The FDA reacted quickly when the coronavirus reached the United States.
In a matter of weeks, the agency issued emergency testing methods and allowed certain types of machines to be used as ventilators. It also approved a new ventilator-splitting device that allows one ventilator to be used by multiple patients to address shortages.
Some of these changes could last even after the worst of the pandemic subsides, impacting the pharmaceutical and medical device industries for years to come.
Here’s a closer look at the biggest medical device trends we might see as a result of the coronavirus pandemic.
5 Medical Device Trends We Could See Soon
1. Faster Time to Approval
While the agency’s emergency testing initiative will likely expire with the public threat of COVID-19, there could be a lasting impact.
We’ll probably see a backlog in approval for other medical devices, as COVID-19 has slowed down trial activity. Many sponsors had to divert funds away from clinical trials because of the sharp decline in medical device sales related to the halt to elective procedures. Likewise, many sites had to pull research staff into clinical staffing or furlough research personnel altogether, leading to a sharp decline or abrupt end to enrollment of new subjects into clinical trials. To address the backlog, the FDA may still need to keep emergency measures in place for some time, even for devices and pharmaceuticals that aren’t related to COVID-19. It may also seek to remove some previously existing red tape.
2. Greater Acceptance of Remote Monitoring
In March, the FDA issued guidance for conducting clinical trials, including encouraging remote techniques as appropriate, both from a subject monitoring standpoint and a research trial monitoring standpoint. In a short time, sponsors and sites are realizing remote clinical research activities are not only possible; in some cases, they may even be preferable.
“The FDA recognizes that many clinical trials require study participants to visit a designated hospital, clinic, physician office, or other clinical trial location to receive investigational drugs or devices or undergo regular protocol-specific medical examinations to monitor various outcomes during the trial,” the agency stated in its guidance document. “For most studies, the protocol prescribes the timing, frequency, and manner of execution for these activities and requires that they are performed by clinical trial investigators or other appropriate team members.”
In April, the FDA issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand use, allowing health care providers to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate, and blood pressure.
“Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” said Amy Abernethy, the FDA’s principal deputy commissioner, in a statement. “This policy reflects the FDA’s commitment to ease burdens on health care providers and facilities as they face this public health emergency.”
During the pandemic, the FDA stated it is also willing to consider alternatives for the administration of investigational products that are normally administered by a healthcare provider, where appropriate, such as home nursing and use of non-study personnel.
Regardless of how the investigational product is provided to trial subjects, sponsors must ensure that study personnel follow regulatory requirements surrounding investigational product accountability, distribution, and documentation.
With regard to the oversight, or monitoring, of clinical trials, the novel coronavirus could be the tipping point that finally leads to remote clinical trial monitoring. The technology to allow for this has already been in place for years, and despite the long-held standard of the clinical research industry to conduct on-site monitoring visits, national regulations and international authorities have been encouraging the use of remote monitoring over the past decade. Nine years ago the FDA released a guidance document that prompts sponsors to tailor their monitoring plans to the specific needs of their trials, including the use of remote monitoring. Two international organizations that regulate clinical trials, ICH and ISO, have also accepted and encouraged the use of remote monitoring within their guidelines. This shift was in response to the growing number of clinical trials and their increasing complexity.
The industry has taken note and many sponsors are beginning to at least explore remote monitoring options as it becomes easier with the emergence of new technology. The use of technologies during the outbreak may speed exploration and use.
3. Using Telemedicine for Clinical Trial Participants
During the COVID-19 crisis, the FDA has encouraged the use of telemedicine, which it defines as conducting meetings and evaluations on the virtual platforms mandated by FDA protocol. With the public growing used to conducting healthcare visits via telemedicine platforms, telemedicine may come to the forefront of treatment.
Depending on the study design, subjects may not have to be seen in clinic or hospital settings, which may help improve compliance and capture better long-term data, while reducing the burden for subjects.
Other benefits may include reducing costs for studies that seek to recruit a large number of subjects and allowing more global populations to be studied.
During the pandemic, the FDA encourages the appropriate use of telemedicine platforms and virtual tools as alternative methods for site visits mandated by a clinical study. Sponsors do need to include adequate information to demonstrate that the telemedicine platform is appropriate for clinical research purposes, including appropriate access controls and the use of consumer-based mobile platforms available to consumers to link to the telemedicine platform, the agency states.
4. Changing Patient Recruitment Strategies
The FDA’s greater acceptance of remote monitoring could lead to more study participants being recruited via social media platforms.
Today, one in five sponsors uses social media to engage, recruit, and retain subjects for clinical trials, according to FDANews.
During the pandemic, the FDA outlined considerations to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize the risks to data integrity. This included considering alternative methods for patient communication.
Many sponsors are considering or actively seeking to change study protocols to allow for fewer onsite visits and more telemedicine or home visits, which can help reduce the risk of virus transmission.
As remote monitoring becomes more common, so could remote recruitment strategies.
5. More Remote Auditing
Similarly, more sponsors are opting to use remote auditing options for their internal study teams as well as their clinical trial sites. Trial Master File reviews are already being done remotely. This saves the time and costs of in-person reviews. Today, electronic TMF review is ideal for sponsors who are already familiar with the FDA’s auditing process and want an extra set of eyes on their documents. That use may expand as device makers realize the benefits and cost savings of a remote trial review. Even a remotely run “Practice FDA Inspection” has proven helpful for study teams who, due to the restrictions currently in place, cannot conduct in-person exercises to help prepare themselves. Running through the motions of an inspection, even remotely, can prepare study teams for the process that they will encounter during an actual inspection.
Staying Prepared for a Changing Future
It's clear the global crisis has changed the clinical trial, monitoring, and auditing measures for the short term. How many of these changes will become permanent remains to be seen.
IMARC continues to stay on top of emerging medical device trends and changing regulations. In these challenging times, we’re committed to helping medical device researchers keep their trials on track through in-person support and remote services, including remote monitoring, auditing, and data documentation.