Addressing this issue increasingly relies on innovation. The medical devices market is predicted to be worth more than $6 billion in 2020, growing 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 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 priorities to help address these issues: more diverse product portfolios, a faster time to market, and leveraging real-world evidence in product development.
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, for example after major surgery, the risk of suffering the negative impact of blood clots increases.
The OnPulse technology aimed
to deploy electrical pulses to stimulate a nerve in the lower leg and activate the calf and foot muscle pumps, resulting in muscle contraction. This has around 60 percent of the impact on blood flow increase as walking without raising someone’s pulse or blood pressure.
We believed this technology had the potential to reduce patient risk of serious illness from blood clots after an operation or an extended stay in hospital. To do so, it needed to become a medical device that could pass regulatory approval and 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 inflates and deflates to move blood through the veins.
From technology to device
Taking OnPulse technology from a series of patents to a functioning medical device was not simple. Critical to success was a close collaboration between R&D, manufacturing, clinical and regulatory functions and the commercial team. Collectively we were charged with creating a process by which a reliable and effective electronic device incorporating OnPulse technology, could be designed, iterated, manufactured, and receive regulatory approval.
Combining a collaborative process with a sharp focus on the needs and requirements of the end user, enabled us to be agile in bringing the product to market, minimising risks
and cost. The result has been the geko, a wristwatch-sized wearable device which is applied to a patient’s knee and delivers painless electrical impulses to stimulate blood flow. The increased blood flow helps to address a range of circulatory disorders, from life threatening blood clots, complications related to swelling after orthopaedic surgery and wound healing.
Key considerations
Central to bringing the geko device to market was balancing the needs and requirements of different groups into a product that delivers for multiple audiences. For example, clinicians know where nerves are located and understand how to find them. This same audience, however, is extremely time poor; they want a device that is quick to administer. Patients, on the other hand, have more time but less knowledge. Balancing these needs required a full, multi-language instruction sheet to help a patient correctly position the device for maximum effect, supplemented with posters and digital materials for clinicians to make application quicker.
A further important consideration was ensuring the geko device was comfortable for the patient to wear. We knew the OnPulse technology was clinically proven to stimulate blood flow in the leg in laboratory conditions. However, every person is different, with varying levels of tolerance: too little stimulation would not provide enough impact to shift the required blood; too much could prove uncomfortable. By incorporating an easy push button mechanism to increase and
decrease the electrical pulse, we could help patients and clinicians find the optimum stimulation.
Manufacturing flexibility
Any individual manufacturing issue, if not identified in a timely manner, could cause delays and additional cost. We are able to minimise this through an open communication channel with all parties: weekly meetings between the heads of R&D, regulatory and manufacturing ensure any issue was addressed quickly, and changes are incorporated early.
In the pursuit of operational efficiencies, we chose to outsource manufacturing and product assembly to partners able to accommodate agile product and process change and, most importantly, with an ability to manufacture small batch prototypes so that changes could be tested and incorporated quickly and effectively. In addition, partners needed to deliver a consistent and exceptionally high-level of reliability when manufacturing a final approved component or within an assembly process.
Regulatory approval
Medical device approvals routinely require the implementation of quality management system certifications, audits and factory inspections consistent with most international regulations and standards, placing pressure on our R&D and manufacturing function to rigorously test rolling product changes at all stage of the production process.
The impact of US FDA clearance is significant: many market regulators follow the FDA’s lead when it comes to approvals, and if a product already has FDA clearance, the approvals process for other territories can be much quicker.
The biggest hurdle to securing
approvals is the generation of clinical evidence to demonstrate beyond doubt the value of an innovation. Real-world data and Randomised Control Trials (RCTs) provide the best chance of success and minimise potential regulatory costs and time delays. Sky Medical Technology has gained nine FDA clearances for the geko device to date.
Product traceability
One important R&D development has been spearheading the addition of traceability within the geko device, giving Sky Medical the ability to pull up an internal log indicating how each device has been used. This has proven useful for measuring product performance during clinical trials and for routine the investigation of any product issues.
As adoption across different medical applications grows, so does the insight in both how the device can be most effectively deployed, and the tangible difference deployment makes. Deployment of the geko device in UK VTE prevention in acute stroke patients, is estimated to save the NHS £334 per patient, amounting to an annual saving to the NHS of £7.6 million.
The future
Key to turning promising technology into successful medical devices is a continuous journey of collaboration, where different disciplines proactively work together to address risks and issues. By doing so we can ensure risk and cost is minimised, helping to bring superior, life changing new medical innovations to market in a cost effective and efficient way. As products become less objects of value and more the means for remotely accessing information and experiences, future iterations of the geko will continue to evolve in this direction.