As our classmates have previously mentioned lapses in the design control benefit no one and are just dangerous for the consumers. As a company manufacturing and distributing novice medical devices coming in contact with human subjects must guarantee safety. If companies start taking lapses in their design controls it is going to decrease the safety and authenticity of the product. It is likely most of the products will function perfectly and cause not dilemma. However it just takes one slip up to discredit the reliability of a company. The second consumers feel any sense of doubt about a corporation it is going to decrease sales and revenue. You also do not want to put any lives in danger. As the lecture mentioned even if there was no formal design controls there still would be a standard all companies followed when putting out new product designs.
Lamiaa:
Designs controls, in my opinion, is the most important thing a medical device manufacturer needs to get right. Could you imagine working for a company that never implemented the proper design controls for their product? I recall once working for a company where any change you wanted to push down the line was stonewalled by other managers. Why? Because everyone was afraid of touching the design inputs/outputs. What this led to was a dysfunctional organization that eventually ceased to improve their processes.
I think a properly implemented DHF eliminates that fear and allows a company to grow from a solid foundation. If a process change will reduce waste and increase output but requires an engineering review of the DHF, there should be no issues planning, implementing, and tracking the change.
In design control, there are "checks" to verify that everything (mostly) is accounted for. Companies must question whether the design outputs conform to the design inputs. Was the design done right? Was the right device designed? That being said, it seems like companies get tripped up when design verification and validation are not up to par. Other issues can arise from not having effective periodic design reviews during the design process.
Insufficient design control can lead to added stress post market. The finalized product may not even be fit for use. It might be too late to be able to change the design entirely (just like the Samsung smartphones.) A company with insufficient design controls can receive many CFR and ISO violations as well. Insufficient design controls also make it difficult to improve on post market products in the future.
The current events mentioned by others show that poor design control is something that is not just limited to the medical device industry. It's ALL industries.
I would like to focus one particular aspect of design controls, specifically planning. Poor planning can be disastrous for a project. From my own experience, pre-clinical and clinical trial dates are planned well in advance, which means when the time comes as a researcher, your device/product must be ready. However the people planning these dates often do not realize what goes into the research and who long things could take. As a researcher it is important to put input in so that that everything works smoothly. While in the end the schedule is written by one person, everyone on the team needs to cooperate and have input, and the same goes for other aspects of planning.
You make a great point regarding the dates. Good communications should be kept to makes things move smoothly. Trials as you mentioned is one of the major time consuming factors. If all involved parties are in good synchronization with each other. I believe this problem can be avoided.
- Lamiaa
Hey Lamiaa,
Good discussion question. I agree with all of the points on here. I just wanted to add also, that for a medical device, not following design controls can result in severe safety issues. It can cause numerous medical problems in patients as well as death in some cases. The reason that we have stringent design controls is to minimize patient harm. We create medical devices in order to help people, rather than cause more harm than good. Therefore, we need to be careful in following control guidelines, no matter how tedious or difficult they are.
-Zohour
Poor planning can definitely lead to a lack of proper design controls and therefore a medical device lacking in quality, as others have mentioned. As you mentioned in your example, when the people responsible for development & documentation of the device are not on the same page as the clinical team, it could cause misalignment and the necessary steps could potentially be skipped to deliver the product to the clinic. Rushing the product to the clinic is never a good idea because it compromises product quality and patient safety.
Hello,
There are many consequences of the insufficient design control. The design control must contain different stages such user need, design input and design output. User need is important because we need to know what the user expects. For the design inputs we must know what this product will do. In the design output we must figure out the way to construct out product. Because of the insufficient design control the product might not work properly. There are also cases when the design doesn’t meet the needs of the users.
It’s important to use the design verification and validation to ensure that the product is designed correctly.
Thanks
The credibility of a company is arguably its most important feature. Like you mentioned, as soon as there is even a hint of doubt, sales and revenue will decrease. As mentioned by another one of our classmates in the example of the Samsung Note 7, incidents such as that ruin the reputation of a company. Many airlines have even began banning the Galaxy S7, which has had no issues with its battery, simply because it is a Samsung phone and looks somewhat similar to the Note 7. Samsung phones are beginning to be associated with unreliability because of the issues with the Note 7. I believe that insufficient design controls can impact the reputation of a company, as stated by our classmates.
