Hello Lamiaa,
Many times insufficient quality checks can lead to dire consequence not only for the consumer but also for the manufacture. Generally speaking devices not properly monitored can lead to the lives being but in jeopardy. When consumers receive defective object they are given ample opprotunity to sue for false advertisement reckless endangerment and etc. It is pretty much vital for companies to hire a quality design control.
Design Controls are important for any product development project. However, just any Design Controls thrown together haphazardly and insufficiently will not suffice. Design Controls are the blueprints and building blocks fro everything else in the product development process. Design controls stem back to one of the first and most essential topics we covered in this course, communication. We all know how important communication is in product development, it can make or break the entire thing. If design controls are not properly set during the initial phases of project planning, there will not be sufficient communication is what is required and what is expected. this could result in an unorganized, inefficient, development process. And in turn, this could then lead to design flaws that make the product less successful, or even worse, require a recall. In short, design controls are necessary to keep the project on track, and keep all branches of development on the same page, and working efficiently.
Design control is important as it sets the workflow of the product in the market if is insufficient Design Control then there will be no direction as to how the product will be built and there will be a lot of design flaws to which the product will be sent back by the verification team and will have to be worked on again which will waste a lot of time and money. Also, the project could be scrapped due to insufficient funds, hence it is important to it right the first time itself.
If used appropriately, design controls can lead a company to design and produce a product that is a success in terms of effectiveness, marketability, safety, and revenue generation. However, misuse or lack of certain design controls steps can prevent a product from ever touching the market or even lead to the downfall of the entire company. The product can be hard to sell, if the marketing team didn't successfully compile accurate and current demands of potential clients and the project team during planning. There may also already be a product that fulfills those needs, and will be in direct competition with the proposed product. The product could lead to injury or fail to meet the users needs, due to poor verification and validation. Recalls, or lawsuits in extreme cases can follow, resulting in substantial loss in financial resources and time. Rushing through any of the design control steps may seem save valuable time at that moment, but it will also jeopardize future success of the product. It is important to ensure that the final product is in compliance with FDA standards, even if it pushes back the release date.
The main consequence of design control failure directly results of the failure of the product in market and may also affect the functionality of the product and then to make changes would result in delay of launch date. It is more likely that if they do not meet the standards the product might be recalled and making the alterations may create further delay.
Deign Control problems seem obvious only after adverse events, before that they are not so evident. Not starting out with a set of product requirements and do a top-down design the way the FDA expects is another factor that causes failure/inefficient design control. This results in failure of the product and would be seen as a delay in the project to be completed. This will have a lot of bad impact as it is needed to trace back to check what caused the failure by going through the design history file which would have all the necessary information of the product.
Insufficient design controls arise when the procedures are not followed properly or the standard procedures aren’t written. Insufficient design controls lead to the failure of the whole product. So the design inputs should be given about what is asked for; while the design output is what you got, as the product which should resemble the users need. That is the main concern in designing the medical devices. The verification and validation are important in design controls. Design verification must be performed, to know that each input has its output and all the outputs must be verified. While the design validation should be performed by, taking tests for each and every user needs.
As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is used insufficiently ?
-Lamiaa Abdelaziz
Proper design controls ensure that the device will not fail in the field under expected usage conditions. Of course, there will always be someone who uses a device incorrectly, but ideally, the design engineers would try to poke yoke their designs to prevent any sort of misusage of the device. If the device fails under typical use conditions, then hopefully the design controls would have captured that failure mode. In that case, it would be easy for anyone in the sustaining side of the business to check back in the design controls, identify the failure mode, and the corresponding severity levels with that failure to determine what the impact is to the user.
Design Controls organize everything about a product, and the product development stages. The importance of proper design controls stems back to the importance of communication. Design controls play a major role in every aspect of product development because it is the framework of what needs to be accomplished. Without proper design controls, there will be no inputs to be met, no plans for clinical and pre-clinical research, no timelines, no organization between branches of product development, and ultimately no success overall in the grand scope of the project.
