From updates to the FDA’s 510(k) clearance pathway for medical devices in the US to the introduction of new MDR regulations in the EU, both national and international regulatory bodies are adapting to a digital age.
Many of these new rules are compensating for more complex and advanced medical devices, as well as responding to criticism of old requirements being inadequate or inefficient. The challenge for regulatory bodies comes down to finding a balance that ensures that products are safe and effective without slowing down time to market – especially for in-demand devices.
For medical device manufacturers, the ability to navigate these changes is the key to success.
Medtech approval rates: are we at the end of the lull?
According to GlobalData’s Pipeline Products database, there are more than 20,000 active medical devices currently in the pipeline, with approximately 41% of these in the early stages of development or pre-clinical development.
Large numbers of medical devices are developed each year, but only a few make it to the market. The FDA was forced to limit its traditional approvals to prioritise emergency authorisations for Covid diagnostics and devices in 2021, and early 2022 saw the lowest six-month total new approval devices since the first half of 2013. Fortunately, this is beginning to improve.
The region can have a significant impact on approval times, as regulatory requirements and device classification can greatly differ. Additionally, the process of obtaining approval is significantly longer for new technology than for devices that are similar to existing technology.
With these challenges in mind, GlobalData estimates that it takes approximately four to six years for devices to be approved.
Medical device classification
Quality control processes and approval times will differ depending on a medical device’s classification. A medical device manufacturer pursuing an international market will encounter challenges if their product is categorised differently in one region than another.
The FDA provides one example of medical device classification. These specifications split devices into three categories: Class I (products that present minimal potential for harm, such as bandages), Class II (examples include powered wheelchairs and some pregnancy test kits), and Class III (devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Pacemakers are a common device in this category).
While a device’s class will impact which regulations are relevant, all medical device manufacturer’s quality management systems must adhere to International Organization for Standardization (ISO) standards. ISO13485 is an internationally agreed upon set of requirements for a quality management system specific to medical devices, which specifies what an organisation needs to demonstrate its ability to provide medical devices and related services.
ISO13485 is designed for organisations that are involved in the design, production, installation, and servicing of medical devices. It can also be used by internal or external parties, such as certification bodies, to help with auditing.
Quality control for medical device components
For advanced medical devices such as pacemakers and continuous glucose monitors, OEMs will need to work with external partners to find expertise specific to certain components. One example is medical wire, which plays a vital role in sensing and transmitting patient data.
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 works with OEMs to produce medical wire that is perfectly calibrated to the application.,
Alleima’s wire-forming facilities in Italy, Switzerland and USA adhere to ISO 13485 and ISO 9001 (for quality management systems), as well as ISO 14001 and ISO 45001 for environmental management and occupational health/safety respectively.
To find out more about how Alleima can help with your medical device project, including its list of certifications, visit their website