The heart of the matter

Most people’s lives will, in some way, be touched by cardiovascular diseases (CVDs). It might be through the loss of a loved one or through their own struggle with coronary heart disease, cerebrovascular disease, deep vein thrombosis, congenital heart disease or another of the many diseases that affect the heart and circulatory system. According to the World Health Organisation (WHO), CVDs are still the leading cause of death globally, and that’s been the case since 1980. CVDs claim about 17.9 million lives every year, around 85% of which are due to heart attacks and strokes. The fact that one third of those deaths occur prematurely in people under 70 years of age is another startling fact. Whether due to hereditary risks or the typical behavioural risk factors of heart disease and stroke – unhealthy diet, physical inactivity, smoking and excessive consumption of alcohol – the human body is susceptible to weakness in the heart and the blood vessels, and raised blood pressure, elevated blood glucose, a high concentration of blood lipids and obesity are clear indicators that a body is at risk.

It is no surprise, therefore, that the market for medical devices to diagnose or treat CVDs is expected to grow strongly in the next few years. According to Precedence Research, the global cardiovascular devices market was valued at $52.9bn in 2021 and is expected to exceed $92.5bn by 2030. “The market for cardiovascular devices is constantly growing and fast – as much as 6–8% each year,” says Christa Schnider, director of business development at Jabil Healthcare, which produces a long list of equipment for the cardiovascular device market, from radiofrequency generators for hospital ORs and heart/lung machines, to pacemaker communicators that sit on the patient’s bedside and balloon catheters to clear clogged arteries.

Many different factors will likely contribute to that projected growth, but a very important one is the fact that a large number of countries have an ageing population, making more people prone to strokes and heart conditions. “This means demand for devices for diagnosis and treatment is growing,” says Schnider, pointing to technological advances like robotic surgery and more advanced implants as evidence. “Finally, more and more people are getting access to those treatments due to growing awareness and a higher level of wealth in society, which enables more people to get access to better healthcare,” Schnider adds.

At the cutting edge of cardiovascular devices, there’s no shortage of examples either. In 2021, Remo Care Solutions launched an AI-powered cardiac monitoring device; Angel Medical Systems announced the first commercial implantation of its FDA-approved heart attack warning system, ‘Guardian’; and the FDA approved the world’s first non-surgical heart valve treatment for paediatric and adult patients suffering from a native or surgically repaired right ventricular outflow tract (RVOT). In 2022, Biosense Webster launched the HELIOSTAR Balloon Ablation Catheter in Europe, which supports cardiac electrophysiological mapping of the atria and, when used with a compatible multichannel radiofrequency generator, cardiac ablation.

Fertile ground for innovation

As the global population continues to grow, and the average age in developed nations continues to rise, there is likely to be a growing incidence of CVD, which will encourage the adoption of even more technologically advanced cardiology devices for diagnostic and surgical use. At the same time, this will continue to reduce the cost of many critical cardiovascular devices used today – coronary stents being a prime example – and make current treatments increasingly accessible to a wider global market.

A recent study by the Harvard T.H. Chan School of Public Health (HSPH) showed that lower prices for coronary stents have fuelled a 43% increase in the number of heart operations in the Indian state of Maharashtra. As the market grows, there is increased incentive for medical device companies to invest heavily in research and development, so innovation should be rife in the coming years. For innovation to flourish, however, robust manufacturing processes – and the development of relationships with contract manufacturing organisations – will be crucial.

Jabil is the world’s largest healthcare contract manufacturer. Headquartered in St. Petersburg, Florida, it has around 100 plants in 30 countries, and 260,000 employees worldwide. As part of its healthcare division, Jabil’s medical device business unit provides foundational expertise in manufacturing and supply chain solutions, combined with engineering and design capabilities for the development of a broad range of product solutions. The company manufactures devices that are used in many healthcare applications, including anaesthesia, cardiology, diabetes care, endoscopy, haemodialysis, neurology and patient monitoring.

Among these, the cardiology segment is particularly important, given the growing market for devices that treat cardiovascular conditions. “Our portfolio includes self-assembly devices and entire products, as well as services for final testing, packaging and shipment to customers’ distribution centres, and we also provide design and development services,” Schnider explains. “We are involved with our clients very early in the process to help with design and development, and cardiology is a very important sector for us.”

In recent years, the revenue of Jabil has risen by $5bn, and Schnider says the cardiovascular sector has been a significant part of that growth. “The importance of that market means that we are investing in technologies like robotics and photonics to remain at the forefront of manufacturing processes for all of these products and devices,” she adds. Devices for the treatment of CVDs increasingly need to be smaller, as well as more sophisticated, and they need to enable minimally invasive procedures.

