Digital transformation consultant Sopra Steria believes its solution will enable medical device manufacturers to rapidly improve internal process with the tightening of medical device regulations (MDR) fast approaching.
Research from Climedo Health has suggested that more than three quarters (77%) of medical device manufacturers consider the new regulation to be “very challenging,” and that as many as half are still using paper for clinical data collection.
The introduction of MDR (2017/745) will bring about stricter enforcement of standards for medical device manufacturers across Europe and a more transparent regulatory framework. It places increased responsibility on manufacturing companies to identify their products currently being used in the market and prove their effectiveness, provide evidence of product benefits and claims for each device, take action where performance falters and ensure post market processes are compliant.
Sopra Steria has worked with a medical device manufacturing company to help make them MDR (2017/745) compliant, helping them to achieve:
- 95% reduction in time spent searching for and retrieving information across disparate data sources
- Potential labour saving of 50+ people resources through the solution
- Improvement in the ability for all employees in the organisation to search, find, consolidate and analyse content quickly
- A single solution for all relevant clinical, scientific research & post-market surveillance data – making it easier to demonstrate compliance with MDR (2017/745)
- Replacement of manual processes with Google-style search and quick, easy access to data for employees who need access to this information
- Utilisation of machine learning capabilities to refine and enrich incoming content
Michelle Scarsbrook, head of manufacturing at Sopra Steria, said: “With MDR 2017/745 coming into force in May 2021 medical device manufacturers can no longer rely on excel spreadsheets and legacy technology systems to find, retrieve or extract data for regulatory reporting purposes. The old approach to finding data and managing information is manually intensive, resource heavy and takes a up a significant amount of budget. Instead medical device manufacturers need to put in place a robust plan, the right processes, and have access to data and analytics capabilities so they can meet this regulatory change and set their organisations up for future success.”
With less than year until MDR is live, there is an urgent need for clarity regarding the new requirements, as well as action surrounding the costs and resources. Sopra Steria believes organisations in this marketplace have a unique opportunity to make sure they have the data foundations in place to unlock a range of business benefits alongside the impending regulatory deadline.
Through Sopra Steria’s help, manufacturers should see this as an opportunity for change and not just another short-term regulatory headache that they have to deal with.
