Design controls are like a system of checks and balances to help comply with the law and ensure safety. For those that work in industry what part of the design control process have you had a chance to be part of? For those that haven't worked in industry what part of the design control process would you like to be part of? Verifications, validations, design review, design transfer?
During my internship I was able to take part in a packaging validation for a product. In the future I would like to join a project team in the early stages of a project to see it develop from the very beginning.
During my internship I worked on the Verification process of a product. It was heavily research based, and was in its early stages of testing. I think I would like to stay in the design verification phase for a few years when I graduate and work full time. Eventually, I think I would like to become a part of the planning/design control. The place I worked at was a project based organization; which I really enjoyed as it made conveying information to the proper people much easier, than how I imagine a matrix organization. But then again, I also have no experience within a matrix organization. If someone else has personal experience I would be interested to read their post about it.
I currently work in manufacturing/production at a cell-research company where I process autologous cell-therapy products that is in its clinical phase with the hopes of becoming marketed. The most imperative design control I've had the chance to be a part of is design changes, which is sensible for me since this step occurs before, during, and after the production process. The most frequent design changes mainly revolve around the technical writing style/format of the standard operating procedures (SOPs) along with the batch record of each lot for each patient that is administered the treatment. Growing, expanding, and overall processing of human cells requires following distinct number-based equations that are written into the batch records which can determine important factors such as the quantity of cryo-protectant added to cells prior to freezing, or how much media must be added to a cell culture. There has been an incident where a set of parenthesis were not included in an equation (similar to how x+y/2 is not the same as (x+y)/2) which would have resulted in many cells dying, but this was luckily pointed out and corrected prior to the initiation of production.
The above situation refers to a pre-production design change that simply addressed a design mistake. What other known methods are there to reduce the likelihood of having to change an aspect of the design process? Quality function deployment (QMD) for example is a proactive method of reducing the frequency of design changes by correlating customer preferences to available resources. What would happen if design changes were implemented too late or not at all?
I haven't had the opportunity to work in industry yet, but if I could choose one of the nine parts of design controls to focus on I would choose design validation. Having a product that is ready for a clinical trial or to be tested out on a cadaver seems very rewarding, especially if everything goes right, and even when things go wrong there is valuable data to be learned about how a product can better meet a users needs. As a second option I would choose design transfer because here you're taking the project team's hard work and preparing for production by creating the manufacturing instructions and setting the ground rules for the quality you expect.
If I was placed in the Design Control process of a project, I would likely find preference in the putting together the Design Specification Document (DSD). This is where the meat of the engineering is. The DSD is the transitioning stage from planning to execution, and requires detailed consideration in the design of a successful project. Several factors and output from verification allows for a carefully thought out design to be created. The work in verification with putting together verification protocols and tests would also require a lot critical thought in the developing of procedures, but may tend to become too procedural. I would most enjoy directly making decisions on the design specs if working in the Design Controls process.
While I haven't been part of Design Control process yet as I am new in my current role, I do know that in a few weeks I will be part of a project that will be involved in creating a packaging verification/study for an existing medical device combination kit. This will involve making a change to how the MD is packaged. Because the product itself in terms of the device is not actually changing no design verifiactions are going to have to be done, however, going through the design control is still neccessary for something as "small" as changing how the device is packaged/delivered to the customer. Something small can make a big difference or have a ripple effect down the line and as such even small changes need to be verified to prove that the end product produces the same or better results.
I haven't been a part of the Industry but I want to be involved in the planning phase of the design control process as this is the crucial step for all the other processes to follow. The project should be well thought through the project description, business output, device scope etc as only if you have proper planning, the necessary resources and most importantly the possibility of good returns for it, the project will find the investment it requires.
While I have yet to work in industry, I am most interested in the initial product design/planning phase that includes determining spec and coming up with a new design that combats the problems of existing products. However, I think I would need to have experience working in the verification stage first, in order to fully understand what it takes for the FDA to approve the final product for clinical testing and eventually release to the public. This will hopefully prevent my team and I from setting unrealistic goals from the very beginning of the design process, which can push completion past the deadline. It can even lead us to dropping the project completely due to underestimating FDA requirements and amount of time needed for approval.
