I believe that design controls should be part of the process used to determine the commercial viability of a product in development. Design input requirements can help customers and stakeholders identify and satisfy product requirements. Another vital part of the product development process is design output. A medical device cannot exist without it. Design output enables companies/entrepreneurs to sell their creations. Design output gives the inventor/seller the objective evidence needed to communicate precisely what the medical device is and the clinical needs it serves.
Design verification determines whether the design output meets design input requirements. More simply stated, it helps companies figure out if the medical device meets specifications. This is a basic component of any design effort, and therefore it is valuable.
So is design validation, which can help manufacturers determine whether the medical device being developed actually works. Design validation is performed in the environment or simulated environment in which the product is intended to operate.
Inadequate design control procedures are commonly cited in many FDA warning letters, CAPAs (corrective and preventive actions), and product recalls. In fact, about 44 percent of all quality problems that result in recall actions are attributed to deficiencies that probably could have been prevented by having a solid design control process. And approximately 30 percent of warning letters over the last several years highlighted inadequate design control procedures.
While FDA design control regulation applies to all Class II and Class III devices, and also some Class I devices (many, but not all, Class I devices are exempt from design controls), every single medical device company should have design control systems in place. Yet having a design control system in place is clearly not enough, as evidenced by the high level of citations.
I think insufficient design control would, firstly, waste money and energy, since engineers spent time and money on useless design. It is also kind of financial loss for the company. Moreover. It is also damage the image of company if the insufficient design caused problems on usage of the product. Furthermore, It would effect the market of the product, because the poor design of the product does not match the requirement of the consumers
Insufficient design controls will result in a loss for the company. The loss will occur first off by the product not making it to market and this will result in a trickle down effect. As the time, money, and energy focused into the product will be a waste and the company will most likely have to make cutbacks and perhaps, depending on the scale of failure, scrap the whole project altogether. Design controls are set forth as a methodology that companies must follow in order to ensure that they are compliant with the FDA. If the scale is large enough this can be a large blowback to the company causing stock to fall, for publicly traded companies, and employees to lose their jobs if not followed properly. FDA will send out warning letters as mentioned by woolyn and state specific violations based off 21 CFR and Design control guidelines. Examples of these are linked below.
https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm515195.htm
Without sufficient design controls, a number of things can happen. Entire systems can fail due to the inputs not reflecting the standards of the industry. People can get fired after those entire systems fail. Without complete and accurate design controls there is nothing to ensure that people are getting a quality product that is safe. From the start with planning, an engineer has to ensure that all the right people are in the room. This can have a profound impact on the quality of your end product because you didn't get the right information from the beginning because you never identified the correct technical experts at the planning stage. This has an effect on inputs because now your inputs don't reflect that up to date knowledge of the industry. As someone mentioned before, the Samsung Note 7 failure is a huge industry failure and while you might have DHF's for products in your company, you have to understand the failures in industry as well. The technical expert would have knowledge that very well might not be written down in your companies files. This is just one example of not having sufficient design controls but there are infinite examples. Sufficient design controls are a must.
Design controls always important for each class of medical device. For instance lets take pacemakers. If the design of pacemaker is not properly validated then the failure of pace maker would lead to the death of a human. In a generalized way design control of a medical device/drug should be considered because the consequence would more serious than any other domain. Proper DHD and DMR should be maintained and regular check ups should be done.
Design controls are required to:
1. Deliver the intended use and functionality
2. Ensure safety and reliability
3. Ensure human factors pertaining to design control are considered and addressed in the final design of the device
Failure to meet the above criteria would mean that the device has not met the sufficient design control requirements. Some of the consequences would be: software glitches in the device if it is operated using a GUI, compromising safety of the patient while handling the device and in some cases unintended mishandling of the device due to insufficient conformance to device specifications.
