The Medical Device Industry: Where's the problem? by Tim Wilcox

When you go to the GP’s office, the hospital, or to A&E, you expect to receive quality healthcare which is tried, tested, and approved by regulatory bodies. However, in recent years a disturbing trend of commercialism has begun to arise within the healthcare industry. On the surface, it seems that all big companies are committed to delivering excellent health care as is stated on their websites: “we have aimed to keep people well at every age, […] we are committed to using our reach and size for good.” (Johnson & Johnson) (1), and “We exist to help people thrive.” (Bayer) (2). One would expect this from companies that create medical devices for use in hospitals; however, instances are starting to occur which throw doubt onto their humanist mantras with suggestions that these companies prioritise profits and shareholders over wellbeing and customers.

Something that particularly inspired this article was the documentary “The Bleeding Edge”, a 2018 film by Kirby Dick, which was premiered at the Tribeca Film Festival this June. The film examines instances of malpractice within the medical device industry in recent years, which has resulted in deaths and injury at almost no expense to those responsible. What seems to be the main reason behind this malpractice according to Kirby? Profit.

The focus of the documentary is on how such harmful devices came to be approved through the American Food and Drug Administration (FDA) whose job it is to test all new medical devices and to ensure they are safe to use. As it turns out, there are two ways for a medical device to be market approved: one, is the Premarket Approval (PMA), which involves a single study done on as few as 50 people; or, two, passing through what’s called a Premarket Notification 510(k) where the producer of the device must show that the device is “substantially equivalent, to a legally marketed device” (3). In theory this second route should be a rarely used path to reduce the amount of time spent testing products, which are only tiny modifications onto existing devices. That may have been the theory back in 1976, when the ruling was introduced, but today 98% of medical devices in the United States are passed through a 510(k), as opposed to undergoing a PMA (4). This becomes an issue when certain branches of design all stem from one preliminary device which passed a PMA, whilst a whole series of follow-up modifications can be cleared via 510(k)’s without actually being properly assessed for safety. Furthermore, even if the original device passed a PMA but later got pulled from the market because of safety concerns, the stemming devices are still allowed to be used (3).

An example of hip joints where one predicate approved through the PMA system can result in countless designs being approved via the 510(k). CITATION The18 \I 2057 (9)

A major example of the fallibility of this system is the existence of cobalt-chromium alloy (CCA) joint replacements, despite several previous warnings of their dangers. In 1975 studies began to show that metal joint replacements using CCA was dangerous in many ways, mainly related to wear and tear releasing ions into the blood and surrounding tissue which was carcinogenic as well as harmful to tissue in contact. A further five studies from 1988 to 1998 reinforced this idea (5). Despite this, in 2003 a huge trend in metal hip joints returned with a large proportion (estimated to be around 70,000 people) (6) of these being CCA. One of the main reasons this could happen is that while a few CCA joints were pulled from the market because of their dangers, the rest of the devices, which were brought in via 510(k)’s based off these original designs, were not removed. In the United States doctors are still allowed to give CCA joints, particularly in the hip area. These choices are up to the doctors themselves, as in America it is legal for doctors to recommend any treatment they feel is appropriate regardless of any evidence to the contrary (7).

A far more interesting case in terms of technicality which Kirby examines, is that of the Da Vinci Surgical System brought in by the Intuitive Surgical company. DaVinci is a surgical robot system which can be used to remotely perform surgeries via a series of specialist tools, and in a manner which is as minimally-invasive as possible, mainly used for hysterectomies and prostate removals (7). The machine itself looks very futuristic and while we shouldn’t be selecting medical devices based off looks, it would certainly win an award for something out of a science fiction film as opposed to a modern-day hospital device.

The patient side of a Da Vinci medical device in a US army hospital CITATION Fir18 \I 2057 (14)

While the theory behind the device is excellent, it’s actual use in the real world has been called into question. The first questionable piece of data is that when it was originally submitted to the FDA for the more intense PMA process of clearing, a manager intervened and had the system passed through the 510(k) process instead with little testing (8). Following its approval and initial sale to hospitals, the requirements for a doctor to use it was scaled back from 9 weeks intense training to one day of training and two supervised real operations before a doctor was considered fully competent on the device. One doctor claims he was told it would take “ten cases to become proficient at robotics […] I didn’t really start to feel comfortable until I was about 200 or 300 cases in.” (9) This lack of practice in order to circumvent expensive and time-consuming training procedures is not only risky but is completely different to what the initial proposal to the FDA was. In an FDA survey in 2013, of 11 surgeons who were using the machine, every single one reported mechanical issues with the system ranging from instrument and memory malfunctions to the arms not working correctly and drifting while inside the patient. (10) In addition to these mechanical issues, a view expressed by many experienced surgeons is that these machines are used almost as “cheat” devices by less capable doctors, with this feeling being further reinforced by the lack of training being given to most of the doctors using the machines (9). And beyond this, approximately three to nine times more incidents occur when using robotic surgery as opposed to surgeries done purely by hand (11). This, combined with an average unit cost of $2.5 million (USD), raises many questions as to whether this machine is worth it (12). Supporters of the device on the other hand do have some valid arguments: the fact that the device can perform the same surgery as a human whilst making an insertion cut less than a third of the size can cut hospital recovery time from up to a week to less than a day. So, while the benefits are clear in some areas, questions are there to be raised as to why this product, which has been out for 18 years, still has many issues which could easily be called “teething problems”; issues which should have been sorted out long ago.

