Navigating the maze of medical technology regulation: a solo voyage or a team effort?
Medical technology is a global business, generating annual revenues of over $400bn. The sector encompasses a broad range of technologies: from in-vitro diagnostics and diagnostic test equipment to medical devices that include toothbrushes, MRI scanners, orthopaedic joint replacements and drug delivery devices. It is also a sector characterized by high innovation: it attracts the largest number of applications to the European Patent Office of any technical field and more than the combined filings of pharmaceuticals and biotechnology.
However, all is not plain sailing. The publication in November 2018 of the Implant Files by the International Consortium of Investigative Journalists has caused reputational damage to the medical device industry, undermined patient confidence and prompted calls from many quarters for improved oversight and tighter control by regulatory authorities.
Given the public health impact of medical technology, it is no surprise that the industry is heavily regulated. A significant complicating factor is the diversity in global regulation faced by manufacturers. The US Food and Drug Administration has a dedicated unit overseeing medical device regulation, the Center for Devices and Radiological Health. In Europe, medical devices and companion diagnostics are regulated by national competent authorities with conformity assessments being conducted by approved notified bodies. However, certain medical device categories are assessed under European legislation by the European Medicines Agency.
Naturally, the two biggest global markets, the US and Europe, have different regulators that apply different rules. Together, these two markets represent around 70% of global medical device usage, the remaining countries introduce a plethora of different national requirements. With China set to become the second largest global medical technology market by 2020, the requirements of its National Medical Products Administration will undoubtedly become more prominent.
On top of regulatory requirements, the medical technology sector is also subject to international standards, such as EN ISO 13485: Medical devices – Quality management systems and EN ISO 14971 Risk management for medical devices. Supplementing these universal standards is a host of technical standards that apply to particular products and technologies.
Given the complexity of this environment, there have been some attempts to harmonize audit requirements, if not the rules themselves. Selected members of The International Medical Device Regulators Forum have introduced a single audit program (MDSAP) to assess the relevant requirements of participating authorities (Australia, Brazil, Canada, Japan and the US). A successful pilot was concluded in 2017 and a number of organizations have been authorized to conduct audits under the program.
Any company developing and manufacturing products in this sector faces a huge challenge: given the multitude of national and international regulations and standards, how should they comply with all necessary requirements, for all products, in all relevant markets? The answer, like the whole regulatory environment, is far from simple.
Each company designing processes for regulatory compliance will devote significant effort in deploying their own knowledge and experience. If multiple companies in the industry were to collaborate on designing effective and efficient regulatory compliance processes, then this broader knowledge base would deliver a more comprehensive output and the individual effort would be reduced. Moreover, the collective benefit would be enhanced for the participating companies while greater rewards could be delivered in terms of public health and for the multiple stakeholders in the industry: patients, health care professionals, health authorities and regulators.
Faced with the raft of current and emerging regulations and with possibly negative public perception, can the medical technology industry afford not to take the bold step of collaborating?