The fact people are living longer globally is great news for mankind, but it does not come without new challenges. In the 1950s, there were approximately 14 people employed to every single person retired. By 2050, the ratio will be closer to two employed for every one retired¹ and—in some developed countries—it is possible as many people will not be working as will be employed. This trend has been accelerated by the pandemic, with more than 3 million people retiring early in the U.S. alone.²

The challenge is one of dependence. Those paying taxes need to fund those who are not, so fewer people working increases the burden on those that do. Healthcare services are further complicated by their own success. We are now much better at keeping people alive for longer than we ever have been in the past. But, of course, this comes at a significant cost. As we become more proficient at treating people, the cost of healthcare services increases. Additionally, the burden placed on healthcare systems by COVID-19 will have a lasting and significant impact, requiring additional investment to address backlogs in care and surgery.

All this combined means healthcare systems of the mid-21st Century will need to be very different from those of the earlier century. Increasingly, the conversation will focus on finding breakthrough methods through which to deliver better healthcare at a more effective cost.

Enter Medtech

One potential way of narrowing the gap between unlimited demand and limited resources is through technology. The deployment of medical technology (i.e., medtech) can be transformational for healthcare systems. It can help reduce the cost of treating people, deliver critical insight to help further improve treatment, and see the deployment of products that address multiple clinical issues with one solution. Medtech could significantly contribute to bridging the gap between medical need and healthcare affordability.

However, bringing a medtech solution to market can be difficult. The journey from idea to adoption is long, expensive, and challenging, as we discovered when developing a device to help address life limiting medical conditions in the hospital and home.

The Power of Electricity

This journey began with a simple concept: to mimic the body’s own nerve signals in the lower leg to increase blood circulation back to the heart. Through an innovative mechanism of non-invasive neuromuscular electro-stimulation, we developed a ground-breaking technology platform—OnPulse—designed to contract the calf and foot muscle pumps to increase blood flow in the deep veins of the calf. When this occurs, biologically and physiologically, it has a positive impact. For example, swelling is reduced in patients experiencing edema following orthopedic surgery, and wounds heal more quickly. For patients in the hospital, unable to move, improved blood circulation helps significantly reduce the risk of life-threatening blood clots.

For the last decade, our business has been focused on turning this principle into a compliant and commercially viable product. The result has been the geko device: a wearable medical device that has regulatory clearances in the U.K., U.S., and globally. It is clinically proven to provide blood clot prevention for immobile acute-stroke patients, alongside the management of post-operative and trauma-based edema in orthopedic patients. The device has been far from simple, however, as it traveled from concept to commercialization.

Early Beginnings

The first challenge involved the question of how to productize the concept. It was immediately obvious that any product we manufactured would need to achieve wide regulatory compliance and be supported by clinical data that demonstrated its positive impact on patients. Additionally, health economic data would be critical to commercial adoption.

The challenge, therefore, was to make a product, prove it worked in the laboratory, conduct trials to demonstrate it helped patients, and show it could save healthcare systems money and gain the necessary approval to commercialize the product. This entire process relied on coordinating a wide range of functions including R&D, design, regulatory affairs, supply chain, and manufacturing, as well as ensuring the product was simple to adopt, use, and dispose of at the end of life.

Designed for Life

Working with a respected product design company, we created prototypes of a device that could incorporate the electronics and components required for the product. It needed to be lightweight and small in size (no wires or leads), but also robust, reliable, and easy to use. Critically, the clinical use case needed to be a device that could follow the patient home, post discharge, to aid enhanced recovery after surgery.

One of the satisfying elements of the design process was, when the device is working as expected, the patient gets a twitch in their foot every second or so. It is not enough to keep someone awake at night, but is reassuring in letting patients know the product is working as expected and the level of electrical pulse is correct.

Regulatory Hurdles

The process of achieving regulatory approval can often be long and complex. The geko device was the first bioelectronic product of its kind to receive both National Institute for Health and Care Excellence (NICE) approval and U.S. Food and Drug Administration (FDA) clearance for venous thromboembolism (blood clot) prevention across all patients, including non-surgical patients. However, the process of generating approvals to sell in new markets never ends, not least because the regulatory landscape is constantly changing.

The support of clinical champions is absolutely critical to this process. Early adopters of technology can provide valuable feedback and help progress clinical trials, but most importantly, evangelize a product to wider audiences. We were fortunate to work with many clinicians that sacrificed their own time to support the development of the geko device real-world data.

One simple example of how challenging the market is comes in the form of the instructions on how to use the device. These need to comply with specific regulations in every country where a device is being sold. Each country will have different regulations, so while the product itself may not change, the packaging and instructions will, meaning moving stock from one market to another is complicated and expensive.

Manufacturing Smart

Regulatory compliance has an impact on manufacturing—not only in terms of ensuring a product is reliable and compliant, but also, in managing specific stock levels. Excess stock can be a significant cash drain for any startup business, but in medtech, there is further friction caused by ensuring there is always a steady and reliable supply of devices upon which patients can depend.

Sky invested in building and continuously improving a quality management system to ensure compliance with medical device regulations, including ISO 13485 and 21 CFR. By participating in the Medical Device Single Audit Program (MDSAP), we have gained access to multiple geographies including the Americas and Australia through one single, efficient audit process.

Open Communication

In many ways, the most important element of bringing a product to market in medtech is effective cross-business communication. A business can have a team of subject matter experts in manufacturing, regulation, design, research and development, and clinical approvals, but the key to success lies in extracting and sharing relevant information other parts of the business need to know—whether that is commercial, marketing, or operations.

A Long-Term Investment

Despite the challenging hurdles that medtech companies face in commercializing products, there is a growing interest in investing in the industry. We may have a longer runway before commercialization than traditional technology products and services, but investors often show considerable patience and support for medtech companies, recognizing they can be both shrewd investments and contribute positively to mankind.

Our investors have been incredibly supportive to the business as it negotiates a path through the necessary challenges before commercialization, helped by our ability to provide a commercially viable partial exit along the way. For many investors, the longer-term opportunities offered by innovative medtech solutions that can address multiple markets with one common product or technology outweigh the shorter-term demands for a faster return.

A Long but Rewarding Journey

Medtech innovation is not for the impatient or faint hearted, but while the journey itself can be extremely complex, the destination is worthwhile. It is hard to imagine a better feeling of satisfaction than knowing the process of development has led to improvements in people’s wellness or helped reduce the risk of a significant health risk. 

References

1. bit.ly/odt221151
2. bloom.bg/3NuxjZw

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Bernard Ross is founder and CEO of Sky Medical Technology (Sky), a company that creates innovative medical technology products that help save lives and cut the costs of healthcare. Sky has faced the complex challenge of balancing design, manufacturing, regulatory and compliance issues to commercialize a product for global adoption in medtech.