Regulatory requirements within the medical technology sector demand verified proof that products continue to perform effectively. But what does this mean in reality? Is the provision of proof a data management exercise or can the data collected from different sources actually be used to inform other business decisions?
As Medical Device Manufacturers are aware the MDR (2017/745) legislation coming into force next year includes the strengthening of post-market surveillance requirements. This means manufacturers of all medical device products will need to track and document the performance of their products. The aim of this part of the legislation is to help increase product safety and raise standards in the industry by having a common set of certification guidelines everyone can adhere to.
This means Medical Device Manufacturers must analyse all available data sources to have a fact based view of product safety and performance at product level across their portfolio. Failure to establish and operate effective post market surveillance and clinical evaluation processes is highly likely to increase the risk of potential revenue loss caused by withdrawal of product certification, exposure to class action litigation, and most importantly puts patient safety at risk.
To prevent these issues many Medical Device Manufacturers face a short term tactical imperative to make sure ongoing certification of their product portfolio is happening. A short term fix to meet post market surveillance reporting requirements is likely (over the next 12 months) to increase operational costs and bring to the fore resourcing challenges around the availability of highly skilled people who are required to understand, interpret and report on the data.
Those organisations maintaining manual processes may successfully meet short-term MDR challenges. However the capacity of their manual processes will always be constrained by the availability of suitably qualified resources. At Sopra Steria we have already seen several Medical Device Manufacturers evaluating short terms fixes to meet the legislation. Our view is MDR (2017/745) presents an opportunity to not only identify data sources and make sure of compliance with the legislation, but also utilise data to improve business operations.
For example, the establishment of scalable, automated processes based on appropriate technologies, as a foundational data backbone will be crucial to unlocking the value of data. This will enable organisations to satisfy ongoing regulatory and safety requirements. When coupled with an automated connection to master data sources and a common portal for access to product performance data, many manual data collection and analysis processes can be automated.
The obvious benefit here is existing people and resources can be made available to address the more complex compliance analysis and reporting workload and avoid significant short term increases in resource costs. The integration of business intelligence tools to identify performance trends and the use of document authoring and publication workflows can further reduce the post-market surveillance workload.
More efficient data and information management can lead to significant and measurable benefits including reduced errors and re-work, process automation and clearer ownership resulting better quality information and more efficient decision making. For MDR (2017/745) such processes can provide assurance that as external reporting obligations expand and the internal leveraging of newly available data sources and information increases, organisations will remain able to fulfil their compliance obligations whilst fully exploiting their data assets, information and insights to deliver business value.
As identified earlier in this short article the sourcing, collation, analysis and critical appraisal of structured and unstructured data from multiple sources necessary to maintain product certification will increase the breadth and depth of information available to Medical Device Manufacturers.
Yes, a short term fix may help Medical Device Manufacturers satisfy their regulatory reporting and patient safety requirements. But those organisations who take the time now to put in place the right tools, processes and technology partnerships will have a strategic opportunity open to them over the next 12 months and beyond when the legislation comes into force in May 2021.
Our Medical Device Manufacturing team at Sopra Steria have real world expertise of guiding organisations through the MDR journey, equipping the business with an effective, data driven solution to facilitate regulatory compliance whilst reducing the reporting burden associated with this type of legislation.
For more information on Sopra Steria compliance solutions for MDR please contact:
Global Account Manager