Why is Medical Device Regulatory Harmonization So Hard?

I was going to write something about public trust in artificial intelligence, but that will have to wait. Because, instead, I attended a very interesting panel discussion at Northeastern University this evening that got my mind thinking endlessly about harmonization and why it is so damn hard to do in medical device regulatory affairs. While I am still planning to discuss AI, I am now coming at it from a different perspective. And that perspective took me to broader issues beyond the regulation of AI. 

The panel discussion was an intriguing conversation about the history and future of governance in artificial intelligence led by faculty from the Center for International Affairs and World Cultures and the Institute of Experiential Robotics. During a wide ranging conversation, the panelists described some of the history and issues associated with governing AI, particularly those that have come to a head in the last decade. One of the panelists, Denise Garcia, talked about the need for an organization akin to the International Atomic Energy Agency (IAEA), whose mission is to govern atomic energy for the greater good, to govern AI technology at a global scale. In essence, there is a need for an international agency to govern the use of “AI For Good”. This makes sense when we think about how AI can be weaponized (is already being done so) or used to disenfranchise cultural groups, races, or any variety of community or individuals. The issue is recognized as urgent with potentially catastrophic global implications. Harmonization of standards, policies, and legal frameworks is a priority.

Meanwhile, in the global medical device sector, technology is advancing at breakneck speed to bring AI-driven medical devices to patients and practitioners. As such we are seeing a rapid increase in policy implementation and legislation all intended to govern the use of AI in medical devices - but without much harmonization. It’s not an issue of catastrophic global importance - but it is a global issue of great importance, particularly to patients. So, why is it so hard for global regulatory authorities to harmonize regulation of medical products? And why couldn’t we escalate the issue of AI-driven medical device governance to the level of requiring global regulatory authority cooperation?

We have a similar problem when it comes to harmonization of regulatory policy around real-world data (RWD) and real-world evidence (RWE). At the RAPS Convergence conference in Montreal last month, this issue was elegantly demonstrated by Heather Colvin in her talk about global RWE policy. There are now a patchwork of regulatory guidances and policies in the U.S., EU, Japan, South Korea, China, and Australia. The International Medical Device Regulators Forum (IMDRF) Patient Registries Working Group disseminated guidance in 2016 to help generate harmonization across national medical device registries, but registries are typically limited to specific therapeutic areas and are completely voluntary in the United States. Lack of harmonization among regulatory authorities around the requirements, data standards, submission expectations, and evidence requirements for RWD and RWE studies creates barriers and costs for the medical device industry, and limits the ability to use RWD to support market authorization of innovative medical devices. This lack of harmonization around the regulation of medical device RWD/RWE ultimately hurts patients. 

Another example is lack of harmonization for quality system regulations. Since 1997, the U.S. FDA Quality System Regulations (21 CFR 820) have been out of harmony with the international standard for quality systems, ISO 13485, creating two sets of quality system requirements for medical device manufacturers located in the U.S. or those who want to market their products here. Fast forward to today - over 25 years later - and word is we will get our harmonized Quality Management System Regulation (QMSR) in the U.S. by the end of this year. Similar issues exist with various classification schemes for medical devices across various regulatory jurisdictions. 

The reality is that harmonization is hard because governance, legislative, regulatory, and policy frameworks vary from one country to the next. There are decades of history, cultural norms and expectations, and existing legislation creating barriers to harmonization of global medical device regulation. But, that doesn’t mean it is impossible. U.S. FDA has a program for collaboration with other global regulatory agencies to strengthen regulatory systems and support global public health. In 2021, FDA released 10 guiding principles of GMLP in collaboration with Health Canada and  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The IMDRF is an important organization for promoting harmonization among its voluntary members.  But, even FDA has said “When finalized, IMDRF members adopt these documents where appropriate, and in some cases adapt them to meet the regulatory requirements of their jurisdictions.” While this is absolutely a worthwhile effort, the result of IMDRF collaboration isn’t really policy harmonization - it’s harmonization of good ideas that are then voluntarily implemented as policy within the existing governance framework of the members. 

Medical device regulatory harmonization will never rise to the level of need associated with the nuclear arms race or the threat of AI weaponization. But, I do believe lack of harmonization contributes to increases in the cost to develop and commercialize medical devices, contributes to health inequity, and prevents patients from gaining access to potentially life saving - or even life improving - medical technology. As medical device technology continues to increase in complexity, why not make the global regulation of these innovations more simple, less burdensome, and more transparent and predictable? Why does it have to be so hard?