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When Technologies Collide, Outcomes Improve for Cardio Patients


Posted in Cardiovascular by Jamie Hartford on August 21, 2014

Technological advances are enabling innovation in the cardiovascular space. The challenge for device makers is keeping up with these new developments.
 


By Benjamin A. Hertzog

In forecasting the future of cardiovascular disease in the United States, a report by the American Heart Association shows Baby Boomers and cardiovascular disease on a direct collision course. By 2030, it is projected that more than 40% of Americans will have some form of cardiovascular disease. Even the most health-conscious Baby Boomers won’t escape cardiovascular disease. One in three members of this generation will eventually develop heart problems.

Learn about innovations in cardio devices in an October 30 session at the MD&M Minneapolis conference.

With their active lifestyles and desire to play a more assertive role in making healthcare decisions, Baby Boomers are forcing manufacturers of cardiovascular devices to rethink quality of life design requirements. Design and functional compromises that might have been tolerated by previous generations could be the kiss-of-death to the commercial success of new devices aimed at Boomers. Even with life-sustaining devices, such as left ventricular assist devices (LVADs), focus has shifted to quality of life they provide, not just the quantity of years they can add to it. At the same time, increasing focus on the cost of healthcare is putting new pressures on medical device manufacturers to provide high-value solutions.

The good news is that recent (and rapid) advances in technology and fabrication methods have improved the safety and performance of cardiovascular devices, and these technologies are also laying the groundwork for improved quality of life and reduced costs. Improvements to electronics, battery power density, wireless communications, biomaterials, minimally invasive procedures, wireless power transfer, rapid prototyping, and microfabrication have all provided designers with a new set of tools to make dramatic improvements on the previous generations of medical devices.

The CardioMEMS HF system consists of an implantable, wireless device for measuring pulmonary artery pressure and heart rate (top) and a pilow and transmitter (bottom).

The bad news, or at least the challenge for designers of cardiovascular devices, is that innovation often requires the integration of increasingly complex technologies to meet tomorrow’s needs. Commercially and clinically viable devices must incorporate sophisticated electronics with advanced materials to deliver simpler implantation techniques, fewer hospitalizations, reduced readmission rates, lower costs, and improved patient convenience. These advanced materials and technologies may come with additional short-term burdens (e.g., regulatory scrutiny), but they are likely to pay huge dividends in the long-term.

At the same time that technological advances are allowing designers of cardiovascular devices to innovate and do more with less, devices are also becoming increasingly more complex. One continuing trend is miniaturization and a move toward fully implantable devices, making indwelling electric or mechanical drivelines a thing of the past. As direct result of fully implantable designs, wireless power and communication features are being introduced to many next-generation designs, ushering in new era of remote monitoring. This has played out in the rhythm management arena. Pacemakers have evolved from wearable devices, to fully implantable, to multifunction devices like internal cardioverter defibrillators and cardiac resynchronization therepies, and now to a new era of leadless pacing and devices equipped with wireless communication and monitoring capabilities.

Some innovators in the cardiovascular space are bucking the trend of complexity by intelligently deploying new technologies to create artfully simple devices. Earlier this year, FDA approved the CardioMEMS HF system, the first implantable, wireless device for measuring pulmonary artery pressure and heart rate in heart failure patients. The device allows physicians to monitor patient data and make changes in the therapy before a medical event leads to hospitalization.

Effectively powering implantable devices has long been a challenge due to battery limitations, functionality, electrical connectivity, and biocompatibility. The CardioMEMS system includes a battery-free sensor, a resonant circuit consisting of a capacitor and an inductor, a transvenous delivery system designed to deploy the implantable sensor, and two nitinol wire loops that fix the device into position. As described by the company, which was recently acquired by St. Jude Medical, the device eliminates the need for a battery because the presence of an inductor coil allows the sensor to be electromagnetically coupled and the resonant frequency of the inductor-capacitor circuit measured remotely, allowing for wireless communication with the sensor. This clever use of technology has resulted in a passive implantable device that does not require internal power and can be read from outside the body.

