Hi Lamiaa,
A good topic to start a discussion. The main consequence is the failure of that product in market.Here i would like to give some examples recently happened though they are not related to medical devices but i think they are suitable to the topic and they all are the results of insufficient design control.

First one is Samsung Note 7 failure because of explosion problem. I read somewhere that the Lithium battery comes with the sheets which separate the +ve and -ve sides of battery. In Note 7's battery the separation sheet layer was not too thin and if it gets heated while charging, it can be burnt away and causes the explosion.

Second case is similar and happened in 2004 with Nokia BL5c Batteries. The company went under loss and had to recall all the similar products from market as Samsung did now with Note 7.

Third example is from automobile industry, where Hyundai Motors recall all their Elentra Model (Not sure exactly) from market as there was some engine noise problem in new cars.

I hope you get some idea that what happens if there is insufficient design control.

Hi Lamiaa,

Thank you for your questions and the examples provided by the others.

I believe that one main issue that would occur is that the project would be extremely disorganized and would be greatly delayed. 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.

-Andrew Nashed

Hi Lamiaa, thanks for bringing this topic up. From what others have mentioned, it can be seen that the problems that arise from insufficient design control are significant. I wanted to give a couple of examples of medical device failures that have occurred in this year and led to recalls:

1. The company HeartWare recalled their Ventricular Assist Device Controllers because there were loose connectors that could have inhibited its alarm from sounding, making the pump stop working.

2. St. Jude Medical recalled a few models of the Fortify, Unify, and Assura ICDs and CRT-Ds because of rapid battery failure caused by deposits of lithium on the battery.

3. Cook Medical recalled Roadrunner® UniGlide® Hydrophilic Wire because the hydrophilic coating has potential contamination by glass particles.

There are more examples of recalls that you can find on the FDA website.
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm480134.htm

Sufficient design controls are made to reduce the chance of product recalls. This way, the company can prevent any major time and money loss for their products.

When the process is not used properly, it results in a failed medical device as stated by those examples above. In the case of those recalled medical devices, it would be interesting to know what their design controls were and if they passed. It would also be interesting to know what made those companies feel that their products was able to be put on the market. Maybe those devices did go through all of the design controls, but there were some that were not thought of. If there were design controls that were not addressed for those devices, that would certainly be a case where the process was insufficient.

The reason design controls fails is because either procedures are not followed or the procedures themselves are poorly written, and the planning of every aspect of the device and documentation is poor. However, in a medical device industry that rarely occurs when design controls are inefficient. The FDA is very strict with its guidelines and acceptance criteria in 510k submissions or PMAs, that if design controls do fail for the company it usually does not reach the FDA submissions phase for that device. Usually a thorough design development plan is thought of along with the project proposal, with design review meetings to make sure the device is progressing. Verifications and validations are performed to find bugs before the product is launched on market, however as others have noted sometimes these protocols do not find these issues before the product is out on the market.

Unless your product has already been on the market, the FDA will not allow you to take your product to market if your Design Controls are not deemed safe and effective. Design controls are documented, objective evidence you establish throughout the product development process to prove your device is safe and effective. There is almost no way to submit a 510k or PMA without your design controls and design history file. They don’t necessarily have to be a part of the submission but logically they should be, and they should be established prior to submission.
Once submitted there are several things that the FDA can bring up to delay your approval process.
Some common mistakes that I found from an article include:
1. Inadequate device description
2. Discrepancies throughout submission
3. Problems with indications for use
4. Failure to follow or address current guidance or recognized standards
5. Inadequate or missing performance or clinical data
6. Comparison to predicate is missing or inadequate
7. Other testing data is missing or inadequate
Source: http://www.emergogroup.com/blog/2015/05/seven-mistakes-can-delay-your-fda-510k-clearance

Design controls are essentially implemented to ensure traceability on their released product. The idea is that 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 consumer. When processes/procedures are not properly implemented in a lab or by a technician/operator nor documented, could potentially result in a failed device. The FDA has very strict guidelines to ensure traceability of devices as well.

