. Types of Requirements in SRS: 1. Functional Requirements: Define what the device does (operations, input processing, and output results). 2. Physical and Performance Requirements: Specify performance metrics (e.g., speed, strength, size, weight, accuracy, safety, reliability). 3. Interface Requirements: Define compatibility with external systems (e.g., user, patient interfaces). 4. System Architecture: Describe relationships among functions, subsystems, and interfaces. 5. Software Requirements (if applicable): Detail functionality, performance, interface, and safety requirements for software subsystems. Additional Design Details (if applicable): Specification limits, tolerances, toxicity, biocompatibility, EMC, human factors, reliability, regulatory requirements, manufacturing, and testing. Decomposition: If the design breaks into subsystems, the SRS generates subsystem- level requirements. Traceability: https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 24/454 16/12/2024, 23:28 Medical Product Development Challenges SRS links to product requirements and design outputs. Identifies essential requirements for quality, safety, and functionality. Managing Incomplete or Conflicting Requirements: 1. Program team reviews inputs to identify issues. 2. Remaining issues addressed in a formal design review. Approval and Documentation: SRS is reviewed, approved, and stored in the Design History File (DHF). srs stands for system requirements specification Thank you for the clarification! Here's an updated version of the notes with SRS referring to System Requirements Specification: Notes on System Requirements Specification (SRS): Purpose: Translates product requirements into detailed engineering-level design specifications. Includes inputs from risk management results. Types of Requirements in SRS: 1. Functional Requirements: Define what the system does (operations, input processing, and output results). 2. Physical and Performance Requirements: Specify performance metrics (e.g., speed, strength, size, weight, accuracy, safety, reliability). 3. Interface Requirements: Define compatibility with external systems (e.g., user and patient interfaces). https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 25/454 16/12/2024, 23:28 Medical Product Development Challenges 4. System Architecture: Describe relationships among functions, subsystems, and interfaces. 5. Software Requirements (if applicable): Detail functionality, performance, interface, and safety requirements for software components. Additional Design Details (if applicable): Include specification limits, tolerances, toxicity, biocompatibility, EMC, human factors, reliability, regulatory requirements, manufacturing processes, and testing. Decomposition: If the design breaks into subsystems, the SRS generates subsystem- level requirements. Traceability: Links SRS to product requirements and design outputs. Identifies requirements critical to quality, safety, and functionality. Handling Incomplete or Conflicting Requirements: 1. Program team reviews inputs to resolve incomplete, ambiguous, or conflicting requirements. 2. Remaining issues addressed during a formal design review. Approval and Documentation: The SRS is reviewed, approved, and documented in the Design History File (DHF). can you make short notes from this text: Each product program must establish design inputs to ensure that design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. There should be a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements are documented, reviewed, and https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 26/454 16/12/2024, 23:28 Medical Product Development Challenges approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements is documented. Each product program establishes product requirements. Product requirements include the needs of the users and patients and intended use of the device. Product requirements are translated into technical design inputs that are specified at an engineering level of detail. Product requirements and the SRS obtained from the translation of product requirements constitute design input for the product program. Traceability is maintained to ensure that product requirements are linked to the corresponding SRS and design outputs. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 27/454 16/12/2024, 23:28 Medical Product Development Challenges Notes on Design Inputs: Purpose: Ensure design requirements are appropriate and address the device's intended use, including user and patient needs. Handling Requirements: Mechanism in place to address incomplete, ambiguous, or conflicting requirements. Design input requirements are documented, reviewed, and approved by designated individuals. Approval is documented with signatures and dates. Establishing Product Requirements: Include user and patient needs and the device's intended use. Translate product requirements into technical design inputs at an engineering level of detail. Design Input Components: Product Requirements. System Requirements Specification (SRS) derived from product requirements. Traceability: Maintain links between product requirements, SRS, and design outputs to ensure alignment. can you make short notes from this text: 6.5 DESIGN OUTPUT Design outputs are the results of the design effort. Initial design activities result in intermediate design outputs. As design and development progresses, intermediate design outputs evolve into final design outputs that form the basis of the device master record (DMR). The following general requirements apply to design outputs:. Design outputs are maintained and documented such that they can be evaluated for conform- ance to design inputs. Traceability of design outputs to design inputs shall be maintained. https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 28/454 16/12/2024, 23:28 Medical Product Development Challenges. Acceptance criteria for design outputs are established to enable verification and validation. Acceptance criteria related to device performance, such as accuracy and reliability are defined with tolerance limits.. Design outputs that are essential to the quality, safety, and proper functioning of the device are identified. These outputs are identified by design and risk analysis. 6.5.1 INTERMEDIATE DESIGN OUTPUT Intermediate design outputs are deliverables, which define and characterize the design. The follow- ing intermediate design outputs are created and recorded in the DHF as applicable:. Preliminary design specifications. Models and prototypes. Software source code. Risk analysis results. Traceability documents. Biocompatibility and bioburden test results. Other intermediate design outputs as appropriate 6.5.2 FINAL DESIGN OUTPUT Final design outputs form the basis of the DMR, which are recorded in the DHF, and shall include the following elements:. Device specifications. Device drawings. Component. Assembly. Finished device. Composition, formulation, and component specifications. Subassembly specifications (if applicable). Component and material specifications. Product configuration documents. Parts list. Bill of materials. Software specifications (if applicable). Software machine code, such as a diskette or master EPROM. Production process specifications. Critical production process specifications. Equipment specifications. Production methods and procedures. Test protocols. Work instructions. Production environmental specifications. Quality assurance procedures and specifications https://chatgpt.com/c/674873fc-b86c-8004-a3a7-b311ad162dfb 29/454 16/12/2024, 23:28 Medical Product D