Procyrion’s Aortix intraaortic support pump can be fully implanted without any indwelling leads thanks to the use of a number of technological advancements.

Innovations in wireless power and miniaturization are also driving step-change improvements in other cardiology tools designed to treat heart failure patients earlier and with less invasive procedures. An example is Aortix, a first-in-class intraaortic circulatory assist device designed to allow the heart to rest and heal without surgery. Positioned downstream of the heart, the tiny device is quite complex, combining an implantable blood pump, self-expanding nitinol anchors, and a sophisticated power and control system. The catheter delivery system leaves behind a small-diameter electrical power lead that connects to the power and control system, which can be externalized and worn on the patient’s belt like a smartphone or fully implanted under the skin. The device has the potential to reach younger, healthier patients, thereby treating the illness before it reaches advanced stages requiring more invasive treatment.

Although fully implantable and wirelessly powered heart pumps have been attempted for many years, recent advancements in the fields of biomaterials, micromotors, batteries, and rapid prototyping have enabled Aortix’s designers at Procyrion Inc. (Houston, TX) to create a micro-pump around 6 mm in diameter that can be fully implanted without any indwelling leads. The small size and low power requirements mean that power and communication with the device can be achieved wirelessly through the skin and battery life can be engineered to provide extended periods of tether-free use, allowing patients to remain active and enjoy a high quality of life.

As manufacturers of cardiovascular devices feel the pressure to reduce the time and cost required to bring their products to market, another technological advancement they can leverage is rapid prototyping. Developers of cardiovascular devices can use the many rapid prototyping platforms available today to accelerate and reduce the costs associated with product development and design. Procyrion has used the following rapid prototyping technologies at various points throughout the development of the Aortix device:

  • Direct metal laser sintering for structural metal implantable/sterilizable pump components in 17-4 stainless and Ti 6-4.
  • Sterolithography for small pumping components for in vitro performance testing
  • Thermoplastic extrusion (e.g. FDM) for enclosures and form-factor prototypes.
  • PolyJet for implantation tool prototypes (e.g., sterilizable handles).
  • Selective laser sintering (SLS) for fixtures and performance prototypes using engineering resins.

With rapid prototyping, new concepts and different design iterations can be made, received, and tested within days. Compared with the high cost and long lead times of conventional CNC machining, rapid prototyping is especially advantageous for early-stage startups, for which commercializing a product involves time concerns and monetary risks. Moreover, recent advances in rapid prototyping have led to an ever-increasing range of materials including metals and engineering-grade plastics as well as improvements in accuracy and resolution. The main challenge for cardiovascular device innovators is keeping up to date with the various rapid prototyping technologies. They each have their strengths and weaknesses with respect to material properties, cost, and resolution, and the field is evolving rapidly.

While patient needs drive design requirements for mobility and quality of life, it is up to innovators in the cardiovascular space to deliver devices that meet these needs. Manufacturers are striving to come up with solutions that meet innovation challenges and stand up to regulatory scrutiny. From impellers to pump housings and electronics, next-generation devices require newly conceptualized parts rather than off-the-shelf components. OEMs and their supply partners must be aware of these trends and be willing to push the boundaries to deliver innovative and cost-effective solutions that are so desperately needed by the clinical community.

One model that has worked well for Procyrion is the partnership model. Procyrion actively seeks out contract manufacturing partners that can work in a highly collaborative environment and are willing to share in the risks and rewards of each project. This team-based approach leverages the best practices and specific skills across each organization. Because innovation is so often being driven by small technology startups, these companies need the help of suppliers and contract manufacturers willing to find creative ways to collaboratively support the project and participate in the development of novel, life-saving innovations. Particularly in the cardiovascular space, this collaboration among various players creates a competitive advantage. Ultimately, it is a win-win-win for innovators, suppliers, and, most importantly, patients.

Learn about innovations in cardio devices in an October 30 session at the MD&M Minneapolis conference.

Benjamin Hertzog, Ph.D., an experienced startup entrepreneur with a focus on medical devices, diagnostics, and healthcare services, is president and CEO of Houston-based medical device firm Procyrion Inc.

 


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