How to Navigate Global Regulatory Hurdles to Successfully Launch a Medical Device

The global market for medical devices is expanding and manufacturers have an opportunity to introduce novel technologies to patient communities around the world if they successfully navigate local authorities’ requirements for approval and commercialization. Getting a medical device into various global markets requires mapping out a strategy that involves regular touchpoints with a region’s regulators and payors to ensure standards are being met, developing pathways for patients to access medical devices, including coordinating reimbursement within healthcare systems, and being mindful of cultural considerations.

Launch location matters

One of the first considerations when launching a medical device is the obligation to prioritize areas with the greatest need to meet patients and surgeons where they live, rather than following a traditional route by consistently launching from the company’s home country.

Samsara Vision rolled out our the Smaller-Incision, New Generation Implantable Miniature Telescope (SING IMT®)¹, a novel intraocular telescope for people with late-stage, age-related macular degeneration (AMD) in the European Union (EU) largely because the large patient population is in need of solutions. According to a study in the British Journal of Ophthalmology², approximately 67 million people in the EU are affected by AMD and this number is expected to grow by 15 percent until 2050. Further, the National Center for Biotechnology Information (NCBI)³ predicts there will be 4.8 million people living with late stage AMD by 2040.

In the United States, as many as 11 million⁴ Americans are affected by some form of AMD and this number will increase to 22 million by 2050.⁵ Already, nearly two million⁶ Americans have advanced forms of AMD with associated vision loss. While treatments exist to try to slow the progression of AMD, and there are assistive devices that can help people with reduced vision see better with magnification, many patients will progress in their disease. With that in mind, the company launched the CONCERTO clinical study⁷, required to secure a supplemental Premarket Approval (sPMA) from the U.S. Food and Drug Administration. That trial is in progress with results expected in the near future.

Looking beyond the typical US and EU targets, we are also active in China, which has the largest population⁸ in the world with a growing aging population and the greatest number of people with AMD. Currently, there are 26 million people living in China⁹ with AMD, and six million have progressed to late-stage AMD. Yet, many manufacturers wait to invest in China, as it can be a difficult process to launch a medical device, requiring local support to navigate regulations. Samsara Vision decided to take the opposite approach to help the greatest number of people suffering from AMD, and recently completely the first¹⁰ surgery there.

Track market trends & competitors activity

Staying up to date on current market trends allows you to see what might be ahead, and pinpoint how your device can satisfy demand and solve an important need. Further, it is beneficial to know what your competitors are doing, and what their strengths and weaknesses are so you can differentiate your device.

Particularly in ophthalmology, we see significant resources dedicated to incremental improvements in existing technologies that address preventable blindness. However, when you only focus on improvement, rather than innovation, you leave behind patients who could benefit from new treatment approaches. In developing the SING IMT we targeted patients who have long been considered ‘non-preventably blind’, as many are relegated to their homes and isolated from life once their straight-ahead, central vision is compromised by AMD.

Regulatory compliance and standards

Knowing the ins and outs of international regulatory rules and standards is tricky, as each region or country will have its own standards. And these standards are constantly changing as medical device technology evolves, particularly with the introduction of remote patient monitoring, advanced software built into devices (including AI integration), and improvements in personalized implanted devices.

The International Medical Device Regulators Forum for more than twenty years has convened the Global Harmonization Task Force (GHTF) “to bring together experienced regulators and industry members on a regular basis in order to discuss ways in which medical device regulatory practices within their jurisdictions could be harmonized,” recognizing the need to smooth out commercialization of health breakthroughs across borders. One of their main goals¹¹ is to introduce “consistent application of regulatory principles and approaches and [to improve] regulatory-system effectiveness and efficiency,” to reduce duplication of activities country to country. Their 2021-2025 strategic plan¹² reaffirms these goals and their Medical Device Single Review Program (MDSRP)¹³, a project working towards “reducing unnecessary regulatory burdens on stakeholders while protecting health and safety of citizens and the environment,” is an example of cooperation between Canada, Brazil, the United States, Japan, and Australia. Similarly, the World Health Organization¹⁴ has tried to outline best practices for the evaluation and approval of medical devices.

However, their efforts do not remove the burden companies face learning and navigating discrete regulatory systems worldwide. Hence, it is critical to onboard experts and/or local partners who can dedicate their efforts to managing global approvals, conducting proactive reviews of clinical study designs, manufacturing, quality and more to avoid an external auditor citing future non-compliance issues.

