Two of the most significant challenges in medical device manufacturing are getting the product to market faster than the competition and meeting high client demands. Larger original equipment manufacturers or (OEMs) that sell medical devices to institutions, such as hospitals and clinics, can expedite speed to market by working with clinicians to quickly identify unmet needs and indications for use.

I think every foundation needs to be revamp every 10 years, to ensure that it is meeting the needs of their stakeholders. To answer this question, I honestly would need to look at their business plan to identify, if the FDA business model needs to be revamped to meet the needs of all stakeholders.  Sometimes companies are not doing enough work because they are often outdated on technology and platforms. If we assume that the process is slow due to staffing, and if the FDA hire more staff, would the process to make the product become higher to cover the cost of the staff? To me, I think the problem is the price.

I don't think there is a way to speed up the medical device approval process. There are many reasons why there is a bottle neck during medical device development that is not always the fault of the FDA. There are trials that each company has to run in order to push a PMA and if there is anything the FDA finds questionable, they should pause the approval process until all answers are found to ensure a safe product can be used with a customer. There are also other aspects of medical devices going through the PMA route that can slow it down during the approval process such as clinical trial results and animal studies that may kick back the project if positive results were not verified for the product. There are many steps that a company needs to take during the approval process that can cause a project to halt if the FDA has questions on specific portions of the project. Every company finds that it will have personnel constraints that can't be fixed by just adding people as you need trained personnel to read through the documents which also requires a larger budget to be approved. 

@jaf22 I think you make great points, especially pertaining to PMA. To add to that, even the quicker approach that many medical device companies take, 510(k), will still take time and come with its own challenges to be cleared by the FDA, something more staff won't necessarily fix. On average, a 510(k) takes around 5 months to clear. Different devices take different amounts of time to clear too. That being said, the FDA still needs time to review and process the documentation. More staff might help reduce the workload, but not speed up the approval time.

I think one way to speed up approval time is to reduce the amount of regulation/red tape needed to pass a medical device. This would come at a cost, reduction in safety... which is one of the main pillars of the FDA to begin with. I don't see a practical way for the FDA to speed up its process without compromising its main purpose: keeping people safe. 

I would love to know if anyone could think of a way to speed up the FDA approval process while ensuring the safety/efficacy of the devices.

Thanks,

Matt

I think one interesting point that this thread has not mentioned is how the pandemic has worsened the backlog of device awaiting approval due to the delays in inspection. According to medtechdive, the FDA still has 3,229 device inspections which need to go underway. The medical device department also has a backlog larger than that of the human and animal medical products as well as tobacco products, combined. In this case the bottleneck will continue to get worse until these inspections are able to be performed in a timely manner. Having alternate routes for inspection such as mailing the device or virtual meetings should have made talks in order to prevent the backlog from occurring initially. Therefore, to answer the question, yes, I do think the approval process could be made much faster. It seems to be the norm that in government everything is quite slow, especially something which grants an inventor or company approval for their device. (Similar circumstances may be seen in the USPTO).

Medical devices need an extensive amount of testing and research before a PMA can be sought after which requires plenty of documentation and time. This, plus the amount of other devices in the process of approval as you mentioned can easily slow down the rollout of a device. In addition to testing, data obtained from testing also needs to be repeatable and reproducible with little variation to prove it's viability. While the FDA lays out many steps to get a device approved, I believe the real delay comes into play during design, testing, and measurement system analyses before a PMA or 510(k) is obtained. 

As some have said before me, I don't believe we should "speed up" the approval process. I am sure there are areas which can be done more efficiently and move an approval along more quickly, but fundamentally the review of a medical device should be a long and detailed process. The American people have no other choice but to put their faith into the FDA to protect them from possibly unsafe products made by companies whose primary goal is to make money, albeit safely. I agree with what you have mentioned such as the amount of FDA staffers and increasing amount of medical devices submitted for approval being reasons for slowing the process, but I don't believe any macro-change will can be more efficient AND safe.

