Recycling and saving lives!

Client: Project My Heart Your Heart (MHYH)

Problem: Identify and build tools and methods to increase the throughput and ease of the pacemaker refurbishing process.

Project My Heart Your Hearth (MHYH) is a non-profit organization that aims to create a blueprint for safe cardiac implantable electronic device (CIED) reuse. In collaboration with the University of Michigan Frankel Cardiovascular Center, MHYH has collected numerous pacemakers and implantable cardiac defibrillators (ICDs), developed protocols for re-sterilization and electrical testing, and started a clinical trial to demonstrate that reused pacemakers can be as effective as new ones. The target population for these devises are low- and middle-income countries (LMIC) as the people here do not typically have the same access to these lifesaving therapies due to the cost of the devices.

MHYH came to East Hill Studio because while they had a method to re-sterilize and test the devices, the actual refurbishing process was long, tedious, and needed a highly trained person to do the work. This meant that volunteers who can only came once in a while were not able to help in this process as the burden of training was too high. The goal of this project was to develop a more efficient and easily trainable workflow to allow the team to have a higher throughput of pacemakers and reach more people in need. The trickiest part of the refurbishing process is removing the silicone screw cap. This is a silicone cylinder that protects a screw that the surgeon will pierce through to connect the pacing leads to the pacemaker while installing the device. This needs to be removed so it can be sterilized, then replaced onto the pacemaker and covered with a new coating of silicone. The first step was to reverse engineer the pacemaker to understand how to better remove and preserve the screw cap for reuse. With a little patience and a sharp scalpel this was achieved. Knowing exactly what the screw cap looked like made it easier to remove and train novices on removing.

The next step was understanding the silicone application process and building an assembly line that achieved the desired throughput. The requirements were:

Assembly line shall accommodate multiple device sizes/shapes
Process should minimize use of silicone as it is $400/pint
Assembly line shall hold devices vertically as they dry
Assembly line should make it easy to go through 3 application/drying cycles per device
Assembly line should hold 100+ devices
Assembly line should have low cost, low maintenance, and require minimal training.

A number of concepts were developed and evaluated against the criteria. With cost being a high factor and a relatively low throughput the team decided that a manually actuated track in combination with an off-the-shelf controllable silicone dispenser was the best solution for this project. Checking in with the team a year later I got the following response: "The system is working perfectly and I could not be happier with the outcome."