Insights into an expanding industry
Globally, heart disease continues to grow at alarming rates with risk factors including congenital disease, diabetes, hypertension, myocarditis, poor diet, lack of exercise, and lifestyle choices. Indeed, according to recent World Health Organization data, cardiovascular diseases (CVDs) are the number one cause of death globally:
- An estimated 17.9 million people died from CVDs in 2016, representing 31% of all global deaths. Of these deaths, 85% were due to heart attack and stroke.
- Over three-quarters of CVD deaths take place in emerging markets.
A substantial percentage of those with a CVD will reach what is known as Class IV heart failure or end-stage failure. Once this point is reached, the patient prognosis is typically very poor.
Unfortunately, there are more people on heart transplant waiting lists than there are available donor hearts. In the USA, 3400 cardiac transplants were performed in 2018, while the current waiting list is 3760. This waitlist number remains relatively consistent due to a lack of donors.
Cardiac assist devices including Ventricular Assist Devices (VADs) together with Total Artificial Hearts (TAHs) are therefore becoming an increasingly common alternative for many people throughout the world. These devices are implanted mechanical pumps that either assist or completely replace a diseased heart. VADs may be temporary until an injured heart repairs (bridge to recovery), temporary until a donor heart is located (bridge to transplantation) or permanent (destination therapy). VADs typically consist of an implanted ‘pump’ connected to the heart which connects through the chest to an external controller and battery packs via a percutaneous (driveline) cable. Patients have options to carry the external components on belts, in pockets, in specifically tailored garments or bags/backpacks giving them a degree of independence and improved quality of life.
The technology and maturity of cardiac assist devices systems are advancing at a rapid rate, with new and improved systems under constant development. But there remains a significant opportunity to continue to improve the technology, and the experience, for the patient.
Hydrix has gained a reputation in the cardiac technology market over the past decade for its work in helping mature VAD and TAH technology. Our combined engineering, usability, and regulatory guidance offering is delivering a more comprehensive development outcome that provides greater confidence to our clients as they commercialize their core IP, and transition from proof-of-principle concepts to First-In-Human (FIH) trials.
Controller system innovation
The heart is an extraordinarily complex organ, able to adapt its output to rapidly respond to dramatic changes in physiological demands. This includes adapting to biomechanical changes with age and or fitness, accommodating changes in body mass, pumping blood efficiently without causing damage to cells, and doing it without tiring (typically) for many decades. The level of technology required of an electro-mechanical system to replicate these functions is therefore substantial and challenging.
The key challenges for electro-mechanical cardiac assist systems are associated with:
- achieving a dynamic response at least capable of supporting patients through normal cardiac output changes; e.g. moving from lying to standing or walking upstairs
- avoiding mechanical damage to blood cells and possible thrombosis
- over-pumping (suction) induced inlet collapse
- providing sufficient battery powered time (walk around time)
- delivering a system, particularly a pump, capable of reliably operating for many years
The development of the complex control system algorithms to address these challenges is a specific area of expertise for Hydrix. This level of technology can be required because of the inherent complexity of the device, e.g. fully levitated magnetic bearings, or because of a need to synchronize to physiological signals e.g. adjusting heart rate to match physical exertion, or due to the need to deliver reliable systems capable of being resilient to fault conditions. Architecting and designing for these requirements in the early stages of the development process is essential to delivering a product that is inherently safe and acceptable to market regulators.
Improving the patient experience
The reality of having an implanted mechanical device to either augment or replace the function of a heart results in a substantial upheaval to the life of a patient. It is a very stressful time for the intended patient, and for their broader ecosystem that either supports or is impacted by the VAD including:
- Surgeons, clinicians
- VAD coordinators (inpatient and outpatient care and support)
- Family and broader social network
Hydrix is applying user experience design methodologies as we work with VAD developers, patients, and patient support networks to innovate and improve on the experience of these devices and the broader VAD ecosystem. Starting from the basis of “How can we improve quality of life and the experience of the patient, their family, and their extended social network?” we are regularly testing novel ideas and design proposals within the VAD community. Activities include visiting cardiac units in the US and Australia, participating in fly-on-the-wall patient consults, gathering insights from the medical services providers, and identifying technologies that can be adapted into new controller devices.
As insights are gathered, we translate these into disruptive concepts for new product architectures, communications protocols, battery arrangements and power densities, maintenance and cleaning protocols, alerts and alarms, and information transfer ideas. Concepts are consolidated and tested again, progressing to more tangible prototypes to trial within the community. Our goal is to create solutions that are flexible, adaptable, and ultimately invisible.
Regulatory insight and guidance to accelerate device development
Achieving FDA and other regulatory body clearance for a medical device can be a major challenge, particularly for start-ups. The time, expense, and resources needed to obtain the necessary certifications can be an overwhelming barrier to successfully launching a new medical product, particularly in the cardiac technologies space.
In recognizing this common challenge for many clients, Hydrix has assembled a regulatory team with past experience including working for regulatory bodies (TGA), notified bodies (TUV Rheinland), as well as private industry with large and small medical device manufacturers. The team works closely with clients to understand their product landscape, maturity and vision to provide real-time guidance and feedback, and which may in perform tasks such as:
- Design History File gap analysis
- Design History File Remediation
- Standards compliance
- Tailoring a unique regulatory strategy that aligns with client needs and vision
- Understanding various regulators expectations of documentation rigor, allowing a streamlined & efficient process
The benefit of an experienced integrated regulatory team available to help implement regulatory strategy is that there is an opportunity to guide, prioritize and streamline key elements of the VAD controller development process. When combined with User Experience design and controller system innovation, we are developing the best solutions in a timely manner, and preventing the need for complex and costly corrective actions later in the development project.