In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval. However, the landscape has shifted since the introduction of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Now, an increasing number of medical device companies are prioritizing the US market, the largest medical device market in the world.
The decision of where to launch first requires careful consideration. When deciding on an initial target market, medical device developers should begin with a thorough understanding of three key elements—their product, the regulatory landscape, and the market dynamics in the countries being contemplated for launch.
- Knowing the Product
Key product characteristics that should be considered include:
- Device classification. Identifying the appropriate risk classification for the device is critical, as classification will determine the level and type of evidence required to support regulatory submissions.
- Generally, the level of evidence required will increase with complexity. Devices with intricate technologies, such as AI algorithms or nanotechnology, may require specialized expertise for regulatory evaluation, which may extend review timelines.
- Underlying medical technology. Invasive technologies typically undergo more rigorous scrutiny than non-invasive ones and software-based medical devices may face different cybersecurity requirements compared to hardware-based devices. Devices that rely heavily on software may also require a robust plan for updates and patches, which can impact both regulatory clearance/approval and post-market surveillance.
- Degree of novelty. Innovative technologies may lack established regulatory pathways, requiring specialized expertise or customized approval processes.
- Therapeutic area. Certain indications may be more competitive than others and the degree of unmet medical need may vary.
- Materials used. It may be easier and less costly for biocompatible materials to meet safety requirements compared to novel, untested ones.
- If the device is designed to work in tandem with other medical technologies, it may face additional regulatory scrutiny to ensure compatibility and safety.
- Combination products. Products which integrate devices with drugs and/or biologics present unique regulatory challenges. The primary mode of action (PMOA) of the product—whether it is device-led or drug-led—determines the regulatory pathway. Most device-led products are regulated as medical devices but must also comply with relevant regulations for the pharmaceutical component.
- Understanding the Regulatory Landscape
Historically, the EU had a faster time-to-market for medical devices compared to the US. However, MDR and IVDR have increased the complexity of gaining a CE mark and made the process more unpredictable. In the US, the regulatory framework may be more structured and predictable, and for devices that qualify, Breakthrough Device Designation can expedite the review process and the time to market.It is also important to evaluate the clinical data requirements in each country or region under consideration. These requirements have become stricter in the EU under MDR and IVDR, especially for implantable and class III devices, and have always been rigorous for class III devices in the US. In general, the higher the risk class, the higher the quality and quantity of clinical data required for market clearance or approval. It may be helpful to gauge the robustness of the current clinical data and determine whether additional clinical studies are needed for either market. If they are, consider the associated costs and timelines to inform decision-making.Further, most countries require post-market surveillance and reporting to ensure continued device safety and efficacy. Device developers will need to ensure they have the infrastructure and processes in place to comply with these requirements.
- Factoring in Market Dynamics
Medical device markets vary not only in size, but also in ease of access and rate of adoption. To gauge the anticipated viability of the device in a target market, consider the following:
- Market size and growth. Determining the size and growth of the addressable market is critical for evaluating the commercial potential of the device or IVD.
- It is imperative to assess the level of competition in each region and to determine whether the device or IVD has unique or differentiating features that could give it an advantage in the market.
- Market preferences and needs. Healthcare practices, standard of care, cultural preferences, and patient needs may vary from country to country. Each of these factors can impact device adoption. Conducting market research may be useful for understanding the needs, preferences, and potential barriers to adoption in each region.
- Market access and reimbursement. In the EU, reimbursement strategies differ across member states and reimbursement must be negotiated with each country, amidst intense pricing pressure. The US reimbursement landscape is also complex, with a mix of public and private payers. For devices with Breakthrough Device Designation, the Medicare Coverage of Innovative Technology (MCIT) rule can facilitate faster reimbursement.
- Distribution channels and logistics. How will the device be commercialized? What distribution channels or partners are in place to help generate sales? If the device developer is not based in their target market, they will need an in-country authorized representative or agent. They will also need to consider local business requirements, including the potential need for a local office, and how these requirements affect speed to market.
Choosing a priority market for initial launch of a medical device is more than a regulatory decision. Understanding how their product will be viewed by clinicians, patients, and payers early in the development process will help device developers build layers of value into their devices, positioning the products for acceptance and adoption in their target markets.
To learn more about planning for success with a new medical device, read our Expert Guide: Building Flexibility into a Medical Device Launch Strategy.