Device design: addressing issues

Challenging the industry views expressed at an Ethics and Patient Safety seminar, hosted by the Royal College of Surgeons, which focused on the introduction of new device technology (Published in the February issue of The Clinical Services Journal – p17), Peter Wilmshurst, consultant cardiologist at the Royal Shrewsbury Hospital and senior lecturer in Medicine at the University of Keele, took the opportunity to put forward his personal experiences regarding the regulation issues surrounding medical devices. He said: “Ideally, assessment of any treatment should be sufficiently rapid to ensure that good treatments get to patients quickly. However, there should also be sufficient checks in place to ensure that less effective or unsafe treatments do not make it to market. There also needs to be adequate post-marketing vigilance to detect problems. “For the patient, it is important that assessments of treatments are comparable, whether it be a coronary stent or a drug. They both need to be tested. However, regulators will view an intracoronary stent, or any other medical device, as a device like any other, and this can be a problem.” There are a number of classes of medical devices – for low risk devices (Class 1) manufacturers are able to selfdeclare conformity, affix a CE mark and register the product with a competent authority. For medium risk devices (Class 2) such as X-ray equipment, monitoring equipment and ultrasound; and high-risk implantable devices (Class 3) such as stents and prosthetic valves and joints, a conformity assessment procedure needs to be undertaken. Comparing the procedures for drugs Challenging the industry views expressed at an Ethics and Patient Safety seminar, hosted by the Royal College of Surgeons, which focused on the introduction of new device technology (Published in the February issue of The Clinical Services Journal – p17), Peter Wilmshurst, consultant cardiologist at the Royal Shrewsbury Hospital and senior lecturer in Medicine at the University of Keele, took the opportunity to put forward his personal experiences regarding the regulation issues surrounding medical devices. He said: “Ideally, assessment of any treatment should be sufficiently rapid to ensure that good treatments get to patients quickly. However, there should also be sufficient checks in place to ensure that less effective or unsafe treatments do not make it to market. There also needs to be adequate post-marketing vigilance to detect problems. “For the patient, it is important that assessments of treatments are comparable, whether it be a coronary stent or a drug. They both need to be tested. However, regulators will view an intracoronary stent, or any other medical device, as a device like any other, and this can be a problem.” There are a number of classes of medical devices – for low risk devices (Class 1) manufacturers are able to selfdeclare conformity, affix a CE mark and register the product with a competent authority. For medium risk devices (Class 2) such as X-ray equipment, monitoring equipment and ultrasound; and high-risk implantable devices (Class 3) such as stents and prosthetic valves and joints, a conformity assessment procedure needs to be undertaken. Comparing the procedures for drugs by the manufacturer, and a device does not even have to demonstrate any clinical benefit. It only needs to be able to do what the manufacturer says it can do.” He went on to comment about a device that he is aware of, which only has a 50% success rate, but this did not stop the product coming to market. “It is not necessary to demonstrate equivalence with similar devices. Also, if the manufacturer suggests that the device is similar to an existing device it may only require a literature review to gain a license. “There are obvious problems with this system,” said Dr Wilmshurst. “There are discrepancies between the notified bodies. Further, the notified bodies are not working for patients or the EU. Their clients are the device manufacturers, and the reason for granting a CE mark is not published – it remains commercially confidential. Such secrecy contrasts with the published rationales for approval by the EMA for drugs or indeed, the Food & Drug Administration (FDA) in the USA for both drugs and devices.” Dr Wilmshurst went on to discuss the issues of potential conflicts of interest in clinical trials set up to support licensing applications. “Clinicians are in a good position to identify a gap in the market for a device and then go on to design a solution and become involved in research in which they may have a financial interest. This can lead to a clear conflict of interest.” There are other areas where conflicts of interest can occur. He said: “When surgeons use a device for the first time they will want someone to show them how to use it. Often, the device manufacturer will bring in a surgeon from another unit who has previously used the device. This person will be paid for their time by the device manufacturer. The surgeon may think that they are acting as a clinician but in fact they have become part of the marketing arm of the manufacturer. “Consultancy payments to clinicians are quite common. I was offered consultancy fees exceeding £50,000 for my role in helping to design a major trial, sitting on the steering committee and being the principal cardiologist. I refused to take the money, opting instead to do it for free to avoid a conflict of interest.” Another issue highlighted by Dr Wilmshurst is that of reporting adverse events. He said: “If I see an adverse event with a drug, I have no problem with reporting to the MHRA using the Yellow Card Scheme. However, if you report an adverse event relating to a device that you have implanted, there is a concern that the problem may be shifted back to you, the surgeon. No one wants to gain a reputation as being someone who cannot make devices work, particularly if they undertake private work.” Dr Wilmshurst has some personal experience of libel actions being brought by device companies. “I was sued by a medical device company, which has since gone bankrupt and I have subsequently been vindicated – I refused to put my name on a paper relating to the trial because the contents were false, in my opinion, and omitted relevant adverse facts about the product. “I am also aware that concern about litigation has prevented other cardiologists from reporting adverse events. There is a device, used relatively infrequently in the UK, that has caused cardiac tamponade by perforation of the heart requiring emergency surgery in several patients. It has also required additional devices to be put into other patients to help seal leaks that occur. However, some of these complications have not been reported to the MHRA, possibly because the manufacturer concerned has a record of litigation.” In conclusion, Dr Wilmshurst said it was important to ask why standards of evidence for drugs and implantable devices are different? How do we deal with conflicts of interest around medical devices and clinical trial used as evidence for licensing? And how do we get operators/implanters to report adverse events with medical devices?

A new route to market

At the same seminar, Andy Goldberg, consultant orthopaedic surgeon and founder of the Medical Futures organisation, suggested an alternative route to market for medical devices. “Just because an innovation is new does not necessarily mean that it is any better than existing products,” began Mr Goldberg. Some innovations come about as a result of the introduction of a disruptive technology – one that offers a change in the paradigm of how things are done. However, the majority of innovations are in reality incremental improvements to an existing norm. Mr Goldberg offered a healthcare example to demonstrate this point. “Charnley pioneered the metal on polyethylene hip replacement in the 1960s – a good example of a disruptive innovation. Since that time there has been a wealth of similar innovations and these have all been incremental innovations, offering variations of the same. Indeed, the National Joint Registry today now lists more than 600 combinations of different brands of hip and knee replacements. It is a daunting task for a clinician to make a decision about which device to use when there is so much choice.” Mr Goldberg then showed the audience a chart produced by the National Joint Registry, which identified the top five cementless hip stem brands dating from 2003 to 2010. The chart showed that the number of protheses being used has increased rapidly, from 4,000 in 2003 to over 32,000 in 2010. “The outcome data for the top two brands – Corail and Furlong HAC – are similar,” said Goldberg. “So what led to one of the products being, by far, the market leader today?” He believes that product success is often more down to the marketing capabilities of the device manufacturer and that this has a huge impact on healthcare practice today.