13 March, 2019 by Linda Chatwin, Esq., RAC, Sr. Customer Solutions Consultant, Health Sciences Division UL
Gaining access to global markets is an important consideration for many medical device manufacturers. As technologies rapidly evolve, gaining the marketing authorizations is vital, particularly for new and novel devices. Often, gaining development and marketing capital depends upon a strong and well-built regulatory strategy.
Navigating the maze of global requirements can be excruciating. Many markets are rapidly expanding their regulatory requirements in an effort to match new medical technologies as they emerge, and to respond to regulatory concerns that have evolved in some of the world marketplaces. It has become necessary for regulators to carefully look at the entry requirements for devices to ensure that their citizenry is provided safe and effective devices.
Because of these factors, and to meet manufacturers’ competitive challenges, it becomes vital to look strategically at achieving regulatory approvals. Oftentimes, companies can use a market clearance in one major marketplace to help in gaining market clearance in others. For instance, preparation of a market clearance submission package for the U.S. Food and Drug Administration (FDA) will provide many of the materials needed for the technical documentation that now must be in place for the new European Union (EU) Medical Device Regulation (MDR) compliance. Achieving a quality System Certification to ISO 134585:2016 is a basis for clearance in other countries such as Canada and Australia and also forms a basis for Medical Device Single Audit Program (MDSAP) participation.
Global Medical Device Markets
According to SelectUSA, in a report prepared in collaboration with the International Trade Administration, the United States remains the largest medical device market in the world, with a market size of around $156 billion, and it represented about 40 percent of the global medical device market in 2017. U.S. exports of medical devices in key product categories identified by the Department of Commerce exceeded $41 billion in that year. The medical device marketplace worldwide is expected to experience a 5 percent annual growth rate over the next few years. By the year 2020, the total market is expected to reach approximately $440 billion.i While the U.S. commands this lead at present, other marketplaces are expected to grow, particularly emerging markets, as access to medical care in these regions expands.ii
The expansion of the global medical device market will undoubtedly result in continued regulatory complexity. 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. Clear examples of this thinking can be seen in the MDR and In Vitro Device Regulation (IVDR). Many companies are now rushing to begin their gap assessments and compliance to the vast requirements in these regulations. 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 mark scheme are expected to follow suit.
Developing a Regulatory Strategy
Enjoying this article? You may also enjoy this White Paper:
Top 5 Medical Device Industry Trends in 2019
Download Free White Paper
The factors enumerated above points to a burden on medical device manufacturers to effectively plan the marketplaces that they will enter and the order in which they will enter them. 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.
An effective strategy must contain a number of elements, refined to the markets the company desires to enter, including:
- Determining a cost/ROI 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 market clearances and approvals gained in primary markets to extended markets.
- Financial, professional and technical resources.
Therefore, a strategy plan should identify all the marketplaces of interest, the regulatory requirements in each, and the factors noted above for each market.
Potential Benefits of First Gaining U.S. Market Clearance
As noted, the United States represents the largest single market for medical devices. Devices that have received premarket approval (PMA), 510(k) clearance, or DeNovo designation are likely to gain more rapid acceptance by regulatory authorities in a number of other countries, particularly in emerging economies. Because the FDA recognizes a wide variety of international standards to support the safety and effectiveness determination of many devices, documentation used to achieve FDA clearance and approval can then become the basis for technical files required in other jurisdictions.
Another benefit of gaining clearance in the U.S. is realized by the fact that once a clearance is gained, it does not require renewal. Unlike some other jurisdictions, the FDA does not require companies to update their testing requirements and documentation when standards are updated, unless the company has made a significant change which requires an updated 510(k) clearance.
Potential Benefits of First Gaining CE Marking in Europe
Europe is currently the next largest economic opportunity for medical device markets. Through the CE mark 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 U.K. has determined to leave the EU) leaves uncertainty regarding the on-going requirements for approval. Also, consider the consequences of compliance to the new MDR and IVDR. We are seeing companies grapple with meeting the many added requirements, including those of manufacturers, distributors, authorized representatives, notified bodies and 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.
As with documentation prepared for FDA market entry, the technical documentation required for the CE mark constitutes 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. Companies should plan their market entrance plans based on their ability to meet economic challenges in getting products to market, and the regulatory strategy should identify the documentation and testing that will be required in each jurisdiction. By doing this, companies can plan the most efficient use of the economic resources available to them.
Global acceptance of medical devices requires regulatory approvals in a variety of schemes and contexts. The initial focus should be in key target markets, and then to leverage the documentation into other markets of interest. This, of course, requires a detailed understanding of the regulatory requirements and the device approval process applicable in those markets, as well as a well-constructed strategy plan that outlines activities, requirements and responsibilities. An effective regulatory strategy can help device manufacturers achieve global acceptance more efficiently, bringing their device technologies 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 ROI while providing a roadmap for success.
- Study the regulatory compliance landscape. There are commonalities in regulatory requirements, but also important differences. Knowing these can help manufacturers get to market in target areas sooner and in a more cost-effective manner.
- Utilize your document control system to manage the many items that will be collected, and will facilitate timely responses to inquiries from regulatory authorities.
- Engaging resources that are experienced in the nuances of gaining market clearances and leveraging the documents can provide valuable insights into the structure and implementation of the strategy plan.
i “Medical Technology Spotlight” https://www.selectusa.gov/medical-technology-industry-united-states
ii “2016 Top Markets Report: Medical Devices,” U.S. Department of Commerce, International Trade Administration,” May 2016. Web. 12 December 2016.
Linda Chatwin has been involved with regulated medical products for over 30 years. Through years of watching regulations evolve and change, she has gained a thorough understanding of the global regulatory maze required to bring products to market. Ms. Chatwin has obtained product approvals for a wide range of products and remains involved in changing requirements for medical devices worldwide. Her regulatory expertise includes U.S. FDA 510(k), 21 CFR Part 11; interoperability and cybersecurity issues; training for QSR, MDR, IVDR, risk management, RoHS and safety standards; writing protocols, obtaining IRB approval and providing oversight of clinical trial for pharmaceutical product development. Ms. Chatwin has navigated many FDA inspections and has negotiated favorable outcomes with the FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, product submissions and regulatory road mapping, in‐depth training on world‐wide regulatory requirements and quality system development and improvement.
She has spoken at a number of forums, including Regulatory Affairs Professional Society (RAPS), AdvaMed, various global industry associations and at a number of FDA public seminars. Ms. Chatwin is an attorney in the U.S. and holds a Regulatory Affairs Certification (RAC).