Supporting innovation through risk-based regulation

As a leader in global regulatory policy and intelligence at Roche Diagnostics, Danelle Miller understands the ripple effect of overregulation. When products are bundled together without regard to key differences in the risks they pose to patients, innovation will be slower to materialise.

That’s why, according to Miller, we’ve entered a pivotal time for policymakers and regulators in the EU, the U.S. and across the globe. “They have the power to enact new, risk-based policies that support diagnostic development rather than restrain it,” says Miller. “The solution lies in risk-based regulation.”

In other words, to sustain growth in diagnostics, patient risk is a noteworthy distinction when creating medical device regulation policies. Compared to other types of medical devices, in vitro diagnostics (IVDs) represents a category of medical devices with lower associated risks than others. Therefore, separate validation requirements for IVDs make sense – a notion we are seeing take flight today in the EU with similar perspectives emerging in the U.S.

How are IVDs different?

The differences among in vitro diagnostics and  medical devices
Medical devices vs IVDs

To understand how IVDs come with lower patient risk, consider two tools used for heart patients. One is an IVD test performed in a laboratory. It helps doctors diagnose heart failure by measuring the level of a specific protein in a routine sample of the patient’s blood. The second tool is a pacemaker, a medical device implanted in a patient’s chest to control an abnormal heartbeat. Both help doctors save or improve lives, but they are very different in terms of intended use and risk:

  • The IVD functions outside the body and provides information. Like most IVDs, it does not come into direct contact with the patient, nor does it provide any therapy. The risk associated with an IVD is in the intended purpose of the information it uncovers, not the direct effect of an intervention on a patient.
  • The pacemaker functions inside the body and provides therapy. It has a direct impact on patient outcomes and has risks associated with direct patient interventions. Unlike most IVDs, most medical devices do come into direct contact with patients (even if the intended purpose is diagnostic rather than therapeutic, as is sometimes the case). Therefore, risks associated with therapeutic medical devices include how well they perform on patients.

How will risk-based regulation matter?

Miller emphasises the link between regulation and innovation. She says longer life expectancies, aging populations and rising disease rates are driving high demand for new diagnostic capabilities worldwide. Reasonable, risk-based regulation will strengthen the future for IVDs, which doctors need to make better, more informed healthcare decisions.

"Fullfilling the promise of personalised healthcare starts with making accurate diagnosis for every patient", said Miller.

“As an industry, if we want to advance the world’s diagnostic capabilities, we need regulation that recognises the differences in patient risk among IVDs and other medical devices.”

All devices used in patient care need to be safe, reliable and appropriately validated. That fact is not in dispute. But, when we draft regulation policies that ignore differences in patient risk, we impose undue regulatory burdens on IVDs, ultimately delaying growth in the diagnostic industry.

The time has come to change that, Miller says, and the world is watching.