FDA has required that medical device that want to market certain categories of medical devices in the UISA follow Design Control requirements.
Design and development planning . Design input, including intended use and user needs.
Design output: including evaluation of conformance to design input requirement through Design verification: confirming that the design output meets the design input requirement , and Design validation: ensuring that devices conform to defined user needs and intended uses.
While currently working in the industry, I had a chance to be apart of the Design Changes and a little bit of the verification and validation part of the design controls steps. I would definitely like to be more involved and learn more about each of the steps in the industry that is applicable to my work. I make changes to drawings or create new drawings for instruments that already exist but when new projects come along for new instruments, I got to be involved in creating the design (the output) and verifying the product after it was manufactured. Asking doctors if they like it and if it fits all the specific criteria of the instrument was also apart of the validation that I got to see. I would like to start from the beginning with the research and planning stage to see how the DHF file and project proposal get approved by the different departments in the company.
Design controls are like a system of checks and balances to help comply with the law and ensure safety. For those that work in industry what part of the design control process have you had a chance to be part of? For those that haven't worked in industry what part of the design control process would you like to be part of? Verifications, validations, design review, design transfer?
During my internship I was able to take part in a packaging validation for a product. In the future I would like to join a project team in the early stages of a project to see it develop from the very beginning.
In my opinion, both the verification process and validation process are both extremely interesting. In the verification process, you are ensuring the design outputs meet the design inputs. This typically is done through product testing, which gives you the opportunity to do some real engineering work and test the acceptability of your design. When verification testing passes, it feels great because then you know you successfully designed your device. For validation testing, you are ensuring the user needs are being met. For medical devices such as implants, the customers are surgeons, so meeting with surgeons is extremely informational because they have a lot of clinical knowledge and are passionate about the device you're designing.
Design control process are a set of steps used to assure that device design and testing are planned, executed and documented systematically. They are a set of quality practices and procedures that control the design process that a device requires. Design verification and validation are main elements in design controls. Design verification is where the design inputs are verified with its output and all outputs must be verified. Whereas design validation is needed to check how well the device is designed for customer needs.
I’ve had the opportunity to work on the output and verification phases of Design Control at the company I work for. The output phase mainly involved creating specifications for components that went into the device, which allowed me to use my technical background to determine which component attributes should be considered critical. And I enjoyed design verification since it involved working with the device hands-on while designing and executing laboratory tests. During design verification, you must ensure your device can withstand the limits of its requirements without failure, and that the testing conditions accurately represent how the device will perform in reality, which creates an interesting challenge for engineers. In the future I would also like the chance to contribute to the earlier phases of a project such as planning and determining design inputs, since these phases are very important in setting the foundation for the rest of the project.
I do not currently work in industry, but if given the choice, I would want to work in the validation stage of the design controls process, if the project has a validation step. As Dr. Simon mentioned, some designs do not go through the validation step, if the project does not require clinical trials or if no further changes are made to the product after verification. More specifically, I would want to validate that the product works clinically, as my current position in research works very closely with the clinical realm and I believe validation that the product or medical device can be used clinically is of great practical importance. Furthermore, going through the clinical trials process ensures safety for those using the medical device. I believe a great deal of responsibility is needed in this validation phase, because of the severe detriments that could ensue if the product has any negative side-effects on human populations. Therefore, I believe that validation is a very important step in the design controls process, especially with medical devices that require clinical trials, as it is a very practical area and I would like to ensure that the product is properly validated before going on to the next step.
I currently work as a biomedical equipment technician and although I am not involved with design control processes, I do provide manufacturer functional testing. Functional tests are designed by the manufacturer and consist of performing every function of the device to ensure it is operating properly. If I worked in product development, I think I would enjoy working in verification and validation. I have always enjoyed performing tests and writing reports on the results in my undergraduate lab courses. In verification and validation, I think it would be interesting to brainstorm the actual testing protocols and procedures in order to verify and validate design specifications.
