The different areas of the Design Controls allow for each section of the project to be organized and ensure the product released is of the highest quality. Without design controls, the company is running the risk of their product not being completed. If the released product has a defect which interferes with its function and effects the consumer, all history of the product from design to manufacturing is traced, which could be found in a Design History File, in other words, design control tries to ensure the highest quality to the consumer. When the procedures are not properly implemented nor documented accurately, it could potentially result in a failed device.
It is difficult to exactly pinpoint the issues that arise from insufficient design controls, since the process of design controls has 9 parts within it: planning, input, output, review, verification, validation, transfer, design changes, and design history file. If a company insufficiently addresses all 9 components, then I think there is a large likelihood that the medical device will fail. This not only has major consequences for the patient who receives a defective device, but the medical device company also suffers, from both the failed device and the loss of trustworthiness in future products. The company will also likely lose considerable sums of money from the process of having to start over. Additionally, the brand-name loses its reputation, or the company could even suffer from lawsuits. Essentially, the negative outcomes from an insufficient design controls process are endless, affecting both the company and the patient.
Disorganization and lack of planning and distributing of tasks can tear the design control system down. The nine steps of design control need to be implemented per code. When the process is not followed completely or specifically, it can cause many issues within the project, and that could lead to undesired results, such as not passing the FDA regulations. There needs to be proper organization as well as proper use of time and distribution of roles and tasks to avoid insufficient design controls.
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
Consequences that can arise from design control are lack of confidence in the product, poor quality if the product is launched, high costs towards investing in the product due to either delays or any other inconvenience. All factors that fall under your prototype, quality, manufacturing, risk, regulatory, verification, and validation, along with your launch plan needs to go accordingly. Poor control design can increase the susceptibility of a process to a variety of risks. On the other hand, process design done as planned reduces inherent risk by the simple fact of organizing tasks properly, without the need to add controls.
I agree with you on the failure in the market. This is one costly measure when it comes to companies and their ability to ensure the safety of the products. Recalls have cost companies billions of dollars and in some cases the business end up being bankrupt.As of 2021, we are on track to break the record for recalls ever. How many companies will be out of business after this?
What do you think a company should do after receiving a disapproval from the FDA? We all know the most companies do not survive "the desert valley". Do you think the company will be able to repeat the process again? In my bio industry class, the professor often stated that most companies are heavily indebted to their investors during the process of bringing ideas to life.
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
Some issues that can arise of a process or design control if it is used insufficiently is the quality of the product will be poor and it will not be something that will be safe and effective for the user. There are several issues that can arise when creating a product that can take one back to the drawing board to make some much needed adjustments. Such as the life of the product is not what expected and there are shortages in the product. Also in testing the product design it was known to hurt those it was intended to help. These are things that can arise but if handled insufficiently and the product is still brought to market then it ultimately lead to death of the user.
Design controls are a necessary procedure of medical device development. According to the FDA, 44% of voluntary recalls from October 1983 to September 1989 could have been prevented by adequate design controls and the most frequent causes for recalls are related to design, software, and non-conforming materials and components. If design controls are not developed sufficiently, the product runs the risk of being recalled and causing harm to the patient. To ensure that the best design controls are implemented, after research has been completed for developing the product, design controls should begin. This is done by referencing previous design and development activities, identify any interfaces, responsibilities, and/or functions that would impact design, and constant reviewing to make any necessary changes.
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
Some possible things can happen if the design control is not right. It can lead to the medical device not being approved by the FDA, because if things are different from what was initially submitted to them it can lead to that denial. It can also lead to the product not being what your team sought out for it to be.
If the design control isn’t efficient nor effective the project could be disastrous because of ineffective scheduling, there could be missed requirements, or missed steps. Also, the all the 9 steps in the design control could not be done to its fullest potential, but also there could be recalls, parts of the products could be faulty or not properly tested/made, and potentially could not be safe to use.
The design controls allow to create a roadmap for the project, pinpoint every single action done to create the product, and if this has flaws in it, it would be difficult to go back to trace where there was an error in a product if one has occurred.
The design control process is extremely important in the medical device industry. While it may seem like a never ending process with many steps, each step is imperative to ensuring the medical device makes it to the market. By not following all of the steps, there are several issues that can occur. Some include an unorganized planning process as well as rollout process, maybe even resulting in the product not being rolled out. With a chaotic planning process, that can lower the quality of the project and may cause it to be ineffective or even harmful.
As I am going through this course and gaining more knowledge on medical devices and the process which it takes for them to reach the market I realize it goes back to the basics. As a scientist, the scientific method is a proven method that if followed correctly leads to new discoveries and great outcomes. The same is true for medical device design and the design controls that are key components individually that support the goal of getting the end result. There are several issues that arise when these design controls are not sufficiently established and complied with. It was only in 1996 that the FDA set up the FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. This is what I found in the DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS that mentions insufficiently use design controls.
The essential quality aspects and the regulatory requirements, such as safety, performance, and dependability of a product (whether hardware, software, services, or processed materials) are established during the design and development phase. Deficient design can be a major cause of quality problems.
If you produce poor quality products it will eventually bankrupt your company.
With poor design controls, you will bestow unnecessary risks. With these risks, you will need a team to mitigate them by coming in early enough in the design planning to prevent this. You will need a group of people to cover the risk management team. Risk analysis that identifies and evaluates the risk associated with various potential product failure modes should be conducted. Failure Mode Effects Analyses can help determine potential sources of failure and potential patient hazards due to Customer Use/Misuse (UFMEA), Design (DFMEA) or Process (PFMEA). For complex product systems, Fault Tree Analysis can be an effective alternative for risk analysis. Risk analyses are done prior to final qualification testing since verification and validation testing frequently are part of risk mitigation. Design For Six Sigma (DFSS) is frequently applied to critical design elements to ensure a statistically adequate safety margin in reliably meeting requirements. Unfortunately, risk analyses are not always comprehensive, and risks are not always fully mitigated. This can ultimately lead to recalls of commercialized products, or expensive product re-engineering programs. Risk analysis needs to tap appropriate expertise regarding medical use, product design, and manufacturing. Even with the most rigorous of efforts to develop risk analysis, there are legitimate unknowns regarding frequency of occurrence of certain failures when estimated early during product development. This is why risk analysis documents must be updated periodically as frequency of occurrence or severity of the hazard become better understood or new failure modes are discovered. Risk Management is central to implementation of and compliance with Design Controls. Expectations and best practices in the utilization of Risk Management have evolved significantly over the past 10 years. Since many medical products were developed prior to adoption of expanded risk management methodologies, supporting technical files sometimes lack comprehensive risk analysis. Hence, many companies have remediation programs in place to address the need for supporting risk analysis.
Without proper design controls the whole project is in high jeopardy of failing. The product/device can be missing requirements or be built improperly or may even be harmful to the patient its supposed to help. Many injuries, deaths, and lawsuits could occur along side a faulty product that has poor design control.
One issue that could arise is that the developers can misunderstand what the user needs. Prototypes are used in the initial stages to help define and relay what users need. Some engineers can get ahead of oneself and create a prototype that seems to work but misses the mark on what was needed. User needs should guide the design and development process especially before the device's design input requirements are established.
