Even with one of the most stressful years behind us and COVID-19 vaccinations underway, some of the biggest healthcare and medical device stories will have a lasting impact on the clinical research community this year.
The most prominent example has been the speed with which more than a dozen companies have brought COVID-19 vaccines to Phase 3 testing. The FDA has now given emergency use authorization to two vaccines, one by Pfizer-BioNTech and one by Moderna.
In the meantime, we’ve also seen advances in the discovery, development, and application of new medical devices. Some of these devices have been the result of efforts to continue effective healthcare treatment in the midst of the pandemic.
Here are six stories we’re continuing to follow because of their potential to have widespread implications on clinical research and patient health.
6 Medical Device Stories To Watch
Medical devices related to COVID-19
Since the beginning of the COVID-19 pandemic in February 2020, the FDA has received over 5,000 requests for emergency use authorizations (EUAs) for medical devices, according to a statement by FDA Commissioner Stephen Hahn.
During this time, the FDA conducted more than 280 tests (an average of one per day) and ultimately granted EUAs for over 550 medical devices.
These included everything from blood purification devices and decontamination systems for personal protective equipment to respirators and remote monitoring devices. While this was in many ways good news for patients, physicians, and device manufacturers, the FDA continues to struggle to review a record number of submissions.
In his statement during a virtual meeting in October, Hahn said this strain was unsustainable. The meeting came six months after the FDA was scheduled to begin the process of reauthorizing the fifth round of its fees program for medical device submissions.
The new fee structure has not yet been set, but as the number of submissions continues to grow, it’s likely medical device manufacturers will see an increase in the costs of these fees.
Robots for spinal and other surgery
Surgical robots and their continued development are a good example of how medical device technology not directly related to COVID-19 sustained momentum through 2020. Orthopedic and spine specialists kept advancing robotic surgery systems, with Stryker, NuVasive, and Globus Medical reporting updates on both their pre-commercial and on-the-market medical device technology. Nor did predictions prove true that COVID-19 financial stress would postpone hospitals and health systems from moving into robots. Use of the Stryker Mako System for knee and hip replacements grew over the past year, for instance. As of September 2020, there were more than 1,000 systems installed globally and over 350,000 robotic-assisted surgeries have been performed, according to a release from the company. Future applications will be for spine and shoulder procedures.
Four major medical device companies — Medtronic, Globus Medical, Zimmer Biomet, and NuVasive, are also developing robotics systems for spinal surgery.
Medtronic acquired Mazor Robotics and launched the Mazor X Stealth Edition in 2019, which enables surgeons to create personalized 3D surgical plans and hold instruments in place during surgery.
Globus Medical’s Excelsius GPS includes a robotic arm with built-in navigation to improve the accuracy of screw placements. And Zimmer Biomet’s Rosa One Spine System is becoming more popular. Physicians who have used these systems have all reported high levels of accuracy, according to an analysis by Neurospine.
However, some robotics companies experienced delays due to the disruptions of COVID-19. NuVasive delayed the launch date of its Pulse platform for spinal surgery, anticipating FDA approval by this summer and the first use of its applications in 2022.
We expect to see the continued growth of existing robotic-assisted technologies and new ones emerging this year.
New roles for smartphones, wearable medical devices
The use of smartphones and other wearable medical devices to assist with patient monitoring and clinical research is another major device development we’ve been following for several years now. However, the potential continues to grow.
The Cleveland Clinic identified smartphone-connected pacemaker devices as its top medtech innovation for 2021. Medtronic introduced the first mobile app for a smartphone connected with a pacemaker. The MyCareLink Heart app takes the place of a patient's bedside monitor in sending data from the patient's pacemaker. It also enables the patient to see information about a device's batteries and if uploads have succeeded. Cleveland Clinic physicians see the potential of the pacemaker mobile app to improve remote patient monitoring and give patients a better understanding of their health.
Smartphones and wearable medical devices are giving patients direct access to powerful technology only available in doctors’ offices and hospitals until recently.
Examples include visual acuity assessments, optic disc visualization (ophthalmoscope), inner ear visualization (otoscope), lung function (spirometer), heart function (ECG), body sound analysis (stethoscope), and even sonography (ultrasound). Patients can now connect to these using an app or a wearable device.
These devices also have the potential to transform clinical research as we know it. They can make it easier to monitor patients remotely and automatically gather clinical data.
However, the use of these devices brings additional concerns related to cybersecurity, data management, and patient privacy.
Communications about cybersecurity
In October, the FDA proposed a new model for communicating cybersecurity vulnerabilities that can arise from the use of connected medical devices. Although the FDA is still seeking comments on its discussion paper, it demonstrates an important step in addressing these risks.
The paper outlines six considerations that should be part of a communications framework:
- Weighing risks and benefits
- Acknowledging what is not yet known
- Availability and accessibility of information
- The structure of the communications material
- How to achieve outreach and distribution
The document suggests that both the FDA and medical device industry are responsible for ensuring that the information about medical devices is easy for patients to find—raising issues related to mobile accessibility, language translation, and search engine optimization.
While this is just a proposal for discussion, medical device companies could see more formal guidelines or regulations later.
Trans-Atlantic collaboration on FDA and EMA regulation
The trans-Atlantic collaboration that began almost 20 years ago continued with a two-day meeting between officials from the European Commission (EC), European Medicine Agency (EMA), and the FDA in June. The groups set additional priorities related to the COVID-19 pandemic, but they also affirmed a broader collaboration under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The EMA stated it now works almost daily with the FDA to "better align and advance scientific and regulatory excellence worldwide." The meeting emphasized new opportunities to use data to support regulatory decisions.
Other potential collaborative projects include gene therapies for rare diseases and pediatric initiatives. There was also mutual recognition of agreement on good manufacturing-practice inspections.
Digital health technology
Digital health technology, another trend closely related to the challenges of COVID-19, proved its value even more in 2020. In effect, the pandemic is fast-tracking trends that have been gaining momentum for years. Healthcare professionals embraced telehealth and wearable devices to provide better care to patients at a higher risk of having complications related to the virus. One issue is home delivery of care or the "hospital at home" as older patients with chronic health issues require more help to sustain their quality of life. That is compounded by a shortage of healthcare workers.
Digital health technology improves the delivery of these services.
For instance, wearable devices such as connected pacemakers or commercial fitness trackers become even more innovative when integrated with internet platforms or sensors that capture biometric data. One implication is the need for interoperability of devices and platforms. A digital healthcare platform cannot reach the market without the expertise of different service providers of elements such as artificial intelligence, 5G connectivity, cloud applications, and Internet of Medical Things devices.
But there will be no true interoperability without standardized data collection, for example, or electronic record-keeping and communicating of biometric data. These are just a few of the issues that will make the concept, application, and marketing of digital medical devices an ongoing challenge in the coming year.
What this means for medical device manufacturers
Many of the top medical device stories that made the news in the past year will continue to dominate headlines in this coming one. Some could result in changes that impact the medical device approval process, while others will affect the larger competitive landscape.
The pace of innovation has never been faster, so it has never been more important for manufacturers, investigators, and others involved in medical device research to stay up to date on the latest trends. At IMARC Research, our mission is to help companies earn approval for their medical devices. Navigating that ever-evolving process requires knowledge of global regulations and standards, as well as team members trained in medical device monitoring, auditing, safety, and data management.
As a global medical device CRO, we have that expertise and a dedicated in-house team who can support your trial at any stage.
We are constantly learning and sharing new information about the latest medical device trends and regulatory updates that will affect the research community. For a closer look at the six emerging trends we expect to see in the coming year, download our whitepaper.