Build an Effective Global Regulatory Strategy

By Laura Elan, Linda M. Chatwin, Esq, RAC
January 30, 2017


• Categories: 05-Quality/Regulatory, Market Access, RC - Medtech Regulatory Resource Center

For medical device manufacturers, gaining access to multiple major markets is important for the success of the company, particularly when the product lines involve new or novel medical technologies. Rapid time to market is vital to secure a prime place in a rapidly evolving marketplace, as well as ensure the flow of much needed capital to pursue company goals.

Attend the Global Regulatory Strategy Conference, February 28–March 1, 2017 | Attend in-person in Washington, D.C. or virtually | LEARN MOREThe global regulatory landscape presents varied compliance issues, requirements, accepted test methods and standards, and clinical experiential factors. Navigating the maze of global requirements can be a daunting task, and requires a concerted effort at the project planning stage to make the best use of available company resources. Global differences in regulations and requirements typically result in a long and costly path to global regulatory approval.

Taking a strategic approach in achieving regulatory approval can be an effective tool in reducing the compliance burden facing medical device manufacturers. Manufacturers may find that first obtaining market clearance from the FDA for access to the U.S. market can result in leveraging documentation required for the prompt and efficient review of new device applications in other markets.

Global Medical Device Markets

According to the U.S. Department of Commerce, the medical device marketplace worldwide is expected to experience a 5% annual growth rate over the next few years. By the year 2020, the total market is expected to reach approximately $440 billion. The U.S. accounts for 45% of this market share. However, emerging markets, including Central and Eastern Europe, the Middle East and Africa are expected to grow even more rapidly as the marketplaces mature, and as access to medical care in these regions expands.¹

Factors that are expected to contribute to the growth in demand for medical devices include:

• Aging populations who will require more medical attention, where smaller and more portable devices will play a part in home healthcare use
• The rapidly increasing technologies incorporating wireless capabilities
• Upgrading legacy devices to newer technologies
• Personalized medicine and nanomedicine pushing the frontiers of medical care to more people

The expansion of the global medical device market will undoubtedly result in regulatory authorities increasing the complexity of the regulatory landscape. In fact, we have already seen the evidence of this over the past few years, as more standards, updated standards and additional guidance documents are published more often by the various regulatory agencies. A clear example of this thinking can be seen in the Medical Device Regulation and In Vitro Device Regulation currently being promulgated in the European Union (EU). These schemes are much more rigorous than the existing directives and place much greater emphasis on notified body responsibilities, as well as manufacturers, distributors and authorized representatives. As these schemes are strengthened, other countries that base their market access requirements on the ISO and CE scheme are expected to follow suit.

Developing a Regulatory Strategy

The increasing complexity of the global medical device marketplace directly translates into a greater burden on medical device manufacturers, especially when seeking market access across multiple marketplaces. Since small and medium-sized entities comprise the majority of companies in the medical device industry, the impact to costs and lead times can be significant. These companies often lack internal expertise to conduct appropriate market research or to navigate the regulatory maze.

In light of the expanding complexities to bring product to market, the importance of developing a comprehensive go-to-market strategy for a new medical device, or an expanded market area for existing medical devices, can readily be seen.

An effective strategy must contain a number of elements, including:

• Determining a cost/return on investment for anticipated market areas
• Perceived market demands
• Current competitive landscape
• Distribution methods
• Reimbursement strategies and policies
• Legal issues, including intellectual property protection
• Ability to leverage approvals gained in primary markets to extended markets
• Financial, professional and technical resources

Potential Benefits of First Gaining U.S. Market Clearance

As noted, the United States represents the largest single market for medical devices. Although FDA regulations applicable to medical devices are among the most stringent worldwide, devices that have received pre-market approval (PMA) or 510(k) clearance are likely to gain more rapid acceptance by regulatory authorities in a number of other countries. The documentation used to achieve these clearances then become the basis for technical files required in other jurisdictions.

Another benefit of reaching FDA approval or clearance is realized in there not being requirements to update the product documentation, approvals and clearances when standards are changed. There is no lifespan to these approvals/clearances such as there are in many other countries.

Potential Benefits of First Gaining CE Marking in Europe

Europe is currently the next largest economic opportunity for medical device markets. Through the CE scheme, companies have access to the various countries within Europe with the one CE requirement. There are some considerations to take into account, however: Brexit (where the UK has determined to leave the EU) leaves uncertainty regarding the on-going requirements for approval. And with the new Medical Device Regulation, there will be many more requirements on all the economic operators in the EU (Manufacturers, Distributors, Authorized Representatives, Notified Bodies, Competent Authorities). In addition to these issues, when standards are revised or updated, companies must meet the requirements in those updates for all products on the market rather than only newly introduced products.

However, some companies find that working with Notified Bodies to gain CE marking, or even self-certification where available, is a beneficial starting place from which to move to other countries for market approvals and clearances. The technical files that must be in place to avail the CE mark constitute a good share of the requirements for other countries’ regulatory schemes.

Leveraging Market Access outside the U.S.

Medical device manufacturers who have obtained U.S. or EU clearance for their medical devices can more easily consider seeking access to countries and jurisdictions where local laws or regulations provide for an abbreviated review and registration procedure for devices with these clearances. Further, underlying country-specific regulations applicable to medical devices typically reference internationally-accepted standards such as ISO 13485 for quality management systems (QMS), or other standards addressing product safety, labeling and other issues that have been harmonized across multiple countries.

Conclusion

For medical device manufacturers, the global acceptance of new and advanced medical devices requires a focused effort to obtain regulatory approval for their products in key target markets. Such an effort requires a detailed understanding of the regulatory requirements and the device approval process applicable in those markets, as well as a strategy that helps to leverage the work of each regulatory approval achieved in support of future device approval applications. An effective regulatory strategy can help device manufacturers achieve global acceptance more efficiently, bringing potentially life-saving devices to people around the world. Points in such a strategy can include:

• Develop a go-to-market strategy early. Developing a detailed strategy early in the product development process can identify the options offering the best return on investment while providing a roadmap for success.
• Study the regulatory compliance landscape. While there are many commonalities in the regulatory requirements applicable to medical devices in major jurisdictions, there are also important differences. Developing an in-depth understanding of the processes and requirements applicable to medical devices in selected target markets can help manufacturers to avoid delays and setbacks in the market plans.
• Strengthen the focus on quality. The implementation and maintenance of a robust quality management system is an essential requirement under nearly all regulatory approval schemes for medical devices.
• Implement formal documentation collection and retention systems. An effective document management system can eliminate duplication of effort and can facilitate timely responses to inquiries from regulatory authorities.
• Engage a knowledgeable advisor. There is no substitute for experience. A knowledgeable advisor or consultant with extensive medical device expertise and first-hand experience in dealing with regulatory authorities can quickly determine the requirements applicable to specific medical devices in key target markets.

Reference

1. “2016 Top Markets Report: Medical Devices,” U.S. Department of Commerce, International Trade Administration,” May 2016. Accessed December 12, 2016. Retrieved from http://trade.gov/topmarkets/pdf/Medical_Devices_Top_Markets_Report.pdf.