This, however, is familiar ground for experienced manufacturing organisations. “Miniaturisation and minimally invasive procedures have been around for 30 years, but the industry still faces a lot of pressure to find ways to achieve better outcomes and treat more patients,” says Ramy Awad, technical business development manager at Jabil Healthcare. “From an electronics perspective, we are able to utilise what we have learnt from other portfolios to bring novel solutions to the cardiology market. We have experts in electromechanical design, as well as many other areas – optics, augmented reality, virtual reality, mechatronics and more.”

When you make a device smaller, you need to make sure it is “still ergonomic”, adds Schnider. “You need to think about the surgeon. You need to be close to the end users as well as to your customers, which means you need two-way communication all along the supply chain.”

Primed for partnership

Successful manufacturing organisations, such as Jabil and Flex, will not only have extensive experience in the medical device sector, – and likely other industries where innovation and sophisticated engineering are essential – but also a strong approach to partnership.

Jabil, for instance, has a broad client base in the cardiology sector, and Awad says this is down to the breadth of services the company can provide. “Medical device companies really need a full solution provider,” he adds. “We provide a complete design and manufacturing service. Every OEM has a different need, so sometimes we come in from a design perspective, sometimes to act as an extension of the engineering team, or maybe to be an integral part of their team. At other times, we just handle the design of components.”

When it comes to innovation, the OEM owns the design and Awad says Jabil are not interested in competing with customers. “The contract manufacturer is just there to help and support them,” he adds. “Even if we design something brand new, the customer owns it and that is key, though that is not the case with all contract manufacturers out there. For us, it is all about relationships.”

A strong contract manufacturing partner is one that will dedicate resources to all stages of product development – including design, development and manufacturing – and considers the outcome for the OEM over the long term. Jabil’s approach is to create a business unit for each customer with a single point of contact and a business unit leader who acts solely to leverage the company’s resources for that customer and its device development programmes.

“At the heart of everything we do is the idea that we must have a sense of the patient at all times,” notes Schnider. “Our quality management system and our FDA registration are important, but we also have behavioural procedures in place so employees can understand why a particular product is being made and why it is important. Engineering and culture must go together.” Innovation and market growth are the dominant themes in the cardiovascular device market, but for long-term success, embedded relationships may be the bedrock on which those trends will be built.

 A STELLAR idea?

Catheter ablation has evolved into an established therapeutic option that aims to electrically isolate the pulmonary veins (PVs) from the atrial myocardium. The traditional method comprises point-by-point radiofrequency current ablation guided by electroanatomical mapping and has proven to be effective and safe in experienced hands. However, balloon-based ablation allows for quick, easy isolation of the PVs in a single shot. One of the most prominent balloon-ablation devices is the HELIOSTAR RF balloon from Biosense Webster.

In its STELLAR study, the company investigated the safety and efficacy of pulmonary vein isolation (PVI) using the HELIOSTAR Balloon Ablation Catheter in drug refractory symptomatic paroxysmal atrial fibrillation (AFib) – meaning cases of intermittent AFib that did not respond to treatment with pharmaceuticals. In the analysis, acute PVI was achieved in 98.8% of subjects and in 93% without additional use of focal catheters. Primary effectiveness at 12 months was 67.7% and >90% of patients were free from repeat ablation at 12 months. In addition, the rate of clinical success – defined in the study as freedom from 12-month symptomatic atrial arrhythmia recurrence – was 77.7%. The STELLAR study was an FDA-regulated investigational device exemption study conducted in the US, China and Italy to assess the safety and efficacy of PVI using the HELIOSTAR Balloon Ablation Catheter in drug refractory symptomatic paroxysmal AFib.

An article in the journal Arrhythmia & Electrophysiology Review noted the efficiency gained using RF balloons – isolating PVs within a minute as opposed to the two to three minutes of a cryoballoon. But the article said the long-term safety of such powerful devices remains to be seen, noting that in the previous RADIANCE trial that evaluated the one-year outcome and safety of the HELIOSTAR balloon, asymptomatic cerebral lesions were seen in 30% of patients, which is on the higher end of accepted ablation technologies. Gastroscopy also revealed asymptomatic oesophageal erythema in 13% of patients, which is also higher than reported for other ablation technologies. It should be noted that these outcomes fall within an acceptable range for ablation technologies, but it will be interesting to see if they’re consistent once the full STELLAR study results are released.