It is, however, important to note that there are two sides to every story. On the day of the documentary airing, one of the main companies attacked in it, Bayer, began a fact checking process. They then proceeded to publish a damning report against the “Bleeding Edge” and its producers, accusing them of “relying almost entirely on anecdotes” and “cherry-picking information” to suit their needs. Whilst the impartialness of such an internal fact-check can obviously be questioned, these claims cannot be dismissed; sensationalism within media is not an uncommon occurrence. There can be endless debate about the merits and drawbacks of certain medical devices, but clearly there will always be two extremes: people who trust the device and the system which approved it, and people who believe that devices such as these present a very clear healthcare issue and that the system is broken. The difficult part is finding just how dangerous these devices are, and whether the danger is justified by the benefit of the device for the patient.

Clearly the American FDA system has its flaws; even with only two examples being showcased here which seemed to have slipped through the cracks. After all, the European Regulation 2017/745 article 61 (13) has a similar phrase to the 510 (k) which is causing so many issues; namely the fact that if a device is merely a modification of an existing approved system, it can be cleared. The main difference appears in that the European system still requires tests to be shown whereby this new development is up to the same or better standard than what it is replacing, and any side effects resulting are pinned onto the manufacturing company very quickly.

While neither system is perfect, the laws need constant adaption thanks to the incredibly fast-moving nature of technology and medicine these days. Perhaps that is where one of America’s main issues stems from – the FDA act was written in 1976, and the EU regulations were last adapted in April 2017. Whilst both the documentary “The Bleeding Edge” and the two examples covered here focus on decisions made by the American FDA, in the coming years there is an increasing likelihood of the British system moving to mirror the American one, as opposed to that of the European Union, due to the changing political landscape.

One thing is for sure, whatever happens next in the UK political climate, we must strive to keep our medical regulations as tough and anti-profit as possible, ensuring that people are the first and last thing in the mind of these manufacturers; not profits.


  1. About us. Johnson And Johnson. [Online] [Cited: August 7, 2018.] https://www.jnj.com/about-jnj.
  2. Our Values. Bayer Global. [Online] [Cited: August 7, 2018.] https://www.bayer.com/en/our-values.aspx.
  3. Premarket Notification 510(k). US Food and Drug Administration. [Online] [Cited: August 7, 2018.] https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm.
  4. FDA Medical Device Approval Rate hits 15 Year High. Lexology. [Online] [Cited: August 7, 2018.] https://www.lexology.com/library/detail.aspx?g=be0da6d0-1bb1-4d16-a533-56f088a01446.
  5. Release of Chromium from Orthopaedic Arthroplasties. US National Library of Medicine. [Online] [Cited: August 7, 2018.] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2685051/.
  6. Hip Implants: how safe is metal on metal? British Medical Journal. [Online] [Cited: August 7, 2018.] https://www.bmj.com/bmj/section-pdf/187462?path=/bmj/344/7846/Feature.full.pdf.
  7. The Kindness of Strangers. The Economist. [Online] [Cited: August 1, 2018.] https://www.economist.com/babbage/2012/01/18/the-kindness-of-strangers.
  8. Regulatory Clearance. Intuitive Surgical. [Online] [Cited: August 7, 2018.] https://web.archive.org/web/20130116100318/http://intuitivesurgical.com/specialties/regulatory-clearance.html.
  9. The Bleeding Edge. Netflix. [Online] August 7, 2018. https://www.netflix.com/watch/80170862?trackId=13752289&tctx=0%2C0%2C28b9f7496c0135a4f9a2b3543273d70b42b32465%3A1ac241851973138911c6855fec2b4e5d51e221e6%2C%2C.
  10. da Vinci Surgical System. Drug Watch. [Online] August 7, 2018. https://www.drugwatch.com/davinci-surgery/.
  11. Failure and Malfunction of da Vinci Surgical Systems. ScienceDirect. [Online] [Cited: August 7, 2018.] https://www.sciencedirect.com/science/article/pii/S0090429509007857.
  12. The Slow Rise of the Robot Surgeon. MIT Technology Review. [Online] [Cited: August 7, 2018.] https://www.technologyreview.com/s/418141/the-slow-rise-of-the-robot-surgeon/.
  13. Regulation of the European Parliament 2017/745. Official Journal of the European Union. [Online] [Cited: August 7, 2018.] https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=EN.
  14. First DoD use of Robot Surgery. Defense Visual Information Distribution Service. [Online] August 7, 2018. https://www.dvidshub.net/image/2569259/wbamc-first-dod-use-robot-surgery.


Created with images by Marcelo Leal, The appearance if U.S. Department if Defence (DoD) visual information does not imply or constitute DoD endorsement.

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