AUGUST 20248In My OpinionAnn Vu, SVP, Regulatory Affairs, Quality Assurance and Clinical, ZimVieByThe wisdom of Benjamin Franklin that "If you fail to plan, you plan to fail" still rings true in virtually every sector of business, especially in the highly regulated world of medical devices and healthcare.Within our industry, an all-too-common perception is that quality and regulatory processes are barriers to market entry. However, with foresight and proper planning, they can actually be strategic springboards to accelerate market expansion and product adoption. Balancing the need for regulatory compliance with the desire to access markets with high potential is essential for success.Most organizations historically began with either the U.S. or the EU as their `first' market entries. This was for two reasons--first, the opportunity. With literally millions of patients in each of these markets, both are definitely deep pools to begin commercialization. Additionally, the `rules' for getting into these markets were clear; in the U.S., the FDA pathways of 510(k) and PMA are relatively straightforward. But, with the 2017 ratification of the (EU) 2017/745 regulation by the European Parliament, (affectionately EUMDR) requiring more clinical evidence, the need for demonstrated clinical benefit, more data around biocompatibility and cleaning, and tighter requirements around what is or isn't a change, getting to market became increasingly difficult in Europe.In 2017, the World Health Organization (WHO) published a global regulatory framework for medical devices and in vitro diagnostics. This document was drafted and intended for regulators worldwide to develop harmonized considerations for the regulation of medical devices. Although the WHO does not regulate, nor do they provide oversight, there is a vested interest in ensuring that safe and effective medical devices are available for the benefit of patients around the world. At the time of the first data gathering, 62% of the participating countries had a legal framework for regulating devices. As of 2022, the WHO published its Global Medical Device Atlas, with 177 member countries participating and 82% now having a regulatory framework for bringing medical devices to their residents. This is quite a marked increase in expectations over a brief five-year period. With businesses desiring to expand globally, visibility into these additional markets must become an essential element of our design and development planning lifecycle.When considering market entry strategies, it's essential to identify regions with relatively low regulatory burdens while still maintaining adequate standards for safety and efficacy. Emerging markets in Asia, Latin America, and parts of Africa often offer more streamlined regulatory pathways compared to mature markets like the U.S. and EU. Countries such as India, Brazil, and China have established regulatory agencies that are actively working to harmonize their standards with SPEED TO MARKET: THE ROLE OF REGULATORY STRATEGY IN A GLOBAL APPROACHAnn Vu
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