Consider the Design Controls lecture that Dr. Simon has made available. Yes, we know that all parts work together to support the goal of medical device development. What aspect of Design Controls do YOU feel is most important to the process?
Within the design controls I would like to think that design verification may be the most important. Without design verification the product can be pushed along for manufacturing. This can be an expensive cost to the product being manufactured if an aspect of the device or product has the incorrect specs. They would need to go back to the beginning to begin the process over which would be a substantial cost and cost them the product.
I consider the customer's input the most important part of the design control. Why? I believe all steps in the design control are some what important but I believe that the customer input is the most important because a product is unsuccessful if it is not profitable or lucrative. You can design and produce the most amazing product in your mind and with your team but if you have no customers to purchase it then it was all fruitless. It is important to put the device out for a trial and see how it fairs on the market and modify it to the customer's wants if necessary to ensure we make a profitable return.
I believe the customers input is the most important section. I believe there input could validate sells as well as marketing. While designing the device you can know what to target and focus on to accommodate the customers. You also can listen to there complaints and make changes for the issues that they have voiced a concern for. Lastly they may use there inputs to verify and make sure the device is safe for the customers.
I think the required documentation for design control is most important. Revised design control documentation serves as a valuable source of truth for the project. Recording everything in one document helps you to organize your thoughts, makes it easier to reach a mutual understanding, and ensures that there is no ambiguity. Documenting design control also streamlines design implementation. The people implementing the design may not be the ones who created it. Having design control documentation with some implementation details, or even step-by-step instructions, will make development much easier and will result in far fewer questions and mistakes. Documenting design control is also very helpful when it comes to analytics and metrics tracking. It gives us the ability to look back and see how design affected other areas, what worked, and what didn`t.
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I agree with @ssbufford that the customer input is the most important. If the needs of the customer are not properly understood from the beginning, the whole design control process may be wasted by focusing on aspects that are not part of the customer's image of the product. In today's age where time is of the essence, it is critical to save on doing work twice and in order to do that one must fully understand the "assignment" to start off on the right footing.
In my opinion, input is the most important aspect in design controls. Some examples of design input include: performance, safety, maintenance, sterilization, as well as labeling and packaging. If standards are not specified, the manufacturing team could create an item far from what was expected. The details in the design input are clearly stated, thereby significantly reducing errors. For example, if I were to ask you to design a chair (with no further instructions), you certainly would be able to because you understand what a chair is and its purpose. There are folding chairs, swivel chairs, ones that have three legs, others with four, but which one do I want? You don’t know because I did not provide specifics. This same idea applies to medical devices. In order to receive the correct output, the input must be clearly described.
The most important part of design controls is the design verification. This is crucial as it accounts for the inputs and outputs. It checks that every input has an outputs. This is important because you have to ensure that all that has been asked for is met. Keeping track of this ensures that there are no missed specifications. The design verification also ensures the the outputs are verified by testing and checking the results. This document gives an extremely clear pictures as to whether the device is performing as planned and documented everything that has passed or failed into a report.
I believe that the documentation part of the design control process is the most important. This is not to undermine the importance of any other portion of design control as they are all equally responsible to producing a safe and effective product, but good documentation not only helps further design changes by being able to track what works and what doesn't but also satisfies the requirements laid by regulatory bodies. Furthermore, good results mean little in the eyes of company leaders and customers if the process to get there is loosely documented and is filled with holes that may come back to bite them later in the case of an audit or product problem.
Every part of the design control process plays an important role in the overall design and development of a medical device. Furthermore, all design controls function as one overall process and each control is dependent on the other parts. The design history file is arguably the most important design control because it is the final output all of the design control documents, notes, market research, protocols and etc. However, it would not be possible to obtain this document without any of the other controls. Each of the nine controls build off of one another to create the final outcome. For example, in order to obtain design outputs, design inputs need to have been developed and specified. Similarly in order to have validation activity design verification needs to have been defined. In conclusion, I do not think that there is one design control that is more important than the others as they are interconnected.
With Design Control, I believe that Output is the most important part. The output is considered as any work that's produced at the end of the design. That would include any drawings, manufacturing instruction, or material specifications. The output is what controls the overall design. The fact that the output should also meet design input criteria that is initially defined in the planning stage of the project during design verification would ensure that output is the most important part.
Consider the Design Controls lecture that Dr. Simon has made available. Yes, we know that all parts work together to support the goal of medical device development. What aspect of Design Controls do YOU feel is most important to the process?
Personally, I think all parts of design controls are important but I think Verification and Validation are especially important. I work in bench top performance testing and from what I've seen and experienced, making sure a product satisfies minimum specified criteria is crucial in regulatory and commercial claims (Verification). Validation is the flip side of what I do, understanding a product's effectiveness within human subjects and being able to understand how a product meets customer needs is the practical portion of design controls. These two pieces are able to answer the important specific and technical questions while also providing information about how a product is actually used by and in humans.
Thanks,
Matt
Debating between the documentation process and the verification process, I think the verification process is the most important in design control. I say this because checking the product before it goes off to production determines if the product is ready or if changes need to be made. This process can also show if the documentation part was done correctly through being easy or difficult to find where the problem is or change needs to be made in the documents. Completing the verification process correctly can offer many benefits to a company during their design control phase by catching issues before they can become expensive and showing that the product is capable of producing what is expected from it.
The most significant part, in my opinion, is customer input. If the customer's wants aren't recognized from the start, the entire design control process could be squandered by focusing on components that aren't part of the customer's picture of the product. I believe verification is a close second, considering the importance of ensuring that a product meets minimum defined criteria.
There are nine components that make up design controls that build from one to the other. Knowing the goal of medical device development and meeting that goal is the outcome of the design controls. I believe the planning aspect is the most important part of the process. My justification is the simple matron if you fail to plan then you plan to fail. In other words, if you do not plan well thought out design controls for your project you will fail to implement the steps to meet the goal. Planning is the upfront investment cost that will save you in the long run from product failure costs. Nothing is fail-proof but if you plan you have room to pivot correctly without huge losses. Working in food ingredient manufacturing for an international company with several different product lines required efficient planning for launching a new product ingredient. Do you all remember when Splendia came to the market? The behind, the scene work involved planning for lab facilities on-site at manufacturing plants to send teams to each location and set up pilot plants (initial testing stations) to come up with design controls for large-scale manufacturing that meet standards internationally as well as FDA approvals. So planning before any other aspect is the most important part of design control as it involves all the persons and moving pieces of the project.
