How the CDC can Influence the Medical Innovation Pipeline

Medical Patents Broker Inc.
By Kenneth Pearce, President

The Centers for Disease Control and Prevention (CDC) can positively or negatively influence the movement of a medical invention to the patient. Authorization from the FDA and a CMS CPT code are two major pieces of the puzzle. However, the CDC can also dictate a market for biologics, diagnostics, pharmaceuticals, and preventative medical devices. When the CDC speaks, the medical invention industry listens.

CDC influences can include:

1. The ACIP Recommendation: The Billion-Dollar Valve for Biologics

For vaccines and complex biologics, the pipeline goes directly through a specific CDC panel: the Advisory Committee on Immunization Practices (ACIP).

When the FDA approves a new biologic or vaccine, it simply means it is safe and effective. It does not mean doctors will routinely prescribe it. Real-time commercial acceleration happens when the CDC’s ACIP officially adds that biologic to its recommended immunization schedules.

An ACIP recommendation is a financial catalyst for the owner of a vaccine. MPB’s attorney tells me that several federal laws require private insurance, Medicare, and Medicaid to cover the costs of recommended vaccines. There is no charge to the patient. For a pharma or biotech patent holder, a CDC recommendation instantly converts a niche innovation into a mass-market mandate. Of course, the public needs to be educated about the benefits of such a niche innovation to create that mass-market mandate.

2. Clinical Guidance Documents: Steering Medical Device Adoption

The CDC doesn't clear medical devices, but its clinical guidelines dictate how hospitals and clinicians utilize them. When the CDC issues or updates its clinical guidance protocols—such as standards for managing hospital-acquired infections or screening for emerging pathogens—healthcare administrators update their procurement playbooks according to those exact guidelines.

If your medical device addresses a clinical priority highlighted by a CDC guideline, it has an open door to increased use by the 6,000 plus US hospitals.

If it falls outside CDC priorities, however, it’s like trudging one foot after another through a flooded bottom. For most everyday hospital devices caught in this situation, it results in exhausting travel to all the hospitals just to make one sale at a time.

3. Advance Notice: CDC Epidemiological Data Fueling Manufacturers and Venture

The CDC is the premier data engine for disease prevalence, tracking everything from chronic conditions to infectious outbreaks. When the CDC publishes data identifying a rising public health trend or an underserved patient demographic, it frequently creates a cascade of “sooners” racing to the finish line.

The President’s Viewpoint

I am not an MBA, but from the moment of the 1960s “English Invasion,” I understood that it was a really big deal to be first to the market in a particular space. Like everything else, we never know what the next megahit medical invention will be until it happens.

Is your company using CDC guidance to develop the next billion-dollar market?