Design controls are an integral part of the success of any product, from the quality, performance, safety, reliability, performance standards and physical characteristics. Design controls looks into the inputs, outputs, validation, verification, and design planning, if there exists any poor planning in lets say user needs (inputs) the output of the product could fail and not meet the needs of it's customers. When looking deeper into design controls and viewing it in a larger spectrum, if lets say the design fails due to poor testing, it could potentially either harm patients, mal-diagnose, or even cause fatalities. These types of problems could cause companies to lose shareholders, go bankrupt for lawsuits and lose reputation, these types of problems could have been avoided if more attention to detail was applied to the design controls. the design controls created by the FDA and gold standard procedure in the US was created after the many years prior of medical devices creating products and hurting many of their customers, these regulations have intended purposes.
When the design controls are not proper, it may cause the project to be set back because the product can not be cleared unless everything is correct. Design controls are in place to have the product design properly so that there will be no mistakes. Also if the design controls are not sufficient, and there is an audit by the FDA, this will not be good. The FDA make sure all the paper work is there and it is correct because it is their job. The FDA will mark down every little thing so missing design control documents will not be a good sign.
Design controls designates the application of a proper process or method for the developmend of a product. It is mandatory to implement controls when designing and developing products within regulated industries such as medical devices. "The Food and Drug Administration has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30)." Therefore sufficent controls are always needed. When design controls are not sufficent all the blame falls in the company for the lack of meeting the standards. "This guidance is intended to assist manufacturers in understanding the intent of the regulation. Design controls are based upon quality assurance and engineering principles. This guidance complements the regulation by describing its intent from a technical perspective using practical terms and examples." The FDA provides documentation to help firms. Therfore a insufficent design control and not following the FDA guidelines can lead to issue witht he atualy product and hinder its process to reach market. When the foundation of something is subpar, then everything built on top is under huge risk. Therfore, not having a good desgin control flow can lead to failure in many areas along the timeline.
https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170251.htm
Issues with design controls:
· assessing new product ideas
· training and retraining of design managers and design staff
· use of consultants
· evaluation of the design process
· product evaluation, including third party product certification and approvals
· patenting or other means of design protection
Source:
(2017). Fda.gov. Retrieved 13 November 2017, from https://www.fda.gov/downloads/MedicalDevices/.../ucm070642.pdf
One of the most problems common with design controls is that medical devices companies put emphasis on following the regulation rather than understanding the intent. For instance, some of the regulations are vague and contain scant details about what manufacturers ought to do to meet the requirements. While manufacturers are required to come up with design control systems that comply with the relevant regulation, the most important aspect is that they design the products in the most prudent way possible.
I agree with the comments above that inadequate design controls lead to lower quality and the possibility of developing dangerous products. Many FDA warning letters and product recalls cite insufficient design control procedures, something which companies can easily overcome. While it is not unusual to find one or two companies with design controls in trouble, having adequate design controls in place means that your product will be released to the market. From this, it becomes apparent that failure to release products to the market is a consequence of inadequate design controls.
Design controls are important because they keep the product up to standard and up to date and competitive with other products. Sub par products can turn out to become dangerous and deleterious. This can be avoided by having strict design controls and quality control. It is also necessary to make sure that a product follows FDA guidelines so that consumers can use it and this is part of a successful design control.
Some potential problems from not following the design controls process and using the process wrong is to have major delays or changes in your device. By being too specific in documents such as the DID and DSD you may run into a problem where you need to make a very small modification to your device, but now you can not because of what you put in your documents. Now you must start over and spend extra time to figure out how you can meet your design specifications. Design controls makes it difficult to make necessary changes to a device that could make it significantly better, which is why you must take amble time to develop your design documents, to look over all possibilities, assess their risk level, and pick the most definite option. In addition, by developing a timeline you may set unrealistic dates for completeness. This can cause the group to work too quickly and obtain poor results and in the end a poor product that barely meets their expectations or may fall short of expectations and the project would result in a failure. Some problems that can also arise, is a good product being turned down because of minor mistakes in paperwork or not filing paperwork on time.
Yes I agree that design control is an integral process and its failure can have a wide effect. If not done properly, the company will have to make recalls on the product which results in a large loss of money and time. Even worse, if it is a medical device and there is a flaw in its design that is not caught by design controls, it can harm a human being. On a lesser level, if there are minor flaws in the design that don't have any immediate effect but are documented in the design control, these can be improved upon in future versions of the product.
