Passion of the Heart

The exacting task of designing and manufacturing lifesaving medical devices that must work perfectly - each and every time - is daunting.

SynCardia Systems Inc. is the manufacturer of the world's only FDA-, Health Canada- and CE-approved Total Artificial Heart: the SynCardia temporary CardioWest Total Artificial Heart.

Currently in the United States, patients supported with the Total Artificial Heart are confined to the hospital while they wait for a matching donor heart because they must be connected to the 450 lb "Big Blue" hospital driver that powers the device. Due to the scarcity of donor hearts, these patients often spend months in the hospital waiting for a heart transplant.

SynCardia, whose Total Artificial Heart has been implanted in more than 800 patients, recognized the need for a discharge driver that would allow stable patients to enjoy a quality lifestyle at home until a matching donor heart was found, explains Rodger Ford, SynCardia president and CEO.

In October 2007, SynCardia started development of the wearable discharge driver appropriately named Freedom. SynCardia chose to manage this project in-house using virtual design, development and manufacturing.

This resulted in the smallest pneumatic Artificial Heart driver in the world, much smaller than industry experts thought possible.

"The way we did it really involved product management with people who know the complete ins and outs of what we are trying to accomplish," Ford says.

FOCUS, DEDICATION

Passion is a word frequently used at SynCardia, and something the company looked for in its business partners.

Passion brings focus and dedication to the project, Ford states.

"We searched for the right subcontractors for each of the component pieces," Ford explains. "We wanted our vendors to understand our passion, and we wanted them to be the very best in the business of what they do." Ford and other SynCardia top management made a point of visiting subcontractors and meeting not just with the business leaders, but also with the people who would be doing the hands-on work, designing and building components for the Freedom discharge driver.

The selected subcontractors were invited to come to Tucson for a twoday meeting to work on the Freedom project and - just as important - bond with each other as a team, recalled Karen Nakamura, SynCardia's product manager.

The July 2008 meeting began with 28 people representing eight vendors.

"The event was to get everyone comfortable with each other and have a good time," Nakamura explains.

"Rodger is big on team building and how important that commitment is to success." The next day was all business. "It was the first time everyone was assembled together," Nakamura says.

"They walked away with a good understanding of what everyone's role was." Online meetings, phone calls and 24/7 internet messages were also instrumental in getting the job done.

"The number of e-mails I devoted to this project was more than 10,000," Ford says. "Everyone we are working with knows we are saving lives. If you get them passionate about a problem they are thinking about it all the time.

They believe in making it manufacturable, they believe in continuous improvements." The dedication from suppliers, combined with virtual engineering and manufacturing, meant a quick turnaround when problems often seen with new products arose.

ISSUE SOLVED!

During reliability testing of the Freedom driver, it was discovered that the units were producing more heat than expected. In addition, the foampadded Freedom carrying bag was retaining heat produced by the 12 lb driver, exacerbating the problem.

"We went into problem-solving mode at light speed," Nakamura says. "It was all hands on deck for vendors and SynCardia. It was a moment where virtual design and manufacturing allowed us to rise to the challenge." At SynCardia, a small fan was purchased and vents were opened in the driver's plastic body. Nakamura hurriedly worked to redesign the bag, replacing some of the foam padding with mesh fabric to increase airflow.

Freedom project vendors around the world worked to resolve the problem, Nakamura explains. At 5 a.m.

Tucson time, suppliers on the East Coast were called and activity followed the sun westward to include a supplier in the Philippines. "I was in the eye of the storm, watching everyone move quickly and making sure everything was getting addressed and moving forward," Nakamura says.

The addition of a fan and vents to the driver's body and the redesign of the bag resolved the temperature issue.

"We identified the problem on the 15th and on the 19th we had a solution," Ford says. "And, we revised the entire Freedom driver in only a month."

FREEDOM TO MOVE

No one - including Total Artificial Heart patients who are often stabilized within a few weeks - wants to be cooped up in the hospital. However, without a discharge driver, these patients must remain in the hospital, occupying an acute care bed, while running up thousands of dollars in hospital costs daily.

The Freedom driver is designed to allow these stable patients to return home and enjoy a quality lifestyle in their communities. The 12 lb driver is intended to be worn using the shoulder bag or back pack while the patient shops, drives, does chores and exercises, Ford says.

Freedom also offers big benefits to SynCardia Certified Centers because discharge eliminates most in-hospital costs for this portion of the patient's care, Ford explains.

The Freedom driver is now undergoing extensive lab testing prior to a U.S. Food and Drug Administration (FDA) application to conduct an IDE clinical trial to demonstrate that patients can effectively manage their driver while enjoying life at home, Ford explains.

The SynCardia reliability lab hums with the sound of Total Artificial Hearts powered by Freedom drivers. Independent components are durability tested to failure. Complete units are tested for reliability and to determine how often service will be required.

Freedom units are also being tested to make sure they can survive being dropped on each of its six surfaces and can operate at an elevation of 10,000ft. For patient safety, the Freedom driver utilizes a redundant design with a primary motor and a back-up motor in case of emergency.

In addition, as standard practice for any life-sustaining device, each Total Artificial Heart patient will receive two Freedom drivers. If there is an issue with one driver, it is designed for the patient to easily switch to the back-up unit, Ford says.

The cost of the Total Artificial Heart includes the use of drivers to power the patient's Artificial Heart for up to one year. The drivers are not for sale, and are returned to SynCardia after the patient is bridged-to-transplant or when scheduled maintenance is required, Ford says.

Once regulatory approval i s granted for the Freedom discharge driver, the company plans an initial production run of 500 units, which will support up to 250 people with the Total Artificial Heart.

Patients must be stable before they can be listed for a donor heart, Ford explains. SynCardia's Total Artificial Heart provides immediate, safe blood flow up to 9.5 liters per minute through both artificial ventricles. This high blood flow helps speed patient recovery, which shortens the time it takes for the patient to be listed to receive a donor heart. Statistics show that SynCardia Artificial Heart patients receive donor hearts sooner than patients with other mechanical circulatory support devices.

Each year, 300,000 people die of heart failure. For people dying from end-stage biventricular failure, there are only two options for survival: an immediate donor heart transplant or the Total Artificial Heart as a bridgeto- transplant.

For the last 20 years, the supply of donor hearts has remained flat, with only 2,200 heart transplants performed in the United States each year, he said. Ford believes about 12,500 patients per year could benefit from using the Total Artificial Heart, which means more than $1.5 billion in business for SynCardia in the United States alone.

"The Freedom driver is designed to free stable Total Artificial Heart patients from the hospital and provide them with a quality lifestyle while they wait for a matching donor heart," Ford explains. "Our commitment is to provide our device and drivers to the people who need it as their ‘Bridge To Life.'"

SynCardia Systems Inc.
Tucson, AZ
syncardia.com