I think it is the responsibility of the device producer to ensure that adequate measures are taken to ensure proper validation and quality. while FDA regulations are expansive and precise, they are not perfect. therefore, every company's main goal should be to produce a safe and efficacious product, making any product failures or recalls are on the device designer/manufacturer.

I agree with @zw2 that FDA regulations aren't perfect, but I think the regulations and guideline documents really set the bar to ensure to the best of the its abilities the safety and effectiveness of devices. Sometimes companies follow all the regulations and still something unexpected happens and the product needs to recalled. As we have discussed risk, there needs to be a plan on how to address problems and fix them quickly so that the company still has a profitable business while also ensuring the safety of its customers'.

I agree with both zbw2 and alexandra. The FDA establishes minimum requirements in terms of safety and testing. Many companies choose to hold themselves to a higher standard. If something goes wrong, they can lose millions in terms of recall or settlements. The hits to their public image also affect their sales and stocks. I'm not sure the FDA can be stricter with some of these, there are a lot of reasonable standards. If companies don't do their best to create a safe and effective product, it hurts them more in the long run than spending the time and money to do it right the first time ever could.

I would agree with the participants statements who posted before me. The FDA already has set regulations and guidelines that are established to aid companies with the creation of their devices. Most devices have to go through rigorous testing, and protocols in order to begin being marketed. However, there is always room for improvement! In order to assure that nothing goes wrong, companies can add a quality assurance branch to ensure that there products are properly working. That being said I do not believe the FDA should have anything to do with that, as the FDA only serves as a type of itinerary for companies. I suppose that in a perfect world the FDA would do quality tests for these companies, but in order to do that a lot more funds would need to be allocated to the FDA; which is mostly tax payer money, and would cause for a rise in taxes as this quality assurance branch would require many more people to be hired at the FDA. To wrap up, one thing that could be improved upon during the design process could be: more product quality tests.

There are certain protocols given by FDA, Every manufactures should go through the protocols. The main purpose of the FDA is for safety measures. Even though, there is a flaw in the design of the product cause huge problems for patients

FDA standards are there to be followed and every manufacturer has to follow the standards. The product should be tested for enough amount of times in suitable working conditions to be sure enough of its working, sustainability, the FDA standards of testing should be taken into consideration for the device testing. There are cases where the devices were recalled for defects in its design one such example is Johnson & Johnson's DePuy Knee replacement device which was approved under 510(k) in 2010 as there were similar devices in the market at those time hence there was no clinical trial of the device. Soon after there were many reports stating loosening Attune system and a lawsuit was filed as the product had design issues.

I think that it is important to note that the safety recalls and inadequate testings are mainly from products that have not reached the patient yet. The customer has noticed a problem and filed a complaint with the manufacturer well before the product made it to the patient. That being said, the FDA already has a set standard of regulations that are always under scrutiny and speculations. I feel that the quality systems that are already set up at manufacturing sites are compliant with the FDA regulations and are continually being audited. The only way that I feel the FDA could be more strict on these medical device companies is to audit more frequently. As already mentioned above, this is a tactic that would require more taxpayer money to be allocated to the FDA. However, if there are enough recall complaints coming to companies and the FDA, then having more audits would seem necessary.

I believe no matter how flawless a medical device design and manufacturing process is, there is still potential for users to be harmed (e.g. use error). That said, the manufacturer is responsible for understanding all risks related to the medical device and controlling those risks (reducing them as far as possible) within an acceptable level. With regards to how processes can be improved, regulations are already clear and strict on requirements that manufacturers need to comply for development. FDA could improve their review process to ensure device testing was tested adequately before granting approval. On the other hand, I think the post market surveillance could be improved with regards to oversight by agencies. Manufacturers are required to have processes in place such as to address complaints, report device issues, etc. and document these through annual management reviews reports. However, FDA does a poor job overseeing the post market surveillance. This is one of the reasons that Medical Device Regulations are changing in EU to better enforce controls in the post market space and I believe FDA will soon follow.

I believe, with the way the FDA enforces its regulations, improvements on the design process must improve. The FDA can only do so much to prevent companies from producing medical devices that may harm users down the line. As time progresses, medical devices have grown more and more complex, which undoubtedly calls for stricter and more elaborate regulations on the FDA's side, but also calls for more responsibility on the company's side. In addition, it is in the companies' best interest to produce a safe and well-tested product that does not harm their customers and image.

A flaw in any design process can be detrimental. It could hold up work to be done for months or even worse, produce wrong results. To prevent this from happening, companies must test their devices repeatedly using different parameters to test every possible scenario. This can be achieved through computer simulations that model the device and incorporate different aspects in each run to ensure that when the device goes out on market, it will not cause any harm. The FDA has strict regulations put in place that forces companies to do so but some companies don't treat these regulations with seriousness.

The FDA has regulations in place in order to protect the general public. Therefore, the design process of a product is crucial to its success. I believe that in order to ensure a flawless design process the most important step is to create a team with the necessary expertise to create this design process. This is where technical ability surpasses interpersonal ability. There is an extreme level of detail that needs to be attended to when creating an adequate design process, and it should not be limited to the capabilities of those team members. Additionally, the FDA should also have a representative that is assigned to overlook over the design process and give the needed knowledge on FDA regulations.

Although FDA approval is very useful to protect public health thru controlling medical devices and pharmaceutical drugs and ensure safety and effectiveness. Some of the most important points to be followed by the design process team in order to ensure production efficiency is to meet the pre-set development goals in a well-studied time frame (the device launch date). Another point is to meet the medical device market aims and learn about other competitors. It is also important to meet all the FDA main demands before submitting the product for regulation such as meeting the Premarket Approval (PMA) application needs or a Premarket Notification 510(k) requirements and labeling.

Even with the FDA regulations and procedures, I think there is always room for improvement but they do try to update the guidelines as more information comes out. Yet I think most of the responsibility should fall on the device producers and project team to make sure that their validation and verification testing is up to par with the FDA's guidelines. Also, when there is a short timeline for a lot of these products, there are some tests that are not done for the sake of saving time but also the project team deciding which tests are more important for their device. Since there are so many fail safes in place to make sure that products put out into the market are safe and reliable but sometimes things are missed due to new technologies coming out or new manufacturing processes that have not been tested yet. 

Overall I believe it is the responsibility of the product manufacturer project team to ensure guidelines are being met and that their product does not cause any harm to the public. As stated above medical device production is not always perfect but this is why clinical trials are important. If a device is not functioning well it should be altered and go through a new phase of clinical trials.