Design control is a formal methodology to conduct the product development activities. It is mandatory to implement such practice when designing and developing products within regulated industries like medical devices. Design control is one of the most important thing in medical device since the design of the product can lower the profit of the company. It causes the poor understanding of the user needs. The product will be very inefficient which would not fulfill the needs of the consumer. Insufficient design control will lead to possibility of non- conformances and non- compliance with regularly expectations. It will cause to lose money and time for insufficient design. It may cause the product to work inefficiently.
I believe that the design control portion can be used insufficiently if there aren’t proper design review meetings or if these meetings are not facilitated correctly. These meetings are used to help create the product without any faults or misunderstandings between departments but these meetings aren’t there or are off topic, there can be many issues that arise and can extend the timeline of the product. Also some issues that could arise from the process is if one department misunderstands what another department is saying and then the design is delayed. This section also requires a lot of documentation which can take up a lot of time but it is for the good of the product. There are issues where it takes a lot of time to change a document or procedure when there is a more efficient way to do things which can extend the timeline. These documents should be looked over many times and see if there are other efficient ways to do things from the beginning then having to make the changes later on. This part of the product should also give enough room for how long everything will take otherwise people can rush and make mistakes while trying to meet a deadline.
If there is no way of mapping out how the device was made, the effects can be very detrimental. If something were to go wrong, there needs to be way of tracing back and figuring how/what went wrong and if there's anyway to rectify this mistake. The FDA wants to make sure that the manufacturers are held accountable for everything regarding their product. If there are insufficient design controls, your company can be in serious trouble because there is no outline that describes the process of how your product was made.
At my internship theirs many design controls set in place to ensure we get good coatings on the ammunition we coat. For example after the bullets have been coated from a basket, I take three parts weigh them and then strip the coating from them. Afterwards, I weigh them again to evaluate the coating weight. Theirs a range for different bullets in terms of the coating weights that are set by government regulations. This coating weight process is considered verification. Another example is using minitab to analytical evaluate the concentration of the tanks. When it comes to the place I work at it has no solid verification process to analyze the tanks day by day. In general the more design controls you have the quality of the product will surpass other products however, with more design controls it can be more time consuming.
There are a lot of things that can go wrong when you have insufficient design controls. The obvious outcome would be a decrease in quality which can put your costumers in danger. Sometimes when the design control is too detailed, it can make it very difficult in the future to change a process. For example, we had an increase of defected parts with depth issues. I can't recall exactly what the issue was but it took awhile to come up with a solution that did not involve having to change the design controls.
Often times the case of insufficient design controls is actually the failure to establish good document management. The success of a medical device depends largely on its foundation. Good document management will consequently lead to clear and concise design controls. Clear organization of documents will allow the team to adequately update documents. Inadequately prepared Design Controls can lead to confusion among team members and even mistakes in several documents. For example, parameters that appear in more than one document might not be consistent due to insufficient management.
Not having good design controls can definitely cause product failures as mentioned above. If design controls are not used properly, users of products may use it and cause great harm to themselves or to their assets. However, another degree of this that is not always talked about is not sufficiently meeting the performance standards of customers. If proper design controls are not used, a product may not perform in the way that a customer needs, failing to meet the expectaions that were set out to be met in the first place. This hurts the reputaion of the company as they are now treated as unreliable. In addition, the company would be hurt in profits as that would cause customers to go to competitors that offer similar products with better performance.
In the company that I work for, we interchange the term "Design Control" and "Document Control" because everything in design control is detained in documents called Standard Operating Procedures (SOPs). So when design control fails, it means we have taken a detour for the procedure. This introduces variability or failure in production. This could be batch variability or the whole production variability. Batch variability could go unnoticed if the batch being tested passes but other batches are not functioning properly. Either way having variability in production means that we literally don't have control or full knowledge over the end design and product, this is a major failure in productions first of all, costing the company a fortune. If somehow it slips out of the company, it could also pose a potential risk and harm to customers using the product, which will strike back at the company. Therefore, a lot of damage is done to the company and the customer when design control fails.
