In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices.
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.
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.
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.
Sonna has extensive experience in the heart failure medical device space.
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.
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.
Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being.
I hope you enjoy my conversation with Sonna Patel-Raman.
Sponsors:
This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit https://www.slopeclinical.com/.
Resource and Links Mentioned:
University of Virginia – Biomedical Engineering Program
Food and Drug Administration (FDA)
Investigational Device Exemption (IDE)
Ventricular Assist Devices (VADs)
Abbott’s HeartMate LVAD Medical Device HeartMate
New York Heart Association Classification System (NYHA)
Transcatheter Mitral Valve Replacement (TMVR)
Transcatheter Aortic Valve Replacement (TAVR)
Contract/Clinical Research Organization (CRO)
Books and Literature Mentioned:
Show Notes:
- technical review of PMAs, IDE, 510ks
[3:18] Sonna Joins and Provides Background
- 20 years of experience in cardiovascular medicine
- Undergraduate degree in Chemical Engineering and a Ph.D. in Biomedical Engineering from University of Virginia
- First job out of graduate school was at the FDA focused on VADs (Ventricular Assistance Devices)
- Moved from FDA to consulting for a brief period before joining NuPulse
- Counterpulsation device for heart failure
- COO and then eventually CEO
[5:48] How Sonna Started Working with the FDA?
- Connection at a conference led to her first job at the FDA
- Sometimes making introductions at a conference is intimidating, but Sonna found in a chance meeting that they were looking for her exact skillset
- Conferences are a great opportunity to broaden your network
[7:04] Current Heart Failure Medical Product Landscape
- Heart failure is the most prevalent deadly disease across the US and the world
- $9 billion spending on treatment for it in the US annually
- Broadly is the issue of the heart being inefficient or effective at getting blood to the rest of the body
- Causes can be congenital, infection, or heart attack.
- Can be both muscular, electrical, or flow problem
- Can result from structural problems with the heart
- Huge market for valve devices
- Transcatheter aortic valves, mitral valves, tricuspid valves.
- New York Heart Association Classification System (NYHA)
- Simplest approach to stratifying patients cross the condition
- Somewhat subjectivity
- Each patient needs to be assessed individually to determine the heart disease cause
[13:40] Misunderstood Aspects of Heart Failure Products and Product Development
- Very hard to design device trials that meet the requirements for every single stakeholder
- FDA cares about size of trial, CMS cares about justifying the costs, and clinicians who want extensive amounts of data to drive adoption
- Investors care about patients but also bottom line of product development and value
- Companies are challenged with being in the center of all of this trying to design a study that meets everyone’s needs
[15:41] What is Best for Consumers vs What is best for FDA/CMS?
- Everyone wants what’s best for the patients in their own way
- The challenge is really on the patient delivery side of things
- How long it takes to get devices into the hands of clinicians to treat patients
- Always have to meet the basic criteria of safety and effectiveness to get approval/ clearance from the FDA
[17:52] FDA Career Experience and its Impact on How Sonna Thinks About Medical Product Development
- Valuable experience getting an understanding of what the FDA is looking for in clinical trials
- What are the reasonable endpoints, how many subjects should a trial have
- Nature of the FDA is you are going to be more risk averse in your assessment of research
- The FDA is very willing to interact. They want companies to reach out to them
[20:40] FDA Training Programs
- New reviewers are often trained up and paired with a mentor to help guide you through a product review
- Many process documents like SOPs and guidance documents to set you up
- Reviewing team comes from a diversity of backgrounds to make sure new products are assessed in a variety of ways
[22:36] Tips for Working with the FDA
- Transparency is most important
- You are telling a story through the collection and analysis of data when presenting to the FDA
- Bring all the information together and explain different aspects of the development research of the product
- Advisory panel meetings let you see public discussions of new devices
- Even when you fail a trial, the FDA may still be willing to have a serious conversation with the Sponsor
- Don’t walk away from the table just because you failed a particular study or test
- FDA is willing to work with you
[26:30] Sponsor Message: Veeva SiteVault (https://sites.veeva.com/.)
