Path to innovation: Crafting the gold standard in Ventricular Assist Device certification

August 17, 2021  //  FOUND IN: Our Employees,
Graphic of a heart with an attached VAD device.

A Ventricular Assist Device — or VAD — is a life-sustaining technology for severe heart failure patients. And now, two U-M nurses are helping develop a comprehensive certification program for clinicians who treat VAD patients.

The first-of-its-kind certification will be a comprehensive exam that goes beyond how to work the device, delving into the specific skills and expertise nurses need to best care for patients with a VAD.

Caty Johnson, R.N., and Stacy Haverstick, R.N., began working together as part of the world-renowned VAD team at U-M, one of the first VAD programs in the U.S. As highly experienced nurses, they recognized the need for more thorough VAD training to provide impeccable patient care and help patient quality of life.

“VAD equipment is very complicated,” said Haverstick. “The device is surgically implanted into a patient’s heart and pumps blood throughout their body. If the pump stops, a patient would die without immediate medical help. A patient is on a VAD for life unless they’re a transplant candidate.”

The VAD team wanted to learn more about inpatient nurses’ VAD skills and understanding, so they created a survey to study how VAD-trained nurses felt about working in the specialized area.

“Overwhelmingly, we found that because there is no standardization to be an expert in VAD care, there is a lack of knowledge and confidence in caring for the VAD population, a lack of frequency working with VAD patients and a fear of VAD equipment,” said Johnson.

Looking for a solution

The team started looking at ways to enhance in-house VAD training for U-M nurses. It didn’t take long for the idea to evolve into providing the highest level of VAD training to nurses not just at the university, but around the world. So they started exploring the idea of developing an international certification exam for Ventricular Assist Device Clinicians called VAD-C.

U-M is uniquely positioned to establish care standards because the Frankel Cardiovascular Center (FCVC) Heart Failure Program is a leader in both research and clinical experience implanting and managing VAD devices in patients. Some of the longest living VAD patients in the world are at U-M.

Innovation Challenge sets stage for success

The project really began to take shape when the team presented their VAD-C certification idea and won the $100,000 grand prize in the 2017 FCVC Innovation Challenge, an annual competition offered by the FCVC and Fast Forward Medical Innovation (FFMI) that is open to all FCVC faculty, staff, trainees, patients and families.

“Winning the Innovation Challenge gave us the ability to move the VAD-C project forward,” said Johnson. “We started off by working with the Simulation Lab and providing in-house education, but we didn’t know where to go after that.”

FFMI fastPACE Course fills in the business blanks

That’s when they were contacted by FFMI and learned about FFMI fastPACE, a four-week biomedical innovation and commercialization course that helps life science innovators with early-stage projects prepare a successful business case for funding and development partnerships.

“FFMI fastPACE was invaluable to our project,” said Haverstick. “We wouldn’t be where we are without it. The course provided the guidance we needed to learn the business side of things and how to move the project along. From customer discovery, market share and benchmarking, to procurement, legal and shared services, the course taught us all the logistical aspects we needed to make this work.”

“FFMI fastPACE also taught us how to push forward and not take ‘no’ for an answer,” said Johnson. “We had the grant money but didn’t know what to ask for or plan for — and the mentorship and direction FFMI fastPACE provided helped us organize and create a solid plan to present to the FCVC directors to get the additional support we needed to take this project to the next level.”

Building a strong foundation

When the VAD team had their plan in place, it was time to connect with outside organizations to put things in motion. The VAD team entered into an equal partnership with the well-known International Consortium of Circulatory Support Clinicians (ICCAC), which provides credibility for the exam, and takes equal responsibility for the exam preparation and for ongoing marketing and financial costs/risks.

Once the ICCAC partnership was established, the VAD team contacted PSI, a global leader in delivering successful testing programs that helps create test questions and certification exams, as well as provides the infrastructure to support the financial aspect, psychometrics of the exam and the actual exam taking.

Taking the next steps

With these collaborators in place and the VAD-C certification taking shape, the team still needed help navigating U-M’s entrepreneurial ecosystem and finding the appropriate business path forward. Once again, the VAD team turned to FFMI for guidance. 

“The FFMI Business Development team stepped in and has been extremely helpful,” said Haverstick. “They have been invaluable in answering our questions, connecting us with the right people, helping us find a path through the university for contract negotiation and working with U-M Tech Transfer for a mechanism to handle proceeds.”

As the VAD team gets closer to seeing their VAD-C project become an internationally recognized certification exam — which is expected to happen in early 2022 — they are grateful for the guidance they’ve received from FFMI along the way.

“Our experience with FFMI has been instrumental to our success as we continue to move this project forward,” said Johnson and Haverstick. “The FFMI team helped us shape our idea and build it into a reality. We’re excited to bring it to fruition and help heart failure patients around the world enjoy full, active lives.”

Learn more about the U-M VAD program.