According to the most recent KPMG/RAPS survey of 230 medical device manufacturers, 83% of respondents cited the clinical evaluation report (CER) requirements of the EU’s new Medical Device Regulation (MDR) as a challenge. While the 12-month delay to the date of application of the MDR provides invaluable breathing space for manufacturers to get in line with the revised post-marketing clinical follow-up (PMCF) and post-marketing surveillance (PMS) requirements, continued social distancing related to COVID-19 make data collection using traditional approaches more difficult.
This scenario provides the opportunity for renewed focus with the objective of exploiting the extra time to gain broader advantage. Because PMS/PMCF must comprise performance data from humans and must extend over the entire lifetime of devices, coupling these activities to product lifecycle management would produce strategic sales/marketing and growth benefits.
The generation of RWE, real world (clinical) evidence, is one approach that is gaining recognition. Regen Med’s inCytes™ platform allows delegation of remote data input to patients using any type of device, thereby overcoming historic hurdles, including data collection compliance by investigators as well as new barriers, such as COVID-19 social distancing. The capability to construct observational protocols using a combination of standard PROM’s and custom queries, to implement ad hoc scoring systems and to form Circles among multiple users, in addition to remote data entry by patients, has attracted numerous device manufacturers to Regen Med’s Solution.