@troy-lovette I think you bring up a really important point that the industry procedures should constantly be updated to increase efficiency and its relevancy today. As mentioned in the course, a lot of policies that were initially enacted had to be updated such as the 1976 Medical Device Amendments as more products and complex concerns arose. However many of these initiatives came as a result of an issue coming up to the attention of the FDA rather than getting ahead of it in the first place. Periodic updates would most definitely ensure a more efficient process of use of resources to get more done in a timely manner. However I do realize these updates would also require time for retraining and sharing of information but I do believe if this is integrated within current practices the benefits will outweigh the costs. 

While hiring more employees would definitely allow for more work to get done, it would also come with a price. But with the number of devices significantly increasing over time, some proportion in the increase in workforce should also be seen. However, I think the most important factor to focus on would be the process itself to make the most use of the time these employees are putting in. 

While I certainly agree with those who say that the FDA process could be made more efficient with an increase in workforce, I don't believe that the FDA process can really be accelerated. The phases in the FDA process that get a drug or medical device to market are in place ultimately to ensure the safety and efficacy of the product so while the FDA process is a lengthy process, it is a necessary one. With that being said, phases like the clinical trials cannot really be rushed as they are required to determine the risks of a drug or device and to make sure that the final product is safe for human use. 

@mmd55 I think that part of the delay in the approval process, specifically for new devices that require PMA, is in the classification system that the FDA has for 'new' devices. As opposed to drugs, which have a pretty standard testing process to monitor side effects, dosage, etc., medical devices have unique testing requirements depending on the device and how it works and how it is applied to the patient. Therefore new high-risk devices have to go through extensive testing (which is great because it ensures safety). However, since the devices are classified by whether or not they are similar to a predicate device, it does not take into account whether the underlying technology is similar and previously reviewed by the FDA. Therefore, the extensive testing and time delay may not be necessary as the technology has been previously reviewed, but just because this device is 'new' and applying this technology in a different way, it must go through the full time-consuming approval process. This can be detrimental especially if the device can be life-saving to suffering patients but is delayed simply because of a classification issue. Additionally, this causes smaller companies with limited financial spending on development costs to be cautious about developing new products and opt-out of that in favor of developing devices similar to predicate devices. Certainly, extensive testing on new devices is essential, but perhaps there needs to be greater review done on what actually constitutes a 'new' device.

I believe the fact that the procedure and ultimate rigor and length of time that is used in getting an FDA approval is ultimately for the best for safety consideration. A medical device is such a product that directly interfaces with a person one way or another and thus needs to be absolutely fool proof and fail proof up to a certain designation. Being able to prove that your medical device is safe and effective to be used on a patient is the ultimate test for a medical device and the appropriate steps are in effect to make sure that there are no failures or catastrophic events that may occur that is at the fault of the company. The best case I can think of is an implant inside a person which must be surgically installed. If said product had a defect that was not caught because the proper procedures were not in place, each and every patient that got the product must then get the device removed which may cause very big implications on the company and on the FDA for approving the device without appropriate scrutiny. Often times in countries that do not have such stringent guidelines as the FDA, suffer from product failure just so that the company could start selling their product as fast as possible, and in doing so often times the patient is the one who suffers the most as well as the company, through physical trauma for the patient as well as monetary and brand reputation consequences.

@cem34 This is a good point. There are already several testing and approval stages that medical devices must undergo. To add a pandemic to the mix only further complicates and prolongs the process. It falls way down on the priority list, even at this juncture of the pandemic.

People often think of the younger generation as one that always want things to happen quickly. Unfortunately, not everything can be sped up. Sometimes speeding up the wrong thing can result in a worse outcome. When it comes to medical devices, I’m sure the lengthy approval process was put into place for a reason. It shouldn’t be easy to make and get approved for a medical device. Speeding up the process could cause things to be overlooked. However, I do agree with another post on this thread that processes should be reviewed every 10 years. I understand speeding up can cause issues, but sometimes if what you’re doing isn’t working, then maybe there’s a more efficient way to get it done. Especially with the way things are evolving these days, you never know until you look into it. I haven’t looked deeply into their process, but I do imagine that the time could be shortened slightly, if reviewed properly.

Although there are many steps, I believe they are necessary to ensure the safety of medical devices. The number of devices that are in process of approval are in high amount and have a buildup. The lack of models and employees are also good points to be brought up. The process of approving medical devices could be faster if those issues were addressed and dealt with. Some ways to do that could be computer automation, more employees, and deadlines and cutoff numbers to try and prevent overflow.