Building a programme of clinical trials to drive faster medtech adoption
Kieron Day, head of clinical affairs at Sky Medical Technology, describes the process of gaining sufficient evidence for the commercialisation of devices and some of the challenges medtech companies face bringing innovation to market.
New medtech devices provide innovative ways to treat patients, offering healthcare services alternatives to traditional pharmaceutical interventions. But before such technologies can be adopted, they must demonstrate their ability to deliver positive patient outcomes.
Finding the space for clinical trials
According to a recent study by ClinicalTrials.gov, there have been approximately 390,000 clinical studies registered globally in 2021 – a significant rise from the 82,861 registered in 2009. This exponential growth in clinical trials demonstrates a huge demand for new medical solutions that improve patient outcomes and represents a global surge in innovation and technology in healthcare.
This presents advantages and disadvantages for medtech companies. There is a growing acceptance and support of technological solutions in healthcare, meaning faster recovery times and more cost-effective care could be on the rise. However, the growing number of clinical trials also suggests huge commercial competition in modern healthcare. This makes roles such as mine – creating and executing large scale, multi centred clinical trials – challenging, to say the least.
Have you explored the full potential?
Executing successful clinical trials is always complicated, even more so when medtech devices are potentially applicable across multiple medical conditions. For instance, our geko device is a wearable, watch-sized device that attaches to the leg, using electricity to stimulate nerves, creating blood flow equal to 60% of walking without the wearer having to move. Devices like the geko that are clinically proven to increase blood circulation have a plethora of benefits associated with improved circulation, such as the reduction of swelling, faster healing wounds, and the prevention of deep vein thrombosis (DVT).
Such technologies are recognised as ‘platform technologies’, meaning they can – in theory – help to address a range of conditions. While platform technology devices have the potential to offer huge benefits for healthcare systems, this does not mean that clinical evidence in one area is applicable in others.
For instance, having already completed the appropriate certification to use the geko device on patients, demonstrating that it can improve blood flow significantly, suggests it could also prove effective in addressing post-operative oedema in a proof-of-concept trial.
However, specific evidence is always required before the device can be deployed commercially across each new medical application.
A challenging environment for clinical trials
Completing successful clinical trials has become more challenging during the COVID-19 crisis: the pandemic brought many outpatient clinics to a standstill. Multiple centres actively recruiting patients into clinical studies closed during lockdown, medical resources have been shifted, and healthcare systems have been overwhelmed. COVID has been a disaster for medical services deemed non-essential - the most disturbing element is that many patients either have not had the treatments they should or have developed other illnesses during the pandemic.
Finding the right champions
All clinical trials rely on the goodwill of key opinion formers within the clinical environment. These are busy people, even more so in a post COVID environment. A good starting place is to find people that are well published in the area and consider how best to approach them.
It is important to make a good first impression, so it is worth preparing an initial presentation to introduce the technology itself and then the clinician may further evaluate a device. It is critical to build trusted and sustainable relationships with clinicians particularly those that are well connected globally. For example, if you have trusted clinical contacts in the UK, they can help introduce you to their peers in the US. However, companies need to be respectful of the goodwill of a clinician that is helping to further medical innovation in addition to a full-time medical role – and understand the throughput of patients.
A healthy investment
Regulatory environments are becoming stricter, so medtech companies need to be prepared to invest significantly in clinical trials. Typically, trials are funded by companies – known as ‘industry sponsored studies.’ Companies pay for the trials, write, and manage the protocol for the trial and verify the data. They can successfully apply for grants to help fund such trials but responsibility for the safety of the patient always falls on the companies’ shoulders.
There is also the option of Investigator Sponsored Studies whereby a clinician wants to use the device for a specific purpose. In these cases, the physician owns, analyses, and publishes the data but this can be beneficial for medtech companies, which may contribute towards the cost of the study.
A long term, properly funded, approach
When building an evidence base to support commercial deployment of medtech, it is important to be patient. Companies need to remember the regulatory pathway is at least three years long; then there is a further three to five years to create commercial and marketable data. It is not simply enough to be safe to use. Medtech companies need to prove that they deliver positive patient outcomes, and I am pleased that the regulatory environment has become so stringent in recent times.
If companies are fortunate enough to have a product that can address multiple medical conditions, they need to ensure they can properly manage all of their commitments. It is not viable to do all the trials immediately, across every medical condition and every country. However, medtech companies should view investment in the clinical trial process as an investment in their own future success since this will pay significant dividends in terms of commercial success.