As part of MD+DI's coverage last week of the Netflix documentary, The Bleeding Edge, we asked readers for feedback on the film and its assessment of the medical device industry. A total of 62 respondents took the three-question survey.
1. The Bleeding Edge claims that FDA's 510(k) process, reportedly the most popular way medical devices reach the U.S. market, doesn’t require the submission of as much safety data as does the premarket approval (PMA) process. Do you believe this is a fair depiction?
Of the 62 respondents who answered this question, 48 (77.42%) said yes, and just 14 (22.58%) said no. Additionally, 25 respondents chose to explain their answer. Those comments include the following, selected to represent the full range of viewpoints:
"FDA requires evidence that any device will be clinically safe (and also effective). In the case of a 510(k), a predicate is submitted by the applicant and judged by FDA as a comparison to the device seeking marketing approval. The collective data supplied for both the predicate and the new device are judged by FDA for sufficient evidence that the new sought device will be safe. The preponderance of evidence necessary for a PMA device or a 510(k) device may be considered the same, it's just a matter of whether there's a predicate to start from. 1976 was the baseline for which predicates began. However, that was 42 years ago."
"Since its introduction in 1976, the 510(k) path for medical device approval has been perverted into a means of getting products out faster with as little regard for patient safety as possible. This is because safety testing costs time and money in the short term, even though it can cost far more in the long term. 'Never time to do it right, but always time to do it over' ... or just stop selling it if it doesn't work out, has become a feeding frenzy of medical device firms. I personally have left companies because of this obsessive attitude."
"The 510(k) process is one that measures substantial equivalence to a predicate device. The purpose of the information submitted, therefore, is to show equivalence, not safety. In addition, there is no guarantee that the predicate device is safe because there is no check for recalls or adverse event history for that predicate."
"It is true, but just in the cases where the safety of the device has been proven before, that's why you don't have to show all the evidence again. It must be important to consider that this predicate device shouldn't [have] been withdrawn previously from the market or had a series of adverse events."
"The film misrepresents the regulatory process as it seems the filmmakers themselves don't understand the process."
"That is somewhat due to the devices that are cleared via a 510(k) are lower risk than those requiring a PMA."
"I have worked for a company that was under 510(k) and then went through the PMA approval process. PMA definitely requires more safety testing and data, but in my opinion, it's still not enough. Biocompatibility studies are key, and they are not performed for long periods of time. A product could pass 510(k) requirements (or even PMA requirements for that matter), but the issue with the device won't show up for months or years after the device is used/implanted."
"A 510(k) is 'the most popular' pathway to clearance because most medical devices are classified as Class II or lower. Class II devices (those cleared through 510k) are a lower risk product by nature. They shouldn't have the same documentation burden as a Class III device (PMA)."
"Companies aren't using "grandfathered" predicates anymore. That is ridiculous to imply. The process is robust and appropriate."
"Predicate device relationships are abused. There are products approved that have very little relationship to predicates stated. Design control and design histories are laxly reviewed. You cannot add quality at the end of development it has to be continuous during development. You also can't test quality into products. The agile methods are the worst thing to happen to device development since snake oil."
2. Please select any of the following suggestions that you believe could reduce risks to patients:
A total of 58 respondents selected one or more of the listed choices, and 22 respondents provided further comment. Select comments appear below the appropriate suggestion.
This question received a total of 58 responses and four skips.
- Overhaul the regulatory process to require more upfront safety data for 510(k) submissions – 31 (53.45%)
"Without an overhaul, it would help if surgeons and hospitals did their homework regarding device safety. Too much is taken for granted by healthcare providers and they mostly get their info from the industry. If we had publicly accessible registries, like they do in other countries, it would help. In the meantime, providers can check with UK or Australian registries if they want to see the record."
- Require longer postmarket surveillance studies on the safety of 510(k) cleared products – 35 (60.34%)
"Longer postmarket surveillance studies (more than three years) should be the norm for Class III and anything implanted."
