Heart Failure Clinical Trials with Sonna Patel-Raman

<p><span style="font-weight: 400;">In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices.</span></p> <p><span style="font-weight: 400;">Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart.</span></p> <p><span style="font-weight: 400;">At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations.</span> <span style="font-weight: 400;">Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle.</span></p> <p><span style="font-weight: 400;">Sonna has extensive experience in the heart failure medical device space. </span><span style= "font-weight: 400;">Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more.</span></p> <p><span style="font-weight: 400;">In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more.</span></p> <p><span style="font-weight: 400;">Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being.</span> <span style= "font-weight: 400;">I hope you enjoy my conversation with Sonna Patel-Raman. </span></