Clinical Researcher—February 2025 (Volume 39, Issue 1)
DEVICES TODAY
Edited by Gary W. Cramer, Managing Editor for ACRP
Late last year, a series of ACRP blogs on the various certification credentials offered through the Academy of Clinical Research Professionals concluded with a look at the ACRP-MDP for medical device professionals. As a follow-up to that blog, we are pleased to share feedback that we received recently on careers in the field and the state of the sector from Stacey Banks, MS, MBA, CCRC, ACRP-MDP, Director of the Clinical Research Support Office for Inova Health System in Virginia, and Danyel Carr, MS, CCRA, Senior Director of Clinical Affairs for Argon Medical in Texas.
Q: How did you become involved in medical device studies in a clinical research context? Was this your first area of work in the field or did you have other duties along the way?
Banks: I first became involved in medical device studies as a clinical research coordinator while working in our Heart & Vascular Institute. I had two device studies to start—one for an investigational ventricular assist device and one for an absorbable cardiac stent. I had previously worked in oncology drug studies for seven years. Luckily, that previous drug study experience meant I knew how to manage clinical trials, but I still had a big learning curve for devices.
Carr: After graduate school, my first full-time job was in the medical device sector as an in-house clinical research associate. Prior to this, I worked in the pharmaceutical industry handling data management for drug studies.
Q: In your opinion, what is the biggest modern challenge (or opportunity) for people wishing to get into the medical device side of the clinical research enterprise, and your best advice for those seeking employment in this area under current workforce conditions?
Banks: At a site, one of the biggest challenges is simply knowing who to connect with before you can start your study. When we start a study under an Investigational New Drug application, I only have to talk to the investigational pharmacist to get the drug added to our electronic medical record. However, when I start a device study, I have to connect with multiple people. I need to talk to supply chain, value analysis, chargemaster, billing reviewers, and sometimes more. The device needs to be entered in up to four different software programs. The best advice I give is to read and learn the country-specific device regulations where you will be doing research. Knowing the terminology and processes will make a huge difference, especially when the sponsor/contract research organization personnel start using unique device-related terms.
Carr: Although clinical research as a discipline is straightforward, it is important to understand that there are differences between device and drug studies. My best advice for someone seeking employment in the medical device sector is to familiarize themselves with the applicable regulations and guidance for this industry. For example, both types of studies follow Good Clinical Practice, but ICH E6 is specific to pharmaceutical studies whereas ISO 14155 is specific to drug studies.
Q: What should medical device professionals be looking out for (or most aware of) in terms of new industry and/or regulatory oversight expected in 2025?
Banks: I think we are about to see a proliferation of both software as a medical device, artificial intelligence (AI), and AI/machine learning–enabled medical devices. Software is always challenging for sites, who have their own information technology security concerns whenever outside software is installed on their networks. This will take significant pre-planning for sites to be able to start new trials in a timely manner. AI brings with it unique challenges related to the volume of patient data needed to feed the algorithms and allow them to improve. For example, a principal investigator (PI) at our site wanted to do a trial with an AI company that requested records on hundreds of thousands of unique patients. What happens if the AI company accidentally gets protected health information instead of fully redacted data? What happens if they have those data, but the business shuts down? All these are questions that must be considered at the highest levels of every organization, but the potential for these tools to improve medicine is enormous.
Carr: The new medical device regulation in the European Union is revolutionizing the industry by putting greater emphasis on clinical evidence to show safety and performance, so it’s critical to establish global clinical strategies early in the product lifecycle for obtaining the right data to support the device throughout its lifetime use.
Q: How would you characterize the main difference(s) between concentrating on medical device studies and on drug studies, and what kind of ideal skillset differences that entails?
Banks: Device studies take a different approach during the consenting process, because you can’t necessarily just turn off an implanted investigational device. Patients must be well educated about the intricacies of device trials. Medical device professionals need to be on the lookout for therapeutic misconception. I have too often seen investigators who think the investigational device is far superior to the approved products. I worry that their excitement will make potential participants think it is superior, even while the research into the device is ongoing.
Billing for medical devices can also be complex. In the United States, U.S. Food and Drug Administration category B devices can be billed to the patient/insurance, under some circumstances. This can make the institutional device set-up more challenging and can have a large impact on the financials of a given procedure. When devices are provided for free, coding adjustments often need to occur, as the cost of the device is usually built into the payment for the procedure. These and other scenarios must be considered prior to starting a trial.
Carr: A key difference between medical device and drug studies is understanding and differentiating between complications inherent to the disease state and those that are related to the device. The medical device professional must be able to understand and articulate the device failure modes that can lead to a hazardous situation for proper risk management.
Q: Is there anything else you would like our readers to know about work in the medical device studies arena and/or the benefits of being certified as an ACRP-MDP if you are?
Banks: With the growth of software and AI, the device world is in for major areas of growth in the coming years. We are already seeing large numbers of startups trying to get into this space, and this is a trend that will likely continue in the decades to come. Certification brings with it a stamp of knowledge. It doesn’t mean you know everything (for that you’d need a 1,000-question exam test), but it means you know the foundation of device trials and know where to look to find the information you need. Certification shows that you care enough about medical device research to study, learn, and retain the material needed to be successful.
Carr: Medical device studies have their own unique challenges and should not be assumed to be “just like drug studies.”
**ACRP**
