From reviews online, it says Lenzer has written about several devices that have been proven problematic. Investigative journalism can sometimes bring notice to problems that may be overlooked.

For example, Lenzer makes a point, "So the FDA has a database where doctors and hospitals can report deaths and serious adverse events, but they don't know how many people are implanted with a particular device. So if you have 100 deaths in a database from a particular device - I mean, if there are only 200 of those devices implanted in people, that's really scary.If there are 2 million people implanted, that's another story. And that's exactly what we don't know because the FDA doesn't require manufacturers to report how many people are implanted." I think that this is something that can be adjusted and would make sense. While it may be a nuisance to have to record every single one implanted, it is not costing the hospital or company a significant amount of extra time or money and this small change can help us analyze the device risks better.

While the other problems discussed in her book probably stem larger than this, I think it is important to not defend the medical device industry until one has fully read the book to make a well-informed argument. In the past, our medical devices were not even regulated by the FDA. Thus, there is always room for improvement and investigative journalism like this should be taken seriously, while also realistically thinking about budgeting and time.

Source: https://www.npr.org/2018/01/17/578562873/are-implanted-medical-devices-creating-a-danger-within-us

Online reviews of this book explain how Lenzer compares and contrasts pharmaceuticals with medical devices. Lenzer makes the claim that pharmaceuticals go through more testing than medical devices. Does anyone have an opinion on this statement from their experience? Also, if you do believe this to be a true statement, why do you think that pharmaceuticals currently go through more testing?

I think she is making a great point. Though I haven't read the book, from the sound of it I can see it has value. While funding and business needs the "easy" class system to report new devices, I think it should be adjusted so the devices are updated on their public records. I get that just because you make a slight modification to an already existing device that extensive testing may not be needed; but their records are relatively easy to update at little cost to the hospital. If i was in the hospital and they offered me a choice between two similar devices, I would want to know everything I can possibly know about them before deciding.

I believe there is more scrutiny in the pharmaceutical industry simply because it is a much larger industry. This means many more companies with many more products for the FDA to regulate. Since Pharmaceuticals affect many more people and also involve products that may have far more subtle complications compared to an implant or other biomedical device, they have the potential to adversely affect many more people. It is for these reasons that I think that pharmaceutical products require more regulation compared to biomedical devices.

Having previously worked in the medical device industry I have seen the testing they do on products that have already been tested and approved and I can say it is very intensive. To see that products from other companies are being produced without significant testing is very disappointing. It is not surprising entirely because the FDA can go years without checking up on a company, but usually consumer reports of a failed product usually will spark an FDA investigation. The FDA when alerted is extensive and thorough in their investigations and normally will have zero hesitation in shutting down or ring fencing a company. The company will then either face heavy legal issues and/or a multitude of fines and other sanctions. I do believe low testing is a large issue, but I hope that the fear of the FDA and the aftermath of a failed audit keeps companies away from sloppy development.

The concerns that have been brought up in this thread make a good argument for the importance of test method validation. It is important to make sure that the testing that is done is in fact adequate for verifying the test criteria. While Lenzer brings up concerns with having sufficient clinical evidence, there is a lot of bench-top testing that is done in a lab before the device will be used in animals and eventually humans. By using validated test methods, there is more evidence that the device has been sufficiently tested before it starts being used on patients.

I agree with f-dot, I think there is a good purpose for this book to open people's eyes to the medical industry. If a company fails a clinical trial, the results still become public which can hurt trust and confidence in the company brand name. And if that failed product moves forward, the failed clinical trial can be used by competition to show it's unreliability. I think companies take several precautions to ensure they pass a clinical trial. From what I have seen in the industry, several reliability tests are completed when the product is being developed and then thorough preclinical and formative (usability) studies are conducted right before the scheduled clinical trial. The internal preclinical and formative studies provides results that will be expected to be seen in the clinical trial because they use the same procedures and materials that will be used in the external clinical study. I honestly believe if companies didn't have the freedom in selecting the parameters that go into clinical trials (such as the staff, equipment - especially, and location of the site), and these were determined by the FDA limited variability in testing procedures, many medical devices would be in question about passing or not.

I found a New England Journal of Medicine blog that provides some examples (in Tables 1 and 2) of alternative ways that companies can use to collect data for a medical device compared to conducting clinical trials, demonstrating some of the FDA's flexibility.

http://www.nejm.org/doi/full/10.1056/NEJMra1512592?rss=searchAndBrowse&

i don't think using the pharmaceutical industry as a comparison is a good idea since drugs like thalidomide were allowed on the market and cigarettes caused "no health issues" for such a long time. I believe that the government should have strict design of experiment guidelines, require companies to submit all raw data results and analysis methodology, as well as hire skilled statisticians,who would look at the methodology to ensure significance of the statistical analysis. With a good enough statistician, poison ivy laced bandages could be proven to be harmless and have no adverse dermal effects. (no joke). With the rise of big data analytics, man power required to do tasks deemed to time consuming or taxing on the workforce 20 years ago can be completely autonomously with proper system designs. The FDA as well as other governing agencies should all go through a modernization transition to better improve their oversight and efficiency without putting a burden on companies and facilities that are fully compliant with nothing to hide. A lot of the data mentioned above are already recorded in the facilities and companies, its just that it is not required for submission. If a secure cloud server or some other collection mechanism is created to facilitate the transmission of such data, the AI big data analytic programs can do the assessment and point out issues that human employees would then address.
Making assessing testing procedures a part of government audits would also help rid certain unethical or inadequate testing method currently used by companies. Also note that not all defects are reported. If gauze rips in surgery, the doctor will simply grab more. If its a systematic issue they may get a new supplier but the defects don't always make their way to the FDA's ears. Assessing inventory use may also provide hospitals mechanisms of improving cost while giving a big data analyzer the information needed to find potential issues with products even if the users don't notice.

I do not agree with this statement of the book. I do not think medical device companies "lack transparency and proper clinical trials". None of the medical devices will be in the market if they were not good. The FDA does a very through job ensuring everything is proper and is safe for the consumer to use. Maybe the book is talking about something else or a different point of view. But on the information that is posted, it is making the FDA look like they are not doing their job which is not correct. More information on the book should be posted.