Differences in global regulatory processes and standards vary country by country

When working to get approval in various countries and markets here are some guidelines mapped out by region to consider:

European Union

This area has a unique regulatory challenge due to its multi-country makeup. The EU’s Medical Device Regulation (MDR)¹⁵, which replaced the Medical Devices Directive, has significantly increased the requirements for clinical evidence and post-market surveillance. In the EU a CE mark is a label that indicates the product has been approved for patients in the European market and generally more quicky obtained¹⁶ provided that safety data is submitted.
Culturally, there are many different languages, requirements, and various healthcare systems and practices, making it necessary to have a localized strategy to enter the market and be in compliance after securing commercialization approval.

China

China is regulated by the National Medical Products Administration (NMPA)¹⁷, formerly the State Food and Drug Administration (SFDA), which requires rigorous clinical evaluation and testing, which often leads to local clinical trials.

Culturally it’s key to engage with local partners to understand the ins and outs of business etiquette in China. Samsara Vision is collaborating with Lansheng Medical¹⁸ “My Vision”, a China-based company focused on ophthalmology, to help execute the clinical program necessary for regulatory approval, commercialize the SING IMT, coordinate reimbursement, and drive sales, marketing, and customer relationships.

Canada

Canada has a similar regulatory system to that of the U.S. Their Medical Device License¹⁹ (MDL) process involves a review of safety and effectiveness evidence and can vary in complexity depending on the device’s class.

A recent review article²⁰ details the recent shift in Canada’s regulatory framework as a result of two forces – a concern over the rapid pace of technology and the more linear development of regulatory frameworks, and secondly the regulatory development on the post market side, as the goal is to create more transparency to ensure the safety and effectiveness of products in the real world.

Latin America

There are diverse regulatory structures in various Latin American countries. Asphalion²¹ reports efforts are in place to bring these disparate systems together, but individual counties still employ their own regulatory frameworks and requirements. In Brazil, the National Health Surveillance Agency (ANVISA)²² regulates medical devices. The regulatory process includes the need for Good Manufacturing Practice (GMP) certification and local testing for certain devices. Cultural considerations involve understanding Brazil’s complex tax system and the importance of local business relationships.

Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS)²³ oversees medical device regulation. Cultural aspects in Mexico include the significance of personal relationships in business dealings and the need for proficiency in the Spanish language. The approval process can be expedited for devices approved in the United States or Canada, highlighting the benefit of strategic regulatory planning.

Reimbursement systems and policies

Access to care and pricing strategies differ by country and may need to be adjusted to align with government or private insurance models. The relationship between manufacturers and future payers should start early in the process, to ensure the product has a higher chance of approval.

In the United States, our healthcare system includes a labyrinth of private and public payers who, in many ways, dictate how patients access care recommended by their physician. Given that our specific medical device is exclusively for an older adult population (65 years and older), Samsara Vision works directly with the Centers for Medicare & Medicaid Services (CMS). Our first-generation device secured FDA approval in 2010 and as we pursued that approval, we simultaneously worked to secure CMS coverage of the device, outpatient procedure, and require vision rehabilitation to make it accessible and affordable to patients and appealing to their health care team. As we are pursuing a sPMA in the United States for our second- generation device, our Medicare coverage will carry over. Notably, securing initial Medicare approval is a rigorous process²⁴ in that you have to work across different regions in the United States in absence of a national coverage decision window (which are infrequent) and, in some cases, create new codes for physicians. It can take years and tens of millions of dollars²⁵ to secure Medicare reimbursement, and we started early in the process. Delays in reimbursement delay care and inhibit company’s ability to earn their investment back, which dampens future innovation.

In the United Kingdom, their single payer National Health Service (NHS) system makes the UK an easier place to do business, especially when real world data for each patient is collected and stored centrally. The NHS reimbursement system pays for treatments and procedures using a simple coding system. More complicated is the EU in that one central authority approves medications and devices, but each country has its own payer system. For example, in Germany the German Institute for Hospital Remuneration (InEK) has granted NUB (Neue Untersuchungs- und Behandlungsmethoden) Status 1 reimbursement designation for the SING IMT.²⁶ The NUB process allows negotiations between participating hospitals and health insurance providers regarding supplemental reimbursement of new medical treatments with the potential to improve the standard of care for patients in Germany. In the EU, our device has been implanted in 17 countries and each country has its own reimbursement system, requiring significant investment in setting up relationships between providers and payers.

A final consideration: physician training

Another potential barrier can be physician uptake. It is key to identify and train surgeons to understand and know how to use your medical device effectively. For instance, Samsara Vision’s new device treats a disease located in the back of the eye, while the outpatient surgery required was originally designed for the physiology of the front of the eye (cataract surgery technique).

Looking ahead

There is immense opportunity to improve the quality of life of patients through innovative medical devices. But success lies in addressing and planning for global regulatory challenges to anticipate and effectively manage product launches and gain market access with fewer obstacles, ultimately helping patients wherever they may live.

Thomas Ruggia is the President and CEO of Samsara Vision

References

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