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S&MA Partners to Offer Risk Analysis for Medical Industry


Catherine Ragin Williams |
October 1, 2019

NASA’s Johnson Space Center is pairing with BiVACOR, Inc., to improve the robustness and reliability of the company’s Total Artificial Heart (TAH) system — an implantable rotary bi-ventricular blood pump and associated external electronics. On Oct. 1, the partnership was inked via a Reimbursable Space Act Agreement during a commencement ceremony.

BiVACOR will leverage NASA’s expertise in Problematic Risk Assessment to help the medical industry assess the risk of ground-breaking high-reliability technology for medical components in extreme environments.   


“We are very pleased to be able to use the expertise of our safety community here at the Johnson Space Center to help BiVACOR advance their life-saving technology,” said Rex Walheim, deputy manager of Safety and Mission Assurance at Johnson.

NASA is a leader in providing risk management and analysis where test capability and data are limited, and BiVACOR hopes the TAH will benefit from the unique methods and technologies perfected by the agency for human explorers who routinely live and work in hazardous situations. The insight gained from this collaboration could positively impact the safety, reliability and physical dimensions of future medical devices.   

Using Problematic Risk Assessment, NASA will focus on analyzing the hardware design of the Non Form Factor Controller components, filling in the gaps to compensate for scenarios where test data is limited. BiVACOR will, in turn, use the findings to implement risk improvements to the controller.  

“Our company is excited to cooperate with NASA’s Johnson Space Center to enhance the safety critical features of our artificial heart,” said CEO and Chief Technical Officer BiVACOR Daniel Timms, Ph.D.

Though the fast-changing world of medical technology is inherently risky business, with Johnson’s proficiency in mitigating hazards in other worlds, the resulting added reliability for devices like the TAH will give future recipients hope — and, optimistically, heart.

Left to Right: Donna Shafer, JSC Associate Director, Rex Walheim, Astronaut and Deputy Director of Safety & Mission Assurance, Daniel Timms, Ph.D., CEO, CTO of BiVACOR, Inc
Left to Right: Donna Shafer, JSC Associate Director, Rex Walheim, Astronaut and Deputy Director of Safety & Mission Assurance, Daniel Timms, Ph.D., CEO, CTO of BiVACOR, Inc
 Walheim and Timms celebrate the agreement.
Walheim and Timms celebrate the agreement.
Spot Jim McIngvale “Mattress Mack,” Houston businessman & entrepreneur who was responsible for making the introduction of Walheim and Timms, which led to the agreement.
Spot Jim McIngvale “Mattress Mack,” Houston businessman & entrepreneur who was responsible for making the introduction of Walheim and Timms, which led to the agreement.