While verification ensures that the design meets the specifications, and validation ensures it meets the user needs, there can be times when these two processes will run into each other and overlap. Do you think verification and validation can be conducted simultaneously, or should they always remain separate? What challenges might arise when trying to integrate both processes?
Verification ensures a product meets its design specifications, while validation ensures it meets user needs. These processes can be conducted simultaneously, especially in iterative and agile development methodologies. Integrating both allows for early detection of issues, improving product quality by aligning technical requirements with user expectations. Simultaneous verification and validation enhance flexibility, adapting to changes without losing sight of specifications. However, challenges include resource constraints, as conducting both processes together may strain budgets and timelines. There may be conflicting objectives between adhering strictly to specifications and adapting to user feedback. Integrating both processes can complicate testing procedures, making it harder to isolate specific issues. Communication overheads may increase, requiring clear and continuous dialogue among cross-functional teams. Scope management becomes critical to prevent scope creep due to changes arising from validation activities. Best practices involve adopting iterative development, establishing clear communication channels, prioritizing requirements, implementing robust testing frameworks, and carefully managing scope changes. With careful planning, integrating verification and validation can enhance product quality and better meet user expectations. Balancing both processes effectively ensures the product is both technically sound and user-centered.
I agree that it is possible to conduct validation and verification simultaneously in some cases, but that should not be the norm or the goal. It's best to keep verification and validation separate to ensure clarity in evaluating if the design meets specifications (verification) and if the final product meets user needs (validation). Combining the two can blur these objectives, leading to challenges such as conflicting test priorities, resource allocation issues, and potential gaps in addressing needs. This overlap would likely also introduce biases or compromises, ultimately impacting the reliability of the product's performance.
Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and validation ensures that the design meets the user needs. Although they are different, there are situations where these processes can be run in parallel. Some situations where they can be run in parallel include in prototype testing, in which early prototypes can be tested to see if they meet both technical requirement and user needs. Some benefits to combining these two processes include time and cost efficiency and improved design feedback. Running tests in parallel can reduce the time and labor required to get a product to the market. Challenges associated with running these tests in parallel are conflicting outcomes and difficulty in isolating issues. Verification and validation can sometimes reveal conflicting results, as what meets technical specifications may not always align with user expectations. In addition to this, running verification and validation together can make it more difficult to pinpoint where failures may come from. If there is a high level of confidence that both verification and validation will pass based on previous testing or approved devices, then it may make sense to run them together. In cases where a product is new or not into a far stage in development, it will ultimately be more cost efficient to take the time to run processes in isolation.
To answer this question, verification and validation (V&V) can be conducted simultaneously in some instances, especially with iterative or agile development, which can save time and improve feedback. For example, in developing a medical software application, verification tests might check that each software module functions according to specifications, while at the same time, validation tests assess if the entire application meets user needs, like ease of use for healthcare providers. However, due to different focuses, V&V should generally remain distinct for high-risk devices, like implantable medical devices. Overlapping V&V in high-risk devices can lead to challenges such as complexity in documentation, difficulty in maintaining traceability, and testing bias towards one process over the other.
I think verification and validation can sometimes happen at the same time, especially during prototype testing or early design iterations, but they shouldn't completely merge. Doing both together can help teams spot issues early and make adjustments before things get too expensive to fix. For example, testing a prototype with users can confirm that it meets both the technical specs and their expectations at once, saving time and giving more relevant feedback. Still, I think it's important to keep a line between the two, so the results don't get too confusing. For high-risk products like medical devices, it's probably safer to keep them separate and use simultaneous testing only for low-risk or early-stage projects where quick learning matters more than strict documentation.
I would probably say that this is more a case by case approach. For devices or features that are high risk, verifications and validation should be strictly separate to keep results trustworthy. But for lower risk features, you can afford to let some overlap happen to save time and get feedback faster. However, there should be strict guidelines when this happens. For example, having two separate teams handle verification and validation, setting criteria beforehand, and following good documentation practices so nothing gets changed without approval. Having structure and clear separation between the two processes could allow them to run parallel to each other. What other type of safeguards do you think should be considered to keep results unbiased when this happens? Is this proposal feasible at all in the first place?
