A poorly defined product development process will immediately wreak havoc on the design control. Sometimes companies will leave certain aspects of the project too vague or too detailed which can create burdens before the execution of the product has begun. Every aspect of the process needs to be examined but too many tasks and actions can present numerous opportunities for risks and vagueness can lead to complacency and non-compliance. The design input is vital to the product development and if rushed can place undue burdens in the verification process.
Design controls are often used to make sure that an appropriate plan is in place for a product's development and manufacturing. Effective design controls lower product risks and ensures the highest product quality. Without quality controls a company runs the risk of it's product failing in the market. Companies also run the risk of producing an unsafe product and putting customers at risk. If there is no plan for the product, there is also the risk of delays and other issues that may increase costs. Lack of design controls can result in lesser confidence in product success.
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
Based on Dr. Simon's lectures, there are heavily consequences if the medical design fails such as the obvious a danger to customers which can lead to lawsuits and heavy financial consequences. Keep in mind of the fact that if anything fails, you have go back to square one and review everything from the design verification process which is time consuming, thus causing delays and missing the initial deadline to submit your device. There are a lot more consequences that I could list, but the main focus is thoroughly review every step of the process and correct anything that could be problematic in the future. This could be a lot, however this can save you from the long run.
There are several factors that could arise as a result of insufficient design control for a medical device. One instance in particular that could arise if the medical device was not designed properly would be a newly developed product that quickly undergoes a worldwide recall. In this case, there may have been something in particular that caused the flaw in the product, whether it was caused by human error or just a simply flaw in the designing process. While conducting research and outcomes on medical devices that were poorly developed, the writer discovered am article about Allergan breast implants. These items are typically used for breast augmentation surgeries and in breast reconstruction surgery post cancer removal; however, in this case, later studies showed that the Allergan implant played a major role in the development of anaplastic large cell lymphoma, which is a cancer of the immune system. In this case, this particular implant was shown to increase a patients’ likeness to develop cancer when compared to other implants. As a result of the potential increase of lymphoma, which could later result in death, the company had to recall over 200, 000 implants. In this case, it is important to discover the material or method in which the implant was created to lead to this issue. Ultimately, if there were problems with the development of this implant, that later result in cancer for many patients, It is important to understand what about the implant could have been created differently, which could have ultimately prevented the development of cancer for many individuals.
There are many inconsistencies that have arisen in medical device productions due to improper integration of risk management into the design control. Problems with validation have also arisen due to lack of clarity in documentation, such as in specifying the safety and efficacy baseline of comparison. The execution phase of medical device design, such as the output phase are often "frozen" due to a number of factors along the lines of inadequacies in the design causing the team to work backwards. I believe that hesitation, lack of clarity, and an inability to transition or adapt to changes in the workflow are all potential errors that can arise with regard to Design Control.
@woolynn All great points, and to add, It can also cause the company to lose profit and damage to reputation. As far as the customer, it can result in an injury, or worst a loss of life. Ultimately it shows a breakdown in the process.
As others have said beforehand, a poorly defined and disorganized development process will dive the design control into chaos. If a product were to be designed outside the boundaries of the tolerances given, it would potentially use significant damage to the customer using it. On top of that, legal and ethical issues might take place as a result. In the end, the company will lose profit and future customers if requirements within the design control were overlooked or used as a guideline.
If it is insufficient, product will fail, it will have a very bad impact. Better nothing than faulty product which may give false results to user or have detrimental effect in the body.
I think the most prevalent issue to insufficient design controls is a wastage of time and resources which will inevitably snowball into a wastage of money, and that is made worse especially if that money is coming from a third party. Insufficient design controls, that are not detected in the controls or specification documents will reveal themselves during testing, and that is the worst time for this reveal to happen, as there are most likely plans to continue or further develop the product. This not only sets you a few steps back, but it does so with additional stress on how you can bring your device back to a functioning state that will coincide with the plans you had already made to move forward.
As many others before me have said, many of the issues that would occur from poor design controls is parts of the design process falling between the cracks. Instead of having all the documentation organized, done in the correct order, and signed by the right people, you would have products trying to go to market that were not checked over diligently. If the documents are still done, but not correctly and the FDA or other controlling agencies may not realize the product is not as well tested as the documentation is showing. This would lead to recalls which leads to many adverse effects. The first and most important is with biomedical products, lives could be put at risk, and people can have their life irreversibly changed because the company did not follow the law. It would financially cause problems due to lawsuits, reimbursements required if the product hurts people. It would also lead to a general distrust of the company if the product failure were widely known, which would hurt future business. Overall, this is a situation where it pays to do it right the first time for the product to benefit the people who need it and the owners and employees of the company.
When making a device, it is extremely important to have design controls that has been thoroughly researched and has a sufficient amount of evidence to back up its safety and efficiency. When you have insufficient design controls, it could cost the company and the team time and money to alleviate the problems that arise along the way, especially if the product ends up on the market. Not having sufficient design controls could lead to injury of the customer, delayed project steps, delay in release of the product, loss of time and money, and also lawsuits. If the insufficiencies are caught during the device creation, it could lead to a loss of time and money to fix the problems and get more clarification on the specifications of the device, which could lead to the team missing important deadlines and delaying the release of the device. A poorly designed product that gets released into the market could also affect the company's reputation and could lead to a loss in customers due to their poor planning and design controls. I think it is extremely important to create good design controls in the beginning, even if it might take more time, because it leads to a better product overall.
As per the responses from most of my peers, without clear design controls the project timeline will continuously have to be modified and updated as new design inputs reveal themselves or a scope change is required. Furthermore, all design controls are documented within the Design History File which is then reviewed by regulatory bodies such as the FDA to ensure all medical devices comply to the same quality system regulations and so any ambiguity, incompleteness, or discrepancies will make obtaining FDA approval that much more difficult. Consequently, in addition to an extended project lifecycle, the cost of implementing any design changes may be substantial and ultimately cause a project to fail if there is a limited budget.
As forum members have mentioned before, design controls benefit both the company and the end user. This device produced by the company should be compatible with people and should not harm people. therefore safety is a priority. If a company ignores the design controls at every stage of a product and fails to meet the requirements, if it somehow bypasses them, it may notice and fix it in the later stages of the product. however, the later it realizes these errors and deficiencies, the cost will be very high for the company and even for the end user in terms of health. That's why design controls are essential for every company.
Insufficient design controls can lead to failure of the device on the market and mass recalls. With medical devices, there is also a the risk that it could fail during use which could be very dangerous and have severe negative consequences. An example would be the recall of the Medtronic StealthStation software auto-registration feature in August 2019. Essentially, the software was a brain mapping tool that assisted neurosurgeons during surgery. Patients had their brains mapped pre-surgery and the software would save the path that the neurosurgeon would follow. However, the software failed to take into account small patient movement that would occur during mapping, providing the surgeon with the wrong navigation. The FDA characterized this as a Class 1 recall as any wrong movement in the brain could have negative life altering effects.
Design controls, in my opinion, ought to be taken into account when determining if a product in development is commercially viable. Customers and stakeholders can identify and satisfy product requirements with the use of design input requirements. Design output is a crucial step in the process of developing a product. Without it, a medical gadget is impossible. Design control is a crucial procedure, and it can have a significant impact. If not done correctly, the business may need to recall the goods, which will cost a lot of money and effort. There are a few problems that come up when they are not done well and when they fall short, such as inadequate awareness of user demands or poorly defined product development processes. Design controls are crucial to all aspects of product development because they provide the framework for what must be done.
