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Building a programme of clinical trials to support adoption of MedTech devices


Building Better Healthcare 

Kieron Day, head of clinical affairs at Sky Medical Technology, argues that instead of relying solely on traditional pharmaceutical interventions, the adoption of MedTech devices can help transform patient wellbeing and improve outcomes, and offers advice to MedTech companies looking to market innovations.


Despite being considered a relatively-new industry, the medical technology (MedTech) sector has a long and rich history.

Arguably, the first MedTech device was the magnifying glass and technologies such as X-rays and electrocardiograms are still widely used in medicine today, despite being invented more than a century ago.

However, the second half of the 20th Century saw the development of the first devices that could directly support a patient’s wellbeing automatically, rather than acting as an aid for diagnosis or human intervention.

And, during the first part of the 21st Century, investment and innovation in MedTech has exploded, with a wide range of new devices that directly address critical and non-critical medical conditions directly, often delivering more-positive patient outcomes at a lower cost.

From academic to MedTech

Kieron Day, head of clinical affairs at Sky Medical Technology, is something of a veteran of the MedTech industry.

Having worked in MedTech for 20 years, the former academic has built a reputation for leading clinical studies for MedTech companies.

In 2019 he joined Sky Medical Technology to lead the company’s efforts to create and execute large-scale, multi-centred clinical trials for its geko device.

The device is a wearable, watch-sized innovation that attaches to the leg, using electricity to stimulate nerves, creating blood flow equal to 60% of walking without the wearer having to move.

Day instantly grasped that a device could be deployed across multiple medical conditions and describes the concept as being a simple idea, adding: “It is a well established that if you stimulate a specific nerve in the leg, this will also stimulate the muscle, which in turn compresses the vein and increases blood circulation from the leg back to the heart.

“When this takes place, biologically and physiologically, good things happen.

“For example, swelling will reduce in patients experiencing oedema, and wounds will heal more quickly.

“The potential benefit of the technology was immediately obvious to me.” Kieron Day

But the challenge he faced was taking what had been completed from a clinical trial perspective and quickly widening and increasing its scale.

At the time, Sky Medical Technology had already completed the appropriate certification to use its device on patients, following a study by St Bart’s Hospital which demonstrated that it could improve blood flow significantly.

It had also proved effective in addressing post-operative oedema in a proof-of-concept trial.

But much more evidence was required to ensure the product could be commercially viable across multiple medical issues.

“The good thing about having a doctorate in life sciences is that you have the knowledge to design research protocols and develop hypotheses to look for appropriate outcomes,” said Day.

“With my academic background and experience in MedTech, the timing was right for me to help Sky Medical Technology build a clinical trials process and team to deliver the evidence needed for the geko device to reach its commercial potential.”

Creating the right trials

When Day joined the company there was already evidence that the geko device was helping prevent deep vein thrombosis (DVT) in immobile stroke patients at the University Hospital of North Midland NHS Trust’s acute stroke unit in Stoke on Trent.

“Thanks to the incredible commitment of clinicians such as Professor Christine Roffe at Keele University, and Dr Indira Natarajan at the acute stroke unit, we already had evidence that the device was effective in addressing risk of DVT,” said Day.

“But this was a patient audit, not a randomised control trial.

“In other words, the geko device had been deployed where patients were unable to use the current ‘gold standard’ treatment to reduce the risk of DVT in acute stroke patients – this being Intermittent Pneumatic Compression (IPC).

“Some 30% of patients find this treatment intolerant and the geko device was successfully providing these patients at Stoke with a viable alternative.

“When we took the device to a wider clinical audience with this evidence, many other clinicians embraced its use to address the unmet need. Some, however, see unmet need as a small requirement and remain to be convinced for this reason.”

For Day the next step was to develop a randomised control trial to compare the geko device directly to IPC across a cohort of 1,200 patients.

The objective of the trial was to deliver ‘rigorous outcomes that can be judged by medical peers and published data that delivers translatable evidence of positive patient outcomes’.

A platform technology

Sky Medical’s geko device is what Day describes as ‘a platform technology’; meaning it is potentially applicable to a range of conditions that can be improved by increased blood flow.

And, 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.

Day is, for example, currently completing a randomised controlled trial around the product’s impact on venous leg ulcers (VLU).

Currently, the gold standard treatment for VLUs is achieved through compression bandaging of the wound.

In this RCT, the geko device is being used additionally on half of the patients to identify if the combined treatment speeds up wound healing.

“The RCT involves using the geko device for four weeks and us photographing the wound,” explains Day.

“We then calculate how quickly the wound is healing compared to the use of dressings only.

“We are extremely close to completing that trial and the interim outcomes are very positive.

“Current gold standard therapy takes between three months and a year to close a wound, and some never close entirely. But we’ve seen average healing time in patients using the geko device in addition to wound dressing fall by half.”

A challenging environment

Despite the success to date, the COVID-19 crisis has hampered efforts to complete this RCT.

“COVID brought things to a standstill,” said Day.

“We had 12 centres actively recruiting patients into the wound study. Nine were closed during lockdown, and the other three stopped doing wound clinics.

“COVID has been a disaster for medical services that are deemed non essential and it has been a frustrating and expensive experience as large-scale equipment, rented for the purpose of the RCT, still needs to be retained despite not being used.

“Of course, the most-disturbing aspect is for patients who have either not had the treatments they should have, or have developed further illness during COVID.”

Finding the right champions

All clinical trials rely on the goodwill of key opinion formers within the clinical environment.

And these are busy people, even more so in a post-COVID environment.

Advising companies looking for the right clinical leaders to help champion innovation, Day told BBH: “Initially, we look at the academic media and find people that are well published in the area.

“Then we need to consider how best to approach these people.

“We may make an initial presentation to introduce the technology itself and, then, if we are fortunate, the clinician may further evaluate a device.

“It’s critical to build trusted and sustainable relationships with clinicians as they are typically well connected globally.

“For example, we are currently looking to complete a large trial in the US on woundcare.

“We are looking to use our trusted clinical contacts in the UK to help introduce us to their peers in the US.”

But he warns against trying to move too quickly, adding: “You need to be respectful of the goodwill of the clinician and understand the throughput of patients.

“And the pressure on healthcare services globally means MedTech companies need to be prepared to invest significantly in clinical trials.

“Typically trials are funded by companies – known as ‘industry sponsored studies’.

“We would pay for the trials, write, and manage the protocol for the trial and verify the data.

“We have successfully applied for grants to help fund such trials, but responsibility for the safety of the patient always falls on our shoulders.”

To overcome the insinuation of bias in an industry-funded trial, Day points to the importance of multi-site studies.

“By carrying out RCTs across multiple sites, we can ensure that data is robust across the entire study,” he adds.

Occasionally, though, Sky Medical does get involved in Investigator Sponsored Studies where 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 approach

Day is keen to highlight the importance of being patient when building an evidence base to support commercial deployment of MedTech.

“Companies need to remember the regulatory pathway is three years long; then there is a further three to five years to create commercial and marketable data,” he said.

Despite the burden of providing evidence, though, he is reassured that the regulatory environment is so stringent.

“Unlike other technologies, it is not simply enough to be safe to use,” he said.

“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.”

But his overriding message to other MedTech companies is to ensure they invest in clinical teams.

“At Sky Medical we are fortunate to have a product that can address multiple medical conditions and, of course, I would love to do all the trials we need to do immediately, across every medical condition, and every country; but I am realistic enough to know that we need to ensure we can properly manage all of our commitments,” he concludes.

“However, I would say that 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.