Hi Lamiaa,
If design controls are not adequately used often time the concluding result would be the termination of the project if it’s in early phases or if it’s an approved project this could lead to lower quality product. Design controls ensure all phases in the product development lifecycle will reach an acceptable level of efficacy and safety, while ensuring traceability of processes. The uses of this methodology, if used correctly, increases the probability will reach a level of acceptable quality. Insufficient or inadequate design controls are commonly result in product recalls, FDA warning letters, and CAPA (corrective and preventive actions). I attached a link to article from MED Device online regarding the topic Medical Device Design Controls: Following the Regulation VS. Understand its Intent and it covers the consequences of Insufficient Design controls.
Chris
Hey smk45,
I found another FDA search database that seems to include a more comprehensive search. Thought you might find it interesting.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
I have found all the earlier posts informative and very interesting but some other problems associated with failure to establish a robust design control system is that it can:
Lead to the development of product which is not “suitable for use”
> Inability to be able to correct issues once a product is on market
> Open you up to audit observations for violations of CFR’s and ISO standards
> reduction in device fitness for purpose
> failure to protect those involved in clinical evaluations
> in-market device modifications
> loss of company image
> liability and litigation
> user injuries and deaths
Appropriate procedures for design controls is a critical requirement of 21 CFR 820.30 to ensure the product development follows a systematic approach while documenting the decisions made along the way. Insufficient/ Inappropriate design control procedures will result in inconsistency developing products which could translate to product failures and consequently patient risk/ harm. Also, if the procedures to development a product are insufficient and did not follow a documented systematic approach, it will be difficult to maintain quality of the product, for example, during complaint handling performing complaint investigation and looping back into the design if the design (DHF) was not properly documented in the first place.
Design controls are parameters that are vital to the completion of a medical device. These controls are given out in conjunction with the customer needs. In fact, the design controls are put together in response to the customer needs and each design control will correspond to a particular need. Working on a capstone project right now has made me realize the critical nature of following design requirements. If the design requirements are not met, the project may end in failure. The customers will not accept the final product and in many cases the product will fail. Also because we are dealing with medical devices, it is important to realize the consequences if the product fails. A person may die or get severally injured in certain cases. Thus the importance of following design requirements cannot be stressed enough.
Let’s dive deeper into why your design controls and risk management processes may be failing, and discuss what you can do about it.
1. Poorly Defined Product Development Processes — A medical device product development process needs to establish the major stages, deliverables, and milestones from project initiation through market launch. Design controls and product risk management should be integrated within that development process.
However, medtech companies commonly err in one direction or another during product development, making the process too detailed and overly burdensome, or too vague (or maybe, not defined at all).
The overly burdensome process is difficult to follow. Too many tasks and actions are required. Following a lengthy, detailed process often presents numerous opportunities for non-conformances and increases risks for non-compliances. The vaguely defined process is also problematic. Lack of clearly defined stages and deliverables leads to possible non-conformances and non-compliances with regulatory expectations.
Your product development process needs to be “right-sized,” according to the type and size of your company, as well as the types of medical devices you design and develop. Use 21 CFR 820.30 and ISO 13485 (section 7.3) as a guide to determine minimum design control deliverables requirements. Use the requirements of ISO 14971 to identify minimum risk management requirements. Then, build your product development process around the design controls and risk management requirements you’ve defined.
If your company has additional business needs, add these to your process, erring on the side of minimal deliverables.
2. Poor Understanding Of User Needs — Medical device development often is triggered by a desire to address unmet clinical needs, or to improve upon current treatment options. Identifying a clinical issue to solve lays the groundwork for defining intended use and indications for use for your medical device.
Often, a prototype is involved in the process at this stage, used to help further define and articulate user needs. For many product development engineers, this early discovery is one of the most thrilling parts of the medical device process — so much so that it is common to go full speed ahead once the prototype seems to be sufficient and satisfactory, even though the end user’s needs may not be fully understood.
