- Intense scrutiny of medical devices by regulatory authorities (EU-MDR and FDA) increasing both in Europe and US.
- High quality data driven clinical research, ISO 14971 compliance and post-market surveillance and should bolster safety and mitigate risks.
- CAPA issues better addressed with more robust practices at manufacturing facilities.
Medical device makers have a critical social responsibility of consistently making sure they manufacture high quality devices that not only to pass the regulators’ stringent approval parameters, but also address the public health safety standards. To achieve the same, the design, development, pre and post marketing processes for each device maker has to be responsibly innovative to meet the changing guidelines of not just the regulators, but end user at large.
For device makers, the climb is uphill, quite significant. They cannot afford serious post marketing roadblocks like adverse events, field safety corrective actions (FSCAs) and device recalls.
Below, we discuss some key considerations device companies should evaluate in order to build more robust safety and risk management processes, including clinical research and post-market surveillance capabilities, best practices for product usability engineering and design as well as ISO 14971 compliance and related risk management approaches.
Regulatory challenges for device makers are not new. The EU-MDR, comes fully into force in May 2020. Post its introduction, CE Markings will go through a major overhaul. The FDA in the US introduces a major overhaul of its 510(k) premarket notification program that will cover more than approximately 75% of all medical devices sold in the united States. Such changes calls for rigorous process improvements on the manufacturers side to stay on the good books of the regulators. Companies with more well entrenched risk management practices will find themselves on a stronger footing when regulators introduce these changes fully.
ISO 14971 Compliance: Total adherence to ISO 14971 protocols is a must to demonstrate to the regulators the seriousness of the device makers. This is a global standard and companies complying with these standards not only score brownie points with the regulators but also gain a competitive advantage vis a vis market competition. Device manufacturing companies must ensure high quality manufacturing practices are in place to mitigate risks arising out of non-compliance.
Post-market surveillance: Once devices are launched, detailed reporting of post launch market reports of adverse events and FSCA’s are a must. Manufacturers will need to find the right processes and development methodologies to reduce the regulatory scrutiny at this most critical phase, which determine the true success or failure of a device.
Strong Clinical research: There is a strong regulatory focus on clinical data by both Food and Drug Administration and European Medical Devices Regulation. Getting device related clinical research data correct is non-negotiable. At the same time, clinical study and compliance regulations vary from one geography too another. There seems to be a strong case for partnering with capable Clinical Research Organizations who have the ability to help not only with different Clinical Research phases but also during post marketing surveillance.
Human factors design: To mitigate evolving regulatory requirements, companies have to incorporate proven usability (UX) expertise into their product design philosophy. Rigorous testing after incorporating design best practices while taking into consideration both device safety and aesthetics will go a long way in getting quick regulatory approvals and happy customers.
Online Connectivity and Cyber Security: Interconnected devices are a growing concern area for regulators and device makers both, particularly when certain devices deal with Electronic medical records and personal health databases of patients. Their vulnerability of cyber-attacks and data theft is high. Devices of the future will get ‘smarter’ with the application of artificial intelligence (AI) and machine learning tools increasingly being used by manufacturers to stay ahead of competition. Food and Drug Administration’s ANSI UL 2900-2-1 regulations have already started laying out the guidelines and this will be a key regulatory area in the future ahead.
Overall, exciting times ahead for the devices makers as new innovative products hit the market and new, more stringent regulations come in. Regulators, too, will have to be up to date with the evolving complexities as far as regulating the new ecosystem goes.