Design control is very important in marketing product, if design control is not sufficient the product release will be delayed. The reason being is that design control helps check if the product is working as it was intended. Design control also makes sure if the design product is safe for the public, the ones need the product because if it is not, the product could do more harm than good: injury the consumer or even damage the market reputation for releasing a bad product, no one will be able to trust their product being release.
As my classmates mentioned above, insufficient design control would lead to a production failure at one point. And as FDA stated on their website: "Design control does not end with the transfer of a design to production. Design control applies to all changes to the device or manufacturing process design, including those occurring long after a device has been introduced to the market. Thus, the design control process is revisited many times during the life of a product." This ensures the importance of a sufficient control design for any medical device in the industry.
Multiple issues could arise if the design controls were used insufficiently, this includes device safety mandatory recalls, increase the need for beds and rooms in the hospital, more nurses are needed (more staff), low level of effectiveness and efficiency, more treatment and recovery time, etc. FDA statistics showed that 3,202 medical devices were recalled in 2017. This high number in the healthcare industry did cost companies a huge amount of money, time, effort, etc. This could have been avoided with a better and sufficient design control process which assure that the device meets the patient's intended needs uses and the specified requirements.
I found this FDA PDF really helpful for this topic.
As many have mentioned above, the more insufficient the design controls are, the more likely it is for the product to fail. There are a few examples of this scenario, such as when vehicle manufacturers have to recall a certain model due to some structural issues. Ethically, this can be related to the Ford Pinto fiasco. The bending iPhone 6 and 6 plus is also another example. Medically, insufficient use of design controls could have catastrophic results on the health of the patient as well as cost companies millions of dollars as a result of recalls, lawsuits, future trust, etc.
Hello,
General consequences of insufficient design controls:
• Design not meeting the needs or wants of the intended market/customer
• Faulty product in the market requiring replacements
• Product having a negative ROI
• Product success = company reputation; potentially harm the company’s identity
• Product providing misunderstanding/analysis of medical information
• Design injuring or killing the patient
• Product being having field corrective actions, recalls, lawsuits
An example I found online is where an insufficient design input led to the FDA issuing an industry-wise recall of glucose meters. Glucose meters allowed users to choose between units of measure (UOM: mmol/L or mg/mL) during setup of the glucose meter. This design input allowed the meter to be marketed to both US and Europe, decreasing production cost of having multiple configurations of the same product. This design input also accommodated users who traveled frequently. The difference between the two units of measure is by a factor of 18, which if mistaken could lead to patients incorrectly interpreting the shown blood glucose readings and taking incorrect insulin dosages. Insufficient design controls for blood glucose meters could result in patients suffering from hyperglycemia, hypoglycemia, diabetic coma, or death. This use error resulted in the FDA requiring all manufacturers to remove the capability of changing the UOM.
When design controls are not set up properly, it results in a failed medical device as stated by those examples above. In the case of recalled medical devices, it would be interesting to study and review their design controls and analyze errors and what could have been done differently. It would also be interesting to study what those companies missed and how to prevent future mistakes. The possibility that a device design can fail or be recalled is in itself a failure in design controls, as it shows it is a flawed system. Using AI or machine learning to learn from past mistakes and hundreds of device examples could help foolproof and improve the process.
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
I think some major issues that arise from the insufficient use of design controls ultimately surround the increased likelihood of failures being realized by the end-users, products that are generally less safe and effective due to the insufficient validation and verification, and products that are generally more expensive to produce due to ineffective or inefficient transfer from design to manufacture. Insufficient use of design controls could also lead to products that are difficult to reproduce due to insufficient record-keeping.
I think that one of the major issues that may arise in design control is organization. You want the documentation to be well organized with minimal changes needed. Time is also a critical factor. I also believe that you have to fully trust your device. If not, then why waste time? Knowing your device and how you expect it to perform can lead to a very efficient product, which would more likely be successful when it’s time to go on the market.
