Design controls are very useful in the fact it allows you to set a standard of product that you want to be made throughout the process. For example in manufacturing you may have checks throughout the process to make sure that after certain steps of the process the process is still meeting requirements such as dimensional and visual criteria. This helps to maintain the quality of the product. It is very important to be checking these types of things so you know the process is capable of producing quality product. I know for the company I work for during the manufacturing process that are multiple visual and dimensional checks as well as some functional testing to show that as the product is moving down the line it is still a good product. Design controls are very important because it shows you have a good process and it allows to do process validation which is also important. It is important to know at all times how the process is operating and having controls is not only good for knowing things are fine but it allows you to react accordingly if things are out of control. Having controls helps pinpoint problems in a process because you know that after a certain step you witnessed a failure then you can go back to that step in zero in on what may need to be changed to fix the process. Design controls are very important in this way so that you can keep track of just how well the process is and it allows for the up most quality in the product.
The main reason why Design controls are useful is because they test the quality, liability of the product. This would make sure that the clients do no get affected in a bad way by it. On the same way, it would prevent a lot of demands against the company that produced it. For example: Imagine that a patient gets an ulna replacement of titanium, most of the properties have passed the regulations required by the FDA but the elastic modulus of Titanium does not match with the bone and therefore it causes a lot of harm to the patient and it lowers the credibility of the company that made it. Design controls would make sure that all these details are solved.
Design controls are a vital aspect of product development. Throughout the entire developmental process—from concept to prototype to product—design controls are constantly referenced in order to guide the aspects of the product while remaining within the constrictions supplied by regulatory agencies such as the FDA. The nature in which design and its controls are intertwined enables developers to amend their design in order to better suit the needs of the end-user while also remaining mindful of regulations. There is risk management control which needs to be taken under consideration throughout the design development processes by each department.
Design controls is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently reflects that design and the product's intended use. Design inputs, outputs, review, change controls, validation, verification, transfer and the design history file all constitute aspects of design controls.
As someone who has worked in the medical device field for a few years, I can say that having effective design controls in place can go a long way in preventing and bolstering the defense against products-liability claims alleging a design defect—one of three bases for products liability. The basic allegation behind a design-defect claim is that a safer design exists for the product in question, but that the manufacturer failed to use the safer design. Robust design controls help to ensure that the safest, technologically feasible, design for the product is being used. Further, in the event of litigation, design controls can be used by the manufacturer to demonstrate that the risks associated with alternative designs were weighed and considered.
Design controls of a medical device covers the design plan, the design itself, the outputs to meet the required design inputs, the design validation and the DHF. It is an important aspect in the design of a new medical device as it ensures that the medical device is capable of performing its intended purpose.
It is a method of controlling and mitigating risk on a medical device. Any deficiencies in the design can be immediately corrected if the design controls are properly implemented.
I believe that the design control process is actually one of the hardest things to implement correctly. Not only does a device manufacturer have to meet the requirements but also extensively test to ensure the device is not defective. This requires a management and corporate culture that is willing to take on these challenges and dispense the necessary resources to do so.
Design controls are a set of methods used to complete/finish your design and it goes into more details are you all have already mention. The crazy thing is that all types of industries use design control in some sort,but may have a different name for it. According to the FDA design control is a major factor for medical devices manufacturers. I feel as though design control helps organize your idea of the medical device or product that you may be interested in developing. Just think if there was no design control for medical devices everything would be all over the place, even though some medical device final product seems as though it did not have a design control in the beginning.
I agree with Abhishek first sentence about design control is a broad term, because it can be used in different forms depending on different aspects.
Design verification is part of the quality control system where documents, resources, specifications, equipment installation and associated operation & performance qualifications, vendor qualifications and re-qualifications, etc. Verification is part of the quality management system and ensures that the resources utilized in making a medical device function in their intended manner.
Design validation is to simply ensure that the device operates within the purview of the design inputs.
