Rob Fraser (RF), MSc., Lab Manager at ViVitro Labs, met Dr. Padala during a tour of the southeast US and was impressed with Dr. Padala’s work and use of the SuperPump in his research. The following interview was conducted in late spring.
RF: Please tell us a bit about your current work.
MP: My primary job is to oversee and direct the structural heart research program in Cardiothoracic Surgery where our focus is on studying mitral valve disease and heart failure. Primarily we are studying mechanisms of mitral valve disease, in a manner that turn these findings into new technologies or solutions for use in patients. We start by studying mitral disease in human subjects with imaging, create the condition in bench and in-vivo animal models, develop new catheter technologies to treat the disease in these models, and translate the technologies back to use in humans.
From a device commercialization standpoint, we are yet to commercialize our inventions, but we have transcatheter technologies in pre-clinical trials. We do most of the testing in our laboratories and are hoping to spin these off into viable companies in the very near future.
RF: What are reactions from colleagues in the industry?
MP: Being at the interface of engineering, surgery and pre-clinical research, we get to interact with industry small and large. There is a lot of interest in the mitral space, which is our main area of interest. There is a lot of activity to treat mitral regurgitation and associated heart failure with new devices, but no one has ‘skinned the cat’ yet. So it’s an interesting and emerging field to be in.
RF: You are definitely in the forefront working in the mitral space. Can you give us an overview of how you go from basic science through to chronic animal studies?
Sure. The process we typically follow is: We start with the patient and we hope to end with the patient. We have a four step process –
(Step 1) Use cardiac imaging in patients to study mechanisms of mitral valve disease. At Emory, we have a pretty high volume of patients presenting with mitral valve disease, so there is a chance to conduct hypothesis driven clinical studies. We use echocardiography and MRI in these patients to understand the disease process.
(Step 2) Deriving from the human studies we try to mimic similar conditions in bench models and animals. This becomes our test bed for new insights, new techniques for valve repair, and new technologies as well.
(Step 3) We study the efficacy of the new techniques and technologies we have developed and publish them in literature, but before that we patent them so we can continue to develop them into products. Being at a university, we have access to a dedicated team that helps us with prosecuting the patents in a timely manner. Once the idea is protected, we develop the prototypes, mostly 3D printing the designs in our own lab or work with commercial vendors for Nitinol machining or silicone molding. We implant them back into the animal or bench models we have developed to get the proof of concept data.
(Step 4) Once that stage has passed through, we have a dedicated engineering team within our laboratory that focuses on taking these technologies forward to first in man studies. The team has engineers and technicians who are adept at validation studies, conducting failure and durability testing, and a person with dedicated time to document everything according to defined standards. We built this team over time, after realizing that this process really cannot happen in a traditional research environment.
RF: Could you highlight your benchtop testing and how ViVitro Labs plays a part?
MP: We use ViVitro SuperPump and the programmer for ex-vivo flow loop studies. In our lab we have developed pulsatile heart and aortic flow loops to test our devices and the SuperPump is an effective solution for us.
RF: What are your future research plans and goals?
MP: We are continuing the work in the mitral space. We have some exciting new surgical techniques that we recently presented at the American Association of Thoracic Surgeons meeting. We are on the verge of taking those techniques to try them out on patients. In parallel we are also developing transcatheter mitral valve repair and replacement technology in our laboratory.
RF: Do you have any advice for start-ups designing a novel device?
MP: That’s a tough question, as I never ran a start-up, not yet. I work amidst cardiac surgeons and cardiologists, and one thing I found very useful for engineers is a good understanding of the anatomy and mechanism of action. I have learnt that the simplest and most elegant solutions are the ones that make it to clinical use, not those over engineered or with too many moving parts. Spending substantial time in understanding the 3D anatomy has benefited us, and I have found surgeons to be great to bounce ideas off. They look at structures in 3D everyday, feel the tissue and have an intuitive feel of which devices might fail or stay. Cardiologists are great too, but I have found that their thinking is limited to echo views or fluoroscopic views that they see everyday, they think in 2D!
RF: Very valuable advice. For my final question, do you consider yourself an engineer or a clinician? Or both? And how does that impact your work?
MP: I’m not a clinician. I’m a mechanical engineer by training, with my research team in a clinical cardiac surgery division at Emory. I feel I design better solutions to clinical problems now after seeing human surgeries and doing several animal surgeries. It helps bridge the gap between theoretical solutions and practical solutions.
Read more interviews with Cardiovascular Pioneers.