Who is the “end-user”? Is it the patient? Is it the clinician? Usually, “yes” answers all of those questions; these are the easy users to identify. But, are there other users? Typically, yes. End-users can include distributors, doctors, nurses, biomed technicians, patients, patient caregivers, reprocessing personnel, and so on
Consider all the steps that occur between a medical device leaving your facility, through point of use, and ending when the product is no longer is use. Each end user likely has a list of needs, each of which you need to document. User needs feed the design and development process and are the precursor to establishing your device’s design input requirements.
3. Too Little Time Spent Defining Design Inputs — Design inputs are the most important part of product development, establishing the foundation of a medical device.
Often, there is a rush to get through the design inputs stage so that additional prototypes can be built, tested, etc. I get it. Just about every product development project I have ever worked on had the target completion date defined before the project ever officially began, so getting everything done sometimes seemed to take precedence.
But design inputs are a continuation of user needs, as well as a precursor to design verification. When defining design inputs, you need to consider exactly how the design outputs will confirm design inputs have been met. By rushing through design inputs, you risk producing requirements that are not readily verifiable.
To avoid this scenario, use your desire to prototype to your advantage. Mini tests or experiments performed with your prototypes can help determine how to verify.
4. Starting Risk Management Too Late — Many medical device product developers engage in formal product risk management activities way too late in the process. The right time to start documenting risk management activities is when you are defining user needs and design inputs, so that identified risks can guide those requirements, as well as improve your ability to manage design verification and validation.
Understanding possible hazards, hazardous situations, and possible harms will help you improve your medical device design. By incorporating risk management earlier, you will be able to leverage later stage product development activities, such as design verification and validation, to support risk-based decision-making regarding product development.
5. Poor Design Reviews — Design reviews are important opportunities, conducted at appropriate stages throughout product development, to assess progress with respect to overall product design and development.
Design reviews should be constructive and introspective, and design control activities should be included and reviewed. Design review attendees should vary, depending on the design review’s focus during a particular development stage. Common design review mistakes include a lack of review documentation, failure to represent all appropriate functional areas, and/or omission of objective evidence verifying that action items identified during design reviews have been completed.
Another common issue is trying to cram too much into a single design review. While, technically, this might be considered acceptable (provided it aligns with your design and development plan), a design review that includes too many design controls and product development stages is likely to add little overall value and be ineffective. Plus, more information included within a design review will correlate to a longer meeting and more action items.
I recommend having more frequent design reviews, each focusing on a finite set of information, and trying to limit your design review to under an hour.
6. Design Verification Misses The Mark — Design verification will only be as good as the design input requirements. While that connection is clear, keep in mind that design outputs also contribute to successful design verification.
Design verification demonstrates that the design outputs meet the design inputs, serving as proof that you designed your product correctly. Your design verification acceptance criteria may be captured as part of design outputs or inputs, and you must ensure that acceptance criteria has been defined before conducting verification.
Finally, testing is considered to be synonymous with design verification. While testing is an acceptable method for conducting design verification, so are inspection and analysis.
7. Design Validation Is Ineffective — Design validation should demonstrate that the medical device meets the needs of the end user, who must be clearly defined and identified. Failure to do so can lead to design validation that is haphazard and misses the mark.
Furthermore, design validation needs to involve those end-users, and products built for design validation need to be from production-equivalent materials and processes.
8. Poor Design Change Practices — Chances are, your medical device product will change. The design may change, or the manufacturing processes may change. If so, you need to document these changes and ensure that the design controls are updated accordingly. Additionally, you likely will need to have design reviews for the changes.
Even after the medical device it is transferred to production, changes may continue to happen, making design controls a continuous process.
Sometimes, this is not clear: Conventional wisdom states that design controls are a set of historical records describing design and development, and then archived after design transfer. But, any changes you make to a medical device in production / post-production require design controls.
You also need to determine if verification and/or validation is required for your design change, as well as evaluate the impact on user needs and design inputs. The design outputs you established during product development now become the basis of the product device master record.
Thus, design controls are a continuous, total product lifecycle process. As the medical device world continues to move toward risk-based approaches regarding quality management systems, I would expect there to be more scrutiny when it comes to product lifecycle risk management, too. By keeping these two ideals at the forefront of your product development process, you both insulate yourself from regulatory repercussions and better your chances of market success.