I believe it is more common for verification and validation activities to remain separate processes. Verification ensures that a device has been designed correctly, while validation confirms that the correct device has been designed to meet user needs. Verification can be performed on individual components or subsystems before the device is fully assembled, demonstrating that design outputs match design specifications. Validation typically involves clinical evaluation, where the end user interacts with the device under actual or simulated conditions to ensure it performs as intended and meets user needs. These processes should not be conducted simultaneously, as each requires its own distinct protocol and report. For example, during my undergraduate senior project, my team designed and developed a prototype training model of the upper extremity to help medical students and physical therapy students learn ligament integrity tests and joint reduction techniques. Most of our verification testing involved tensile tests on individual components to confirm that the materials met our specified stiffness requirements. In contrast, our validation testing took place in a clinical environment, where physical therapists used the complete prototype and provided feedback through a survey with questions about the devices design inputs.
In medical device development, verification and validation are two critical processes that ensure the safety, efficacy, and quality of a product. Verification refers to the process of checking whether the device meets its specified design requirements, ensuring that it was built correctly. This involves testing, inspecting, and analyzing the device to confirm that it functions as intended according to its specifications. On the other hand, validation is the process of confirming that the device meets the intended use and performs effectively in the real-world setting. It focuses on ensuring that the device satisfies the needs of the user and complies with regulatory standards. While verification ensures the device was built correctly, validation ensures it will function as expected in the hands of the user. Together, these processes complement each other and are essential in minimizing risks, ensuring compliance, and ultimately safeguarding patient health.
I think that verification and validation can be conducted simultaneously, but that depends mostly on what design input it is for the device. Most of the time, verification testing is done first and validation testing is done later in the process, but all in all, it always brings the device together. Verification testing has a criteria for meeting the design input specifications, while validation testing has a criteria for meeting the design input requirements. Both are conducted on different design inputs for the device that engineers are building. There is one example I can think of that verification and validation testing were performed at the same time based on my previous experience on my senior project during my undergrad. One design input was that the device must provide assistive support to medical staff for moving the patient. Specifications were that the angle of elevation was at a minimum of 30 degrees. Verification activity involves testing if the device is capable of getting to 30 degrees and when it is fully inflated in relation to a body, the angle is measured up to 30 degrees. Validation activity involves testing to determine if the recommended minimal degree of elevation is met on both left and right side of the device. It also included having someone mimic the actual function of the device to elevate their body. As seen, these two tests were done at the same time since we were testing if the device can get up to 30 degrees on both sides of the device or not. Both tests also included utilizing someone to mimic the device’s function in relation to the body being placed on the device to ensure the device is up to 30 degrees while their body is being elevated for someone else to move them.
Previously mentioned, verification testing is mostly done during the development phase, while validation testing is conducted later into the phase towards the end. There could be challenges, such as meeting the deadline and requirements for the design inputs. Usually verification testing comes first to confirm that the device specifications are met and validation testing comes later to show that the design inputs are being met along with the specifications. It could help to do them together to increase productivity and to decrease the time needed to complete testing for that design input. But as said before, sometimes you cannot conduct validation tests until the verification tests are completed. Verification and validation tests can also have different test protocols and documentations needed to perform these tasks. There can be specific different tests and documentation done for verification and something completely different for validation. If the wrong tests are performed on both, then there are risks involved throughout the development process. This can cause additional delay and confusion while failing to meet design input expectations and requirements. There could also be conflict within the team if these two tests are being done at the same time by different team members. If verification is done a certain way by someone while they do not take into consideration what the person doing the validation testing is doing and vice versa, then the design input requirements are not being met. You have to make sure that the device works a certain way while making sure that the product is actually meeting user needs.