What are the barriers to adoption for new surgical technology?
Quality of clinical data
When developing a medical device, it is easy to assume that once a device gets clearance or approval, the hard work is done. But market adoption has its own challenges, particularly in the UK, where manufacturers need to sell not to the NHS as a whole, but to individual trusts. Likewise, even when devices are procured, surgeons still have a say on whether they use them on their patients or not.
“My main concern with new technology would always be patient safety because ultimately, while we can design whatever we want and it could change the world, if that causes harm or has the potential to cause harm, it’s absolutely not worth it, especially if there’s already an alternative. You can’t justify anything that could put a patient at risk because that’s the whole ethos of what underpins us as clinicians, as physicians, when you go back to the Hippocratic Oath of ‘do no harm’.”
Emily Mills
In a profession where patient safety is paramount, surgeons will scrutinize clinical data extensively and will only use devices where there is a clear benefit to the patient. Clinical data is not just a tick box exercise to enable clearance/approval either – it should be gathered and presented with consideration to the fact that surgeons will read it before using a device. Poor quality data will reflect poorly on the device, which may impact the chance of it being used. Surgeons do not necessarily take CE marking or FDA clearance as gospel for device safety and efficacy.
Emily Mills highlights how she looks closely at any clinical data which accompanies new medical devices: “There is going to be a risk when you’re bringing something new, even if it’s been clinically tested and trialed, because new technologies should be looked at very closely under the microscope. This is because if things go wrong, people get harmed.”
For Josh Burke, evidence-based assessment is also key when he is considering using new medical devices: “There is a lack of trust of the evidence-based assessment of new devices by industry and the slow regulatory process that exists within the UK and Europe.”
Duncan Light adds: “We’re so deep into the information age and there’s so much material around. What we do know as physicians or surgeons is how to read a paper and read research; that’s the one thing that we’ve got that we can trust.”
The need for quality clinical data should come as no surprise to many device manufacturers, especially for higher risk medical devices where clinical evidence is essential to getting to market. However, the quality of that data and how it is presented may also be critical for adoption. Surgeons will always put their patients first and a lack of quality in clinical data can result in a lack of trust in your device. Just as involving surgeons in earlier phases of development is critical to identifying unmet needs, having input into your clinical data reporting and analysis will improve its quality.
Sustainability
As the world becomes more focused on sustainability, this is also a big consideration for surgeons. With the NHS contributing 4-5% of the UK’s carbon emissions and the operating room contributing to a significant part of that, surgeons are growing increasingly aware of their impact on the environment. So much so that it can influence their decision of which medical device to use.
Josh Burke reflects on this in his role as Trustee of The CORES Patient Safety Charity:
“Patient safety is paramount when considering utilizing a new medical device. Historically, if two similar devices offered similar clinical outcomes and usability profiles, the decision to use would usually come down to availability and cost. More recently attitudes within the NHS have rightly turned to the sustainability of the devices we use, which one has the lowest carbon footprint and whether we in fact need to use particular devices at all.”
Josh Burke
This is a sentiment shared by several of the surgeons interviewed for this article. If devices have significant packaging, disposable elements or are single use, surgeons may opt for a device which has a lower environmental impact at the expense of their own comfort or time (though only if there is no difference in patient safety or benefit).
As SSIs (Surgical Site Infections) remain a significant cause of morbidity and mortality in surgery, there is a rise in new single-use technology which aims to tackle this. However, as awareness of surgery’s carbon footprint increases, single use devices may struggle with gaining adoption. To tackle this, new surgical instruments can be designed to improve compatibility with reprocessing methods, which can reduce the chances of SSIs occurring.