- Eliminate the 510(k) process – 5 (8.62%)
"The 510(K) process is totally flawed and should be eliminated. All devices should go through a full approval, having nothing to do with being similar to an existing device."
- Bar FDA staff from joining industry or vice versa –16 (27.59%)
"Bar medical device companies from the regulatory process making, and forbid lobbying in Washington."
- Bar doctors from accepting compensation from medical device companies –30 (51.72%)
"Doctors who are in the employ of industry should not practice. This is a serious conflict of interest."
- No regulatory changes are needed –5 (8.62%)
"Reducing risks to patients could be taken to the extreme point of view that no intervention is ever allowed. Our regulatory system has to use a reasonable approach to balancing risk versus benefit."
"However, some sort of maintenance of 510k's should be required. Recalled or devices that aren't marketed anymore shouldn't be allowed to be predicates for other devices. Consider a re-registration process for 510k devices like CE mark. Perhaps once every 5 years?"
"Examples in the documentary (mesh, cobalt in implants) indicated inadequate biocompatibility or clinical studies. Depending on the situation, more is needed here. Perhaps introduce a mandatory pre-sub process?"
3. What lessons can be learned from this documentary?
"Tons of lessons: 1 - when an [adverse event] surfaces, don't rationalize it, don't brush it under the rug, use proper risk management to figure out what happened and correct it - the way the aviation industry does. 2 - Don't succumb to the greed that pervades the industry today. Timelines for product pipelines are based as much on making money as they are on helping patients with needed technology. I know: I've spent 40 years as a serial entrepreneur in this industry. 3 - Do let people know that the scenarios in this film are the exception to what is a very good (note that I didn't say excellent) safety record over the past 40 years. Don't hide from the debate - engage objectively and openly."
"Never treat a reported adverse event lightly. Some are inevitable as nothing is ever perfect, but [an adverse] event affects a person that could have been close to you. We are working in this industry because it is different, and it is different because what we do has an impact on patients' lives."
"I have three implants for different reasons. Being a biomedical engineer, I searched for my physicians and selected them on their background and track record. I also went to a reputable medical facility for my procedures, as well as researched the devices themselves. I used to think this was a bit overkill. Not anymore. And, with the Internet and the ease of obtaining information, I say there is little to no excuse for not doing this yourself before you go for medical treatment. If you don't feel you are able, get someone you trust involved to do it for you. Do not rely on TV and/or radio commercials, or go to someone only because you know them or are connected to them only personally."
"The presentation was very one-sided, but they did bring out some issues that we need to address. We know that our regulatory process is sufficient for the 510(k) pathway, but we need to respect the process and not try to get around it. We also need to police our industry more and make sure that the 'snake oil' approach is not tolerated."
"It's easy to tell the difference between a smear piece and a documentary when only one side of the story is told and the details that are shown are inflammatory. I agreed with many things in the film, but overall felt it was an unfair depiction. I don't label it a documentary.
"The FDA medical device approval process requires a complete overhaul. This will become more important as technology development surges forward. We cannot leave regulations as they were set up in the past when it comes to safety and effectiveness for a device."
"There are issues with the medical device process for sure. But what's the answer? Doing exhaustive testing for 10 years before a medical device is considered 'safe'? The company would go out of business. Right now, the best thing we have is a risk/benefit analysis where a company has to prove that the benefits to the public health greatly outweigh the risks. This documentary highlighted a few bad cases where the process failed the public. But for most medical devices, this doesn't happen. And the public is better off with them in the market.
"Is it really a documentary as Roger Moore makes, or was it just another Netflix program to boost viewership?"
"There is certainly room for improvement in the medical device industry and regulation space. That said, it is a very complex network of stakeholders, processes, and procedures. In order to improve, all stakeholders (FDA, device companies, patients, and doctors) must work together acknowledging that they have at least one common mission- and that is improving patient care. Silos and fingerpointing will not help us drive positive change."