Beyond reviewing and approving drugs, the FDA plays a pivotal role in overseeing and approving medical devices, a realm defined by its innovation, complexity, and diversity. This article aims to provide clarity on the multifaceted process of medical device development, with a focus on understanding the various stages and factors that contribute to the evolution of these innovative healthcare solutions.
In the evolving landscape of healthcare, the recent discussions sparked by the Inflation Reduction Act (IRA) drug negotiation provision have shed light not only on the transparency of drug prices but also on the broader considerations surrounding healthcare costs. In our recent blog post, we explored the intricacies of drug development costs.
Understanding Medical Device Classification
According to the World Health Organization, a medical device is any “instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.”
The FDA classifies medical devices into three categories, each associated with distinct levels of risk and regulatory requirements.
- Class 1 devices, such as oxygen masks, fall under general controls and do not require submission to the FDA before a manufacturer markets the product to the public.
- Class 2 devices, including x-rays and over-the-counter pregnancy tests, require both general controls and special controls like a 510(k)-submission proving a device is substantially equivalent (SE) to an existing class 1 or 2 device.
- Class 3 devices, like pacemakers and stents, require premarket approval due to their potential life-sustaining or life-supporting nature. Scientific evidence is used to determine if the device is safe and effective.
The Development Journey
The path to developing a medical device is a systematic process, starting with the discovery and conceptualization phase. During this initial stage, scientists meticulously identify unmet medical needs, seeking innovative solutions to address gaps in existing healthcare practices. This foundational phase sets the tone for the subsequent stages of development, as it lays the groundwork for creating a device that not only meets regulatory standards but also serves a meaningful purpose in the medical field.
Subsequent stages involve preclinical research and prototyping, paving the way for the FDA approval process. In the preclinical phase, scientists conduct extensive laboratory-based research to evaluate the feasibility, functionality, and safety of the proposed device. Prototyping follows, allowing for the creation of tangible models that can be tested in controlled settings. This process is crucial for refining the device's design, identifying potential challenges, and optimizing its performance before advancing to more extensive testing. The level of scrutiny and evidence required varies significantly between device classes.
FDA Approval Process
The FDA approval process is a pivotal stage in the journey of medical devices, delineated by distinct requirements for each device class. Class 1 devices, considered low-risk, may not necessitate FDA submission prior to market release. However, Class 2 devices, which pose higher risks, require a 510(k) submission. This submission ensures that the device is substantially equivalent to an existing legally marketed device with respect to safety and efficacy.
In contrast, Class 3 devices, characterized by their potential life-sustaining or life-supporting nature, mandate premarket approval. This stringent process involves a thorough evaluation of the device's safety and effectiveness through extensive clinical data and scientific evidence. The scrutiny applied to Class 3 devices makes the premarket approval process the most comprehensive and rigorous within the FDA's regulatory framework.
Post-market surveillance assumes paramount importance in the aftermath of approval to ensure the continued safety of medical devices in real-world scenarios. Monitoring the device's performance and addressing any emerging safety concerns or unexpected issues becomes a critical aspect of maintaining the overall integrity and safety of medical devices throughout their lifecycle in the market.
Certain exemptions within the medical device approval process aim to facilitate and expedite the journey for devices designed to address rare medical conditions. One notable exemption is the Humanitarian Device Exemption (HDE), a regulatory pathway established to streamline the approval process specifically for medical devices intended to diagnose or treat conditions that affect fewer than 4,000 individuals in the United States per year. This exemption acknowledges the unique challenges associated with developing devices for rare diseases, where the patient population is limited, and traditional regulatory requirements may not be practical.
Breakthrough Devices Program
The FDA’s Breakthrough Devices Program, aimed at facilitating the development of innovative and life-changing devices, provides a streamlined pathway for eligible devices. The medical device must “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” and meet at least one of the following criteria:
- Represent breakthrough technology
- Has no approved or cleared alternative exists
- Offer significant advantages over existing or cleared alternatives
- Availability is in the best interest of patients
Examples include Aveir DR Leadless System, DETOUR system, and REWALK P6.0. Despite the absence of IRA provisions for medical devices, the evolving pharmaceutical landscape may influence investment decisions for stakeholders in this field.
Cost Considerations
The cost of developing and submitting a medical device for approval varies widely between classes and manufacturer size. A small business can expect to pay ~$5,000 for a 510(k) review, whereas a larger manufacturer will pay ~$20,000. Additionally, all medical devices are required to pay an FDA annual registration fee of $7,000. FDA approval fees saw steep increases between 2022 and 2023, with a 56% increase in the 510(k) premarket fees and an 18% increase in the De Novo Classification and Premarket Approval fees. These large jumps in costs for drug approval could be contributing to the cost increases being seen in medical devices.
The cost of developing medical devices varies widely, with Class 3 devices costing between $25 million to $250 million, excluding capital costs and failed clinical studies. This is likely contributed by the extensive costs associated with maintaining a large-scale manufacturing process. When including capital costs and any failed clinical studies that may have occurred in the process, costs can reach up to $522 million.
The medical device market is continuing to grow and is expected to reach over $250 billion by 2029. Research, development, and FDA approval contribute to the high cost of bringing these life-saving technologies to market. The FDA’s dedication to streamlining their review process can help create an accessible market for small businesses and have a transformative impact on patient care. The rigorous approval process, classification criteria, and evolving programs like the Breakthrough Devices initiative collectively shape an environment where innovation can thrive. While the IRA does not directly impact the cost of medical devices, it is important for policymakers and manufacturers to consider the cost of development and the need for device accessibility in pricing decisions.
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