[27:44] Site Selection for Heart Failure Clinical Trials
- Site selection is a bit like dating
- You’re trying to meet as many investigators as possible. Present what you can bring to the site with the study. Be critical when assessing the site’s interest in the project
- Interest means they will likely be more committed to doing a good job
- Consider which sites (centers) have the patient population you want to recruit
- Sometimes top academic sites aren’t always the best recruiters
- Relationship building is key
[33:35] Protocol Development for Heart Failure Clinical Trials
- Look at past clinical trial designs that are similar to what you are developing
- Figure out the journal articles where your therapy or a competitive therapy has been discussed
- The intention isn’t to copy but instead to use these references as place to learn and start
- Review these ideas with key opinion leaders or investigators in the space to make sure your protocol is up to date
- Make sure to reference the most up to date treatment guidelines
[36:18] Origin of Clinical Guidelines for Heart Failure Trials
- Likely similar to standards development. These guidelines come out of committees of experts
- Involves the review of successful treatment practices across a large number of sites to identify what is working best for patients
[2:40] Patient Recruitment Challenges for Heart Failure Trials
- Important to consider where your patient fits into the care and referral process
- The care professional that uses the product on patients might not be the one that encounters them before treatment to recruit them for a study
- Your PI needs to be your greatest advocate for your product
- Is it because they’re the treating physician or is it because they’re the referring physician
[41:00] Concept of Heart Teams
- Most clinics have some version of a Heart Team
- Encompasses cardiothoracic surgeon, heart failure cardiologist, and other care team members
- Strong communication across these groups is really important
[42:51] Explaining Roles on a Heart Team
- Interventionalists/Surgeons: treat patients in catheterization lab
- Access vasculature through a small incision; catheter based approach
- Done without visualization. You don’t look inside the patient. Use imaging techniques instead
- Cardiothoracic Surgeon: treat patients in an operating room
- Cutting patient open and potentially implant a complex device
- Can visualize and see into the patient
[45:21] Revisiting Patient Recruitment Challenges
- Underrepresented patient populations across both gender and race
- Women need better representation in studies
[47:27] Sponsor Message: Slope Clinical (https://www.slopeclinical.com/.)
[48:33] Motivation for Working in at Startup like NuPulse
- Get to work with a really talented and tight knit team of people
- Opportunity to bring something new that is minimally invasive to the market is really exciting
- Actively fundraising to be able to get through commercialization in 2024
- Looking for a lead investor
[51:38] Finding the Best CRO
- CROs are similar to any external vendor
- Make sure someone within your organization has enough in house understanding to manage the vendor well
- Handing over work to a vendor doesn’t remove responsibility. You still need to manage the work the vendor is doing
- Clearly define who owns what in the relationship with the CRO
- Leverage experts in or outside your organization to make sure you are making the best selections
[55:15] Challenges Working in the Startup Space
- Can have Up’s and Down’s just like any organization
- Often times people are very committed to the goal of the organization unlike what you may see at larger companies
- Transparency regardless of company size is critical
- Risk exists in every kind of work environment; it’s just about the kind of risk you are comfortable with for your career
[58:46] Sonna’s Experience as a Woman in Leadership
- Very grateful for the people who have been willing to mentor or share connections
- Doesn’t always feel like she’s “in the club” of what a typical medical tech executive looks like
- Women are continuing to be more represented in leadership within medical tech companies but change takes time
[1:01:00] Sonna’s Recommended Resources
- FDA guidance documents & past publications on cardiology clinical trials
- Continue to always diversify your talent pool as you are growing your company
[1:04:17] Sponsor Message: Slope (https://www.slopeclinical.com/.)
Major Themes:
- Heart failure is a problem that affects a large population of people and treatment of it is very expensive. The causes of heart failure are multifaceted from muscular issues, electrical issues, or even blood flow issues; this adds to the complexity when trying to treat heart failure patients
- Transparency is critical when working with the FDA. It is important you always tell them the full story of your research including both successes and failures. Sharing your failures can be insightful and can help to determine if there is still a path to market
- Working in startups can be tremendously rewarding and attracts people that are passionate about the mission of the company
Quotes:
- “You can’t forget the most important stakeholder which is our patients who want to feel better and live longer and need data that are able to convince them of that.”
- “Don’t walk away from the table just because you’re nervous about having failed a particular study or a test.”
- “When you hand over a project, whether it is regulatory consulting, or site selection, for example, when you hand that over to a vendor, you still have to manage it.”
Audience Question:
Have you ever participated in or worked on a heart-failure clinical trial? What are some emerging heart-failure medical devices or therapies that you think are exciting?