Chris

I agree with what everyone has already said about inefficient design control leading to dangerous devices, lower quality, traceability of the product, or the FDA not allowing the product to get to the market. To add to all of this, design control is also a key factor in fixing any problems that arise. The Design History File (DHF) contains all of the design control documents, logs the design process, and is frozen once the product is created. The Device Master Record (DMR) is a continuously updated folder that contains everything about the product from scratch to finish.If a device fails a company should be able to go back and look at the DHF and DMR to see exactly where the design process or design change went wrong. If a company does not keep good records because of a poor design control process it can be very difficult to see where the product failed and how to fix it.

There are many places within design control that can result in failure. This can either be in the early development stages of development or all the way at the end when the product is communicated with the public and released. In the early stages, a major error can be made when not listing all of the necessary design inputs. Especially in the medical device industry, if a safety constraint is forgotten, it can lead to a very difficult problem to fix in the future. In the middle of the process, redesign is very important of well. This is where the company should be refining the product because of any problems found during initial testing. Towards the end of the design process, if the creators of the product do not communicate the product correctly, it can also result in problems. As we learned earlier, they cannot state the product can do something without proof to back it up. Without this proof, with product with not sell as intended.

The biggest issues are that you can be producing product that is either bad or not up to the quality that you would want. Design controls are so important in making sure you have a process that you know is in control. If you have no design control how do you really know how your process should be operating. By not having controls how do you know what type of quality you are getting out of your product. With medical devices quality if of the up most importance. They are going to be used on humans and there can be serious risks to the patients which can create huge problems. Another thing in my experience working so far is that when you have controls it makes it easier to pinpoint things when you have an issue with the process. Meaning if you experience a failure in process and you know how your process should be operating it makes it easier to pinpoint the failure and make the necessary changes. If you have no controls it makes it a lot harder to try and fix things that go wrong within the process. So have no design controls it can be very risky when it comes to producing medical devices. There is a lot of risk involved and there can be some serious consequences.

Hey Lamiaa,

I guess the most obvious consequence of insufficient design controls is wasting time. Designing a medical device is no easy task and therefore requires many moving parts and complex processes. Small insufficiencies here and there can add up and cause major delays in the development of the product. Further, these insufficiencies can also introduce production errors which would ultimately impact everyone involved. Customers would get potentially unsafe products and the manufacturing company would be held responsible. Therefore, it is critical that companies spend the requisite time to make product development efficient and effective.

- Saad Ali

One thing, possibly less significant than many of the other suggestions here, is the difficulty in improving. If documentation is not done well and thoroughly from the beginning, it makes it difficult to improve later. Rationale and successful improvements cannot be made as easily when new employees cannot understand the reason for the previous work. I have run into problems like this in my work where I want to make a change to reduce some of the burden off of the process only to find the company moved to the thing I am changing but without enough rational.

Additionally, sometimes documentation was required but it is so difficult to change, it makes employees not want to make changes so they avoid it at the expense of the product or people making it- for example extra checking and documentation steps due to poor quality at the end o the process instead of fixing the issues at the source.

The timeline done by the project management would be significantly changed. A poor product would bring down the credibility of the company and it would put in risk the safety of the patients (Additionally, if the project affects the person, demands against the company could arise representing loss of millions of dollars). Whenever a company assigns a project, you want to finish it as soon as possible. If you fail to do so, it could cause you your job and the company would be wasting valuable time during the process. Imagine how disorganized the project would be after all these things happen! I've always said it does not matter how awkward a situation could be, a good worker should always stick to the procedures established by the company.

Hey Saad,

You bring up a great point! Inefficiency and wasting time is extremely costly to the device development process. Issues such as unclear requirements may lead to an insufficient design control and review. When the objectives of the device are unclear it is difficult to give accurate feedback. To avoid this issue clear cut requirements must be put in place.

-Romany