The medical device industry, like most industries, has felt the repercussions of the COVID-19 pandemic. Medical device teams have always had to face the “hurry up and wait” dynamics of moving complex diagnostic and therapeutic innovations through even more complex regulatory pathways. In many ways, COVID-19 has exacerbated these challenges.
It is no longer business as usual. In a recent Mednet survey, half (50%) of medical device respondents reported placing a study on hold due to COVID-19. And while respondents listed multiple reasons for the hold, 100% listed “sites weren’t able to perform elective procedures” as one of the reasons. This delay in elective procedures has impacted the entire medical device marketplace. Uncertain demand can potentially create supply chain disruptions. Elective procedures involving medical devices (think aesthetics and orthopedics) can potentially impact the research and development (R&D) side of the business as well as the commercial side.
Most medical device R&D teams (86%) reported making changes to ongoing clinical trials due to COVID-19. A renewed sense of urgency, coupled with constant innovation, is pushing teams to find new ways to support their patients remotely. COVID-19 has tested the resilience of these teams. They have responded with new operating models, new ways of managing remote trial data and new ways of interacting with site personnel.
The majority of respondents (71%) believe that COVID-19 will have a lasting impact on clinical trial design and conduct. These teams have stepped up and employed innovative approaches throughout the medical device R&D lifecycle. They have proven that different operating models can work and still deliver the quality and safety required in human trials. 100% of medical device respondents listed some aspect of technology as being helpful in better adapting to current and future dynamics brought about by COVID-19.
EU MDR and COVID-19
The pandemic has even impacted the implementation of the EU MDR (European Medical Device Regulation). On April 24, 2020, the European Parliament and the Council of the European Union, delayed the implementation date for the EU MDR. The official notice changed the implementation date from May 26, 2020 to May 26, 2021, citing the global pandemic as the reason for the change. Many companies were already deeply involved in efforts to ensure compliance with the new regulation. Though their efforts will still be relevant, the pressure of an impending deadline has lessened a bit.
As noted earlier, device manufacturers and diagnostic developers have always dealt with an array of complex processes, technologies, and regulatory pressures. Though the burden of implementing the EU MDR may have lessened, these same teams must accommodate the conflicting reopening schedules of numerous countries around the world. Each region has new restrictions for visiting patients and their care teams. These restrictions continue to change and evolve based on COVID-19 spread statistics.
New Constraints on Trial Interactions
Recently we have seen more countries impose travel bans to minimize the risk of COVID-19 spread. In the U.S., some states are trying to contain or limit travel to and from current hotspots. If patients can’t get to a site or are scared to visit a site, a trial delay occurs. Adding complexity to this scenario, some medical device sponsors themselves have enacted travel bans within their organizations. These restrictions mean that trials that require personnel on-site (e.g., sponsor team working with operating room (OR) teams in surgery) must be delayed until the travel bans are lifted. Regardless of whether the reason is fear of the pandemic, regional restrictions, or company policy, teams are communicating and completing more tasks remotely.
Learning from a Pandemic
Research teams in medical device companies have learned a great deal from the pandemic experience. It has opened new operational challenges as well as new opportunities. Research teams must maintain resilience and flexibility to continue their valuable research. The clinical technologies they use must support and enable these priorities.
Mednet’s comprehensive, cloud-based eClinical and electronic data capture (EDC) platform helps teams stay resilient and flexible by accommodating innovative trial designs, changing operations, and emerging requirements. It is built for success, for all study types and phases.