Medical and health technology service provider IMed Consultancy has launched its free whitepaper on how post market surveillance (PMS) can benefit medical device manufacturers.
The whitepaper can be found here.
To better safeguard patient safety, regulators across the world are raising the bar on PMS. In particular, the updated requirements of new EU Medical Device Regulation 2017/745 (EU MDR) and EU In Vitro Diagnostics Regulation 2017/746 (EU IVDR) and the new PMS Statutory Instrument (SI) in the UK place a greater onus on the medical device manufacturer to perform more rigorous and extensive PMS.
The burden of providing clear and comprehensive information on the safety and use of their products — including labelling, design, technical features, composition, packaging and instructions for assembly, installation, use and maintenance is significant in terms of labour and documentation, though companies can also use it as an opportunity.
The new requirements should not be seen only as a box that needs to be ticked to achieve compliance, as PMS can yield huge strategic business potential. Specifically, PMS is key to monitor the safety and performance of a medical device throughout lifecycle, helping businesses avoid costly remediation and brand damage but it can also support companies to achieve commercial advantage by opening up to opportunities in geographies with similar requirements, identifying new uses, user demographics and more.
Thorough, ongoing PMS that spans the entire lifecycle of the product, should help identify emerging risk early, before it creates serious harm to patients but it can also help identify weaknesses in design leading to improvements that eventually make the device far more user friendly and competitive on the market. Gathering more extensive data is also key to substantiating claims, carrying out effective performance evaluations and potentially also to exploring new claims thus expanding the devices’ market.
From a more operational perspective a well-planned and consistently managed, cyclical process can help achieve huge efficiencies. Take for example literature searches: these can be optimised through scheduling of PMS in close succession to Clinical Evaluation Reporting (CER) or Performance Evaluation Reporting (PER). Similarly, intelligent use of AI can support (though not replace) Expert Authors and Evaluators.
Jonathan Ripley, Managing Director at IMed Consultancy, comments: “The evolution of PMS confirms that compliance can be a strategic opportunity. By adopting a comprehensive, cyclical approach to PMS, manufacturers can not only ensure patient safety but also streamline operations, enhance product development and explore new international markets.
“At IMed Consultancy we’ve long espoused this approach, where regulatory compliance is not just a tick of the box, but a strategic activity that reveals new opportunities for efficiency and growth. As regulations continue to evolve, the need for meticulous documentation, proactive risk management, collaboration and transparency across the supply chain increases. It is critical that medical device manufacturers are able to embrace these changes and leverage them to help fuel innovation, reactivity and market advantage.”
