The Medical Technology (MedTech) industry has rapidly developed in the last decade, offering new and innovative ways to address some fundamental medical challenges.
Matt Watts is head of Product Research & Development at Sky Medical Technology, a British MedTech company that has created the first NICE-approved, bioelectronic muscle pump activator of its kind indicated for use in the US for VTE prevention across all patients, including non-surgical patients, alongside clearances for blood flow increase and oedema reduction.
In this article, Matt outlines the collaborative processes that turned a patented technology into a medically proven product, and how this process was driven by close collaboration between the R&D, regulatory, manufacturing and commercial functions – informed by valuable feedback from those who would be prescribing and using the device: patients and clinicians.
The age of MedTech
The global Covid-19 pandemic may have accelerated the need to manage limited healthcare resources effectively, but this is not new. The growing number of people living longer continues to place increased pressure on healthcare systems globally.
Addressing this issue increasingly relies on innovation. The medical devices market is predicted to be worth more than $6 billion in 2020, growing rapidly to $8.5 billion by 2025 – with bioelectronic medicine being one of the fastest growing areas. In 2019 alone, almost 14,000 patent applications were filed with the European Patent Office (EPO) in the field of medical technology.
A 2018 report from the Deloitte Centre for Health Solutions neatly encapsulated the challenges facing the industry. The report conducted research with 22 MedTech companies to understand how research and development leaders were responding to pressure to improve efficiencies and reduce costs. The companies interviewed identified three key priorities to help address these issues: more diverse product portfolios, a faster time to market, and leveraging real-world evidence in product development.
Building a case for medical adoption
These three priorities resonated closely with our own experience at Sky Medical Technology. Our journey began with a technology called OnPulse™.
For millions of years mankind has maintained its wellbeing by walking. As well as acting as an excellent form of exercise, walking causes blood to be evacuated from deep veins. When blood remains in the deep veins, it can increase the risk of life-threatening blood clots. When people are unable to move, the risk of suffering the negative impact of blood clots increases. This is often a complication or risk for patients who are immobile after major surgery. It is also one of the reasons why clinicians want post-operative patients up and about as soon as possible.
The OnPulse™ technology aimed to deploy electrical pulses to stimulate the common peroneal nerve and activate the calf and foot muscle pumps, resulting in muscle contraction in the lower leg. This has around 60 percent of the impact on blood flow increase in the deep veins as walking but does so without raising someone’s pulse or blood pressure.
We believed that this technology had the potential to reduce patient risk of serious illness from blood clots in the aftermath of an operation or an extended stay in hospital. However, to do so, it needed to become a medical device that could pass regulatory approval and ultimately be recommended by clinicians to patients as a viable alternative for patients unable to be treated by or to tolerate intermittent pneumatic compression devices (IPC) – a cumbersome, full or half leg plastic sleeve that repeatedly inflates and deflates to move blood through the veins.
The journey from technology to device
Taking OnPulse™ technology from patent to a functioning medical device was no simple process. Critical to success was a close collaboration between the R&D, manufacturing, clinical and regulatory functions and the commercial team. Collectively we were charged with creat