Medical technology is constantly evolving, with innovative devices in 2023 offering groundbreaking solutions to improve patient care and outcomes. However, the journey from conceptualisation to market availability is not without its challenges.
Medical device development involves several stages, each marked by specific milestones and regulatory requirements. Pipeline products undergo a rigorous approval process that ensures safety, efficacy, and adherence to regulatory standards. There has been a push for streamlined regulatory pathways and improved collaboration between regulatory agencies and industry stakeholders in recent years, which was further catalysed by the COVID-19 pandemic. These efforts aim to expedite the approval process for devices that address unmet medical needs, particularly in fields such as digital health and personalised medicine.
How do regulatory agencies affect medical device approval times?
The time it takes for a pipeline product to obtain regulatory approval varies depending on factors such as the complexity of the device, the nature of the medical condition it addresses, and the efficiency of the regulatory process in different regions. In the US, the Food and Drug Administration (FDA) is responsible for regulating medical devices. In Europe, medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.
The FDA categorises medical devices into three classes based on their potential risks and regulatory controls, from low-risk class one to high-risk class three. Class one and two devices undergo a simpler regulatory process, such as a 510(k) clearance, which compares the device to a previously cleared predicate device.
Class three devices are high risk because they play a crucial role in sustaining or supporting life, including implantable devices such as pacemakers. They represent approximately 10% of medical devices regulated by the FDA and require more rigorous regulatory processes, meaning they have long approval times.
The EMA uses a similar classification system comprised of Class I, IIa, IIb, and III devices.
Medical device approval and AI
According to GlobalData, artificial intelligence (AI) is expected to become a key driver of medical device innovation in 2023. Alexander Murdoch, Medical Devices Analyst at GlobalData, states: “AI has the capacity to improve medical device manufacturing efficiency and reduce risk through machine learning (ML). Computers can take in huge amounts of data and are able to learn errors along the way.
“AI can also be used in hospitals and other healthcare facilities to provide an efficient experience for patients while also making room to treat more patients daily. Some AI platforms focus on automating and prioritising patient safety, and these platforms can help hospitals better manage their operational costs through tracking wait times, as well as reducing inpatient and emergency department length of stay.”
Over the past decade, the FDA has reviewed and authorised medical devices via processes such as 510(k) clearance or premarket approval (PMA) using machine learning. In fact, the FDA has published a list of AI/ML-enabled medical devices marketed in the US as a resource to the public about these devices and the agency’s work in this area.
Reducing approval times with experienced partners
For advanced class 3 medical devices such as pacemakers and continuous glucose monitors, medical device manufacturers will often need to work with external partners to find expertise specific to certain components.
Alleima is an international medical wire supplier that works with manufacturers from the design to the production stage. With extensive expertise and a global footprint, Alleima not only works with OEMs to produce medical wire that is perfectly calibrated to the application but also helps partners to navigate regulatory challenges and reduce approval times.
Alleima supplies a broad range of customised ultra-fine medical wire, offering its partners a “one-stop-shop” approach for their medical wire component needs. Utilising expertise in metallurgy, more than 200 alloys, and various customisations such as coiling and coatings, Alleima has worked with manufacturers to design and develop medical wire components for devices such as continuous glucose monitors, guidewires, and deep brain stimulation systems. For more information, visit the Alleima website.
