Jonathan Harrington, Divisional Vice President of Operations and Global Supply Chain at Abbott’s Cardiac Rhythm Management business03.20.24
Medtech is witnessing a revolution across industries, especially in cardiac rhythm management. People who have heart irregularities often turn to a cardiac pacemaker, a hockey puck-sized device that delivers electrical impulses to the heart. While innovative for its time, today’s cardiac pacemaker is essentially the same device it was in 1958. People with heart irregularities deserve modern, innovative treatment options.
Traditional pacemakers pose several health challenges. Inserting each device requires a two- to three-inch incision in the upper chest. The “pocket” it is placed into is visible and causes scarring. In addition, the cardiac leads in the device can result in infections, which often require another procedure to replace the pacemaker.
The medical device industry has long sought solutions to these challenges, but they have been unsurmountable—until now. Approved by the U.S. Food and Drug Administration, Abbott’s AVEIR DR is the world’s first dual chamber leadless pacemaker system to treat people with slow or irregular heartbeats.
In order to be implanted directly into the right atrium and right ventricle, it was crucial for the device to be miniaturized. The device and leads were replaced with two separate capsule-size devices roughly one-tenth the size of a traditional pacemaker. When implanted directly inside the heart they are not visible and reduce lead-related complications. This design allows the leadless pacemaker device to be inserted using a minimally invasive procedure, helping many people to quickly return to their normal lives.
A person’s therapy needs can evolve. That’s why the team developed the devices to be retrievable. The AVEIR DR leadless pacemaker system attaches to the interior surface of the right atrium and right ventricle with a screw-in mechanism known as a helix. This unique helix design also provides real-time mapping capabilities during the procedure so physicians can determine the proper placement of each device before implantation.
Finally, the individual devices need to communicate with each other at every heartbeat to deliver the appropriate stimulation for ideal pacing. To overcome this communication challenge, the R&D team developed proprietary i2i (implant-to-implant) technology that provides beat-to-beat synchronized pacing based on a person’s clinical needs. The first-of-its-kind i2i technology uses high-frequency electrical pulses to relay messages via the body's own blood and tissue. This conductive process uses less battery current than other forms of communication like radio frequency or Bluetooth, which are used in traditional pacemakers.
Externally, Abbott invested in its suppliers and created long-term partnerships to identify and secure the materials needed to produce innovative and high-quality components. For example, because the devices had to be small enough to be placed into the chamber of a heart, the battery, docking mechanism, and titanium external case needed to be a single unit. This required special engineering involving the coordination and cooperation of suppliers as well as revamping Abbott’s internal processes.
Internally, the company sourced new production and test equipment while training employees on how to produce the devices efficiently and effectively at high volumes. Abbott adapted its entire manufacturing process, test fixtures, and programs for AVEIR DR’s unique i2i communication protocol. All of these new processes and equipment are managed by a performance system that leverages the latest Industry 4.0 concepts. This enables Abbott to drive productivity and ensure the highest possible quality. As a last step, Abbott evolved its distribution and customer delivery model to avoid potential shipping and customs delays caused by the new technology included in the breakthrough device.
Revolutionary devices are a reminder that we must innovate manufacturing techniques, technology, and processes to drive the industry forward. We can’t settle for the status quo. When leading organizations address unique manufacturing challenges, it opens the potential for other medical device manufacturers to advance their own capabilities and help improve the lives of people worldwide.
Jonathan Harrington is the Divisional Vice President of Operations and Global Supply Chain at Abbott’s Cardiac Rhythm Management business.
Traditional pacemakers pose several health challenges. Inserting each device requires a two- to three-inch incision in the upper chest. The “pocket” it is placed into is visible and causes scarring. In addition, the cardiac leads in the device can result in infections, which often require another procedure to replace the pacemaker.
The medical device industry has long sought solutions to these challenges, but they have been unsurmountable—until now. Approved by the U.S. Food and Drug Administration, Abbott’s AVEIR DR is the world’s first dual chamber leadless pacemaker system to treat people with slow or irregular heartbeats.
Overcoming the Status Quo Required a Revolution
To build this medical marvel, Abbott’s cardiac rhythm management (CRM) R&D team completely reimagined the pacemaker. Their new design, communication, operation, and insertion process transforms the paradigm of pacemaking. The team of medical product designers focused on three innovative components to overcome the engineering technological challenges: it needed to be small, retrievable, and communicative.In order to be implanted directly into the right atrium and right ventricle, it was crucial for the device to be miniaturized. The device and leads were replaced with two separate capsule-size devices roughly one-tenth the size of a traditional pacemaker. When implanted directly inside the heart they are not visible and reduce lead-related complications. This design allows the leadless pacemaker device to be inserted using a minimally invasive procedure, helping many people to quickly return to their normal lives.
A person’s therapy needs can evolve. That’s why the team developed the devices to be retrievable. The AVEIR DR leadless pacemaker system attaches to the interior surface of the right atrium and right ventricle with a screw-in mechanism known as a helix. This unique helix design also provides real-time mapping capabilities during the procedure so physicians can determine the proper placement of each device before implantation.
Finally, the individual devices need to communicate with each other at every heartbeat to deliver the appropriate stimulation for ideal pacing. To overcome this communication challenge, the R&D team developed proprietary i2i (implant-to-implant) technology that provides beat-to-beat synchronized pacing based on a person’s clinical needs. The first-of-its-kind i2i technology uses high-frequency electrical pulses to relay messages via the body's own blood and tissue. This conductive process uses less battery current than other forms of communication like radio frequency or Bluetooth, which are used in traditional pacemakers.
Insights for Medical Device Manufacturers
Manufacturing revolutionary devices presents unique challenges. For nearly a decade, the team worked to establish these game-changing features, with the most significant one being the i2i technology. They conducted a variety of tests to establish communication between two leadless pacemakers on every heartbeat, one of which occurred in a fish tank. This test mimicked the sensation of having the two leadless pacemakers implanted in two different chambers of the heart. When the test chips worked, the team knew the i2i technology was a success for the device and would revolutionize the way we treat irregular heart rhythms.Externally, Abbott invested in its suppliers and created long-term partnerships to identify and secure the materials needed to produce innovative and high-quality components. For example, because the devices had to be small enough to be placed into the chamber of a heart, the battery, docking mechanism, and titanium external case needed to be a single unit. This required special engineering involving the coordination and cooperation of suppliers as well as revamping Abbott’s internal processes.
Internally, the company sourced new production and test equipment while training employees on how to produce the devices efficiently and effectively at high volumes. Abbott adapted its entire manufacturing process, test fixtures, and programs for AVEIR DR’s unique i2i communication protocol. All of these new processes and equipment are managed by a performance system that leverages the latest Industry 4.0 concepts. This enables Abbott to drive productivity and ensure the highest possible quality. As a last step, Abbott evolved its distribution and customer delivery model to avoid potential shipping and customs delays caused by the new technology included in the breakthrough device.
Positive Future Outlook
The availability of AVEIR DR marks a pivotal moment in the history of cardiac rhythm management for patients, physicians, and manufacturers. By overcoming the long-standing challenges of pacemaker technology, this device sets a new standard for the Medtech industry.Revolutionary devices are a reminder that we must innovate manufacturing techniques, technology, and processes to drive the industry forward. We can’t settle for the status quo. When leading organizations address unique manufacturing challenges, it opens the potential for other medical device manufacturers to advance their own capabilities and help improve the lives of people worldwide.
Jonathan Harrington is the Divisional Vice President of Operations and Global Supply Chain at Abbott’s Cardiac Rhythm Management business.