HeartMate III LVAD
About
During my fourth year in undergrad, I accepted an offer from Abbott Laboratories in Pleasanton, CA to co-op in the R&D manufacturing team. This location was the Mechanical Circulatory Support Division, for the HeartMate Left Ventricular Assist Device (LVAD) product line. An LVAD is surgically attached to the patient’s left ventricle to assist in blood circulation, with a driveline that exits the stomach region to an external controller unit and batteries.
Contributions
In the manufacturing department, I was exposed to behind-the-scenes of Class III medical device production. The major project of my co-op was verification and validation of an alternative production procedure for epoxy potting. I investigated the different variables in epoxy mixing and curing in addition to performing and analyzing data from differential scanning calorimetry to differentiate resultant epoxy cures. By the end of my co-op, I finalized the new epoxy curing procedure with an improved process control, and laid groundwork for the ensuing process validation plan.
Additionally, I provided FEA support in COMSOL and ANSYS. To explore an alternative helium leak testing method, I simulated helium diffusion in COMSOL to see what parameters and geometries would be useful. I already had a decent grasp of COMSOL from my microfluidics research for Sohn Lab, but I gained experience in defining conditions for larger-scale conditions like this. This simulation project opened the door for me to join a rigid object dynamics project: while I had no initial experience with ANSYS, I assisted a team addressing potential issues with packaging vibrations and climate conditions.
On the side, I performed occasional IQ/OQ and TMV tasks and gained a better appreciation for the documentation required in every little detail. My co-op coincided with a major CAPA so I glimpsed the pressure and planning behind addressing significant design changes. Another highlight experience was participating in a surgical practicum: I attached the LVAD pump to a goat heart’s left ventricle and sewed on the aortic graft. It was fascinating to experience the surgeon’s side of handling the product (picture here; not advised for the faint of heart).
Skills
SolidWorks, COMSOL, Manufacturing checks (IQ/OQ, TMV, etc), Class III medical device processes, Epoxy characterization, Design for manufacturing and assembly, Iterative prototyping, Hermetic sealing