Scientific Advice

CMTP provides scientific advice to device and diagnostics companies to assist them in refining their evidence development plans to efficiently produce the evidence needed to promote market access following FDA clearance/approval (if required).  The scientific advice process draws upon CMTP’s active working relationships with America’s Health Insurance Plans (AHIP), the Blue Cross Blue Shield Association (BCBSA), the FDA Center for Devices and Radiological Health (FDA/CDRH) and other national and regional health care organizations. 

The scientific advice process focuses on generating evidence needed by payers, health systems, hospitals, clinicians, and patients, starting early in the clinical development process. It generates specific recommendations for the design of clinical studies that will demonstrate the clinical or comparative effectiveness of medical devices and the clinical utility of diagnostic tests.   Depending on the specific nature of each technology, the evidence generation strategy will draw on the input of individuals from payers and other key decision makers, as well as others with relevant expertise in coverage and payment policy, health technology assessment, clinical care, and clinical research methods. 

Scientific advice is primarily intended for companies with products that are early in the clinical development process, as they develop studies intended for regulatory review (if required).  The advice may also be useful later in the clinical development process, though this may require the conduct of clinical studies in addition to those done for regulatory purposes.  By including the perspective of payers and a broad range of other stakeholders early on, the process is designed to produce studies with strong internal validity, direct relevance to key decision makers, and feasible to complete in a reasonable amount of time and at an acceptable cost.  The service is expected to result in a more efficient clinical development program, and not promote increased evidence demands from regulators or payers.