Verification includes testing to determine if the inputs match the outputs. Validation, on the other hand, assesses whether the inputs meet the user's needs and whether the device does what it’s supposed to do. For design validation, the product must meet the specs and fulfill its intended purposes. Once the device is established, production needs to validate its processes to ensure the product can be made consistently. Verification and validation occur during the executing phase and appear in the monitoring and controlling phase. Not all medical devices require validation; for example, when the product is not critical or lifesaving, and does not require a clinical trial. What are other reasons why a medical device does not need validation? 

Validation in project management is the process of checking that deliverables meet project requirements. The deliverables must align with the project scope and any established acceptance criteria. Using a work breakdown structure for project validation can confirm that all deliverables are included and that the tasks are relevant and assigned correctly. 

This weeks videos on PM are really interesting. In my job (working as a process dev eng in a medical device manufacturing company) verification vs validation both in very loose terms mean ensuring that the customer spec is met--in other words if input=output like what the prof said.

The difference is that in my company verification may be like checking something visually and ensuring it means the customer spec (for example 100% inspection of cables on a device to check that they meet the customer requirement of being free of debris, bird-caging, tears, or any other defects). Meanwhile validation would mean thoroughly testing a spec to ensure that you can meet it repeatedly. Can you ensure that the welds on the end effector jaws of a device meet the spec of a minimum 50N load repeatedly to a certain precision wherein you would meet a certain cpk? Features created to meet customer spec are analyzed for capability and ensured that they can be met repeatedly in production; that is validation.

PM validation is ensuring that the various overall validations throughout a project cycle are completed by the team and met on time. For ex (IQ, OQ, PQ).

Verification focuses on confirming that the device was built according to the design specifications which typically occurs during the design and development phase through testing and analysis. Validation ensures the final device meets the user’s needs and intended clinical use and basically answers: “Did we build the right device?” This usually occurs later in development and may involve usability or clinical testing. The role of a project manager in validation differs from engineers or manufacturers. Engineers validate technical performance and manufacturability while the project manager ensures the overall project meets stakeholder expectations. To make sure everything goes well, teams should clearly define design inputs and outputs, maintain traceability between requirements and tests, perform risk analysis, and maintain strong communication across departments.

To me, verification and validation are different mainly in what they are checking. Verification is making sure the design and specs were followed correctly, while validation is making sure the final product actually works for the user in the real world. Verification usually happens more during development, while validation tends to happen closer to the end when the product is more complete.

One difference for a project manager is that they are not directly performing the technical tests. Instead, they are responsible for making sure the validation activities are properly planned, documented, and completed on schedule.

One thing that helps the V&V process run smoothly is strong change control. If design changes happen without proper documentation or approval, it can create confusion about which version of the device was actually verified or validated. Keeping clear records of changes helps make sure testing stays organized/traceable.

I agree with all the responses so far. Verification checks whether the device meets the specifications that were outlined. This happens during development. Validation checks whether the device meets the user's needs and happens closer to the end of the project. However, I wanted to bring a new twist to how Verification and Validation should be seen. Validation, in my opinion, should be treated like discovering failure. Usually, validation is thought of as the way to prove that a device works. However, if you actively try to break the system in validation, you will find issues that you would have never thought of before. This will allow you to correct your product and make it even stronger for the market. Moving from just checking off the validation box to actually using Validation to make sure you have a well-made product will put your company way ahead of many others. However, it is important to make sure that all tests make sense and the product doesn’t fail because of a flawed test, as it did in Simulation 1. 

However, one must always look at the difference between lab success and behavior in the real-world. Under controlled conditions, devices will behave a certain way. But in the real environment, there are many confounding variables that can heavily affect device performance. Validation should try to focus on those confounding and unexpected variables, which means it should try to break the system so it can be built thoroughly enough to prevent a breakage in the field. 

With verification, there is a timing mismatch issue where verification can give a false sense of progress early. We saw this in the third simulation, where a false sense of progress led to a major dilemma later on because not everything was fully verified when deals were made. You can be “on track,” but there could be unseen issues that lead to drift, and that may come up down the line, leading to setbacks and an extra cost to fix. 

Additionally, there is a chance for re-validation fatigue where too many design changes lead to too many validation cycles. This could cause teams to become fatigued or frustrated, eventually leading to sloppier work and cutting corners. This creates more risk, even though more testing is technically happening. If teams over-validate, on the other hand, then there would be timeline delays and cost increases. There needs to be a balance. Engineers should focus on technical performance, and the PM should make sure that the project still addresses the intended purpose and expectations of the stakeholders. Ultimately, using proper traceability features and having proper version control will make verification and validation balanced. 

What role do flawed assumptions at the beginning of the project make on validation failures? Do you think teams become too committed to designs that passed verification, leading to larger problems down the line? How can PMs or companies convince their teams to actually address the issues that come up at the start, instead of trying to push through them to meet deadlines and get the project done faster? Do you agree with my method of validation, where the testing should try its best to push the product to failure? 

Verification and validation are both needed in medical device projects. Verification means checking that the product was made correctly based on the design and requirements. Validation means checking that the product works for the user and solves the right problem. Verification usually happens during development, while validation happens closer to the final stage. A project manager focuses more on user needs, project goals, and deadlines, while engineers and manufacturers focus on testing and performance. Clear requirements, good documentation, test plans, and design reviews help make both processes successful.

Clinical trials, usability testing, and software validation are common methods used in the medical device industry. For example, software validation can ensure the system does not crash and includes preventive measures when a user makes mistakes, which replicates a real-world scenario. Validation checks to see that the design works as intended for the user. I understand testing until failure as a popular method for supporting safety, specification, and design verification. If testing to failure determines the minimum value at which an implant fractures, a safety margin can then be applied to establish the design specification. Additionally, early usability testing helps to identify design flaws and errors based on how each individual uses the product. Not doing early testing with prototypes can lead to larger problems when the team is committed to passing results during verification. 

Design verification focuses on testing if the device is built correctly according to design specifications and validation ensures that the “correct device” is built and meets the user needs or intended use. Most of the verification and validation activities take place in the executing phase of a project, but they can also be tied to the monitoring and controlling phase, if any changes to the device need to be made after testing. The validation that a project manager does wouldn’t really be considered validation under design controls. Project managers are responsible for ensuring project goals, timelines, and stakeholder expectations are met. This is different from engineers, who are responsible for performing the testing that validates the intended use of a device. To ensure a smooth verification and validation process, it is important to follow company standardized protocols or SOPs and clearly define acceptance criteria. SOPs typically would outline how tests should be performed and how data should be documented. Acceptance criteria should be measurable and directly tied to a design input or specification. Overall, having clearly defined processes and well-planned verification and validation activities helps to ensure that a device meets all requirements, and is safe and effective.