Turning a corner: The positives following a turbulent period for the medical device sector

Regular contributor Reece Armstrong looks for the positive repercussions in what turned out to be a challenging past year for the medical device sector.

When news that millions of patients across the globe had suffered serious side-effects due to medical devices, it seemed like a long time coming.

After all, stories on patients experiencing life-changing effects due to devices such as surgical mesh, contraceptives and pacemakers have been circulating for years.

The Implant Files highlighted the scale of the issue though and showed the regulatory cracks and loopholes through which ‘faulty’ or ‘poorly-tested’ devices have reached the market and ultimately patients.

If anything, the investigation highlights to the public the potential dangers that medical devices can bring with them. Public awareness over the safety of medtech products is inarguably important, especially when information regarding the risks posed by devices has been limited to both patients and doctors.

The response from the medtech industry was mixed, with certain groups such as the Advanced Medical Technology Association (AdvaMed) stating stories from the Implant Files “counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide.”

MedTech Europe took issue with the investigation’s view on how the industry works, iterating that “every day millions of people benefit from medical devices,” but that it has “always supported a regulation that better serves patients and provides a predictable, sustainable and appropriate regulatory environment.”

Perhaps then more of the blame should be directed at regulatory agencies including the Food and Drug Administration (FDA) and Europe’s notified bodies.

In particular, the FDA’s 510(k) process has come under strong criticism due to the way it can ‘fast-track’ medical devices to market on the basis of equivalence. This means that if a medical device manufacturer can demonstrate its device is as safe and effective as another predicate device already on the market, then it doesn’t have to undergo clinical trials.

Fortunately the FDA seems to have responded to criticisms regarding the 510(k) process and has announced new steps to ‘modernise’ the premarket programme.

Going forward, the FDA will introduce an alternative premarket approval system that aims to do away with the focus on predicate devices and will remove devices that are more than 10 years old as a basis for safety equivalence. The organisation believes that this alternative system will give patients and doctors a choice among older and newer versions of devices, and ensure that medtech products have adopted modern features that improve safety and performance.

Additionally, in 2019 the FDA hopes to finalise guidance on its alternative 510(k) pathway which will be based on safety and performance criteria. The FDA’s terminology is vague, pertaining to manufacturers of certain “well-understood” devices, but it essentially boils down to a set of guidelines through which predicates which will be based on to support new devices.

This new “Safety and Performance Based Pathway”, is being touted by the FDA as a transparent approach for classifying the safety and effectiveness of low to moderate risk devices.

In response to the modernised 510(k) pathway, president and CEO of AdvaMed, Scott Whitaker, said: “While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved, and we stand ready to work with FDA and all stakeholders toward the shared goal of enhancing the current review paradigm.”

Hopefully the medtech industry responds positively to the FDA’s new changes but what’s most important is that the regulatory updates benefit patients in the long run. So far, announcements made by the FDA in regard to post-market surveillance and women’s health products, including gynaecological surgical mesh, appear to be genuine in concern to the efficacy of these devices.

The medtech industry has always been a bastion for medical innovation but ignoring the global cry of patients threatens its very foundations. Let’s hope then that the Implant Files investigation represents a landmark moment for the regulation of medical devices all across the world.