Personally, I believe the ultimate purpose of design controls is to make the project team think thoroughly about every minor to substantial aspect of the project. Through such an in-depth analysis, the benefit received is that it helps reduce the chances of there being an issue or failure within the product post market. As a result, I believe some major issues that may result if the process of design controls is used insufficiently is that it increases the chances of there being some flaw that was missed during the development process. Furthermore, it may seem from a general overview on design controls that another issue that it presents is that it significantly increases the time needed to complete a project due to the creation of multiple documents. On the contrary, I believe that it doesn’t increase the duration of a project because instead it is preventing an increase in time due to flaws or errors that may have been missed early on if there were no standardized design controls. Ultimately, even if it did substantially increase the time needed to complete a project, I believe it is a needed necessary to make sure that at the end of the day the product being released on to the market is safe and performs as it was intended to.
Well, the possibilities are endless. Even with a well thought out design control documents, there are possibilities of things going wrong due to us being human beings and not able to predict all the possible outcomes. The only job of the Design Control documents, in my opinion, is to decrease the likely hood of a product failing or hurting someone. All the planning and design are there to guide a person who makes the device follow to minimize the error that can show which will ultimately improve the safety of the product. Therefore, it is extremely important that the design control portion of the phase is well thought out and do not cut corners to save time or money during this phase. If this portion of the project is not strong the device success rate and the product to last will significantly decrease.
Design controls are tools for professionals to ensure that medical devices are designed, developed, and manufactured to be safe and effective. However, there are few issues that arise when these are not done effectively and where they fail like Poorly Defined Product Development Processes, Starting Risk Management Too Late, or not an adequate understanding of user needs. We also need to determine if verification and/or validation is required for our design change. Design controls are a continuous, total product lifecycle process. As the medical device world continues to move toward risk-based approaches regarding quality management systems, I would expect there to be more scrutiny when it comes to product lifecycle risk management, too.
One issue that can arise from the design control process is the improper assessment of the risks associated with the product. If the potential risks of a product are underestimated, certain tests may be overlooked, leading to a potentially defective product and financial loss. Not only does this cause problems for the company, but issues that occur can be harmful to the consumer of the product. For example, a defective ventilator can lead to death. A ventilator is a device that helps you breathe. if it is defective, a patient can die from lack of oxygen.
Another issue is preparing paperwork for the design controls as an afterthought. Not only can this lead to issues with the product, but it can also lead to a drawn out planning and production process, which can also lead to increased expenses and potential financial loss.
From a purely manufacturing or engineering perspective, insufficient design controls can pose dire consequences for medical device development. The FDA even cites that poor design controls are consistently the number one reason for Form 483 inspections for non-compliance or deficiencies. Risk management must be a priority in medical device development. Lack attentiveness to the prospective customer or market can result in a product that is ignored once it goes commercial, which usually means that millions of research and development dollars just went down the drain. Cutting corners in product due diligence is another critical mistake.
Design verification (meeting the customer's needs and expectations) and design validation (ensuring a well-made, reliable product to specifications) are both risk management and cost-saving measures. Having to redesign a medical device due to failed and lax validation processes near market launch or after market launch are errors that many companies, startups in particular, cannot overcome. The cost is extremely high; the company's brand is damaged; investors may become dismayed.
However, the worst scenario with insufficient design controls is when a product reaches the market and its poor design contributes to consumers being harmed or even dying. Consider the lawsuits and product recalls that the automobile industry must endure. A bad product reputation is perhaps more detrimental in the medical device industry, because its primary customers are usually the smaller subset of healthcare providers (business-to-business clients), rather than the most broader market to individual consumers, although that is changing as technology evolves to create more portable devices that patients can handle outside of a health provider setting.
Lastly, I just don't see a scenario where it is worth not being vigilant about implementing strong design controls. A company can get "lucky" and still succeed in delivering a well-received product after skimping on their design controls, but history reminds of too many horror stories where companies were not lucky, and they ended up paying a devastating price.
While design control is not required for all medical devices, it applies to nearly every medium- and high-risk device. And this isn’t just for new devices – in the US, FDA requires design controls for all Class II and III medical devices and even some Class I devices .
Design control is not a “once and done” process – it applies to modifications or improvements to existing designs, or changes to processes. Design control does not, however, apply to the ideation stage of medical device development. You don’t need to document the development of prototype concepts or feasibility studies. However, you do need to start creating a plan once you have decided that a specific design will be developed. To assist regulators, you should document the flow of the design process so it is very clear where research is ending and development of the chosen design is beginning.