Safety is a key factor when designing and developing a medical device. Regulatory bodies, such as the FDA, wants assurance that the medical device is safe before bringing the product to the market. Thus, the essence of Design Controls is proof that a company designed a safe product that meets user needs and requirements. Design verification, DHF, design validation, and design inputs and outputs, all create traits of design controls. Effective design controls prevents against product-liability claims, such as design defect. According to the customer who files a design-defect claim, there is a safer design that exists for the product. However, Design Controls can be used by the company to demonstrate that the risks associated with other designs were considered and that the safest design for the product is currently being used. It has important advantages for regulatory compliance, products-liability avoidance, and assures the most efficacious product design.
Design Control is a set of management practices such as procedures, processes and policies. They have to be followed to ensure proper quality and to correct any errors during the product development. Medical devices must meet quality and safety standards. Otherwise these products might be called for recall due to design problems. The recall can be very costly for the manufacturer. In the order to make sure that the medical device is done correctly manufacturers develop proper documentation to confirm that the design criteria are met.
The Design and development plan is written to plan the design activities. It forms the roles to all the departments so the product meet the right criteria.
Thanks
Design controls essentially lay the framework for a product to be as safe and effective as possible, both for the customer and for the company making it. As mentioned by many of our classmates, design controls largely involve risk management. These controls are not static and are always evolving. As more risks are identified, the controls change and so does the product itself. The DHF (Design History File) is arguably the most important document in Design Controls. All notes, market research, research protocols, meeting minutes, and design controls documents are located in this file. Without these controls, it is extremely difficult for products to be safe and effective. Furthermore, I believe that without these design controls, the FDA would not even approve a device.
-Murad
A Design Transfer Procedure makes sure of mishaps do not occur during the transfer process. The procedure is typically overseen by the medical device company’s management.
Design Change Procedures must dovetail with the Design Transfer Procedure to make sure the correct information is provided to the company’s management staff in the procurement, manufacturing, product service, and warehouse departments.
DHF all documentation created during the life cycle of the project, meaning, movement from creation to completion and on into market introduction.
Hi Grzegorz, it is true like you have said that design control is important in order to ensure quality and correct errors. It is also important to note that design controls are required for all Class II and Class III medical devices developed in the US as part of the Quality Management System (QMS) and IDE. Also, it is important to note, that experts suggest keeping a developmental plan high level and short in order to not overcommit. According to the CFR, Design inputs must be unambiguous and verifiable.
Regardless of the device classification, Design Controls are a critical component to medical device product development. Design Controls demonstrate you have designed and developed a medical device that meets user needs, is safe and effective.
The relationship between Design Controls and regulatory submissions is strong. Design Controls are needed to ensure that you have the data to support your submission to the FDA for pre-market notification. A traditional FDA 510(k) submission contains 20 sections, and many of those sections are linked directly to Design Controls.
Design controls are mandated by the FDA according to 21 CFR (Code of Federal Regulations) towards medical device manufacturers. They are guidelines that help to ensure a proper quality device is created and provide checks and balances for the manufacturer. Primary application of design controls is during the product development phase as they provide a step by step process in adhering to the regulations set forth by the FDA.
As @JP528 and many others have described the guidelines that the FDA lays out to make sure that you designed a safe product that meets the user needs and requirements as stated in FDA 21 CFR 820.30. I found an interesting website regarding Design controls in the US. and also making the comparison to FDA clauses for Design Controls to ISO 13485 clauses regarding Design & Development.
FDA 820.30_____________________________________Design and Development ISO 13485
(a) General____________________________________7.3.1 Design and development planning
(b) Design and development planning____________7.3.1 Design and development planning
(c) Design input_______________________________7.3.2 Design and development inputs
(d) Design output______________________________7.3.3 Design and development outputs
(e) Design review______________________________7.3.4 Design and development review
(f) Design verifications_______________________7.3.5 Design and development verification
(g) Design validation__________________________7.3.6 Design and development validation
(h) Design transfer ___________________________7.3.1 Design and development planning
(i) Design changes_____________________________7.3.7 Control of Design and development changes
(j) Design history file________________________Not required, no referenced material
As many have stated in other discussions it is interesting that DHF are not required for ISO, but a company does benefit to still have a "living" DHF for internal purposes, development, and auditing purposes.
