Defining and demonstrating clinical benefits of diagnostic imaging
The prevalence of research into brain imaging modalities has solidified this practice into a relied-upon tool to provide information on a variety of neurological conditions. These devices are tools to not only see the structure of that once elusive yet fascinating part of the anatomy but to also guide treatments for nearly any neurological condition including epilepsy, stroke, cancer, and Parkinson’s disease to name a few.
When it comes to assessing these imaging devices and determining regulatory and market acceptability, the fundamental question is “do the benefits outweigh the risks?” This question is captured in both GSPRs 1 and 8 (state GSPRs) and rely on the clinical evaluation report (CER) to demonstrate compliance.
Intuitively, the answer is straightforward. Yes, of course we want a noninvasive method to see the brain. These pictures give us valuable insight into lesions, masses, and other structural anomalies under the surface. However, if you’ve ever submitted a CER to a notified body, you know that intuitive arguments don’t take you very far. We need to dig into the data, figure out a way to define benefits and risks, and provide evidence to justify the acceptability of the device.
Balancing Benefits and Risks in Medical Imaging Devices
Risk is generally the easier part to define, which is done by considering any potential harms to the patient. The most prevalent modern imaging techniques include MRI, CT- and PET-scans. While these methods are noninvasive, that doesn’t always equate to no risk. For example, some of these technologies emit radiation to both patient and user if precautions are not taken. Downstream cumulative effects of exposure can lead to very serious health risks, but are they acceptable considering the benefits of the technology?
Describing benefits of the device should be done with the perspective of the state of the art in medicine. What are the alternatives to the device under evaluation? If this device was not on the market, what other options do clinicians have to view the brain? Consider a glioma patient whose healthcare provider uses diffusion tensor imaging (DTI) to determine tumor grade. Without DTI, the clinician’s other options may be a standard MRI or CT-scan.
Communicating Value for Regulatory and Market Success
Since the device does not provide a direct therapeutic effect, this is where manufacturers get stuck. They find it difficult to put a finger on the benefits of a diagnostic imaging device. Clinical benefit, by definition, is the positive impact of a device on the health of an individual, expressed in terms of any of the following:
- a meaningful, measurable positive impact on the health of an individual
- a meaningful, measurable, patient-relevant diagnostic outcome(s),
- a positive impact on patient management
- a positive impact on public health
While DTI has no direct therapeutic benefit to the patient, we can highlight improvements in diagnostic outcomes and patient management that it provides.
- More accurate diagnosis (higher sensitivity and specificity) compared to traditional MRI and CT
- Less time to diagnosis compared to traditional MRI and CT
Given the appropriate comparator, these outcomes can be evaluated against the state of the art to understand the value of DTI and the latest imaging technologies in neurological diagnoses. The true value of these images is in the accurate information they provide aiding clinicians in providing the appropriate care and treatment for their patients. As manufacturers recognize and communicate the ways that these devices can aid in patient management, they pave the way for regulatory success and true evolution in healthcare.
Let’s Make Neurology Happen
If you’re navigating the complex regulatory landscape for neurological imaging devices, you’re not alone—and you don’t have to go it alone. At RQM+, our experts specialize in helping manufacturers define clinical benefits, assess risks, and craft compelling CERs that meet regulatory expectations. Whether you’re developing cutting-edge imaging technologies or refining existing devices, we’re here to support your journey to market success.
Looking for more neurology device advice? Join us on June 26th for our RQM+ Live! panel discussion, “Electric Brains & Regulatory Pains: Accelerate Neurology Innovation, Slash Risk, & Win Approval.” Gain practical insights from industry leaders and get your questions answered live. Contact us today to learn how we can help bring your neurological innovations to life—and don’t forget to register for the panel!
